cyrilzakka/clinical-trials huggingface dataset:
To Measure Pain Perception Following De-Epithelized Free Gingival Graft Harvesting

This randomized clinical comparative study will evaluate the postoperative pain following the FGG graft harvest procedure technique covered by four different methods for coverage of the palatal donor site.

This study will compare the application of :

* hemostatic collagen sponge
* collagen sponge sealed with abio-adhesive material
* Platelet rich fibrin
* physical barrier (stent) on the palatal donor sites with the purpose of which one of these will result in least postoperative pain after epithelialized gingival graft (EGG) harvesting.

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* At least 18 years old- 70 years old
* Must be a patient of the UAB Dental School
* Able to read and understand informed consent document
* Patients needing soft tissue graft with teeth that have miller class I or II recession (\>=2mm) on the facial aspects
* Presence of periodontally healthy teeth at the recipient site.
* Ability of the participants to maintain good oral hygiene
* Patient not pregnant or breastfeeding
* Not taking medications known to cause gingival enlargement

Exclusion Criteria:

* Non-English speaking
* Less than 18 years old, older than 70 years old
* Smokers/tobacco users
* Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing
* Patients that have severe gingival recession (Miller class III and IV) or \< 2 mm.
* Presence of periodontal disease at the recipient site.
* Poor oral hygiene
* Patient pregnant or breastfeeding
* Taking medications known to cause gingival enlargement
RuSsian RegisTry of Acute CoronaRy SyndromE TreAtMent and Approach in Dual Antiplatelet Therapy

This NIS is a multi-centre, observational, descriptive, cross-sectional study including all consecutive patients with Acute Coronary Syndrome (ACS) and a single-arm, prospective, longitudinal cohort study which will include patients hospitalized for ACS and who are with ticagrelor on discharge from hospital.


Eligibility Criteria:
Inclusion Criteria:

* Part A,B: Subjects whose data have been entered in the Russian ACS Registry
* PART A,B: Discharged from hospital after MI with ST-segment elevation (STEMI), MI NST segment elevation (NSTEMI) or Unstable angina. Hospitalized during 24 hours of ACS symptoms onset
* Part B: Patients on ticagrelor at the time of discharge from hospital

Exclusion Criteria:

* The existence of serious / severe concomitant diseases which can in the short term (i.e. within 6 months) limit the duration of life
* Current participation in a clinical trial with a non-licensed investigational medicinal product
Ultrasound Guided Rhomboid Intercostal Plane Block Versus Thoracic Erector Spinae Plane Block in Upper Abdominal Surgery

The aim of the work is to evaluate the analgesic efficacy of ultrasound guided rhomboid intercostal plane block versus ultrasound guided thoracic erector spinae block in patients undergoing upper abdominal surgery.

Abdominal surgery is one of the most definitive and mainstay treatment options for abdominal pathologies in clinical practice. Acute postoperative pain is a major challenge in the postoperative period.

The improved safety and efficacy that ultrasound brings to regional anesthesia helped promote its use and realize the benefits that regional anesthesia has over general anesthesia, such as decreased morbidity and mortality, superior postoperative analgesia, cost-effectiveness, decrease postoperative complications and an improved postoperative course .

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 21-65 years.
* Both gender.
* American Society of Anesthesiologists (ASA) classification I-II.
* Presented for elective upper abdominal surgery.

Exclusion Criteria:

* Patients refused to participate.
* Patients with known or suspected allergy to the used medication.
* Patients with preoperative chronic pain.
* Patients with major cardiac, renal, respiratory, or hepatic disease.
* Patients with potential risk of coagulopathy.
* Obese patients with body mass index (BMI) \>35.
Hepcidin as a Predictor for the IVI Mediated Increase in Haemoglobin Levels

The study is a multidisciplinary study, which involves all kind of medical specialties. Patients, who are scheduled for elective surgery, will be seen at a multidisciplinary anaesthesia/Patient Blood Management (PBM) clinic and screened for anaemia prior to surgery. Anaemic patients will eventually be treated with 500mg of iron isomaltoside.

Hgb levels, standard iron parameters and hepcidin will be assessed. Additional parameters that might influence Hgb or IVI levels will be documented.

All main analyses will be pre-defined in detail in a statistical analysis plan. In order to analyse the responsiveness to IVI, the change in Hgb levels from PBM clinic to day 0 will be analysed using multivariable regression models. The association of change in Hgb and hepcidin will be analysed adjusting for potentially confounding factors as age, gender or number of days from PBM clinic to surgery. The correlation of hepcidin and standard iron parameters will be assessed. Based on the increase in Hgb levels, responders to IVI will be defined. The definition of good- bad responder in terms of delta Hgb levels depends on the time between IVI substitution and surgery. ROC analyses will be performed and potential predictors (e.g. hepcidin, ferritin) will be compared concerning the area under the ROC curve (AUC).

Eligibility Criteria:
Inclusion Criteria:

* informed consent
* iron deficiency anemia
* elective surgery planned during the next 4 to 28 days

Exclusion Criteria:

* Contraindications for an IV iron Infusion severe infections, hepatocellular carcinoma, liver metastases, acute severe asthma, a simultaneous oral iron medication, another IV iron preparation, iron overload, chronic renal failure and regular IV iron substitution
* Pregnancy or lactation
* Allergy against iron
* chronic renal failure on dialysis
* iron overload
Pathogen Detection in HIV-infected Children With Non-malarial Febrile Illnesses Using Metagenomic Sequencing

In Uganda, 130,000 children (0-14 years of age) were living with HIV in 2018. Last year, nearly 450 infants acquired HIV every day; most of them during childbirth and these are at extremely high risk of dying in the first two years of life from treatable infections which present with fever. While fevers are commonly attributed to malaria, most fevers in African children are not due to malaria and clinicians are challenged by the similar clinical features of wide spectrum of potential aetiologies. The prevalence of treatable causes of non-malarial febrile illnesses in children in Africa has been reported to be 45%.

Rapid diagnostic tests (RDTs) for malaria have highlighted the decreasing proportion of malaria-attributable illness in endemic areas. Unfortunately, once malaria is excluded, there are few accessible diagnostic tools to guide the management of severe febrile illnesses in low-resource settings. RDTs for non-malarial tropical infections currently rely on detection of host antibodies against a single infectious agent yet their sensitivities and specificities are inherently limited. It should be noted that causes of non-malarial febrile illnesses (NMFIs) in HIV-infected children in Uganda remains scarce. There's minimal guidance on how to manage HIV-infected children with NMFIs. Thus, it is important that other causes of fever in African children be better characterized to facilitate optimization of diagnostic and therapeutic algorithms.

Considering these limitations, there is a pressing need for sensitive pathogen-detection-based approaches such as shotgun metagenomics sequencing (sMGS). Ultimately, in the near future, integration of whole-genome based approaches such as long-read sequencing technologies to tropical fevers is urgently needed to improve management of severe and treatable infections especially among the vulnerable groups such as HIV-infected children and adolescents presenting with NMFIs.

This project aims to utilise sMGS to characterize microbial pathogens in HIV-infected Ugandan children and adolescents admitted to Baylor College of Medicine Children's Foundation - Uganda with NMFIs and associated clinical presentations or comorbidities.

Eligibility Criteria:
Inclusion Criteria:

Study population will include a total of 200 (100 who are \<5 years and 100 who are 6-to-14 years, including equal number of female and male study participants) HIV-infected Ugandan children and adolescents admitted with non-malarial febrile illnesses (NMFIs) to Baylor College of Medicine Children's Foundation - Uganda.

Exclusion Criteria:

Critically ill patients will not be recruited.
Study of the Impact of Time of Vaccination on Response to Influenza Vaccine in Patients With Chronic Renal Failure - CHRONOVAX 2

Immune response to influenza vaccine in patients with chronic renal insufficiency.

Seasonal influenza vaccination is recommended for patients with chronic renal insufficiency, as influenza is responsible for significant morbidity and mortality in this immunocompromised population. However, the immune response to this vaccination is limited in this population.

There are currently no recommendations concerning the timing of influenza vaccine in the general population or in immunocompromised patients.

In this context, recent studies have shown that the time of vaccination can have an impact on vaccine efficacy. This is the case for BCG, influenza and COVID vaccinations.

On this basis, our main hypothesis is that the administration of influenza vaccine to patients with chronic kidney failure is more effective in the morning than in the evening.

Eligibility Criteria:
Inclusion Criteria:

* Chronic renal failure patient at stage 4 or 5 (i.e. estimated GFR \< 30mL/min/1.73m2); or Dialysis patient; or renal transplant patient regardless of GFR;
* Age ≥ 18 years;
* Indication for influenza vaccination;
* Express free and informed consent.

Exclusion Criteria:

* Known hypersensitivity to influenza vaccine or egg proteins;
* Previous influenza vaccination for the current season;
* Current infection;
* Current acute illness;
* Treatments with a major impact on vaccine response:
* Treatment of rejection within the previous 3 months;
* Renal transplantation with induction performed within the previous 6 months;
* Immunosuppressive treatment including CTLA4 agonist, complement inhibitor, anti-CD20;
* Treatments that may distort the serological response: Polyvalent immunoglobulin infusion within the preceding 3 months;
* Vulnerable persons (minors, adults under guardianship or trusteeship, persons deprived of their liberty, persons unable to speak French);
* Subjects not affiliated to Social Security.
Special Investigation (Long-term Investigation) in Patients With Crohn's Disease

This study of Humira will be conducted to obtain information on the safety (especially profile of malignant tumors and serious infections) and effectiveness in patients with Crohn's disease who are receiving Humira for a long period of time.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Crohn's disease indicated for Humira treatment with the recommended dosage regimen
* Patients with no past- or present malignant tumors
* Patients who are not currently receiving Humira

Exclusion Criteria:

* None.
Gastrointestinal Transit Times and Motility in Healthy Volunteers Obtained by Motilis-3D-transit

The purpose of this study is to describe gastrointestinal motility and transit times in healthy subjects by using Motilis 3D-Transit and to compare the total gastrointestinal transit time (GITT) to GITT obtained using radioopaque markers.

The investigators end points are to measure the transit times through different segments of the gastrointestinal canal,e.g. gastric emptying, small intestine, total GITT.

The study is descriptive and is designed to test and evaluate the usefulness of the Motilis 3D-Transit system. The investigators hypothesize, that with the system transit times through different segments of the gastrointestinal canal can be measured.

The design is made for evaluating the transit times, the inter-subject reproducibility and comparison with gold standard for colonic transit time measurement.

The investigators have chosen to include 20 healthy volunteers.The study is descriptive and therefore power calculation is not needed.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteer
* Signed informed consent obtained
* Fasted since midnight

Exclusion Criteria:

* Subject has known GI related symptoms complaints or GI diseases, including swallowing disorders
* Subject has cancer or other life threatening diseases or conditions
* Subject is pregnant
* Subject has undergone abdominal surgery
* Subject has abdominal diameter \>140cm?
* Drug abuse or alcoholism
* Subject's bowel movements are irregular
* Subject has known cardiovascular or pulmonary diseases
* Participation in any clinical study within the last 30 days
* Subject has cardiac pacemaker or infusion pump or any other implanted or portable electro-mechanical medical device.
* Subject takes any medication affecting GI motility
* Subject having MRI within the next four weeks
Evaluation of the Possible Relationship Between Preeclampsia and Periodontal Disease

The primary objective of the study is to assess the incidence and severity of the periodontal infection of patients with preeclampsia.

The secondary objective of the study is to analyze the relationship between preeclampsia and periodontal infection, using clinical, biochemical and microbiological methods.

Preeclampsia is identified as an important cause for mother and newborn mortality. Inspite of extensive research, the exact etiological relations have not been established.

Periodontal disease is a subclinical and persistent infection source which induces the systemic inflammatory reactions and increases the risk of preeclampsia. It is believed that the results will set light to the etiology of preeclampsia and will help to develop strategies to prevent the disease.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women with preeclampsia
* 37. weeks of pregnant women with no history of preterm labor

Exclusion Criteria:

* Genitourinary infection,
* pregnancy or pre-pregnancy hypertension,
* HIV infection,
* diabetes mellitus,
* multiple pregnancy, preterm labor / low birth weight,
* smoker and alcohol use history,
* IVF pregnancy,
* placental, cervical and uterine anomalies,
* pregnancy with intrauterine growth retardation,
* pregnancies with congenital or chromosomal fetal anomalies,
* significant vaginal bleeding,
* infertility stories,
* drug addicts,
* poor socioeconomic level
Role of Self-focused Attention in Depression

Using a task measuring the tracking of eye movements, the aim of this study is to demonstrate that individuals suffering from depression focus their attention more on their reflection in the screen after recalling a failure (and this all the more so as their depressive symptomatology is strong) .


Eligibility Criteria:
Inclusion Criteria:

* patients with depressive disorders according to the Diagnostic and statistical Manual of Mental Disorders (DSM-V) criteria
* Men or women, aged 18 to 60
* patients without mental impairment
* patients without neurological impairment (epilepsy, encephalopathy, head trauma)
* patients with a sufficient command of French
* free patients, without guardianship or curators or subordination
* patients benefiting from coverage by a social security scheme or benefiting from it through a third party in accordance with the French law on biomedical research
* obtaining oral non-objection by the patient after clear and honest information about the study
* Patient with normal or corrected vision without rigid contact lenses

Exclusion Criteria:

* patients with an intelligence quotient \< 70
* patients aged \< 18 years or \> 60 years
* patients with mental impairment
* patients with neurological impairment (epilepsy, encephalopathy, head trauma)
* patients who do not speak French well enough
* patients hospitalized under duress
* patients without social security
* Patient wearing rigid contact lenses
Proof of Concept of Model Based Cardiovascular Prediction

CARDIOPROOF is a proof-of-concept project that consolidates the outcomes of previous virtual physiological human (VPH) projects and checks the applicability and effectiveness of available predictive modelling and simulation tools, validating them in interrelated clinical trials conducted in three European centres of excellence in cardiac treatment (from Germany, Italy and the UK). CARDIOPROOF focuses on patients with aortic valve disease and aortic coarctation, which, if left untreated, can ensue irreversible heart failure. As a result treatment becomes mandatory, but optimum timing and the best type of treatment still remain difficult to determine. With more than 50.000 interventions per year within the EU, the diseases addressed by CARDIOPROOF have a significant socio-economic impact. Present clinical guidelines are highly complex and rely mostly on imaging diagnostics and clinical parameters, without benefiting, as yet, from patient-specific disease modelling based prediction. CARDIOPROOF goes beyond the current state of the art by conducting validation trials aimed at covering and comparing the complete spectrum of cardiovascular treatment, predicting the evolution of the disease and the immediate and mid-term outcome of treatment. Operational clustering is going to provide a seamless clinical solution that applies different modeling methods to realize the potential of personalised medicine taking into account user-friendliness as a key component of clinical usability. CARDIOPROOF's goal is to provide first-hand data on comparative cost-effectiveness and clinical efficacy of the most advanced VPH approaches compared to conventional diagnostics and treatment algorithms, thus accelerating the deployment of VPH methods in clinical environments, and bring to maturity holistic patient-specific computer-based predictive models and simulations.


Eligibility Criteria:
Inclusion Criteria:

* patients with the need for surgical or interventional treatment with Aortic Coarctation
* patients with the need for aortic valve disease surgery

  * both according to current treatment guidelines

Exclusion Criteria:

* contraindications for MRI
Effects of Watermelon or Low-fat Cookie Consumption on Wellness

The objective of the proposed research is to determine the effects of fresh watermelon consumption on physiological indicators of wellness regarding sexual, skin and gut health in adults.


Eligibility Criteria:
Inclusion Criteria:

* Generally healthy subjects
* BMI 20-40 kg/m2

Exclusion Criteria:

* Smoker
* Pregnant woman
* Required antibiotics use
* Required dietary supplement use
* Required medication of metabolic disorders, mental health and sexual health
* Allergy to watermelon or wheat
Adolescent Mental Health InSciEd Out

The study herein seeks to determine whether students undergoing InSciEd Out curriculum in mental health and addiction (called My Mind, My Body) experience changes in their mental health-related knowledge, attitudes, and help-seeking behavioral intentions. The research group hypothesizes that students undergoing InSciEd Out mental health and addiction curriculum will exhibit pre-post increases in mental health literacy, decreases in mental health stigmatization, and increases in mental health help-seeking behavioral intentions.

Integrated Science Education Outreach (InSciEd Out) is one novel program that seeks to promote scientific and health literacy through fostering scientific inquiry. The guiding premise of InSciEd Out's health promotion arm is a concept called Prescription Education (PE), which uses science education as a direct and early intervention for disease behaviors. The underlying hypothesis of InSciEd Out PE is that a student who lives a scientific experience in his or her own voice (undergoes true inquiry-based science) will be empowered to elect healthier behaviors in any targeted health paradigm. PE's proposed mechanism of change is that inquiry-based science catalyzes transitions from knowledge to understanding to attitudes to intents to actual behavioral change.

InSciEd Out partnership with the the school in this study began in Spring of 2013 with a projected health promotion arm targeting mental health and addiction. The current iteration of the partnership commenced in Summer of 2014 under the annual InSciEd Out summer internship. This internship led to creation of grades 7 and 8 curriculum in mental health and addiction. Version 1 of this curriculum was piloted last year. A revised version of the curriculum will be implemented in Spring of 2016. Although there are education-specific metrics for assessment already built into program evaluation of InSciEd Out, there are currently no clinically relevant inventories in place to specifically probe efficacy of the lesson plans upon key mental health outcomes.

The study herein is the establishment of clinically relevant inventories around implemented InSciEd Out curriculum in mental health and addiction (called My Mind, My Body). These inventories are selected to measure student changes in their mental health-related knowledge, attitudes, and help-seeking behavioral intentions. The research group hypothesizes that students undergoing InSciEd Out mental health and addiction curriculum will exhibit pre-post increases in mental health literacy, decreases in mental health stigmatization, and increases in mental health help-seeking behavioral intentions.

Eligibility Criteria:
Inclusion Criteria: Partner school students who do not opt out of and assent to the study

Exclusion Criteria: Partner school students opting out of or not assenting to the study
E-Bike Versus Classic Bike Intervention Trial

The effects of active commuting with an e-bike, as compared with a "classic" bike, on cardiorespiratory fitness and vascular health are largely unknown. To assess whether active commuting with an e-bike or a classic bike increases peak oxygen consumption (VO2peak) in untrained and overweight individuals.

Riding an electrically assisted bicycle (e-bike) is thought to be suitable to increase physical activity in daily life, to promote health, and to increase cardiorespiratory fitness in normal-weight individuals. The positive effect of commuting to work by a normal bike on cardiorespiratory fitness has been shown to be an important predictor of cardiovascular mortality in previous studies. We thought to improve maximal oxygen uptake by commuting to work by e-bike vs. classic bike. Besides cardiorespiratory fitness we assessed arterial stiffness as brachial-ankle pulse wave velocity as an independent predictor of cardiovascular events and all-cause mortality.

Eligibility Criteria:
Inclusion Criteria:

body mass index 25-35 kg/m2, and willingness to commute to work by e-bike or by normal bike at least 3 times per week with a one-way distance of ≥ 6 km.

Exclusion Criteria:

cycling as a leisure-time activity, active commuting to work or exercise training more than once per week within 4 weeks before the start of the study, uncontrolled cardiovascular diseases limiting cardiorespiratory fitness, stage II arterial hypertension (systolic blood pressure \> 160 mmHg, diastolic blood pressure \> 95 mmHg), renal diseases, uncontrolled diabetes mellitus (HbA1c \> 6.5%), or active malignancy or chemotherapy during the past 6 months.
Case Fatalities in Hospitalised COVID-19 Patients in the UK

This study will investigate how the case fatality in hospitalised patients with COVID-19 has changed throughout the pandemic. It will also explore possible mechanisms that could be driving these changes. This analysis will enhance our understanding of the virus, which will be important for researchers and clinicians to respond appropriately.


Eligibility Criteria:
Inclusion Criteria:

* All patients admitted with a proven or high likelihood of COVID-19