cyrilzakka/clinical-trials huggingface dataset:
COMMUNITY - the COVID-19 Immunity Study

The principal aim of the COMMUNITY study is to investigate immune responses following SARS-CoV-2 infection and/or vaccination in healthcare workers and hospitalized COVID-19 patients. The study aims to enroll a total of 5,000 healthcare workers and 500 COVID-19 patients. All participants are enrolled at Danderyd Hospital in Stockholm, Sweden. Participants will be followed every four months with blood and mucosal sampling in addition to demographic and clinical data provided by the participants and from national registries.

Primary outcome:

- Antibody responses in blood and mucosa following SARS-CoV-2 infection and/or vaccination

Secondary outcomes:

* Cellular immune responses following SARS-CoV-2 infection and/or vaccination
* Antibody responses in blood and mucosa following following Influenza A/B infection and/or vaccination
* Antibody responses in blood and mucosa following following RSV A/B infection

Blood and mucosal samples are collected every 4 months and at tighter intervals in sub studies. PCR testing is conducted upon symptoms of respiratory infections and with regular intervals regardless of symptomatology in sub studies. Participants provide detailed demographic and clinical data through a smart phone application-based questionnaire. Data on infection and vaccination history is collected from national registries

The COMMUNITY study is designed to longitudinally follow healthcare workers and recovered COVID-19 patients to assess SARS-CoV-2 immune responses over time. Follow-ups are conducted every four months, including serum, PBMC, and mucosa (saliva and nasal secretions) samples. Sub studies with additional samplings and PCR screenings are conducted with regular intervals to assess vaccine responses and correlates to protection against infection.

Analyses include:

* Quantification and characterization of antibody responses
* Evaluation of T and B-cell responses
* RT-qPCR detection of viral infection
* Mucosal microbiome evaluation

Clinical and demographic data, including information on hospital workplace, exposure, immunosuppressive treatments or conditions, and results from SARS-CoV-2 Rapid Diagnostic Tests, are collected at each follow-up through a smartphone-based app system. Data on SARS-CoV-2 infections and vaccinations are obtained from national registries. In addition, data from home based PCR-screenings are continuously being monitored for SARS-CoV-2, Influenza and RSV infections.

All samples are stored in Biobank Sweden.

Eligibility Criteria:
Inclusion Criteria:

* Health care workers: Employment at Danderyd hospital at time of enrollment
* COVID-19 patients: Admitted to Danderyd Hospital with confirmed SARS-CoV-2 infection at time of enrollment

Exclusion Criteria:

* No exclusion criteria
Transcatheter Aortic Valve Replacement Versu Surgical Aortix Valve Replacement for Treating Elderly Patients With Severe Aortic Stenosis and Small Aortic Annuli: A Prospective Randomized Study The VIVA Trial

To date, no formal, randomized, prospective, head-to-head comparisons of surgical aortic valve replacement (SAVR) versus transcatheter aortic valve replacement (TAVR) have been undertaken in the severe aortic stenosis (AS) population with small aortic annuli. Objectives of the present study are to compare the hemodynamic performance (incidence of severe PPM and ≥ moderate AR) and clinical outcomes (death, stroke, major or life threatening bleeding) between TAVR and SAVR in patients with severe AS and small aortic annuli.

This is a prospective, multicenter, randomized open-label trial including patients with severe AS and small aortic annulus (mean aortic annuli diameter ˂23mm and minimal diameter ≤21.5mm, evaluated by 3D-CT or 3D-TEE). Patients will be randomized in a 1:1 fashion to either TAVR or SAVR. The TAVR procedure will be performed with the ACURATE neo Aortic Valve, the Edwards SAPIEN 3 valve (20, 23 or 26mm) or the CoreValve Evolut R or Evolut PRO valve system (23 or 26 mm).New iterations of these valve models may also be included. The SAVR procedure will be performed using standard techniques, with no limitation in terms of type and size of the valve prosthesis or surgical procedure (e.g. enlargement of the aortic root). For both TAVR and SAVR, the choice of the type and size of valve, access route (for TAVR), utilization of additional procedures such as root enlargement will be left at the discretion of heart team of the site treating the patient.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥65 years-old diagnosed with severe AS (defined as: jet velocity ≥ 4.0 m/s or mean gradient ≥ 40 mmHg or velocity ratio \<0.25 AND aortic valve area ≤ 1.0 cm2 or aortic valve area index ≤ 0.6 cm2/m2; OR mean gradient \>30 mmHg AND aortic valve area ≤ 1.0 cm2 or aortic valve area index ≤ 0.6 cm2/m2 AND \>1200 Agatston units for women or \>2000 Agatston units for men as determined by non-contrast CT).
* Small aortic annulus defined as a mean aortic annulus diameters ˂23 mm and a minimal aortic annulus diameter of ≤21.5 mm as measured by 3D-computed tomography (CT) and/or 3D-transesophageal echocardiography (TEE).

Exclusion Criteria:

* Prohibitive surgical risk as determined by the Heart Team
* Porcelain aorta
* Aortic root dilatation \>45 mm
* Coronary artery disease (CAD) not treatable by percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG), or SYNTAX score \>32 (in the absence of prior revascularization) or severe left main disease
* Non-calcific aortic stenosis
* Severe mitral regurgitation
* Moderate-to-severe tricuspid regurgitation requiring surgical repair
* Prior surgical valve in aortic position
Preperitoneal Umbilical Mesh Area

The aim of this study is to measure the mesh shrinkage and the visualization of the mesh with MRI scan at 1 month and 13 months after robot assisted preperitoneal hernia repair using the visible CICAT mesh (Dynamesh®).

The study will be conducted in the department of surgery in het AZ Maria Middelares, Ghent, Belgium. Dr. Filip Muysoms will personally select and operate all patients eligible for this study. He will inform all patients about the surgery and the follow-up with MRI scan thereafter. Dr. Beckers will perform all MRI examinations of the patients at 1 month and 13 months post-operatively and will be available for questions from the patient.

We want to show that with this type of mesh it is possible to visualize the preperitoneal placed mesh in a safe manner. Furthermore, the positioning of the mesh, mesh shrinkage or mesh shifting will be monitored with this technique. This provides long-term benefit and provides early treatment possibilities in case of post-operative complications related to the mesh position.

Eligibility Criteria:
Inclusion Criteria:

* Primary umbilical hernias up to 2 cm
* Incisional hernias limited to zone M3 (EHS classification) and smaller than 2 cm

Exclusion Criteria:

* \<18 years
* Emergency surgery (incarcerated hernia)
* Clean-contaminated, contaminated or dirty procedures (according to the CDC classification)
* Lateral hernias
* Hernias close to the sternum or the pubic bone
* Hernias bigger than 2 cm in diameter.
* Hernias that need a component separation technique.
* Previous mesh repair on the midline
* ASA score\> 4
* Pregnancy
* No patient Informed Consent
* Life expectancy of less than 2years
* Contraindications for MRI
WAVE: AudioVisual Stimulation Enhances Cognitive, Mental and Physical Health in Elderly

The goal of this randomized controlled trial is to 1) carry out a screening of cognitive function, depressive symptoms, agility and functional balance and chronic inflammatory conditions in older adults; 2) analyze the influence of AVNS on cognitive function, depressive symptoms, agility and functional balance and chronic inflammatory conditions in older adults.

The main question it aims to answer is: "Does AVNS have influence on cognitive function, depressive symptoms, agility and functional balance and chronic inflammatory conditions in older adults ". Participants will be randomly assigned to a control group or to a intervention group, where they will use AVNS to see if influences the above mentioned outcomes, compared to the no intervention (control) group.

Mild Cognitive Impairment (MCI) can be defined as a pre-dementia symptom and, when associated with aging, characterizes individuals with cognitive decline below the level of dementia. This decline, which can begin as early as 45 years of age, leads to impairments in memory, learning, language, orientation, and executive functions, which are more visible from the sixth decade of life onwards, with a risk of reduced autonomy and independence, and is seen by researchers as the first stage of a process of loss. This loss is progressive, lasting several years and resulting in MCI, characterized by objective cognitive loss, which does not yet compromise autonomy but has a conversion rate to dementia of 10% per year. Cognitive decline can be accompanied by increased depressive symptoms and decreased functional capacity and is related to inflammatory conditions, described in the literature as "inflammaging". Studies with beat stimulation have shown benefits in different important outcomes of cognitive function and depression. Thus, audiovisual neurostimulation (AVNS) is a possible non-pharmacological treatment that might have a direct influence on the brain wave patterns, altered in MCI and depression, modulating these specific wave frequencies to functional patterns similar to those found in healthy individuals. Having this, it can also influence agility and functional balance and reduce chronic inflammatory conditions.

Eligibility Criteria:
Inclusion Criteria:

* Know how to read and write

Exclusion Criteria:

-
Augmented Reality Mobile Application for Glaucoma Education in the South Bronx

A team at the National Healthcare Group Eye Institute in Singapore have developed an augmented reality mobile phone application, EyeCU, to simulate glaucoma progression and enhance understanding about the disease and its course. It is a bilingual (English/Spanish) application that is free-to-download on the Android and Apple app store. As eye care physicians in the South Bronx, the investigators are hopeful that the findings in this study can be extrapolated to our patients in the South Bronx, where poor health literacy, non-adherence to glaucoma medication and poor follow-up remains a large barrier. The investigators hope that by offering the simulation in both English and Spanish, the investigators will not only be able to improve our patients' understanding of glaucoma, but also improve glaucoma treatment adherence and assess our patient population's responsiveness to augmented reality as an educational platform.

Experimental design: Pilot cohort study

Data collection: Patient characteristics such as age, sex, ethnicity, preferred language, zip code, employment status, highest educational attainment, current topical eye medications, Past Ocular History, Past Medical History

Recruitment for participation in the study will be performed during glaucoma clinic registration Consent will be conducted by a member of the research team who is not directly involved in the participant's clinical care Pre-intervention glaucoma knowledge questionnaire (NEHEP glaucoma knowledge questionnaire) will be given to participants, to be completed on dedicated clinic tablet device.

Post-intervention glaucoma knowledge questionnaire (NEHEP glaucoma knowledge questionnaire) will be given to participants, to be completed on dedicated clinic tablet device.

Rate of missed glaucoma follow-up appointments before and 6 months after application use will be collected from the electronic medical record.

Rate of medication adherence before and 6 months after application use will be collected from the electronic medical record.

Eligibility Criteria:
Inclusion Criteria:

- Patients with a clinical diagnosis of glaucoma on medical therapy for at least 4 months

Exclusion Criteria:

* Patients with optic neuropathies unrelated to glaucoma
* Patients with VA 20/100 or worse in both eyes
* Visual defects involving fixation in both eyes
* Patients with symptoms impairing ability to operate a smartphone during visit including diplopia, motor difficulties, cognitive impairment, illiteracy
* Patients who are unable to read or understand English or Spanish
Oral and Gut Microbiota Changes During Long-term Fasting in Humans

The aim of this longitudinal trial is to investigate the effects of a 10±3-day fasting period in 30 subjects. Changes in the oral and gut microbiota, halitosis, as well as inflammatory and antioxidative parameters and biomarkers of sulfur metabolism will be analysed.

Fasting has been linked with changes in gut microbiota as part of the physiological adaptation. Furthermore, associations have been described between oral disease and nutrition (diet rich in carbohydrates). The aim of the present longitudinal clinical study is to explore the effect of a 10±3-day fasting period on the oral and gut microbiota. 30 systemically healthy subjects attending the Buchinger Wilhelmi Clinics for fasting, will participate. Changes in oral microbiota will be assessed in plaque and saliva samples and a number of inflammatory markers will be analyzed in Gingival Crevicular fluid (GCF) and blood obtained before, during and after the fasting period. The changes in the oral microbiota will be associated to the composition of the gut microbiota. Changes in periodontal parameters and halitosis related to the fasting period will be further evaluated. Given the known association between sulfur metabolism and the redox status, parameters from the antioxidant status and oxidative damages will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Both subjects with periodontitis and healthy periodontium will be included.
* Signed informed consent

Exclusion Criteria:

* Not able to sign the informed consent
* diagnosticated with cachexia, anorexia, nervosa, advanced kidney, liver or cerebrovascular insufficiency
* Smoking
* the intake of antibiotics within the last 8 weeks, as well as the intake of probiotics within the last 4 weeks
* periodontal treatment in the last 6 months
* chronic manifest psychical and psychiatric diseases
* participation in another study
* pregnancy or breastfeeding
Responsiveness Index Versus the RASS Based Method for Adjusting Sedation in Critically Ill Patients

Systematic evaluation of pain, agitation and delirium in ICU-patients is recommended and deep sedation should be avoided. Sedation is still monitored with clinical assessments, like RASS. The Responsiveness Index (RI) is a recently described method for ICU sedation monitoring. It is based on processed frontal EMG and reflects the interaction between a patient's conscious state and the intensity and frequency of stimulations during treatment. RI has not been randomly compared to RASS to titrate sedation to target at a clinically adequate sedation state. In this open randomized controlled pilot study of 32 critically ill, mechanically ventilated adult patients, investigators will evaluate the feasibility, safety and efficacy of RI based sedation compared to standard RASS based titration of sedation. Investigators hypothesize first that RI controlled sedation will be safe and, second that RI controlled sedation will associate with increased number of ventilator free days alive in 30 days without excess adverse events.

Sedation of intensive care patients is needed for patient's safety but deep sedation is associated with adverse outcomes. Frontal electromyogram based Responsiveness Index (RI) aims to quantify patient's arousal. RI monitoring together with staff education may have potential to improve sedation quality. Investigators will evaluate the safety of RI based sedation versus standard care using Richmond Agitation-Sedation Scale (RASS) for sedation.

Methods: randomized study, critically ill adult patients with mechanical ventilation and administration of sedation to either RI- or RASS-guided sedation. Propofol (and midazolam combined with if needed) as a hypnotic drug and oxycodone as an analgesic drug. Investigators will follow standardized sedation protocol in both groups to achieve the predetermined target sedation level: either RI 40-80 (RI-group) or RASS -3-0 (RASS group). RI measurement is continuous in both groups, but blinded in the RASS group. Accordingly, RI group is blinded to RASS assessments. State Entropy (SE) will register in both groups.

Eligibility Criteria:
Inclusion Criteria:

* Intensive care patients
* Need of mechanical ventilation and sedation

Exclusion Criteria:

* contraindication to propofol or oxycodone
* hypoxic or traumatic brain injury
* intracranial hemorrhage
* status epilepticus
* drug overdose as admission diagnosis
Efficacy and Safety of IntraSPINE® Associated with Discectomy in the Treatment of Lumbar Disc Herniation.

IntraSPINE® is a novel device that, unlike interspinous positioned implants, is unique in being placed more anteriorly in an interlaminar position, closer to the normal center of rotation of the motion segment. Mechanical advantages are thus conferred over more posteriorly positioned devices through the possibility of more physiological 'rocking' type movements in flexion and extension . This enables IntraSPINE® to off-load the facet joints in extension without blocking movement. Having a more anteriorly placed fulcrum also helps control excessive flexion movements by virtue of an improved lever arm in conjunction with an intact posterior tension band.

The underlying hypothesis of this work is that a clinical gain is achieved by adding an IntraSPINE® interlaminar device to discectomy in patients suffering from a lumbar disc herniation. This should result in an improvement in incapacity level and a reduction in pain.


Eligibility Criteria:
Inclusion Criteria:

Disease-related criteria:

* single segment L4-L5 or L5-S1 lumbar disc hernia identified on imaging (lumbar spine MRI)
* median or posterolateral disc hernia.
* failure of correct medical treatment which has not provided lasting symptom relief absence of contraindications to surgical discectomy and implantation of the IntraSPINE®.

Population related criteria:

* subjects of either sex and over 18 years old
* who have given their free informed signed consent to participate in the study
* patients who are able to respond to the questionnaires and who can communicate in the language of the study country
* and who are affiliated to a social security system or have rights from a social security system.

Exclusion Criteria:

Disease-related criteria:

* recurrent disc hernia post-discectomy at any level
* foraminal and extra-foraminal disc hernia
* paralysing disc hernia (score of 3/5 or less) and cauda equina syndrome
* any grade of spondylolisthesis
* degenerative scoliosis ≥ 15°
* osteoporosis or Paget's disease
* BMI \> 30
* procedure required on more than one vertebral level
* endoscopic microdiscectomy prohibiting insertion of the IntraSPINE®
* chronic infection
* systemic or metabolic disorders
* active ongoing malignant disease (liable to prevent the study being conducted and does not carry a risk of vertebral lysis)
* occupational disorder responsible for the disease Treatment or device-related criteria
* allergy to any of the constituents of the medical device

Population-related criteria:

* past history of spinal procedure.
* withdrawal of consent
* pregnant women
* breast-feeding women
* participation in a clinical study within 3 months before the initial visit.
* drug addiction
* predictable lack of availability during the study. Patients deprived of their freedom or under legal guardianship.
Vitamin D Supplement Study for Adolescents

The purpose of this study is to determine if 14-19 year old African American adolescents are able to take a daily vitamin D supplement daily for about 4 months and how well a daily dose of 400 IU or 2000 IU vitamin D supplement raises their vitamin D blood level.

To determine the feasibility of African American teenagers taking a daily vitamin D supplement over a 4 month period in terms of compliance and practical implementation.

To determine the differences in response in blood 25-OH D level between those randomly assigned to taking a 400 IU supplement versus 2000 IU per day and to determine if there are differences in blood 25-OH D level response depending on subject gender and overweight/obese versus healthy-weight status.

Eligibility Criteria:
Inclusion Criteria:

* Healthy African American Adolescents

Exclusion Criteria:

* Hypertension
* Pregnancy
* Medications that affect study outcome measures
* Use of other vitamin and/or mineral supplement or herbal supplements
* Individuals of other races
To Evaluate the Safety and Efficacy of Remsima™ in Patients With Crohn's Disease (CD) or Ulcerative Colitis (UC)

An observational, prospective cohort study to evaluate the safety and efficacy of Remsima™ in patients with Crohn's disease (CD) or Ulcerative Colitis (UC)

This is a longitudinal, observational, prospective cohort study to assess the safety and efficacy of Remsima™ in patients with IBD, who have active Crohn's disease (CD), fistulizing Crohn's disease (CD), or Ulcerative Colitis (UC). Patients will be included in this registry who are receiving treatment with 5 mg/kg of Remsima™ by IV infusion at weeks 0, 2, 6, and every 8 weeks thereafter in accordance with the product label. If a patient has been treated with infliximab prior to enrollment, his or her dosing schedule will be continued appropriately. Patients will undergo safety and efficacy assessments in accordance with routine medical practice. The decision to treat with RemsimaTM will be independent of the decision to enroll the patient in this registry.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with moderate to severe active CD
* Children and adolescent patients, aged 6 to 17 years old with severe active CD
* Adult patients with fistulizing active CD
* Adult patients with moderate to severe active UC
* Female patients of childbearing potential who agree to use of adequate contraception to prevent pregnancy and continuation of contraceptive use for at least 6 months after their final dose of Remsima™.
* Patients (or legal guardian, if applicable) who are willing to give informed consent for long term follow-up including access to all medical records.

Exclusion Criteria:

* Patients with a history of hypersensitivity to infliximab
* Patients with a current or past history of chronic infection
* Patients with current diagnosis of Tuberculosis (TB) or severe or chronic infections (e.g. sepsis, abscesses, opportunistic infections, invasive fungal infections), or previously diagnosed with TB or severe or chronic infection, without sufficient documentation of complete resolution following treatment.
* Recent exposure to persons with active TB, or a positive test result for latent TB (determined by a positive interferon-γ release assay \[IGRA\] test, with a negative chest X-ray) at Screening
* Patients with moderate or severe heart failure (NYHA class III/IV).