cyrilzakka/clinical-trials huggingface dataset:
Dual Epicardial Endocardial Persistent Atrial Fibrillation(AF) Study (Staged DEEP)

The purpose of this study is to assess the safety and technical feasibility of treating subjects with Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation in a minimally invasive thoracoscopic ablation procedure utilizing the AtriCure Bipolar System, with mapping and additional lesion creation/ gap closure (as needed) provided by currently approved catheter technology, when the epicardial and endocardial phases are performed in a staged manner within 1-10 days apart, during the same hospitalization.

The purpose of this clinical investigation is to evaluate how safe a less invasive cardiac surgery using the AtriCure Bipolar System in conjunction with a catheter ablation procedure performed approximately 1-10 days after, in treating atrial fibrillation, and how effective is this staged procedure. The AtriCure Bipolar System will be used to perform the less invasive cardiac surgery and a standard electrophysiology catheter, currently available, will be used to perform the catheter ablation procedure. This surgical procedure is considered less invasive because it is done through tiny surgical punctures on the sides of the chest near the ribs instead of one large surgical incision of the breast bone to completely open the chest and access the heart, and it also avoids the need for the heart-lung bypass machine.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 year
* Patients with symptomatic persistent or longstanding persistent AF refractory to a minimum of one Class I or III antiarrhythmic drug (AAD).
* Patients with failed catheter ablation attempts are eligible if the patients are symptomatic with persistent or longstanding persistent AF. (catheter ablation procedure must be more than 3 months prior to index procedure)
* Life expectancy of at least two years
* Patient will and able to provide informed consent
* Patient is willing and able to attend the scheduled follow-up visits

Exclusion Criteria:

* Prior Cardiothoracic Surgery
* Patient has NYHA (New York Heart Association) Class IV heart failure
* Evidence of underlying structural heart disease requiring surgical treatment
* Surgical procedure within the 30 days prior to the index procedure
* Ejection fraction \< 30%
* Measured left atrial diameter \> 6.0 cm
* Renal Failure
* Stroke within previous 6 months
* Known carotid artery stenosis greater than 80%
* Evidence of significant active infection or endocarditis
* Pregnant woman or women desiring to become pregnant in the next 24 months
* Presence of thrombus in the left atrium determined by echocardiography
* History of blood dyscrasia
* Contraindication to anticoagulation, based on Investigator's opinion
* Mural thrombus or tumor
* Moderate to Severe COPD
Effect of Apidra Compared to Humalog in Decreasing Post-Prandial Hyperglycemia

This study aims to compare the post-meal blood glucose values of two drugs in a "real-world" setting.

This is a randomized, open-label trial that aims to compare the glycemic excursion following food intake following post-meal injection of Glulisine (Apidra) insulin and Lispro (Humalog) insulin in a real-world setting. Children participating in the Florida Camp for Children and Youth with Diabetes will be randomized to receive either Glulisine or Apidra to cover carbohydrates after meals. The difference in blood glucose values will be analyzed before and 2 hours after meals to see if there is a difference in post-prandial hyperglycemia between groups.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 1 Diabetes
* Children and Youth attending Florida Diabetes Camp in DeLand, FL

Exclusion Criteria:

* only campers participating in sessions I and II are eligible to participate
Using Survey to Explore Perceptions of Adults With Low Socioeconomic Status Regarding the NutriQuébec Study

Populations with low socioeconomic status (SES) are more likely to develop diseases across lifespan and are frequently underrepresented in large cohort studies. The aim of this study is to examine beliefs, preferences and concerns towards participating in an e-cohort prospective study on nutrition (NutriQuébec) among this population.

A cross-sectional survey will be completed by 418 adults in the Province of Québec (Canada), including individuals with low SES (high school or less and gross annual household income \< $55,000 canadian). The survey is based on the Theory of Planned Behaviour and assesses intention to participate in NutriQuébec as well as attitude, subjective norm, and perceived behavioural control. The survey also assesses preferences regarding the recruitment.

A cross-sectional survey will be completed by 418 participants from several administrative regions of Québec (Canada). A special effort will be made to recruit men and women with low socioeconomic status (SES), but without rejecting adults from middle/high SES. First, 325 adults from low SES (high school or less and gross annual household income \< $55,000 canadian) and from several administrative regions of Québec will be identified by a survey firm. In addition, an e-mail mailing list from the Institute of Nutrition and Functional Food (INAF, Laval University) will be used to distribute the recruitment ad to complete our sample (n=93 from all SES).

The survey is based on the Theory of Planned Behaviour and assesses intention to participate in NutriQuébec as well as attitude, subjective norm, and perceived behavioural control. The salient beliefs underlying the determinants of individual's intention to participate in the NutriQuébec study most frequently cited in the focus groups (from a preliminary elicitation study: 2018-042 A-1/18-05-2018) were used to develop the survey questions. The survey also assesses the preferences regarding the recruitment. Sociodemographic questions are also asked.

Eligibility Criteria:
Inclusion Criteria:

* Adult (18 years of age or older)
* Living in the province of Québec
* Have access to the Internet and have an active email address
* Be able to answer questionnaires in French

Exclusion Criteria:

* None
Evaluating the Role of Neuroinflammation in Low Back Pain

In this research, the study team will use brain imaging to evaluate the presence of neuroinflammation in the brains and spinal cords of patients with low back pain. The efficacy of minocycline use for low back pain treatment will also be evaluated by observing whether short-term minocycline administration will reduce neuroinflammation and low back pain symptoms.

The goal of this research study is to evaluate whether the central nervous systems of those with low back pain are different from those of healthy, pain-free individuals. Specifically, the researchers will test whether "glial cells" (the immune cells of the brain and spinal cord) are more active in patients with low back pain than in healthy volunteers. The investigators' previous study showed that patients with chronic low back pain demonstrated elevations in brain levels of the 18kDa translocator protein (TSPO), a marker of glial activation.

To test this hypothesis, the study team will image the brains and spinal cords of patients suffering from low back pain using integrated magnetic resonance- positron emission tomography (MR-PET), and a radiotracer called \[11C\]PBR28, which tracks levels of glial activation.

The efficacy of minocycline as a treatment for chronic low back pain will also be evaluated. A recent study demonstrated a statistically significant reduction in pain in those with lumbar radiculopathy after treatment with minocycline, leading the investigators of this study to believe that minocycline may have potential efficacy in treating other back pain populations.

The study team will observe whether a short course of minocycline hydrochloride may reduce glial activation along with self-reported low back pain symptoms. To this end, patients will be evaluated clinically and/or re-scanned after completing a 2-week trial of minocycline or placebo (a sugar pill).

This study will be enrolling individuals who have been suffering from sub-acute (short-term) and chronic low back pain.

Eligibility Criteria:
Inclusion Criteria:

* the ability to give written informed consent
* fluency in English
* on a stable pain treatment
* Chronic or sub-acute low back pain

Exclusion Criteria:

* no interventional pain procedures during drug trial
* contraindications to MRI and PET scanning (including presence of a cardiac pacemaker or pacemaker wires, metallic particles in the body, vascular clips in the head or previous neurosurgery, prosthetic heart valves, claustrophobia)
* pregnancy or breast feeding
* any use of recreational drugs in the past 6 months
* allergy to minocycline or other tetracyclines, or taking medications known to interact with minocycline
* any other contraindications to minocycline administration
Assessment of the Accuracy of Surgical Guide Designed From Dental Model Optical Scan Versus Impression Inversion With Markers Techniques in Computer Guided Implantology. Randomized Clinical Trial.

Dental model cast accuracy can be affected by many variables as tray material, impression material and time elapsed before pouring the impression. All these factors would affect the accuracy of the surgical guide

Impression inversion with markers technique avoids the dimension changes that may happen from pouring of the dental model cast. Also it saves time as no need for optical scan of the model cast and for scan appliance even in cases of multiple restoration. Adding markers to impression tray ensures an accurate merge even if the patient has restored dentition that may cause scatter during the CT/CBCT scan.

This study will is for Assessment of the Accuracy of Surgical Guide designed from Dental Model Optical Scan versus Impression Inversion with Markers techniques in Computer Guided Implantology.


Eligibility Criteria:
Inclusion Criteria:

1. Partially Edentulous patients seeking for dental implants
2. Patients with Bucco-lingual bone thickness more than 6 mm allowing flapless implant placement.
3. Medically free patients.

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   Exclusion Criteria:

1- Patients with thin ridges. 2- Patients with systemic disease that may affect bone quality. 3- Patients with poor oral hygiene and active periodontal diseases. 4- Anatomical situations requiring regenerative procedure. 5- Completely edentulous patient 6-Patient with limited mouth opening

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Inflammatory Genetic Polymorphism and Acute Lung Injury After Cardiac Surgery

Acute lung injury is a common complication of cardiac surgery with cardiopulmonary bypass, and it is significantly related to prolonged postoperative recovery, hospital stays and medical cost. Currently available predictors of acute lung injury after cardiac surgery are still limited within clinical data. Several genetic polymorphism of inflammatory mediators have been reported to be associated with severity of sepsis and ARDS, but the association of these inflammatory polymorphism and acute lung injury after cardiac surgery has never been reported. This study is performed to investigate the association of genetic polymorphisms including TNF -308A/G, IL-10 -1082A/G and IL-6 -572C/G and postoperative lung injury.


Eligibility Criteria:
Inclusion Criteria:

* Chinese Han unrelated population
* adult patients
* undergoing elective cardiac surgery with CPB

Exclusion Criteria:

* malignant tumor
* autoimmune disease, immunodeficiency or immunosuppressive therapy
* chronic renal disease (glomerular filtration rate \< 60ml/(min•1.73m2)) or liver dysfunction (Child Pugh classification\>A)
* COPD, tuberculosis or other chronic pulmonary diseases
* anemia with hemoglobin lower than 90mmHg
* bleeding disorders
* postoperative pericardial tamponade requiring re-operation
* postoperative low cardiac output syndrome or acute pulmonary edema after left cardiac failure.
Tributyrin: Time Course & Efficacy to Improve Health & Performance

The purpose of this study is to determine if tributyrin supplementation improves metabolite concentrations, overall health biomarkers, and performance in sedentary men and women. The study would further understand the potential usage of tributyrin as a health and performance increasing supplement through improving gut and immune health, sleep, and performance as well as reduce inflammation. Participants will supplement for tributyrin for 4 weeks and complete fecal metabolite measures, cardiovascular evaluation, sleep assessment, and exercise testing as well as provide blood samples.


Eligibility Criteria:
Inclusion Criteria:

* Age: 30-50 years
* Sedentary (\<150 minutes of aerobic exercise per week)

Exclusion Criteria:

* Chronic, uncontrolled metabolic, cardiovascular, gastrointestinal, or hepatic disease
* Consumption of supplements known to impact the microbiome, hydration status, core temperature, or exercise performance
* Experienced previous heat illness
* Known injuries that limit exercise
* BMI ≥ 40 kg/m\^2
* Pregnant
SARS-CoV-2 (COVID-19) Longitudinal Study: Understanding Susceptibility, Transmission and Disease Severity (Legacy Study)

The study aims to investigate SARS-CoV-2 susceptibility, transmission and disease severity in healthcare workers and patients.

Residual specimens from an existing collection of samples in viral inactivating buffer and derivatives and serum from the Crick COVID-19 Consortium Testing centre (Cohort A1) and additional biological material collected prospectively (Cohorts A2 and B) will be used for research into SARS-CoV-2 transmission, evolution and immune control. This testing centre is a partnership between UCLH and The Francis Crick Institute to provide COVID 19 RT PCR testing for healthcare workers (HCWs) and patients in London Hospitals and care homes. A third group (Cohort C) of the study will allow for collaborative work with other REC approved research studies that have used the Crick COVID-19 Consortium Testing centre and will involve the use of study samples already collected from each study to be analysed under the SARS-CoV-2 Longitudinal Study end points


Eligibility Criteria:
Inclusion Criteria:

* Individuals who have previously provided nasal throat swab samples for SARS-CoV-2 testing at the Crick COVID 19 Consortium Testing centre.
* ≥18 years of age
* To enrol in the SARS-CoV-2 positive cohort of the study, the participant should have a positive RT qPCR result
* Employees based at the participating sites including who had their serology and/or swab tested (for recruitment to Cohort B)
* Participants enrolled in other studies who had their samples processed by using the Crick COVID 19 Consortium Testing centre (for recruitment to Cohort C).
* Written informed consent (except Cohort A1)
Relationship Between Muscle Strength and Quality of Life in ICU Survivors

The aim is to study the impact of muscle strength measured in ICU and after ICU discharge on health-related quality of life measured after hospital discharge.


Eligibility Criteria:
Inclusion Criteria:

* critically ill patients with an ICU stay of at least 7 days
* collaborative

Exclusion Criteria:

* non collaborative, confusion, coma
* limb paresis or plegia
* patient refusal
Physiological and Environmental Data in a Remote Setting to Predict Exacerbation Events in Patients With Chronic Obstructive Pulmonary Disease

The study plans to monitor around 300 people from different hospitals with COPD for a period of 3 months after they are discharged from the hospital using a smartphone app and a Fitbit device. This device can passively track certain health metrics; this way the research team can research whether it is possible to identify the early warning signs of a decline in health by using these ongoing measurements of vital signs and symptoms. This could allow doctors to intervene early and potentially prevent further deterioration in health decline and hospital admission altogether.

The study seeks to investigate how similar these physiological measurements are when collected in the real world rather than just in the hospital setting, and what influence environmental factors have on a patient's health and experience of their condition.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 or over.
* Diagnosis of COPD, currently admitted to hospital and clinically stable with a confirmed acute exacerbation of COPD.
* Ownership of a smartphone (iOS version 13 or above, Android version 8 or above).
* Able to provide informed consent to participate in study.

Exclusion Criteria:

* Patients who require less than 24 hours in hospital at initial visit.
* Patients deemed unlikely to cooperate with study requirements.
* Patients with implantable devices.
* Patient not felt to be suitable for research enrolment by admitting clinical team.
* Patients requiring non-invasive ventilation or deemed to have a life-expectancy of less than 90 days following discharge.
A Study Comparing SYB PDO Thread and MINT Lift® for Temporary Nasolabial Fold Improvement

The objective of this clinical trial is to verify the safety and efficacy of SYB PDO Thread in the temporary improvement of nasolabial Folds.


Eligibility Criteria:
Inclusion Criteria:

1. Those desiring temporary improvement of central facial nasolabial folds and having a Wrinkle Severity Rating Scale (WSRS) score of 3 or 4.
2. Individuals willing to discontinue all dermatological procedures or treatments, including wrinkle improvement in the central facial nasolabial fold, throughout the duration of this clinical trial.

Exclusion Criteria:

1. Individuals who need to take anticoagulants from 2 weeks before the application of the clinical trial medical device to 2 weeks after (low-dose aspirin 100mg, maximum 300mg/day, is allowed).
2. Those who need to take Vitamin E supplements, NSAIDs, or collagen supplements from 1 week before the application of the clinical trial medical device to 1 week after.
3. Individuals with a history of bleeding disorders, either past or present.
4. Those who have received treatments such as deep chemical peels, skin rejuvenation procedures, plastic surgery (including Botox injections), wrinkle improvement, or acne scar treatment on the face within 24 weeks from the screening date.
Evaluation and Treatment of Patients With Lung Disease Not Participating in Research

This study was developed in order for the professional-staff at the Pulmonary-Critical Care Medical Branch (PCCMB) of the National Heart, Lung, and Blood Institute to maintain their skills and increase their understanding of lung diseases.

The study will permit PCCMB staff members to evaluate and treat patients with lung disease who do not meet the criteria for other research studies.

The professional staff in the Cardiovascular and Pulmonary Branch (CPB) needs to maintain their clinical skills and to enhance their clinical knowledge. The purpose of this protocol is to permit CPB staff to evaluate and treat patients with pulmonary disease who do not meet the criteria for existing research protocols.

Eligibility Criteria:
* INCLUSION CRITERIA:

Patients 8 years old and older with signs or symptoms of pulmonary disease of medical interest to the professional staff of CPB will be eligible for participation in this protocol. Only standard diagnostic procedures and conventional therapy will be performed. Patients will not be subjected to any research procedures. This protocol does not commit the NIH to medical or surgical treatment of protocol participants after discharge. Patients will be discharged to the referring physician.

Consenting to pregnancy testing in minors of childbearing age:

We will inform the minor during the assent process that for safety, we need to do a pregnancy test. She will also be told that if it is positive, we will counsel her and help her tell her parents. If the minor does not want to proceed she will be advised not to sign assent and her enrollment on this training protocol will end.

EXCLUSION CRITERIA:

Patients without symptoms of pulmonary disease will be excluded from this protocol.
Positron Nuclide Labeled DOTA-FAPI PET Study in Colocrectal Cancer

To evaluate the normal physiological distribution of positron nuclide labeled DOTA-FAPI PET/CT in human body and its diagnostic efficiency for colorectal cancers

Participants first undergo an 18F-FDG PET/CT, followed by 68Ga-FAPI04 PET/CT in groups. The purpose of the study is to explore the possibility of superiority of FAPI in diagnosis of colorectal cancer (TNM staging) by the comparison of the two tracers uptake (the maximum of standardized uptake value, SUVmax). Histopathology and conventional imaging follow-up are served as the reference standard.

Eligibility Criteria:
Inclusion Criteria:

* ECOG score 0-2
* patients with newly diagnosed or previously treated colorectal cancers
* patients who underwent paired 18F-FDG and 68Ga-FAPI PET/CT for tumor staging to decide the most proper treatment strategy
* patients who underwent paired 18F-FDG and 68Ga-FAPI PET/CT to detect tumor recurrence and metastases (repeat staging)
* expected survival ≥12 weeks
* blood routine, liver and kidney function meet the following criteria : blood routine: WBC≥4.0×109L or neutrophils ≥1.5×109L, PLT≥100×109/L, Hb≥90g/L;PT and APTT ULN 1.5 or less; Liver and kidney function: t-bil ≤1.5×ULT(upper limit of normal value), ALT/AST≤2.5ULN or ≤5×ULT(subjects with liver metastasis), ALP≤2.5ULN(ALP≤ 4.5ULN if there is bone metastasis or liver metastasis);BUN 1.5 x or less ULT, SCr 1.5 x or less ULT
* at least one measurable target lesion according to RECIST1.1
* women must use effective contraception during the study period and for 6 months after the end of the study (effective contraception means sterilization, hormone devices, condoms, contraceptives/pills, abstinence or vasectomy by a partner, etc.);Men should consent to subjects who must use contraception during the study period and for 6 months after the end of the study period
* able to understand and sign the informed consent voluntarily, with good compliance.

Exclusion Criteria:

* severe abnormalities of liver and kidney function;
* women preparing for pregnancy, pregnancy and lactation;
* cannot lie supine for half an hour;
* refuse to join the clinical researcher;
* suffering from claustrophobia or other mental illness;