cyrilzakka/clinical-trials huggingface dataset:
CD0104 VEST II Post Marketing Surveillance Study

This study is designed to collect post market data on use of the VEST, particularly on saphenous vein grafts to the right territory of the heart.

The primary objective is to test the early-mid term patency rate of VEST supported Right Coronary Artery (RCA) bypass grafts. The research participants will undergo CABG preparations and CABG procedure routinely as is the standard of care. During the procedure the VEST will be implanted on the vein graft to the Right Coronary Artery according to the IFU. Perioperative care is according to standard of care. Upon discharge patient will be prescribed statins and aspirin for 6 months. Patient will attend a routine clinic visit 4-6 weeks post operatively. The last study visit will occur 3-6 months post operatively. Patients will undergo a noninvasive coronary CT angiography.

Eligibility Criteria:
Inclusion Criteria:

1. Patient scheduled for on-pump CABG on clinical grounds
2. At least one vein graft bypass indicated for right coronary artery and LIMA indicated for the LAD on clinical grounds
3. Appropriately sized and accessible target coronary arteries, with a minimum diameter of 1.5 mm and adequate vascular bed, as assessed from the pre-operative cardiac angiography.

Exclusion Criteria:

1. Concomitant non-CABG cardiac procedure
2. Prior cardiac surgery
3. Emergency CABG surgery (cardiogenic shock, inotropic pressure support, IABP)
4. Contraindication for on-pump CABG with cardioplegic arrest (e.g. severely calcified aorta)
5. Calcification at the intended anastomotic sites, as assessed upon opening of the chest and before VEST implantation.
6. Prior debilitating stroke less than 1 year before surgery
7. Severe renal dysfunction (Cr\>2.0 mg/dL)
8. Concomitant life-threatening disease likely to limit life expectancy to less than 2 years.
Newborn Nursery Reach Out and Read

The purpose of this research study is to learn new things about how parents and others who care for babies think about sharing books with their baby and how they might respond to guidance from their doctors. The study involves participants filling out a survey with questions about a newborn baby and thoughts about the baby's development. The study should not take more than an hour and fifteen minutes during the delivery hospital stay and another 20 minutes at the baby's one month well child visit by phone or emailed survey link. Participants may also be interviewed and asked some questions about these topics. The conversation will be audio recorded, and should last no more than 30 minutes. The survey should take no more than 15 minutes to complete. The participant and their child will be randomized, like flipping a coin, to either receive the study intervention book, Cluck and Moo, along with standard or care or solely standard of care at your time of hospital discharge. The greatest risks to this study would be feeling uncomfortable about answering some of the questions and potential risk of loss of confidentiality.


Eligibility Criteria:
Inclusion Criteria:

* Child delivered at Duke Hospital Birthing Center
* Families who can read and write in English
* Families with children born at \>36 weeks gestation
* Families who plan to continue primary pediatric care with Duke Children's Primary Care

Exclusion Criteria:

* Parent with severe medical or mental health condition limiting ability to attend appointments
* Newborn with severe medical condition
* Families who plan to move out of state in the next 6 months
Manual Versus Oscillating-rotating Toothbrushes After Root Coverage Procedure

The aim of this study is to evaluate the gingival margin stability with the use of oscillating-rotating toothbrushes compared to manual toothbrushes.

BACKGROUND Oscillating-rotating power toothbrushes have been proven clinically efficacious. To the investigators' knowledge, a clinical evaluation of the safety of these toothbrushes after surgical root coverage procedure have not been published. The aim of this study is to evaluate the gingival margin stability with the use of oscillating-rotating toothbrushes compared to manual toothbrushes.

METHODS Sixty healthy patients with at least a single Miller Class I or II gingival recession underwent surgical root coverage procedure. Soft-bristle manual and powered toothbrushes were given to participants randomly assigned to control and test group, respectively. Full-mouth plaque score, Full-mouth Bleeding Score, Probing Pocket Depth and Recession Depth were recorded 1, 3 and 6 months after completion of surgical procedure. Longitudinal analyses were performed using linear random-intercept models to take into account within-subject correlations over time. Temporal trend differences across treatments by including treatment-time interaction terms were then tested using a global Wald test.

Eligibility Criteria:
Inclusion Criteria:

* Full-Mouth Plaque Score (FMPS) ≤25%
* Full-Mouth Bleeding Score (FMBS) ≤25%
* Miller Class I and II buccal recession ≥2 mm

Exclusion Criteria:

* Relevant systemic condition or disease
* Smokers
* Teeth with prosthetic crowns or restorations in the cervical area
* Presence of pulling frenum in the keratinized tissue
* Previous mucogingival or periodontal surgery in the experimental site
Involvement of Archaea in Carious Disease

Dental caries is a major public health probleme the result of hard tissue demineralization and oral microbiota changes.

Methanogenic archaea, mainly Methanobrevibacter oralis, are associated with various oral problems, including pathologies periodontal.

Previous research has not really studied the Archaea in carious lesions, hence the importance of our study.

Our study aims to explore their potential role in the the development of caries by analysing their prevalence and their quantification in relation to the carious risk individual. The aim is to improve understanding of the Cavity microbiology to advance management of this pathology in terms of prevention or of treatment.

Our team is particularly competent in the field of Archaea, especially in the cultivation of Archaea methanogens since we have a dedicated platform. We also discovered the first human Nanoarchaea, opening up a whole new possible search field.


Eligibility Criteria:
Inclusion Criteria:

* Male or female of legal age.
* Patient who is a beneficiary or entitled beneficiary of a social security
* Patient under the care of the Restorative and Preventive Dentistry of the PROMOD - Timone Dentistry Unit.
* Patients capable of giving written consent.

Exclusion Criteria:

Patient in a period of exclusion from another research protocol at the time of signing the consent form, Subjects covered by articles L1121-5 to 1121-8 of the Public Health public health code (minor patients, patients of full age under guardianship, patients deprived of their liberty, pregnant or breast-feeding), A person who does not have a sufficient command of reading and understanding of the French language to be able to consent to take part in the research Presence of periodontitis (gingivitis not being a criterion for a criterion for non-inclusion). Antibiotics taken in the previous month. Use of mouthwash in the previous 7 days.
Effect of Training of Patients With Dysphagia

Effect of training of patients with dysphagia

A randomised controlled study in the effect of training in patients with dysphagia.

The patients are randomised for training or for usual care.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with dysphaigia
* Patients living in the participating locations

Exclusion Criteria:

* Patients who are linguistically or cognitively unable to participate
* Patients who are unable to collaborate about the training
* Palliative patients
* Patients with a probe
COVID19 and Physical and Emotional Wellbeing of HCP

The current COVID-19 pandemic has affected more than 3 million people worldwide across more than 200 countries.

In the United Kingdom alone, at the end of April, there were almost 160,000 confirmed cases with more than 20,000 deaths. This has undoubtedly had significant physical and economical impact on the public.

Healthcare workers are at high risk of developing life-threatening infectious diseases with increased exposure to patients' blood and bodily fluids. As such, health care workers arguably experience heightened anxiety and are predisposed to greater negative psycho-social impact from the current COVID-19 pandemic.

The aim of this study is to evaluate the physical and psychological impact of COVID-19 on healthcare workers. This will be performed in two phases.

In phase 1, investigators will collect information to evaluate the current psychiatric symptom profile (in particular, screening for anxiety or depression related symptoms), alcohol use, sleep-related complaints and overall well-being among healthcare workers who participate in this survey (with a focus on junior doctors). In addition the association of these mental health and behavioural parameters with the prevalence of stressful occasions, such as long-hours, unpredictability of work / redeployment, availability of personal protection equipment and concerns regarding family/relationship and self will be assessed.

In phase 2, investigators will then reassess for the development or progression of psychiatric symptoms, use of alcohol and other substances, behavioural or interpersonal relationship changes as well as physical well-being at 6 weeks and 4- months. Physical well-being is assessed through the presence of suspected or confirmed COVID-19 infection and absence from work. Specifically, investigators will study the impact of variable provision of personal protection equipment (supply and training), extended working hours, and concern for well-being of family members, on work morale and anxiety levels.

Another aim is also study the longer term mental health consequences of the current pandemic on health care workers.


Eligibility Criteria:
Inclusion Criteria:

1. Aged \>=18
2. Electronic consent
3. Either:

a - healthcare workers in contact with patients with confirmed or suspected COVID-19 b - Healthcare staff not having direct patient contact c - Non-healthcare academic staff with no direct patient contact

Exclusion Criteria:

1. Age\<18
2. Individuals not belonging to the 3 cohorts of interest listed in the inclusion criteria.
3. Those who are not able to understand written English will be excluded, indeed by the design and methodology of the study, as the study invite and all other information provided is in English.
Ultrasound Guided Quadratus Lumborum Block Compared to Caudal Bupivacaine/ Neostigmine in Pediatric Lower Abdominal Surgeries

The aim of this study is to compare the postoperative pain control in children undergoing lower abdominal surgeries receiving QL block with those receiving caudal bupivacaine/ neostigmine.


Eligibility Criteria:
Inclusion Criteria:

* Patients American Society of Anesthesiologists physical status (ASA) I or II.
* Consent from parents or legal guardian(s).
* Lower abdominal surgeries.

Exclusion Criteria:

* Parents' refusal or legal guardian's refusal.

  * Infection at the injection site.
  * Known allergy to bupivacaine and/or neostigmine.
  * Contraindications to regional anesthesia (including coagulopathy and local infection).
  * Anatomical anomalies at the site of the block.
Driver-guided Ablation of Persistent Atrial Fibrillatiom

This is a prospective, single-center, study. A targeted number of 181patients with persistent AF will be included according to pre-defined criteria. The ablation procedure consists on the identification of the arrhythmic substrate using a novel integrated mapping technique. We hypothesize that such approach may potentially lead to a mechanisms-targeted ablation strategy of persistent AF.

This is a prospective, single-center, study enrolling a total of 181patients with persistent AF according to well defined inclusion and exclusion criteria. The ablation procedure consists on the identification of the arrhythmic substrate using a novel integrated 3D mapping technique followed by standard CPVA at the end of the procedure. We will ablate substrates showing fast and regular electrical activities, starting from areas with the fastest mean cycle length and/or areas that have consistent rotational or focal propagation pattern and/or areas that comprise the slow conduction zone of possible arrhythmia circuits. After substrate ablation and AF termination, arrhythmia inducibility will be assessed and, if not inducible, the procedure will be completed by standard CPVA. If AF is still inducible, a new 3D map will be performed to identify further targets to be eliminated. Electrical cardioversion may be done at the end of the procedure. We hypothesized that such approach may potentially lead to a mechanisms-targeted ablation strategy leading to elimination of arrhythmic sources in individual patients, thus improving their clinical outcome. We will also characterize, identify and target the real pathophysiological substrates. After ablation, AF recurrence will be assessed by implantable loop recorder or thans-telephonic ECG recording from the end of the 3 months blanking period to 12 months following the procedure.The duration of this study is expected to be 24 months, from the first patient enrollment to the last patient follow-up.

Eligibility Criteria:
Inclusion Criteria: Age (18-85 years), persistent AF according to ESC/EHRA guidelines, first or second ablation procedure, ability to provide informed written consent.

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Exclusion Criteria: Secondary AF, Hyperthyroidism, LVEF\<30%, NYHA functional class IV, uncorrected valvular heart diseases, contraindication to anticoagulation, left atrial thrombus, recent (\<6 months) myocardial infarction, thoracic surgery for congenital, valvular diseases, History of cerebrovascular events, pregnancy, cancer or other significant comorbidities.

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MRI Development for Radiotherapy Planning and Delivery in Non-Patient Volunteers

Non-patient volunteers will be scanned on the MR-Linac and MRSIM to facilitate the development, optimisation and validation of MRI protocols at The Christie NHS Foundation Trust.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide written consent
* Volunteers must undergo and satisfy MRI safety screening
* Volunteers must be ≥ 16 years of age
* Participants must agree to registration as a non-patient in CWP (the Trust's Electronic Health Record - EHR- system) and have their MRIs read and reported for incidental findings by a clinical radiologist

Exclusion Criteria:

* Any contraindications to MRI identified after MRI safety screening including completion of an MRI Safety Screening Form
* Unable to tolerate MRI scan
* Known Pregnancy
* Known or suspected pathology in body region to be scanned
* Member of study team
Metabolomic Analysis of Lung Cancer

The purpose of this study is to learn more about the metabolic properties of lung cancer cells.

It has long been known that cancer cells absorb and break down substances in the body differently than healthy, non-cancer cells. This process of absorbing and breaking down substances is known as metabolism and is increased in cancer cells. Recent research suggests that this increased metabolic activity makes it easier for cancer cells to multiply. The objective of the study is to characterize the metabolism of glucose by lung tumors by serum metabolite analysis, using a variant of glucose (sugar) which makes up 1% of glucose in nature.

Eligibility Criteria:
Lung Cancer Patients (Groups 1 \& 2)

Inclusion Criteria:

* patients with suspected, clinically diagnosed, or histologically diagnosed lung cancer. Occasionally, other cancers (including metastatic cancers to the lung) may be resected for the study as negative controls for NSCLC, as warranted by the particulars of the case.
* patients must have general medical conditions to allow them to undergo surgical resection of their primary tumor

Exclusion Criteria:

* history of diabetes for the experimental group (surgery + glucose); patients with a history of diabetes are allowed in the control group (surgery/no glucose)
* known hepatitis C or HIV (AIDS)

Healthy Subjects (Group 3)

Inclusion Criteria:

* at least 30 years of age
* preferably be fasting for 12 hours (minimum 8 hours) prior to enrollment

Exclusion Criteria:

* prior history of diagnosed lung cancer
* known hepatitis C or HIV (AIDS)
Toothbrushing and Ventilator-associated Pneumonia

The hypothesis is that adding the toothbrushing to the oral care with clorhexidine 0.12% could be reduce the incidence of ventilator-associated pneumonia due to that oral cavity may be an important reservoir of pathogens that could cause pneumonia.


Eligibility Criteria:
Inclusion Criteria:

* mechanical ventilation

Exclusion Criteria:

* edentulous
Preserving Left Colonic Artery During Radical Resection of Rectal Cancer

To evaluate the feasibility and clinical significance of preserving left colonic artery in rectal cancer surgery.The investigators will focus on the effect of preserving left colonic artery during radical resection of rectal cancer on anastomotic leakage and oncology efficacy.

The investigators performed three-dimensional (3D) reconstruction to investigate the vascular anatomy, including the inferior mesenteric artery (IMA) and left colic artery (LCA),to help make pre-operative strategies of rectal cancer surgery.The investigators will preserving the left colonic artery during rectal cancer surgery and evaluate its feasibility and clinical significance.The investigators will focus on the effect of preserving left colonic artery during radical resection of rectal cancer on anastomotic leakage and oncology efficacy.

Eligibility Criteria:
Inclusion Criteria:

1. Pathological biopsy confirmed adenocarcinoma of the rectum；
2. Preoperative assessment of tolerance to surgery without major organ dysfunction；
3. Patients must be able to understand and voluntarily sign written informed consent；
4. The surgical method is laparoscopic or robotic anterior rectal cancer resection.

Exclusion Criteria:

1. The patient cannot tolerate the operation；
2. Refusal to sign informed consent；
3. Patients with distant metastasis of rectal cancer；
4. The surgical method was changed to miles or Hartman;
5. Unable to complete the follow - up
Protein Requirements Amongst Male Masters-Level Athletes Following a Cycling Exercise Bout as Determined by the Indicator Amino Acid Oxidation Technique

Masters level cyclists are a population above the age of 35 years who frequently participate in prolonged as well as heavy-volume training. Like most endurance-trained athletes, a greater recommended dietary allowance (RDA) for protein of 1.2-1.4 g/kg/bw is suggested.

Dietary protein intake is vital for maximizing the benefits of training and ensuring optimal recovery. Dietary recommendations traditionally have been determined through nitrogen balance techniques, however, recent research indicates how this method is potentially underestimating protein requirements. Therefore, there is a need to reassess current dietary recommendations in order to meet the demands of physical activity for highly active populations.

Recent efforts to understand protein requirements during rest and following exercise have been completed using the indicator amino acid technique (IAAO). This non-invasive method is reported to provide a robust measure of protein requirements. However, there is limited work in older (≥60 years) active populations.

The purpose of this study is to measure the protein requirements in master cyclists, following an endurance training session, using the non-invasive IAAO technique.


Eligibility Criteria:
Inclusion Criteria:

* 18.5\< BMI \<35 kg/m\^2
* Overtly healthy masters level cyclists ≥65 years
* Masters level cyclist training (\>4 days per week; \~100 km per week)
* Body mass stable over previous 6-months
* Availability for multiple metabolic trials (\~7 trials)
* Ability to travel to and from laboratory facility

Exclusion Criteria:

* Recent history of weight loss or weight gain (\>5% body weight)
* Uncontrolled hypertension
* ≥2 chronic diseases (e.g. diabetes, osteoporosis, dyslipidemia)
* Acute illness that could affect protein metabolism (HIV, renal dysfunction, influenza)
* Currently using anti-inflammatory medications
* Inability to adhere to study protocol (i.e., alcohol, caffeine, dietary restrictions)
* Regular tobacco user
* Illicit drug use
* Habitually ingesting ≥3 g/kg/bw
Surgical Management and Outcome of Tethered Cord Syndrome

The aim of this study is to assess surgical management and outcome of Tethered cord syndrome

Tethered cord syndrome (TCS) is a developmental abnormality of the neuroaxis which is usually diagnosed in childhood. The actual tethering has been attributed to a variety of pathologic entities, including a thickened tight filum terminale , intradural lipomas with or without a connecting extradural component, intradural fibrous adhesions, diastematomyelia, and adherence of the neural placode following previous closure of a myelomeningocele. However, sufficient differences in the mode of onset, clinical manifestations, and outcome exist between pediatric and adolescent patients with tethered cord to warrant a more detailed analysis of the adult syndrome. The most problematic technical consideration in surgery for the release of the tethered cord is how to preserve functioning neural elements and rebuild the dural sac to avoid CSF leak. The purpose of this study is to review causes of Tethered cord, clinical presentation, diagnostic tools, treatment options and outcome in school-aged children, adolescents, and young adults with Tethered cord.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Tethered cord syndrome presenting at our institute
* Patients with spinal dysraphism
* Lipomyelomeningocele with Tethered cord
* patients presented with neurological deficit after lipomyelomeningocele repair due to Tethered cord
* patients presented with neurological deficit after myelomeningocele repair due to Tethered cord
* Diastematomyelia with Tethered cord - Tethered cord due to filum terminale.
* Tethered cord due to fibrous adhesions

Exclusion Criteria:

* Asymptomatic Patients with Tethered cord discovered accidentally
Alfuzosin Hydrochloride to Relieve Ureteral Stent Discomfort

To assess the impact of alfuzosin vs. placebo on ureteral stent discomfort, urinary symptoms and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18
* Undergoing unilateral retrograde ureteroscopy with ureteral stent placement

Exclusion Criteria:

* Significant ureteral trauma
* Concomitant ESWL or other secondary surgical procedure than may impact patient comfort
* Subject with know hypersensitivity to alfuzosin hydrochloride or any component of alfuzosin hydrochloride tablets.
* Pregnancy, nursing mother, or woman of child-bearing age unwilling to take contraception for the duration of the study
* Undergoing bilateral ureteral stenting
* Undergoing antegrade ureteral stenting
* Undergoing simultaneous extracorporeal shockwave lithotripsy
* Urinary infection (fever \>101, positive urine culture, many bacteria on urinalysis)
* Primary bladder dysfunction that would impact ability to void without a catheter
* Neurologic dysfunction that would impair pain sensation
* History of chronic pain or substance abuse
* Potent CYP3A4 inhibitors such as ketoconazole, itraconazole, and ritonavir, since alfuzosin blood levels are increased
* Other alpha-blockers
* Phosphodiesterase type 5 inhibitors for erectile function Any subject for whom the principal investigator feels it would not be in his or her best interest to participate in the study.