cyrilzakka/clinical-trials huggingface dataset:
Metabolomics of Insomnia-Related Hyperarousal

Individuals with insomnia have been shown to have higher overall metabolic rates compared to good sleepers, but it is not known which metabolic processes are involved. The goal of this study is to compare a wide array of metabolic processes in 15 people with insomnia and 15 good sleepers. We hypothesize that there will be distinct metabolic processes that are functioning differently in those with insomnia.


Eligibility Criteria:
Inclusion Criteria:

Criteria for primary insomnia:

* subjective complaint of difficulty initiating or maintaining sleep, waking up too early or nonrestorative sleep
* daytime consequences as a result of the poor sleep
* duration of at least 1 month
* sleep disturbance is not secondary to a medical or psychiatric condition

Criteria for good sleepers:

-subjective report of consistent good sleep

Exclusion Criteria:

* significant medical or psychiatric illness
* diagnosis of a sleep disorder other than insomnia
* women who have been pregnant or lactating in the past 6 months
* non-fluency in spoken or written English
* Current shift work defined as working during the evening or night shift
* Current use of medications that affect sleep
* BMI \>27
Feasibility and Therapeutic Potential of Free Fat Grafts in the Treatment of Esophageal Strictures (ESOGRAFT)

In this study the investigators investigate the feasibility and therapeutic potential of free autologous fat grafting combined to dilation therapy in the treatment of benign esophageal strictures.

In this study the investigators wish to proof the concept of free fat graft transfer into esophageal stricture via flexible video gastroscope.The investigators will recruit twenty patients suffering from (endoscopy proven) benign stricture of the esophagus. The Eckardt score is recorded upon recruitment and one day before operation.

The operation is performed at the gastroenterology outpatient clinic in Turku University Hospital by a gastrointestinal surgeon. The patient is sedated with alfentanil and midazolam. First, abdominal liposuction (roughly 20 ml) is performed under local infiltration anesthesia. The fat graft is processed into nano-fat using Tulip GEMS Single-Use NanoTransfer Set. Esophagoscopy with gastroscope is performed and stricture is visually graded (location, length, lumen) and photographed. Then esophageal stricture is biopsied with biopsy forceps and dilated with through-the-scope CRE(controlled radial expansion) balloon dilator. Prepared fat graft is injected beneath the mucosal layer at the stricture site (volume of 0,1-0,5 ml) at three locations. Patients are either discharged after two hours follow up or admitted to the inpatient ward, depending on the pre- and postoperative condition.

Patients are contacted by phone 1 week after the operation. Post-operative symptoms are recorded and patients are requested to contact the researcher if needed. Patient records are screened for pre- and postoperative symptoms, medication, long term illnesses and possible postoperative contacts to hospital.

Follow-up esophagoscopy is performed and biopsies taken three and 12 months after the first operation. The stricture site is visually graded and photographed. The Eckardt score is recorded. If the patient has problems with eating (Eckardt score dysphagia points more than 1) the stricture is re-dilated and fat grafting repeated.

If a patient would have recurrence in dysphagia before three months the patient is treated according to normal routine and dilation is repeated earlier.

The follow-up time is 12 months counting from the last fat grafting.

Eligibility Criteria:
Inclusion Criteria:

* Esophageal stricture that has re-occurred at least once

Exclusion Criteria:

* Malignant etiology of esophageal stricture
Improving Post-acute Stroke Follow-up Care by Adopting Telecare Consultations in a Nurse-led Clinic

Since 2017, Hong Kong has provided post-acute stroke services in clinics operated by stroke advanced practice nurses (APNs). Currently, the applicability of the clinics has been further limited by the emergence of the coronavirus (COVID-19) pandemic due to restrictions on visits to the clinics and tightened social distancing requirements. Telecare consultations may be a viable option for contributing more flexible, interactive, and cost-efficient care models to support stroke survivors over the longer run. The present study takes advantage of this opportunity by utilizing implementation science to simultaneously implement and evaluate a telecare model of care in a nurse-led post-acute stroke clinic.


Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of stroke within 1 month before enrolment, will be discharged home within a week, aged 18 or above, cognitively competent with a score equal to or greater than 22 in the Montreal Cognitive Assessment Hong Kong version, own a smartphone

Exclusion Criteria:

* have unaccompanied hearing or vision loss, cannot be reached by phone, bedbound, have no Internet connection at home, participating in other clinical trials at the same time, require physical contact, i.e. wound dressing
Alveolar Ridge Preservation in Molar Extraction Sockets With an Open Healed Collagen Membrane: A Randomized Clinical Trial.

The resorption of alveolar ridge after tooth extraction develop difficulty in restoring the extraction area with implant or bridge. Therefore, try to preserve the alveolar ridge width and height at extraction socket and gaining its bone volume in maximal is worth for clinical investigation. There are several method to deal with alveolar ridge preservation (ARP), the most popular way for its approach, the trend is toward to minimally invasive treatment. Alveolar ridge preservation which is done with open-healed wound without primary closure is the key for minimally invasive approach.

This three-armed randomized clinical trial would like to determine the effect of applying ribose cross-linked collagen membrane without primary flap closure in molar extraction sockets for alveolar ridge preservation. The procedure is for implant site development.

Three groups were designed as test group1 was grafted with freeze dried bone allograft (FDBA) and covered by ribose cross-linked collagen membrane (OSSIX® PLUS). In test group2 sockets filled with collagen plug(Teruplug®) and sockets healed naturally as control group. Cone-beam computed tomography(CBCT) scans are obtained immediately and 4 months after ARP as the primary outcome and secondary outcome. A biopsy from implant site and histomorphometric analysis will be done as well. The change of marginal bone level and the width/height of keratinized mucosa are measured.


Eligibility Criteria:
Inclusion Criteria:

* Age\>20
* according to periapical film, the bone defect over bucco-lingual and mesio-distal direction less than 50%
* patient agreed to undergo implant therapy after tooth extraction

Exclusion Criteria:

* systemic diseases which will affect wound healing (ex. Diebetes)
* heavy smoker (10 cigarette/day)
* patient who underwent oral-maxillary surgery or who diagnosed with oral cancer
* patient who is pregnant or who is breast-feeding
* patient who is allergic to Lidocaine
* patient who cannot cooperate the study design
Comparison of Color Measurements of Postgraduate Dental Students Using Different Color Determination Methods

This study evaluates the accuracy of tooth color identification skills in the anterior region using a new technique, the button technique, in comparison with other methods.

The human eye is effective in detecting subtle differences in tooth color. However, variations in the shade, translucency, opacity, and characterization of a tooth may not be accurately identified. Visual color matching is subject to physiological variables that may lead to inconsistencies, such as age, gender, experience, the type of scale used, varying degrees of light exposure, eye fatigue, and color vision deficiency.

Studies comparing visual and instrumental methods have demonstrated that spectrophotometers yield better results compared to visual color scales. Therefore, it is expected that color measurement devices improve the accuracy of tooth color determination, thereby enhancing the interpretation and aesthetic execution of restorations.

In recent years, the button technique has been described for shade selection in direct aesthetic restorations in the anterior region. In this technique, small composite samples in the form of dots are polymerized on the tooth surface using a curing light. Digital photographs are then taken, and appropriate enamel and dentin shades are selected on a computer using polarized and black-and-white images.

Very few clinical studies have investigated the use of digital color images obtained through intraoral digital scanners for shade selection, comparing them with other existing methods.

The aim of this study is to evaluate the accuracy of shade determination skills in the anterior region by comparing a new technique, the button technique, with other methods and to recommend the most suitable method for shade selection

Eligibility Criteria:
Inclusion Criteria:

* Being healthy individuals,
* Not having any systemic diseases,
* Being young individuals (18-40 age range)
* Vital, decay-free and healthy upper central teeth,
* Absence of caries-free hard tissue abrasions, any restoration, fracture, crack, intrinsic or extrinsic discoloration in the upper central teeth
* Lack of removable prosthesis feet for central teeth

Exclusion Criteria:

* Tetracycline, fluorosis staining of upper central teeth
* Patients with dentin exposure or loss of bine in the upper central teeth for any reason
* Pregnant and lactating patients will not be included.
Infant Formula and Toddler Drink Feeding Intervention

The purpose of this randomized, multi-center, controlled, double-blind, parallel study is to evaluate the health and developmental outcomes of children fed a new infant formula and toddler drink through 24 months of age.


Eligibility Criteria:
Inclusion Criteria:

* Participant is judged to be in good health as determined from participant's medical history
* Participant is a singleton from a full-term birth with a gestational age of 37 - 42 weeks
* Participant's birth weight was ≥ 2490 g (\~5 lbs. 8 oz.)
* If parent(s) elect to formula feed the participant they confirm their intention to feed their participant the study product as the sole source of feeding until 4 months of age, and as the sole milk beverage during the first 12 months of life
* If parent(s) elect to formula feed the participant, they confirm their intention to feed the participant the assigned toddler drink from 12 months of life to 24 months of life as the primary milk beverage
* If parent(s) elect to feed the participant mother's human milk, they confirm that their infant was exclusively fed mother's human milk since birth and confirm their intention to continue exclusively feeding human milk as the sole source of feeding through 4 months of age
* If parent(s) of human milk fed participant elect to supplement or wean after 4 months to 24 months of age, they confirm their intention to use the supplemental/weaning formula or toddler drink as the primary milk beverage
* Parent(s) of formula-fed participant confirm their intention not to administer vitamin or mineral supplements, from enrollment through the duration of the study
* Parent(s) confirm their intention not to administer solid foods or juices to the participant from enrollment through 6 months of age
* Participant's parent(s) has voluntarily signed and dated an informed consent form (ICF), approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study.

Exclusion Criteria:

* An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development
* Participant is taking and plans to continue medications (including over the counter (OTC), home remedies, herbal preparations, prebiotics or probiotics, or rehydration fluids that might affect GI tolerance
* Participant is in another study that has not been approved as a concomitant study
* Participant has been treated with antibiotics prior to enrollment
Clinical Evaluation of the "NICU Clinical Decision Support Dashboard" - MHSB

This study evaluates the use of a NICU clinical integration system (Dashboard and accessories) in improving the quality of care delivered, patient health outcomes, and parent and clinician satisfaction. Clinicians will be asked to follow their current standard of care practices with the aid of this technology. About half of participants will receive care in NICU rooms with the Dashboard installed while the other half will receive standard care without the Dashboard.

The current NICU environment can be stressful and overwhelming for parents of babies admitted and for clinicians caring for the babies. There is a wide range of monitors in a very clinical environment that does not take into account the comfort of neonates.

The Dashboard works in parallel with EHR and systems of record, and provides a cohesive view of the patient's status and planned clinical workflow in a single location for both parents and staff. Accessories such as environmental sensors and cameras are used to ensure that the environment is comfortable and promotes optimal development of the baby. Caregivers can educate and coach parents to facilitate integrating them into their infant's care. The NICU Dashboard also supports a family view to facilitate education and assist the family in tracking core measures and developmental milestones.

Eligibility Criteria:
NEONATES AND THEIR PARENTS

Inclusion Criteria:

* Admission to the NICU
* At least one parent (biological, guardian, or adoptive) involved
* One parent can understand and speak the English language
* Parent aged 18 years or older
* Parent with sufficient mental capacity to provide written informed consent as determined by a RN
* Signed informed consent from the parent

Exclusion Criteria:

* Expected discharge from the NICU in \<48 hours

CLINICIANS INTERACTING WITH THE NICU DASHBOARD

Inclusion Criteria:

* Employee of institution with direct patient care in the NICU (e.g. physician, NP, RN, therapist)
* Expected interaction with the NICU Dashboard
* Signed informed consent

Exclusion Criteria:

* No interaction with the NICU Dashboard
A Safety and Feasibility Study of IS-001 Injection in Patients Undergoing Robotic Colorectal Surgery

This study evaluates the safety and feasibility of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation

Injury to the ureter, the duct by which urine passes from the kidney into the bladder, is a well-known and serious complication of pelvic and abdominal surgery that frequently goes unrecognized intraoperatively. This study seeks to evaluate the safety and feasibility of intravenous IS-001 injection to improve surgeon ureter visualization during robotic-assisted surgery with the da Vinci® Surgical System and Firefly® imaging.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects between the ages of 18 and 75, inclusive
2. Subject is scheduled to undergo robotic-assisted rectal, sigmoid, or left colon resection surgery using the da Vinci® X/Xi Surgical System with Firefly® Fluorescent Imaging

Exclusion Criteria:

1. Subject is pregnant or nursing
2. Subject has known hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
3. Subject has any of the following screening laboratory values:

   1. eGFR \< 60 mL/min/1.73 m\^2
   2. Aspartate aminotransferase (AST) or serum glutamic oxaloacetic transaminase ≥ 2.5 × ULN
   3. Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase ≥ 2.5 × ULN
4. Subject is already enrolled in another investigational drug or device study receiving therapeutic agents within the past 6 months
5. Subject has any other condition or personal circumstance that, in the judgment of the Investigator, might interfere with the collection of complete quality data or represents an unacceptable safety profile
6. Subjects with known or suspected hypersensitivity to indocyanine green (ICG) or any components of the formulation used.
Vasovist Endoleak Study

After endovascular treatment of an abdominal aortic aneurysm, lifelong imaging follow-up is needed to monitor the effectiveness of the treatment. One parameter in this follow-up is endoleak, which is leakage of blood into the aneurysm sac. The aim of this study is to investigate the value of magnetic resonance imaging using Vasovist as a contrast agent for the detection of endoleaks.

After endovascular abdominal aortic aneurysm repair, life-long follow-up is needed to monitor the effectiveness of exclusion of the aneurysm sac from blood flow. For this reason, aneurysm diameter and the presence of endoleaks is evaluated with computed tomographic (CT) angiography yearly after Endovascular Aneurysm Repair (EVAR).

The aim of this study is to investigate the value of magnetic resonance imaging using Vasovist as a contrast agent for the detection of endoleaks.

The advantages of magnetic resonance imaging with respect to CTA are no use of ionizing radiation, use of less nephrotoxic contrast agents.

Eligibility Criteria:
Inclusion Criteria:

* Patient is more than one year after endovascular abdominal aortic aneurysm repair
* Patient has a stable or growing aneurysm according to diameters measured on CT angiography images
* No evidence of endoleak on recent CT angiography

Exclusion Criteria:

* contraindication for MRI examination

  * claustrophobia
  * pacemaker
  * other non-MRI compatible implants
* contraindication for use of contrast agent

  * known allergy to drugs or contrast media
  * MRI examination with the use of gadolinium within 24 hours of the blood-pool agent injection
  * severe renal impairment = creatine \> 2 mg/dl (=176 mmol/l)
  * patient clinically instable
  * Participation in drug research within 30 days before and 1 day after MRI-examination with use of Vasovist.
Breast Cancer Detection: Comparison of Breast Tomosynthesis and Conventional Mammography

The primary hypothesis to be tested is:

The detection of breast cancer will be increased with tomosynthesis (3D) imaging

The purpose of this study is to determine if: 1 the detection of breast cancer will be increased with conventional (2D) imaging plus tomosynthesis (3D) imaging, or 2. if the the detection of breast cancer will be increased with tomosynthesis (3D) imaging alone.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Any ethnic origin
* No contraindication for routine bilateral mammography

Exclusion Criteria:

Potential subjects with any of the following will not be enrolled in the study:

* Any contraindications to mammographic screening, including, but not limited to:
* Significant existing breast trauma
* Under the age of 30 at the time of consent
* Breast Implants
* Prior Surgeries

  * Unable to understand and execute written informed consent
  * Pregnant
  * Lactating
Bioequivalency Study of 450 mg Lithium Carbonate Under Fed Conditions

The objective of this study was to assess the bioequivalence of two Roxane lithium carbonate 450 mg extended release tablet formulations compared to GlaxoSmithKline's Eskalith CR 450 mg extended release tablet under fed conditions using a single-dose, randomized, three-treatment, three-period, six-sequence crossover design.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Participation in a clinicl trial within 30 days prior to study initiation.
* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
Pain Processing in Inflammatory and Non-Inflammatory Chronic Pain Syndromes

Fibromyalgia (FM) is a chronic musculoskeletal pain disorder that afflicts up to 4% of the general population. The evaluation of pain mechanisms in FM has shown predominant central abnormalities and therefore has been designated as nociplastic pain syndrome. Rheumatoid arthritis (RA) is characterized by polyarthritis and pain from inflamed tissues, consistent with nociceptive pain. FM and RA patients may utilize overlapping pain mechanisms resulting in nociceptive and nociplastic pain.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18-70
* Fulfills the 1990 and 2011 American College of Rheumatology Criteria for FM
* Fulfills the 2010 ACR-EULAR classification criteria for RA
* Healthy volunteers: No significant pain/fatigue/depression/anxiety.

Exclusion Criteria:

* Diabetes
* Cancer
* Advanced liver, kidney or cardiovascular disease
* Neuropathic pain
Embolic Stroke of Undetermined Source, Continuous Electrocardiography and Transthoracic ECHOcardiography in Hospitalized Patients With Ischemic Stroke

Transthoracic echocardiography (TTE) is recommended in patients with ischemic stroke when cardiac etiology is suspected to help plan secondary stroke management. However, discrepancy for specific clinical recommendation exists between cardiologists and neurologists, and data evaluating usefulness of TTE in unselected patients with cryptogenic strokes (CS) and embolic strokes of undetermined source (ESUS) are lacking. The investigators sought to evaluate the value of routinely performed echocardiography in consecutive CS/ESUS patients. The investigators will perform TTE as recommended by guidelines including agitated saline contrast and speckle-tracking to investigate potential implications for secondary stroke management. In addition, the researchers aim to evaluate the effectiveness of long-term continuous electrocardiogram (cECG) monitorering with newer Holter monitors to detect cardiac arrhythmia in patients with CS/ESUS.

In this prospective study, the investigators aim to evaluate 500 consecutive patients, regardless of age, in sinus rhythm with acute IS and potential cardioembolic stroke (CES) or cryptogenic stroke (CS/ESUS) according to Trial of Org 10172 in Acute Stroke Treatment (TOAST) criteria. Strokes are determined by magnetic resonance imaging. The researchers will perform TTE as recommended by guidelines including agitated saline contrast and speckle-tracking to investigate potential implications for secondary stroke management.

The investigators aim to explore underlying heart conditions and comorbidities among CES and ESUS patients. Data will include left atrium morphology, atrial septal aneurysm, valvular disease, mural thrombus and patent foramen ovale (PFO). Focus will be analysis of data on older patients, as some studies indicate that in ESUS patients \>60 years of age, there is a higher prevalence of PFO in patients with low atherosclerosis and cardioembolic risk.

This project can potentially guide cardiologists and neurologists, on common grounds, for stroke management of potential cardioembolic origin. Implications of referring all-comers with stroke of potential cardioembolic origin to echocardiography will be illustrated.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients with verified acute ischemic stroke determined by magnetic resonance imaging (MRI) and/or computed tomography (CT) of cerebrum.
* Patients, regardless of age, in sinus rhythm with acute IS and potential cardioembolic stroke or cryptogenic stroke (CS/ESUS) according to Trial of Org 10172 in Acute Stroke Treatment (TOAST) criteria.

Exclusion Criteria:

* Persons not able to cooperate.
* Persons unable to understand and sign "informed concent."