cyrilzakka/clinical-trials huggingface dataset:
The TOGETHER Project - Liver

To validate the use of a RNAseq-based peripheral blood assay in liver transplant recipients when correlated to liver biopsy results.

The study is a prospective, observational study utilizing peripheral blood assays that will be collected at time points that are considered standard of care at most institutions. 100 participants will be enrolled in study. Participants will have peripheral blood collected at 4 months and 12 months after liver transplant, as well as any for cause time points. Participants will also have liver biopsies collected at these time points. The results from the liver biopsies will be used in correlation with the results from the peripheral blood assays.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have given informed consent and are willing to comply with the protocol, including the use of their peripheral blood specimens and data for subsequent research.
* Patients with increased risk of rejection. Patients must meet at least one of the following criteria:

  1. Autoimmune etiology of the original liver disease (autoimmune hepatitis, primary biliary cirrhosis or primary sclerosing cholangitis)
  2. Recipients of donation-after-cardiac death (DCD) donors
  3. Recipients of simultaneous liver-kidney transplantation
  4. Positive crossmatch liver transplant (T cell flow crossmatch or B cell flow crossmatch).

     Exclusion Criteria:
* Adult ( ≥ = 18 years) renal transplant recipient.
Teneligliptin-Glimepiride DDI Study

An open label, one sequence study to investigate the pharmacokinetic drug interaction between Teneligliptin and Glimepiride in healthy male subjects


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male adult aged 20 to 45 years
2. Body weight ≥ 50kg, and BMI between 18 and 29 kg/m2 at screening
3. Subject who agrees to use a medically acceptable double-barrier method of contraception and not to donate sperms from the first dose until 2 months after the last dose.
4. Subject who was given, and fully understood, the information about the study, and has provided voluntary written informed consent to participate in the study and agreed to comply with the study requirements.

Exclusion Criteria:
Real-World Registry - The Vivally® System

This is a Real-World Registry Study to collect real-world dosing, utilization, demographic, quality of life, and data from the e-bladder diaries of patients utilizing the Vivally® System. Data points will be drawn from the Avation Medical HIPAA-compliant cloud database including but not limited to:

Therapy compliance and stimulation metrics

Diary entries provided by patients

Various questionnaires

Participants have the option to opt out of allowing their data to be part of any publication at any time.

Collect real-world dosing, utilization, demographics and quality of life data from the eDiaries of patients utilizing the Vivally® System.

Gather feedback from patients on their experience and satisfaction with the Vivally® System therapy

Identify trends in dosing, compliance, and therapy parameters in order to optimize the wearable, Vivally® System neuromodulation therapy for participants

Eligibility Criteria:
Inclusion Criteria:

To be eligible for the Real-World Registry Study, Participants must satisfy all of the following criteria:

* Are an appropriate candidate for the Vivally® System as determined, and prescribed by a licensed clinical professional
* Have provided informed consent to have their data included in publications associated with this study

Exclusion Criteria:

While it is up to the discretion of the clinician to prescribe the Vivally® System for a specific patient, the Vivally® System is contraindicated for use on patients who have the following history or conditions:

* Patients with pacemakers of implanted defibrillators
* Patients with nerve damage that could impact either transcutaneous tibial nerve stimulation or pelvic floor function
* This product is not intended for intra-cardiac or trans-thoracic use

Additional contraindications, warnings and precautions are listed in the User Guide.
Motivations for Weight Loss

This study tests the effects of emphasizing different motivations for wanting to lose weight on weight loss maintenance in women. At the start of the study, participants will be weighed and will complete questionnaires about their health, weight history, eating and exercise habits, body satisfaction and mood. Participants will then be randomly assigned to 1 of 4 treatments. Participants in all 4 groups will receive information on topics related to eating and exercise, and will receive calorie and fat intake goals, and exercise goals. The 4 treatments will differ in the emphasis given to various reasons for wanting to lose weight. At 6, 12 and 18 months after enrollment, participants will again have weights measured and fill out questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index greater than or equal to 27 and less than or equal to 35
* Rating both physical appearance and health concerns as important motivations for weight loss
* Successful completion of a food and exercise diary over a 5-day period
Pilot Study of Stellate Ganglion Injection to Provide Relief From Hot Flushes

This study is being done to determine whether stellate ganglion injection with local anesthetic (the study procedure) can reduce the number and severity of hot flashes in women who have hot flashes.

Hot flashes can have a significant impact on daily living, disrupt sleep, and lead to fatigue and irritability during the day. Hot flashes are the most common reason that women seek hormonal therapy. However, for many women, including breast cancer survivors, this is rarely an option, and these women seek alternatives to hormonal therapy to treat hot flashes.

The study procedure has been in clinical use for more than fifty years in treating certain disease states and chronic pain. The study procedure has not been used to relieve hot flashes and the use of the study procedure with local anesthetic for the reduction of hot flushes is considered experimental.


Eligibility Criteria:
Inclusion Criteria:

* Women surgically or naturally menopausal,
* Experiencing moderate to severe hot flushes, AND
* Elect to undergo stellate ganglion block procedure.

Exclusion Criteria:

* Subjects who are currently sick,
* Subjects have acute infections or cardiac compromise,
* Subjects who have local infections of the anterior neck region, severe
* Subjects who have pulmonary disease,
* Subjects who are anticoagulated,
* Subjects who are on hormone therapy,
* Subjects who have a blood clotting disorder,
* Subjects who have an American Society of Anesthesiologists (ASA) physical status score of 3 or higher (severe systemic disease, not incapacitating),
* Subjects who have allergic reactions to local anesthetics and/or contrast dyes,
* Subjects who have past or present diagnosis of psychosis,
* Subjects who have current diagnosis of depression, OR
* Subjects who have current substance or alcohol abuse.
Risk Assessment and Treat Compliance in Hypertension Education Trial

The RATCHET study assesses if patient knowledge of estimated cardiovascular risk at current and recommended target blood pressure levels improves compliance in the management of hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Essential hypertension (new diagnosis or established diagnosis) meeting criteria for pharmacologic therapy as defined by current guidelines

Exclusion Criteria:

* Lack of written informed consent
* Previous myocardial infarction
* Previous stroke
* Congestive heart failure
* Stage 3 or greater chronic kidney disease
* Pregnancy
* Usage of medication bubble/blister package
Deep Brain Stimulation for Laryngeal Dystonia: From Mechanism to Optimal Application

Deep Brain Stimulation (DBS) is a neurosurgical procedure used to treat tremors, and dystonia. This study will enroll people who have a form of focal dystonia that affects their vocal cords called Adductor Laryngeal dystonia (ADLD). Participants will undergo Deep Brain Stimulation surgery to treat laryngeal dystonia as part of their clinical care. Before surgery, as part of the study they will have specialized testing to study the movement of the vocal cords, as well as functional magnetic resonance imaging (fMRI). While in the operating room, researchers will examine brain waves to better understand how faulty brain firing patterns lead to dystonia. After surgery, and activation of the deep brain stimulator, participants will repeat speech testing and vocal cord imaging as well as magnetic resonance imaging (MRI).


Eligibility Criteria:
Inclusion Criteria:

* Patients with ADLD and ADLD plus tremor, as diagnosed by routine clinical examination by laryngologist, speech language pathologist, and neurologist.
* Patients undergoing globus pallidus interna (GPi) deep brain stimulation (DBS) for ADLD with tremor
* Age range of 18-80 years
* Native speakers of American English will be recruited since there are known differences in voice and neural signals of native and non-native speakers
* No evidence for dementia as assessed by neurologist.
* No evidence for severe untreated mood disorder as assessed by neurologist, or as evident on self-report (Beck Depression Inventory-II score \> 29, Beck Anxiety Inventory Score \> 26.
* At least 3 months since last botulinum toxin injection and the patients would need to be fully symptomatic with no residual effects of botulinum toxin on voice quality.

Exclusion Criteria:

* Individuals younger than 18 years and older than 80 years of age.
* Women who plan to become pregnant during the study period or are currently breastfeeding.
* Prior history of stroke, brain surgery, or other neurological disorder besides the one under study.
* Prior laryngeal framework surgeries or other disorders affecting the vocal folds
* Patients who are asymptomatic due to treatment with botulinum toxin into the vocal folds.
* Presence of ferromagnetic implants and cardiac implants that would be contraindicated to MRI
* Gagging or discomfort that would preclude the placement of the endoscope to visualize the larynx
* Dementia, severe depression or severe anxiety.
* Any clinical condition or medication judged by the investigators to potentially preclude the patient from safely completing awake brain surgery and research protocols.
Anterior Vertebral Body Tethering (AVBT) Using Zimmer Biomet Tether System or Dynesys System Components to Treat Pediatric Scoliosis

The Researchers want to assess the short-term safety of Anterior Vertebral Body Tethering (AVBT) in skeletally immature subjects with moderate to severe scoliosis and compare them with a fusion cohort.


Eligibility Criteria:
Inclusion Criteria:

1. Male \& female, age 10 years to 16 years.
2. Scoliosis curve between 40-70 degrees.
3. At least 1 year of growth remaining measured by Sanders bone age 4 or less or Risser stage 2 or less.
4. Adolescent idiopathic scoliosis.
5. Lenke 1, 2, 3C, 5 (thoracic, thoracolumbar, or thoracic and lumbar).
6. Parents must be able to understand the study and sign the consent document. Assent will be obtained and documented as age appropriate.
7. Patients and parents must be able to comply with study procedures and visits, including 3-month, 1-year, and 2-year follow-up visits.

Exclusion Criteria:

1. Congenital, neuromuscular or syndromic scoliosis.
2. Underlying neuromuscular disease.
3. Pregnancy.
4. Nonflexible curves (bending films show residual curve greater than 40 degrees).
5. Prior surgery for scoliosis treatment.
6. Patients with active systemic infection.
7. Known, reported allergies to titanium, PET, or PCU. Known, reported substance abuse, including alcohol.
Mask-associated Dry Eye Symptoms in China

To review the relationship of increased face mask usage arising from lockdown measures instituted during the COVID-19 pandemic with dry eye symptoms on Chinese people, and make recommendations for mitigating potential detrimental effects on dry eye symptoms.


Eligibility Criteria:
Inclusion Criteria:

* age \>=8 years mental health

Exclusion Criteria:

* eye diseases mental or systemic diseases
The Duration of Humoral Immunity and the Memory Cell Function After Vaccination With 7-valent Pneumococcal Conjugate Vaccine in CLL

Patients with chronic lymphocytic leukemia (CLL)have had very poor humoral responses to pneumococcal polysaccharide vaccine (PPV). The vaccine in which pneumococcal polysaccharide antigens are conjugated to protein (PCV) have been immunogenic in CLL patients in our previous studies.

The purpose of this study is to evaluate the duration of these vaccine-induced antibodies and the function of memory cells by giving a one dose of PPV-vaccine after several years of PCV-vaccination.


Eligibility Criteria:
Inclusion Criteria:

* CLL patients and controls who have been vaccinated with PCV in our previous study

Exclusion Criteria:

* Vaccinated with PPV-vaccine within the last 5 years, immunoglobulin substitution, corticosteroid treatment (equivalent of 20mg prednisolone per day)
Magnetic Resonance Imaging (MRI) and Decline of Aging Aviator Performance

The primary purpose of this study is to apply state-of-the-art Magnetic Resonance Imaging (MRI) and Magnetic Resonance Spectroscopic Imaging (MRSI) techniques to measure changes over time in the brain.

We expect that MRI and MRSI techniques will be a useful adjunct in research efforts to understand individual differences in performance of a complex attention-demanding task, such as flying a plane or driving a car. Other predictors of change in performance of a complex task may include simple tests of processing speed and working memory, past training and recent practice of the task, and genetic risk factors for degenerative brain disease. In this project, we will examine whether baseline MR measures are as useful as longitudinal MR measures in predicting amount of change over time in task performance.

This research is part of a long-term effort to achieve earlier identification of individuals at risk of decline and ultimately minimize loss of function.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will be included if they have participated in the protocol "Age-Related Longitudinal Changes in Aviator Performance" and agree to participate in this protocol.

Exclusion Criteria:

* Subjects will be excluded if they currently have a major neurological disease, unstable/untreated medical disease (such as untreated hypertension).
* In consideration of the magnetic fields in which subjects will be placed for the MR scanning, we will also exclude subjects who are unable to safely and comfortably complete the scanning session. This includes individuals who are wearing any metal prosthesis or who have cardiac pacemakers or any other nonremovable metal objects.
* Subjects reporting a history of severe claustrophobia or poorly controlled back pain will be excluded because it is unlikely they could comfortably remain still in the MRI scanner for the duration of the scan.
* In addition, subjects who do not fit in the apparatus will also be excluded.
Performance and Safety of the Polylactic Interference Screw Used in Anterior Cruciate Ligament Reconstructions

The evaluation of the clinical data has demonstrated the conformity of the Polylactic Interference Screw (PIS), with the relevant essential requirements for its use in orthopaedic applications. The Polylactic Interference Screws are intended for tibial and femoral ligament/graft fixation in the case or Anterior Cruciate Ligament (ACL) reconstructions. It has been concluded that the risks associated with the use of the device are acceptable when weighted against the benefits to the patients. In order to improve the clinical data on the PIS, the manufacturer, Biomatlante, decided to assess that the performance and safety of the device are maintained until the reaching of its intended use. In this objective, the goal of this study will be to observe the following parameters:

Objective IKDC score (clinical evaluation) Subjective IKDS score (functional evaluation) Safety (report of any adverse event) Follow-up of the patient's recovery


Eligibility Criteria:
Inclusion Criteria:

* Acute or chronic Anterior Cruciate Ligament deficiency with complete or partial lesion of the anteromedial bundle requiring primary reconstruction of the Anterior Cruciate Ligament with hamstring tendons
* Males or females aged from 18 to 60 years
* No history of surgery on the affected knee
* Patients not under guardianship or judicial protection
* Signature of non opposition form (consent of the patient

Exclusion Criteria:

* History of ligament, meniscal surgery or fracture of the affected knee
* Pregnancy of breastfeeding women
Prolonged Exposure (PE) Treatment for Post Traumatic Stress Disorder (PTSD) 20 Minutes Versus 40 Minutes

Comparing the efficacy of 40 minutes PE treatment to 20 minutes of the same treatment


Eligibility Criteria:
Inclusion Criteria:

* PTSD

Exclusion Criteria:

* Psychotic symptoms
* Dissociation
* Drug or Alcohol dependence
A Rural OPTIFAST Intervention for Partial Remission of Type 2 Diabetes in Adults With Obesity

As rural Canada is a resource poor health service environment, we propose to test whether an OPTIFAST dietary replacement intervention, without the service intensive behavioural component, can cause partial remission of DMII in patients with obesity and DMII.

The objective of this study is to see if a rural-specific OPTIFAST intervention, of dietary replacement only, can cause a partial remission of DMII patients with obesity between the age of 18 and 65 diagnosed with DMII within the last 6 years. The goal is to inform the current diabetes routine care by standardizing a rural protocol on the effectiveness of rural-specific OPTIFAST intervention for people with DMII who want to attain partial remission of DMII.

Eligibility Criteria:
Inclusion Criteria:

* Study participants will be patients of the MFHT, aged 18 to 65, BMI between 27 and 45 kg/m 2 , and newly diagnosed with DMII within the past 6 years.

Exclusion Criteria:

* The exclusion criteria will be anti-hyperglycemic medications, slow onset of type 1 diabetes (DMI) or maturity onset diabetes of the young (MODY), renal dysfunction (serum creatinine\>150 μmol/l), history of myocardial infarction, untreated thyroid disease, consumption of 4 alcohol units/day by men and 3 units/day by women, chronic steroid consumption, unstable psychiatric conditions, and atypical antipsychotic medication.
Hydromorphone vs Fentanyl in Children Undergoing Tonsillectomy Surgery

A RCT to compare hydromorphone versus fentanyl for pain control following tonsillectomy or adenotonsillectomy surgery.

This is a randomized clinical trial with masked assessment, comparing recovery indices for patients receiving intermediate acting versus short acting opioid analgesia using hydromorphone or fentanyl as intraoperative analgesics. An otherwise standardized anesthetic and analgesic regimen will be utilized, consistent with routine care at SLCH. Patients will be randomized 1:1 in block sizes of 5 per group. Patients will be randomized to receive either hydromorphone or fentanyl throughout the perioperative period by opening a sealed protocol envelope.

Eligibility Criteria:
Inclusion Criteria:

1. Children ages 2 to 15 years old
2. Presenting for tonsillectomy or adenotonsillectomy surgery
3. American Society of Anesthesiologists Physical Status (ASAPS) Classification 1, 2 or 3
4. Provide Informed Consent / Assent (as appropriate)

Exclusion Criteria:

1. Additional Concurrent surgeries, exclusive of myringotomy tubes, minor oral/nasal procedures (e.g. frenulectomy), and endoscopic procedures
2. Revision tonsillectomy or revision adenotonsillectomy surgery
3. Known pregnancy
4. Any condition which would make the participant, in the opinion of the investigator or the attending anesthesiologist caring for the patient, unsuitable for the study.
Ultrasound Perfusion Estimation for Assessment of Peripheral Arterial Disease

The purpose of this study is to develop a new noninvasive tool for early diagnosis of Peripheral Arterial Disease (PAD) and use the proposed method for monitoring the disease progression and the response to interventional treatment in PAD patients.


Eligibility Criteria:
Inclusion Criteria:

Patient volunteers:

* Male and Female, ages 18 years old and up
* Symptom of claudication and suspected for PAD
* Scheduled for vascular testing.

Healthy volunteers:

* Male and female, ages 18-75 years old and up
* Normal BMI
* No history of smoking, cardiovascular disease, or diabetes.

Exclusion Criteria:

Patient volunteers:

* Patients with gangrene
* Patients having surgery or stent
* Patients with ulcer on their leg
* Any health condition that does not allow proper use of ultrasound scanning
* People considered in "vulnerable" populations.

Healthy volunteers:

* Include volunteers with BMI not more than 30
* No history of smoking
* No history of (diabetes, hypertension, cardiovascular diseases)
* People considered in "vulnerable" populations.
Comparison Study Between Cefdinir & Amoxicilline/Clavulanate in Acute Sinusitis and Assessment of Quality of Life

This study is a comparison between two commonly used antibiotics (Cefdinir vs. Amoxicillin/Clavulanate) in patients with acute sinus infection, surveying quality of life. The hypothesis is that the two treatments would be at the least equivalent based on clinical outcome measures of improvement in quality of life.

The purpose if this investigation is to evaluate the rate of improvement ub Quality of LIfe (QOL) in two different medications, a 10-day course of Cefdinir 300 mg PO BID versus a 10-day course of Amoxicillin/Clavulanate 1000 mg/62.5 mg XR BID, in the treatment of acute bacterial sinusitis.

Eligibility Criteria:
Inclusion Criteria:

* Male and female outpatient adults greater than 18 years old fulfilling the case definition for acute bacterial sinusitis
* Case definition includes clinical signs and symptoms, radiographic findings and collection of purulent material from the sinus

Exclusion Criteria:

* Symptoms less than 7 days and more than 3 weeks
* History of sinus surgery within 3 months
* History of frequent sinus infections (more than 2 episodes within the last 6 months)
* History of kidney and liver disease
* Pregnant and nursing women
* Pre-existing disease that could predispose to sinus infections (cystic fibrosis or nasal polyps
* Immunosuppressed patients
* History of allergy to either drug. Patients with a documented history of allergies to either penicillin or cephalosporins will be excluded.
Outcome of TKA Using Customized Cutting Block Compared With Conventional Intramedullary Cutting Guide

Customized cutting block and conventional cutting guide are both effective in improving accuracy and function of OA knee patients.

Customized cutting block and conventional cutting guide are both effective in improving accuracy and function of osteoarthritic knee patients.

Eligibility Criteria:
Inclusion Criteria:

* Age 60-90
* Diagnosis of osteoarthritis or rheumatoid arthritis of the knee and qualify for surgery, as indicated by one of the following:
* Painful and disabled knee joint resulting from osteoarthritis where one or more compartments are involved;
* Correction of varus or valgus.
* Willing to participate and return for follow-up study visits.

Exclusion Criteria:

* Vascular insufficiency
* Previous deep vein thrombosis and pulmonary embolism
* Previous osteotomy
* Previous patella fracture or surgery
* Previous healed tibia or femur fractures
* Previous joint replacement surgery