cyrilzakka/clinical-trials huggingface dataset:
Basis: Evaluating Sirtuin Supplements To Benefit Elderly Trauma Patients (BES2T BET)

Basis: Evaluating Sirtuin Supplements To Benefit Elderly Trauma Patients (BES2T BET) A phase I, randomized, double-blind, placebo-controlled, single institutional pilot trial investigating the impact of nicotinamide riboside/pterstilbene (BasisTM) on functional recovery after traumatic fall in elderly patients

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This Phase I pilot study will determine if supplementing with the combination of NR and Pter (BasisTM) is well tolerated and will provide the pretrial data necessary to plan a randomized clinical trial aimed at determining if BasisTM improves the functional outcome of injured elderly patients.

Primary Objective

• To determine if BasisTM is well tolerated by elderly patients up to 90 days post injury

Secondary Objectives:

* To determine if BasisTM preserves or improves muscular strength, endurance, and activity following traumatic injury in elders.
* To determine if BasisTM preserves or improves physiologic composition (muscle/fat ratio) following traumatic injury in elders.
* To determine if BasisTM decreases 90 day incidence of recurrent falls
* To determine the impact of BasisTM on subjective well-being (pain) and quality of life (EQ-5D-5L)
* To determine if BasisTM alters NAD and sirtuin activity in inflammatory cells.

Elderly trauma patients who present after a traumatic injury will be screened and enrolled within 48 hours of their trauma evaluation. Baseline status will be determined using functional surveys, physical assessments, and physiologic measurements. Patients will be randomized to either BasisTM or placebo for 90 days. Patients will be reassessed at 2 weeks, 6 weeks (optional) and 90 days. Activity and heart rate will be monitored continuously using a wrist FitBit Device.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 65 year old
2. Patient presenting to trauma bay

Exclusion Criteria:

1. Currently taking medication for severe to moderate dementia (see Appendix 9)
2. Currently taking niacin, nicotinic acid, nicotinamide, or nicotinamide riboside
3. Pre-existing immobility (wheel chair or bed bound)
4. Renal failure requiring hemodialysis or peritoneal dialysis
5. End-stage Liver Disease (Model for End Stage Liver Disease Score ≥ 25) (see Appendix 11)
6. Intubated prior to enrollment (excluding intubation for surgery)
7. More than 48 hours post-injury
8. Thoracic Anatomic Injury Score \> 3 (see Appendix 10)
9. Other Injuries with Anatomic Injury Score \>2, excluding thorax (see Appendix 10)
10. Hip fractures
11. Non-English speaking
Dental Anxiety Among Children Pre and Post COVID 19 Pandemic

Dental fear and anxiety is a significant issue that affects pediatric patients and creates challenges in oral health management. Considering that the coronavirus disease 2019 (COVID-19) pandemic, along with its associated sanitary regime, social distancing measures and nationwide quarantines, could itself induce public fears, including in children, it is of great interest to explore whether this situation and the necessity of reorganizing dental care could potentially affect the emotional state of pediatric patients facing a need for urgent dental intervention


Eligibility Criteria:
Inclusion Criteria:

* parental consent
* no previous dental experience
* medically free children

Exclusion Criteria:

* children with negative behavior according to Frankl Rating Scale
* children require general anesthesia
A Study of MM-121 Combination Therapy in Patients With Advanced Non-Small Cell Lung Cancer

A Phase 1-2 study of MM-121 in combination with standard therapy for non-small cell lung cancer (NSCLC).

Phase 1: Patients with Non-Small Cell Lung Cancer (NSCLC) may be enrolled to evaluate the safety, tolerability and recommended Phase 2 dose of MM-121 in combination with standard therapy.

Phase 2: Patients with Non-Small Cell Lung Cancer (NSCLC) may be enrolled to estimate the progression-free survival of the MM-121 + standard therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with locally advanced or metastatic non-small cell lung cancer.
* Patients must be \>/= 18 years of age.
* Patients must have adequate Performance Status (PS) as measured by ECOG and adequate end organ function.

Exclusion Criteria:

* Patients with a recent history (within 5 years) of another malignancy.
* Patients who are pregnant or nursing.
* Patients with clinically significant heart failure.
* Patients with clinically significant eye or gastrointestinal abnormalities.
The BRAINFOOD Trial to Prevent Recurrent Hepatic Encephalopathy.

This study is being completed for patients with cirrhosis, including patients with a prior history of hepatic encephalopathy (HE) to evaluate the feasibility and benefits of medically-tailored meals as an intervention.

Patients will be enrolled from the University of Michigan and will complete the baseline assessments in-person or remotely. In addition participants will complete study related materials before, during and after treatment with medically-tailored meals (MTM). After completing the study meals, participants will return for follow-up or have this visit completed remotely as well as have an observational period for 12 more weeks.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cirrhosis will be based upon:

  1. liver biopsy, OR
  2. history of cirrhosis complication: ascites, variceal bleeding, hepatic encephalopathy, OR
  3. 2 of the following 4 criteria:

     1. Ultrasound, Computed tomography (CT), or Magnetic resonance imaging (MRI) findings of cirrhosis (cirrhotic appearing liver, splenomegaly, varices, ascites)
     2. Fibroscan liver stiffness score \>13 kilopascals (kPa)
     3. Laboratory testing: aspartate aminotransferase/platelet ratio index (APRI) \>2.0
     4. CT, MRI or esophagogastroduodenoscopy (EGD) showing presence of esophageal varices
* Patients with history of \> grade 2 HE within 180 days of enrollment based on review of clinical documentation verifying the event. If a description of HE symptoms is provided in clinical documentation, but it is unclear if it meets Grade 2 criteria, the principal investigator will assess the clinical documentation and provide an HE grade.

Exclusion Criteria:

* Non-English speaking
* Model for End-Stage Liver Disease (MELD) Score \> 20
* Pregnancy (self-reported)
* Unable or unwilling to provide consent
* History of liver transplant
* Current or planned admission to a nursing facility
* Serum creatinine \> 2.0 milligrams per deciliter (mg/dL) (with the exception that we will include patients with a serum creatinine \> 2.0 mg/dL if they are receiving hemodialysis)
* Disorientation at the time of enrollment
* Barcelona-Clinic Liver Cancer (BCLC) Stage D Hepatocellular Carcinoma with Child-Turcotte-Pugh (CTP) Class C
* History of eating disorder
To Quantify the Impact of Addition of the GAAD Score to Imaging in Patients with Chronic Liver Disease Eligible for HCC Surveillance.

The goal of this prospective observational study is to test the impact of addition of the GAAD score to imaging in patients with chronic liver disease eligible for HCC surveillance. The main questions it aims to answer are:

* Diagnostic accuracy of the GAAD score (cut-off 2.57 (3)) for detection of HCC (overall and by BCLC stage), expressed using sensitivity, specificity, negative predictive value and positive predictive value.
* Change in GAAD score over time, and proportion of patients with a GAAD score above the cut-off over time in relation to potential confounding factors (e.g. age, bilirubin levels, presence of HCC).

  1000 participants with chronic liver disease eligible for HCC surveillance will be enrolled. Data will be collected for 3 consecutive years after enrollment. As per clinical practice, patients will undergo standard bi-annual HCC surveillance comprising liver imaging with ultrasound (or CT or MRI based on previous investigations) and GAAD score assessment based on blood samples.


Eligibility Criteria:
Inclusion Criteria:

* All patients with cirrhosis
* Non-cirrhotic chronic hepatitis B patients meeting any of the following criteria: positive family history for HCC, intermediate-high aMAP and/or (m)PAGE-B score (if non-Caucasian)
* Non-cirrhotic chronic hepatitis C patients (with or without SVR) with a history of F3 fibrosis (based on histology or liver stiffness assessment)
* Non-cirrhotic NASH patients with a history of F3 fibrosis (based on histology or liver stiffness assessment)

Exclusion Criteria:

* Diagnosis with any other cancer other than non-melanoma skin cancer
* History of HCC
* Women who are pregnant or lactating
* Patient with glomerular filtration rate \<45 ml /min/1.73 m2
* Unwillingness or inability to undergo both CT and MRI imaging
* Life expectancy \<2 years
* Use of vitamin K antagonists
Pilot Study of PDL to Treat BCC and SCCIS

This is a research study to find out more about the use of the pulsed dye laser in the treatment of basal cell carcinoma and early stage squamous cell carcinoma that has not invaded deep into the skin. The purpose of this study is to determine whether the use of the pulsed dye laser (PDL) can completely clear or regress basal cell carcinoma or early stage squamous cell carcinoma.

Pulsed dye laser is a type of laser that is commonly used to treat lesions on the skin that have a prominent blood vessel component. It has been used to treat broken blood vessels on the face, hemangiomas in children and adults, leg veins, port wine stains, and other lesions with a prominent vascular component.


Eligibility Criteria:
Inclusion Criteria:

* Patients requiring surgical excision (conventional or Mohs) for biopsy-proven basal cell carcinoma and biopsy-proven squamous cell carcinoma in situ that is clinically present at the pre-operative visit and measures greater than 0.4cm and less than 3cm in size.
* Lesions in the Trunk, Extremities, and Scalp
* Presence of clinically identifiable residual tumor.
* Patients, males and females, aged 18-90 years.
* Willing to participate.
* Able to give informed consent.

Exclusion Criteria:

* Age younger than 18 years
* Location of lesion not in the Trunk, Extremities, and Scalp
* Fitzpatrick skin type V or VI.
* Prior history of known light sensitivity.
* Pregnancy
* Cognitive Impairment
* Prisoner
Ultrasound Elastography in Imaging Patients With Thyroid Nodules

This clinical trial studies how well ultrasound elastography works in assessing the cancer status of potentially malignant thyroid nodules.

PRIMARY OBJECTIVES:

Determine the utility of ultrasound elastography in evaluation of thyroid nodules being evaluated for the presence of cancer.

Elastography measures the passages of ultrasound shear waves through tissue to gauge the stiffness and compressibility of the tissue, collectively "tissue stiffness," and may be a better way to image thyroid nodules. Tissue stiffness is a physiological parameter that is being evaluated for differences between non-cancerous (benign) and cancerous thyroid nodules.

Participants will undergo elastography over the 10 minutes prior to either fine needle aspiration of a biopsy specimen or surgical resection of the thyroid nodule. Tissue specimens from the biopsy specimen or surgical resection will be assessed pathologically to determine actual cancer status.

Eligibility Criteria:
Inclusion Criteria:

* Presence of a thyroid nodule that is amenable to ultrasound guided fine needle aspiration

Exclusion Criteria:

* Patients who are unable to lie supine for a biopsy
* Pregnant patients
Virtual Mind-Body Exercises for People Having Pancreatic Surgery

The purpose of this study is to find out if it is practical to provide 2 interventions, VMB exercise classes and EUC (pre-recorded self-care videos), during the perioperative period (before and after surgery) to improve health-related outcomes and quality of life for people undergoing a pancreatectomy.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years or older
* Any pancreas disease (benign, pre-malignant, or malignant) and will be undergoing pancreatectomy
* Has at least one week to participate in the study prior to the anticipated surgery date
* Eastern Cooperative Oncology Group (ECOG) Performance status 0 or 1
* English-speaking only

Exclusion Criteria:

* Unable to give informed consent due to cognitive impairment or impaired decisionmaking capacity
* Cognitive impairment precluding response to study assessments
* Received neoadjuvant or any chemoradiation in the past 60 days
* Unwilling to accept random assignment
* Unwilling to commit to the 12-week study time period
* Unlikely to be compliant because of social factors that prevent patients from attending classes or doing home practice (e.g., unreliable internet, no access to a computer)
Topical Cyclosporin A 0.05% Eye Drops for Management of Symptomatic Acquired Punctal Stenosis. A Prospective, Controlled Clinical Study.

A prospective, controlled, interventional clinical study, includes all patients (16 years) with symptomatic epiphora and diagnosed with grade 1 or grade 2 acquired punctal stenosis. All patients undergo punctal dilatation, canalicular probing and nasolacrimal duct irrigation. Afterwards, patients are divided into two groups: Group A: patients receive only medical treatment in the form of topical 0.05% cyclosporin (Restasis®, Allergan Inc) twice daily for 6 months. Group B: patients receive mini-Monoka stent insertion in the lower canaliculus for 6 months. Outcome measures are changes in Munk scoring, grading of the punctum, functional and anatomical success. Functional success is defined as Munk score 0 to 1. Anatomical success is defined as grade 3 punctum.


Eligibility Criteria:
Inclusion Criteria:

* The study includes all patients (more than 16 years) with symptomatic epiphora and diagnosed with grade 1 or grade 2 acquired punctal stenosis

Exclusion Criteria:

* Patients presented with congenital epiphora, previous eyelid surgeries, neoplastic or traumatic causes of punctual or canalicular obstruction, or any other causes of lacrimal passage obstruction such as canalicular, common canalicular or nasolacrimal duct obstruction NLDO are excluded from this study.
i-Matter: Investigating an mHealth Texting Tool for Embedding Patient-reported Data Into Diabetes Management

This study will integrate a technology-based patient-reported outcome (PRO) system \[herein MJS DIABETES\] that incorporates patients' perspective of their disease and functional status into the management of type 2 diabetes (T2D) in primary care practices. MJS DIABETES is an innovative mobile platform that utilizes text-messaging to capture patients' self-reported PROs in real-time; enhance patient engagement through data-driven feedback and motivational messages; and create dynamic visualizations of the PROs that can be shared in printed reports, and integrated into the EHR; thus making it actionable for patients and their PCPs.

Using a mixed-methods design, this study will be conducted in 2 phases: 1) a formative phase, using the evidence-based user-centered design approach; and 2) a clinical-efficacy phase. For the formative phase, a qualitative research method will be used to: a) adapt MJS to the needs of PCPs and T2D patients; b) integrate MJS DIABETES into the EHR system, the primary care practice and the lives of patients with T2D; and c) evaluate the usability of MJS DIABETES in a subset of T2D patients and their PCPs in order to optimize the tool's performance and workflow integration.

For the clinical efficacy phase, a randomized control trial will be used to identify the efficacy of MJS DIABETES versus Usual Care (UC) on reduction HbA1c at 12-months, among 282 patients with T2D who receive care in safety-net practices.


Eligibility Criteria:
Inclusion Criteria:

Primary Care Provider Inclusion Criteria:

* Fulltime primary care provider (MD/DO, NP) practicing at the participating family health centers (FHCs) and,
* Provide care to at least five patients with a diagnosis of T2D.

Patient Inclusion Criteria:

* Have a diagnosis of T2D for ≥6 months;
* Have uncontrolled T2D defined as HbA1c \>7% documented in the EHR on at least two visits in the past year;
* Fluency in English or Spanish;
* Be willing to send/receive text messages; and

Exclusion Criteria:

* Have a diagnosis of T2D for ≥6 months;
* Have uncontrolled T2D defined as HbA1c \>7% documented in the EHR on at least two visits in the past year;
* Fluency in English or Spanish;
* Be willing to send/receive text messages; and
Effects of Hold Relax With Agonist Contraction and Active Release Therapy on Clinical Outcomes in Piriformis Syndrome

The aim of this study is to compare the effects of hold relax agonist contraction and active release therapy on reducing pain intensity, improving functioning and sleep quality in patient with piriformis syndrome.

Both these techniques are passive, non-invasive manual therapy techniques which are easy to perform and less time consuming and may yield better outcomes resulting improved quality of life.


Eligibility Criteria:
Inclusion Criteria:

1. Age group 25-55 years
2. Both male and female.
3. Gluteal pain with or without radicular symptoms.
4. Patients of piriformis syndrome diagnosed by orthopedic consultant.
5. Sub-acute and chronic piriformis syndrome.
6. Unilateral pain.
7. Pain score equal to and greater than 3 according to pain rating scale.

Exclusion Criteria:

1. Intermittent vascular claudication and spondylolisthesis.
2. Past history of hip, femur or vertebral fracture
3. Past history of spinal surgery.
4. Spinal tuberculosis.
5. Rheumatoid disease.
6. Disc pathology, sacroiliac joint dysfunction or mechanical back pain.
7. History of infectious disease.
8. Leg length discrepancy.
9. Any postural abnormality or deformity.
Effect of Ultrasound-guided Left Stellate Ganglion Block on Rapid Recovery of Patients Undergoing Cardiac Valve Replacement and Its Mechanism

In this study, Valve replacement patients undergoing cardiopulmonary bypass were randomly divided into control group and experimental group (SGB Group) , main outcome measures: postoperative complications (pulmonary infection, oxygenation injury, arrhythmia, hemorrhage, enteroparalysis, incision infection, renal insufficiency, cognitive impairment, etc.) and 30-day mortality. Secondary outcome measures: Hemodynamics, postoperative extubation time, length of stay and total cost of hospitalization. To investigate the effect of SGB on the rapid recovery of patients with Valve replacement heart disease after cardiopulmonary bypass.

The aim of this study was to investigate the effect of left stellate ganglion block on the incidence and severity of postoperative complications in patients with cardiac Valve replacement undergoing cardiopulmonary bypass, to compare the difference of inflammatory reaction between the control group and the stellate ganglion block group at different time points, and to preliminarily elucidate the molecular mechanism of stellate ganglion block in the protection of cardiac Valve replacement during cardiopulmonary bypass (CPB) . The first part is a prospective study on the effect of left stellate ganglion block on cardiac Valve replacement Hemodynamics during cardiopulmonary bypass (CPB) , the incidence, length of hospital stay, cost of hospital stay, and 30-day mortality of the common Valve replacement complications after cardiopulmonary bypass (pulmonary infection, oxygenation injury, arrhythmia, bleeding, intestinal paralysis, incision infection, renal insufficiency, cognitive impairment, etc.) , to determine the effect of left stellate ganglion block on rapid recovery from cardiac Valve replacement during cardiopulmonary bypass. In the second part, we collected the dynamic changes of inflammatory factors in plasma of control group and patients with stellate ganglion block before and 1,3,6,24 and 72 hours after operation, to explore the molecular mechanisms by which left stellate ganglion block promotes rapid recovery and reduces severe complications in patients with cardiac Valve replacement undergoing cardiopulmonary bypass (CPB) .

Eligibility Criteria:
Inclusion Criteria:

- Sixty patients with cardiac Valve replacement undergoing elective cardiopulmonary bypass, with cardiac function class II-IV and ASAII-IV, aged 18-70 years.

Exclusion Criteria:

- Patients with off-pump cardiac Valve replacement, age \> 18 years or \> 70 years, cardiac function ≥ III, ASA grade ≥ III, local anesthetic allergy, concomitant immune disease or immunosuppressive status, patients with severe mental disorders who could not cooperate with SGB, abnormal neck anatomy, and failure of stellate ganglion block refused to participate in the study.
The Application of Enhanced Recovery After Surgery Clinical Pathway in Posterior Cervical Spine Surgery

This study intends to establish a multidisciplinary collaborative ERAS clinical pathway of cervical posterior surgery,and to verify its effectiveness, safety and value in health economics.

Enhanced recovery after surgery (ERAS) is a new model of deep cooperation between surgery，rehabilitation medicine, anesthesiology, nursing and other disciplines in recent years, which enables patients to start rehabilitation training as soon as possible after surgery and improves the comprehensive effect of surgery. Posterior cervical surgery is traumatic, and it is significant to enhance postoperative rehabilitation to improve the overall efficacy of patients. Currently, there are no clear guidelines supporting the clinical effectiveness of ERAS in reducing complications, reducing costs, and enhancing recovery after posterior cervical surgery. Therefore, this study aims to establish a multidisciplinary ERAS model for posterior cervical surgery in Peking University Third Hospital and verify its clinical effectiveness. This is a multi-center, multidisciplinary prospective cohort study,in which the orthopedics department was combined with the anesthesiology department, rehabilitation department, nutrition department, operating room and nursing team to establish the ERAS clinical pathways for posterior cervical spine surgery. Clinical pathways include surgical procedure optimization, rehabilitation procedure optimization, anesthesia and nursing procedure optimization. As it is optimized and promoted,the ERAS clinical pathways will improve the curative effect and prognosis of posterior cervical surgery, so that more patients with cervical spondylosis will benefit.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-70, gender unlimited;
2. Diagnostic diagnosis of cervical spondylosis and consistent with the indications of posterior spinal canal extended laminoplasty;
3. Basis of serious diseases of centerlessness, brain, lung, kidney or other important organs, preoperative ASA score I-II;
4. Agree to participate in the study and sign the informed consent.

Exclusion Criteria:

-
Covid-19 Convalescent Plasma and Monoclonal Antibodies Treatment of Immunocompromised Patients

Data on the use of convalescent plasma in the treatment of covid-19 are scarce: the results of randomized studies involving mainly immunocompetent patients are disappointing, while case series or retrospective data on more selected patients , in particular immunocompromised patients suggest a benefit in these patients whose clinical manifestation seems essentially related to the uncontrolled infection and not the cytokine storm.


Eligibility Criteria:
Inclusion criteria:

* Adult patient
* Immunocompromised patient (solid neoplasia, malignant hemopathy, solid organ transplantation, primary immune deficiency, systemic disease, chronic inflammatory disease, etc.)
* Hospitalized between 25/02/2020 and 15/01/2023 at HUS, ICANS, CH Colmar and CH Mulhouse
* Having received curative monoclonal antibody treatment or convalescent plasma treatment for SARS-Cov2 infection
* Patient who has not expressed, after being informed, his opposition to the reuse of his data for scientific research purposes.

Exclusion criteria:

* Subject who expressed their opposition to participating in the study
* Subject under guardianship, curatorship or safeguard of justice