cyrilzakka/clinical-trials huggingface dataset:
Is it Safe to do Laparoscopic Cholecystectomy for Acute Cholecystitis up to Seven Days?

Objectives: To compare the safety of early (≤72h) versus late (\>72h-7days) laparoscopic cholecystectomy (LC) from symptom onset for acute cholecystitis (AC).

Background: As LC within 72h of symptom onset was considered the optimum time, sometimes there was a delay in diagnosis and management. So, we raised the question of safety and feasibility of performing LC to patients with AC who failed to have LC within 72h of acute attack.

Patients and Methods: This was a prospective, randomized, double-blind, clinical trial; carried out on 120 patients presented with AC between September 2017 and April 2019. Patients were randomly allocated into two equal groups assigned to LC; group E: within 72h of symptom onset, and group L: after 72h up to seven days from symptom onset.


Eligibility Criteria:
Inclusion Criteria:

* Patients with AC within seven days from symptom onset
* American Society of Anesthesiologist (ASA) physical status ≤ II
* Age from 21 to 60 years

Exclusion Criteria:

* Patients with ASA physical status \> II
* Age \< 21 years or \> 60 years
* Child classification B or C
* Choledocholithiasis
* Acute pancreatitis
* Severe sepsis
* Gallbladder perforation
* Pregnant women
Long-Term Follow-up Study of Subjects Treated With Autologous T Cells Using the Sleeping Beauty System to Express TCRs

Long-Term Follow-Up Study for Subjects Enrolled in the Phase I/II Study of Autologous T Cells Engineered using the Sleeping Beauty System to Express T cell Receptors (TCRs) Reactive Against Cancer-specific Mutations in Subjects with Solid Tumors

This is a prospective observational, non-interventional study for the long-term follow-up of safety and efficacy for subjects who have received autologous T cells engineered using the Sleeping Beauty System to express T cell receptors (TCRs) reactive against cancer-specific mutations (neoantigen specific TCR-T cells). In this study, subjects will be followed for up to 15 years after initial TCR-T cell drug product administration for evaluation of delayed adverse events (AEs).

Eligibility Criteria:
Inclusion Criteria:

1. Subjects treated with TCR-T cell drug product on study TCR001-201 or any other Alaunos TCR-T cell drug product study and have either completed their original treatment protocol or have discontinued early.
2. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
3. Subject must be capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
4. Subjects agree to allow clinical samples to be collected and stored at study site and/or Alaunos Therapeutics, Inc. (Alaunos) or designee for testing.

Exclusion Criteria:

1. Subjects that were consented to this LTFU study but did not receive TCR-T cell drug product on study TCR001-201 will be excluded. No other exclusions are permitted.
Inflammation in Methamphetamine and STIs (IMSTI)

This clinical trial aims to investigate the effects of a decline in methamphetamine use on rectal inflammatory cytokine levels, substance use contexts, and HIV/STI risk behavior. This clinical trial also seeks to evaluate joint effects of methamphetamine use and rectal gonorrhea/chlamydia infection on rectal inflammatory cytokine levels. The proposed trial will consist of 40 MSM, half with rectal gonorrhea/chlamydia infection at enrollment (n=20), with methamphetamine use disorder that will receive contingency management for methamphetamine reduction. Following baseline measurement, participants will be observed over the course of 8 weeks, where participants will complete behavioral surveys, provide urine for drug testing, and rectal samples for measurement of rectal inflammatory cytokine levels.


Eligibility Criteria:
Inclusion Criteria:

* Cisgender male
* 18 years of age or older
* Understand written and spoken English
* Condomless receptive anal intercourse in past 90 days
* Meet DSM-5 criteria for methamphetamine use disorder
* Positive urine toxicology screen for MA metabolites at study entry
* Negative rectal GC/CT screen (n=20) or Positive rectal GC and/or CT screen (n=20)
* Able to provide written informed consent and willing/able to complete study visits.

Exclusion Criteria:

* Reports current treatment for another substance use disorder
* Positive test for opioids, cocaine, and/or hallucinogens
* Treatment for gonorrhea and/or chlamydia infection in past 3 months
* Presence of a condition that in the opinion of the investigator would compromise the safety of the patient or the quality of the data
The Role of Glucagon in the Effects of Dipeptidyl Peptidase-4 Inhibitors and Sodium-glucose Co-transporter-2 Inhibitors

In normal physiology, glucagon from pancreatic alpha cells plays an important role in maintaining glucose homeostasis via its regulatory effect on hepatic glucose production. Patients with type 2 diabetes exhibit elevated plasma glucagon levels in the fasting state, and in response to ingestion of glucose or a mixed meal.glucagon, glucagon concentrations fail to decrease appropriately and may even increase. This diabetic hyperglucagonaemia may therefore contribute importantly to the hyperglycaemia of the patients.

Several glucose-lowering treatment modalities have been shown to affect glucagon levels in patients with type 2 diabetes, but the role of glucagon in the glucose-lowering effects of these treatment modalities has been difficult to discern. By using a glucagon receptor antagonist (GRA) the investigators will exploit glucagon receptor antagonism to delineate the role of glucagon during treatment with sodium-glucose co-transporter 2 (SGLT2) inhibitors and dipeptidyl peptidase 4 (DPP-4) inhibitors, which have been shown to increase and decrease plasma glucagon levels, respectively.


Eligibility Criteria:
Inclusion Criteria:

* Caucasians above 30 years of age with diet or metformin treated type 2 diabetes for at least 3 months (diagnosed according to the criteria of the World Health Organization)
* Normal haemoglobin
* Informed consent

Exclusion Criteria:

* Inflammatory bowel disease
* Intestinal resections
* Nephropathy (serum creatinine above normal range and/or albuminuria)
* Liver disease (serum alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) \>2×normal values)
* Treatment with medicine that cannot be paused for 12 hours
* Pregnancy and/or breastfeeding
* Family history of pancreatic islet tumours
* Age above 75 years
* Treatment with loop-diuretics (applies only to arms with empagliflozin or empagliflozin placebo)
* Chronic heart failure
NINLARO Capsules Drug Use-Results Survey (All-Case Surveillance) "Relapsed/Refractory Multiple Myeloma"

The purpose of this study is to evaluate the safety of NINLARO in participants with relapsed/refractory multiple myeloma in daily clinical practice.

The drug being tested in this study is called Ixazomib (NINLARO). Ixazomib is being tested to treat people who have relapsed/refractory multiple myeloma. This study will look at the safety of NINLARO in participants with relapsed/refractory multiple myeloma in daily clinical practice.

The study will enroll approximately 480 patients.

• Ixazomib 4 mg

This multi-center trial will be conducted in Japan.

Eligibility Criteria:
Inclusion Criteria:

* All patients who have been confirmed as administration of the drug.

Exclusion Criteria:

* None
African American Children, Glycemic Control, and Type 2 Diabetes

Using a randomized, placebo-controlled trial design in subjects with vitamin D deficiency, the investigators propose to determine if vitamin D treatment improves glycemic control in vitamin D deficient subjects with T2DM. The investigators hypothesize that oral vitamin D treatment will improve glycemic control and ß-cell function in vitamin D deficient AA subjects with T2DM. The investigators further hypothesize that maintaining serum 25(OH)D concentrations above 20 ng/ml with oral supplementation of vitamin D will have additional glycemic control effects.

Current literature suggests that 25-hydroxyvitamin D (25(OH)D) is inversely related to risk of type 2 diabetes mellitus (T2DM). African Americans (AA) have significantly less 25(OH)D concentrations, greater chances of poor glycemic control compared to European Americans (EA). The primary objective is to evaluate if the differences in glycemic control in children with type 2 diabetes are explained by differences in serum concentrations of 25(OH)D. A secondary aim is to demonstrate that subjects with vitamin D deficiency (serum 25(OH)D \<20ng/ml) and T2DM who receive an 8 week of vitamin D treatment (50,000 IU oral vitamin D2/once per week) have greater improvement than subjects who receive placebo in glycemic control, as measured by HbA1c and endogenous insulin secretion, as assessed by area under the concentration-time curve (AUC) for mixed meal-stimulated C peptide, at 3 months after study drug administration. Research design: Randomized, placebo-controlled, double blind study design in children with T2DM and vitamin D deficiency. Glycemic control will be determined by HbA1C levels, fasting glucose and area under the curve (AUC) for glucose after a mixed meal tolerance test (MMTT). Measures of beta cell function will be determined by AUC for c-peptide and glucose after MMTT. This study is warranted in AA adolescents with T2DM as any positive interventions could have life long impact and will lead to future larger clinical trials.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 DM with acanthosis
* African American
* 12-18 years
* BMI\> 85%
* Tanner Stage \> 4

Exclusion Criteria:

* Those taking vitamin D
* Pregnancy
* Those with chronic health conditions other than diabetes
* Those who are deemed medically unstable to participate in research
Physical Activity and Inactivity in Lung Cancer Survivors

The purpose of this study is to learn how often lung cancer survivors exercise. We also want to learn what helps people to be active or prevents them from being active. Learning this will help us to expand services for lung cancer survivors.

Despite the potential benefits of physical activity, particularly for cancer survivors with comorbid pulmonary and cardiac conditions, no previous research has examined the physical activity levels of lung cancer survivors, an underrepresented subpopulation in cancer survivorship research. We address this research gap in the current study, in which a random sample of 200 lung cancer survivors will complete a comprehensive telephone interview or use self-report to complete a questionnaire focusing on physical activity, related covariates, and preferences regarding physical activity counseling and interventions. We estimate the total time for the completion of the interview or self-report questionnaire to be 45-60 minutes. This study will be conducted with survivors of primary lung cancer who are from 1 to 5 years posttreatment and were treated at Memorial Sloan-Kettering Cancer Center (MSKCC).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary Stage IA or IB NSCLC;
* Underwent surgical resection for NSCLC at MSKCC;
* From 1 to 5 years post-treatment for NSCLC prior to study recruitment;
* No evidence of disease (NED) at the time of recruitment;
* Can be reached by telephone;
* Able to provide informed consent.

Exclusion Criteria:

* Undergoing active antineoplastic treatment;
* Major psychopathology or cognitive impairment likely in the judgment of the investigator to interfere with participation and compliance with the protocol.
Evaluation of Pain Following Scoliosis Surgery.

The main objective of this study was to evaluate acute pain following scoliosis surgery in adolescent.


Eligibility Criteria:
Inclusion Criteria:

* adolescent from 10 to 18 years of age
* idiopathic scoliosis
* posterior surgery for spinal arthrodesis
* non opposition children and parents

Exclusion Criteria:

* complication following surgery needing reoperation
* secondary intervention
* anterior surgery
* non idiopathic scoliosis
Nurse-Led Heart Failure Care Transition Intervention for African Americans: The Navigator Program

Heart failure (HF) affects over 5 million Americans with HF morbidity reaching epidemic proportions. Annual rates of new and recurrent HF events including hospitalization and mortality are higher among African Americans. In this study, the investigators are testing an interdisciplinary model for heart failure care, with focus on enhancing self management and use of telehealth, which has significant potential to improve self management and outcomes.

The main purpose of this study is to learn how to help African Americans with heart failure care for themselves at home. We hope to find out if a team including a nurse and community health navigator using a computer telehealth device can help people with heart failure stay healthier. The team will help people with heart failure to manage their medication, monitor their symptoms and weigh themselves every day after they leave the hospital. The team will also help people with heart failure learn to solve problems that may keep them from following their treatment plan.


Eligibility Criteria:
Inclusion Criteria:

* hospitalized with admitting diagnosis of heart failure in prior 8 weeks
* self-identified as African American
* community-dwelling (i.e., not in a long-term care facility)
* residence within a predefined radius in Baltimore City
* working telephone in their home
* provide signed informed consent

Exclusion Criteria:

* cannot speak or understand English
* severe renal insufficiency requiring dialysis
* acute myocardial infarction within preceding 30 days
* receiving home care services for HF post discharge
* legally blind or have major hearing loss
* screen positive for cognitive impairment on the Mini-cog at baseline
* unable to stand independently on a weight scale (limited ability to participate in HAT system)
* weigh more than 325 pounds (exceed scale capacity)
* serious or terminal condition such as psychosis or cancer (actively receiving chemo or radiation)
* pregnant
Sphenopalatine Ganglion Block Study

The goal of this clinical trial is to compare the administration and dosage of bupivacaine for sphenopalatine ganglion (SPG) nerve block. The main question\[s\] it aims to answer are:

* Does a high dose (3ml) give more relief than a low dose (1ml)?
* Does bilateral administration give more relief than unilateral? Participants with headaches will be asked to lie down and have SPG block performed.

Researchers will compare dosage and administration to see how symptoms are reduced.


Eligibility Criteria:
Inclusion Criteria:

* Present to ED for management of headache
* Headache is moderate or severe in intensity

Exclusion Criteria:

* Allergy to bupivacaine
* Nasal or sinus surgery
Safety and Efficacy of Zevalin in the Treatment of Non-Hodgkin's Lymphoma

The purpose of this study is to provide treatment for patients who have relapsed NHL or refractory NHL, and to determine the effectiveness and safety of the Zevalin and Rituxan regimens or Rituxan therapy alone on your disease.


Eligibility Criteria:
Summary of major inclusion and exclusion criteria. Other Safety criteria will need to be met.

Inclusion Criteria:

* Histologically confirmed, relapsed or refractory CD20+ follicular B-cell NHL within 12 months of Study Day 1 (without clinical evidence of transformation). NHL must require treatment as determined by an increase in overall tumor size. The presence of B symptoms, and/or the presence of masses which are causing ongoing clinical symptoms.
* Bidimensionally measurable disease meeting the minimum requirement of at least 1 lesion \>/= 2.0 cm in a single dimension.
* No lymphoma therapy for 3 weeks prior to Study Day 1.
* Patients must be recovered from all toxicities associated with prior surgery, radiation therapy, chemotherapy, or immunotherapy.
* Signed IRB-approved informed consent.
* Greater than 18 years of age.
* Expected survival \>/= 3 months.
* WHO performance status of \</= 2.
* Acceptable hematologic status, liver function, renal function, and pulmonary function.
* Female patients who are not pregnant or lactating.
* Men and women of reproductive potential who are following accepted birth control methods.

Exclusion Criteria:

* Patients with impaired bone marrow reserve, which may be indicated by prior myeloablative therapy with autologous bone marrow transplantation (ABMT) or peripheral blood stem cell (PBSC) rescue.
* Prior radioimmunotherapy, including the Zevalin regimen.
* Prior immunotherapy, including Rituxan therapy within 6 months of Study Day 1.
* Rituxan-refractory (no response to most recent Rituxan-containing regimen, or TTP was \< 6 months).
* Presence of CNS lymphoma.
* Patients with chronic lymphocytic leukemia (CLL).
* Known history of HIV or AIDS.
* Serious nonmalignant disease or infection
* Major surgery, other than diagnostic surgery, within 4 weeks of Study Day 1.
* Patients who received investigational product within 4 weeks of Study Day 1 or patients who may experience long-term toxicity from a previous investigational therapy.
Exploratory Analysis of Enhanced Liver Function (ELF) Test to Detect Early Fatty Liver in High Risk Population

In this initial investigator-initiated retrospective study, aim to analyze the enhanced liver fibrosis (ELF) scores in this high-risk population for NAFLD/nonalcoholic steatohepatitis(NASH)-related fibrosis. Study define 'high-risk' to include metabolic syndrome, which can be further defined by an atherosclerotic cardiovascular disease (ASCVD) score \>7.5, any diagnosis of hyperlipidemia, history of coronary artery disease, history of heart failure, hypertension and/or type 2 diabetes. Study would also like to compare the performance of this score with historical methods of fibrosis assessment, where applicable, including vibration-controlled transient elastography, magnetic resonance elastography, blood markers and liver biopsy. Study will assess the impact of ELF scores on predicting liver events in the time, have used it and determine if diet, lifestyle changes and/or pharmacotherapy will improve serial ELF scores. Will also seek to understand how ELF scores are distributed in our community.

Methodist Health System consists of nine hospitals and over one hundred clinics that serve 7% to 10% of patients in the Dallas metropolitan. In November 2021, adopted the use of ELF tests in patients who had risk factors for NAFLD/NASH based on abnormal liver enzymes, metabolic risk factors, and evidence of hepatosteatosis on imaging. There is a knowledge gap in the literature when it comes to ELF scores in our population and the data we collect in this study will contribute to filling that knowledge gap.

Historically, assessment of fibrosis has been accomplished with FibroScan,elastography or liver biopsy. However, these tests are not widely available in most clinics, and can be invasive and costly. At present, the two primary inexpensive and non-invasive alternatives are the fibrosis-4 (FIB-4) and ELF scores, which employ algorithms that utilize routine lab draws. While a low FIB-4 score has a negative predictive value of 90% for advanced fibrosis, it does not provide a risk assessment of liver-related events. For this reason, the study explore the newer ELF serum test as a non-invasive, more affordable and available means to detect patients with developing fibrosis and as a predictor of liver-related outcomes that could be easily used in a primary care setting. This will better risk-stratify this patient population at the primary care level, without need for invasive and expensive testing, and will guide appropriate referrals to Hepatology.

Eligibility Criteria:
Inclusion Criteria:

* Age: ≥ 18 years
* NAFLD/NASH and non-NAFLD/NASH patients who have had an assessment with ELF score at Methodist Dallas Medical Center from November 2021 to December 2023.

Exclusion Criteria:

* Patients with incomplete data and those lost to follow up.
A Trial Comparing the Effect of Pravastatin and Rosuvastatin on Atherosclerosis Progression Measured by Carotid Intima Media Thickness in Patients With Coronary Artery Disease After Biolimus Eluting Stent (Nobori®) Implantation: CPR IMT

Current consensus papers recommend statin medication to reduce Low density lipoprotein (LDL) cholesterol level less than 100mg/dL (optional 70mg/dL) in patients with coronary artery disease. However, there is lack of solid evidence whether a specific kind of statin have the superiority against other statins in clinical outcomes. Furthermore, recent data have showed that several kinds of statin could have an adverse effect on glucose metabolism and increase the risk of development of diabetes. Carotid Intimamedia thickness (CIMT) is a surrogate marker of atherosclerosis to predict long term cardiovascular outcomes in not only general population but also patients with established coronary artery disease. Consequently, we will evaluate the efficacy of high dose of pravastatin on CIMT, comparing with moderate dose of rosuvastatin in patients with established coronary artery disease. Additionally, we will assess the clinical outcomes of pravastatin after percutaneous coronary intervention as well as adverse outcomes including insulin resistance and new onset diabetes compared with rosuvastatin. Our main hypothesis is that pravastatin 40mg would be non-inferior to rosuvastatin 20mg regarding CIMT at 1 year follow up.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 20 years old
* Patients with coronary artery disease who are candidate for coronary revascularization with DES implantation.
* Significant coronary de novo lesion (stenosis \> 70% by quantitative angiographic analysis)
* Patients eligible for statin treatment (initial LDL cholesterol \>70mg/dL or patients taking lipid-lowering agent)

Exclusion Criteria:

* Severe hepatic dysfunction (3 times normal reference values)
* Pregnant women or women with potential childbearing
* Life expectancy \< 1 year
Minimally Invasive Three-dimensional Knee Kinematic Assessment and Surgical Guidance Using Ultrasonic Rigid Registration

Problem:

Currently, no system allows precise kinematic assessment of the knee and accurate guiding of orthopedic surgical actions in a minimally invasive fashion. However, such a system would prove useful in the clinical setting to improve the quality of surgical interventions at the knee.

Hypothesis:

A novel knee kinematic assessment and surgical guidance tool using 3D personalized imaging and minimally invasive bony fixation allows precise kinematic assessment and surgical guidance in the routine clinical setting.

Objectives :

* Demonstrating the capacity of the system to precisely measure 3D knee kinematics
* Quantifying the reproducibility of the kinematic measurements
* Measuring the impact of knee surgical procedures on knee kinematics
* Assessing the correlations between measured articular kinematics and clinical results after knee surgery
* Integrating the novel measuring system to the surgical flow of three knee surgical procedures
* Quantifying the precision and reproducibility of the surgical actions guided by the system
* Comparing the clinical results of surgeries guided by the system to those performed with the traditional technique

A novel knee kinematic assessment and surgical guidance tool using 3D personalized imaging and minimally invasive bony fixation allows precise kinematic assessment and surgical guidance in the routine clinical setting.

Eligibility Criteria:
Inclusion Criteria:

* Patients awaiting a knee surgery (total knee arthroplasty (TKA), high tibial osteotomy (HTO), anterior cruciate ligament reconstruction(ACLR))

Exclusion Criteria:

* Active infection
* Atypical morphology and/or alignment of the lower limbs
* Knee instability (other than secondary to ACL deficiency in patients awaiting ACLR)
* Knee flexion contracture of 10 degrees or more
* Knee flexion of less than 120 degrees