cyrilzakka/clinical-trials huggingface dataset:
A Perspective, Self-control Study on the Progression of Carotid Plaques in Anti-PD-1 mAb Treated Tumor Patients by Artery Ultrasound Follow-up

A Perspective, Self-control Study on the Progression of Carotid Plaques in Anti-PD-1 mAb Treated Tumor Patients by Artery Ultrasound Follow-up

This is a perspective, self-controlled cohort study. This study aims to evaluate the effectiveness of anti-PD-1 mAbs (PD-1 immune checkpoint blockades) on atherosclerotic carotid plaques in those anti-PD-1 mAbs treated patients. The method for quantification and evaluation of atherosclerotic plaques are based on the: ① The mean intima-media thickness of the common carotid artery (Mean CCA thickness); ② The maximum intima-media thickness of the internal carotid artery (maximum ICA thickness); ③ Carotid plaque burden: by calculation of the plaque area of atherosclerotic plaques on the long axis direction of artery on the ultrasound images. By comparing the above-mentioned parameters at the same location of carotid artery in each patient when initiate the first-dose of anti-PD-1 mAbs therapy and 3 months post anti-PD-1 mAbs therapy. It is designed to assess the effectiveness of anti-PD-1 mAbs on the progression of carotid plaques.

Eligibility Criteria:
Inclusion Criteria:

1. The age of subjects are between 18-90 years old (including 18 and 90 years old);
2. All kinds of tumor diseases of subjects are acceptable;
3. All kinds of PD-1 immune checkpoint blockades or dosages are acceptable;
4. The subjects knew about the experiment and signed the informed consent voluntarily;
5. The subjects plan to receive PD-1 immune checkpoint blockades and potentially to be treated for over 3 months;
6. The subjects complicated with atherosclerotic carotid plaques.

Exclusion Criteria:

1. Subjects stop receiving or changing the PD-1 immune checkpoint blockades during follow-up;
2. Subjects are reluctant to continue to be involved in this study;
3. Known pregnant and lactating women;
4. The parameters (e.g., CCA intima-media, ICA intima-media or carotid plaque burden) could not be calculated because of the quality of ultrasound image;
5. Other situations that the researchers judged were not suitable for inclusion.
Prophylactic Antimicrobial Catheter Lock

This is a randomized, double blinded, prospective, multicenter, clinical trial of the use of Heparin versus Gentamicin as a pos-dialysis catheter lock solution.

The study is a randomized, double blinded, prospective, multicenter, clinical trial. All patients requiring vascular access with a tunneled central venous catheter for hemodialysis are eligible for enrollment. Patients will be randomized to receive either Heparin 1,000 U/ml in a volume sufficient to fill the catheter length in both ports or to receive 4% Sodium Citrate with Gentamicin 320 mcg/mL in a volume sufficient to fill the catheter length in both ports.We hypothesize that the device related infection rate in the Citrate/Gentamicin group will be less than the heparin arm.

Eligibility Criteria:
Inclusion Criteria:

* Requires placement of a central venous catheter or currently has a central venous catheter for hemodialysis access.
* Must be at least 18 years old
* Compliant with a dialysis treatment schedule
* Plans to continue hemodialysis treatment and follow-up at the investigational site
* Must be able to care for the exit site independently or have someone who is able to care for the site for them
* Must be able to sign the informed consent document

Exclusion Criteria:

* The subject who has had an infection associated with one or more positive blood cultures is not eligible until 14 days after blood cultures have become negative and clinical resolution of the episode has occurred
* Active exit site or tunnel infection
* Systemic or localized infection that is unresponsive to antibiotic therapy and/or is life threatening
* Known to have antibodies to heparin
* Allergy to pork heparin
* Allergy to gentamicin
* Subject is pregnant
* Known intravenous drug abuse
Clears On the Day of Anesthesia Permissible up to One-Hour Prior (CODA-POP) to Surgery

The purpose of this study is to assess whether residual gastric volumes in patients who receive clear liquids one hour prior to time of procedure is non-inferior compared to patients who are NPO past midnight, to compare efficiency and flexibility of operating room scheduling between two fasting conditions, to assess patient satisfaction and post-operative nausea, vomiting, pain, hunger and thirst.

and to assess wound healing and post-operative complication rates.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing laparoscopic cholecystectomy during the day or night of a weekday (including those consented on a Friday who get postponed to a weekend surgery start time).
* Modified rapid sequence intubation (mRSI)

Exclusion Criteria:

* History of reflux disease
* History of hiatal hernia
* History of esophageal disease
* History of gastroparesis
* Known history of difficult airway or planned fiberoptic intubation
* HbA1c greater than 12
* Pregnant women
* Prisoner
* Procedures conducted on weekends and holidays
* Emergency or non-elective procedures
Study of IMRT Radiotherapy Concurrent Chemothrerapy for Anal Cancer

The purpose of this study is to evaluate the efficacy and adverse events of intensity modulated radiation therapy (IMRT) concurrent with chemotherapy for anal squamous carcinoma. All enrolled anal squamous carcinoma patients are intented to receive IMRT concurrent with Capecitabine + mitomycin ± cetuximab targeted therapy.


Eligibility Criteria:
Inclusion Criteria:

* CT/MRI diagnosed stage cT1-4N0-3;
* Histologically confirmed anal squamous carcinoma;
* KPS \>= 70
* Adequate organ function;
* No previous radiotherapy or chemotherapy;
* No surgery.

Exclusion Criteria:

* Previous malignant cancer history;
* Allegic to 5-fu or MMC
Improvement of Hard Endpoint in Chronic Hepatitis B Patients Treated With Antiviral Therapy

Patients who have completed 3 years follow-up of the past Beijing Science and Technology Commission Research will receive another 7-years anti-viral therapy. Patients will be assessed at baseline and every six months for blood cell count, liver function test, HBVDNA, AFP, prothrombin time, liver ultrasonography, and Fibroscan. CT or MRI and endoscopy will be performed at baseline and 7 years. At the end of the study, the cumulative rate of clinical hepatic hard endpoint will be calculated.

Patients who have completed 3 years follow-up of the past Beijing Science and Technology Commission Research will receive another 7-years anti-viral therapy. Patients will be assessed at baseline and every six months for blood cell count, liver function test, HBVDNA, AFP, prothrombin time, liver ultrasonography, and Fibroscan. CT or MRI and endoscopy will be performed at baseline and 7 years. At the end of the study, the cumulative rate of clinical hepatic hard endpoint will be calculated.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have participated in the research funded by Beijing science and Technology Commission and have completed 156 weeks follow-up.
* Patients comply with the requirements of the trail voluntarily
* Written informed consent

Exclusion Criteria:

* Pregnant woman or patient with severe disease
* Patients with poor adherence to the study
* Patients not suitable for the study evaluated by the investigator
Protocol of Diuretics Use in Congestive Therapy in Heart Failure

The main objective of the study is to determine if a diuretic adaptation protocol in the decompensation of chronic heart failure is more effective but also safer than the current non-protocolized practice.

Diuretics are the main treatment for congestive decompensation of chronic heart failure. For symptomatic purposes, the goal is to decrease the volume overload. In these patients, loop diuretics are used in high doses, sometimes in combination with other classes of diuretics such as thiazides to achieve synergistic, faster and more effective action, and to combat diuretic's resistance. This use, well known to cardiologists and based on a rich pharmacology, more than 40 years old, lacks robust scientific data in real life. Current studies are mainly based on patients with renal insufficiency or limited to cardio-renal syndrome. The CARRESS-H study in 2012 is one of them. The protocol for the use of diuretics from this study was included in 2017 as a benchmark in a publication of the NEJM. It therefore seems necessary to consider the exercise of this protocol in the management of the decompensation of chronic cardiac heart failure. There is, to the investigator's knowledge, no similar study to test this protocol as a "real life" exercise.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients hospitalized for chronic decompensated congestive heart failure without acute pulmonary edema and acute cardiac decompensation against a background of hypertensive crisis
* covered under a social security program
* with legal capacity to give voluntary informed consent to participate in the study

Exclusion Criteria:

* First episode of decompensated congestive heart failure
* Protocolized shock or hypotension (\<90 mmHg blood pressure) managed or requiring nitrovasodilators or non-invasive ventilation
* One of the following cardiovascular pathologies: acute myocardial infarction / cardiac tamponade / aortic dissection / acute pulmonary embolism / heart transplant / ventricular assist device / acute pulmonary edema / hypertensive crisis
* More than 12h of intravenous diuretics administered prior to inclusion
* Generalized edema caused by cirrhosis or nephrotic syndrome
* Requiring pleural or peritoneal tap for therapeutic purposes
* Patient allergic or intolerant to furosemide and on long-term bumetanide use
* Patient in dialysis or end-stage chronic kidney disease (CKD-EPI-calculated GFR \<15 mL/min/1.73m²) or acute kidney injury of known non-cardiac cause
* Severe hypokalemia (\< 3 mmol/L) on admission
* Patient who is pregnant, breastfeeding, or of childbearing age not on effective contraception
* Adult patient safeguarded under court protection measures (guardianship, wardship, or judicial protection)
Measles Vaccination at Health System Contacts

In addition to protecting against measles infection, measles vaccine (MV) strengthens the individual's ability to combat infections in general - MV has beneficial non-specific effects (NSE) lowering the risk of death and admissions by around 30%.

In Guinea-Bissau 30% of children do not receive a routine MV scheduled at 9 months of age, putting both the individual child's health and measles eradication at risk. WHO recommends vaccination at health system contacts, including those for curative services. At the paediatric ward of the national hospital in Guinea-Bissau, there are more than 2600 yearly contacts with measles-unvaccinated children aged 9-59 months, but no vaccines are given. In a randomised controlled trial, we will assess the effect of providing MV vs placebo to 5400 children at hospital contacts (at discharge or after an out-patient consultation) to test the hypothesis that MV reduces the risk of admission or death (composite outcome) by 25% over the subsequent 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Measles-unvaccinated children
* 9-59 months with a hospital contact (discharged or outpatient consultation) at the paediatric ward at the national hospital Simao Mendes.

Exclusion Criteria:

* Axil temperature \>38.0
* Mid upper arm circumference \<110 mm
Heart Healthy Lenoir: Return of Results Study

The investigators are conducting a two group intervention to study to the effect of individualized heart disease genomic risk results on motivation towards diet and physical activity behaviors to reduce heart disease risk. The intervention includes provided participants with genomic and lifestyle risk estimates. Investigators will follow participants for 3 months to determine if motivation towards and engagement in diet and physical activity behaviors change.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled in Heart Healthy Lenoir Genomics
* African-American (self-identified)
* Wants to be contacted for future studies

Exclusion Criteria:

* Enrolled in an arm of the Heart Healthy Lenoir Lifestyle study with intense behavioral intervention (e.g. weight loss or weight maintenance programs)
HTA of NIVATS Based on RWE

This research focuses on a Health Technology Assessment (HTA) of non-intubated video-assisted thoracic surgery (VATS) for lung nodules. Lung cancer, one of the most prevalent malignancies globally, has a high incidence and mortality rate, particularly in China. Traditional treatments like thoracotomy are highly invasive, while conventional thoracoscopic surgery can induce anesthesia-related complications. Non-intubated VATS offers a promising alternative by avoiding intubation and mechanical ventilation, thus reducing complications, anesthesia burden, and recovery time.

The study aims to comprehensively assess the clinical effectiveness, safety, and economic viability of non-intubated VATS for lung cancer treatment through systematic literature reviews, real-world evidence (RWE), and cost-effectiveness analysis. The research will also explore patient preferences using discrete choice experiments (DCE).

By evaluating this technology from a Chinese perspective, the study seeks to provide evidence-based recommendations for the broader adoption of non-intubated VATS in clinical settings.


Eligibility Criteria:
Inclusion Criteria:

- Experimental Group (Non-intubated Video-assisted Thoracic Surgery)：

1. Patients diagnosed with pulmonary nodules or lung cancer who are scheduled for minimally invasive surgery (including wedge resection, segmentectomy, or lobectomy).
2. Aged between 18 and 75 years, regardless of gender.
3. Preoperative assessment indicates that the patient can tolerate non-intubated video-assisted thoracic surgery.
4. The patient has signed an informed consent form and voluntarily agrees to participate in the study.

Control Group (Intubated Video-assisted Thoracic Surgery)：

1. Patients diagnosed with pulmonary nodules or lung cancer who are scheduled for minimally invasive surgery (including wedge resection, segmentectomy, or lobectomy).
2. Aged between 18 and 75 years, regardless of gender.
3. Preoperative assessment indicates that the patient can tolerate minimally invasive surgery.
4. The patient has signed an informed consent form and voluntarily agrees to participate in the study.

Exclusion Criteria:

1. Patients unable to provide sufficient preoperative and postoperative follow-up data.
2. Pregnant or breastfeeding women.
3. Patients with severe cardiopulmonary dysfunction preoperatively, making them unfit for surgery.
4. Patients who have previously undergone surgery or radiotherapy in the same chest region.
5. Patients with active infections or other severe comorbidities that may affect surgical outcomes.
6. Patients with mental illness or cognitive impairment who cannot understand the study content or comply with follow-up requirements.
Study to Test Use of a Decision Aid in a Clinical Visit to Help Patients Choose a Diabetes Medication

The goal of this study is to test the relative merits of a decision aid for diabetes medications that we have developed - Diabetes Medication Choice Cards- versus usual care in translating comparative effectiveness research (CER) into real world clinics. This study will involve about 20 primary care practice sites affiliated with Mayo Health System, Park Nicollet, or Hennepin County Medical Center. There will be no recruiting done at the Mayo Clinic.

To conduct a cluster-randomized practical trial to evaluate the impact of our decision aid (Diabetes Medication Choice Cards) versus usual care as strategies to translate CER into practice among patients with poorly controlled diabetes in need of drug intensification (Hemoglobin Alc (HbA1c) \> 7.3%). Patient outcomes including reaching glycemic control target (HbA1c less than or equal to 7.3%), medication choice and adherence, satisfaction and knowledge. From the physician perspective, we will be measuring physician adoption and satisfaction with the decision aid.

To identify, describe, and explain factors that promote or inhibit the uptake of complex interventions such as decision aids in practices participating in the trial.

To conduct an exploratory analysis of the ability of patients to adhere to the medications chosen while exploring the factors that enable or hinder the patients' ability to incorporate these medications into their routine.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* Have a diagnosis of Type 2 diabetes mellitus and on diabetes medication
* Have a diagnosis of Type 2 diabetes mellitus for 1 year or more if not currently on diabetes medication
* Recognize their primary care provider as their main diabetes care provider
* Use 0, 1, 2, or 3 oral hypoglycemic agents
* Have a recent HbA1c measure (within 12 months) of greater than 7.3, with priority to patients with rising HbA1c levels.

Exclusion Criteria:

* Not available for follow-up for 12 months after study visit.
* Unable to read and speak English.
* Has major barriers to providing written informed consent.
Genetic Factors and CP Pregnancy Outcomes

To explore the impact of chronic pancreatitis (CP) susceptibility genes on pregnancy outcomes.

The goal of this observational study is to explore the impact of CP susceptibility genes (SPINK1, PRSS1, CTRC, CFTR) on pregnancy outcomes (including both maternal and fetal outcomes) in a large Chinese cohort. Participants will be asked to provide their pregnancy-related data.

Eligibility Criteria:
Inclusion Criteria:

* female patients with a diagnosis of chronic pancreatitis
* have known genetic backgrounds and pregnancy history
* agree to join the study and provide informed consent

Exclusion Criteria:

* patients without documented pregnancy
* patients who denied to provide pregnancy-related information, or with incomplete pregnancy characteristics and/or outcomes
* patients with other autoimmune comorbidities that might influence pregnancy outcomes, such as systemic lupus erythematosus, autoimmune thyroid diseases, etc
LC-MS/MS 25(OH)D Status in a Large Cohort

The present study assessed serum 25(OH)D in a cohort of 74235 outpatients by liquid-chromatography-tandem-mass-spectrometry (LC-MS/MS).

The investigators studied the distribution of serum 25(OH)D concentrations in males and females of different age groups, the prevalence of measurable amounts of 25(OH)D2 and seasonal variability.

Measurements were performed under routine circumstances. Samples were collected in serum tubes with clot-activator. As per routine procedure, samples were centrifuged upon arrival in the lab and stored at 4° C until measurement. 25(OH)D3 and 25(OH)D2 were quantitated separately. Results from subjects \<18 years were excluded from the analysis. The study was approved by the local Ethics Committee.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years, outpatients;

Exclusion Criteria:

* \<18 years, inpatients;
Echocardiography Guided Fluid Resuscitation in Critically Ill Patients.

To compare between the impact of echocardiography guided fluid resuscitation and clinically guided fluid resuscitation on critically ill patients in hospital outcome.

Resuscitation often requires the infusion of intravenous fluid in an effort to reverse organ dysfunction. The harms of inappropriate use of fluid are becoming increasingly apparent The question of whether the patient improves with fluid, additional vasopressors or inotropes can be difficult to answer. The gold standard for assessing fluid responsiveness to guide fluid administration in critically ill patients is to perform a fluid challenge. The rationale for volume expansion is to increase the cardiac output (CO) and oxygen delivery to ultimately improve tissue oxygenation. This involves the infusion of a specific amount of intravenous fluid to assess ventricular preload reserve and subsequent systemic haemodynamic effects. In a patient with acute hemodynamic instability, a fluid challenge will cause an increase in stroke volume, according to the Frank-Starling curve. This increase in stroke volume has a salutary effect because it improves tissue perfusion. In contrast, higher hydrostatic pressures in the vascular system predispose the patient to edema, organic dysfunction, and increased risk of in-hospital mortality.

Fluid responsiveness is conventionally defined as an increase of at least 10% to 15% in SV in response to a fluid challenge, which is a reflection of the limits of precision of the technology used.

Assessment of the response in flow to a fluid challenge can be guided with echocardiography. It is achieved by measuring left ventricular outflow tract velocity time integral (LVOT VTI) immediately before and after fluid challenge.

Eligibility Criteria:
Inclusion Criteria:

1- All Critical ill-patients with Acute Physiologic Assessment and Chronic Health Evaluation II score (APACHE II score)≥ 25

Exclusion Criteria:

1. Bad echocardiographic window
2. APACHE II score \< 25.
Intrathecal Morphine and Fentanyl for Knee Arthroplasty

This study is planned to investigate the efficacy of combined infusion of intrathecal morphine and fentanyl in patients undergoing total knee arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled total knee replacement under spinal anesthesia
* ASA I-III

Exclusion Criteria:

* Coagulopathy
* Heart disease
* Liver disease
* Kidney disease
* Infection
* Psychological disorder
* Allergy to bupivacaine
* Allergy to morphine
* Allergy to fentanyl
* Inability to use patient-controlled analgesic device
* Opioids due to chronic pain