cyrilzakka/clinical-trials huggingface dataset:
A Study of MG7 Redirected Autologous T Cells for Advanced MG7 Positive Liver Metastases(MG7-CART)

The purpose of this study is to collect the data on the safety and potential effectiveness of intra-tumor injection of MG7-CART cells under ultrasound guidance in patients with liver metastases expressing MG7 positively.

Designer T cells are prepared by PBMC which from patients by leukapheresis, and then activated and re-engineered to express chimeric antigen receptors (CARs) specific for MG7, which is a glycosylated protein of CEA. Cells are expanded in culture and returned to the participant by intra-tumor injection at the dose of (1-6)×108 CAR positive T cells. The cells perfusion process would last for 1min to 2min. The dose of 1.5 grams/m2 of cyclophosphamide will be given two days before CART cell infusion.

Eligibility Criteria:
Inclusion Criteria:

* MG7 expression positive by histologically confirmed;
* Aged between 18 and 69;
* Persistent cancer after at least one prior standard of care chemotherapy, has no willing for surgery or cannot be suitable for surgery patients;
* Tumor is too big to surgical resection;
* Life expectancy greater than 4 months;
* Satisfactory organ and bone marrow function as defined by the following: (1) creatinine \<1.5mg/dl; (2) cardiac ejection fraction of \>55%; (3) hemoglobin\>9g/dl, bilirubin 2.0×the institution normal upper limit;
* Without bleeding disorder or coagulation disorders;
* Dont allergy to Radiocontrast agent;
* Birth control;
* Adequate venous access for apheresis, and no other contraindications for leukapheresis;
* Voluntary informed consent is given.

Exclusion Criteria:

* Pregnant or lactating women;
* Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary;
* Patients in the situation of: (1) 30 days before apheresis is still in the period of other antitumor drug observation; (2) patient dont recuperate from earlier acute adverse influence brought by any treatments accepted before;
* Four weeks before recruit accepted radiation therapy;
* Previously treatment with any gene therapy products;
* Feasibility assessment during screening demonstrates\<30% transduction of target lymphocytes, or insufficient expansion (\<5-fold) in response to CD3/CD28 costimulation;
* Any serious, uncontrolled diseases (including, but not limit to, unstable angina pectoris, congestive heart failure, grade III or IV cardiac disease, serious arrhythmia, liver and kidney disorders or metabolic diseases, CNS diseases);
* Patient with severe acute hypersensitive reaction;
* Taking part in other clinical trials;
* Study leader considers not suitable for this tiral.
Real-world Evaluation of GLP-1 Receptor Agonists (GLP-1RA) on Efficacy and Persistence, Adherence and Therapeutic Inertia Among Type 2 Diabetes Adults With Obesity

Type 2 diabetes (T2D) is a progressive chronic condition associated with a high morbi-mortality that has a considerable impact on healthcare resources.

Glucagon-like peptide-1 receptor agonists (GLP-1RA) are incretin mimetics that have been shown to improve glycemic control with a low associated risk of hypoglycemia. Additionally, previous studies have linked the use of GLP-1RA with a reduction in the risk of cardiovascular events and kidney disease progression. Despite these positive results, GLP1-RA´s prescription, following the failure of treatment with metformin monotherapy or dual therapy, remains low in Spain compared to other countries in our milieu. Furthermore, the use of this therapeutic class is not homogeneous across the different autonomous communities in Spain, and, no objective justification for these differences seems to exist. Consequently, there is a need to understand which are the benefits associated with the use of GLP-1RA, versus intensification with other oral agents, in real-life conditions.

In this study, the impact of the use of GLP-1RA on clinical outcomes such as all-cause mortality, cardiovascular and renal outcomes as well as severe hypoglycemia will be evaluated based on the analysis of longitudinal databases that collect the variables of interest generated in a real-life scenario. In addition, both persistence and adherence to treatment in patients treated with GLP-1RA and its impact on the clinical outcomes of interest will be studied. Finally, therapeutic inertia will be analyzed.

All these data will contribute to generating cost-effective strategies aimed at improving health outcomes among T2D patients in our setting, reinforcing persistence and adherence to the prescribed treatment, and reducing therapeutic inertia in this group of patients.

Since the use of GLP-1RA versus intensification with other oral agents has been associated with better glycemic control, and, when compared to intensification with basal insulin, with a lower incidence of severe hypoglycemia, we hypothesized that T2D adults treated with GLP-1RA would present a lower incidence of cardiovascular and renal outcomes and fewer hospitalizations due to severe hypoglycemia events as well as a decreased all-cause mortality. On the other hand, patients on GLP-1RA who would present greater persistence and adherence to treatment should experience fewer cardiovascular and renal outcomes and lower mortality compared to those with less persistence and adherence. Finally, it is possible that the type of GLP-1RA and the mode of administration, weekly versus daily, may influence adherence, persistence and therapeutic inertia in this group of patients.


Eligibility Criteria:
Inclusion Criteria:

* Adults with type 2 diabetes
* Individuals with at least a 6-month prescription

Exclusion Criteria:

* Individuals below 18
* Individuals with less than a 6-month prescription
Primary Care-Hospital Embedding: a Prospective, Multicentric, Observational Study

This is a multicentric, prospective, observational study with two cohorts and adjunctive procedure. It aims at collecting and analyzing data about the function of an innovative hospital-territory integration health service for the management of patients with intermediate urgency, or emergency department "white codes." This service, activated in the participating centers, will be provided in two alternative modalities, one so-called "dual specialty" (cardiology and diabetes specialist outpatient clinic) and a second one more focused on the figure of the specialist in Internal Medicine.

The investigators will monitor the population treated in these centers (presenting complaint, medical history, clinical-radiological data, performed therapies and overall health path) and the degree of satisfaction of the General Practitioners who sent their patients there and the degree of satisfaction of the patients themselves. The data collected will also be used to evaluate the effectiveness of the outpatient clinics in terms of reducing improper admissions to the Emergency Departments and hospitalizations. The two modes of service delivery will be compared.

This is an 18-month study, sponsored by our Scientific Directorate and carried out on a nonprofit basis. The study will enroll 246 patients and 30 healthy volunteer General Practitioners. The clinical trial will be conducted in accordance with Good Clinical Practice standards.


Eligibility Criteria:
Inclusion Criteria:

* Patients sent by General Practitioners for outpatient evaluation in the two models
* Patients able to read and sign the informed consent
* Patients able to read and fill the questionnaire

Exclusion Criteria:

- Pregnant women
Deferiprone for the Prevention of Contrast-Induced Acute Kidney Injury

The primary objective of this trial is to assess the impact of CRMD-001 on markers of contrast-induced acute kidney injury (AKI) in high-risk patients with chronic kidney disease (CKD) undergoing coronary angiography and PCI.

This trial will evaluate whether treatment with CRMD-001 (unique formulations of the iron chelator, Deferiprone) will reduce the incidence of AKI in subjects with CKD and additional risk factors. Adult subjects with moderate to severe CKD who are undergoing coronary angiography and PCI will be randomized to either placebo or CRMD-001 and followed for 90 days. Subjects will receive 8 days of randomized therapy starting 1-3 hours prior to angiography. The primary endpoint of the trial will be the difference in mean paired change of a panel of sensitive renal biomarkers between the groups. Differences in renal or cardiovascular clinical events will also be evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or older
2. eGFR of \< 60 ml/min/1.73 m2
3. Presence of at least one additional risk factor:

   * Diabetes Mellitus
   * Age ≥ 75 years
   * Left Ventricular Ejection Fraction ≤ 40%

Exclusion Criteria:

1. End-Stage Renal Disease
2. Recent change in serum creatinine
3. Primary PCI for STEMI
4. Currently receiving mechanical ventilation
5. Severe heart failure of cardiogenic shock
6. Requirement for inotropic support (prior 30 days)
7. Sustained hypertension \> or = 200/110
8. Subject not expected to live for 90 days
9. Anticipated use of ioxaglate or iohexol
10. Currently receiving fenoldopam, dopamine, theophylline, aminophylline, mannitol, N-acetyl cysteine or Ascorbic acid
11. Absolute neutrophil count \< 1500
12. Hemoglobin \< 8 gm/dL
Effectiveness Between Two Surgical Techniques for Reconstruction of Humeral Proximal Extremity Fractures

The purpose of this study is to evaluate the effectiveness and safety of two surgical techniques for the treatments of proximal extremity humeral fractures and fractures luxation in three o four fragments of Neer's classification.

Proximal extremity humeral fractures present high prevalence. It's estimated about 10% of all fractures. Their incidence is 6,6/1000 people-year and this amount increases from 40 years old. The majority are successfully treated with immobilization and rehabilitation. The surgical treatment is recommended in case of displacement. In elderly population with fractures types three or four of Neer's classification there is no consensus on which technique is the best surgical option. Classically hemiarthroplasty has been widely performed as a reconstruction method but its outcomes in old patients are unclear due to the bad bone quality and joint features. Recently some authors recommend the reverse arthroplasty in patients over 70 years old . The aim of this study is to compare the results between Hemiarthroplasty and reverse arthroplasty in patients over 70 years old. As far as the investigators are concerned there's no published studies like this.

Eligibility Criteria:
Inclusion Criteria:

* Patients with humeral proximal extremity fracture or fracture luxation in three or four fragments of Neer's classification.
* Patient 70 years older
* Signed informed consent.

Exclusion Criteria:

* Any condition to make worse the functional recovery or avoid the patient collaboration with the rehabilitation program ( cognitive disability, neurological pathology...)

  * Glenohumeral osteoarthritis
  * Inflammatory arthropathies
  * Previous cuff arthropatyy
  * High surgical or anesthesia risk
  * Any disease or condition that the investigator finds decisive for exclusion.
Bilirubin Increases the Risk of Nosocomial Infection in Cirrhotic Patients

Nosocomial infection (NIs) is a major challenge in healthcare facilities and has been associated with prolonged hospital stay as well as increased morbidity and mortality.

This research aimed to estimate the impact of acute decompensation (AD) consequences on the successive risk of nosocomial infections (NIs) and the go after outcome.

Cirrhosis is the 14th most widespread cause of mortality worldwide \[1\], cirrhosis can take one of the following forms: compensated and decompensated phases \[2\]. The latter is related to subsequent complications such as ascites, hepatic encephalopathy (HE), gastrointestinal hemorrhage (GIH), jaundice, or spontaneous bacterial peritonitis (SBP) \[2\]. Decompensated cirrhosis is a common cause of frequent hospital admission and high fatality rate \[3\]. Patients with cirrhosis and decompensation have bacterial translocations (BT) and immune deterioration \[4\]. Therefore, they are susceptible to getting infections and septic shock \[5\]. On the other hand, the infection can worsen the course of cirrhosis and hasten the progression of related morbidities with a subsequent increase in death rate owing to its ability to accelerate organ failure \[6\]. For cirrhotic patients, the occurrence of NIs is an essential standpoint \[7\]. Several studies on cirrhotic patients revealed that the incidence of NIs is much higher in patients with cirrhosis and thus worsens the prognosis \[8,9\]. Recent studies showed that around 30 to 50% of bacterial infections (BIs) in patients with decompensated cirrhosis are NIs which is related to a higher risk of acute-chronic liver failure (ACLF), severe sepsis, and mortality \[10-12\].

Nevertheless, current studies have not clarified how decompensation differentially predisposes to the occurrence of NIs and affects the outcomes. Henceforth, this study aimed to assess the incidence of NIs in cirrhosis with differential decompensation consequences, the bond between the type of decompensation at admission and the progress of NIs, and the synergism between decompensation and subsequent NIs on the outcome.

Eligibility Criteria:
Inclusion Criteria:

* cirrhotic patients both sex

Exclusion Criteria:

* pregnancy
* lactation
* HCC
Validation Study of CONTEC08C Electronic Sphygmomanometer

The purpose of this study is to assess the accuracy of the CONTEC08C automated oscillometric upper-arm sphygmomanometer in the general population for clinical use according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension /International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018).


Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 12 to 79 years
* Subjects voluntarily participate in the clinical trial and sign the informed consent.

Exclusion Criteria:

* Subjects with cardiac arrhythmias;
* Pregnancy;
* Poor quality Korotkoff sounds;
* Subject with an arm injury incompatible with the use of a cuff-based sphygmomanometer;
* Other conditions that the investigator considers ineligible for clinical trial.
NKI Therapy Compared to Usual Care of Recurrent Esophagogastric Anastomotic Strictures

Rationale: The study hypothesizes that NKI followed by endoscopic bougie dilation therapy will result in an increased dysphagia-free period, a reduction of endoscopic procedures and dysphagia-related quality of life, and lower costs, when compared with the standard endoscopic bougie dilation (EBD) in recurrent esophagogastric anastomotic strictures.

Objective: To evaluate the efficacy and cost-effectiveness of needle-knife incision (NKI) followed by EBD compared to standard EBD in patients with recurrent esophagogastric anastomotic strictures.

Study design: This multicenter study is an randomized controlled trial in which NKI followed by EBD will be compared with standard EBD.

Study population: Patients with recurrent dysphagia (at least 1 and a maximum of 5 previous dilations) due to an anastomotic esophagogastric stricture that requires treatment with repeated endoscopic bougie dilations.

Intervention : The intervention to be investigated is the addition of NKI therapy to EBD to 18 mm esophageal diameter.

Main study parameters/endpoints: The primary outcome of this study will be EBD-free time during follow-up of 6 months. Secondary outcome parameters will be the number of endoscopic procedures for treatment of dysphagia, quality of life (QoL), cost-reduction and cost-effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* Recurrent intra- or extrathoracic benign esophagogastric anastomotic stricture after esophagectomy. The definition of a stricture is based on the Ogilvie Dysphagia score (severity of dysphagia), i.e. Ogilvie score ≥2 (= ability to swallow semi-solid food or worse (Appendix table 1)).
* No patency for a standard endoscope (diameter \< 10 mm)
* The recurrent stricture has been previously treated with at least 1 to a maximum of 5 EBD sessions that reached an esophageal diameter of ≥16 mm.
* The stricture should be suitable for endoscopic incision (stricture length ≤10 mm).

Exclusion Criteria:

* Benign esophageal stricture other than an esophagogastric anastomotic stricture.
* Strictures with a morphology unsuitable for NKI, such as long (\>1 cm), irregulair or tortuous strictures.
* Previous endoscopic treatment of the esophageal stricture with steroid injection, incision therapy or stent placement within the past 3 months.
* Previous stent placement post-esophagectomy for anastomotic leakage.
* (Suspicion of) locally recurrent or metastasized esophageal cancer.
* Persisting postoperative esophageal fistula.
* Inability to discontinue anticoagulants or high-dose antiplatelet drugs at time of the baseline procedure. Low-dose aspirin (max. 100 mg/day) may be continued.
* Known clotting disorder that cannot pre-procedural be corrected.
Improving Cancer Prevention and Control Through Academic-local Public Health Department Partnerships

The purpose of this study is to understand how to leverage structures and processes of academic health department (AHD) partnerships to facilitate implementation of cancer related evidence-based programs and policies (EBPPs).

The investigators will conduct a group-randomized study (total N=28 AHD partnerships) to evaluate the effect of strategies to increase implementation of cancer control and prevention EBPPs by supporting AHD partnerships. Partnerships will be randomized 1:1 to either an active implementation arm in which they will receive tailored strategies based on prior knowledge of successful partnerships or to an existing set of resources for AHD partnerships. A mixed methods approach will be used to evaluate changes in AHD partnerships and understand how contextual factors may have impacted the AHD partnership's ability to support EBPP adoption.

Eligibility Criteria:
Inclusion Criteria:

* Local health department practitioners who are involved in the implementation of cancer prevention and control programs within their communities and are engaged in an academic-health department partnership.
* Employees in academic settings currently partnering with local health departments. These partnerships could be located anywhere within the United States.

Exclusion Criteria:

• Individuals under the age of 18 years old.
Effect of Introperative Ketamine and Lidocaine Infusion on Postoperative Opioid Consumption in Posterior Spinal Fusion Surgery

Objective: The primary aim of this study was to investigate the effect of ketamine and lidocaine on postoperative opioid consumption in posterior spinal fusion surgery.

Materials and Methods: Ethics committee approval was received from our faculty. Seventy-five cases between the ages of 18-65, who have an ASA (American Society of Anesthesiologists) risk classification I-II-III in the preanesthetic evaluation, planned to be operated by the Neurosurgery clinic for lumbar posterior spinal fusion surgery under elective conditions have been included in the study after the informed volunteer consent form was read and approved.

The patients were randomly divided into 3 groups using the closed envelope method. The ketamine group (Group K) (n = 25), the lidocaine group (Group L) (n = 25) and the placebo group (Group P) (n = 25). Propofol, rocuronium and fentanyl i.v. done. In group K, 0.5 mg / kg i.v. ketamine bolus and 0.25 mg / kg / hr i.v. ketamine infusion was administered. In group L, 1.5 mg / kg i.v. lidocaine bolus and 1.5 mg / kg / hr i.v. lidocaine infusion was administered. In group P, i.v. saline (in the same volume and duration) was applied. Maintenance of anesthesia was provided by propofol and remifentanil infusion. The propofol and remifentanil doses were adjusted according to the BIS monitoring and the increase or decrease in basal blood pressure and heart rate values of 20% or more. The BIS value was kept between 40-60. At the end of surgery, infusions were closed. After extubation, the patients were taken to the recovery room. Patient controlled analgesia (PCA) prepared with fentanyl was applied to the patients for postoperative analgesia. The PCA device was attached for 24 hours postoperatively.

Postoperative 0-4 hours, 4-8 hours, 8-24 hours and total fentanyl consumption of the patients were evaluated. Pain scores were measured at 1, 2, 4, 8, 12 and 24 hours in the postoperative recovery room. Intraoperative propofol and remifentanil consumption was recorded. Tramadol 1 mg / kg i.v. as rescue analgesia (in patients with VAS pain score of 4 and above) done. Possible side effects due to opioid, ketamine and lidocaine were followed.


Eligibility Criteria:
Inclusion Criteria:

* between the ages of 18-65, who have an ASA (American Society of Anesthesiologists) risk classification I-II-III

Exclusion Criteria:

* Previous spinal surgery, Morbid obesity (BMI\> 35 kg / m2), Lidocaine, ketamine or opioid allergy. Severe cardiac or pulmonary disease, Liver or kidney dysfunction Poorly controlled hypertension, Substance abuse, Chronic opioid use, Pregnancy, Psychiatric disorder, Cognitive impairment History of stroke, head injury, and intracranial mass or bleeding and patients who did not want to participate in the study were excluded from the study.
A Safety Study of Intravitreal PP-001 in Patients With Chronic, Non-Infectious Uveitis

In this study, PP-001 is assessed for safety and efficacy in patients diagnosed with non-infectious chronic uveitis. PP-001 is a novel small molecule that inhibits a specific enzyme (Dihydroorotate Dehydrogenase) and has shown pre-clinical efficacy in treatment of non-infectious uveitis. PP-001 will be administered to participants as a single intravitreal injection in ascending doses.

This study assesses safety and efficacy of PP-001 after intravitreal injection in patients diagnosed with non-infectious chronic uveitis. PP-001 is a novel small molecule inhibitor of Dihydroorotate Dehydrogenase (DHODH) and has shown pre-clinical efficacy in treatment of non-infectious uveitis. PP-001 is to offer a local treatment alternative to corticosteroids with the objective to reduce or possibly replace steroid intake of non-infectious uveitis patients. In the current study, PP-001 will be injected in ascending doses into the vitreous body of the eye of study participants who suffer from non-infectious uveitis. Participants will be monitored for safety and efficacy evaluation of the study drug.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients at the age of 18 years or older who have diagnosis of chronic, posterior uveitis, intermediate uveitis or panuveitis

Exclusion Criteria:

* Patients receiving specific medication/interventions as specified per protocol
* Pregnant or nursing patients