cyrilzakka/clinical-trials huggingface dataset:
Anti-inflammatory Effect of Therapeutic Hypothermia in Out-hospital Cardiac Arrest Patients With Cardiogenic Shock

Acute myocardial infarction complicated with cardiogenic shock trigger IL-6, the strong inflammatory response, result in multiple organ failure, even death.

While therapeutic hypothermia,to expect the possibility of anti-inflammatory effect via IL-6 bi-phasic effect and IL-10 , to improve the multiple organ failure, to increase survival rate and well cerebral performance.

Despite emergency coronary revascularization coupled with medical stabilization, intra-aortic balloon pump have significantly improved survival in patients with cardiogenic shock complicating acute myocardial infarction, mortality still remains excessively high, being actually about 30-50%. Future research should focus on new therapeutic strategies, aimed to further decrease mortality rate of these patients or improve possible hospitalization and prognosis.

Heart pumping failure result in cardiogenic shock. Increased LA filling pressure result in acute pulmonary edema, hypoxemic respiratory failure, even congestive kidney and congestive liver. Decreased stroke volume result in hypoperfusion obviously direct induce acute renal failure, disturbance consciousness and lactate accumulation, even, shock liver. Multiple organ failure is the major mortality in the patients suffered from cardiogenic shock after acute myocardial infarction.

Cardiogenic shock remains the leading cause of death in patients hospitalized for myocardial infarction . Systemic inflammation , especially endovascular Interleukin-6, triggered by Tumor necrosis factor-alfa and Interleukin-1 beta result in inappropriate vasodilatation is observed in many patients with cardiogenic shock and may contribute to an excess mortality rate. In recent study, interleukin-6 represented a reliable independent early prognostic marker of 30-day mortality.

Therapeutic hypothermia (34℃) increase stroke volume, reduce muscle oxygen consumption and enhance anti-inflammatory action . The mechanism of anti-inflammatory effect for therapeutic hypothermia in cardiogenic shock is still unclear, need to further study in clinical trial. Furthermore, this study will provide new strategy to increase survival rate in cardiogenic shock.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-100 years
* Cardiogenic sock including initial lactate level \>18 mg/dL, necessary of vasopressor to keep mean artery pressure \>65mmHg after adequate fluid supply, and signs of reduced cardiac output including disturbance consciousness, cold limbs, decreased urine output, acute pulmonary congestion and so on.

Exclusion Criteria:

* Patient or family refuse
* Metastatic cancer
* Pregnancy
Cannabioids as a New Intervention for Amphetamine Dependence

Addiction to amphetamine is characterized by alternating phases of intoxication and short abstinence, followed by recurrent drug-craving episodes which result in distress and relapse. Addiction involves a number of neurotransmission systems, including the endocannabinoid system (ECBS). It has been demonstarted that cannabidioids can have physiological, anxiolytic and neuroprotective properties. It has been shown to have multiple therapeutic properties for treating anxiety, schizophrenia and interestingly cannabinoids have been shown to be potentially helpful in treating addiction, due to their effects on various neuronal circuits involved in this disorder.

The investigators overall hypothesis is that cannabinoids are an interesting pharmacological contender to decrease amphetamine craving and treat amphetamine addiction.


Eligibility Criteria:
Inclusion Criteria:

* Current DSM-V criteria for amphetamine use disorder
* Ability to give valid, informed consent

Exclusion Criteria:

* Severe and/or unstable hepatic, neurologic (including diagnosis of seizures), cardiac (including arrhythmias) or renal disease, or any other severe or unstable medical condition that precludes safe participation in the study according to the study physician.
* Severe psychiatric condition (history of schizophrenia, schizoaffective disorder or bipolar disorder; current acute psychosis, mania or severe suicidality
* Any serious medical condition or psychiatric illness that precludes the subject from signing the informed consent form
Post Market Registry for GORE® TAG® Thoracic Branch Endoprosthesis

The goal of this observational study is to collect mid-term post-market clinical follow-up data of GORE® TAG® Thoracic Branch Endoprosthesis used according to the standard medical practice in patients presenting with vascular disease. This registry aims to answer questions related to the efficacy and safety of GORE® TAG® Thoracic Branch Endoprosthesis.

The purpose of the GORE® TAG® Thoracic Branch Endoprosthesis Registry is to collect real-world data for this device. Due to the nature of the registry, patient selection, diagnostic imaging, and treatment interventions will be determined by physicians based on standard clinical practice. Therefore, the Sponsor will not be outlining requirements that would influence healthcare decisions.

Participants will be asked to return for regular scheduled visits as requested by their surgeon. Patients will report any issues they may have regarding the device or surgery to their surgeon/doctor.

Eligibility Criteria:
Inclusion Criteria:

Patient or legally authorized representative (LAR) provides written authorization and/or consent per institution and geographical requirements Patient has been or is intended to be treated with an eligible registry device Patient is age ≥ 18 years at time of informed consent signature.

Exclusion Criteria:

Patient who is, at the time of consent, unlikely to be available for standard of care (SOC) follow-up visits as defined by the site's guidelines and procedures.

Patient with exclusion criteria required by local law. Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study within 12 months of Together Registry enrollment. Subjects cannot be enrolled in another Together Registry module protocol.
STUDY OF GLUCOSE IN DIALYSIS WATER WITH REGARD TO BLOOD PRESSURE AND QUALITY OF LIFE

We wanted to test the hypotheses that blood pressure level was lower, that the variability of blood pressure and blood glucose was reduced, and that quality of life was improved when glucose was added to the dialysis fluid.

The purpose of the study was to determine the effect of glucose added to the dialysis fluid on 1.blood pressure and variation in blood pressure, 2.blood glucose and variation in blood glucose, and 3.quality of life in patients treated with chronic maintenance hemodialysis in a randomized, placebo-controlled, unblinded cross-over study.

Eligibility Criteria:
Inclusion Criteria:

* age more than 18 years, both men and women, and hemodialysis treatment for more than three months

Exclusion Criteria:

* treatment with hemodiafiltration, change to another dialysis modality, renal transplantation, alcohol abuse defined as more than 21 drinks a week for men and more than 14 drinks a week for women, and unwillingness to participate.
Diagnostic Performance of Dual Energy CT for the Detection of Gallbladder Gallstones

To assess diagnostic performance of Dual Energy CT fo gallblader gallstone detection.

Detection of gallbladder gallstone using Dual Energy CT compare to gallblader ultrasound (gold standard).

All patients who undergo dual-energy CT scans will undergo abdominal ultrasound for gallstones.

Performance of CT to conventionnal KeV will be compare to low Kev monoenergetic reconstruction, and Effective Z.

Expected duration of inclusion 3-6 months. No follow-up.

Eligibility Criteria:
Inclusion Criteria:

* patient referred to the radiology department for an abdominal CT for abdominal pain, suspicion of cholangitis, cholecystitis, migration of stones, acute pancreatitis, suspicion of perforated ulcer in the emergency setting.
* Non-objection of the subject to participate in the study
* Affiliation to a French social security scheme or beneficiary of such a scheme.

Exclusion Criteria:

* Cholecystectomy
* Legal incapacity or limited legal capacity, legal safeguard
* Pregnant women
* Subject unlikely to cooperate in the study and/or low cooperation anticipated by the investigator
* Subject being in the exclusion period of another study
Efficacy of L-methylfolate and Methylcobalamine in Treating Resistant Hypertension Associated with Elevated Serum Homocysteine in Hemodialysis Patients.

The aim of the study is to evaluate the efficacy of L-methylfolate in combination with methylcobalamine in reducing homocysteine blood levels in hypertensive end-stage renal disease patients on regular hemodialysis and its association with blood pressure control in treatment of resistant hypertension

1. Ethical committee approval has been obtained from Ethics committee of Faculty of Medicine, Alexandria University
2. Agreement from all participants should be taken in this clinical study by assigning an informed consent
3. Adult end stage renal disease patients maintained on hemodialysis three times a week for at least 3 months with resistant hypertension will be recruited from hemodialysis unit in Alexandria University Hospitals
4. Patients will be screened for resistant hypertension as determined by the mean of mid-week pre-dialysis BP \> 140/90 mm Hg, post-dialysis BP \> 130/80 mm Hg over a period of one month.
5. A blood sample will be collected for homocysteine measurement at baseline
6. Patients will be randomized using simple randomization technique via computer based program to take one tablet daily containing L-methylfolate and methylcobalamine or no treatment.
7. Patients will be followed over a period of 3 months after which blood pressure measurement and blood sampling would be repeated and compared to baseline values
8. As a measurement of the prognosis of elevated homocysteine, we should follow the development of myocardial infarction, stroke and cardiovascular events for 3 months
9. The appropriate statistical tests will be held according to the study design and parameters to evaluate the significance of the results
10. Results, conclusion, discussion and recommendations will be given

Eligibility Criteria:
Inclusion Criteria:

* Adult end stage renal disease patients maintained on hemodialysis three times a week for at least 3 months with resistant hypertension as determined by pre-dialysis BP \> 140/90 mm Hg, post-dialysis BP \> 130/80 mm Hg despite the use of three or more drugs

Exclusion Criteria:

* Age \> 75 years
* Excessive use of alcohol or smoking
* Severe hepatic impairment
* Acute kidney injury on top of chronic kidney disease
* Pregnant females
* Allergy or intolerance to any component of the formulation
* Medication side effects (methotrexate, theophylline, phenytoin, and cyclosporine) or any drug proven to cause hyperhomocysteinemia
Comparison of Efficacy and Ocular Surface Assessment Between BRIDIN-plus and Combigan in Glaucoma or Ocular Hypertensive

Comparison of Efficacy and Ocular Surface Disease Assessment between BRIDIN-plus Eye drops and Combigan Eye drops in Glaucoma or Ocular Hypertensive Patients : Phase 4, Parallel Group Design, Investigator-blind, Active-control, Randomized, Multi-center Trial

The purpose of this clinical trial is to prove lower negative effects on ocular surface disease and higher patient compliance of a single-use formula BRIDIN-PLUS® eye drops group, comparing to a multi-use formula COMBIGAN® eye drops after 12 weeks of administration to glaucoma or ocular hypertensive patients.

Eligibility Criteria:
Inclusion Criteria

1. Male or female adults who are 19 years or older with a diagnosis of glaucoma or intraocular hypertension
2. A person who has completed an appropriate washout period if glaucoma treatment medication has been used
3. Intraocular pressure measured by Goldman applanation tonometer at visit 2 is 15mmHg or above and less than 40mmHg
4. A person who has signed the written consent form by himself/herself or by a legal representative

Exclusion Criteria:

1. A patient with primary close angle glaucoma, congenital glaucoma, secondary glaucoma caused by steroids
2. Best corrected visual acuity of both eyes measured by Snellen acuity charts is 20/80 (decimal 0.25) or less
3. A patient with progressive intraocular inflammation
4. Central corneal thickness is less than 470um or greater than 591ums
5. A patient who has had lacrimal punctual occlusion done within the last 3 monthds or who has eye surgery plan during the clinical study
6. Pregnant or lactating women
7. Other cases if investigators judge the patient is difficult to participate the clinical trial
Conversion From Fast Acting Oral Opioids to Abstral®

The purpose of this study is to evaluate safety and efficacy when using a novel dose conversion strategy to switch from immediate release oral opioids to sublingual (SL) fentanyl (Abstral) for treatment of breakthrough cancer pain (BTcP).

The study aims to show that in the advanced stage of cancer the individual patient already on high doses of BTcP medication will benefit from starting treatment on a higher first dose of SL fentanyl thus reducing the number of dosing steps with insufficient pain relief.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent obtained.
* 18 years or older, of both genders.
* Opioid tolerant patients
* Estimated frequency of BTcP 0.5-4 times a day.

Exclusion Criteria:

* Treatment with SL fentanyl within two weeks prior to screening.
* Recent or planned therapy that would alter pain or responses to analgesics.
* Treatment with monoamine oxidase inhibitor \< 14 days before or concurrent with SL fentanyl treatment.
* Significantly reduced liver and/or kidney function.
* Significant prior history of substance abuse.
* Pregnancy, breast feeding or woman of childbearing potential not using adequate birth control.
Efficacy of Using 50 ml Syringe Manual Thrombectomy Catheter in Primary PCI With Heavy Thrombus Burden

In high thrombus burden subgroup of Acute STEMI, manual aspiration thrombectomy was associated with reduced cardiovascular death but increased stroke or transient ischemic attack. The role of aspiration thrombectomy is still a matter of active debate. Manual aspiration suffers from decreasing aspiration force as the syringe fills with fluid and requires the operator to exchange syringes during the procedure to maintain suction.

Acute ST-segment elevation myocardial infarction (STEMI) poses a major hazard to human life and health due to its high morbidity and deaths. The frequency of STEMI is increasing. Although dual antiplatelet treatment (DAPT) and primary percutaneous coronary intervention (PPCI) have enhanced survival in STEMI suffers during the last 20 years. Complications after myocardial infarction continue to be a major contributor to high mortality and disability.

Treatment focuses on minimizing infarct size by reopening the occluded artery and restoring myocardial perfusion While PPCI is an established treatment option and can reliably re-establish flow, it can also cause distal embolization, resulting in persistent microvascular obstruction and poor myocardial perfusion. Poor myocardial perfusion after PCI is associated with worse left ventricular functional recovery and increased long-term mortality. By removing thrombotic material, aspiration thrombectomy before PCI may reduce the risk of distal embolization and improve myocardial perfusion. A meta-analysis of large randomized trials comparing aspiration thrombectomy and PCI alone found that routine manual aspiration thrombectomy did not improve clinical outcomes. However, in the high thrombus burden subgroup, manual aspiration thrombectomy was associated with reduced cardiovascular death but increased stroke or transient ischemic attack.

For select cardiac populations, particularly those with high thrombus burden, the role of aspiration thrombectomy is still a matter of active debate. Manual aspiration suffers from decreasing aspiration force as the syringe fills with fluid and requires the operator to exchange syringes during the procedure to maintain suction.

Eligibility Criteria:
Inclusion Criteria:

* Patients with STEMI within 12-24 h of symptom onset in native coronary vessel with heavy thrombus burden (Thrombolysis in Myocardial Infarction \[TIMI\] thrombus grade 4 or 5 on angiography after the guidewire crossed the target lesion)

Exclusion Criteria:

* Very delayed STEMI presentation.
* STEMI with low thrombus burden.
* STEMI with cardiogenic shock.
* Failed recanalization of culprit vessel.
* Complex coronary anatomy candidates for coronary artery bypass graft.
Dissecting How Peripheral Lymphocytes Are Lost During Sepsis

There is an observational, clinical study. We recruit sepsis patients to investigate what drives peripheral lymphocyte loss in sepsis.

There is an observational, clinical study. We recruit patients with diagnosis of new onset sepsis within 24h, collect and record clinical characteristics：

①Demography data，diagnosis, admission source, infection source, APACHE II,SOFA scores;②Endotoxin levels and PaO2 measured;③Immune and systemic inflammatory indicators：T, RR, WBC, ALC, etc.;④Complicated organs dysfunctions: duration and therapy;⑤Incidence of ICU-acquired infection and prognosis.The blood samples were collected for apoptosis,necrosis,autophagy,pyroptosis measurements.The aim of this study is to investigate how peripheal lymphocyte loss relates to outcome and the mechanisms of peripheal lymphocyte loss in different condition.

Eligibility Criteria:
Inclusion Criteria:

* Health volunteers

Exclusion Criteria:

* History of tumor, hematological or immunological disease, and treatment with chemotherapy agents or corticosteroids within 6 months prior to or during the hospitalization.
Genotypic Resistance-guided Versus Empirical Therapy for H. Pylori Eradication.

This study aims to investigate the efficacy of a 7-day genotypic resistance-guided triple therapy, compared with empirical concomitant therapy, for first-line eradication of H. pylori.

Empiric eradication of H. pylori becomes steadily more challenging because of increasing antibiotic resistance. In high-resistance countries where bismuth and/or tetracycline are unavailable (eg; Greece), non-bismuth quadruple therapies are currently recommended as first-line therapeutic options; however, eradication rates \>95% are infrequently achieved and even \>90% are disputed. Antimicrobial susceptibility-guided therapy is a promising alternative in order to maintain high therapeutic efficacy. However, traditional culture-based susceptibility testing methods have several shortcomings, including they are time-consuming and they do not 100% reflect in vivo eradication. Recent guidelines also recommend the use of molecular testing for evaluation of H. pylori antibiotic susceptibility. Nevertheless, the efficacy of genotypic resistance-guided treatment of H. pylori has been seldom appraised. Therefore, the investigators conducted this prospective randomized controlled trial aiming to investigate the efficacy of a 7-day genotypic resistance-guided triple therapy, compared with empirical concomitant therapy, for first-line eradication of H. pylori.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive outpatients aged ≥18 years with documented H. pylori infection. Mental and legal ability to provide written informed consent.

Exclusion Criteria:

* previous history of H. pylori eradication therapy
* history of allergies to the medications used
* previous esophageal or gastric surgery
* serious systemic disease
* pregnancy or lactation.
Immunophenotyping of Patients With Postoperative SIRS

The purpose of this study is to develop an immune-phenotype based prediction of postoperative SIRS in patients undergoing open heart surgery.

The study will have a pre-, intra and postoperative phase in which several demographic and clinical variables will be assessed. The samples for the immunophenotypic analysis will be drawn directly after induction of anesthesia and at various time points after end of surgery. The diagnosis of SIRS will be made during routine clinical visits on the first seven postoperative days using the Sepsis-related Organ Failure Assessment score (SOFA-score). The patients will be followed up for 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Informed consent of the patient
* Patient undergoing a open heart surgery using a cardiopulmonary bypass

Exclusion Criteria:

* Age \< 18 years
* Missing informed consent
* Renal failure
* Liver failure
* Neurodegenerative disease
* Malignancies
* Immune therapy
Primary Chemotherapy With Adriamycin/Cyclophosphamide(AC) vs Taxotere/Xeloda(TX) for Stage II and III Breast Cancer

This is an open labeled phase III randomized trial. The patients with clinical stage II and III will undergo mammotome biopsy of breast tumor for histologic diagnosis, immunohistochemical studies for estrogen receptor(ER), progesterone receptor(PR), HER-2/neu and others. PET results will determine the positivity of lymph node metastasis.

- Patients will be randomized to receive regimen A (AC) and regimen B(TX), preoperatively,as follows: Regimen A (AC): Intravenous infusion of Adriamycin 60mg/m2 , over 30 min, onD1 and Intravenous infusion of cyclophosphamide 600 mg/m2 over 30 min on D1. Regimen B(TX): Intravenous infusion of Taxotere 75 mg/m2 over 1 hr, on D1, and Xeloda 1000mg/m2.p.o. BID x 14days on D1-D14 The cycle repeats every 3 weeks for 4 times. Premedication for regimen A includes antiemetics, for regimen B, dexamethasone as routinely given.

Patients who do not respond to the initial two cycles of preoperative chemotherapy will undergo operation.

The response rate will be determined by the number of patients with complete and partial responses according to RECIST guidelines. Pathologic complete response is defined as no pathologic evidence of residual disease. Safety will be evaluated by the frequency, severity, and relationship of adverse events graded by NCI Common Toxicity Criteria(CTC) that occur during the treatment and follow-up periods. Time to disease progression will be calculated from the date of study entry to the first objective documentation of progressive disease. Response duration will be measured from the date a patient first fulfills the CR or PR criteria to the first date of objective documentation of disease progression. Survival time will be calculated from the date of study entry to the date of death

Eligibility Criteria:
Inclusion Criteria:

* All patients must have histologically confirmed and newly diagnosed breast cancer: stage II and III breast cancer.
* PET results will determine node positivity.
* No prior hormonal , chemotherapy or radiotherapy is allowed.
* No breast operation other than biopsy to make diagnosis is allowed.
* Age:18-years and older, not pregnant pre-, and postmenopausal women with good performance status (ECOG 0-1)
* Adequate hematopoietic function:

  1. Absolute granulocyte count \>=1500/mm3,
  2. platelet \>=100,000/mm3, Hemoglobin \>=10 g/mm3
* Adequate renal function: Serum creatinine \<=1.5 mg/dl
* Adequate hepatic function:

  1. total bilirubin: \<=1.5 mg/dl
  2. AST/ALT: \<=three times normal
  3. Alkaline phosphatase: \<=three times normal
* Adequate cardiac function: normal or nonspecific EKG taken within 1 mo of enrollment

Exclusion Criteria:

* Patients who received hormonal , chemotherapy or radiotherapy for breast cancer
* Patients who underwent surgery for breast cancer
* Patients who have history of cancer other than in situ uterine cervix cancer or nonmelanotic skin cancer