cyrilzakka/clinical-trials huggingface dataset:
Treatment of ARDS With Sivelestat Sodium

Neutrophil elastase (NE) released by neutrophils play an important role in inflammatory cascade and lung tissue injury of ARDS.Inhibition of NE is expected to prevent the pathophysiological process of ARDS and alleviate lung injury. Siverestat sodium is a specific inhibitor of NE, which has been proved by basic and observational clinical studies to be effective in alleviating lung injury of ARDS, but there is a lack of prospective multi-center randomized controlled clinical trials.Therefore, this study was intended to evaluate the efficacy of sivelestat sodium in the treatment of ARDS patients with SIRS in a multicenter randomized controlled clinical trial


Eligibility Criteria:
Inclusion Criteria:

1. Males and females \> 18 years old and \<75 years old (non-pregnant, non-lactating females).
2. Patients fulfilled the Berlin diagnostic criteria of acute respiratory distress syndrome, with a arterial oxygen partial pressure (PaO2) to fraction of inspired oxygen (FiO2) between 150 mmHg and 300 mmHg.
3. Signed written informed consent has been obtained

Exclusion Criteria:

1. History of chronic respiratory disease
2. Single cardiogenic pulmonary edema
3. Apach2 score ≥21 points
4. Complicated with end-stage disease, or poor prognosis judged by the clinical doctor in charge
5. ARDS course\>3 days
6. Agranulocytosis or receiving immunosuppressive agents or high doses of corticosteroids (methylprednisolone\>40mg/day)
7. Pregnancy or breastfeeding
8. Participated in this study
9. Do not agree to participate in this experiment
Efficacy and Safety of a Triptorelin 6-month Formulation in Patients With Advanced Prostate Cancer

Efficacy and safety of a triptorelin 6-month formulation in patients with advanced prostate cancer. It was assumed that during the study treatment \>90% of the patients would achieve and maintain castrate levels of serum testosterone.

Efficacy of triptorelin treatment on gonadotropin (LH) stimulation from hypophysis, as well as on the PSA (prostate specific antigen) levels and safety laboratory parameters. The triptorelin pharmacokinetics and testosterone pharmacodynamics were assessed in a subset of 15 patients.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically proven prostate cancer.
* The prostate cancer should be staged T3-4NxMx or TxN1-3Mx or TxNxM1 according to the TNM classification or the patient should have rising PSA after failed local therapy and be candidate for androgen deprivation therapy.
* Serum testosterone levels \>5 nmol/L.
* Karnofsky performance index \>40.
* Expected survival \> 18 months.
* Absence of another malignancy, other than local dermatological, for the previous 5 years.
* Signed informed consent before entry into the study.

Exclusion Criteria:

* Prior hormonal treatment for prostate cancer within 6 months prior to study start.
* Use of finasteride (Proscar®) or dutasteride (Avodart®/Avolve®) within 2 months prior to study start.
* Presence of another neoplastic lesion or brain metastases.
* Prior hypophysectomy or adrenalectomy.
* Known or suspicion of vertebral metastases with risk of spinal compression.
* Severe kidney or liver failure (creatinine \> 2 times the upper normal limit, ASAT and ALAT \>3 times the upper normal limit).
* Any concomitant disorder or resulting therapy that is likely to interfere with patient compliance or with the study in the opinion of the Investigator.
* Participation in another study with an experimental drug within 3 months before study start or within 5 drug half-lives of the investigational drug (whichever is the longer).
* Known hypersensitivity to any of the test materials or related compounds.
* Known active use of recreational drug or alcohol dependence in the opinion of the Investigator.
* Any current use or use within 6 months prior to treatment start of medications which are known to affect the metabolism and/or secretion of androgenic hormones: ketoconazole, aminoglutethimide, oestrogens, and progesterone.
* Use of systemic or inhaled corticosteroids (topical application permitted).
* Use of anticoagulants: heparin and coumarine derivatives (acetylsalicylic acid permitted).
* Inability to give Informed Consent or to comply fully with the protocol.
Cutibacterium Acnes in Deep Tissues in Primary Spine and Shoulder Surgery

Obtain deep tissue samples from patients undergoing primary prosthetic surgery of the shoulder and patients undergoing primary instrumented surgery of the spine. Patients will be randomized to receive benzoyl peroxide 3 days prior to surgery.

Shoulder prosthetic surgery as well as interventional surgery on the spine are commonly contaminated by Cutibacterium Acnes. Although the significance of this contamination is unknown, it represents a cause for concern since in some patients, contaminating Cutibacterium Acnes from surgery may develop long-term infection of the implant. Unlike knee and hip surgeries, where the most common infection-causing germs are Staphylococcus aureus, in shoulder and spine surgery, Cutibacterium Acnes represents one of the germs most frequently associated with infections. peri implant. Skin preparation with chlorhexidine as well as antibiotic prophylaxis with cefazolin have been shown to be ineffective in eradicating Cutibacterium Acnes. Recently, different studies support the use of benzoyl peroxide in topical application, to reduce the load of Cutibacterium acnes on the skin. Despite this, it has not been shown to reduce the rate of infection, nor to reduce the phylotypes of Cutibacterium acnes associated with peri-implant infections (IA, IB and II).

Obtain deep tissue samples from patients undergoing primary prosthetic surgery of the shoulder and patients undergoing primary instrumented surgery of the spine. Patients will be randomized to receive benzoyl peroxide 3 days prior to surgery.

Eligibility Criteria:
Inclusion Criteria:

* patients \> 18 yrs.
* Primary prosthetic shoulder surgery.
* Instrumented primary surgery of the spine.

Exclusion Criteria:

* active infection.
* previous surgeries.
* interventionism prior to surgery in the last 6 months (infiltrations, arthro-CT, arthro-MRI)
Induction of Opioid-Dependent Individuals Onto Buprenorphine and Buprenorphine/Naloxone

The purpose of this study is to compare the presence, degree, time course and profile of opioid withdrawal symptoms associated with induction onto new formulations of buprenorphine or buprenorphine/naloxone in persons with active opioid dependence. The primary outcome measure is the severity of withdrawal symptoms measured using the Clinical Opiate Withdrawal Scale (COWS). The primary study hypothesis is that neither drug formulation will precipitate an opioid withdrawal syndrome.

Buprenorphine sublingual and buccal soluble films are being developed to be used for the same indication and over the same buprenorphine dose range as Subutex and Suboxone sublingual tablets in the treatment of opioid dependence. However, only films administered by the sublingual route were evaluated in this study.

The soluble film dosage is expected to provide the following enhancements and potential advantages over the current Subutex and Suboxone product:

* Mitigation against unintentional pediatric exposure by providing child-resistant packaging in unit dose format.
* Improvement in subject convenience and compliance by ensuring rapid disintegration.
* Protection against diversion by providing a dosage form that is very difficult for the subject to remove from the sublingual or buccal mucosa after administration. This provides assurance to the caregiver that the dose has actually been taken appropriately in a supervised setting.
* Provision of a unit dose product format for hospital and institutional use.
* Decreased product damage during shipping as compared to Subutex and Suboxone tablets.

Eligibility Criteria:
Inclusion Criteria:

Subject must:

* Provide written informed consent.
* Have a Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) diagnosis of opioid dependence.
* Be male or female, 18 to 65 years of age, inclusive.
* If female, have a negative pregnancy test during screening and agree to use an acceptable method of birth control.

Exclusion Criteria:

Subjects must not:

* Have participated in an experimental drug or device study within the last 30 days.
* Be currently (past 30 days from start of screening) engaged in opioid agonist, opioid partial agonist, or opioid antagonist treatment.
* If female, be breast feeding or lactating.
* Have any medical condition that in the opinion of the physician investigator would preclude the subject from completing the study.
* Have any clinically significant non-substance use psychiatric disorder (e.g., schizophrenia).
* Have current suicidal ideation.
* Have a Mini Mental Status Exam score less than 24.
* Have physical dependence on alcohol.
* Have physical dependence on sedative-hypnotics.
* Have active aphthous stomatitis.
* Have active oral herpes.
* Need on-going prescription medications that interact with the P450 3A4 (a member of the cytochrome P450 superfamily of enzymes) system.
Piloting a Dietary Vitamin E Intervention During Pregnancy

In the last forty years the prevalence of asthma has increased in westernised countries. We have hypothesised that this increase may be a consequence of changing diet. Several birth cohort studies have now reported an association between reduced maternal vitamin E intake during pregnancy and childhood asthma.

However, it remains to be seen whether increasing maternal vitamin E intake during pregnancy reduces the risk of childhood asthma. We are planning a large placebo controlled trial in pregnant women, to investigate whether optimisation of dietary vitamin E intake to the recommended 15mg/day reduces the likelihood of childhood asthma. We believe that a dietary intervention using vitamin E in its natural form of food is more likely to be successful and acceptable than a vitamin E supplement. We have previously demonstrated than pregnant women can optimise their vitamin E intake using a personalised dietary plan with the help of a dietitian however this intervention was complex and could not be translated into everyday use. With commercial support we have developed a range of soups containing foods naturally rich in vitamin E designed to optimise maternal vitamin E intake to 15mg/day. A range of similar tasting and looking placebo soups has also been developed. In this study we will pilot a randomised controlled trial of the active and placebo soups to ascertain whether pregnant women are willing and able to optimise their vitamin E intake during pregnancy using the soups in order to reduce the risk of their child developing asthma. optimising maternal vitamin E intake during pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* 10-12 weeks pregnant.
* Routine low risk antenatal care.
* A personal or partner history of asthma at anytime.
* Able and willing to give informed consent to participate
* Able and willing to participate in the study procedures

Exclusion Criteria:

* Use of vitamin E supplements.
* A history of diabetes, coagulopathies or use of anticoagulants, use of clopidogrel, cholestyramine, cyclosporin A, gemfibrozil, isoniazid, orlistat, anticonvulsants.
* Any other significant disease or disorder which, in the opinion of the investigator, either puts the woman at risk because of participating in the study or may influence the results of the study, or the woman's ability to participate in the study.
* Participating in another clinical study
* Previous allocation of randomisation code in the study.
Neuromusculaire Monitoring Survey - Usability

This survey aims to better define Anesthesiologist's perceived usability of existing anesthesia Neuromuscular Monitoring devices.

This study consists of a simple online survey that takes approximately 2 minutes to complete.

The study aims to assess Anesthesiologist's perceived usability of the different types of anesthesia neuromuscular monitoring devices (quantitative and qualitative). The survey is targeted to individual anesthesiologists, independetly of their degree of experience.

Eligibility Criteria:
Inclusion Criteria:

* Active Anesthesiology department heads of European Anesthesiology departments.

Exclusion Criteria:

* None
TruFreeze Cryotherapy Central Airway Disease

Rationale: Spray cryotherapy (SCT) using liquid nitrogen has been safely and effectively used in the esophagus, airways and pleura. Treatment with SCT for central airway stenosis may provide an effective, and more durable and perhaps safer alternative to the current therapeutic modalities.

Objectives:

1. To investigate the feasibility of using Spray cryotherapy (SCT) for the treatment of malignant and benign central airway disease.
2. To investigate the safety of using Spray cryotherapy (SCT) for the treatment of malignant and benign central airway disease.
3. To investigate the efficacy of using Spray cryotherapy (SCT) for the treatment of malignant and benign central airway disease.

Study design: This study will be a prospective, single arm, open label intervention study performed at the University Medical Center Groningen, The Netherlands Study population: The study population exists of 25 patients with malignant or benign central airway disease. Patients in which current treatment options are regarded to be suboptimal can be included in the study.

Intervention: TruFreeze Spray CryoTherapy

Main study parameter:

Feasibility is defined as being able to apply the SCT as planned in one, or more bronchoscopies according to the instructions for use (IFU).

Secondary study parameters:

Safety will be assessed by capturing all adverse events (AEs) that occur 1) during the SCT procedure, and 2) all AEs that occur until hospital discharge.

Efficacy will be measured using 1) patient reported outcomes (questionnaires), 2) percentage improvement in airway stenosis, 3) durability of treatment effect, 4) need to re-intervene with other therapies because of treatment failure.

Nature and extent of the burden, risks and benefit associated with participation.

Patients that will be recruited and participate in this prospective clinical trial have a severe central airway disease which is highly symptomatic for which current available therapies are either very difficult to perform, are hazardous, have no real benefit, or just simply not available yet. The current treatment risks of this patient group are high, especially in the patients where the airway patency is at risk. The main additional risk associated with the use of SCT is the occurrence of a pneumothorax. Patients participating will adhere to their current medical care, with the one addition of a voluntary follow-up bronchoscopy after SCT.


Eligibility Criteria:
Inclusion Criterium:

1. Presence of malignant or benign central airway disease where current treatment options are regarded to be suboptimal.

Exclusion Criteria:

1. Patient has an inability to tolerate bronchoscopy under general anaesthesia.
2. Compromised tissue (significant ulceration or mucosal break in the ablation area, any procedure or pre-existing condition has significantly reduced tissue strength or has significantly reduced the elasticity of the ablation area).
3. Airway diameter causing an anatomical flow resistance inhibiting N2 gas evacuation (Endotracheal tube or equivalent \<8.5mm will be excluded).
Tenofovir Versus Lamivudine for Patients of Chronic Hepatitis B With Severe Acute Exacerbation

In Taiwan, 15% of general population had hepatitis B virus (HBV) infection, HBV is the leading cause of liver cirrhosis and hepatocellular carcinoma in Taiwan. After entering immune clearance, 10-30% of patients of chronic HBV develop acute exacerbation (AE) , some are mild but some developed hepatic decompensation or even death.

Previous study found that early use of lamivudine before bilirubin level is above 20 mg/dl can improve survival in chornic HBV with severe AE. From the study from Hongkong, lamivudine was found to have better survival than entecavir in chronic HBV with severe AE. Recent study from India found that tenofovir is able to improve survival in chronic HBV with severe AE. The aim of this study is to compare the effect of lamivudine and tenofovir for chronic HBV with severe AE.

The study aims to enroll 120 patients with chronic HBV defined as persistence of HBsAg for more than 6 months. Severe AE was defined as ALT \> 400 U/L, prolongation of prothrombin time \> 3 seconds, bilirubin \> 2 mg/dl. Patients with hepatitis A, C, D or HIV infection, drug or alcoholic liver disease, hepatocellular carcinoma, under immuno-suppressive agents use, or previous use of anti-HBV agents are excluded. All enrolled patients are randomized into group A who received tenofovir 300 mg qd for 3 years and group B who received lamivuidne 100 mg qd for 6 months, followed by tenofovir 300mg qd for 30 months. Mortality rate and virological, biochemical and serological response were evaluated at 1,2,4,48,96 and 144 weeks. The values are expressed as mean + SD. Categorical variables were analyzed with Chi-square test or Fisher's exact test as appropriate and continuous variables were analyzed by Mann-Whitney test. Logistic regression test was applied to analyze the independent association of various variables with outcome. A p value \< 0.05 was regarded as significant.


Eligibility Criteria:
Inclusion Criteria:

* HBsAg (+) \> 6 months
* ALT \> 5X ULN
* Prolongation of prothrombin time \> 3 seconds and bilirubin level \> 2 mg/dl
* 20-75 years old

Exclusion Criteria:

* HAV, HCV, HDV and HIV co-infection
* Concurrent hepatocellular carcinoma
* Drug, metabolic or alcohol as cause of hepatitis
* Anti-viral treatment in recent 6 mnths
* Pregnant woman
Upper Endoscopy in Cirrhotic Patients With Upper Gastrointestinal Bleeding

Liver cirrhosis is a common diffuse and persistent liver disease often accompanied by portal hypertension, liver failure, upper gastrointestinal bleeding (UGIB), and other complications. The incidence rate of liver cirrhosis with UGIB is as high as 30-40%, which is related to the rupture bleeding of gastroesophageal varices (GOV), hepatogenic ulcer, portal hypertensive gastropathy, hepatic gastrointestinal failure, etc

In the case of UGIB in patients with liver cirrhosis, acute peripheral circulatory failure may suddenly occur, resulting in decreased blood perfusion in liver tissues, often accompanied by clinical manifestations such as blood volume decline, melena, and haematemesis. This disease progresses rapidly, with a mortality rate of above 10% if not treated promptly

Timing of endoscopy in the management of acute upper gastrointestinal bleeding (AUGIB) has been a subject of perennial debate. Despite remarkable advancements in endoscopic treatments and substantial efforts in reducing mortality, the overall in-hospital mortality rate associated with UGIB is still estimated to be 10%.

Several studies have investigated the clinical impact of urgent (within 6 h of presentation) or early (within 12 h) endoscopy on mortality in patients with UGIB. Some studies showed no significant difference in mortality rate between urgent and elective endoscopy groups among high-risk patients with acute UGIB

In contrast, others found that urgent endoscopy was associated with a lower mortality rate in high-risk patients with acute non-variceal UGIB. Most of the previous studies included highly selected patients with non-variceal UGIB or those at a high risk. However, given that the definitive diagnosis is made after endoscopic examination, these studies may not reflect real-world clinical practice. Furthermore, it is often challenging to predict the cause of bleeding and to identify patients at high risk who require intensive care based on their symptoms and the information obtained in the emergency room

Eligibility Criteria:
Inclusion Criteria:

Any patient who is above age of 18 years old and with liver cirrhosis and present with UGIB will be eligible for the study

Exclusion Criteria:

* Patients with age less than 18 years old
* Non-cirrhotic patients
* Patients with hemodynamic instability
* Patient's refusal
Preventive Application of Letrozole Decrease Incidence of Early Onset of OHSS

Letrozole is one kind of aromatase inhibitors which may have effect on decrease estrogen in luteal phase and inhibit the luteal function of ovary. In 2009, Letrozole was reported as one candidate for the treatment or prevention of ovarian hyperstimulation syndrome.

Letrozole was proved to be effective in decreasing the estradiol level of luteal phase after ovum picked up. In this randomized controlled study, investigators try to observe the effectiveness of letrozole on decreasing the incidence of early ovarian hyperstimulation syndrome and vascular epithelium growth factor level of women with high ovarian hyperstimulation syndrome risks.

Eligibility Criteria:
Inclusion Criteria:

* infertile women undergoing IVF treatment with more than 25 oocytes collected.

Exclusion Criteria:

* letrozole contraindications,e.g. severe hepatic and renal dysfunction
Patients With NMDA Biomarker Data Following Cardiac Surgery

The purpose of this current retrospective study is to perform follow-up analysis on the 22 children from the study # 621-2004 It is important to examine whether an elevated biomarker of brain ischemia before and/or following cardiac surgery has any clinical or functional implications as the child ages.

The N-Methyl-D-Aspartate (NMDA) receptor is unique to the brain. With brain injury or ischemia, fragments of the NMDA receptor (NR2) break off and appear in the bloodstream. These NR2 fragments generate an antibody response (NR2 ab) from the body. A recently developed blood test (CIS-Biotech, Inc) is able to measure these fragments (NR2) and the antibody (NR2 ab) response. In adult patients who suffer from ischemic stroke, elevated blood levels of NR2 ab correlate with the amount of brain damage on brain magnetic resonance imaging.

The purpose of the past prospective study, "Blood Markers of Brain Injury from Cardiopulmonary Bypass and Deep Hypothermic Circulatory Arrest in Infants and Children", Emory #621-2004, was to observe the expression of blood markers of brain ischemia, NMDA receptor fragment (NR2) and antibody (NR2 ab) in infants with congenital heart disease before and after cardiac surgery.

Our intent is to review hospital medical records, the cardiothoracic surgical database and neurological database at Children's Healthcare of Atlanta to assess their clinical and functional outcomes. We will review surgery information, clinic visits to Sibley Heart Center Cardiology, and echo, MRI and neurological testing results as well as mortality for these patients. No patient will be contacted. This retrospective study is important as a follow-up to the initial prospective pilot study as it will provide information regarding the clinical outcome of the patients.

Eligibility Criteria:
Inclusion Criteria:

* participated in previous 621-2004 blood marker study for infants and children having open-heart surgery with cardiopulmonary bypass with or without hypothermic circulatory arrest

Exclusion Criteria:

* Those who do not meet inclusion criteria