cyrilzakka/clinical-trials huggingface dataset:
Post-PMA Approval Study: 10 Year Follow-Up IDE Subjects

primary endpoint of this Study is maintenance of "at least good clinical status" for a period of 10 years following initial implantation among Cormet procedures enrolled inthe pre-market IDE.

Maintaining "at least good clinical status" will be determined based upon the composite clinical success (CCS) criterion which includes no revision, removal, or replacement of any device component and a Harris Hip Total score of greater or equal to 80 points.

Eligibility Criteria:
Inclusion Criteria:

* subjects enrolled in the Cormet IDE study at the 5 identified clinical sites
* Individuals who agree to participate in the study by signing the informed patient consent form

Exclusion Criteria:

* none
Clinical Utility of Monitoring for Human Herpesvirus-6 (HHV-6) and Human Herpesvirus-7 (HHV-7) After Liver Transplant

Human herpesvirus-6 (HHV-6) and -7 (HHV-7) infections are common after transplantation. Such infections may predispose transplant patients to other infections, contribute to a recurrence of hepatitis C virus, and affect rejection and function of the transplanted liver. Given the significant clinical impact of these viruses, routine laboratory monitoring may be beneficial by identifying patients who have persistent or high levels of infection. In these patients, immunosuppressive medications could be adjusted, or antiviral medications administered. There are currently no randomized trials that address this important question. This prospective, randomized trial will analyze whether routine laboratory monitoring for HHV-6 and -7 is clinically useful, and whether it would improve overall outcomes in transplant recipients.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients who fulfill the following criteria are eligible for inclusion:

  * Recipients of a liver transplant
  * Able to give written informed consent
  * Are willing and able to comply with the protocol
  * Age \>= 18 years

Exclusion Criteria:

The following patients are not eligible for inclusion in the study:

* Patients unwilling or unable to give informed consent
A Comparative Study Between Ultrasound Guided External Oblique Intercostal Plane (EOIP) Block and Erector Spinae Plane (ESP) Block for Postoperative Analgesia in Upper Abdominal Surgeries

Upper abdominal incisions, such as the oblique subcostal laparotomy, can cause severe pain and can lead to significant respiratory impairment.

Erector spinae plane (ESP) block is the deposition of local anaesthetic (LA) in the interfascial plane at the paraspinal region. It provides effective visceral and somatic analgesia.

External oblique intercostal plane (EOIP) block is a newly described block at which local anaesthetic (LA) is deposited in the interfascial plane deep to external oblique muscle at the sixth intercostal space. It provides blockade of the thoracoabdominal nerves at the level of T6 to T10.

In this study, the investigators compare between ultrasound (US) guided external oblique intercostal plane block and erector spinae plane block, in providing postoperative analgesia for upper abdominal surgeries


Eligibility Criteria:
Inclusion Criteria:

* Patients with American Society of Anesthesiologists physical status (ASA) I and II.
* Both sex.
* 20 to 60 years old patients.
* upper abdominal surgeries.

Exclusion Criteria:

* Refusal of the patient to consent.
* Patients with ASA status III or IV
* Patients with bleeding disorders and coagulopathy (INR≥1.6 \& PTT≥50 sec).
* Infection at the injection site.
* Allergy to local anesthetics.
* Patients with ages less than 20 or more than 60
* Patients with pre-existing myopathy or neuropathy.
* Patients with chronic pain syndromes.
* Patients with history of long acting opioids or steroids preoperatively.
Does the Addition of Hydrogen Peroxide to Chlorhexidine Skin Prep to Treat P. Acnes in the Shoulder

This is a prospective, randomized controlled trial to evaluate the ability of hydrogen peroxide preparation in addition to chlorhexidine to decrease the colonization of Propionibacterium acnes(a bacteria commonly found in the dermis of the skin surrounding the shoulder in order to decrease postoperative joint infection.


Eligibility Criteria:
Inclusion Criteria:

1. All male patients (\>18) undergoing shoulder arthroscopy

Exclusion Criteria:

1. Female patients
2. Patients with active acne
3. Patients who have taken antibiotics within a month of their surgery
4. Subjects allergic to any of the following agents:

   o Benzoyl peroxide
5. Subjects with psoriatic/eczematous lesions on the shoulder girdle.
Vitamin A Therapy for Tuberculosis

The study will determine whether a daily vitamin and mineral supplement (a multivitamin including Vitamin A) will improve health when added to standard chemotherapy for tuberculosis. This study will compare the effectiveness of the multivitamin in HIV infected and HIV uninfected patients.

By the year 2000, 13.8 % of individuals with HIV will be co-infected with tuberculosis (TB). Despite effective TB chemotherapy, mortality rates remain extremely high, and no simple, inexpensive intervention is available. Prior to the discovery of antibiotic treatment, cod-liver oil, a potent source of Vitamin A, was the standard treatment for TB. Vitamin A is essential for normal immune function, and Vitamin A supplementation is used in many countries to reduce mortality in children. Vitamin A deficiency in HIV infected people has been associated with increased mortality in the United States, Haiti, Malawi, and Uganda. This study will determine whether daily Vitamin A supplementation, given concurrently with TB chemotherapy, will reduce mortality in adults with HIV and TB.

All study participants will receive standard TB chemotherapy (isoniazid, rifampicin, streptomycin, pyrazinamide) for the first 2 months, followed by isoniazid and ethambutol for the following 6 months. Participants will be randomized to receive either a daily vitamin and mineral supplement or placebo. Participants will be followed for 24 months after study enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Sputum-confirmed pulmonary tuberculosis
* Resident of Zomba or Blantyre Districts, Malawi
* Willing to take tuberculosis chemotherapy as recommended by the National Tuberculosis Control Programme

Exclusion Criteria:

* Prior treatment for tuberculosis
Heating Precondition of Streamlined Liner of the Pharynx Airway Decrease the Incidence of Sore Throat

The effect of heating precondition of streamlined liner of the pharynx airway (SLIPA) on respiratory mechanics and sore throat was investigated.


Eligibility Criteria:
Inclusion Criteria:

* Hysteroscopic surgery
* General anesthesia

Exclusion Criteria:

* Upper respiratory disease
* Communication disfunction
Proof-of-Concept Study Assessing VNS Paired With Tones for Tinnitus

This is a proof-of-concept study designed to provide feasibility information on the clinical use of vagus nerve stimulation (VNS) paired with tones for the treatment of severe tinnitus. The study is expected to give preliminary efficacy and safety information.


Eligibility Criteria:
Key Inclusion Criteria:

* 18 to 65 years of age
* Diagnosed with subjective tinnitus due to hearing loss with at least some tonal quality of the tinnitus.
* Diagnosis of tinnitus for at least one year
* Tinnitus severity of 18 or greater on TRQ cross checked with TQ severity of Grade 3 or worse

Key Exclusion Criteria:

* Acute or intermittent tinnitus
* Severe hearing loss
* History of significant ear disease such as Meniere's disease, ear tumors, or evidence of active middle ear disease.
* Any other implanted device
Effects of Blueberry Dry Powder on Glycemic Status in Subjects With Prediabetes

The purpose of the present study is to evaluate the effect of blueberry dry powder on glycemic status (fasting plasma glucose, 2h glucose concentration after the oral glucose tolerance test (OGTT), or HbA1c) in subjects with prediabetes.


Eligibility Criteria:
Inclusion Criteria:

* Fasting plasma glucose 110-125 mg/dL

Exclusion Criteria:

* Taking anti-diabetic drugs
* Taking drugs or functional food that may affect blood glucose level
* Fruit allergy
* Pregnant or nursing a child
* Participation in any clinical trial within 90 days of the commencement of the trial
* Renal or hepatic dysfunction
* Heart disease
Mortality in Pediatric Intensive Care Unit

With the development of national economy and medical technology, patients can extend life rely on high-end medical facilities. At the same time, the continued treatment cannot bring benefits to children, even resulting in poor quality of life of children and bringing high medical costs. This makes the limited medical resources are unreasonable distributed. Research showed that PICU mortality rate halved over ten years ago, but the data did not include death cases who left hospital before death. However, the death number of out-hospital were more than death in-hospital. Therefore, the data cannot actually reflect China's mortality rate of PICU. The reason analysis was limited to the cause of the disease, and does not take the social, economic factors into account. This study include eight PICUs of children's Hospital PICU. Critically ill patients are prospectively studied from death risk factors, admission status, disease diagnosis, severity of illness, analyzing of the risk factors of death from disease diagnosis and death risk factors. In addition, we will illuminate the relationship of death and economic factor, especially for who died out-hospital after withdraw or stop treatment.


Eligibility Criteria:
Inclusion Criteria:

* ALL patients admitted to the PICU of eight study centers

Exclusion Criteria:

* Postoperative monitoring of patients with stable hemodynamics
* PCIS score \>90 and not up to the United States PICU admission standards
Intraperitoneal Paclitaxel and Carboplatin in the Treatment of Women With Carcinoma of Mullerian Origin

The main purpose of this study is to determine the safety and tolerability of giving both paclitaxel and carboplatin in the abdominal cavity by looking at what effects (good and bad) this route of administration has on patients with ovarian cancer. Standard chemotherapy drugs are administered intravenously but a number of trials have shown that injecting drugs into the abdominal cavity, or intraperitoneally, have shown promising results.

Patients will have an intraperitoneal port placed at the time of their initial surgery or at a second procedure prior to cycle 2 of chemotherapy.

Patients will receive a total of 6 cycles of therapy as an outpatient. They will have 1 cycle of paclitaxel/carboplatin intravenously followed by 5 cycles of paclitaxel/carboplatin intraperitoneally. Chemotherapy treatment is given on days 1, 8, and 15 of each cycle. Each cycle is 21 days long.

To help reduce the chance of an allergic reaction, patients will also take decadron tablets orally before paclitaxel administration.

About 1 liter of standard salt solution will be injected through a catheter into the abdominal cavity with each treatment to help distribute the drugs throughout the abdominal cavity.

"Second-look" surgery (laparoscopy or laparotomy) will be performed 3-8 weeks after the last chemotherapy course (cycle 6) if the patient is in complete clinical remission. This surgery is done to see how effective the chemotherapy was.

Tests and procedures will be done throughout the treatment to see how the cancer is responding and to monitor for safety purposes. These tests and procedures include routine history and physical exam, neurological exam, and routine blood tests. As part of this study we will also be checking the amount of paclitaxel and carboplatin in the blood.

Participation in this study will last approximately 6 months as long as the treatment is well tolerated, there are no serious side effects and the disease has not progressed.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed epithelial carcinoma of mullerian origin. Specifically, ovarian, primary peritoneal and tubal carcinoma
* Stage II or III disease
* Patient must have undergone surgical staging and debulking with optimal cytoreduction
* Able and willing to undergo a second look staging laparotomy
* 18 years of age or older
* Adequate bone marrow function with an Absolute Neutrophil Count (ANC) \> 2,500 and platelets \> 100,000/mm3
* ECOG performance status less than or equal to 2

Exclusion Criteria:

* Disease outside the abdominal cavity
* Stage IV disease, including abdominal wall, visceral and/or pleural involvement
* Previous chemotherapy for ovarian cancer
* Suboptimal cytoreduction
* Creatinine \> 1.5 mg/dl
* History of recent Myocardial Infarction or congestive heart failure within 6 months of surgery
* SGOT \> 2x Upper Limit of Normal (ULN), bilirubin \> 1.5 x ULN
* Colostomy or ileostomy
* Concurrent invasive malignancy
* Known hypersensitivity to E. coli derived products
* Active psychiatric or mental illness precluding informed consent
Intraocular Pressure Accuracy and Variability of the Barraquer Tonometer

To determine if the Barraquer tonometer provides an accurate and reliable measurement of intraocular pressure. The Barraquer tonometer is a device used to safely and painlessly measure intraocular pressure.

Intraocular pressure will be checked using four different methods of tonometry. These four methods will include Tonopen, Goldmann applanation tonometry, Schiotz tonometry, and Barraquer tonometer. The data will then be compared to determine the reliability and accuracy of the Barraquer tonometer.

Eligibility Criteria:
Inclusion Criteria:

1. All patients of Barnes Retina Institute who are scheduled to undergo vitreoretinal surgery.
2. All patients scheduled for routine eye examination at the Washington University Eye Clinic or Barnes Jewish Eye Clinic.
3. All ages (patients seen at these locations are adult patients \>18 years of age).

Exclusion Criteria:

1. Any patient who is seen in the outpatient clinics for an urgent or emergency ophthalmological issue.
2. Any patient who has a contraindication to routine, noninvasive methods of tonometry and/or pachymetry (ie corneal ulcer).
The Physiological Response to Routine Head and Neck Cancer Surgery

The main objective of this pilot study is to observe and document the range of changes in the blood concentrations of certain hormones, inflammatory chemicals and immune chemicals in response to the stimulus of Head and Neck cancer

This project is in keeping with the strategy of the anaesthetic and intensive care departments to push towards greater understanding of the immune, metabolic and inflammatory changes associated with surgery and how these may be modified through use of different anaesthetic and intensive care techniques. Through increased understanding of the stress, inflammatory and immune responses to surgery we may be able to modulate peri-operative care to reduce cytotoxic(Natural Killer and Cytotoxic T cell) immunosuppression and hence micrometastatic spread at the time of surgery in future studies.

Eligibility Criteria:
Inclusion Criteria:

* Elective unilateral neck dissections (Levels I-V) and/or Hemithyroidectomy surgery.
* Royal Marsden Hospital patients with head and neck cancer - all histological sub-types.
* Capable of providing informed consent
* Age \>17
* American Society of Anaesthesiologists Classification I-III.

Exclusion Criteria:

* Past history of ipsilateral neck dissection.
* Bilateral neck dissection
* A recent course of systemic steroids (\< 3 months)
* Pregnancy
* Involvement in drug trials
* On following medications: Interleukins, Interferons, Immunosuppressants and long term opiates
* Recent Synacthen Test (within 48 hours)
* Emergency surgery
* American Society of Anaesthesiologists Classification IV-V.
6-month Follow up After Sevoflurane Postconditioning

Retrospective analysis of a 6-month follow up within a randomised controlled study in cardiac surgery with pharmacological postconditioning (sedation on intensive care unit with sevoflurane)

Introduction: In a recent randomized controlled (RCT; NCT00924222) trial the investigators demonstrated in 102 patients that late post-conditioning with sevoflurane performed in the intensive care unit (ICU) reduced myocardial injury. These patients presented with lower troponin T values on the first post-operative day compared with patients undergoing propofol sedation. In order to assess possible clinical relevant long-term implications in patients enrolled in this study, the current retrospective analysis is performed focusing on cardiac and non-cardiac events during the first six months after surgery.

Methods: All patients who had successfully completed the late post-conditioning trial were included in this follow-up. Primary and secondary endpoints were the proportion of patients experiencing cardiac and non-cardiac events, respectively. Additionally, therapeutic interventions such as initiation or change of drug therapy, interventional treatment or surgery were assessed.

Eligibility Criteria:
All patients who had successfully completed the late post-conditioning trial were included in this retrospective follow-up analysis. Written and informed consent of all patients included in the first study had to be available.
Recurrence of Arrhythmias After Pulmonary Veins Isolation Detected by ICM

Post Marketing study, Interventional, Prospective, non randomised

Describe how the MD is using the information of the ICM in addition of standard FU(clinical exam and holter 24h)post AF ablation(1 year FU).


Eligibility Criteria:
Inclusion Criteria:

* AF thermoablation indication
* Informed Consent signed,
* Age between 18 \& 75

Exclusion Criteria:

* Participation to other clinical trial
* Non compliant patient
* Pregnant women
* Left Atrial thrombus
* Endocarditis, infection
T- XELOX in HER2-positive Stage III Gastric Cancer After D2 Gastrectomy

The objective of this study is to assess the clinical efficacy and safety of trastuzumab plus XELOX for treatment of HER2-positive Stage III Gastric Cancer After D2 Gastrectomy.

Gastric cancer is the second leading cause of cancer death worldwide. Highest incidence rate is observed in Eastern Asia.

D2 gastrectomy has been established as a standard surgical procedure. While recurrence rate after resection is still high.

The CLASSIC study showed that Xelox regimen after D2 gastrectomy improves 3-year disease-free survival compared with surgery only. But patients with late stage still have poor prognosis according to subgroup analysis and our retrospective study.

HER2 is an important biomarker and key driver of tumorigenesis in 7-34% gastric cancers. The ToGA study showed that trastuzumab, a monoclonal antibody that targets HER2, plus chemotherapy improved overall survival(16.0m vs 11.8m) in patients with HER2-positive advanced gastric or gastro-oesophageal junction cancer.

Based on previous experiences of trastuzumab in adjunctive therapy of breast cancer and ACTS/CLASSIC/ToGA studies, we suppose that trastuzumab plus XELOX as adjunctive treatment may benefit patients with HER2-positive Stage III gastric cancer after D2 Gastrectomy.

According to the above, we do this single-arm research to assess the clinical efficacy and safety of trastuzumab plus XELOX for treatment of HER2-positive Stage III Gastric Cancer After D2 Gastrectomy.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed-consent form.
2. Aged 18-80 years.
3. Had partial or total D2 gastrectomy and achieved R0 resection.
4. Histologically confirmed gastric or gastro-oesophageal junction adenocarcinoma，mucinous adenocarcinoma ，signet-ring cell carcinoma
5. Pathologic Stage III (IIIA-C).
6. HER2-positive: (IHC 3+ or IHC 2+ and FISH positive).
7. Patients must have received no preoperative chemotherapy or radiation therapy.
8. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 .
9. Adequate liver/bone marrow function.Blood and biochemical parameters;
10. Compliant, and can be followed up regularly.

Exclusion Criteria:

1. Patients who do not meet the Inclusion Criteria.
2. Pregnant or breast-feeding female, or not willing to take contraception measures during study.
3. Serious infection requiring antibiotics intervention during recruitment.
4. Allergic to study drug or with metabolism disorder.
5. Histologically confirmed small cell carcinoma of the stomach、gastric neuroendocrine carcinoma or others.
6. Uncontrolled brain metastasis or mental illness.
7. Organ transplant recipients (Autologous transplantation of bone marrow and peripheral stem cell transplantation included).
8. Congestive heart failure, uncontrolled cardiac arrhythmia, etc.
9. With severe hepatic/kidney/respirator/disease,or chronic disease like uncontrolled diabetes,hypertension,etc.
10. with other malignant tumors.
11. Can be followed up or obey protocol.
12. Ineligible by the discretion of the investigator.
Enhancing Preventative Health Behaviors Among Emergency Department Hyperglycemic Patients

The goal of this clinical trial is to increase Type 2 Diabetes Mellitus knowledge and awareness among patients who present to the Emergency Department with hyperglycemia. The main questions it aims to answer are:

* How do patients view their risk of developing type 2 diabetes based on their demographics and behaviors?
* Does giving patient education increase patient knowledge, leading to healthier behaviors?

Researchers will assess if the educational intervention increases diabetes knowledge and positive health behaviors among Emergency Department hyperglycemic patients.

Participants will:

* Receive the educational packet (intervention) alongside standard Emergency Care.
* Take pre-survey at time of Emergency Department visit and post- survey two weeks later.

Despite the large prevalence of patients presenting to the Emergency Department (ED) with hyperglycemia or disease manifestations related to Type 2 Diabetes Mellitus (T2DM), there remains a gap in our understanding of rapid educational strategies delivered within the ED itself. As such, the goal of this project is to utilize the Health Belief Model (HBM) framework to target ED patients' perceived susceptibility, severity, benefits, and barriers in an effort to enhance proactive health behaviors, such as primary care physician (PCP) follow-up and utilization of medication assistance programs, among ED patients.

We will recruit 400 English speaking adults who present to the ED with a blood glucose of ≥200 mg/dL. All participants will receive educational materials on diabetes, as well as resources to local primary-care follow up and medication assistance programs. Participants will complete pre- and post-surveys to quantify changes in self-perceived susceptibility, severity, barriers to managing T2DM, and behavioral changes, which include presence of PCP follow-up, establishing a new PCP, and utilizing medication assistance programs.

Quantitative pre- and post-survey responses will be analyzed via regression models and paired t-tests to evaluate for statistically significant changes in perceived susceptibility, severity, benefits, and barriers to T2DM self-management among participants before and after receiving the educational intervention.The expected findings of this research study are increases in patient diabetes knowledge and self-perception of susceptibility and severity, leading to higher rates of PCP follow-up among participants following dissemination of educational materials grounded in the HBM framework. These research outcomes can be utilized to inform future interventions that target further barriers or reduce ED recidivism for hyperglycemic patients in the ED.

Eligibility Criteria:
Inclusion Criteria:

* Persons 18 years of age or older who present as patients in the Robert Wood Johnson University Hospital Emergency Department with or without a preexisting Type 2 Diabetes Mellitus diagnosis with a blood glucose of ≥200 mg/dL. Participants must speak English to participate in the study.

Exclusion Criteria:

* Age less than 18 years and blood glucose \&lt;200 mg/dL.