cyrilzakka/clinical-trials huggingface dataset:
Finding Evidence to Treat Or Reassure in Appendicitis (FETOR)

Acute appendicitis is the most common surgical emergency in childhood. Despite access to current diagnostic modalities, diagnosis may be challenging since the child may have difficulty in articulating symptoms. Additionally there is a high frequency of atypical presentation and rapid progression. Delayed diagnosis in children is reported as being up to 60%. Delayed diagnosis \>48hr increases the perforation rate from 21% to 71%. Around 20% of children presenting with appendicitis have perforated by the time they come to surgery.

Appendix perforation is associated with a prolonged hospital stay and increased cost. Once perforated, major complication rates increase from 1.2% to 6.4%, median bed stay increases from 2 to 6 days and hospitalisation costs are estimated at US $33,348.

Conversely, a false positive diagnosis leads to unnecessary surgery in 12%. It has been suggested that only 35% of surgical referrals with possible appendicitis actually need surgery thus impacting on resource use.

A reliable test, especially if painless, would be very useful. If positive the child could undergo early appendicectomy in expectation of a reduction in the perforation rate (and, therefore, reduction in hospital stay). If negative the child could be discharged home safely. No adequate biomarker has been identified.

Technology already exists to detect changes in Volatile Organic Compounds (VOC) in gases. VOC analysis is already used commercially to identify disease processes in animals and crops. Although VOC has been previously used to detect human diseases, it has never been used to look for changes in the composition of breath in appendicitis.

The investigators hypothesise that the composition of VOC's in children with appendicitis will differ from those without. The investigators anticipate these differences will be of diagnostic and prognostic value in clinical practice. The feasibility of collecting breath samples from children with possible appendicitis to allow VOC testing has not been examined.


Eligibility Criteria:
Inclusion Criteria:

* Patients with suspected appendicitis
* Aged 5 and up to their 16th birthday on arrival to A\&E
* Patients referred to the Paediatric surgical team that have presented to the Leeds General Infirmary through A\&E, the Children's Assessment Unit, or via direct referral from another team or hospital.
* Consecutive presentations who can have some or all of VOC sampling during working week.

Exclusion Criteria:

* Patients with known alternative cause of abdominal pain (e.g. known Inflammatory Bowel Disease)
* Patients who are both admitted and discharged when no researcher is available
Safety and Efficacy of IDH1R132H-DC Vaccine in Gliomas

This trial is aimed at evaluating the safety and efficacy of IDH1R132H-DC vaccine in glioma with IDH1R132H mutation.

Eligible patients that provide written informed consent will undergo apheresis to collect blood mononuclear cells for vaccine production. All patients will receive mature dendritic cells for a total of 12 vaccine doses.The DC vaccine will be given subcutaneously every four weeks. Peripheral blood will be taken two weeks after injection each time to monitor the immune response.

Eligibility Criteria:
Inclusion Criteria:

* The patient signed "informed consent" voluntarily;
* The age of patient is between 18 and 70 years;
* The tumor can be resected and tumor resection rate ≥80%;
* IDH1R132H mutation can be confirmed by immunohistochemistry or real-time quantitative PCR;
* Peripheral blood lymphocytes absolute value is not less than 0.8 × 106;
* KPS score ≥70 ;
* The patient has normal bone marrow reserve and normal liver and kidney function ( The bone marrow, liver and kidney function must be confirmed by Laboratory examination to meet the requirements of participating in the study within 3 days before the first acceptance of IDH1R132H-DC tumor vaccine therapy): Medium neutrophil absolute value ≥1,500 / mm3; hemoglobin\> 10g / dL; platelet count\> 100,000 / mm3; total bilirubin \<1.5 × ULN; alanine aminotransferase / aspartate aminotransferase \<2.5 × ULN; serum creatinine \<1.5 × ULN;
* Normal heart function ;
* Better follow-up and compliance;
* For women of childbearing age (15 to 49 years)，pregnancy test must be negative 7 days before starting this study. Male and female patients of childbearing potential must agree to use effective contraceptive measures to ensure that during the study period and three months after cessation of treatment will not be pregnant.

Exclusion Criteria:

* The patient did not sign "informed consent" or signed unvoluntarily.
* Non-glioma patients
* Drugs for brain or antibody therapy had been used 4 weeks before the start of this study
* Active infection
* Human immunodeficiency virus (HIV) positive
* Hepatitis C or hepatitis B infective
* Pregnancy or breast-feeding women
* Patients did not agree to use effective contraception during treatment and the following 3 months.
* Patients also participated in other clinical studies.
* The subjects researchers believe are not suitable for participation or completion of the study.
Effect of Wet Clothing Removal Compared to Use of a Vapor Barrier in Accidental Hypothermia

The optimal method of prehospital insulation and rewarming of hypothermic patients have been subject of debate, and there is a substantial lack og high-quality evidence to guide providers.

One question concerns whether or not the patients clothing should be removed prior to being wrapped in an insulating model with a vapor barrier. Evaporative heat loss is one of four mechanisms of heat loss, and preventing evaporative heat loss should be a prioritized task for providers. Removal of wet clothing usually means subjecting the patient to the environment, but will reduce the evaporative heat loss considerably. An other alternative is to encapsulate the patient in a vapor barrier. Evaporative heat loss will stop when the humidity inside the vapor barrier reaches 100%.

We aim to investigate whether it is recommended to removed wet clothing or encase the patient in a vapor barrier.


Eligibility Criteria:
Inclusion Criteria:

* Age \<18
* American Society of Anaesthesiologists class 1
* No nicotine use

Exclusion Criteria:

* Acute illness on study day, fever or malaise
Safety, Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (H1N1) (GSK2340272A)

This trial is designed to assess the safety and immunogenicity of a prime-boost schedule of GSK Biologicals' investigational vaccine GSK2340272A in children aged between 6 and 35 months.

This protocol posting has been updated following protocol amendment 4, March 2010. The protocol posting sections impacted are number of subjects, primary and secondary endpoints and intervention.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol
* Children, male or female, aged between 6 and 35 months at the time of first study vaccination.
* Written informed consent obtained from the parent(s) or LAR(s) of the subject.
* Healthy children, as established by medical history and clinical examination when entering the study.
* Parent/LAR with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device.

Exclusion Criteria:

* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
* Clinically or virologically confirmed influenza infection within six months preceding the study start.
* Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
* Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
* Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
* History of hypersensitivity to vaccines.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines
* History of any neurological disorders or seizures.
* Acute disease and/or fever at the time of enrolment
* Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.
* Any condition which, in the opinion of the investigator, renders the subject unfit for participation in the study.
* Child in Care.
Fenoldopam and Acute Renal Failure

Patients undergoing cardiac surgery could develop postoperative acute renal failure requiring renal replacement therapy.

Fenoldopam, already used for patients with hypertensive emergencies, could improve renal function in critically ill patients with or at risk for acute renal failure.


Eligibility Criteria:
Inclusion Criteria:

* adult patients
* who underwent cardiac surgery
* have Risk of Acute Renal Failure (R of RIFLE score)

Exclusion Criteria:

* glaucoma
* already on renal replacement therapy
* study drug in the past 30 days
* inclusion in other protocols
Sepsis Electronic Prompting for Timely Intervention and Care for Inpatients

The goal of this clinical trial is to study systemic inflammatory response syndrome (SIRS) electronic health record (EHR) alerts for sepsis in the inpatient setting. The main question it aims to answer is: do nurse alerts, prescribing clinician alerts, or both nurse and prescribing clinician alerts improve time to sepsis treatment for patients in the inpatient setting?

Nurses and prescribing clinicians will receive SIRS alerts based on the group to which the patient is randomly assigned. Researchers will compare four groups: no alerts, nurse alerts only, prescribing clinician alerts only, or both nurse and prescribing clinician alerts.

SEPTIC is a master protocol for two trials on distinct subpopulations: emergency department (ED) patients and inpatients. This protocol "ID: AAAU1002 - IP" describes the inpatient subpopulation study while "ID: AAAU1002 - ED" describes the ED subpopulation study.

Sepsis is a major cause of death both globally and in the United States. Early identification and treatment of sepsis are crucial for improving outcomes. International guidelines recommend hospital sepsis screening programs, which are commonly implemented in the electronic health record (EHR) as an interruptive screening alert based on systemic inflammatory response syndrome (SIRS) criteria. Despite widespread use, it is unknown whether these sepsis screening and alert tools improve the delivery of high-quality sepsis care. This study tests interruptive (pop-up) EHR alerts. Epic Systems, the company that produces the EHR, refers to these types of alerts as BestPractice Advisories (BPAs).

Eligibility Criteria:
Patient Inclusion Criteria:

* age \> 18 years-old
* meets SIRS criteria
* physically located in an inpatient area of the hospital
* not located in a hospital unit that takes care of pregnant and peri-partum patients
* not SARS-COV-2 PCR positive in past 7 days
* does not have an active order for "comfort measures only"

Patient Exclusion Criteria:

* already having sepsis treatment ordered (if prescribing clinician alert) or collected/completed (if nurse alert)
* already enrolled in the SEPTIC study (including as an emergency department patient or as an inpatient)
Effect of Bupivacaine Application on Postthyroidectomy Pain

Investigators aimed to evaluate the impact of bupivacaine administration into the surgical field after total thyroidectomy on post-operative pain and analgesic requirement with a double-blind, prospective, clinical, randomized study.

Pain assessment was performed with the visual analog score (VAS). Participants were pre-operatively, divided into two groups randomly to receive either bupivacaine or not. One group received a 10 ml of bupivacaine solution while the other group was treated with the same volume of 0.9% sodium chloride (NaCl) through the drain after completion of total thyroidectomy procedure. All participants were anesthetized and operated with the same anesthesia and surgical team.


Eligibility Criteria:
Inclusion Criteria:

* Subjects need to be operated for thyroid diseases

Exclusion Criteria:

* History of previous thyroid disease,
* History of previous neck operations,
* Hypersensitivity to the drugs that were used in the study protocol,
* Spinal bone disease,
* Depression,
* Kidney failure,
* Heart failure,
* Liver failure,
* Pulmonary failure,
* Mental retardation,
* Subjects not able to ascertain pain scoring with the visual analog score (VAS),
* Patients with American Society of Anesthesiologists (ASA) scores III or higher,
* Expected airway difficulty according to Mallampati scores,
* Sedative, steroid, and chronic analgesic drug users,
* Alcoholics
Neuromodulation of Inflammation and Vascular Function in Systolic Heart Failure

Heart failure (HF) is the leading cause of death in US. It is associated with abnormal vascular function termed endothelial dysfunction. It is also associated with increased stress on the blood vessels and high levels of inflammation. Vagus nerve stimulation can help improve inflammation, vascular function and vascular stress. The investigator has recently completed a study showing that 1 hour of noninvasive vagus stimulation can improve vascular health. However, it is unknown if 4 weeks of stimulation will be beneficial in systolic heart failure.

The purpose of this study is to determine if transcutaneous vagal stimulation (TVS) will lead to improvement in the function of the inner lining of participants' arteries, memory, and in the levels of certain chemical markers of arterial function in the blood.

Participants will be randomized to receive either TVS or a sham stimulation and undergo 4 weeks of stimulation. Vascular function will be assessed by several non-invasive measurements, including Flow Mediate Dilation (FMD), Pulse Wave Analysis (PWA), EndoPAT, and Laser Speckle Contrast Imaging (LSCI). Participants' memory will also be measured through electronic assessments and blood will be collected and analyzed for arterial function chemical markers.

Visit 1: Following tests(to assess vascular function) will be done: 1. FMD 2) LSCI 3) EndoPAT and 4) Pulse wave analysis (PWA). Patients will rest for 10 minutes between each test. They will be trained to use PARASYMTM unit for TVS. Blood collected, serum/plasma will be stored at -80F. Whole blood will be collected in PAXgene tubes. Patients will be instructed to apply TVS to either ear lobule (SHAM) or Tragus(experimental arm). Baseline characteristics will be collected including data on ventricular function(LVEF and left ventricular volumes).

Visit 2 (4 weeks): Follow up tests(FMD,LSCI,EndoPAT,PWA) and repeat blood collection.

Inflammatory cytokines and vascular function assays will be performed.

Eligibility Criteria:
Inclusion Criteria:

1. Patients (18 years or older) with Heart failure with reduced ejection fraction (HFrEF), which is a history of symptomatic heart failure with left ventricular ejection fraction (LVEF) of \< 40%.

Exclusion Criteria:

1. Patients in overt congestive heart failure / recent acute myocardial infarction (\< 3 months) or Unstable angina
2. Active malignancy
3. Pre-menopausal women and post-menopausal women on hormone supplements.
4. Unilateral or bilateral vagotomy
5. Patients with bilateral upper extremity amputation
6. Pregnant patients
7. End-stage renal disease
8. End-stage liver disease
9. History of recurrent vasovagal syncope, Sick sinus syndrome, 2nd- or 3rd-degree atrioventricular (AV) block.
10. Patients with clinically documented upper extremity arterial disease
11. Patients with a body mass index (BMI) \>35
12. Significant hypotension (blood pressure \<90mmHg) secondary to autonomic dysfunction
Study of the Immune Response After Vaccination in Multiple Myeloma Patients

This study will collect blood samples from healthy volunteers and volunteers with multiple myeloma who are going to get the seasonal flu, pneumonia, haemophilus influenzae B (HIB), and/or meningococcus vaccines.

The main goal of the study is to start to identify differences in the immune response between multiple myeloma patients and people who don't have multiple myeloma. We hope this will provide important information about the best way and time to vaccinate multiple myeloma patients to flu, pneumonia, haemophilus influenzae B (HIB), and/or meningococcus .

This study will consist of a prospective blood sample collection to gather baseline data to confirm antibody protection from vaccines in the Aurora Health Care multiple myeloma (MM) patients.

The overall goal of this study is to obtain a normative dataset for MM patients and non-MM control populations as well as determining baseline IgG levels to seasonal influenza A, influenza B, pneumococcal polysaccharide, and tetanus toxoid and confirmation of antibody protection from vaccines with assays based upon WHO standards of detection.

This is part of a series of studies designed to provide important information about the best way and time to vaccinate MM patients to flu, pneumonia, haemophilus influenzae B (HIB), and/or meningococcus and to gather additional information about MM and immune function.

Eligibility Criteria:
Inclusion Criteria:

* 50 years old or over
* planning on getting the seasonal flu and/or pneumonia vaccine as part of normal care
* have multiple myeloma, or don't have multiple myeloma and want to serve as a health control

Exclusion Criteria:

- do not meet inclusion criteria
A Study to Evaluate the Effects of Combining Cabazitaxel With Cisplatin Given Every 3 Weeks in Patients With Advanced Solid Cancer

This study is designed as a phase 1, multicenter, open-label, single arm, dose-escalation, study of Cabazitaxel in combination with cisplatin, to determine safety, pharmacokinetics (PK), and efficacy in solid tumors (parts 1 and 2) and single sequence, two-treatment, crossover studies to determine the effect of strong CYP3A4 inhibition and induction on the PK of Cabazitaxel in patients with solid tumors (part 3 and part 4, respectively).

There are 4 parts to the study:

Part 1: Determine the Dose Limiting Toxicities (DLT)'s and Maximum Tolerated Dose (MTD) based on safety.

Part 2: Determine the anti-tumor activity of the combination regimen at the Maximum Tolerated Dose (MTD) in an extended cohort of patients.

Part 3: Determine the effect of a strong CYP3A4 inhibitor (ketoconazole) on the pharmacokinetic (PK) of Cabazitaxel.

Part 4: Determine the effect of a strong CYP3A4 inducer (rifampin) on the pharmacokinetic (PK) of Cabazitaxel.

The total duration on the study per subject will be about 26 weeks broken down as follows:

* A maximum of 21-day screening phase,
* 21-days (+/- 2 weeks) study treatment cycles,
* 30-day follow-up visit after the last dose of study medication.
* Cut-off date for parts 1, 2, 3 and 4: when the last patient has completed 6 cycles (parts 1 and 2) or 2 cycles (parts 3 and 4) of treatment or discontinued study treatment (for disease progression, unacceptable toxicity, withdrawal of consent, or investigator's decision to withdraw), whichever comes first, in the corresponding part.

Patients still receiving treatment at the cut-off date may continue to receive treatment beyond the cut-off date at investigator's discretion if benefiting.

Eligibility Criteria:
Inclusion criteria:

* confirmed metastatic or unremovable advanced solid malignancy that is metastatic or unresectable, and for which standard curative measures do not exist, but for which cisplatin based therapy is appropriate
* signed informed consent

Exclusion criteria

* limited physical functioning (as evaluated by the Eastern Cooperative Oncology Group (ECOG) scale)
* inability to follow study requirements and schedule
* treatment of cancer within 3 weeks of study, concurrent treatment in another clinical trial or with any other cancer therapy
* serious medical illness at same time of study and/or significantly abnormal lab reports
* lack of pregnancy contraception (women of childbearing potential), pregnancy, or breast feeding.
* Women of childbearing potential not protected by highly effective contraceptive method of birth control OTHER than hormonal contraception (Part 4 only).
* prior significant hearing or kidney problems
* continued toxic effects of prior chemotherapy
* cancers that cannot be physically measured (Part 2 only)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Randomized Controlled Trial Comparing Residual Kidney Function in Patients Undergoing Three or Four Exchanges CAPD

The purpose of this study was to explore the impacts of different continuous ambulatory peritoneal dialysis (CAPD) dosage (three 2-Liter exchanges CAPD vs. four 2-Liter exchanges CAPD) on residual kidney function, technique survival, patient survival, and peritonitis in incident Chinese peritoneal dialysis patients.

1. The primary end point for this study was changes in residual kidney function including GFR, daily urine volume (Uvol), and anuria-free survival. GFR and Uvol were evaluated within 1 week before CAPD initiation (the baseline), and then at month 1, 6, 12, 18 and 24. At the same time, body weight, blood pressure, daily net ultrafiltration, dialysis adequacy, peritoneal solute transport rate, and biochemical parameters etc. were assessed. Once an episode of peritonitis or other serious reversible intercurrent illness occurred, all the assessments were delayed one month after being cured. Anuria was termed by daily Uvol permanently less than 100 ml.
2. The secondary end points included technique survival, patient survival and peritonitis. Technique failure was defined as switching to maintenance hemodialysis.

Eligibility Criteria:
Inclusion Criteria:

* incident CAPD patients aged 18 to 80 years
* GFR ≥ 2 ml/min and Uvol ≥ 500 ml/day

Exclusion Criteria:

* have a history of maintenance hemodialysis or renal transplantation
* anticipated life expectancy less than 6 months
* with active malignancy, acute infection, significant heart failure or in other severe conditions
* unable to give informed consent