cyrilzakka/clinical-trials huggingface dataset:
Effects of the Sangvia Blood Collection System on Postoperative Infections in Orthopedic Patients

The purpose of this study is to compare the infection rate in patients receiving/not receiving their own blood, collected during surgery, during and after orthopedic surgery.

The hypothesis is that transfusion of autologous salvaged blood may reduce postoperative infection.

Postoperative infections (both systemic and wound infections) are complications that should be avoided both due to the discomfort and the risk to the patients and for the corresponding increment of hospital costs.

There are some studies indicating that transfusion of autologous salvaged blood may reduce postoperative infections. This may be due to immunostimulating cytokines released in these products. However, as these cytokines also may cause adverse events as febrile transfusion reactions and activation of the complement and the coagulation cascades, the overall impact may be different.

There are two publications from an Austrian group indicating that allogeneic blood transfusion in orthopedic patients cause increased postoperative infection rate irrespectively of the leukocyte content of the red cell concentrates.

The Austrian studies were not randomized. Therefore, it would be useful to perform a randomized, prospective study where the patients receive transfusion of salvaged blood versus allogeneic red cell concentrate as their primary replacement product, respectively.

The purpose of the pilot study is to evaluate if transfusion of autologous salvaged blood reduces the infection rate in orthopedic patients compared with patients receiving allogeneic blood transfusion. The study is limited to one source of autologous blood; blood collected by the Sangvia Blood Collection System, and the study is partially sponsored by the manufacturer.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a risk of needing red cell transfusion after surgery estimated to be above 75%, judged by preoperative hemoglobin concentration and known risk of preoperative bleeding
* Patients over 16 years of age
* Patients who have consented to participate

Exclusion Criteria:

* Patients with a known hemolytic anemia (congenital or acquired)
* Patients for whom informed consent has not been obtained
Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Non-Elderly and Elderly Adults

This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in non-elderly and elderly adults.


Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years of age and older in good health as determined by medical history, physical assessment and clinical judgement of the investigator and without influenza within the past 6 months.

Exclusion Criteria:

* History of serious disease.
* History of serious reaction following administration of vaccine or hypersensitivity to vaccine components.
* Known or suspected impairment/alteration of immune function.
* Receipt or planned receipt of seasonal trivalent influenza vaccine within 1 week before or after each study vaccination.
* Sexually active women of childbearing potential must use acceptable birth control during the treatment phase of the study.
* For additional entry criteria, please refer to protocol.
Development of a New Non-radioactive Test for Measuring Glomerular Filtration Rate Using the Tetrapeptide N-acetyl-Ser-Asp-Lys-Pro-amide (AcSDKP-NH2)

The purpose of the study is to validate a new reference marker for evaluation of renal function (glomerular filtration rate).

Chronic kidney disease (CKD) is a worldwide public health problem with an increasing incidence and prevalence, poor outcomes (kidney failure, complications of decreased kidney function and cardiovascular disease), and high cost. Some of the adverse outcomes can be prevented or delayed by early detection and treatment. However, CKD is frequently underdiagnosed and undertreated. The glomerular filtration rate (GFR) is considered as the best index of renal function. The clinical action plan promoted by International Guidelines groups refers to GFR values. Despite recent improvements, prediction equations developed in order to estimate GFR elicit a huge lack of accuracy when considering the individual patient, especially in case of early CKD. Rigorous assessment of GFR requires the measurement of urinary or plasma clearance of an ideal exogenous filtration marker which is either non-radioactive (inulin, iothalamate, or iohexol) or radioactive ( 51Cr-EDTA or 99mTc DTPA. Measuring clearance with the use of exogenous markers is difficult to perform in clinical practice because it is expensive and cumbersome and needs specialised laboratories and thus, is underused. There is an unmet need for the development of a new non-radioactive GFR tracer that could combine both the analytical accuracy of radioactive tracers and the simplicity of its measurement. Such a tracer should improve clinical care and follow-up of patients.

Eligibility Criteria:
Inclusion Criteria:

* Phase I: 18-35 years male
* Phase I: healthy volunteers
* Phase II: 18-80 years patients (both sex)
* Phase II: with Chronic Kidney Disease

Exclusion Criteria:

* Phase I: Smokers
* Phase I: Allergic
Efficacy and Safety of Indacaterol Plus Tiotropium Versus Tiotropium Alone in Patients With Chronic Obstructive Pulmonary Disease

This study assessed the efficacy and safety of indacaterol (150 µg once daily \[od\]) when combined with tiotropium (18 µg od) versus tiotropium (18 µg od) treatment alone in patients with chronic obstructive pulmonary disease (COPD)


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] Guidelines, 2007) and:

  1. Smoking history of at least 10 pack-years
  2. Post-bronchodilator forced expiratory volume in 1 second (FEV1) ≤ 65% and ≥ 30% of the predicted normal value
  3. Post-bronchodilator FEV1/FVC (force vital capacity) \< 70%

Exclusion Criteria:

* Patients who have had a COPD exacerbation requiring systemic glucocorticosteroid treatment or antibiotics and/or hospitalization in the 6 weeks prior to screening or during the run-in period
* Patients who have had a respiratory tract infection within 6 weeks prior to screening or during the run-in period
* Patients with a body mass index less than 15 or more than 40 kg/m\^2
* Patients with concomitant pulmonary disease
* Patients with a history of asthma
* Patients with diabetes Type I or uncontrolled diabetes Type II
* Any patient with lung cancer or a history of lung cancer
* Patients with a history of certain cardiovascular comorbid conditions

Other protocol-defined inclusion/exclusion criteria applied to the study.
Sienna and Sentimag in Sentinel Lymph Node Biopsy

The aim of this study is to evaluate a new method for the localization of breast cancer sentinel lymph node using Sienna+® and Sentimag® detection in comparison to our standard techniques with radio-isotopes.

The use of radioisotope with or without blue dye has long become the gold standard for sentinel lymph node localization in the management of breast cancer. The latest evidence from a number of European trials has proven that a new tracer agent, superparamagnetic iron oxide particles (SPIOs, Sienna+®), is non-inferior to the standard method of lymphatic mapping. Its application and feasibility has yet been tried in most Asian countries.

This is a prospective paired comparison trial involving both the new magnetic technique and the standard method. Patients with preoperative diagnosis of invasive carcinoma or ductal carcinoma in-situ of the breast undergoing SNOLL (Sentinel node and occult lesion localization) will be recruited from the Breast Centre of Kwong Wah Hospital. Informed consent will be obtained. All patients recruited will receive subcutaneous injection of 2 ml of Sienna+® diluted with saline to 5 ml at Breast Centre in the morning of operation, followed by five minutes of massage to the injection site. Before incision, on-table transcutaneous detection with the handheld magnetometer are carried out after at least 20 minutes from injection. Intraoperative counts of sentinel lymph nodes identified as well as the ex-vivo counts of excised nodes are also measured. All procedures are supplemented with localization by radioisotope. All lymph nodes excised will be sent for histopathological examination.

Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed with early-stage breast cancer (including ductal carcinoma in-situ) who are clinically or radiologically node-negative and consenting for sentinel lymph node biopsy
* Patients undergoing SNOLL (Sentinel node and occult lesion localization) with the use of radio-isotope in our Breast Centre

Exclusion Criteria:

* Patients with clinically T3 or T4 breast cancer and any contraindication to sentinel lymph node biopsy
* Patients with pacemaker or other implantable device in the chest wall
Safety and Efficacy of Ginsenoside Rg3 in Combination With First-line Chemotherapy in Advanced Gastric Cancer

Safety and Efficacy of Ginsenoside Rg3 in Combination with First-line Chemotherapy in Advanced Gastric Cancer.The purpose of this study is to assess the safety of Ginsenoside Rg3 in advanced gastric cancer, and whether it improves the efficacy of first-line chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent form
2. Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1;
3. Histologically or cytologically confirmed gastric cancer;
4. At least have one measurable disease(according to RECIST, Response Evaluation Criteria in Solid Tumors )
5. Life expectancy of at least 3 months;

Exclusion Criteria:

1. Received any prior treatment including Ginsenoside Rg3;
2. Active or uncontrolled infection;
3. Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial;
4. Pregnant or lactating women.
Immersive Virtual Reality (IVR) Procedure

A pilot randomised controlled trial to assess the nursing students' learning outcomes of the urinary catheterisation procedure by comparing the immersive virtual reality (IVR) to traditional lab sessions.

Design: A pilot randomised controlled trial was employed to assess the learning outcomes of the urinary catheterisation procedure by comparing the immersive virtual reality (IVR) intervention to traditional lab sessions.

Eligibility: Second-year undergraduate nursing students (n = 200) enrolled into the module NUR2125 (Pathophysiology, Pharmacology and Nursing Practice II) were invited to participate in the study.

Setting: The study was conducted at a university in Singapore from January to April 2023.

Procedure: Ten lab groups of second-year undergraduate nursing students were invited to participate in the study. They received the standard blended learning activities, which included clinical lab sessions and videos on the urinary catheterisation procedure. Out of the ten groups, four groups were randomly allocated to the IVR intervention group, and another four groups were randomly assigned to the waitlist control group (traditional lab sessions).

1. For the intervention group (IVR), the students used the IVR device for practice in class under the supervision of their tutor. They then loaned the IVR device for two weeks for home practice.
2. For the waitlist control group (traditional lab sessions), they learned and practiced the urinary catheterisation procedure in class. Students received the additional intervention (using the IVR device for home practice) after the collection of post-test data.

Data collection: Prior to lab practice, each participant completed a demographic survey and a set of pre-test questionnaires on personality inventory, cognitive load, and representation of VR in education. Only students who voluntarily joined the programme were recruited into the study.

The participants completed the post-test questionnaires in March 2023 prior to their formative clinical assessment.

Eligibility Criteria:
Inclusion Criteria:

* Year 2 Nursing students enrolled in the PPNP2 module

Exclusion Criteria:

* Students who declined to participate
Value of Screening MRI Brain in Stage IV Non-small Cell Lung Cancer

Patients with newly diagnosed stage IV non-oncogene addicted NSCLC, who are fit for systemic treatment and don't have any symptoms of brain disease will undergo an MRI of the brain to screen for brain disease.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed stage IV metastatic NSCLC, not amenable to curative treatment.
* Fit for systemic treatment (PS 0-2) according to standard of care.
* No symptoms of brain disease disease assessed according to standard clinical care by the thoracic oncologist.

Exclusion Criteria:

* Prior/concomitant therapy for stage IV disease.
* Oncogenic diver mutation (e.g. EGFR, ALK, ROS1, RET, MET, and BRAF) with approved targeted treatment.
* Contraindications for MRI scan with contrast as per standard of care protocol of the institution.
Competitive Carriage of Neisseria Spp(Lactamica 2)

In the future it is likely that we will replace the current schedule of injected vaccines with interventions that interrupt transmission of infections in more subtle ways. The agent that causes meningococcal disease (Neisseria meningitidis) colonises the nasopharynx of individuals. In most people, the bacterium is harmless and survives for months in the nasopharynx, however in a minority of people the bacteria can cause invasive disease.

Simply reducing colonisation amongst target groups may protect them, and the rest of the population as well. In a previous study we investigated cross protective antibodies, and found incidentally that inoculating adult volunteers with Neisseria lactamica, a harmless 'cousin' of N. meningitidis, possibly prevents N. meningitidis carriage. If true this could lead to novel mechanisms of reducing colonisation in targeted groups, possibly in the form of a nasal medication. The proposed study large experimental challenge study funded by Meningitis UK that will aim to establish if N. lactamica does or does not inhibit colonisation by N. meningitidis. We will also determine whether N. lactamica displaces existing N. meningitidis carriage, and whether there are individuals who are innately resistant to any Neisseria carriage. The study will recruit 300 volunteers between the ages of 1830yrs from the two universities in Sheffield. It will involve placing droplets of N.lactamica bacteria into the nose of half our group of volunteers, and a harmless water like solution into the nose of the other half of volunteers. We will carry out nose swabs at intervals over a six month period to establish if the pattern of N.meningitidis carriage is effected by N.lactamica colonisation. If the findings are positive we will perform future mechanistic investigations. A62.


Eligibility Criteria:
Inclusion Criteria:

* Currently healthy
* Students and university employees from either Sheffield Hallam University or the University of Sheffield between the ages of 18 and 25yrs.
* Fully conversant in the English language
* Able to attend the full protocol timetable

Exclusion Criteria:

* Individuals who are Immunocompromised due to a medical condition
* Individuals taking immune modifying medications (not including inhaled steroids)
* Individuals in close contact with immunocompromised people including medical students with full time clinical attachments.
* Individuals who have an current infection
* Current Smokers
* People with an allergy to yeast extract.
Spanish Decision Tool for Ovarian Cancer Maintenance Therapy

To develop a shared decision-making (SDM) tool to help Spanish-speaking patients make decisions about their maintenance therapy

Objectives:

* Create a low literacy version of a shared decision-making (SDM) tool for ovarian cancer maintenance therapy for Spanish speaking individuals.
* To explore the feasibility and acceptability of incorporating the SDM tool into routine clinical care for Spanish speaking individuals.
* To estimate the effectiveness of the SDM tool on quality of the decision making in patients with ovarian cancer who are making decisions about maintenance therapy through a pilot study.

Eligibility Criteria:
Study population: This study will enroll patients and clinical providers.

Inclusion criteria: Patients

• Eligible patients must be: 1) individuals ≥ 18 years with advanced stage high grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are receiving or have completed platinum-based chemotherapy for ovarian cancer and are potentially eligible to receive maintenance therapy; 2) able to understand, speak or read in Spanish.

Exclusion criteria: Patients

• Inability or unwillingness to sign informed consent

Inclusion criteria: Clinicians

• Eligible clinicians will include: 1) MD Anderson gynecologic oncologists and advanced practice providers who practice at the Houston Area Locations (HALs), MD Anderson Cancer Center, or our county safety net hospital, The Harris Health System (LBJ Hospital).

Exclusion criteria: Clinicians

• Inability or unwillingness to sign informed consent
Long-term Effects of Non-invasive Ventilation in Hypercapnic Chronic Obstructive Pulmonary Disease (COPD) Patients

In this multicenter study the comparison of the mass flow distribution and redistribution versus the relative blood flow per lobe (as a surrogate for Ventilation/ Perfusion (V/Q) matching) with functional respiratory imaging (FRI) and arterial blood gas (ABG) values will be evaluated in hypercapnic Chronic Obstructive Pulmonary Disease (COPD) patients. Therefore a low dose Computed Tomography (CT) scan will be taken in a population of 30 patients with non-invasive ventilation (NIV) and in a control group of 10 patients without NIV. The CT-scan will be used for FRI.


Eligibility Criteria:
Inclusion Criteria:

* Age: ≥ 40 years old
* Men and women
* Written informed consent obtained
* COPD patients GOLD II, III and IV
* Persisting hypercapnia (pCO2 \> 45 mmHg ) notwithstanding adequate treatment modalities (including oxygen) as proposed by the GOLD guidelines
* Stopped smoking
* Total lung capacity (TLC) \> 85%

Exclusion Criteria:

* Treatment with home NIV or Continuous Positive Airway Pressure (CPAP)
* Asthma
* Restrictive lung disease
* Symptomatic or uncontrolled heart failure
* Current malignancy
* Suspected bad compliance for NIV treatment
* Pregnant women
* Not be able to speak the language of the participating center
* Received an investigational product within 4 weeks prior to inclusion in the study
First Year Growth Response Associated Genetic Markers Validation Phase IV Open-label Study in Growth Hormone Deficient and Turner Syndrome Pre-pubertal Children: the PREDICT Pharmacogenetics Validation Study

PREDICT Validation is a validation pharmacogenetic trial. The purpose of this study is to confirm that some genes can be used to predict how well a subject diagnosed with idiopathic growth hormone deficiency (IGHD) or turner syndrome (TS) will respond to a treatment with recombinant human growth hormone (r-hGH).

This study is an open-label, interventional, retrospective, multicenter, international study, single-arm, non-randomized, and non-controlled study. The subject's trial participation includes a single visit. During the visit, subjects who give consent to participate in the trial will undergo blood sampling for genetic markers testing and retrospective data will be collected relative to the first year of the subject's r-hGH treatment.

The r-hGH treatment followed by the subject is indicated the pediatric population, therefore most of the subjects included into the trial will be below 18 years old.

This study is a non-investigational medicinal product (IMP) trial therefore no drug product data is provided.

Eligibility Criteria:
Inclusion Criteria:

* Pre-established diagnosis of IGHD or TS based on classical criteria with at least 1 year of r-hGH therapy and with Tanner stage 1 at treatment start
* Retrospective availability of a complete set of clinical, auxological and biological parameters necessary for building the predictive model
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Acquired growth hormone deficiency (GHD)
* Any drug or disease that could affect growth during the first year of r-hGH treatment
* Other protocol defined exclusion criteria could apply
Metabolic Syndrome and Fall Risk

Obesity and the metabolic syndrome (MetS) are rapidly growing problems. Individuals with the MetS are at risk for not only future chronic diseases, but they have a higher prevalence of neuropathy, including cardiac autonomic neuropathy, and have a higher incidence of falls. Currently there are no effective therapies to prevent or reverse the neuropathy seen in the MetS or to reduced the fall risk in this population. This research project will determine if a tailored balance exercise program will have functional benefits and result in a reduced fall risk in the growing population of patients with the MetS and neuropathy.

Completed

55 participants with evidence of the MetS and autonomic neuropathy will be assessed for fall risk with the Four Square Step Test (FSST), which is a measure of dynamic standing balance. Additional endpoints include the dynamic gait index. Measures of height, weight, and waist circumference will be taken and an oral glucose tolerance test as well as lipids and blood pressure will also be measured. Autonomic function will be measured using cardiac autonomic testing, quantitative sudomotor axon reflex test and tilt table testing. Participants will be randomized into either a standard care group that will receive fall risk education or a targeted balance exercise intervention group. Both groups will meet once a week. The intervention group will receive a 12 week balance program with personalized incremental increases in the amount and difficulty of each maneuver.

Eligibility Criteria:
Inclusion Criteria:

* MetS at the time of screening based on the International Diabetes Federation definition
* No risk factors for other causes of neuropathy
* Autonomic neuropathy as defined by the Toronto Diabetic Neuropathy Expert Group 2010/11 consensus criteria
* Age 45-75 years inclusive at the time of screening
* Medically stable at the time of enrollment
* Able to participate in a standing balance exercise program without constant standby monitoring
* Women of childbearing potential must be using an acceptable method of contraception for the duration of their participation in the study
* Willing to accept assignment to either training group
* Willing and able to participate in the assigned intervention program

Exclusion Criteria:

* Pregnant women, prisoners, institutionalized subjects and other at risk subjects
* Etiology of neuropathy other than the MetS
* History of severe medical conditions likely to shorten lifespan or alter ability to participate in the trial
* Severe autonomic neuropathy that restricts daily function and the ability to participate in study interventions
* An inability to understand or cooperate with the procedures of the trial or refusal to sign the informed consent