cyrilzakka/clinical-trials huggingface dataset:
Procalcitonin Level to Discontinue Antibiotics on ICU Patients With no Obvious Site of Infection

The purpose of this study is to test whether a U.S. Food and Drug Administration (FDA) approved laboratory test (PCT Kryptor) can help doctors make better decisions on the need for antibiotic therapy in ICU patients with suspected infections.

The study is undertaken as prospective, randomized, controlled, multicenter trial. The study population, ICU patients with empiric antibiotic treatment due to suspected but unproven infection, is randomly assigned to either a Standard Care Group or a Procalcitonin (PCT) Guided Group. In the standard care group, antibiotic treatment would be based totally on clinical decision making with "traditional thought processes" (i.e., cultures, response to antibiotics, risk of untreated infection, other laboratory findings, etc.). The PCT guided group will use the same "traditional thought processes" and in addition the physician will be given access to a PCT value for Day 1 and Day 4 along with the recommended thresholds for likelihood of infection. In conjunction with other laboratory findings and clinical assessments the threshold of PCT is used to continue or discontinue empiric antibiotic treatment.

Eligibility Criteria:
Inclusion Criteria:

* Suspected infection (no clear-cut source of infection) as defined by the treating physician
* Empiric antibiotic treatment
* No clear-cut source of infection by clinical or microbiological criteria
* ICU patient
* Informed consent

Exclusion Criteria:

* Age \<18 years
* Pregnancy
* Hemodynamic instability defined as persistent hypotension, need for on-going aggressive resuscitation and/or vasopressor support to maintain an adequate mean arterial blood pressure
* Need for antibiotic prophylaxis
* Patient withdrawn from empiric antibiotic treatment before Day 4
* Severely immuno-compromised patient (liver cirrhosis (Child-Pugh class C), immunosuppressive drugs after transplantation, neutropenia (absolute neutrophil count \<1000 counts/L), CD-4 count less than 200)
* Patient with suspected bacterial or fungal endocarditis
* Patient with suspected meningitis
* Cardiopulmonary bypass within the last 7 days1)
* Major surgery within the last 7 days (surgery that induces a major inflammatory response such as heart or aortic surgery or major abdominal surgery (i.e. duodenopancreatectomy) or any surgery requiring massive blood transfusion.)
* Multiple trauma within the last 7 days
* Cardiopulmonary resuscitation (CPR) within the last 7 days
* Burns \>20% body surface area
* Patient in terminal status referred for palliative care
* Patient with advanced directives or Do Not Resuscitate (DNR) orders
* Patient who is already enrolled in another therapeutic clinical study
Does Low-Dose Aspirin Improve Outcome in In Vitro Fertilisation/Intra Cytoplasmatic Sperm Injection (IVF/ICSI)?

To investigate the effect of daily administration of low-dose aspirin, compared to placebo, on IVF and ICSI outcome.


Eligibility Criteria:
Inclusion Criteria:

* Dutch-speaking women
* Starting a first or second IVF/ICSI cycle

Exclusion Criteria:

* Women suffering from

  * platelet dysfunction
  * thrombopenia
  * gastro-intestinal ulcers
  * recurrent gastritis
  * aspirin hypersensitivity
* Women on treatment with anticoagulants or aspirin
Coronary Physiology and Its Relationship to Anatomy in Patients With Diabetes Mellitus

Comprehensive assessment of coronary physiology (fractional flow reserve (FFR), coronary flow reserve (CFR) and index of microcirculatory resistance (IMR)) in patients with diabetes mellitus and coronary artery disease (CAD).

Background:

There is currently no data on invasive measurement of FFR, CFR and IMR in patients with diabetes mellitus. Studies such as RIPCORD has shown that using coronary angiography alone to guide revascularization strategy may be flawed in a significant proportion of patients.

Patients with diabetes mellitus are more likely to have diffuse CAD and microvascular disease. Current recommendation of invasive physiological assessment to guide percutaneous coronary intervention (PCI) is limited to FFR alone. This can be misleading in diffuse coronary artery disease and microvascular disease as both conditions are associated with higher FFR. The proportion of vessels which show discordance between FFR and CFR consistent with diffuse CAD and/or microvascular disease in patients has been shown to be as high as 30% in a study not exclusive to diabetics.

This is a pilot study of 50 patients referred for PCI based on angiographic stenosis of ≥50%. Comprehensive physiological assessment will be undertaken in target and non-target vessels to determine the prevalence of discordant FFR and CFR consistent with diffuse CAD and/or microvascular dysfunction in diabetics.

Methods:

1. Patients will receive an information sheet after initial invitation to participate in the study.
2. Written informed consent will be obtained.
3. Patients will undergo invasive assessment of FFR, CFR and IMR in non-target vessels.
4. An optical coherence tomography (OCT) study will be performed to correlate physiological parameters with intravascular imaging for diffuse atheromatous disease.
5. Patients will then undergo OCT and invasive assessment of FFR, CFR and IMR in the target vessel pre and post PCI.
6. Any change in FFR, CFR and IMR post PCI will be recorded.
7. All physiological parameters will be measured using the pressure wire from St. Jude Medical, USA (currently, Certus). Results will be grouped according to 4 possible permutations of FFR and CFR.

Eligibility Criteria:
Inclusion Criteria:

* Diabetic patients with angina and/or evidence of myocardial ischemia (includes ACS patients but not STEMI)
* Willing and able to provide informed, written consent
* Diabetic patients with clinically indicated, abnormal PET scan
* Single or double vessel disease with coronary stenosis ≥50% referred for PCI

Exclusion Criteria:

* Significant left main stenosis ≥50% and/or triple vessel disease referred for CABG
* Recent STEMI (\<5 days)
* Previous CABG
* LVEF ≤ 30% or cardiogenic shock
* Complex coronary anatomy preventing FFR/CFR measurement
Simulated Clinical Use Testing to Evaluate Sharps Injury Prevention Features of HTL-STREFA's Safety Lancets (Test C)

A simulated clinical use testing to evaluate the Medlance Plus and myLance sharps injury prevention feature in accordance with the FDA's guidance on medical devices with sharps injury prevention features.

This study aims to evaluate the safety of the use of the following safety lancets: Medlance Plus and myLance in the prevention of needle-stick injury (NSI) and to evaluate the user's opinion with regard to the handling characteristics of the medical devices.

The simulated use clinical study involves healthcare professionals (HCPs) who routinely use safety lancets to collect blood samples.

Eligibility Criteria:
Inclusion Criteria:

* evaluators who routinely use safety lancets to collect capillary blood samples (prevention of the learning curve artifacts)
* evaluators will be United States (US) residents
* evaluators can read, write, and speak English
* evaluators are at least 18 years old
* evaluators are able to understand and provide signed consent for the study
* evaluators are willing to comply with the study protocol, including being willing to answer questions and complete questionnaires.
* evaluators have no concerns about the ability to perform the simulated skin pricking.

Exclusion Criteria:

* evaluators who do not routinely use safety lancets to collect capillary blood samples,
* evaluators who cannot read, write, and speak English,
* evaluators or a family member have a business or consulting relationship with a pharmaceutical or medical device company, or
* evaluators who have participated in a product evaluation or marketing study involving safety lancets within the last six months
Effect of Quercetin in Prevention and Treatment of Oral Mucositis

The study aims to evaluate the effect of Quercetin (a natural flavonoid) on prevention of and treatment of chemotherapy-induced oral mucositis in patients with blood malignancies.


Eligibility Criteria:
Inclusion Criteria:

* patient under chemotherapy
* for a hematologic malignancy
* the hematologist permits the trial on the patient
* agreement of patient for participating in the trial

Exclusion Criteria:

* presence pf ANY oral lesion at the beginning of the trial
* loss of follow up
* use of digoxin and cyclosporine
* patient death
Observational Study to Assess Sociodemographic and Clinical Features of Patients Treated With Rivaroxaban in Routine Clinical Practice of Hematologists, Cardiologists and Internists of Spain

Depict demographic and clinical features of patients with atrial fibrillation treated with rivaroxaban to prevent stroke and pulmonary embolism in routine clinical practice


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years
* Patients with atrial fibrillation
* Patients in treatment with rivaroxaban for stroke prevention in atrial fibrillation at least 3 months previous to inclusion period in study

Exclusion Criteria:

* Patients in treatment after start of study
* Patients treated with other anticoagulant treatment
Study to Evaluate Safety/Duration in Stomach of Extended Release Capsules in Healthy Adults

To assess how long extended release prototype capsule formulations stay in the stomach as determined by magnetic resonance imaging (MRI).

To evaluate the safety of several extended release capsule formulations (LYN-PLT) and a placebo capsule.

This is a multicentre, observer blind, randomised, single dose study in healthy adult subjects.

The first 5 subjects enrolled into the study will be regarded as Dosing Group 1 (sentinel group) and assigned to each of the five available study formulations. Dosing of subjects in Dosing Groups 1 and 2 will be performed at the endoscopy centre. Dosing of subjects in Dosing Groups 3 through 5 will be performed at the clinical site.

Subjects remain in the inpatient unit for 7 days after dosing. During this time, subjects undergo intermittent imaging assessments for gastric retention (MRI and abdominal U/S), safety assessments and faecal collections for assessments of retrieved components and bowel movement characteristics.

Subjects return to the clinic on Days 10, 15, 22 and 29 (End of Study visit). Safety assessments will be performed at all visits. MRI, abdominal U/S and outpatient faecal collections may continue based on the clinical findings from subjects dosed with modified release capsule formulations. On Day 29, the subjects will undergo final safety assessments at the clinic and thereafter, will be discharged from the study.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male and female subjects
2. Body mass index of 18.0 to 30.0 kg/meters-squared
3. Suitable scores for two swallowing questionnaires
4. Demonstrate normal swallowing and gastrointestinal passage for capsule, as assessed while undergoing imaging studies
5. Must provide written informed consent

Exclusion Criteria:

1. Participants who have previously been enrolled in this study
2. History of any drug or alcohol abuse in the past 2 years
3. Current smokers and those who have smoked within the past 12 months
4. Individuals with clinically significant medical history relating to the gastrointestinal tract and potential complications, thereof
5. Individuals with a positive test for HIV, hepatitis B or hepatitis C
6. Serious adverse reaction or serious hypersensitivity to components of the study formulations or patency capsule
7. Individuals who have received any experimental agent within 30 days (or 5 half-lives), whichever is longer, prior to the date of dosing
8. Individuals with contraindication to MRI imaging
9. Individuals with functional constipation, irritable bowel, or functional diarrhea, as evaluated by standardized questionnaire
10. Individuals with contraindications to elective X-ray based on known or expected radiation exposure
a Smptomatic Bacteriuria in Pregnancy

Asymptomatic bacteriuria (ASB) is defined as the presence of at least 105 colony-forming units (CFU)/ml of 1 or 2 bacterial species in clean-voided midstream urine sample from an individual without symptoms of UTI

ASB is common in women and increases in prevalence with age and/or sexual activity, due to short urethra, pregnancy, easy contamination of urinary tract with fecal flora

The pregnant women are two times more commonly affected than age matched non pregnant females. This is due to urinary stasis due to progesterone effect in pregnancy in addition to different morphological and physiological changes occurring during pregnancy The prevalence of ASB is about 3 times higher in diabetic women (ranging from 15% to 30%) than in non-diabetic women (less than 10%)

Eligibility Criteria:
Inclusion Criteria:

* 1. Pregnant females 2. Non-symptomatic females.

Exclusion Criteria:

* 1. Patients taking antibiotics in the last two weeks. 2. Symptomatic UTI. 3. Suspected urinary tract abnormalities. 4. Urinary catheterization. 5. Renal dialysis.
Intraoperative Laxity Assessment of ACL Reconstruction, ACL Revision and MAT

Intraoperative knee laxity evaluation of patiente undergoing ACL reconstruction, ACL revision, MAT

The study aims to include all thise patients who will undergo anterior cruciate ligament reconstruction, anterior cruciate ligament revision or meniscus transplantation. These patients will undergo an intraoperative kinematic evaluation (pre- and post-ligament reconstruction / meniscal transplantation). There is no follow-up because all the data necessary to carry out the study are obtained during the operating session. In particular, the pre- and post-intervention values (acquired intraoperatively) will be compared using both the surgical navigator and the KiRA system in order to evaluate the effect of the surgical procedure on the value of both static and dynamic laxity of the knee joint. Moreover, limited to the data acquired with the KiRA system, a comparison will be also made with the controlateral limb.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who have provided written informed written consent
2. Patients aged 14 to 65
3. Patients undergoing reconstructive surgery of the anterior cruciate ligament or revision of anterior cruciate ligament surgery or meniscus transplantation. Patients unable to understand and want patients who have not signed informed consent

Exclusion Criteria:

1. Patients unable to understand and to want
2. Patients who have not signed informed consent
Factors Influencing the COVID-19 Vaccine Immune Response According to Age and Presence or Not of a Past History of COVID-19

Age is the main risk factor associated with the severity of COVID-19. From the beginning of the vaccination campaign, elderly subjects are part of the priority population. However, immunosenescence appears to play a role in the natural post-COVID-19 immunity of convalescent elderly subjects and also in the post-vaccination response. However, vaccination recommendations for both naïve (2 doses of vaccine) and convalescent subjects (1 dose of vaccine) do not differ according to age. To date, there is little data to suggest that the response to the vaccine in naïve or convalescent subjects may vary according to age in terms of qualitative and quantitative response and duration.

In addition, the reactogenicity following the vaccine, remains important with COVID-19 vaccines, whether using an Messenger RiboNucleic Acid (mRNA) technique or an adenovirus vector technique. A better understanding of the parameters of early inflammatory response explaining this reactogenicity would allow to optimize the formulation of future vaccines. There are still several unknowns concerning the post-vaccination immune response (immunogenicity and reactogenicity) in older subjects,depending on their history of COVID-19 and the type of vaccine administered. A better understanding of this immune response is necessary in order to propose the best vaccine strategies and regimens in this high-risk COVID-19 population.

Thus, in partnership with Sanofi Pasteur and Bioaster, the Group On Mucosal Immunity And Pathogens (GIMAP) and Circulating Immune Complexes (CIC) vaccinology team proposes to conduct a study comparing the humoral, cellular, mucosal and reactogenic post-vaccination immune response in subjects with a history of COVID-19 \>3 months ago (convalescent, 1 dose of vaccine) versus subjects with no history of COVID-19 (naive, 1 or 2 doses of vaccine depending on the type of vaccine used) according to age.

Eligibility Criteria:
Inclusion Criteria:

* For the group with a past history of COVID-19 (convalescents)= subject within ≥ 3 months after infection
* For the NO past history of COVID-19 (naives), subject with no known history of COVID-19
* Patient affiliated or entitled to a social security plan
* Patients who have received informed information about the study and who have co-signed a consent to participate in the study with the investigator

Exclusion Criteria:

* Immunocompromised or under immunosuppressive treatment
* Subject with a history of COVID hospitalized in intensive care
* Subject allergic to one of the components of the vaccines used in the study
* subject vaccinated for COVID-19
* Subject with persistent symptoms of COVID-19 (long COVID)
* Subjects with unstable chronic pathology
* Persons deprived of liberty, hospitalized without consent
* Pregnant or breastfeeding woman
Lay Tel Compliance Study

This is a randomized controlled study to compare the effectiveness of interactive telephone reminders by a layperson on enhancing compliance with CRC screening by FOBT, when compared with usual care (i.e. no intervention).

Colorectal cancer (CRC) is one of the major global health challenges. CRC is currently the third most common cancer in men and the second common in women worldwide, accounting for approximately 10% of all cancers. It leads to 8% of all cancer mortality in the world and it is the fourth most common cause of cancer deaths. There were 4,563 new cases and 3,893 new deaths in Hong Kong in 2012, while 47.4% of the new cases were diagnosed at stage III or above. In the past decades the Asia Pacific countries like China, South Korea, Japan, and Singapore have witnessed a two to three-fold rise in incidence, gradually catching up the figures in Western countries. The direct medical cost for the care of colorectal neoplasia was estimated US$45,115 for stage IV CRC in the initial year of care, bringing a substantial, global public health burden to the healthcare systems.

Randomized controlled studies have shown that CRC screening using Faecal Occult Blood Testing (FOBT) is effective in reducing cancer mortality by 15-33%. FOBT as a quick office-based procedure has the advantages of being non-invasive, inexpensive, acceptable, feasible, patient-friendly and devoid of needs for bowel preparation. A 25% relative risk reduction in CRC mortality was found for those attending at least one round of FOBT screening, according to a systematic review conducted in 2007. Guidelines from the US Preventive Services Task Force, the European Nations, the Asia Pacific Consensus statements and other authorities recommended FOBT as one of the first-line screening modalities, especially in resource-limited regions. Since yearly testing is recommended to maintain programmatic effectiveness, longitudinal adherence is a critical component of FOBT-based screening programs. Our previous study conducted in Hong Kong showed that the rate of compliance with CRC screening was declining since the first year of enrolment.

Nevertheless, it remains unknown whether interventions based on reminder systems could effectively enhance longitudinal compliance with FOBT, especially among those who have already enrolled in a CRC screening programme. Current evidence does not adequately compare whether interactive reminder are superior to usual care (i.e. no reminders).

Eligibility Criteria:
Inclusion Criteria:

* Subjects who joined the bowel cancer screening programme in the CUHK JC Bowel Cancer Education Centre who are expected to follow-up and return to the centre for annual Fecal Occult Blood Test.

Exclusion Criteria:

* (1) had medical conditions rendering them unable to understand telephone; or (2) had no mobile phone were excluded.
Improving Monitoring of Patients Receiving Case Management

The UK population is ageing and the likelihood of having a long term health condition increases with age. Three out of every five people over 60 in the UK have a long term condition. Ageing and having a long term condition increases the chance of having difficulty being independent and carrying out day to day activities. In recent years the NHS has made a greater effort to prevent these difficulties in patients with long term conditions.

One approach to help patients with long term conditions is case management, where by (usually) a community matron visits patients at home, looking for early warning signs of any worsening of their condition and arranging care and treatment. But the current way this is done varies across the country and hospital admissions are still rising. In order to give the right care at the right time, effective monitoring is needed to help the community matron detect and act on changes in the patient's condition.

Loss of muscle strength in old age is linked to a poor health, but it is not known whether simple measures of muscle strength could be used to detect and predict declines in health in the short to medium term to help maintain independence and prevent an accident or hospital admission.

The aim of this study is to look at whether monitoring muscle strength in case managed patients is practical, acceptable and useful in detecting when a patient's condition worsens. Each patient will be visited by the researcher in their home twice in the first week, then once every two weeks, for another 5 weeks, to carry out three simple measures of grip and respiratory strength, and complete questionnaires about their health and ability to carry out day to day activities. Each visit will last about 20 to 30 minutes. A small group of clinicians will be asked about their views of the strength measures. Database analysis will allow descriptive data on the patient group to be gathered and analysed.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 65 years or over receiving health case management in the community.

Exclusion Criteria:

1. Enrolled in any other research study
2. Preclude consent:

   * Significant cognitive impairment resulting in lack of capacity to consent. b. Unable to communicate without significant aids e.g. Non-English speaking.
3. Preclude participation/ collection of data

   * Significant emotional distress or psychotic illness active within the last 6 months.
   * Receiving end of life care.
   * Current illness that would preclude data collection.
   * Upper limb pathology that would limit participation e.g. bone fracture within the previous 6 months.
   * Identified as high risk patients with regards to lone working safety by their case manager.