cyrilzakka/clinical-trials huggingface dataset:
Spectral Computed Tomography With Photon Counting Detector of Brain and Vessels.

Primary purpose of the study is to show wether computed tomography with photon counting detector has a diagnostic image quality as good as, or better than classic computed tomography in investigations concerning stroke work-up.

Images of the skull/brain at the level of the inner ear/temporal bone and the level of nucleus lentiformis will be compared with the same patients routine brain done in TIA (transient ischemic attack)/stroke workup.

Images of the carotid plaque will be compared with the same patients routine CT-angiogram done in TIA/stroke workup.

Eligibility Criteria:
Inclusion Criteria:

* Brain exam with CT and/or CT neck/brain vessels prior to this study. Regarding neck-vessel imaging - carotid stenosis of 30% or more. Normal kidney function.

Exclusion Criteria:

* no contraindications to iodine contrast for neck-vessel imaging with contrast.
Troponin I and T and Adverse Outcomes in Patients With and Without Diabetes Mellitus After Coronary Intervention

Elevated levels of troponin are associated with future MACE. Data on the prognostic value of high sensitive troponin T (hs-TnT) as compared to high sensitive troponin I (hs-TnI) in diabetic and non-diabetic patients are sparse.

We aimed to assess the risk for MACE according to gender and diabetes status and to compare the prognostic value of hs-TnT and hs-TnI with regards to clinical outcomes in diabetic and non-diabetic patients undergoing percutaneous coronary intervention (PCI).


Eligibility Criteria:
Inclusion Criteria:

* Percutaneous coronary intervention

Exclusion Criteria:

* unsuccessful percutaneous coronary intervention
Study: Tea(m)Time - Strengthening the Team Resilience of Hospital Staff Through the Tea(m)Time Intervention

Employees in hospitals are exposed to various stressors and can be at risk of psychological stress. To counteract this, resilience programs are increasingly being offered. Most interventions focus on individual resilience. In this study, the focus is on the resilience of teams. For this reason, this research paper will focus on the Tea(m)Time intervention. Tea(m)Time is a health promotion intervention that combines the risk assessment of mental stress with a focus on team resilience. In order to generate knowledge about the Tea(m)Time intervention, this study aims to identify factors that promote and inhibit its implementation and mediate its effectiveness. The aim is to gain insights into the promotion of resilience in teams. The aim is to conduct the survey of the participants in the intervention group and the control group at three different points in time.


Eligibility Criteria:
Inclusion criteria:

* be at least 18 years old
* have sufficient knowledge of German
* are not on sick leave at time t0
* work in one of the planned clinics

Exclusion criteria:

* be younger than 18 years old
* do not have sufficient knowledge of German
* are on sick leave at time t0
* do not work in one of the planned clinics
Watchful Waiting Versus Open Tension-free Repair of Inguinal Hernia in Asymptomatic or Minimally Symptomatic Men

This is a multicenter clinical trial to compare pain, physical function, and other outcomes in men with asymptomatic or minimally symptomatic inguinal hernias randomly assigned to watchful waiting without an operation, or a standard hernia repair with mesh. We studied the safety of delaying operation.

CONTEXT Many men with an inguinal hernia have minimal symptoms. Whether deferring operation is safe and a good option for some patients has not been assessed.

OBJECTIVE To compare pain and the Physical Component Score (PCS) of the SF-36 at two years in men with minimally symptomatic inguinal hernias randomized to watchful waiting (WW) or a standard tension-free hernia repair (TFR).

DESIGN, SETTING, AND PATIENTS. Between January, 1999 and December, 2004 we conducted a multicenter trial of 720 men (364 WW, 356 TFR) who were followed for 2-4.5 years. Men were excluded with hernia pain interfering with activities; undetectable hernias; infection; American Society of Anesthesiologists Physical Status \>3; recent difficulty in reducing the hernia.

INTERVENTIONS Men assigned to WW were followed at 6 months and annually and watched for hernia symptoms. Men assigned to operation received TFR, and were followed at 3 and 6 months, and annually.

Eligibility Criteria:
Inclusion Criteria: men 18 years of age and older with asymptomatic or minimally symptomatic inguinal hernias who give informed consent to be randomized.

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Exclusion Criteria:Presence of pain limiting usual activities, difficulty in reducing hernia within last 6 weeks, undetectable hernias, local or systemic infection, ASA physical status \>3, or participation in another clinical trial.

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Anatomic Stenosis Severity as a Prognostic Marker in Patients With Low-Flow Low-Gradient Aortic Stenosis Undergoing TAVI

The ATLAS TAVI Registry is a retrospective, investigator-initiated, multicenter registry including patients, who underwent Transcatheter Aortic Valve Implantation (TAVI) for classical or paradoxical low-flow, low-gradient aortic stenosis (LFLG AS) with available non-contrast MSCT data on aortic valve calcification (AVC). The main objective of this study is the assessment of outcome after TAVI according to AVC density severity in patients with LFLG AS.

Aortic valve calcification (AVC) as assessed by MSCT is highly correlated with aortic stenosis (AS) severity and, thus, has become an important tool for diagnosing severe AS, especially in patients with low-flow low-gradient aortic stenosis (LFLG AS). Moreover, in medically treated AS patients AVC is directly associated with poor prognosis. In contrast, the prognostic benefit of eliminating AS by Transcatheter Aortic Valve Implantation (TAVI) in patients with LFLG AS seems to be larger in patients with high AVC density (AVCd) compared to those with low AVCd, at least in "classical" (low EF) LFLG AS. Hence, we hypothesize that AVCd might be a valuable marker for treatment response among TAVI patients with LFLG AS, who are known to suffer from poor outcome even after elimination of AS.

The multicentric ATLAS TAVI Registry of LFLG AS patients, who underwent TAVI, assesses the impact of AVCd on outcome in these patients.

Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years
* patient gave written informed consent for data acquisition and transfer
* for LFLG AS: -- available non-contrast MSCT data on aortic valve calcification (AVC, Agatston Units)

Exclusion Criteria:

- LFLG AS without non-contrast MSCT data on AVC
Exercise, Gut Microbiota in Sedentary Adults With Overweight

This project offers the opportunity to obtain detailed measurements on the health of body composition, metabolic health, and intestinal microbial diversity in overweight adults; moreover to provide information about the effects of physical exercise on them. The aim of the research is to advance in the understanding of the mechanisms induced by physical exercise, which includes the measurement of nutritional parameters, clinical and biochemical biomarkers of hepatic/cardiometabolic health, as well as the application of differential proteomics technologies by means of Arrays of cytokines and intestinal microbiome, making this study a novel and pioneer in sensitive areas of primary health care in Latin America.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Sedentary males
* BMI\>25 kg/m2, on a stable body weight for the last 3 months

Exclusion Criteria:

* Acute or chronic illness
* Use of antibiotics the past 2 months
* Smoking
Transdermal Contraceptive Patch - Endometrial Effects Study

The aim of the present study is to investigate the effects of the transdermal patch on the endometrium in healthy women who require contraception.


Eligibility Criteria:
Inclusion Criteria:

* Requiring contraception
* Normal cervical smear
* Smokers not older than 30 years
* History of regular cyclic menstrual periods

Exclusion Criteria:

* Pregnancy or lactation
* Obesity (BMI\> 30 kg/m2)
* Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape
* Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic)
* Use of other contraceptive methods than study medication
Using a Personal Heart Rhythm Monitor to Diagnose Paroxsymal Atrial Fibrillation in the Community

This propsective study aims to compare the diagnostic yield of a Personal Heart Rhythm Monitor (PHRM) with an automated cardiac event recorder (ACER) to detect paroxysmal Atrial Fibrillation PAF). The investigators hypothesise that the PHRM, used intermittently for 3 months, will detect significantly more cases of PAF than the ACER, used continuously for one week.

A case-control sub-study will identify individuals with confirmed PAF, and matched individuals with no evidence of PAF, to identify potential serum biomarkers for PAF.

A further case-control study will assess markers of left atrial function in patients with PAF and their matched controls.

Another case-control sub-study will determine the significance of frequent Atrial Premature Beats (APBs) in the development of AF over a one year period.

Patients with suspected AF will be initially referred to a community-based, nurse-led Arrhythmia clinic by their General Practitioners over a 15-month period.

All patients will be issued with a one week ACER (the 'R. Test 4 Evolution'), seen as the 'best-practice' investigation for this population group. Participants will also be issued with a PHRM for three months. They will be instructed to take regular twice-daily, 30 second recordings with additional recordings in the event of relevant symptoms. They will return the ACER after one week and the PHRM after 3 months.

A subgroup of participants (target recruitment number = 100) will undergo transthoracic echocardiography. A 40ml venous blood sample will also be taken. Another small subgroup (target recruitment = 20) will be asked to continue twice-daily recordings using the PHRM for a further nine months and will be issued with a repeat one week ACER at study completion.

Eligibility Criteria:
Inclusion Criteria:

* Suspected paroxysmal AF (either palpitations consistent with AF or an irregular pulse)
* 12-lead resting ECG confirming sinus rhythm
* Capacity to consent to study
* English-speaking
* Life expectancy at least one year

Exclusion Criteria:

* Previous diagnosis of AF
* Recent history of syncope
* Recent history of cardiac-sounding chest pain
* A resting ECG suggestive of alternative arrhythmia
* Inability to use the telephone
* Thyrotoxicosis
Study of the Development of Human Immune System of Newborns by Antigen Chips

The immune system is a dynamic, constantly evolving network. Excluding autoimmune diseases, healthy individuals are also known to have a large number of circulating antibodies that can recognize proteins of their own tissues. These antibodies are known as natural antibodies and previous studies suggested that some features of these "self" components are shared by individuals in certain physiological states. Thus, monitoring self immunoglobulins can provide an overview of the various states of the immune system. To do so, and in the process to obtain systems biology view of the immune system, the newly developed Antigen Chip technology has been used.

To further investigate this subject we plan to carry out broader investigations that will be conducted in collaboration with the group of Prof. Eshel Ben-Jacob from the university of Tel-Aviv and Prof. Irun Cohen from the Weizmann Institute that have the required experimental and analytical expertise and facilities. The studies will include follow-up on the immune state of babies and their mothers for several months post birth using the Antigen Chip and analyzed by the Immune holography method. The investigations will also include comparative studies between the immune signature of different body fluids, the effects of feeding, and the effect method and time of labor.

Antibody reactivities are traditionally studied by their individual reactivities to one or only a few antigens, whereas only a small number of studies have focused on the repertoires of antibodies to large numbers of defined antigens. Only recently, a new technology for system level analysis, the immune microarrays (or antigen chips) was introduced \[Quintana 2004, Quintana and Cohen 2004, Robinson 2006\]. This technology is capable of detecting patterns of antibodies binding to many hundreds of antigens, foreign or self and thus allowing a systems biology view of immune system. To create the antigen chips, a robotic apparatus is used to spot the antigen molecules of choice - proteins, peptides, sugars, lipids, nucleic acids - to a coated glass slide. These antigens are covalently linked to the surface of the slide and a drop of blood serum or any other body fluid can be tested for antibodies binding to hundreds of these antigen spots. The subject's bound antibodies are detected using fluorescence-labeled second antibodies and the reactions are monitored by laser activation.

Eligibility Criteria:
Inclusion Criteria:

* Term and preterm newborns and their mothers
* Age 1 day to 7 weeks

Exclusion Criteria:

* Maternal immune dieases
* Major congential malformations
Pulsed Electro Magnetic Fields (PEMF) Treatment in Patients With Treatment-Resistant Major Depression in Ongoing Pharmacological Treatment of Depression

About 30% of patients with major depression are treatment resistant to pharmacological treatment. In the search for new methods to treat depression a great interest has been put into the use of electromagnetic fields. This study tests the hypothesis that ultra-weak electromagnetic fields with a specific wave pattern (PEMF = pulsed electro magnetic fields) can alleviate the symptoms of depression.

In this study, a patient with treatment resistant depression, as defined by Harold Sackeim, is subjected to 5 weeks of treatment with active or sham PEMF treatment for 30 minutes on every working day. The pharmacological treatment for depression is maintained unaltered throughout the study. Depression severity is measured at the beginning of the study and at each weekly visit. Side effects are closely observed. The ability to concentrate is measured by the AQT test (Alzheimers Quick Test). Personality is assessed by use of the SCID-II-instrument (DSM-IV axis II).

Eligibility Criteria:
Inclusion Criteria:

* Major depression
* Treatment resistance
* Age above 18 years
* Hamilton 17 item score above 13
* Unaltered pharmacological treatment in last 4 weeks

Exclusion Criteria:

* Psychotic disorder
* Mental retardation
* Suicidality
* Earlier treatment with PEMF
* Abuse of alcohol or other substances
* Patient not able to come to appointed visits
* Antisocial, borderline or schizotypic personality disorder
* Women lactating or pregnant
* Unreliable contraception
Comparing Efficacy of 14-day Therapy Doxycycline With Bismuth Subsalicylate Versus Levofloxacin With Tinadizole on Treatment Helicobacter Pylori

Comparison Efficacy of 10-days Therapy with Doxycycline with Bismuth Subsalicylate Versus Levofloxacine with Tinadizole on Eradication of Helicobacter Pylori in Syrian population.


Eligibility Criteria:
Inclusion Criteria:

* Patients are aged greater than 18 years old who have H. pylori infection diagnosed by any of following three methods:
* Positive rapid urease test (CLOtest).
* Histologic evidence of H. pylori by modified Giemsa staining.
* Positive 13C-urea breath test. without prior eradication therapy and are willing to receive therapy.

Exclusion Criteria:

* Children and teenagers aged less than 18 years.
* Previous eradication treatment for H. pylori.
* Patients who took any drug, which could influence the study results such as proton pump inhibitor, H2 blocker, mucosal protective agent and antibiotics.
* History of gastrectomy.
* Gastric malignancy, including adenocarcinoma and lymphoma,
* Previous allergic reaction to antibiotics (Amoxicillin, Tinadizole,
* Doxycycline,Bismuth subsalicylate,) and prompt pump inhibitors (Es- omeprazole).
* Contraindication to treatment drugs.
* Pregnant or lactating women.
* Severe concurrent disease.
* Liver cirrhosis.
Pilot Evaluation of Closed Loop Ventilation and Oxygen Controller

The study compares automated settings (Intellivent) with protocolized settings of the ventilator after cardiac surgery. The settings concern the respiratory rate, the inspiratory and expiratory pressure and FiO2. The aim of the study is to demonstrate that automated settings are feasible and safe.

The study design is a randomized controled study. 30 patients will be ventilated with automated mode and 30 patients with protocolized settings after cardiac surgery.

The hypothesis is that the automated mode allows a safer ventilation with better maintain of the patient in predefined optimal zone of ventilation.

Aim: feasibility and safety study = evaluation of the possibility for a fully automated ventilator to safely manage the ventilation and oxygenation after cardiac surgery

Hypothesis:

Intellivent will maintain the patient with " optimal ventilation " better than during usual management with a minimal number of interventions

Monocentric: IUCPQ, Hôpital Laval, Québec Randomized controlled safety study, unblinded Patients after elective cardiac surgery Two arms Intellivent (fully automatic ventilation) Protocolized ventilation 4 hours study 60 patients planned to be included Primary outcome: number of episodes in the " not acceptable " zone of ventilation and duration

Secondary outcome:

Number of episodes in the " acceptable " zone of ventilation and duration Number of manual settings and duration of interventions Comparison of arterial blood gases Time to wean the FiO2 the PEEP Time to begin the assisted ventilation Duration of mechanical ventilation

Eligibility Criteria:
Criteria for consent (before surgical procedure):

* Elective cardiac surgery
* Age 18 to 90 years
* Absence of pregnancy
* Body Mass Index \< 40 kg/m²
* Creatinine \< 200micromol/L)
* Baseline PaCO2 \> 50 mmHg)

Exclusion Criteria:

* Unexpected surgical procedure
* Major complication during surgery
* Early extubation expected (\< 1 hour)
* Broncho-pleural fistula
* Study ventilator not available
Rethinking Observations in Mental Health

To gain healthcare workers' perception of the current observations practices used in patient care and explore the benefits of using technology to enhance observations in inpatient mental health setting in the United Kingdom.

Periodic intermittent clinical observations are commonly used in mental health services at admission for risk assessment and then for the clinical management of patients.

Nurses follow these practices as routine care to ensure patient well-being. However, being observed may make patients feel uncomfortable and anxious.

The Department of Health (2006) stipulated for the practice of observation to be implemented in a manner that would enable patients to experience it as a healing and compassionate practice. This is apparently not always realised as there are reported differences on how patients are observed, and clinical data obtained.

Whilst this may be attributed in part to lack of or limited training on the use of observations, it can also in part be attributed to lack of a standardised approach to implementation and documentation of the outcomes of observations (Stewart \& Bowers 2012).This contributes to variability among healthcare workers in their interpretation of the outcomes/data of observations. Given that patients' care pathways are influenced by the outcomes/data of observations, it is critical to reduce the variability in the use of this practice. Doing so would lead to obtaining consistent and dependable data that reflect patients' mental state to guide their individual care pathways.

The focus of this qualitative study is to document how clinicians perform routine patient observations, the essential aspects of observations through a clinician's point of view and how can application of modern technology aid this process. This systematic documentation will capture the strengths and limitations of current practice creating a service provide based dataset to inform focused improvements.

Eligibility Criteria:
Inclusion Criteria:

* Healthcare workers such as nurse directors, matrons, ward managers, nurses, healthcare support workers, including; nurse associates, nurse assistants and assistant practioners who work in inpatient mental health settings
* Healthcare workers with at least two years' experience of working in inpatient mental settings
* Healthcare workers who conduct or have conducted patient observations, and have used it for at least two years

Exclusion Criteria:

Students and clinicians in training who do not carry out independent patient observations.
Case Managers to Frail Older People a Randomized Controlled Trial

The aim of is to test the effects of a model for care (case management) to older people with high healthcare consumption and functional dependency on healthcare consumption, quality of life, functional ability and experiences of care.


Eligibility Criteria:
Inclusion Criteria:

* aged 65 or over
* need help with at least two activities of daily living
* been admitted to hospital on at least two occasions, or
* have had at least four contacts with outpatient or primary care during the previous twelve months,
* be able to communicate verbally
* have no cognitive impairment
Persistence of the Immune Response to Hepatitis B in 4-6 Years Old Children Previously Vaccinated With DTPa-HBV-IPV/Hib

Persistence of seroprotective antibody concentrations \& immunological memory shown by the ability to mount a response to a challenge dose of HBV vaccine


Eligibility Criteria:
Inclusion Criteria:

* A male or female aged 4 to 6 years at the time of study entry .
* Subjects who have received a total of 4 doses of DTPa-HBV-IPV/Hib vaccine in previous vaccination studies.
* Evidence of previous hepatitis B booster vaccination or disease since administration of the fourth dose of DTPa-HBV-IPV/Hib vaccine.
Role of HIV on Glutathione Synthesis and Oxidative Stress

HIV infection is associated the development of increased oxidative stress and deficiency of glutathione (GSH), the dominant endogenous antioxidant protein, but the underlying mechanisms contributing to GSH deficiency are hitherto unknown. Furthermore GSH metabolism has not been studied in HIV patients, in whom the burden of risk factors promoting oxidative stress is highest. Our previous studies in non-HIV human subjects with diabetes-related oxidative stress and GSH deficiency have demonstrated that the latter is due to decreased synthesis of GSH. Importantly, short-term dietary supplementation with the simple GSH precursor amino-acids cysteine and glycine, boosted GSH synthesis and cellular concentrations, corrected GSH deficiency, and reduced oxidative stress and oxidant damage. The current proposal will study whether (1) defective synthesis underlies GSH deficiency in patients with HIV, and will test a simple, inexpensive and rational therapy based on protein supplementation to improve GSH synthesis and concentrations and lower markers of oxidative stress and oxidant damage in these patients; (2) study if correction of GSH deficiency is asssociated with any changes in (a) impaired mitochondrial fuel oxidation in the fasted and insulin stimulated states; (b) insulin sensitivity; (c) body composition and anthropometry; (d) forearm muscle strength; (e) plasma biochemistry, and (f) quality of life indices in these subjects.


Eligibility Criteria:
Inclusion Criteria:

(1) HIV infected patients with GSH deficiency

Exclusion Criteria:

1. renal impairment (serum Creatinine above 1.5mg/dL), liver impairment (ALT and AST \> 2x upper limit of normal)
2. any hormonal disorders such as hypothyroidism, hypercortisolemia, hypogonadism, or diabetes mellitus on pharmacotherapy
3. evidence of infections other than HIV in the preceding 3 months
4. subjects with plasma triglyceride concentrations of ≥ 500mg/dL on triglyceride lowering therapy
5. BMI \< 20
6. established heart disease
7. Co-existing viral hepatitis B and C