cyrilzakka/clinical-trials huggingface dataset:
" The Eyes Have it " : Ocular Saccade Abnormalities in Prodromal Alzheimer's Disease

Alzheimer's disease (AD) has a prolonged prodromal phase before the stage of dementia. Subtle executive cognitive function deficits can be detected at this early pre-dementia phase, more than 10 years before dementia. Among them, the digit symbol substitution task (DSST) has been shown to be altered very early, up to 13 years before dementia. This test, as many others executive function tests, requires a fine control of visuomotor coordination. Like executive functions, eye movements, particularly voluntary-guided saccades, are under the control of the frontal lobe and fronto-parietal networks. Previous studies have shown a deterioration of voluntary saccades in AD using various paradigms. There are no data in prodromal AD, although the pathological process of the disease affects very early brain structures implicated in saccades execution (eg. caudate nucleus and pre-cuneus).


Eligibility Criteria:
Inclusion Criteria:

All patient groups:

* Age \>60 years
* Normal vision work-up : (corrected binocular visual acuity \> 8/10)
* Written informed consent
* Subjects affiliated to Social Security

Group A: Prodromal AD.

* Memory complaints.
* Normal or slight restriction of IADL.
* "hippocampal-type" amnesic syndrome defined by poor free recall despite adequate (and controlled) encoding, decreased total recall because of insufficient effect of cuing or impaired recognition, numerous intrusions (RL/RI-16items)
* CDR (Clinical Dementia Rating Scale) ≥ 0,5
* Persistence of memory changes at a subsequent assessment (\>3 months)
* Absence of global cognitive deterioration (MMSE ≥24)
* Exclusion of other disorders that may cause mild cognitive impairment with adequate tests
* 1.5 Tesla diagnosis MRI with at least T2, Flair transversal sections and coronal T1 sections in the coronal plan. Absent or slight medio temporal/hippocampal atrophy or if available (non mandatory) characteristic CSF betaA42/tau ratio

Group B: Typical AD (mild to moderate)

* NINDS-ADRDA diagnosis criteria
* MMSE ≥ 20

Group C: Control subjects

* No memory or other significant cognitive complain.
* MMSE ≥ 24

Exclusion Criteria:

All groups :

* Clinically significant vision abnormality(P8 without glasses)
* Oculomotor deficit or strabismus
* Depression (GDS) with treatment
* Subjects unable to give their informed consent

Controls :

* Memory or any other significant cognitive complain.
* Abnormalities at inclusion (V0) neuropsychology testing suggestive of a cognitive deficit.
Carvedilol 25 mg in 36 Fasted, Healthy, Adult Subjects

The objective of this randomized, single-dose, two-way crossover evaluation is to compare the relative bioequivalence of a test carvedilol formulation (TEVA Pharmaceuticals USA) to and equivalent oral dose of the commercially available carvedilol (COREG®, SmithKline Beecham Pharmaceuticals) in a test population of 36 adult individuals under fasting conditions.

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Eligibility Criteria:
Inclusion Criteria:

* Sex: Male of Female; similar proportions of each preferred.
* Age: At least 18 years.
* Weight: Minimum of 120 pounds and a BMI (body mass index) of less than 30.

Exclusion Criteria:

* Subjects not complying with the above inclusion criteria must be excluded from the study.
* In addition, any one of the conditions listed below will exclude a subject from the study.
* History of treatment for alcoholism, substance abuse, or drug abuse within the past 24 months
* History of malignancy, stroke, diabetes, cardiac, renal or liver disease, or other serious illness.
* History of treatment for any gastrointestinal disorder within the past five (5) years.
* History of, or presence of, asthma
* History of peripheral vascular disease
* History of heart failure
* History of pre-existing cardiac arrythmias associated with tachycardia
* History of severe sensitivity to allergens, requiring urgent medical treatment.
* Females who are pregnant or lactating
* History of hypersensitivity to carvedilol, or any beta adrenergic blocking drug.
* Conditions upon screening which might contraindicate or require that caution be used in the administration of carvedilol, including:
* sitting systolic blood pressure below 100 mmHg, or diastolic pressure below 60 mmHg.
* Heart rate less than 60 beats per minute after a 5-minute rest in a seated position.
* Inability to read and/or sign the consent form.
* Treatment with any other investigational drug during the four (4) weeks prior to the initial dosing for this study.
* Subjects who smoke or use tobacco products or are currently using nicotine products (patches, gums,etc.) Ninety (90) days abstinence is required.
* subjects who have donated blood within four (4) weeks prior to the initial dosing for this study.
Vincere Biobank Research Protocol

The Vincere Biobank aims to make quality biospecimens and associated clinical data available for research studies related to advancing medicine and improving care for patients, including cancer screening, treatment, and care.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older; any gender
* Able to donate a blood, urine, tissue, and/or other biospecimen sample
* Able to provide informed consent to participate in the study

Exclusion Criteria:

* Minors, under the age of 18 years
* Individuals who lack the capacity to give informed consent
Comparison of Tranexamic to Epsilon Aminocaproic Acid: a Prospective Analysis of Blood Conservation in Cardiac Surgery

We designed a prospective double-blinded randomized trial in an attempt to detect a difference between tranexamic acid (TXA) and epsilon aminocaproic acid (EACA) in reducing transfusion in patients undergoing cardiac surgery.

Background: This study compares the efficacy of tranexamic acid (TXA) to epsilon aminocaproic acid (EACA) in reducing blood loss in patients undergoing cardiac surgery. Methods: This was a double-blinded randomized trial. Patients (n=100) undergoing cardi- ac surgery were randomized to receive either TXA (10 mg/kg bolus followed by an infu- sion of 1mg/kg/hr) or EACA (150mg/kg bolus followed by an infusion of 20 mg/kg/hr). The primary outcome measure was a difference in transfusion amounts.

Eligibility Criteria:
Inclusion Criteria:

1. Is the subject 18 years of age or older?
2. Is the subject scheduled for primary cardiac surgery utilizing cardiopulmonary bypass(CPB)?
3. Is the subject more than 30 kg ( 66 lbs)?
4. Does subject understand English?

Exclusion Criteria:

1. Does the subject have existing coagulation defects (INR \> 1.5, platelets \< 100 ?
2. Does the subject have renal failure (defined as BUN/Cr ratio 20:1 ?
3. Does the subject have severe liver disease (AST \& ALT\> 3x normal) ?
4. Is the subject having emergency cardiac surgery, complex aortic surgery, combination valve/CABG surgeries, or redo cardiac surgery?
5. Is the subject having any procedure where CPB is not anticipated?
6. Is the patient weight greater than 150 kg?
Local Anesthesia in Molar Teeth With Molar Incisor Hypomineralization

To compare responses to electrical pulp test (EPT) and cold test among molar incisor hypomineralization (MIH)-effected and not MIH-effected carious teeth before and after administration of local anesthesia for caries removal.

Fifty carious permanent first molar teeth (25 MIH-effected, 25 not MIH-effected) were included. Firstly, radiographic caries depth, International Caries Detection and Assessment System (ICDAS) codes and MIH levels of teeth were recorded. Then, during the treatment, EPT and cold test were performed before and after the administration of local anesthesia. Visual Analog Scale for Pain was used to evaluate cold test and pain during treatment. When interpreting results, significancy level was stated for the values of p\<0.05.

Eligibility Criteria:
Inclusion Criteria:

* Healthy participants

Exclusion Criteria:

* Not being cooperative during treatment procedure
A Study to Assess the Relative Bioavailability of Immediate Release Formulations of ABBV-903 in Healthy Adult Participants

The main objective of this study is to assess the relative bioavailability and pharmacokinetics of ABBV-903 in healthy adult participants.


Eligibility Criteria:
Inclusion Criteria:

* BMI is ≥ 18.0 to ≤ 32 kg/m2 after rounding to the tenth.
* Negative test result for SARS-CoV-2 infection at screening visit and upon initial confinement.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.

Exclusion Criteria:

* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), endocrine, renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
* History of diseases aggravated or triggered by ultraviolet radiation and no history of abnormal reaction photosensitivity or photoallergy to sunlight, or artificial source of intense light, especially ultraviolet light.
Pilot Trial of Family Partner - a Child Maltreatment Prevention Intervention

Prior to this pilot study, it is unclear whether comparing a manualized version of the Family Partner Model to standard practice in the Child Welfare Services would be feasible. Results will inform whether and how to design a fully powered randomized controlled trial to test the effects of a manualized version of the Family Partner Model on child maltreatment. The specific results of the pilot study will inform 1) randomization procedures, 2) data sources to be used, 3) sample size calculations, and 4) adaptations to the design and measures for a fully powered randomized controlled trial.

The objective is to assess the adaptability and acceptability of the Family Partner Intervention, and the feasibility of a future randomised controlled trial. Our specific research questions are:

1. What is the adaptability, acceptability, and feasibility of the Family Partner intervention in a Norwegian municipal context?
2. What are the experiences and possible outcomes of the Family Partner intervention?
3. Is the trial design feasible for an RCT expansion?

The investigators will pilot a parallel randomized trial (RCT), allocated to two groups (treatment and control). Families that fit to the target group, will be invited to take part in the study. Each family which fit the inclusion criteria and consent to participate will be randomized with a 1:1 allocation to experimental and control groups. Each Family Partner can serve 5 families at a time, and the Family Partner will serve families from 6-18 months. As families complete the programme, new families will be recruited. Hence, the recruitment and randomization will be an ongoing process. Any changes to methods after pilot trial commencement will be reported along with study results.

In a future RCT, the objective is to evaluate the effectiveness of the Family Partner Intervention, i.e. whether introducing the intervention would improve the outcome of existing Child Welfare Services. Hence, the trial is a superiority trial, in which the Family Partner Intervention is hypothesized to be superior to existing service provision. The trial is designed according to an intention-to-treat principle, where all consented participants are included in the analyses, independent of their adherence to intervention.

Eligibility Criteria:
Inclusion criteria:

* parents are 18 years or older, and
* children are under 18 years, and
* families with complex challenges who are already involved in the Child Welfare Services, and
* children live under potentially harmful circumstances, and
* parents struggle in several areas, e.g. employment, poverty, drug misuse, mental health

Exclusion criteria:

None
A Phase I Study of a Novel Tracer for Positron Emission Tomography "PET" Myocardial Perfusion Imaging "MPI"

\[11C\]-dimethyl-diphenyl ammonium (\[11C\]-DMDPA) - A Phase I, Open-label, Safety and Tolerability, Radiation Dosimetry, Biodistribution, First-in-Human Study of a Novel 11C-labeled Tracer for Positron Emission Tomography Myocardial Perfusion Imaging


Eligibility Criteria:
Inclusion Criteria:

* body mass index (BMI) between 18.0 and 30.0 kg/m2
* good health
* written informed consent

Exclusion Criteria:

* smokers
* subject receiving medication
* a blood transfusion in the 4 weeks prior to screening
* positive alcohol blood test
* Subjects who suffer from claustrophobia
* Subjects who have had a clinically significant illness
* Subjects exposed to radiation within 12 months prior to screening
MODULA-Study: Modul 10: Benefit of CRT-Therapy in CRT-Patients With QRS-Complex of 120 - 150 Ms

The purpose of this study is to compare the benefit of cardiac resynchronization therapy (CRT)-therapy in patients with a QRS-complex of 120-150 ms to patients with a QRS-complex of \> 150 ms.

The objective of this study is to compare the benefit of CRT-therapy in patients with a QRS-complex of 120-150 ms to patients with a QRS-complex of \> 150 ms within 12 months. A benefit is defined as change in quality of life and change in physical ability.

Eligibility Criteria:
Inclusion Criteria:

* Patients with cardiac resynchronization therapy with a defibrillator (CRT-D) or cardiac resynchronization therapy pacemakers (CRT-P) system
* New York Heart Association (NYHA) III
* Ejection fraction (EF) below 35%
* Optimised medical therapy
* QRS-complex above 120 ms

Exclusion Criteria:

* Patients with CRT-P and atrial fibrillation
Study of New Biological Markers for Prediction of Severe Acute Pancreatitis

Acute pancreatitis refers to inflammation of the pancreas and is associated with sudden onset of severe abdominal pain, often accompanied by transient systemic manifestations, including fever. In the majority of cases, the inflammatory process is self limiting and patient recovers uneventfully; however, in about 20% to 30% of the cases, a protracted clinical course ensues and the disease may progress to a severe necrotizing form, often triggering a systemic inflammatory response syndrome during which time, acute respiratory distress syndrome, renal failure, shock, and disseminated intravascular coagulation may occur. In the worst sequelae, multiple organ dysfunctions may follow and death supervene. The clinical outcome of patients suffering from severe acute pancreatitis depends to a great extent on the early diagnosis and prediction of severity and timely therapeutic intervention to prevent local and systemic complications. However, the course of the disease is often difficult to predict from the outset. Currently, there is still no single clinical or laboratory test that can be considered the "gold standard" for diagnosis and/or assessment of severity of acute pancreatitis. For a disease that may progress rapidly without apparent sign, the ideal marker for the prediction of disease severity in a patient would be one that is measurable rapidly and easily, besides being able to fulfill all the other criteria required of a good biological marker. To identify such a potential marker for acute pancreatitis requires understanding of the pathophysiological process underlying the rapid progression of a fulminant course of the disease. Although much remains to be elucidated, recent studies in animals have suggested that inflammatory mediators substance P and hydrogen sulfide may play critical roles. This study will evaluate if inflammatory mediators substance P and hydrogen sulfide are upregulated early on in the disease process, and if the levels of their elevation predict disease severity.


Eligibility Criteria:
Inclusion Criteria:

The patient should fulfill all of the following criteria:

* The subject should be at least 18 years of age.
* Clinical features compatible with acute pancreatitis.
* First symptoms of acute pancreatitis not more than 72 hours before enrolment.
* Serum amylase level above 480 U/dl (normal 60-160 U/dl or 2-hour urinary amylase greater than 1120 U (normal 280 U).
* Serum lipase levels greater than 2 U (normal \< 1 U).
* Patient has signed consent form regarding participation in the study.

Exclusion Criteria:

The patient should not present any of the following criteria:

* Symptoms of acute pancreatitis present for more than 72 hours
* Clinical evidence of sepsis or other inflammatory diseases.
* Clinical evidence of disorders/disease known to affect endogenous regulation of substance P, e.g. asthma, immune-complex-mediated lung injury, arthritis.
* Age under 18 years
* Pregnancy
Effects of Weight Reduction on Sleep and Alertness in Long-distance Truck and Bus Drivers

The study is a year-long health-behaviour intervention in obese, male truck-drivers to lose weight moderately by 10%, using monthly individual counseling. The investigators hypothesize that lifestyle modification (increased physical activity, changes in eating habits, and improved schedule for sleep) through weight loss improves daytime alertness and quality of sleep, reduces daytime sleepiness, and improves cardiovascular risk factors and health-related fitness.

Daytime sleepiness, i.e., being fatigued at work is an important risk factor for traffic accidents involving commercial vehicles. Sleep-related disturbances and daytime fatigue may be partly related to obesity, which is common among truck drivers. This study is a randomised 12-month health-behaviour intervention in obese, male truck-drivers. We hypothesize that lifestyle modification (increased physical activity; decreased energy intake; and improved schedule for sleep), aimed to reduce weight moderately by 10%, improves daytime alertness and quality of sleep, reduces daytime sleepiness, and improves cardiometabolic health and health-related fitness. The primary aim is weight loss. We will recruit 140 participants aged 30-62 years and with abdominal obesity. The participants are randomised into an intervention (INT) and control (CON) group, for 12 months. The INT group gets individual lifestyle counseling monthly. After 12 months, the CON group receives weight-loss counseling for 3 months. Assessments (psychological vigilance test, sleep duration, dietary intake, physical activity, metabolic syndrome, health-related fitness) take place at months 0, 12 and 24. We expect to develop counseling strategies (leading to weight loss through changes in lifestyle) that can be used to improve sleep, alertness and cardiometabolic health in occupational health care.

Eligibility Criteria:
Inclusion Criteria:

* male
* age 30-62 years
* long-distance truck or bus driver (on average continuous driving for at least one hour daily outside the city center)
* irregular working hours (on average at least once weekly between 0600-1800 hours)
* waist circumference at least 100 cm
* sedentary: leisure physical activity no more than 30 minutes twice weekly at moderate intensity, and no medical contraindications to increase physical activity

Exclusion Criteria:

* no moderate or severe sleep apnoea with CPAP therapy or with previous surgical operations in the neck area (e.g., UPPP)
* no regular use of sleeping medicines (on average not more often than once weekly)
* no severe sleep disorder
* greatly elevated resting blood pressure (\> 180/120 mmHg)
* no diabetes mellitus with medication
European Registry for Hemadsorption in Sepsis With the Seraph Filter

Although new techniques like extracorporeal blood purification have lately emerged, septic patients still have very high hospital mortality rates. Sepsis can be induced by either viremia, bacteriemia or in some cases both. Many studies have reported the effectiveness of different hemadsorbers, but patient sample sizes have been inadequate for definitive conclusions. Secondly, there are still no clear inclusion criteria as well as criteria for when to cease hemadsorption mostly due to immune dysregulation or cascade coagulation disorders. The aim of this observational prospective registry is to evaluate the effectiveness of the Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) in the treatment of septic ICU patients and to evaluate which cluster of these patients should benefit most with this therapy.

Hemadsorption was introduced in everyday clinical practice before the COVID-19 pandemic. The efficacy of hemadsorption removal of endotoxins and cytokines is still, by some, controversial due to the fact that most of the studies were performed in a small number of patients with very different diagnoses, comorbidities and disease severity. Furthemore, some studies enrolled patients over a prolonged period of time with very high SOFA scores and multi-organ failure where it is difficult to expect any significant effect of any kind of organ support therapy. The COSA registry reported that the treatment of COVID-19 patients with Seraph 100 was well tolerated and observed lower mortality in the registry when compared to calculated mortality.

The primary aim of this observational prospective, multi-center, multistate web-based registry is to define the effectiveness and outcome of Seraph 100 treatment(s), investigate possible advantages of early targeted treatment and to set indications/inclusion criteria for the treatment of ICU septic patients with the method of hemoadsorption.

Eligibility Criteria:
Inclusion Criteria:

1. Sepsis or septic shock: sepsis is defined as the presence of suspected or documented infections along with systemic inflammatory response syndrome; septic shock is defined as the presence of sepsis and acute circulatory failure according to European criteria Society for Intensive Care Medicine
2. laboratory and clinical evidence of systemic inflammation: high levels of inflammatory cytokines such as IL-6 (\>25 pg / ml); high values of inflammatory parameters from serum (leukocytes \>15x10 9 / l, CRP \>40 mg / l, procalcitonin \>0.9 mg / l) and a high SOFA score (\>2).
3. clinical symptoms of hemodynamic instability requiring vasopressors
4. diagnosis of ARDS
5. deterioration of respiratory status with the onset of respiratory failure requiring mechanical ventilation (respiration rate \>30 / min, or oxygen saturation \<93%, or PaO2 / FiO2 ratio \<300mmHg).
6. Admission to ICU

Exclusion Criteria:

besides contraindications to the use of the hemoperfusion adopted (as from the manual of instructions), there are no exclusion criteria
Clopidogrel Optimal Loading Dose Usage to Reduce Recurrent EveNTs/Optimal Antiplatelet Strategy for InterventionS

The purpose of this study is to evaluate whether a higher dosage of clopidogrel with aspirin (two doses) will decrease the risk of ischemic complications (cardiac death (CV death), myocardial infarction (MI), stroke) after a percutaneous coronary intervention (PCI).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with acute coronary disease with clinical symptoms and at least electrocardiogram changes or cardiac enzymes elevated

Exclusion Criteria:

* Use of anticoagulants within 10 days with an international normalized ratio (INR) \> 1.5 or planned use during the hospitalisation period
* Administration of clopidogrel \> 75 mg prior to randomization
* Contraindication to clopidogrel or aspirin
* Active bleeding or significant risk of bleeding