cyrilzakka/clinical-trials huggingface dataset:
A Non-interventional Registry for Patients with Hepatitis B Virus Infection

In order to tackle the unmet needs in chronic HBV infection, a consortium of clinical partners has gathered to establish a registry for patients with hepatitis B mono- and co-infections. The partners will build up a European-wide registry to be able to stratify patients for upcoming clinical trials.

Extensive analyses of virus and host-specific parameters are to be carried out from these patients. The knowledge gained thereby should contribute to a better understanding of the HBV control and enable patient stratification with regard to immunomodulatory therapies.

Furthermore, hepatitis B patients are to be identified who are willing to participate in future studies to investigate immunotherapies to cure HBV infections (e.g. therapeutic vaccines).


Eligibility Criteria:
Inclusion Criteria:

* Hepatitis B Virus Infection

TherVacB sub-cohort:

* confirmed chronic hepatitis B virus infection: HBsAg positive for at least 1 year prior inclusion
* HBeAg status documented for at least 6 months

Exclusion Criteria:

TherVacB sub-cohort:

* age \>70 years
* co-infection with HIV, HCV (RNA positive),
* clinically relevant concomitant liver diseases (ALD, NASH, Haemochromatosis, Autoimmune hepatitis, AT1, Wilson's disease, primary biliary cirrhosis etc.)
* significant comorbidities (e.g. malignancies)
* immunosuppressive treatment (\> 40 mg Cortisol- equivalent)
* liver cirrhosis (judged clinically or based on ultrasound/transient elastography)
* History of hepatocellular carcinoma
Intravenous Exenatide in Patients With Acute Brain Injury

The purpose of this study is to assess the feasibility of exenatide infusion for the treatment of high blood sugars following acute brain injury.


Eligibility Criteria:
Inclusion Criteria:

* Adults ≥18 years
* Acute brain injury resulting in admission to the Neurosciences Intensive Care Unit for an anticipated length of stay \>48 hours
* Two Blood glucose concentrations \> 150 mg/dL and ≤300 mg/dL
* Informed consent obtained via proxy

Exclusion Criteria:

* Pregnant (verified by urine or serum pregnancy test within 24 hours of initiation of infusion) or lactating females
* Type 1 diabetes mellitus
* History of pancreatitis or risk factors for acute pancreatitis (i.e ethanol abuse, gall stones)
* Renal insufficiency defined as creatinine clearance (CrCL) \< 45 mL/min
* Known history of gastroparesis
* History of surgery on stomach, esophagus or duodenum
* Diabetic Ketoacidosis or Hyperosmolar Hyperglycemic Nonketotic Syndrome
* Concurrent steroid use or planned post-operative steroid use
* History of organ transplantation
* Brain death or suspected imminent brain death within the next 72 hours
* Refractory intracranial hypertension defined as intracranial pressure (ICP) \> 25 mmHg for greater than 15 minutes and refractory to medical intervention
* Currently enrolled in another investigational drug or device protocol
* Insulin infusion within 3 hours of study drug administration or confirmed long acting insulin or sulfonylurea use prior to admission within 24 hours of study drug administration
* Known allergy to exenatide
The Effect of Endurance Training on Motor and Cognitive Functions and Concentration of Biomarkers in Post-stroke Patients

The aim of this randomised experimental study is to test the effect of different intensities of aerobic exercise on neurotrophin concentration and functional and cognitive functions in post-stroke patients undertaking a single bout and 3-week exercise programme. The main questions to answer are:

1. What is effect of different intensities of aerobic exercise on functional abilities in post-stroke patients undertaking a 3-week aerobic exercise programme?
2. What is effect of different intensities of aerobic exercise on cognitive functions in post-stroke patients undertaking a 3-week aerobic exercise programme?
3. What is effect of different intensities of aerobic exercise on neurotrophin concentration in post-stroke patients undertaking a 3-week aerobic exercise programme?
4. What is effect of different intensities of 45-min single bout aerobic exercise on neurotrophin concentration in post-stroke patients?

The participants were randomly assigned to one of two groups: moderate-intensity continuous training on a bicycle ergometer and standard neurorehabilitation or low-intensity continuous training on a bicycle ergometer and standard neurorehabilitation. Training on a bicycle ergometer was performed four times a week for 45 min for 3 weeks. Each participant attended individual neurorehabilitation sessions 11 times per week (2 physical therapy sessions from Monday to Friday for 45 min each and 1 session on Saturday for 45 min) during the 3-week intervention.

Participants will have pre-tests and post-tests:

* blood samples collection (to measure level of brain-derived neurotrophic factor, glial cell derived neurotrophic factor, insulin-like growth factor, vascular-endothelial growth factor, irisin),
* body mass index
* The Graded Cycling Test with Talk Test
* 6-Minute Walk Test
* Rivermead Motor Assessment
* Barthel Index
* Addenbrooke's Cognitive Examination
* Vo2max
* Beck Depression Inventory

Researchers will compare two groups - moderate intensity continuous group and low intensity continuous group to see if there is a modulating effect of different intensities of exercise in participants' outcomes.


Eligibility Criteria:
Inclusion Criteria:

* age 21-75 years,
* first episode of ischemic stroke confirmed by magnetic resonance imaging (MRI) or computed tomography (CT),
* able to walk for 4 m at a self-selected speed independently or with an assistive device (as needed),
* be in a stable clinical condition,
* able to communicate with investigators,
* provided written informed consent to participate in the study.

Exclusion Criteria:

* aphasia,
* an unstable cardiac status (e.g., evidence of significant arrhythmia or myocardial ischaemia),
* lower extremity claudication,
* weight-bearing pain \>4/10,
* lower extremity spasticity (i.e., an Ashworth Scale score \>2), other neurological conditions in addition to stroke,
* chronic degenerative or inflammatory diagnoses, malignancies, and visuospatial neglect.
Prevention of PTSD III: Neurocognitive Training of Emotional Regulation

The proposed work will evaluate the ability of neurocognitive retraining of executive functions and emotional regulation to reduce neurocognitive dysfunctions that follow trauma exposure and thereby prevent PTSD. The scientific rationale for this work is the hypothesis that impaired emotional regulation interferes with the expected recovery from the early responses to traumatic events, leading into a chronic disorder. In an initial phase the investigators will recruit 20 recently traumatized participants among trauma survivors admitted to a general hospital emergency room and test the planned intervention's acceptance and right 'dosing'. In the second phase the investigators will enroll 80 recent survivors into a randomized controlled study of the new intervention. The intervention will consist of web-based neurobehavioral training interventions that instill an emotional bias toward positive stimuli, improve emotion recognition and labeling, reduce resistance to emotional distraction, and enhance executive functioning. Control participants will complete web-based video games that do not have emotion-regulatory benefits. Outcome measures will include improvement in neurocognitive functioning and in PTSD symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Adult survivors of traumatic events consecutively admitted to a general hospital Emergency Department

Exclusion Criteria:

* Chronic PTSD at the time of the traumatic event. Current and lifetime psychotic or bipolar illness, current substance abuse save alcohol, medical condition precluding participation.
MicroRNA Activation of LOX-1 Mechanisms in Endometriosis

Endometriosis is a disorder that occurs in women. With endometriosis, tissue that should be found in the womb is found in sites outside of the womb. This disorder impairs the function of the cells that line the body's blood vessels (endothelium). The endothelium helps to control blood flow in healthy vessels. Women with this disorder have an increased risk for high blood pressure and high cholesterol. They have a higher risk for cardiovascular disease, too. With this study, we will learn how endometriosis impairs the lining of blood vessels and increases the risk for disease.

Epidemiologic data demonstrate a clear association between endometriosis, reproductive risk factors, inflammation and cardiovascular (CV) risk. Circulating factors, Low-density lipoprotein (LDL) and oxidized LDL (oxLDL), are two of many biomarkers of cardiovascular and inflammatory disease of endometriosis. An important signaling mechanism through which circulating LDL and oxLDL act is the lectin-like oxidized LDL receptor (LOX-1). LOX-1 signal transduction functionally results in pronounced endothelial dysfunction, a hallmark of CV. We hypothesis that one factor mediating the elevated risk of cardiovascular disease in endometriosis is microRNA (miRNA) activation of LOX-1 receptor mechanisms.

Specific Aim 1. To test the hypothesis that LOX-1 receptor activation is increased leading to endothelial dysfunction in endometriosis.

Specific Aim 2. To test the hypothesis that decreased microRNAs (i.e. let7-a, let7-b, let7-g, MiR98, Mi590-p) are driving increased LOX-1 receptor expression and function in endometriosis.

Eligibility Criteria:
Inclusion Criteria:

* Women between the ages of 18 and 45 years with endometriosis (diagnosis by prior laparoscopy by subject's own physician \<5 years prior, and reported by the subject to the researchers)

Exclusion Criteria:

* Use of nicotine-containing products (e.g. smoking, chewing tobacco, etc.)
* Diabetes (HbA1C .6.5%)
* BP\>140/90
* Taking pharmacotherapy that could alter peripheral vascular control (e.g. insulin sensitizing, cardiovascular medications)
* Pregnancy
* Breastfeeding
* Taking illicit and/or recreational drugs
* Abnormal liver function
* Rash, skin disease, disorders of pigmentation, known skin allergies
* Diagnosed or suspected metabolic or cardiovascular disease
* Persistent unexplained elevations of serum transaminases
* Known allergy to latex or investigative substances
Itch Sensation Induced by Simultaneous Application of Pruritogens (Spatial Summation)

In This experiment, the investigators would like to design a new itch model based on the spatial summation of pruritic stimuli. The hypothesis behind this study (spatial summation) is that two simultaneous applications of pruritogens will result in higher itch sensation compared with a single application of pruritogen.

Chronic itch affects approximately a fifth of the global population and is associated with substantial negative consequences for the affected individuals. Furthermore, there is a lack of efficient treatment options for chronic itch. In order to mimic a clinical itch condition as presented in patients, the aim of the project is to investigate a new itch model based on the spatial summation of pruritic stimuli. The aim of this experiment is to assess the itch sensation induced by simultaneous application of pruritogens (spatial summation). In particular, the purpose is to evaluate if a single application of cowhage/histamine (non-histaminergic and histaminergic itch respectively) results in a lower itch sensation compared to two simultaneous applications of the pruritogens, on the same arm or in different arms.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* 18-60 years
* Speak and understand English

Exclusion Criteria:

* Pregnancy or lactation
* Drug addiction defined as any use of cannabis, opioids, or other addictive drugs
* Previous or current history of neurological (e.g. neuropathy), immunological (e.g. asthma, immune deficiencies, arthritis) musculoskeletal (e.g. muscular pain in the upper extremities,), cardiac disorder, or mental illnesses that may affect the results
* Lack of ability to cooperate
* Current use of medications that may affect the trial such as antihistamines, antipsychotics, and pain killers, as well as systemic or topical steroids
* Skin diseases (e.g. atopic dermatitis, pruritus nodularis, eczema, psoriasis)
* Moles, scars, or tattoos in the area to be treated or tested.
* Consumption of alcohol or painkillers 24 hours before the study days and between these
* Acute or chronic pain
* Participation in other trials within one week of study entry (four weeks in the case of pharmaceutical trials)
Cognitive Markers of Response to Treatment in Resistant Depression

Patients with depression are frequently treatment resistant. Clinical manifestations of depression are various, but cognitive dysfunctions are commonly present. Many factors are involved in treatment resistance. As no biological marker is available, clinical markers could be considered in predicting response to antidepressive treatment.

The aim of this study is to investigate the relation between the cognitive changes and the remission of depressive symptoms in patients with recurrent depression (Stage 2 of Thase and Rush classification).

To explore the dynamics of cognitive dimension associated to clinical and functional remission, the investigators will observe neurocognitive functioning before and after introducing a new antidepressive therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients will be aged from 40 to 70, with a major depressive episode diagnosis with a 2 stage degree of resistance.

Exclusion Criteria:

* Patients with major depressive episode during more of 12 months
* Alzheimer dementia or related disease (CIM 10)
* Score Hamilton Depression Rating Scale (HDRS) \< 18
Study to Investigate the Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 and 4 HCV Infection With Autoimmune Disease

This study is evaluating the safety and efficacy of a 12 week treatment LDV/SOF FDC in patients with Chronic GT1 or GT4 HCV infection and autoimmune disease


Eligibility Criteria:
Inclusion Criteria:

* Chronic GT1 or GT4 HCV Infection
* Diagnosed with autoimmune disease (rheumatoid arthritis, psoriatic arthritis, lupus, etc.) and is currently receiving treatment for the condition.

Exclusion Criteria:

* Infection with HIV or HBV
Effect of Daily Low Dose Aspirin on Exhaled Inflammatory Mediators in Normal Subjects

Hypothesis: Low dose aspirin does not change exhaled inflammatory breath mediators in normal subjects.

Aim:

1. To study the effect of low dose aspirin on exhaled breath inflammatory mediators
2. To compare the change to that seen in diseased states such as asthma and Lymphangioleiomyomatosis (LAM)

We will interview healthy volunteers to confirm that they do not have any major underlying medical conditions such as heart disease, diabetes, stroke and bleeding disorders. We will collect breath condensate before and after two weeks of low dose over the counter enteric coated aspirin 81 mg/day therapy. Side effects are extremely rare at this dose, but include bleeding, heart burn and allergic reaction.

Eligibility Criteria:
Inclusion Criteria:

* healthy adults

Exclusion Criteria:

* any underlying major medical conditions such as heart disease, hypertension, stroke, diabetes, bleeding disorders
To Evaluate Hallux Terbinafine Subungual Gel (HSG) in the Treatment of Onychomycosis

The key objective is to establish the efficacy, safety, tolerability, and pharmacokinetics of investigational drug Hallux Terbinafine Subungual Gel (HSG) administered over 44 weeks to patients with distal-lateral subungual onychomycosis (DLSO).

Primary Efficacy: To identify patients achieving Complete Cure in the target toenail at Week 52.

Secondary Efficacy: To identify patients that have achieved 1) Clinical Cure, 2) Mycological Cure, and/or 3) Positive Response in the target toenail at Week 52.

Plasma Pharmacokinetics: To characterize concentrations of terbinafine and major metabolite in a subpopulation of patients over the study period.

Nail Pharmacokinetics: To characterize concentrations of terbinafine and major metabolite in distal nail clippings in patients over the study period.

HSG Safety and Tolerability Profile: To establish from plasma pharmacokinetics, related adverse events, treatment site reactions, pain, clinically significant changes in medical condition and/or medications, and clinically significant changes in liver function, serum chemistry, urinalysis, and complete blood count over the study period.

Subungual Topical Procedure: To establish the ease and durability of once monthly and once bi-monthly HSG subungual topical treatments, the Investigator will record at selected time points 1) nail measurements indicating progressive clearing, 2) the ease and depth of each topical administration, 3) the investigational drug volume administered each treatment, and 4) patient tolerability.

Eligibility Criteria:
Inclusion Criteria:

* Male and females 18 - 75 years of age inclusive
* Patients with DLSO of at least one great toe
* Patients with DLSO in the target toe confirmed by positive KOH and positive fungal culture for dermatophytes
* Willingness to abstain from pedicures, nail clipping, or application of nail polish or nail cosmetics to their toenails over the study period

Exclusion Criteria:

* History of any significant chronic fungal disease other than onychomycosis or an immunocompromised condition
* Any previous surgery to or abnormalities of the target toe that in the investigator's opinion could prevent the toenail surface area from clearing even if eradication of the DLSO infection is achieved
* Participation in another clinical study of an investigational drug or device within 3 months of screening
* No administration of oral terbinafine or another oral antifungal within 6 months of screening
* No topical antifungal used for onychomycosis or a dermatophyte infection (i.e. tinea pedis) within 3 months of screening
* No uncontrolled diabetes mellitus
* No severe psoriasis or severe atopic dermatitis

Other protocol-defined inclusion/exclusion criteria may apply
Residual Pulmonary Vascular Obstruction Index Computed with Ventilation/perfusion SPECT/CT Imaging to Predict the Risk of Venous Thromboembolism Recurrence in Patients with Pulmonary Embolism (PRONOSPECT)

Major risk after pulmonary embolism (PE) is recurrence, fatal in 10% of patients. Patients with PE can be stratified in 3 groups according to the risk of recurrence : very low risk, high risk or Intermediate risk. Little is known about this last group.

Anticoagulation is efficient to prevent recurrence but is currently not recommended for patient with an intermediate risk of recurrence.

Identifying risk factors of recurrent PE remains a major issue to identify sub-groups of patients who would require lifelong anticoagulation.

In 30-40% of cases, PE patients develop residual pulmonary vascular obstruction (RPVO), which has been found to be associated with an increased recurrence risk. This last observation was mostly reported in patients with unprovoked PE (patients with high risk of recurrence) and RPVO was measured using conventional planar lung scan.

In patients with an intermediate risk of recurrence, the impact of RPVO has been much less studied. In addition, the definition of RPVO was variable according to studies and correlation between RPVO burden and recurrence risk has not been clearly demonstrated. This might be explained by the inherent limitation of RPVO quantification using conventional planar imaging, which is only based on a visual estimation on 2-dimensional images.

Ventilation/Perfusion Single Photon Emission Computed Tomography (V/Q SPECT/CT) is a new method of scintigraphic image acquisition that offers the advantage of 3-dimensional imaging, enabling more accurate and reproducible quantification of RPVO.

The main hypothesis of this study is that in patients with PE at intermediate risk of recurrence, RPVO computed with V/Q SPECT/CT imaging may be an important predictor of recurrence.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years,
* who experienced an objectively proven PE,
* who have been treated initially with anticoagulant therapy for 3 to 6 uninterrupted months (180 - 210 days) and for whom anticoagulation will not be prolonged.

Exclusion Criteria:

* Unwilling or unable to give written informed consent (protected adults, under tutorship or curatorship)
* Patients deprived of their liberty by a judicial or administrative decision, patients undergoing psychiatric care by virtue of Articles L. 3212-1 and L. 3213-1 who are not covered by the provisions of Article L. 1121-8 and patients admitted to a health or social establishment for purposes other than research
* No Social security affiliation
* Isolated DVT
* Pregnant women,parturients women
* Other indication for anticoagulant therapy (e.g. atrial fibrillation, mechanic valve)
* Life expectancy \< 6 months
* Any patients for whom there is a strong indication to treat longer than 6 months: PE provoked by a major persistent factor (e.g. cancer) or Recurrent unprovoked PE
* PE provoked by a major transient risk factor
Is There an Immediate Effect on Pectoralis Minor Length After Performing a Prone Scapular Retraction Exercise

The goal of this clinical trial is to test normal participants.

The main question it aims to answer is:

• Do the participant's pectoralis minor muscles change length immediately after performing an exercise that recruits the scapular retractor muscles? Participants will have their pectoralis minor muscle measured, then perform an exercise recruiting the scapular retractor muscles, and then have their pectoralis muscle measured again.

The participants will have their standing height measured in centimeters with a tape measure fixed against a wall. Participants will then step away from the wall and will be asked to stand in their normal resting position. A mark will be placed on the most medial-inferior aspect of the coracoid process and a second mark on the anterior-inferior edge of the third rib, one index finger's width lateral to the sternum. A caliper will then be used to measure the distance between these marks as the participant holds a normal exhalation.

Participants will then lay prone on a treatment plinth with a small towel roll under their forehead. The participants will form both fists and place them on the plinth just superior to their head, with bilateral thumbs up and the ulnar side of the hands resting on the plinth, and their arms relaxed so their elbows remain on the plinth. The participants will then lift their elbows off the plinth as high as possible while keeping their hands on the plinth. The participants will repeat this motion for 10 repetitions, performing three sets of this exercise with 30 seconds of rest in between each set.

After the third set, the participants will stand up and a second caliper will be used to once again measure PM length by the same tester using the same marks. This will conclude the testing procedure and the participant's involvement in the study.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older. At least 130 degrees of shoulder elevation. None of the exclusion criteria.

Exclusion Criteria:

* Current shoulder pathology and or pain, prior shoulder surgery, any neurological impairment, any upper quarter deformity, a fracture of the upper extremity, or systemic inflammatory disease.