cyrilzakka/clinical-trials huggingface dataset:
GORE® Septal Occluder Device for Patent Foramen Ovale (PFO) Closure in Stroke Patients

The primary objective is to determine if patent foramen ovale (PFO) closure with the GORE® HELEX® Septal Occluder or GORE® CARDIOFORM Septal Occluder plus antiplatelet medical management is safe and effective and reduces the risk of recurrent stroke or imaging-confirmed transient ischemic attack (TIA) when compared to antiplatelet medical management alone in patients with a PFO and history of cryptogenic stroke or imaging-confirmed TIA.

A co-primary objective is to demonstrate that medical management plus closure with the study device reduces the risk of new brain infarct compared to medical management alone.


Eligibility Criteria:
Inclusion Criteria:

* Presence of cryptogenic ischemic stroke or TIA of presumed embolic infarction verified by a neurologist within 180 days prior to randomization
* Presence of Patent Foramen Ovale (PFO), as determined initially by positive bubble study utilizing transesophageal echocardiography (TEE), demonstrating spontaneous right-to-left shunting or right-to-left shunting during Valsalva maneuver.
* Absence of an identifiable source of thromboembolism in the systemic circulation
* No evidence of a hypercoagulable state
* Note: Additional Inclusion Criteria may apply

Exclusion Criteria:

* Other co-morbidities including, but not limited to, mural thrombus, dilated cardiomyopathy, atrial fibrillation/flutter, cardiac prosthetics (valves), mitral valve stenosis, aortic dissection, significant atherosclerosis, vasculitis, pre-existing neurologic disorders, multiple sclerosis, arteriovenous malformations, prior intracranial hemorrhage, severe central nervous system (CNS) disease, severe disability related to prior stroke, and autoimmune disorders that would increase the risk of mortality or morbidity above what is typical for the treatment
* Previous Myocardial Infarction
* Active infection that cannot be treated successfully prior to randomization
* Sensitivity or contraindication to all proposed medical treatments
* Pregnancy or intent on becoming pregnant through 24-months after randomization
* Indications outside the parameters accepted for placement of the GORE® HELEX® Septal Occluder / GORE® Septal Occluder, including extensive congenital cardiac anomalies and defect diameter estimated to be \> 18mm
* Atrial septal anatomy that is expected to necessitate placement of more than one GORE® HELEX® Septal Occluder / GORE® CARDIOFORM Septal Occluder
* Need for concomitant procedure(s) that may confound detection of adverse events related to device placement
* Note: Additional Exclusion Criteria may apply
Modulation of the Brain Excitatory/Inhibitory (E/I) Balance in Autism Spectrum Disorder (ASD)

This study investigates the brain response to a single acute dose of Arbaclofen, the R-enantiomer of the GABA-B agonist Baclofen, compared to a single dose of placebo in healthy men with and without autism spectrum disorder.

Previous research suggests that GABAergic drug compounds could shift brain excitation and inhibition (E-I) in the healthy brain and in neurodevelopmental psychiatric conditions, such as autism spectrum disorder (ASD) - where this balance is disrupted. A study by Ajram et al. (2017) has shown an E-I shifted towards more GABA in individuals with ASD, and not in controls, after a single dose of the anti-glutamatergic and pro-GABAergic drug Riluzole. Moreover, brain connectivity patterns in ASD patients where shifted towards the ones observed in the control group. However, it was unclear whether this changes could be driven by GABA receptors, thus more specific probes may help to clarify the mechanism underlying the E-I coordination in ASD. Therefore, this study will use neuroimaging and electrophysiology to investigate the brain E-I coordination in ASD compared to control participants when the system is responding to a single dose of the specific GABA-B (STX209) receptor agonist. 50 adult individuals with ASD and 50 neurotypical adults (25 males and 25 females per group) will be invited to participate. Each participant will receive a single dose of the drug (15mg or 30mg Arbaclofen) or matched placebo). Brain activity and neurochemistry will be investigated using magnetic resonance imaging. Further data will be collected through questionnaires, behavioural tasks, blood samples, and sensory tasks using electroencephalography and retinal imaging.

Eligibility Criteria:
Inclusion Criteria:

* ASD participants must pass diagnostic threshold for ASD on the Autism Diagnostic Interview-Revised (if and informant is available)
* ASD participants must be currently symptomatic on Autism Diagnostic Observation Schedule (ADOS)
* Age 18-60 years
* Can give informed consent
* medication free in the month preceding participation; but regular medication (used in a stable dose over the two months previous to participation) with drug which does not affect glutamate or GABA directly may be permitted
* IQ\>70

Exclusion Criteria:

* IQ\<70
* history of psychosis, co-morbid major mental illness, significant physical illness (heart disease, high blood pressure, seizures) habitual substance misuse (including alcohol)
* ASD caused by a known genetic syndrome e.g. Fragile X or 22q11 deletion syndrome,
* past/present treatment for epilepsy
* Change of medication dose/start of a new pharmacological therapy in the month prior to participation
Pharmacogenomics of Stimulant Treatment Response

The "Pharmacogenomics of Stimulant Treatment Response" (PGx-STaR) study aims to identify genetic profiles related to methylphenidate treatment outcomes in children and adolescents aged 6-24 with Attention deficit/hyperactivity disorder (ADHD).

Background: ADHD is a common neurodevelopmental disorder affecting children and adolescents, with psychostimulants, specifically slow-release methylphenidate (e.g., Biphentin®, Concerta®), being a first-line treatment option. However, the response to medications varies significantly among individuals, with some experiencing limited benefits or intolerable side effects. Unlike other areas of psychiatry, ADHD pharmacotherapy lacks genetic markers to guide treatment decisions, resulting in delayed symptom relief and diminished quality of life for patients.

Objectives:

1. Identifying genomic profiles associated with psychostimulant treatment response and tolerability in children and adolescents with ADHD.
2. Establishing a research platform for the discovery of new genetic and non-genetic markers of drug treatment outcomes relevant to mental health care in children.

Eligibility Criteria:
Inclusion Criteria:

Patients will be eligible for participation if all the following are true.

* Aged 6 - 24 years
* Located in Alberta, Canada.
* Primary diagnosis of ADHD (all types).
* Initiating methylphenidate (excluding immediate release (IR) forms) treatment.

Exclusion Criteria:

Patients will be excluded from participation if any of the following are true.

* Co-occurring psychotic, bipolar or eating disorders.
* Significant risk of suicide.
* An intellectual disability, or diagnosis of autism spectrum disorder (ASD) or tics/Tourette disorders.
* Past 12-month high-risk alcohol or substance use defined as monthly or more frequent use.
* Psychotherapy or brain stimulation-based therapy initiated within 8 weeks of referral or plans to initiate/change these types of therapies during the study
* History of liver or bone marrow (hematopoietic cell) transplant as these events can result in ambiguous genomic results.
Atomoxetine's Effects On Nicotine Response And Stress Response In Smokers

The purpose of this study is to evaluate atomoxetine's effects on the rewarding and reinforcing effects of nicotine in a controlled human laboratory study with 24 otherwise healthy nicotine dependent subjects. It is hypothesized that atomoxetine will attenuate the negative effects of nicotine.


Eligibility Criteria:
Inclusion Criteria:

* female and male smokers, not treatment seeking, aged 18 to 55 years;
* history of smoking daily for the past 12 months, at least 5 cigarettes daily;
* CO level \> 10ppm;
* for women: not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods.

Exclusion Criteria:

* history of major medical illnesses including asthma or chronic obstructive lung disease, history or current gastrointestinal ulcer, hepatic or renal impairment, coronary artery disease, cardiac rhythm disturbances or other medical conditions that the study physician deems contraindicated for the subject to be in the study;
* regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics)
* recent psychiatric diagnosis and treatment for Axis I disorders including major depression, bipolar affective disorder, schizophrenia and panic disorder within the past year. We will make an exception for the following Axis I diagnoses: nicotine dependence and alcohol or other drug dependence (i.e., cocaine, opioid) as long as they are not meeting abuse or dependence criteria within the past 3 months for alcohol or drug use;
* use of drugs that slow heart rate (eg, beta-blockers), which may increase the risk of bradycardia and AV block, or NSAIDs, which may increase potential for developing ulcers/active or occult gastrointestinal bleeding;
* known allergy to atomoxetine
Reverse Total Shoulder Arthroplasty Versus Open Reduction Internal Fixation of 3&4 Part Proximal Humerus Fractures

Will patients who suffer complex humerus fractures have better functional outcomes and less implant failure with shoulder replacement (reverse total shoulder arthroplasty, RTSA) compared to shoulder repair (open reduction and internal fixation, ORIF)?

The purpose of this study is to compare validated clinical and functional outcomes between patients who acutely present with 3 and 4-part proximal humerus fractures treated with either ORIF or RTSA.

Eligibility Criteria:
Inclusion

* Neer 3 and 4-part proximal humerus fractures.
* Age greater than and equal to 70 years old.
* Functional deltoid musculature (axillary nerve intact).

Exclusion

* Less than 70 years old.
* Dementia or inability to provide adequate follow up.
* Associated injuries: injuries of ipsilateral limb, complete brachial plexopathy, vascular injury and polytrauma.
The Relationship Between Sleep and Glucose Tolerance in Prediabetes: the Role of GLP-1 in Short Sleepers

Hypothesis

1. Prediabetes patients who have insufficient sleep will have worse glucose tolerance than those with normal sleep duration.
2. Prediabetes patients with short sleep will have a delayed or reduced GLP-1 response to a standardized meal


Eligibility Criteria:
Inclusion Criteria:

1. Patients with prediabetes (HbA1c 5.7-6.4% or history of fasting plasma glucose 100-125 mg/dl) who receive medical care at Ramathibodi Hospital
2. Age 18 or older
3. Can understand Thai (speaking, listening and reading)
4. Agree to participate by written informed consent

Exclusion Criteria:

1. Those who depend on others for feeding (such as stroke patients)
2. Shift workers
3. History of congestive heart failure or low ejection fraction
4. Chronic obstructive pulmonary disease, end stage renal disease or chronic liver disease (AST or ALT \> 3 times the upper limit of normal)
5. Use of medications: opioids/ narcotics , alpha blockers (prazosin, doxazosin, terazosin), clonidine, methyldopa, nitroglycerin
6. Patients with permanent pacemaker
7. History of previous stroke
The Diameter of the Middle Cerebral Artery Measured With Magnetic Resonance Angiography

To examine the ability of MRA to measure the effect of GTN on the intra-cranial vascular response during the GTN-induced headache in healthy volunteers.

The only intra cranial structures innervated by sensory nerves, and therefore a possible source of the headpain are the meninges and the large intracerebral arteries. The dilatation of the cerebral vessels may not be the origin of the head pain per se, but measurements of the intra cerebral vascular bed in the past has proven valuable in the migraine-research, and has helped elucidate the basis for the migraine aura (Olesen, Friberg et al. 1990). The effects of different signal molecules on the intra cerebral vasculature continue to be an important field in the migraine research, in the search for possible pain causing signaling molecules.

Therefore we have set up at study to examine if MR-Angiography (MRA) can be used for monitoring of the vascular response after challenge with the known vasodilator GTN. This drug was chosen because it is well characterized and a large body of evidence from earlier studies could serve as background data (Thomsen 1997).

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* history of migraine or any other type of primary headaches; any kind of daily medication (including prophylactic headache therapy but not oral contraceptives); excessive use of analgesics (corresponding to \>2 g aspirin/day), pregnancy and all known contraindications for MR-examinations incl. claustrophobia.
Prevalence of Deep Sedation in Terminal Palliative Phase

This nation-wide, multicentric, prospective and cross-sectional study aims to estimate the prevalence of deep sedations (i.e. with a -4 or -5 score at the Richmond scale at the induction time) for patients in terminal phase and receiving cares from a specialized palliative care facility (palliative care units, dedicated beds in acute units, mobile teams for inpatient or outpatients or home-based structures) in France.

Inducing a deep sedation in palliative care is a sensitive practice. The abolition of the communication in a crucial moment of life for the patients is particularly challenging. This practice implies particular experiences for families and caregivers, often increased by the deepness of the sedation. In France, the Claeys-Leonetti law has added additional indications of deep sedation. The lack of data on the prevalence of this practice in palliative care complicates the implementation of research projects and the improvement of professionals skills. In existing literature, the proportions of patients thus sedated varied from 2.5 to 14.5%. To our knowledge, no study on the prevalence of deep sedative practices in terminal diseases has been carried out in France. This observational study will help to better understand the real importance of this practice among each palliative care structures. They will also serve to build research projects on this theme supporting improvement of care for this population.

In this study, the deep sedation is defined as a sedation directly inducing from the induction time a score of -4 or -5 at the Richmond vigilance scale (or a clinically equivalent state for the investigator) as defined by the French society of palliative care and accompanying.

The day of inclusion, the investigator will collect the information about the structure of palliative care (type, team composition, number of patients with an on-going terminal disease), the characteristics of the sedated patient(s) (age, disease, treatments) and of the sedation (sedative molecules, assessment of vigilance, consents and decision-making process). In case of an on-going sedation previously initiated but still in progress the day of inclusion, the investigator will retrospectively collect the required data.

Eligibility Criteria:
Inclusion Criteria:

* Major, minor, major with legal protection patient
* Follow-up by a specialized palliative care facility;
* Palliative situation of a disease (non-curable);
* In terminal palliative phase (life expectancy estimated by the investigator =\< 4 weeks)

Exclusion Criteria:

* Not followed by a specialized palliative care facility;
* In curative situation (curable);
* In non-terminal palliative phase (life expectancy estimated by the investigator \> 4 weeks).
Efficacy and Safety of HIP1601 Capsule

The purpose of this study is to investigate the safety and clinical efficacy of HIP1601 in patients with erosive gastroesphageal reflux disease.


Eligibility Criteria:
Inclusion Criteria:

* 19≤ age ≤ 75
* Esophago-Gastro-Duodenoscopy LA classification ≥ grade A
* Patients experienced heartburn or acid regurgitation within 7 days of screening day
* Patients understood the consents and purpose of this trial and signed consent form

Exclusion Criteria:

* Has malignancy in the upper gastrointestinal tract, digestive ulcer, bleeding disorder or signs of gastrointestinal bleeding
* Has a severe liver disorder(at screening day, AST or ALT level exceeds 3 times more than normal upper range)
* Has a clinically significant renal failure(at screening day, MDRD eGFP ≤ 59 mL/min/1.73m2 or Serum creatinine \>2.0mg/dL)
* Uncontrolled diabetes mellitus
* Before screening EGD, a patient who has taken H2-receptor antagonist or PPI within 2 weeks
* Before screening EGD, a patient who has taken drugs containing following list within 1 weeks : warfarin, anticholinergics for spasmolytic GI, antineoplastic agents, salicylates(except 100mg a day for prevention of cardiovascular disease), steroids, propulsives, sucralfate, NSAIDs, other antacids(e.g. antacids of prostaglandin analogs, antacids of aluminum/magnesium)
Double-Blind, Randomized, Placebo-controlled Comparison of CC-10004 in Subjects With Moderate to Severe Plaque Type Psoriasis

There is an unmet medical need for safe, effective oral therapy for moderate-to-severe psoriasis. CC-10004 will be evaluated in a controlled setting of a clinical study. The information obtained from the study will aid in the design of future clinical trials and to establish the safety and efficacy of CC-10004.


Eligibility Criteria:
Inclusion Criteria:

* Must understand and voluntarily sign and informed consent form
* Must be in good health as judged by the investigator
* Must be able to adhere to the study visit schedule and other protocol requirements
* Must have greater than or equal to a 6 month history of moderate-to-severe plaque-type psoriasis
* Must have a Psoriasis Area and Severity Index (PASI) score greater than or equal to 10 and Body Surface Area (BSA) greater than or equal to 10%
* Must meet specific laboratory criteria
* Must be a candidate for photo/systemic therapy
* Women of childbearing potential must have a negative pregnancy test

Exclusion Criteria:

* Must not have clinically significant underlying disease processes
* Must not be pregnant or lactating females
* Must not have any condition, including lab abnormalities, which places the subject at unacceptable risk if the subject were to participate in the study or confounds the ability to interpret data from the study
* Must not have a history of active mycobacterium tuberculosis infection within 3 years prior to the screening visit
* Must not have a history of incompletely treated active of latent mycobacterium tuberculosis infection
* Must not have a know history of exposure to an infectious case of mycobacterium tuberculosis within 2 years prior to the screening visit
* Must not be an immigrant form a high-incidence country for mycobacterium tuberculosis disease within 2 years prior to the screening visit
* Must not have current erythrodermic, guttate, or pustular psoriasis
* Must not have a clinical history of failure to adequately respond to treatment in the investigator's opinion to one or more treatment courses of cyclosporine or the following biologic therapies: alefacept, etanercept, efalizumab, infliximab or adalimumab
* Must not use topical therapy within 14 days of randomization
* Must not use systemic therapy for psoriasis within 28 days of randomization
* Must not use phototherapy within 28 days of randomization
* Must not use adalimumab or infliximab within 3 months of randomization
* Must not use etanercept or efalizumab within 56 days of randomization
* Must not use alefacept within 6 months of randomization
Cartilaginous Batten Graft Septoplasty in Caudal Septal Deviation

To evaluate the clinical outcomes of septoplasty using cartilaginous batten graft in cases with caudal septal deviation as regards the relieve of nasal obstruction and aesthetic results.

A prospective study will be conducted over 15 patients indicated for septoplasty.

Preoperative assessment:

History

* NOSE (nasal obstruction septoplasty effectiveness score): Higher NOSE scores indicate worse nasal obstruction (range: 0-100).
* Visual analogue scale (VAS) (0-10) of nasal obstruction:For nasal obstruction

Examination:

* Anterior rhinoscopy: to confirm caudal septal deviation.
* Endoscopic nasal examination: to exclude HIT, polyp, mass and discharge.
* Basal view photograph.
* CT nose and paranasal sinuses to exclude other pathology.

Operative procedures:

* General anesthesia.
* Hemitransfixtion incision on the concave side
* The mucoperichondrial flap of the septum will be elevated
* A contralateral flap will be elevated from the caudal aspect of the cartilage
* Subperichondrial dissection into the nasal floor
* The curved portion of the septal cartilage will be harvested by excision, leaving an L-strut of dorsal and caudal cartilaginous septum
* A caudal septal batten graft created from harvested septal cartilage, then will be sutured using three or four stitches (5-0 polydioxanone sutures).
* If C-shaped caudal deviation without angulation or dislocation, cartilaginous batten graft fixed on the concave side
* If there is angulation of caudal septal end, the caudal strut will be cut by scissors at the most convex point in the caudocephalic direction. Excessive lower and upper caudal struts will be overlapped and sutured together with batten graft
* If dislocated, the septal cartilage will be separated from the anterior nasal spine (ANS) and maxillary crest for reposition. If there is an excessive cartilage portion, it will be removed and then the graft will be sutured
* The hemitransfixion incision will be closed using 5-0 Vicryl
* Internal nasal splint and anterior nasal pack will be placed in both sides

Eligibility Criteria:
Inclusion Criteria:

- Patient presented with nasal obstruction or disfigurement due to anterocaudal septal deviation.

Exclusion Criteria:

* Previous septal surgery
* Deformed nose, which necessitate external rhinoplasty approach.
* Other endonasal cause of nasal obstruction other than deviated nasal septum
* Bleeding disorder or systemic diseases.
* Patient who will not complete the follow up periods.
Antibacterial Activity of Urea Against Ocular Bacteria

Antibacterial properties of urea was tested against 35 isolates from ocular infections.

In vitro susceptibility testing was performed with commercially available antibiotic discs, homemade urea discs saturated with urea solution at a concentration of 96 mmol. The weight of urea in one drop = 0.37 mg, in one ml = 10.34 mg (5 microliter/ disc) discs and combined discs (antibiotic discs to which urea solution was added). Combined discs provided better in vitro susceptibility results than antibiotics alone.

Scanning electron micrographs of bacterial isolates incubated overnight with urea solution showed marked disruption of bacterial aggregative patterns and irregularities of their cell walls.

Western blotting showed marked reduction in total proteins in bacterial isolates incubated overnight with urea solution. These findings may explain the possible mechanisms for antibacterial activity of urea solution as a result of protein denaturation.

Eligibility Criteria:
Inclusion Criteria:

* ocular infection

Exclusion Criteria:

* Local antibiotics treatment