cyrilzakka/clinical-trials huggingface dataset:
LAnguage-Motor Imagery Circuits to Improve Motor Learning and Language Comprehension

Recent evidence suggests that cognitive systems do not operate in isolation but interact within broader networks, thus opening new avenues for fundamental and clinical research. An illustrative example is the interaction between language comprehension and motor representations. For instance, motor training (e.g., sports, origami training) can facilitate action verb recognition, whereas motor deficits (e.g., upper limb immobilization) can hinder the processing of action language. Similarly, action language has been shown to affect motor performance. These effects are attributed to an implicit form of motor imagery, an automatic simulation of motor experience (without actual movement) evoked by action words. Interestingly, literature supports the idea that the motor simulations used for imagining an action are also engaged during the reading of action language, leading to similar neurophysiological and behavioral changes in both processes. However, questions remain about the similarity of the simulations generated by motor imagery and action language. This project, encompassing three experimental sequences, aims to address these questions to achieve significant scientific advancements in both theoretical and applied domains.


Eligibility Criteria:
Inclusion Criteria:

* persons who have given written consent,
* healthy subjects
* subjects reading and understanding French
* right-handed,
* affiliated with a social security system,
* between 18 and 40 years old,
* had completed the TMS inclusion questionnaire or had undergone a medical examination prior to participation in the MRI study.

Exclusion Criteria:

* Existence of a severe general medical condition: cardiac, respiratory, hematological, renal, hepatic, cancerous,
* Regular use of anxiolytics, sedatives, antidepressants, neuroleptics,
* Characterized psychiatric pathology,
* Ingestion of alcohol prior to the examination,
* Persons covered by articles L1121-5 to L1121-8 of the CSP,
* Presence of contraindications to MRI or TMS.
Diagnostic and Therapeutic Applications of Microarrays in Liver Transplantation

INTERLIVER is a prospective observational study of the relationship of the molecular phenotype of 300 liver transplant biopsies to the histologic phenotype and the clinical features and outcomes. A segment of a biopsy performed as standard-of-care for indications, or by center protocol, will be used for gene expression study.

The current standard for biopsy-based diagnoses of dysfunction of liver transplants is histology (the Banff system), an arbitrary international empirical consensus based on lesions and rules, similar in principle to the kidney, heart, and lung histology systems. Recent data-driven approaches using molecular and conventional technologies indicate that such systems frequently produce incorrect diagnoses - perhaps 40-50% in abnormal kidney or heart transplant biopsies and even more in lung biopsies, with great potential for harm to patients due to inappropriate treatment.

To address this unmet need and improve diagnostics in the area of organ transplantation, the Alberta Transplant Applied Genomics Centre (ATAGC, University of Alberta) has developed a new diagnostic system - the Molecular Microscope® Diagnostic System (MMDx) that interprets biopsies in terms of their molecular phenotype, and combines the molecular and histopathological features of transplant biopsies, plus clinical and laboratory parameters, to create the first Integrated Diagnostic System. The MMDx, developed first in kidney transplant biopsies because phenotypes are well established, will now be adapted to liver transplant biopsies. The present study will develop a Reference Set of liver biopsies, adapt the MMDx system to assess and report molecular phenotype of liver biopsies; and validate and refine this system in 300 unselected prospectively collected for clinical indications and a standard of care biopsies from North American and European Centers. In addition to demonstrating the real-time feasibility and potential value of this System in patient care, the study will develop and optimize a transparent and user-friendly reporting format to communicate this information to clinicians and obtain detailed feedback to improve its utility.

Thanks to increasing interest and support from participating centers, INTERLIVER has already received 861 biopsies from 739 participants and will extend the Reference Set to 900 biopsies.

Eligibility Criteria:
Inclusion Criteria:

* biopsy for clinical indications

Exclusion Criteria:

* no consent, pregnant women
Safety and Tolerability of Inhaled Treprostinil in Adult PH Due to COPD

This is a multicenter, single-arm trial to evaluate the safety and efficacy of inhaled treprostinil in subjects with pre-capillary pulmonary hypertension (PH) associated with Chronic Obstructive Pulmonary Disease (COPD).


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of WHO Group 3 PH associated with COPD
2. Subjects are required to have a right heart catheterization (RHC) within one year prior to the first dose of study drug with the following parameters:

   1. Pulmonary vascular resistance (PVR) ≥ 4 Wood Units (WU) and
   2. A left ventricular end diastolic pressure (LVEDP) or pulmonary capillary wedge pressure (PCWP) of ≤ 12 mmHg if PVR ≥ 4 WU to \< 6.25 WU or ≤ 15 mmHg if PVR ≥ 6.25 WU and
   3. A mean pulmonary arterial pressure (mPAP) of ≥ 30 mmHg
3. Clinical Diagnosis of COPD will be made using accepted Global Initiative for Chronic Obstructive Lung Disease (GOLD) diagnostic criteria, including Baseline spirometry with the following documented parameters:

   1. FEV1 \< 65% predicted, and
   2. FEV1/ FVC \< 70
4. Baseline 6MWD ≥ 100 meters

Exclusion criteria:

1. The subject has a diagnosis of pulmonary arterial hypertension (PAH) or PH for reasons other than COPD as outlined in inclusion criterion 3. This would include, but is not limited to, the concomitant presence of thromboembolic disease (acute or chronic), untreated or inadequately treated obstructive sleep apnea, connective tissue disease (including but not limited to systemic sclerosis/scleroderma, or systemic lupus erythematosus), sarcoidosis, interstitial lung disease,human immunodeficiency virus-1 infection, and other conditions under WHO Group 1, 2, 4, and 5 classifications.
2. The subject has received any Food and Drug Administration (FDA)-approved medication for the treatment of PAH (ie, prostacyclin, prostacyclin receptor agonist, endothelin receptor antagonist \[ERA\], phosphodiesterase type 5 inhibitor \[PDE5-I\],or soluble guanylate cyclase \[sGC\] stimulator) within 60 days of the first dose of study drug, except for acute vasoreactivity testing.
3. The subject has evidence of clinically significant left-sided heart disease as defined by the following criteria per the most recent assessment:

   1. Left ventricular end diastolic pressure (LVEDP) or pulmonary capillary wedge pressure (PCWP) \>15 mmHg (or \>12 mmHg if pulmonary vascular resistance \[PVR\] ≥4 to \<6.25 WU)
   2. Left ventricular ejection fraction \<40% as assessed by either angiography or echocardiography.
Safety and Efficacy of Switching to Quetiapine in Outpatients With Schizophrenia

This is a single-arm, phase IV, open-label, prospective, non interventional study in approximately 600 patients that will be followed for 6 months in order to evaluate the safety and efficacy of quetiapine. Patients will be switched over a 4 to 7 day cross-titration period from their previous antipsychotic medication to quetiapine according to the approved SPC.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia at least 1 year prior to screening
* Inadequate response or poor safety /tolerability or non-compliance to previous antipsychotic medication
* Provision of Informed Consent prior to enrolment

Exclusion Criteria:

* Known hypersensitivity to active substance of excipients
* Patients receiving P450 3A4 inhibitors
* Pregnancy or lactation
* Substance abuse or dependence
Safety and Efficacy of Topical IDP-108 Versus Vehicle in Patients With Onychomycosis

The purpose of this study is to evaluate the safety and efficacy of topical application of IDP-108 versus vehicle in treating patients with onychomycosis.


Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed onychomycosis of the target nail
* Presence of mild to moderate onychomycosis, defined as 20 - 50% of the area of the target nail being clinically affected
* Has a positive KOH examination from the target nail
* Has a positive dermatophyte culture from the target nail

Exclusion Criteria:

* Presence of any disease or condition that might cause nail abnormalities or may interfere with the evaluation of the study drug
* Use of any systemic antifungal therapy within 4 weeks prior to the Screening visit or non-responsive to systemic antifungal therapy for onychomycosis
* Use of any prescription or over-the-counter topical antifungal therapy for the toenails within 4 weeks prior to the Screening visit
* Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period
Trial Comparing Angiography and Angiography With IVUS for Treatment of Hemodialysis Access Failures

The reason the investigators are doing this study is to compare the results of angiography versus angiography with intravascular ultrasound in dialysis grafts/fistulas that are blocked.

Patients with kidney failure have a fistula or graft for long-term dialysis in order for the dialysis machine to draw blood, filter it, and give it back to the patient. Over time, the fistula or graft may not work well enough to use for dialysis, most commonly because the veins may develop "scar tissue" within and around them that narrows the vein resulting in poor flow or complete blockage.

These blockages are commonly opened with wires, balloons (a procedure called angioplasty), and stents. These blockages are seen with angiography, a special type of x-ray used with a dye that shows the inside of the blood vessels. Intravascular ultrasound (IVUS) is a type of imaging that uses sound waves to produce an image of the inside of blood vessels and to see their condition. Currently, it is not known if angiography alone or angiography with IVUS has better results. The reason we are doing this study is to compare the results of angiography versus angiography with IVUS.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years old
* Male or female (non-pregnant females)
* Patients with hemodialysis access failure (arteriovenous fistulae or arteriovenous grafts)
* Patients must undergo elective angiographies (fistulograms) based on surveillance duplex ultrasound findings (stenosis)
* Patients with outflow stenoses between 1 cm distal to an arterial anastamosis and clavicle in AV fistulae or between venous anastamosis and clavicle in AV grafts found on surveillance duplex ultrasound

Exclusion Criteria:

* Patients with other etiologies (inflow lesions, intragraft lesions, hypercoagulable states, lesions not readily amenable to stenting), advanced failures (thrombosis, central venous occlusion), and non-routine access conformations (chest wall/groin grafts, balloon assisted maturation)
Evaluation of Pharmacokinetics, Safety, And Tolerability Of Ertugliflozin (PF-04971729, MK-8835) In Japanese And Western Healthy Participants (MK-8835-041)

This study is to characterize the pharmacokinetics, safety, tolerability, and pharmacodynamics of single and multiple oral doses (SD, MD) of ertugliflozin (PF-04971729, MK-8835) in Japanese healthy participants. The secondary objective is to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single doses of ertugliflozin in Western healthy participants as compared to Japanese healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects of non-childbearing potential, between the ages of 18 and 55 years, inclusive
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* Japanese subjects must have four Japanese grandparents who were born in Japan.
* Mean body weight and the body weight range of Western subjects are similar to those of Japanese subjects with a 10% plus and minus error.
* An informed consent document signed and dated by the subject.
* Subjects who are willing and able to comply with scheduled visits, treatment plan,laboratory tests, and other study procedures.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
* Asian or Polynesian subjects in Western subject groups.
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* A positive urine drug screen.
* History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males within 6 months of screening.
* History or evidence of habitual use of tobacco or nicotine containing products within 3 months of Screening, with the exception of light smoking (up to 5 cigarettes per day or the equivalent).
* Treatment with an investigational drug within 30 days or 5 half-lives preceding the first dose of study medication.
* 12-lead ECG demonstrating QTc \>450 msec at screening.
* Subjects with ANY of the following abnormalities on safety laboratory tests):
* Evidence of glycosuria, as defined by a positive urine dipstick test;
* Fasting serum triglyceride \>300 mg/dL;
* Fasting LDL-cholesterol \> than or equal to 190 mg/dL.
* Fasting serum glucose \>125 mg/dL.
Global Phase1 Study to Assess the Safety and Tolerability of AZD1208 in Advanced Solid Tumors and Malignant Lymphoma

The purpose of this study is to investigate the safety and tolerability of AZD 1208 up to a maximum tolerated dose (MTD) and define the dose(s) for further clinical evaluation when given daily to patients with advanced solid malignancies including malignant lymphoma

A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD1208 in Patients with Advanced Solid Malignancies including Malignant Lymphoma

Eligibility Criteria:
Inclusion Criteria:

* Patients who have signed this Written Informed Consent Form after a full explanation about the participation in this study
* Patients aged 18 years or older Patients diagnosed with a solid malignant tumour or malignant lymphoma that is refractory to standard therapies or for which no standard therapies exist
* Patients with good physical conditions (you can walk and can look after yourself) within the last 2 weeks.
* Patients who have at least one lesion that can be accurately assessed

Exclusion Criteria:

* Patients who have recently received or are receiving prohibited medications or treatments
* Patients who have any unresolved side effects of previous treatments
* Patients who have spinal cord compression or brain metastases
* Patients who have severe systemic diseases (e.g., uncontrolled hypertension, hepatitis B, hepatitis C and human immunodeficiency virus \[HIV\] infection)
* Patients with significant abnormal ECG findings
Appearance of Far Peripheral Retina in Normal Eyes by Ultra-widefield Fluorescein Angiography

PURPOSE: To characterize the appearance of the far peripheral retina of normal eyes using ultra-widefield fluorescein angiography (UWFA).

DESIGN: Prospective observational case series. METHODS: This study enrolled normal eyes with best corrected visual acuity ≥ 20/20, refractive error \< 3.00D, and without visible retinal pathologic changes under a slit lamp-based condensing lens. The far peripheral retina was detected by UWFA. Ciliary body thickness (CBT) at 3 mm (CBT1) and 2 mm (CBT2) posterior to the scleral spur was measured by ultrasound biomicroscopy.

PURPOSE: To characterize the appearance of the far peripheral retina of normal eyes using ultra-widefield fluorescein angiography (UWFA).

DESIGN: Prospective observational case series. METHODS: This study enrolled normal eyes with best corrected visual acuity ≥ 20/20, refractive error \< 3.00D, and without visible retinal pathologic changes under a slit lamp-based condensing lens. Demographic and clinical data such as age, sex, and reasons for undergoing FA were collected. The far peripheral retina was detected by UWFA. The fundal fields obtained using the Heidelberg ultra-widefield lens in a single shot and in montage images were compared with those acquired using the Heidelberg conventional 55° lens. The signs at the peripheral retina detected by UWFA were described and grouped. Ciliary body thickness (CBT) at 3 mm (CBT1) and 2 mm (CBT2) posterior to the scleral spur was measured by ultrasound biomicroscopy.

Eligibility Criteria:
Inclusion Criteria:

* best corrected visual acuity ≥ 20/20
* refractive error \< 3.00D
* without visible retinal pathologic changes under a slit lamp-based condensing lens

Exclusion Criteria:

* history of ocular surgery
* presence of ocular or systemic diseases
* opacity of refractive media, which interfered with the peripheral retina image quality
Computerized Cognitive Rehabilitation in MS Patients

This study examines a home-based computerized cognitive rehabilitation intervention in adults with multiple sclerosis compared to placebo (videogame). Patients are assessed through pre-and post neuropsychological testing.

Patients will be randomized to enter a 6 week course of computer based cognitive rehabilitation focused on improving attention, learning, and memory. Control patients will receive an alternative home-based computer program not designed for cognitive remediation but of the same duration.

The primary outcome will be performance on neuropsychological testing in the intervention sample compared to controls. Secondary outcomes will be the measures of self-efficacy, work productivity, quality of life, fatigue, depression, anxiety, and healthcare utilization. Healthcare utilization variables include annual total cost (current year and prior), number and cost of ER/hospital/outpatient visits, number of hospital visits, hospital length of stay, number preventive visits, total number claims, and number of new medications initiated. In addition, acute changes in neuropsychological testing induced by a bout of physical activity (i.e. self-paced walking during the Six-Minute Walk Test) will be examined, and that pattern of change will be compared between intervention and control groups at each data collection point.

Each subject will participate for a total of 6 months.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of multiple sclerosis with cognitive complaint

Exclusion Criteria:

1. Patients unwilling to participate
2. Patients who cannot attend NPT sessions
3. Patients with severe cognitive impairment
4. Non-English speaking patients (testing materials are in English)
5. Patients with intact neuropsychological functioning at baseline on testing
Endophthalmitis Cultures

The intent of this surveillance study will be to obtain written permission from patients with bacterial endophthalmitis in order to compare sterilization rates of their cultured bacterial isolates to standard therapy (vancomycin and ceftazidime) versus combination therapy with vancomycin, ceftazidime, and moxifloxacin.

Research hypothesis:

1. Cultured bacterial isolates will demonstrate faster in vitro sterilization rates with combination treatment (vancomycin, ceftazidime, and moxifloxacin) compared to "standard therapy" with vancomycin and ceftazidime.
2. Longitudinal analysis of resistance patterns of cultured isolates will show increasing rates of multi-antibiotic resistance.

Adult patients over 18 years of age presenting with endophthalmitis and able to sign consent.

Eligibility Criteria:
Inclusion Criteria:

* all adult patients age 18 or greater presenting with bacterial endophthalmitis to the Vanderbilt Eye Institute and who grow positive cultures

Exclusion Criteria:

* Patients \< 18 years of age or those patients without positive cultures
Resistance of Helicobacter Pylori to Antibiotics in Children

Helicobacter Pylori (HP) is one of the most common pathogens in humans. This infection can present in children with abdominal pain, vomiting and iron deficiency. The treatment is usually empiric and includes antibiotic treatment usually Amoxycillin and Clarithromycin or Metronidazole. Between 40 to 70 % of the pathogens are resistant to those drugs, and it is important to characterize the specific sensitivity of the pathogens in any specific area and in pediatric population. The aims of this study is to assess the sensitivity of HP in pediatric population in Northern Israel.

The aim of our prospective study is to investigate the rate of H pylori resistant strains to antibiotic treatment including Amoxicillin, Clarithromycin, Metronidazole, Tetracycline and Quinolones in pediatric population in Ha-Emek medical center, Afula. The second aim was to determine if in vitro resistance is being reflected in vivo too.

Should the investigators find high rates of H pylori resistance to Clarithromycin, the investigators will have to reconsider the recommendation to use Clarithromycin as the first line treatment for H pylori.

Our research group will conclude 100 children in the ages of 1-18 years, evaluated for recurrent abdominal pain, iron deficiency anemia, failure to thrive by an upper endoscopy, biopsy specimens taken for a rapid urease test, for histology, for culture and for antibiotic susceptibility testing.

Biopsy specimens for histology will be fixed in formalin, embedded in paraffin and sectioned and stained with hematoxylin and eosin.

The microbiological workup will include an imprint of the biopsy on a slide followed by a gram stain for the purpose of demonstrating H. pylori in situ. Further the biopsies will be streaked out on chocolate agar, Sheep blood agar and H. pylori selective agar supplemented with Polymixin to suppress possible contaminants.

4 days of incubation in a micro aerophilic atmosphere will follow . Susceptibility testing of H pylori will be performed with E test on Mueller Hinton agar supplemented with defibrinated sheep blood using a MacFalrland 3.0 density of a bacterial suspension. Reading the susceptibility will take place following 72 hours of incubation in a micro aerophilic atmosphere.

Eligibility Criteria:
Inclusion Criteria:

* ages of 1-18 years,
* evaluated for recurrent abdominal pain,
* iron deficiency anemia,
* failure to thrive by an upper endoscopy