cyrilzakka/clinical-trials huggingface dataset:
Effect of Teriflunomide Treatment on Microglial Activation in an MS Patient Cohort at Risk of Progression

To evaluate the effect of teriflunomide treatment on microglial activation in late stage multiple sclerosis.

In Multiple Sclerosis (MS), plaques in the white and grey matter of the brain represent the best known pathological changes of the disease, but a significant inflammation process has also been detected outside these plaques in connection with the disease. This extensive, diffuse inflammatory process correlates with the progression of the disease, measured by EDSS score (Expanded Disability Status Scale status) and reduction in patients' cognitive level. According to neuropathological research, the diffuse inflammatory process outside the plaques is connected with powerful activation of microglia, oxidative stress, and deficiencies in mitochondrial activity. The activation of microglial cells can be measured in vivo in patients using positron-emission tomography (PET) scanning and so-called TSPO radioligands, such as the 11C-PK11195 radioligand. 11C-PK11195 radioligand binds to TSPO molecules, which manifest on the surface of activated, but not un-activated, microglia.

Teriflunomide treatment is expected to slow down the process of increasing microglial activation. TSPO-PET imaging allows in vivo follow-up of the pathogenic process associated with the gradual MS disease evolution, and allows to evaluate whether teriflunomide treatment has an effect on disease progression-related pathology.

Eligibility Criteria:
Inclusion Criteria:

* Signing the consent form
* Having used teriflunomide treatment for at least 6 months
* 40-55 years of age at the time of signing the research consent form
* MS diagnosis in accordance with either the Poser or McDonald criteria
* EDSS 2-6.5
* Clear lesion load in brain MRI (\> 9 T2 lesion)

Exclusion Criteria:

* Patients suffering from another brain disease of in addition to multiple sclerosis
* Steroid treatment 4 weeks prior to the scan
* Significant pathology in the MRI scan other than MS-related lesions
* Patients suffering from claustrophobia or panic disorder, or patients who have exhibited hypersensitivity of PET markers (practical obstacle to the scan)
* Exposure to experimental radioactivity in the last 12 months such that the dosimetry threshold would be exceeded due to participation in the study
* Severe hepatic impairment
* Pregnant women, or women of childbearing potential who are not using reliable contraception during treatment with teriflunomide and thereafter as long as its plasma levels are above 0.02 mg/l.
Efficacy of Nebido on Bone Mineral Density (BMD) in Hypogonadal Paraplegic Patients With Confirmed Osteoporosis

Both conditions hypogonadism and immobilisation (paraplegia) may contribute or lead to decreased bone mineral density resp osteoporosis. In this study bone mineral density is assessed in hypogonadal paraplegic patients, who are on standard prophylactic therapy for osteoporosis and and on a standard physiotherapy exercise program one group receiving Nebido for testosterone replacement (TRT). The additional effect of TRT on bone mineral density / osteoporosis is assessed (CT scan lumbar spine).


Eligibility Criteria:
Inclusion Criteria:

* Male patients \> 18yrs
* Osteoporosis prophylaxis/therapy with

  * vitamin D 800 - 1200 mg per day,
  * calcium 800 - 1000 mg per day,
  * Fosamax 70 once a week.
* Standardised physiotherapy exercise programme.
* No proliferative bone disease.
* No history of calcium oxalate stones.
* No use of aromatase inhibitors.
* No use of 5-alpha reductase inhibitors.

Nebido group:

* No contraindications to use of Nebido (known prostate or breast carcinoma or suspicion thereof, no past or present history of liver tumours);
* No known hypersensitivity to testosterone or excipients of Nebido

Exclusion Criteria:

* Androgen dependent carcinoma of the prostate or male mammary gland, past or present history of liver tumours, hypersensitivity towards the active pharmaceutical ingredient or other ingredients.
Radiocontrast Media in the Pulsed Radiofrequency Treatment

Pulsed radiofrequency applied to the dorsal root ganglion (DRG) is an interventional treatment alternative in the treatment of lumbar radicular pain that does not respond to conservative methods. Under intermittent fluoroscopic imaging, the location of the ganglion can be determined by administering contrast media. We consider that determining the localization of the ganglion with this method during pulse radiofrequency application can shorten the procedure time. In this way, we believe that it would help the correct application of the procedure.

Although there are many reasons that can lead to low back pain, radicular pain, which is mostly secondary to lumbar disc hernia, is one of the most common pathologies. Pulsed radiofrequency applied to the dorsal root ganglion (DRG) is an interventional treatment alternative in the treatment of lumbar radicular pain that does not respond to conservative methods and epidural injection treatments.

The electrical field created by the application of pulsed radiofrequency (PRF) changes the cellular activity in DRG neurons. By polarizing cell membranes, reduces nociceptive transmission and contributes to analgesia. In lumbar dorsal root ganglion PRF applications, when the targeted point is reached, the position is confirmed by giving motor and sensory stimuli, and the PRF application is initiated in the follow-up. However, it is a problem that the DRG is not always in the same location, and therefore, time is often lost or even not found while searching with stimulation. Under intermittent fluoroscopic imaging, the location of the ganglion can be determined by administering contrast material.

We consider that determining the localization of the ganglion with this method during pulse radiofrequency application can shorten the procedure time. In this way, we believe that it would help the correct application of the procedure.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years of age.
* Lumbar radicular pain
* Lack of response to conservative methods
* L5 nerve root compression due to disc herniation

Exclusion Criteria:

* Patients younger than 18 and older than 65
* Non-radicular low back pain
* L5 nerve root compression due to reasons other than disc herniation
* Those having spondylolisthesis, or transitional vertebra
* Having an active infection
* Pregnancy
* Bleeding diathesis
* Renal Insufficiency
Pharmacist-driven CGM Use in the Uninsured Population

This is a pilot study. The purpose is to (1) provide access to continuous glucose monitoring (CGM) to patients (purchased through a grant) and (2) systematically record and analyze the results of the glucose monitoring by the clinical pharmacists at the clinic.


Eligibility Criteria:
Inclusion Criteria:

1. adult 18 years of age or older
2. diagnosis of Type 1 or Type 2 diabetes
3. A1c greater than 8%
4. prescribed basal insulin plus either prandial insulin or a glucagon-like peptide-1 (GLP-1) receptor agonist

Exclusion Criteria:

1. pregnant or breast-feeding
2. on dialysis
3. not appropriate for CGM use based on clinical judgment by the investigators
4. patients with limited English proficiency
Deep Brain Stimulation of the Subthalamic Nucleus (STN) and Cognitive Control

In this study, the investigators will follow patients who have had stimulators implanted, at their usual clinic follow-up appointments 3, 6, 9 and 12 months after surgery. It is typical at these appointments for patients to be off medication and for the stimulators to be turned off to observe disease progress and test stimulator effectiveness. Also as part of standard clinical practice, stimulator settings are adjusted for optimal benefit to motor symptoms. Only patients who already have implants will be invited to participate in this study, and no changes to stimulator settings are made for the purposes of this study. Stimulator settings are changed based on clinical evaluation of motor symptoms, and this study has no bearing on how stimulators will be set nor how often they will be set.


Eligibility Criteria:
Inclusion Criteria:

* Meet criteria for "definite" Parkinson's Disease (PD)
* STN stimulators on both sides (right and left)
* Surgery done at Washington University within 2 years

Exclusion Criteria:

* Significant visual deficits (e.g. double vision, untreated eyelid apraxia, blepharospasm) Must be able to see screen
* Secondary Parkinsonism (drug-induced or other known etiologies)
* Brain injury or defect: history of serious head injury, stroke, encephalitis, defect found on brain imaging
* Early severe dementia (within first year of onset) or on cholinesterase inhibitors
* Pre-surgical Mini Mental Status exam score \< 24
* Significant current psychiatric diagnoses (such as depression or psychosis) or on neuroleptics
Imaging Whole Coronary Artery With Intravascular Ultrasound (Ivus) And Imap For Plaque Tissue Composition In Patients With Acute Myocardial Infarction

The iWONDER trial has the following objective:

To analyze the morphological, phenotypic and tissue characteristics of atherosclerotic plaques angiographically considered "culprit" and "not-culprit" in patients undergoing coronary angiography due to STEMI (ST-elevation myocardial infarction).

Coronary artery angiography (CA) is a two-dimensional silhouette of the arterial lumen from a complex three dimensional vascular structure. This exam has several limitations already well documented, including shortening of the vessel, overlapping images, intra and inter-observer variability during the consideration of the severity of injuries. Besides, it offers great limitations in the diagnosis of the composition of atherosclerotic plaque. Furthermore, intravascular ultrasound (IVUS) provides a sensitive and reproducible measure of the dimensions of the vessel and allows direct visualization of the vessel wall, atherosclerotic plaque and arterial lumen. The utility of grayscale IVUS as prognostic tool and as a guide in percutaneous coronary interventions (PCI) is well established. More recently, IVUS has also provided new insights for safety and efficacy of drug eluting stent (DES).

Advances in technology now allow IVUS to characterize the morphology and composition of plaques. Specifically, the analysis of the IVUS wave frequency - beyond the interpretation of wave lengths used in grayscale IVUS- enables in vivo analysis of atherosclerotic plaque composition with high sensitivity and specificity. Although previous studies have reported data using IVUS radiofrequency analysis, the use of a new modality (iMapTM, Boston Scientific, Santa Clara, CA, USA) for characterization of atherosclerotic plaque is poorly known.

Eligibility Criteria:
Inclusion Criteria:

* Age \< 75 years
* Diagnosis of NSTEMI/STEMI with prior use of fibrinolytics in the past 7 days
* Signature of the Term of Informed Consent

Exclusion Criteria:

* Hemodynamic instability
* Clinical signs of post-AMI ventricular dysfunction (Killip III/IV)
* Angiographic findings of (1)coronary anatomy with significant tortuosity, (2) critical coronary obstruction preventing the passage of the IVUS catheter and (3) total occlusion of any of the three epicardial coronary arteries.
Psychological and Clinical Outcomes of Splint Therapy with and Without Doctor-Patient Communication in TMD Management

This study aimed to evaluate the psychological and clinical outcomes of patients undergoing splint therapy with or without enhanced doctor-patient communication in the management of temporomandibular disorders (TMDs). The study compared treatment approaches to determine their impact on patient satisfaction and clinical results.

Temporomandibular disorders (TMDs) are prevalent conditions characterized by jaw pain, functional limitations, and psychological distress. This study investigated the impact of splint therapy combined with enhanced doctor-patient communication on psychological well-being and clinical outcomes. Participants were randomly assigned to receive standard splint therapy or splint therapy with additional doctor-patient communication strategies. The primary outcomes include clinical and psychological status improvements, measured over six months, and patient satisfaction, assessed over a one-year period. The results aimed to provide insights into optimizing treatment strategies for TMD patients.

Eligibility Criteria:
Inclusion Criteria:

* patients complaining of pain in the orofacial region (either arthrogenous and/or myogenous TMD) in the last 3 months, who never underwent any type of treatment for TMD's.
* Age ≥16 years.

Exclusion Criteria:

* patients who have already undergone any treatment for TMD's, edentulous patients,
* patients with any systemic disease that could cause joint and/or muscle changes,
* patients who were undergoing drug treatment for the condition, current pregnancy, or breastfeeding.
Comparative Single-dose Bioavailability Clinical Study of Different Coenzyme Q10 Products

The randomized, open-label, three period crossover single-dose bioavailability study with three coenzyme Q10 products

The randomized, open-label, three period crossover single-dose bioavailability study with three coenzyme Q10 products will include 25 subjects who will test three different coenzyme Q10 products. Serum concentration of coenzyme Q10 will be measured.

Eligibility Criteria:
Inclusion Criteria:

* subject informed consent form
* aged between 40 and 55 years old
* body mass for women 65± 5 kg and for men 85± 5 kg
* non-smoking
* healthy, without cardio-vascular diseases, diabetes, neurodegenerative diseases
* absence of any prescribed medication during the study
* willing to avoid a consumption of any food supplements at least 2 weeks before and during the study
* willing to study all study procedures

Exclusion Criteria:

* cardio-vascular diseases,
* diabetes,
* neurodegenerative diseases,
* gastrointestinal disorders
* hypotension
* pregnancy
* breast-feeding
* intake of any prescribed medication within two week of the beginning of the study
* intake of any food supplements within two week of the beginning of the study
* drug or alcohol abuse
Evaluation of Contact Lenses and Conjunctival Staining in Normal Patients

The purpose of this study was to investigate contact lens fit, lens parameters, and conjunctival staining in a sample of subjects with various contact lens/solution combinations.


Eligibility Criteria:
Inclusion Criteria:

* Successfully wearing hydrogel and/or silicone hydrogel contact lenses;
* Read, sign, and date informed consent/HIPAA document;
* Vision correctable to 20/30 (Snellen) or better in each eye at distance with habitual spectacles;
* Willing and able to discontinue contact lens wear when requested during the study;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Evidence or history of ocular disease or pathology;
* One functional eye or a monofit lens;
* Use of concomitant topical ocular prescription or over-the-counter ocular medications;
* History of seasonal allergies with significant ocular side effects which may have an adverse impact on contact lens wear;
* Other protocol-defined exclusion criteria may apply.
Influence of Hypoxic Induced Factors in Patients With Hereditary Hemorrhagic Telangiectasia

Patients with hereditary hemorrhagic telangiectasia (HHT) suffer from an inherited disorder leading to systemic vascular malformations. Mutations in several genes of the transforming growth factor (TGF)-β superfamily pathway influence angiogenesis in patients with HHT. The genetic loss of ALK1 or ENG alone are not sufficient to induce AVMs; environmental insults that could trigger angiogenesis (e.g. wounding) are also needed. In this study it will be analyzed if hypoxic induced factors could have an influence on the disease HHT.

Hereditary hemorrhagic telangiectasia (HHT) is characterized by systemic vascular malformations leading to recurrent bleedings and shunt formation especially in the liver, lungs and the brain. The underlying pathogenic HHT mechanism remains unclear. The wide variability in age of onset and severity of symptoms amongst patients, even within the same family, suggests several factors contribute to the complexity of this disease. Mutations in several genes of the transforming growth factor (TGF)-β superfamily pathway influence angiogenesis in patients with HHT. The genetic loss of ALK1 or ENG alone are not sufficient to induce AVMs; environmental insults that could trigger angiogenesis (e.g. wounding) are also needed. In this study it will be analyzed if hypoxic induced factors could have an influence on the disease HHT.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed HHT (genetic testing and/ or fulfill at least 3 Curacao Criteria)
* older than 17 years
* ability to consent

Exclusion Criteria:

* if inclusion Criteria are not met
Preoperative Psychological Evaluation as Predictor of Outcomes

Perioperative psychological care is increasingly recognized as an essential part in the surgical environment. Previous studies have developed a strategy to evaluate the psychological influence after operations and found that postoperative psychological states significantly associated with the outcomes of patients. However, preoperative evaluation of patients the physicians do thus far is mainly the physical status assessment following the scale of American Society of Anesthesiologists (ASA). Whether a full-scale evaluation of preoperative psychological status to surgical patients could be a predictor to postoperative outcomes or not is not still completely understood. The investigators hypothesized that the preoperative psychological assessment would be an important predictor to outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective surgical operation
* Age from 18-65 years

Exclusion Criteria:

* Age \<18 years or \>65 years
* Not willing to participate in this study
* Patients from emergency department
Femtosecond Laser-assisted Anterior Lamellar Keratoplasty

The purpose of the study is evaluating safety and clinical efficiency of full femtosecond laser-assisted anterior lamellar keratoplasty (FS-ALK) for curing patients with keratoconus and corneal opacities

Keratoplasty is the most widely spread tissue transplantation procedure. Although penetrating keratoplasty (PKP) is still commonly used for curing corneal dystrophy and opacities of different genesis, lamellar techniques provide significant advantages in terms of safety and predictability.

Al in all 13 FS-ALK procedures were performed for 11 eyes with advanced keratoconus and 2 eyes with superficial corneal scattering Before and after surgery uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), postoperative astigmatism, endothelial cell loss, central cornea thickness, residual recipient's tissue thickness, corneal hysteresis (CH) and corneal resistance factor (CFR) were evaluated . At 1-year follow-up Confoscan investigation of donor-recipient interface was performed.

All FS-ALK procedures were performed with Intralase FS 60kHz femtosecond laser in a following way. At first a 80% thickness corneal graft was prepared. Then maximum thickness recipients corneal dissection was performed according to OCT (optical coherence tomography) data and superficial tissue was removed. Transplant was fixed in a resulted bed by continuous suture.

Eligibility Criteria:
Inclusion Criteria:

* Advanced keratoconus or stromal corneal scattering
* Normal endothelial cell density

Exclusion Criteria:

* Acute keratoconus in the anamnesis
* Low endothelial cell density
* Age under 18 years
Artemis Proximal Femoral Nail for Internal Fixation of Intertrochanteric Femur Fractures

In February 2021, Altior Trauma Innovations™ announced that it had received 501(k) FDA approval for the Artemis Proximal Femoral Nail (PFN) System for internal fixation of intertrochanteric femur fractures. The objective of this pilot study is to evaluate safety, efficacy and feasibility of the Artemis PFN implant for operative fixation of intertrochanteric femoral fractures, compared to matched historical control patients who received other implants.

Intertrochanteric femur fractures are a common injury pattern seen after acute hip trauma, with a very high rate of morbidity and mortality particularly among elderly patients. Cephalomedullary nail fixation has become a mainstay of treatment for both stable and unstable intertrochanteric fractures, offering greater stability than other options without replacing the native hip joint when possible. Despite this, the incidence of fracture nonunion remains high, resulting in poor functional outcomes, higher healthcare costs, and conversion to hemi- or total hip arthroplasty.

In February 2021, Altior Trauma Innovations™ announced that it had received 501(k) FDA approval for the Artemis Proximal Femoral Nail (PFN) System for internal fixation of intertrochanteric femur fractures. The Artemis PFN implant offers several purported advantages over existing implants. It is manufactured with a titanium core coated with carbon-fiber reinforced polyetheretherketone (PEEK), combining the strength of titanium with the bone-imitating biomechanical properties and radiolucency of PEEK. A number of additional features built into the Artemis System are designed to facilitate lower-complexity assembly/insertion, as well as reduce the likelihood of implant failure.

The objective of this pilot study is to evaluate safety, efficacy and feasibility of the Artemis PFN implant for operative fixation of intertrochanteric femoral fractures, compared to matched historical control patients who received other implants.

Eligibility Criteria:
Inclusion Criteria:

* All patients with traumatic, non-pathologic stable intertrochanteric fractures requiring cephalomedullary nail fixation

Exclusion Criteria:

* Pediatric patients (\<18 years)
* Pregnant females
* Patients with other concomitant orthopaedic injuries