cyrilzakka/clinical-trials huggingface dataset:
Image-Guided (68Ga-PSMA-11 PET/CT) Prostate Biopsy for the Diagnosis of Prostate Cancer in Men With Prior Negative/Inconclusive Biopsy

This early phase I trial studies how well an image-guided prostate biopsy using the imaging agent 68Ga-prostate-specific membrane antigen (PSMA)-11 with a positron emission tomography/computed tomography (PET/CT) scan works in diagnosing prostate cancer in men with a prior negative or inconclusive prostate biopsy. PSMA is a protein that is found on the surface of prostate cancer cells. 68Ga-PSMA-11 is made up of a substance that binds to PSMA on tumor cells, linked with a radioactive substance that can then be seen on imaging scans such as PET/CT. 68Ga-PSMA-11 PET/CT-guided biopsy may help improve the detection rate of prostate cancer. This may help reduce over-diagnosis and over-treatment in men with low-risk prostate cancer and under-treatment in men with high-risk prostate cancer.

PRIMARY OBJECTIVE:

I. To assess the detection rate of clinically significant prostate cancer (Gleason score 7 or more) in patients with focal gallium Ga 68 gozetotide (68Ga-PSMA-11) uptake within the prostate.

OUTLINE:

SCREENING PROCEDURE: Patients receive 68Ga-PSMA-11 intravenously (IV) and 50-100 minutes later, undergo a PET/CT scan. Only patients with 68Ga-PSMA-11 uptake within the prostate proceed to image-guided biopsy.

IMAGE-GUIDED BIOPSY: Patients undergo experimental image-guided prostate biopsy using PET/CT images obtained during screening procedure during a standard of care transrectal ultrasonography guided biopsy (TRUS).

Eligibility Criteria:
Inclusion Criteria:

* Men with suspicion of clinically significant prostate cancer with prior inconclusive, discordant or negative magnetic resonance imaging/ultrasound (MRI/US) fusion prostate biopsy
* Scheduled for a repeat transrectal ultrasound (TRUS) prostate biopsy by standard of care
* Focal 68Ga-PSMA-11 uptake within the prostate

Exclusion Criteria:

* Negative 68Ga-PSMA-11 uptake within the prostate (screening failure)
* Age \< 18 and \> 90 years
* Recurrent prostate cancer
* Inability to provide written informed consent
* Known inability to remain still and lie flat for the duration of the PET/CT (about 30 minutes)
Clinical Significance of Retinal Emboli During Diagnostic and Therapeutic Cardiac Catheterization

Retinal emboli is a common phenomenon in cardiac catheterization. In this study the investigators evaluate the incidence of retinal emboli post diagnostic and therapeutic cardiac catheterization over 300 patients. The incidence was 6.3% and had no clinical sequel on visual acuity and visual field.

Background and Purpose Cardiac catheterization may cause retinal embolization, a risk factor for cerebrovascular emboli and stroke. We describe the incidence of clinically silent and apparent retinal emboli following diagnostic and interventional coronary catheterization and associated risk factors.

Methods Three hundred selected patients attending a tertiary referral center for diagnostic and therapeutic cardiac catheterization were studied. Direct retinal examination and examination of the visual field and acuity were done before and after catheterization by a retinal specialist.

Eligibility Criteria:
Inclusion Criteria:

* every patient with diagnostic and therapeutic cardiac catheterization

Exclusion Criteria:

* patient refusal to follow up ophthalmology
* abscence of coronary disease in angiogram
* abnormal retinal angiogram prior to study
Evaluation of the ReVive SE Device for Intra-Arterial Thrombectomy in Acute Ischemic Stroke

The main objective of this study is to assess the safety and effectiveness of the ReVive SE (Self- Expanding) Neurothrombectomy Device in subjects requiring mechanical thrombectomy when used according to its Instruction for use (IFU).


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old
2. Clinical signs consistent with acute ischemic stroke
3. No pre-stroke functional dependence (pre-stroke Modified Rankin Score ≤ 1)
4. NIHSS ≥ 6,, assessed within two hours before treatment with ReVive SE
5. Large (≥ 1.5mm) and proximal vessel occlusion (presenting TICI score of 0 or 1) of MCA (M1-M2), dICA, or BA confirmed by CT/MR angiography that it is accessible to the ReVive SE.
6. Treatment initiated within 8 hours after symptom onset (first ReVive SE pass made within 6 hours
7. Subject or legally authorized representative has provided informed consent on data collection, and consent is documented

Exclusion Criteria:

1. Life expectancy of less than 90 days
2. Neurological signs that are rapidly improving prior to or at time of treatment (NIHSS improves at least 4 points between subject presentation and treatment initiation)
3. Subject is either exhibiting clinical signs suggestive of, or there is angiographic evidence of bilateral stroke
4. Prior use of any other mechanical device to treat this stroke (e.g., Merci Retriever, Penumbra, Solitaire, Trevo, Mindframe, Phenox, stent)
5. Known bleeding diathesis:

   1. Current use of oral anticoagulants (eg, warfarin sodium) with International Normalized Ratio (INR) \> 3;
   2. Administration of heparin or Novel Oral AntiCoagulants (NOAC, eg Dabigatran, Rivaroxaban) within 48 hours preceding the onset of stroke and have an abnormal activated partial thromboplastin time (aPTT) at presentation; and/or
   3. Platelet count \< 100,000/mm3
6. Glucose \<50 mg/dL (2.8 mmol, 2.6mM)
7. Uncontrolled hypertension (SBP\>185 or DBP\>110) refractory to pharmacological management
8. Known hypersensitivity or allergy to nitinol and/or radiographic contrast agents
9. Pregnancy or lactating female
10. Subject already enrolled in a clinical study involving experimental medication or device

    Imaging Exclusion criteria:
11. CT scan or MRI with evidence of acute intracranial hemorrhage, mass effect and/or intracranial tumor.
12. Angiographic evidence of carotid dissection, or high grade stenosis (\> 50% stenosis of the artery proximal to the target vessel) that will prevent access to the clot, or cerebral vasculitis
13. Blood vessel with extreme tortuosity or other conditions preventing the access of the device.
Influence of Cognitive Rest on Minor Traumatic Brain Injury

Background: Head injury is a common presentation to family medicine clinics and emergency departments (EDs), and the majority will not result in intracranial injury requiring neurosurgical consultation, but will have symptoms of mild traumatic brain injury (MTBI). It is estimated between 15-50% of patients with MTBI develop post-concussive syndrome (PCS). Research in the management of MTBI and prevention of PCS has been scarce to date. Although expert consensus recommends cognitive rest and graduated return to usual activities, these and other interventions are not based on prospective clinical evidence.

Objective: The purpose of this study is to determine if providing graduated return to usual activities discharge instructions to MTBI patients in the ED decreases MTBI symptoms post-injury as compared to providing usual ED MTBI discharge instructions.

Study Design: This will be a pragmatic, single-centered, 2-arm parallel-group, superiority randomized trial.

Patient Population: Male and female patients presenting to the ED ages greater than 17 and less than 65 with the Canadian Emergency Department Information System (CEDIS) presenting complaint of "head injury".

Outcomes: The primary outcome of this study is to determine if patients whom receive graduated return to usual activity discharge instructions have more clinically significant decreases in their Post-Concussion Symptom Score (PCSS) 2 weeks after MTBI versus patients who received usual care MTBI discharge instructions. Secondary outcomes include the intervention group's compliance with the intervention, comparison of PCSS between groups 4 weeks after initial ED visit, comparison of groups' number of return visit(s) to either an ED or physician's office, and the mean number of days of school or work missed for each group.

Hypothesis: Given cognitive rest and graduated return to usual activities are concepts recommended by expert consensus, it is expected patients who follow the graduated return to usual activities and cognitive rest guidelines will have less MTBI symptoms at two weeks after ED discharge.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients presenting to the ED with the Canadian Emergency Department Information System (CEDIS) chief complaint of "head injury".
* Age greater than 17 years and less than 65 years.
* Injury occurring within the last 24 hours.

Exclusion Criteria:

* Acute intracranial injury identified on head CT
* Glasgow Coma Scale (GCS) \< 15 at time of discharge
* Non-English speaking
Biomarker for Hereditary AngioEdema Disease

International, multicenter, observational, longitudinal monitoring study to identify, validate and/or monitor Mass Spectrometry (MS)-based biomarker/s for Hereditary Angioedeme (HAE) disease and to test the clinical robustness, specificity, and predictive value of theese biomarker/s

Hereditary Angioedema (HAE) is a rare autosomal dominant genetic disorder, characterized by recurrent episodes of angioedema of the face, larynx, lips, abdomen, and extremities.The most common types of HAE develop as result of mutations in the SERPING1 gene that encodes the C1 inhibitor (C1-INH), a protease involved in limiting bradykinin production. Excessive bradykinin due to low levels of C1-INH (HAE type 1) or dysfunctional C1-INH (HAE type 2) leads to capillary leakage and angioedema formation. The third type of HAE is not associated with a C1-INH deficiency, develops as a result of mutations in the Factor 12 gene (FXII) and affects almost exclusively women. Rare cases of HAE have also been described resulting from mutations in Plasminogen (PLG), Angiopoetin 1 (ANGPT1), and Kininogen 1 (KNG1).

The characteristic symptom of hereditary angioedema is recurrent episodes of swelling due to the accumulation of excessive body fluid. The most commonly affected areas of the body include the hands, feet, eyelids, lips, genitals, larynx and gastrointestinal tract. The most serious complication of HAE is laryngeal edema that can become life threatening; but it is a relatively rare event.

The diagnosis of hereditary angioedema is made by a thorough clinical evaluation, a detailed patient history, and blood tests.Clinical diagnosis is complicated because HAE is highly variable in the clinical phenotype and the majority of the physicians believe that they never seen a patient with that disorder. Laboratory diagnosis involves measurement of the C1-INH function, C1-INH and C4 levels. Both C1-INH protein level and function is low in HAE-1 patients, whereas in HAE-2 individuals the C1-INH concentrations is optimal or even elevated, however C1-INH function is impaired. Generally, C4 levels are low in both HAE-1/2 patients.

CENTOGENE utilizes Liquid Chromatography-Multiple Reaction Monitoring Mass Spectrometry (LC-MRM-MS) method to identify potential disease-specific biomarkers for HAE. Such biomarker/s may support the early diagnosis and treatment monitoring and personalization in the future.

Therefore, it is the goal of this study is to identify new biomarkers for HAE, validate the identified biomarkers, and monitor these biomarkers longitudinally to determine their clinical robustness, specificity, and predictive value.

Eligibility Criteria:
INCLUSION CRITERIA

* Informed consent is obtained from the participant or participant's parent/legal guardian
* The participant is aged between 2 months and 60 years
* The diagnosis of Hereditary Angioedema is confirmed by CENTOGENE

EXCLUSION CRITERIA

* Inability to provide informed consent
* Participant is younger than 2 months or older than 60 years
* The diagnosis of Hereditary Angioedema disease is not confirmed by CENTOGENE
A Study of PF-08046049/SGN-BB228 in Advanced Melanoma and Other Solid Tumors

This study will test the safety of a drug called PF-08046049/SGN-BB228 in participants with melanoma and other solid tumors that are hard to treat or have spread through the body. It will also study the side effects of this drug. A side effect is anything a drug does to the body besides treating the disease.

This study will have 3 parts. Parts A and B of the study will find out how much PF-08046049/SGN-BB228 should be given to participants. Part C will use the information from Parts A and B to see if PF-08046049/SGN-BB228 is safe and if it works to treat solid tumor cancers.


Eligibility Criteria:
Inclusion Criteria:

* All Parts: Participants must have disease that is relapsed, refractory, or intolerant to standard of care. Participants must have histologically or cytologically confirmed metastatic malignancy.
* Participants must have one of the following tumor types:

  * Parts A and B: Participants must have metastatic or unresectable cutaneous melanoma.
  * Part C: Participants must have one of the following tumor types:

    * Cutaneous Melanoma
    * Non-small Cell Lung Cancer (NSCLC)
    * Colorectal Cancer (CRC)
    * Pancreatic Cancer
    * Mesothelioma
* A pre-treatment biopsy or submission of archival tissue is required
* For participants with cutaneous melanoma

  * Must have been previously treated with an anti-programmed death-1 (anti-PD-1) or anti-programmed death ligand-1 (anti-PD-L1) agent given alone or with other therapies.
  * Participants with a targetable BRAF mutation must have been treated with, been intolerant of, or been deemed ineligible to receive treatment with BRAF/MEK targeted therapy prior to study entry.
* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
* Measurable disease per RECIST v1.1 at baseline

Exclusion Criteria:

* History of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death.
* Active central nervous system metastases or leptomeningeal disease. Participants with previously treated brain metastases may participate provided they are:

  * clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment,
  * they have no new or enlarging brain metastases,
  * and are off of corticosteroids prescribed for symptoms associated with brain metastases for at least 7 days prior to the first dose of study drug.
* Prior therapies cannot include any drugs targeting CD228 or 4-1BB
* Immunotherapy, biologics, and/or other approved or investigational antitumor treatment that is not completed 4 weeks prior to first dose of study drug, or within 2 weeks prior to the first dose of study drug if the underlying disease has progressed on treatment
* Melanoma subtypes including acral, uveal, and mucosal are excluded
Efficacy and Cost-effectiveness of Orthodontic Retention Protocols

Objective is to assess changes of dentition and periodontium, and hygiene in retention after the end of the active phase of orthodontic treatment, and relationship with gender, type of retention appliance, pre-therapeutic condition of dentition and duration of active phase of treatment.

A total of 152 subjects will be recruited and randomly assigned into three groups. First group will have a square 8-stranded 0.673x0.268 mm retainer wire bonded in mandibular teeth after completing the active phase of comprehensive orthodontic treatment with fixed appliances. Retainer will be bonded on lingual site canine to canine on each tooth. Second group will have a round 6-stranded 0.40 mm retainer in mandible. Third group will be without fixed retainer, only with thermoplastic vacuum-formed removable Essix retainer in mandible.

Subjects will be examined before orthodontic treatment (T0), upon completion of treatment (T1), six months in retention (T2), two years (T3) and three years in retention (T4). Changes in intercanine width, relapse (unexpected tooth movements), retainer failure, accumulation of biofilm, calculus and gingivitis will be assessed.

Eligibility Criteria:
Inclusion Criteria: finished orthodontic treatment, participants must have all permanent teeth Exclusion Criteria: hypodontia, missing teeth
Cognitive-functional Evaluation of Anosognosia

Acquired brain damage patients usually show severe cognitive deficit that alter their performance on every day life activities. Some of them suffer anosognosia and they are not aware of their own limitations. This situation increases disability by producing a large number of unsafe behaviours, caregivers burn-out and impede rehabilitation by affecting patients desire to follow treatment instructions. From disciplines like Neuropsychology, Cognitive Neuroscience or Occupational Therapy, it is considered a crucial issue to investigate the cognitive and neural mechanisms responsible of anosognosia, as well as to increase our knowledge about the most efficient treatments to deal with this phenomenon. The main general objective of this project is to generate and validate a detailed cognitive assessment protocol within the context of ADL to evaluate the different cognitive components of consciousness proposed on the Toglia and Kirk´s model: 1) Offline componente: metacognitive knowledge and 2) Online component: emergent awareness, self-regulation, anticipatory awareness, self-evaluation and updating processes).

The proposed protocol is composed by two ecological tools: The Cog-Awareness ADL Scale (ADL scale of metacognitive knowledge) and the Basic and Instrumental ADL performance based test (Awareness ADL), to identify the presence of cognitive deficits and anosognosia in patients with ABI always within the context of everyday life activities. One first specific aim is to test the convergent validity of the two proposed ecological tools with other traditional and validated measures usually used to assess similar cognitive processes and components of self-awareness. The second specific objective is to investigate the external validity of the ecological tools, by testing whether they are able to discriminate between acquired brain damage patients with and without anosognosia and a group of neurologically healthy participants on every component.

After conducting a literature review of the subject we found that this would be the first protocol developed to identify all these components in the same study.

Eligibility Criteria:
Inclusion Criteria:

* Presence of an acquired brain damage objectively observed with medical reports.
* Cognitive deficits relative to executive functions and/or memory evaluated by the team of professionals who recruit participants in the hospital.

Exclusion Criteria:

* Presence of a serious visuoperceptual deficit that makes it difficult to complete the ADL tasks, evaluated by the team of professionals who recruit participants in the hospital.
* Presence of an understanding deficit (aphasia) evaluated by the team of professionals who recruit participants in the hospital.
* Presence of spatial neglect evaluated with line cancellation and line bisection tests.
* Presence of motor deficits in both upper limbs that impedes to complete the ADL tasks.
* Total score in MMSE\<18
Digital Media Based Physical Therapy Post Distal Radius Fracture

This trial aims to develop and test the efficacy of a digital media based physical therapy protocol on patients after surgical fixation and non-operative treatment of distal radius fractures.It is hypothesized that there will not be a difference in outcomes for patients after surgical fixation of distal radius fractures with traditional physical therapy and digital media based therapy


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing operative treatment for distal radius fractures.

Exclusion Criteria:

* Poly-trauma patients with significant previous diagnosis of dementia, previous traumatic brain injury, or other reason for significant altered mental status that would interfere with their participation in therapist directed or digital based therapy will be excluded.
* Patients who present to Oregon Health \& Science University for physical therapy who will be treated by a physician at another non Oregon Health \& Science University facility will be excluded.
* Patients who are not proficient in the English language will be excluded.
Further Delineation of the De Santo Shinawi Syndrome Phenotype Using a Series of Individuals Carrying a Pathogenic Variant of the WAC Gene

The aim of this retrospective, multicenter study would be to extend the phenotypic spectrum of DeSanto Shinawi Syndrome and improve the knowledge of its evolution. To this end, the investigators would like to issue a call for international collaboration in order to create a series of new genetically diagnosed patients, not yet described in previous publications, and with a larger number of individuals evaluated in a single study. One of the aims would be to establish a set of standardized clinical and paraclinical examinations to be carried out at diagnosis and for follow-up of affected patients. This would enable patients, their families and the caregivers involved to better anticipate future management.

Main objective :

Update clinical and paraclinical knowledge of DeSanto-Shinawi syndrome.

Secondary objectives:

* Inventory the clinical signs of the syndrome described to date and look for recurrence between patients.
* Select a set of standardized clinical and paraclinical examinations for diagnosis.
* Establish appropriate management and follow-up.
* To compare the phenotype of patients with DESSH due to a pathogenic point variation in the WAC gene and those with a microdeletion involving the WAC gene.

Main inclusion criteria:

Children and adults of any age. Molecular diagnosis of a pathogenic variant involving the WAC gene (SNV, CNV, SV).

Main non-inclusion criteria:

Patients with a molecular diagnosis of another VP (SNV) of a gene responsible for a neurodevelopmental disorder.

Patient having already participated in a DESSH study with published data. No patient data available.

Primary endpoint:

The data collected will enable the investigators to meet the objective, namely to expand clinical and paraclinical knowledge of DeSanto-Shinawi syndrome.

Main secondary endpoints: NA (descriptive study) Statistics: NA (descriptive study)

Eligibility Criteria:
Inclusion Criteria:

* Children and adults of any age.
* Molecular diagnosis of a pathogenic (or likely pathogenic) variant involving the WAC gene (SNV, CNV, SV).

Exclusion Criteria:

* Patients with a molecular diagnosis of another VP (SNV) of a gene responsible for a neurodevelopmental disorder.
* Patient having already participated in a DESSH study with published data.
* No patient data available.
NIDEK Gonioscope GS-1 for Glaucoma

The Gonioscope GS-1 is an ophthalmic camera with gonioscopic prism that is intended to capture, display and store images of the anterior chamber angle and its peripheral part. This study evaluates the efficiency of Gonioscope GS-1 in glaucoma patients.With the captured images, the glaucoma diagnosis and post-operative observation are enabled.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with glaucoma or glaucoma suspect

Glaucoma Suspect

* Glaucomatous optic neuropathy as described in the glaucoma patients below
* AND/OR ocular hypertension (IOP \> 21 mm Hg)
* Normal visual field

Glaucoma Patients

* Clinical characteristics of glaucoma: ONH abnormalities: global rim thinning, rim notch, or disc hemorrhage; RNFL defect
* Typical glaucomatous field loss in reliable VF, reproducible glaucoma hemifield tests labeled outside normal limits on at least two consecutive tests.
* Both eyes will be included, except in cases where only one eye meets study criteria

Exclusion Criteria:

* Corneal opacities (scars, edema, etc.)
* Pregnant or planning to become pregnant
* Inability to fixate gaze