cyrilzakka/clinical-trials huggingface dataset:
The Musculocutaneous Nerve in a High Resolution MRI

The investigators have made a favourable experience with the in 2006 published transarterial triple injection method \[4\]. This classic method combines the block effect of an axillary catheter injection (median nerve position) with a double transarterial injection at terminal nerve level in the axilla.

The investigators experience after a recent published MRI study \[3\], confirms that a proximal axillary local anesthetic injection via an axillary catheter, guided by nerve stimulator, is beneficial for the block effect. The MRI study was conducted using nerve stimulation and a transarterial technique. The proximal injection with an effect at cord level, combined with axillary injections at terminal nerve level, produce an effective block distal to the elbow.

The proximal injection has obviously an effect to the lateral cord and the musculocutaneous nerve (mcn) \[3\]. Recent studies have advocated that a double axillary injection method is sufficient for the axillary block \[5, 6\]. Their block techniques included a selective block of the mcn at terminal nerve level. The investigators MRI study \[3\] demonstrated a successful block effect (analgesia or anaesthesia) of the mcn nerve in all patients (15 of 15 patients) in the triple injection group without a selective block of this nerve. In the 1- deposit (catheter injection) and 2-deposit (transarterial injections) group, 11 of 15 patients (73%) had the mcn successful blocked.

The objective in this study (Article 4) is to examine the mean position of the mcn nerve and its relationship to the coracobrachial muscle. Can MRI indicate / predict that a proximal directed axillary catheter in median nerve position is beneficial in order to provide a successful mcn blockade? Is a selective injection to the mcn at terminal nerve level superfluous when a catheter is used?

45 patients were examined with MRI in a previous study \[3\] and now they underwent an additionally examination with a special focus on the anatomy and course of the mcn nerve. A line was drawn from the most cranial part of the humeral head perpendicular towards the brachial plexus. The distance from this line to the point where the mcn nerve entered the coracobrachial muscle was measured. This entering point was defined as the point where the mcn nerve left the axillary sheat. The visulaity of the mcn was scored as 0 = not visible, 1 = partly visible and 2 = clear visible.

The evaluation was a consensus assessment where all authors evaluated the T2-weighted, fat suppressed MRI images at the same time. If the mcn nerve could not be identified, the patients were excluded.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for hand surgery
* ASA 1 - 2
* Weight from 50 - 95 kg
* MR compatible, suitable

Exclusion Criteria:

* Neurologic deficit
* Reaction to LA
Posterior Macular Adhesion: A Potential Risk Factor for Non-exudative Age Related Macular Degeneration (AMD) to Develop Exudative AMD

Choroidal neovascularisation in age related macular degeneration is one of the major causes of legal blindness in the western world existing in two major occurences, the dry and the wet form.The etiology of age related macular degeneration is yet unknown. Genetic factors, oxidative stress, Ischaemia, and aging of the retinal pigment epithelium are discussed as etiologic factors. The risk of rapid vision loss is much higher in wet AMD, a dry form may transform to a wet form. From a prior study the investigators know that the posterior hyaloid is significantly more frequent attached in wet AMD. This study is conducted to examine whether the attached posterior hyaloid is a risk factor to develop wet AMD in dry AMD cases.


Eligibility Criteria:
Inclusion Criteria:

* Dry MD
* Age over 50 years

Exclusion Criteria:

* Macular pathologies other than age related macular degeneration (like diabetic maculopathy, macular pucker, macular hole)
* Prior vitrectomy or buckle surgery
* Uveitis posterior, multifocal chorioiditis
* Pathologic myopia
* Diabetic retinopathy
* Visualization of the macula not possible (dens cataract, vitreous haemorrhage)
Collecting Tissue Samples From Patients With Cancer Undergoing Radiation Therapy and Healthy Participants

RATIONALE: Collecting and storing samples of tissue from patients with cancer to test in the laboratory may help the study of cancer in the future.

PURPOSE: This research study is collecting tissue samples from patients with cancer undergoing radiation therapy. Healthy participants will also be allowed on the trial so their samples can be used in comparison to patients with malignancy

OBJECTIVES:

Primary

* To maintain and create a University of Texas Southwestern Medical Center (UTSW) Radiation Oncology Tissue Resource and Registry/Database that will be used to explore genetic variations contributing to clinical outcomes through tissue analysis and outcome correlation. Tissue will be stored by the UTSTR and the database managed by Radiation Oncology.

Secondary

* To document disease outcome (local recurrence, distant metastasis, overall survival) by treatment regimen and disease site.
* To document toxicity by treatment regimen and disease site.
* To establish a prospective registry/database consisting of patient demographics and outcomes to be used for future research.

OUTLINE: Tissue, including surgical waste, venous blood/serum, urine, bone marrow, and other body fluids, may be collected (at planned surgery and routine medical visits) and preserved for future research. Demographic and disease and treatment information is obtained from patients (by interview or questionnaire), from medical records, and from national datasets. Patients may also be asked to provide additional blood samples and/or a small skin-punch biopsy sample.

Patients are followed up every 6 months for the first two years following treatment and then yearly thereafter.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Pathologically-proven diagnosis of malignancy
* Planning treatment with radiation therapy

PATIENT CHARACTERISTICS:

* Able to perform follow-up visits
* Is a patient of the University of Texas Southwestern Medical Center physicians

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* Participation in other clinical trials is allowed
* Other prior or concurrent therapy for cancer, such as surgery and/or chemotherapy, is allowed.

Criteria for eligibility:

* Able to provide written informed consent
* Age greater than 18 years old
* Males and Females are eligible
* Any ethnicity is eligible

Criteria for ineligibility:

-Patients not available for follow-up/future contact
Bovine-derived Xenograft With or Without L-PRF for Alveolar Ridge Preservation After Tooth Extraction: a Randomized Controlled Trial

The study is prospective randomized clinical trial that aims to evaluate the adjunctive use of L-PRF in promoting the desired vascularization and bone fill in small and large defects following tooth extraction and report on the long-term implant and patient outcomes


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 or over.
* Require extraction of anterior or posterior single tooth due to caries, endodontic and prosthetic complications.
* The tooth that requires extraction is bordered by two teeth.
* Controlled oral hygiene (full-mouth plaque and bleeding scores ≤ 25% at baseline).
* Good compliance and commitment to attend follow-up review appointments.
* Willing to provide informed consent.

Exclusion Criteria:

* Localised / generalised periodontitis.
* Presence of acute periapical lesion.
* Bone metabolic disease and/or taking medications that affect bone metabolism.
* Long term use of non-steroidal anti-inflammatory medications.
* History of malignancy, radiotherapy or chemotherapy.
* Pregnant or lactating women.
* Severe bruxism or parafunctional habits.
* Large occlusal discrepancies.
Prophylaxis With Intranasal Mupirocin for Prevention of S. Aureus Infections

In order to evaluate the effect of eliminating nasal carriage by mupirocin prophylaxis on subsequent Staphylococcus aureus infection, a prospective randomized trial was performed particularly including patients with predisposing risk factors for S. aureus infections.

In a past study, we showed that there is a strong correlation between strains colonizing the anterior nares, strains isolated from the presumed foci of infection, and strains isolated from blood in patients with Staphylococcus aureus bacteremia. These results suggested that a substantial proportion of cases of systemic S. aureus infections appear to be of endogenous origin and that eradication of nasal colonization should be the chief strategy for reducing the incidence of hospital-acquired S. aureus infections.

In order to evaluate the effect of eliminating nasal carriage by mupirocin prophylaxis on subsequent S. aureus infection, a prospective randomized trial was performed particularly including patients with predisposing risk factors for S. aureus infections. All patients admitted to selected units in clinics for anaesthesiology, hemato-oncology, cardiac surgery, and orthopedics at the University Hospital of Muenster were regularly screened for nasal carriage, i.e. at admission and, subsequently, on a weekly basis. S. aureus carrying patients were prospectively randomized, to be either treated with mupirocin for 5 days, or left untreated. Patients infected with S. aureus at admission and patients detected to be MRSA carrier were excluded from randomization.

Patients were regularly seen during the course of their hospital stay and predisposing/conditional risk factors were systematically documented. In both groups (untreated patients and patients with mupirocin prophylaxis), all nosocomial infections were documented according to CDC guidelines. If infected, specimens were taken for microbiological diagnosis. All S. aureus isolates (from the anterior nares as well as from the focus of infection) were collected and were genotyped.

Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to selected units in clinics for anaesthesiology, hemato-oncology, cardiac surgery, and orthopedics at the University Hospital of Muenster (following information on the study and agreement of the patient).

Exclusion Criteria:

* Patients infected with S. aureus at admission
* S. aureus infection within 48 hours following admission
* Patients detected to be carrier of Methicillin-resistant S. aureus
* Hospital stay shorter than 72 hours
* Patients with anatomic abnormalities in the anterior nares
* Allergy or hypersensitivity to mupirocin or other substances of the nasal ointment
* Persons younger than 18 years
* Known pregnancy
* Persons with psychiatric diseases
* Persons with limited contractual capability and judiciousness
Functional Efficiency of Self-sufficiency Test

The aim of this study is to design and validate new tool for evaluation of self-sufficiency in post-acute stroke patients. And further identify the factors influencing changes in the Functional Efficiency of Self-sufficiency Test (FEST) in post-acute rehabilitation care.

The research included the development of the FEST and its validation and the determination of the influence of selected factors on the change in functional self-sufficiency assessed by FEST.

The FEST consists of nine assessed categories (mobility, stability, locomotion, dressing, hygiene, eating, household care, communication, finances), which allow a comprehensive assessment of the current status of post-acute stroke patients. Patients meeting inclusion criteria are screened: 1/ diagnosed with ischemic or haemorrhagic stroke in the post-acute stage; 2/ aged ≥18 years; 3/ stable vital functions; 4/ rehabilitation load of 4 hours per day; 5/ maintained swallowing functions. Exclusion criteria: 1/ tracheostomy; 2/ not recommended by psychotherapist due to cognitive deficit and unwillingness; 3/ severe sensory deficit (hearing, vision). Patients are tested at the beginning (first measurement) and at the end of the post-acute rehabilitation care (second measurement) at the rehabilitation institute. The battery of tests included FEST, BI, the Action Research Arm Test (ARAT).

Descriptive statistics will use for the basic statistical analysis. Cronbach's alpha will use to assess reliability. The correlation between variables will calculate using Spearman's and Pearson's correlation coefficients and the biserial correlation coefficient. Construct validity will assess using factor analysis. The difference between independent samples will verify by two-sample t-test. The effect of baseline demographic characteristics (age, gender), and UA functional status on the improvement in the level of self-sufficiency measured by FEST will verify by multivariate linear regression. All tests will perform at a significance level of 0.05. IBM SPSS Statistics for Windows (version 23.0) statistical software will use for statistical processing (Armonk, NY: IBM Corp).

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with ischemic or haemorrhagic stroke in the post-acute stage; aged ≥18 years; stable vital functions; rehabilitation load of 4 hours per day; maintained swallowing functions.

Exclusion Criteria:

* tracheostomy; not recommended by psychotherapist due to cognitive deficit and unwillingness; severe sensory deficit (hearing, vision).
MicroRNA Diagnostics in Subarachnoid Hemorrhage

The purpose of this study is to compare the profile of microRNA in cerebrospinal fluid from patients suffering subarachnoid hemorrhage with and without delayed cerebral ischemia.

In this study of patients suffering an aneurysmal subarachnoid hemorrhage (SAH) we would like to investigate the pathophysiological mechanisms that lead to the phenomenon delayed cerebral ischemia (DCI).

We will accomplish this through analyzing the profile of microRNA expression in the cerebrospinal fluid of SAH patients treated with extraventricular drainage.

At first we wish to compare the expression of 376 specific microRNA between 12 patients developing DCI (group 1) and 12 patients without DCI (group 2) in cerebrospinal fluid drawn on day 5 after ictus.

Secondly specific microRNAs of interest in which the expression differs between group 1 and 2 are analyzed daily to investigate the dynamic changes in expression and compared to the clinical course.

Should we find no differently expressed specific microRNAs we will compare the expression of microRNA in group 1+2 with group 3.

In addition, some of the patients as part of another clinical trial (NCT01447095

) will have established invasive neuromonitoring including microdialysis. It is our intention to develop a method for analyzing microRNA in this microdialysate.

DCI as defined by Vergouwen et al in Stroke 2010;41(10):2391-2395:

"The occurrence of focal neurological impairment (such as hemiparesis, aphasia, apraxia, hemianopia, or neglect), or a decrease of at least 2 points on the Glasgow Coma Scale (either on the total score or on one of its individual components \[eye, motor on either side, verbal\]). This should last for at least 1 hour, is not apparent immediately after aneurysm occlusion, and cannot be attributed to other causes by means of clinical assessment, CT or MRI scanning of the brain, and appropriate laboratory studies."

Eligibility Criteria:
Inclusion Criteria:

* Patient admitted to the neurointensive care unit with aneurismal subarachnoid hemorrhage
* External ventricular drainage with 5 days of ictus
* Age \> 18 years

Exclusion Criteria:

* Glasgow Coma Score (GCS) continuously \< 7 during the first 5 days following ictus
* A known and proven complication (rebleeding, clip/coil complication, cardiopulmonal complication requiring full sedation, ventriculitis e.g.) leads to a GCS \< 7 thereby preventing the detection of DCI.
Evaluation of Tetrix Cream in the Healing of Injured Skin in Subjects With Contact Dermatitis

To determine if Tetrix Cream,, when applied to the skin lesions on patients with contact dermatitis, slows or interferes with the healing of the lesions.


Eligibility Criteria:
Inclusion Criteria:

* Normal subjects with sensitivity to nickel.

Exclusion Criteria:

* Under 18 years of age.
Implicit Learning in Stroke Study

This trial will compare an Implicit Learning Approach (ILA) to usual care, during the rehabilitation of mobility post stroke.

It is a multicentre, assessor blind, cluster randomised controlled pilot trial, with embedded feasibility study. It also includes a nested qualitative evaluation, designed to explore the views of participants and therapists.

Re-gaining the ability to stand, step and walk are common goals for people with stroke. During rehabilitation, therapists often tell people how to move, e.g. "straighten your knee when you're standing", or "lift your foot as you step". However, these types of specific instructions may not help people to learn new skills. Reducing the number of instructions or using simpler instructions may help people to learn in a more automatic way - e.g. through trial and error. This is called implicit learning.

There is very little evidence into implicit learning in stroke. This study will investigate whether patients recover the ability stand, step and walk following stroke better when they are given fewer and simpler instructions.

We will do this using a cluster randomised design. We will invite up to 8 stroke units to take part - half will continue to deliver usual rehabilitation, and half will adopt an Implicit Learning Approach (ILA) for the duration of the trial. Which one of the two approaches the unit delivers will be chosen at random. At the ILA sites, therapists will be trained to deliver rehabilitation using fewer and less complex instructions.

All patients at each unit will receive their rehabilitation using the allocated approach. This helps to ensure that the therapy teams manage to deliver the interventions effectively. We will ask individual patients for permission to complete additional assessments, which form part of the study. Some participants and clinicians will be interviewed at the end of the study, to find out what they thought about the intervention.

This is a pilot study, meaning that we are testing how well this works as a research method. We will not know for certain which approach is best, but it will tell us how we should design a larger trial that will give a clear answer.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of stroke, presenting with hemiplegia
* Within 14 days of stroke onset
* Medically stable
* Able to...

  * tolerate daily therapy for a minimum of 30 minutes per session
  * sit for more than 5 seconds without support
  * understand and follow 1 stage commands

Exclusion Criteria:

* Previous stroke with residual impairments
* Other neurological diagnosis (e.g. Parkinsons Disease, Multiple Sclerosis)
* Clinically relevant pre-morbid disability levels
A Study of Vanzacaftor/Tezacaftor/Deutivacaftor (VNZ/TEZ/D-IVA) in Healthy Adult Panelists

The purpose of this study is to evaluate the flavor (basic tastes, aroma, texture, mouthfeel) of VNZ/TEZ/D-IVA fixed dose combination (FDC) granules.

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4) (A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility Criteria:
Key Inclusion Criteria:

* Panelists are trained to detect, identify, recognize, and accurately describe different taste elements and flavor combinations.

Key Exclusion Criteria:

* History of any illness or clinical condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk to the participant.
* Sensitivity to VNZ, TEZ, or D-IVA.
* Pregnant, nursing, or planning to become pregnant during the study

Other protocol defined Inclusion/Exclusion criteria may apply.
STILDEP: Zolpidem in Depressive and Dysthimic Patients

Primary objective: To show that the combination of Zolpidem + antidepressant therapy is more effective in the treatment of the secondary insomnia of depressive and dysthimic patients than antidepressant therapy alone in the acute phase of the disease.


Eligibility Criteria:
Inclusion Criteria:

* Depressive and dysthimic patients in acute phase of mild to moderate severity
* Depressive and dysthimic patients suffering from secondary insomnia (DSM IV) recent antidepressant therapy (less than 1 week)

Exclusion Criteria:

* Regularly use of sleeping pills in the last 2-3 month
* Use of any sleeping pils in the last week
* Insufficient hepatic
* Myasthenia gravis
* Proven hypersensivity to Zolpidem
* Evidence of clinically relevant nervous system disorders (other neurologic/psychiatric diseases associated with depression)
* History of evidence of alcohol or drug abuse
* Evidence of clinically relevant cardiovascular, haematologic, hepatic, gastrointestinal, renal, pulmonary or endocrinologic diseases
* Abnormal snore
* Work an alternating shift
* Suffering from periodic leg movement disorder and sleep apnea
Long-term Effects of Coronavirus Disease 2019 on the Cardiovascular System: CV COVID-19 Registry

Patients presenting with the coronavirus-2019 disease (COVID-19) have a very high risk of cardiovascular adverse events, including death from cardiovascular causes. Unfortunately, there are no reliable statistics on the frequency and severity of these complications during the index hospitalization. Moreover, the long-term cardiovascular outcomes of these patients are entirely unknown. The investigators aim to perform a registry of patients who have undergone a diagnostic nasopharyngeal swab for SARS-CoV-2 and determine their long-term cardiovascular outcomes.

Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) that has posed a significant threat to global health. Angiotensin-converting enzyme 2 (ACE2) has been identified as a functional receptor for coronaviruses, including SARS-CoV and SARS-CoV-2. SARS-CoV-2 infection is triggered by the binding of the virus spike protein to ACE2, which is highly expressed in the heart and lungs.

There are multiple connections between COVID-19 and the cardiovascular system. First, COVID-19 patients and pre-existing cardiovascular disease are at increased risk for serious adverse events. Second, the infection has been associated with multiple direct and indirect cardiovascular complications, such as acute myocardial injury, myocarditis, arrhythmias, and thromboembolism. Third, the therapies under investigation for COVID-19 may have cardiovascular side effects. There is clear scientific evidence linking COVID-19 with cardiac damage, with a subsequent impact on mortality from any cause. The reasons for increased mortality in patients with COVID-19 and heart damage are not fully understood.

The long-term prognosis for patients who have had COVID-19 is entirely unknown. Previous experience with SARS-CoV suggests that both the underlying disease and its treatment could be associated with a worse cardiovascular prognosis. In a study of 25 survivors of SARS-CoV, at 12 years of follow-up, altered lipid metabolism was found. Similarly, viral diseases such as influenza A are associated with increased cardiovascular mortality after infection.

For the reasons stated above, the investigators consider that patients who presented COVID-19 have a high risk of long-term cardiovascular adverse events such as cardiac death, myocardial infarction, stroke, heart failure, and cardiac arrhythmias. To test this hypothesis, the investigators aimed to perform a registry of patients who have undergone a diagnostic nasopharyngeal swab for SARS-CoV-2 and determine their long-term cardiovascular outcomes.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years

Exclusion Criteria:

* None