cyrilzakka/clinical-trials huggingface dataset:
Urology San Antonio MRI/MicroUS Comparison

This study compares micro-ultrasound image targeted prostate biopsy with multi-parametric MRI targeted biopsy in men indicated for prostate biopsy due to suspicion of prostate cancer. Both imaging techniques will be applied to each subject and compared, along with systematic biopsy.

The investigational protocol describes a study designed to compare ultra-high resolution transrectal micro-ultrasound (micro-US), and multi-parametric MRI (mpMRI). These modalities are both used clinically to identify targets for prostate biopsy, however little data is available to compare their sensitivity. While mpMRI is used clinically to identify targets for biopsy, it is not used for real-time biopsy guidance due to challenges performing the biopsy procedure within the MRI gantry. Instead, targets identified on mpMRI are sampled during transrectal ultrasound guided biopsy as part of the prostate biopsy procedure, often using software assisted fusion products. For this investigation, the biopsy procedure will be guided by transrectal micro-US (current standard of care at Urology San Antonio), and will include systematic (standard, random, extended sextant) plus image-guided prostate biopsies among men with clinical suspicion of prostate cancer and an indication for prostate biopsy.

Eligibility Criteria:
Inclusion Criteria:

1. Men presenting for prostate biopsy due to clinical suspicion of prostate cancer
2. 40-75 years old
3. Available mpMRI images and report, performed according to the PI-RADS v2 standard

Exclusion Criteria:

1. Men with anorectal abnormalities preventing TRUS-guided prostate biopsy
2. Men who are unable to provide their own informed consent
3. Prostate volume on MRI \> 100cc
Pilot Study to Assess the Feasibility and Initial Efficacy of Therapist-as-consultant, Game-based CI Therapy

Pilot study to assess the feasibility and initial efficacy of therapist-as-consultant, game-based CI therapy. Pre/post study design. Participant received a target of 30 hours game-based motor intervention, 100 hours constraint of the less affected upper extremity, and 5 hours therapist consultation (including completion of a behavioral contract at the first study visit). Duration of intervention was 10 consecutive weekdays, with pre-treatment and post-treatment testing performed within 1 week prior to and 1 week post-intervention by an independent tester.


Eligibility Criteria:
Inclusion Criteria:

* Provide signed and dated informed consent form
* Willing to comply with all study procedures and be available for the duration of the study
* Male or female aged \> 17
* Preserved ability to comprehend English and participate in basic elements of the therapy
* Community-dwelling
* Experienced mild to moderate hemiparesis at least six months prior
* Can independently operate the gaming system (those with severe cognitive impairments can usually achieve this)
* Corrected vision of at least 20/70 as assessed by their ability to identify game objects on the monitor from 5 feet away

Exclusion Criteria:

* concurrent participation in other experimental upper extremity trials
* concurrent participation in other outpatient rehabilitation for their upper extremity
* Botox within the last 3 months (confound)
* near-normal motor function (9-hole Peg Test score above the 10th percentile of a normative sample)
* minimal nonuse (Motor Activity Log at baseline \>2.5, Accelerometry \> 60%)
* major medical issues that would interfere with study treatments or make intensive rehabilitation difficult to tolerate
Ipsilateral Liver Lobe Devascularization of the Large Hepatocellular Carcinoma

Assessment of short-term outcomes of ipsilateral lobe arterial devascularization of the large hepatocellular carcinoma: single center non-randomized trial.

Assessment of the 30-day mortality and major complications as well as the tumor size changes of the patients undergoing ipsilateral lobe arterial devascularization of the large hepatocellular carcinoma. This is a prospective non randomized trial carried out at the Ribat University Hospital between April 2017 to March 2018.

Eligibility Criteria:
Inclusion Criteria:

* Review and sign informed consent;
* Between 15 and 80 years of age at time of trial enrollment;
* Documented pathological and/or radiological diagnosis of hepatocellular carcinoma;
* Radiologically documented tumor size of \> 5 centimeters;
* Radiologically documented liver cirrhosis.

Exclusion Criteria:

* American Anesthesia Association (ASA) Class IV or V and/or any contraindications to general anesthesia;
* Uncontrollable ascites;
* Deep persistent jaundice;
* Hepatic encephalopathy;
* Coagulopathy;
* Severe thrombocytopenia;
* Unable or unwilling to attend follow up visits and examinations;
* Other associated surgical procedure;
Identification of the Metabolic Signature of Atrial Fibrillation for Personalized Prevention

Atrial fibrillation (AF) is a major public health problem. The efficacy of the existing techniques is limited in the more aggressive forms. It is therefore necessary to develop approaches, in particular the identification of relevant biomarkers, to prevent the onset, recurrence or progression of AF in at-risk patients. The objective of this study is to describe the longitudinal metabolic and biomolecular signature of AF in patients eligible for cardiac ablation.

Atrial fibrillation (AF) is a major public health problem. Its prevalence exceeds 2%. The main aim of drug treatment is to prevent the onset of stroke and heart failure, but side effects often require discontinuation, and contraindications limit their use. Rhythm control strategies based on catheter ablation have led to significant progress in incident AF, improving quality of life. Nevertheless, the efficacy of these techniques is limited in the more aggressive forms. Significant recurrence rates are reported one year after ablation, and access to them is often reserved for symptomatic patients due to their invasive and costly nature.

It is therefore necessary to develop approaches to prevent the onset, recurrence or progression of AF in at-risk patients. While the pathophysiology of AF involves metabolic remodelling that can be observed in animal and human models, no clinically relevant metabolites have been identified as biomarkers of the risk of AF onset or progression, with a view to preventive and personalized management.

In response to this unmet need, this project aims to develop a method for assessing the risk of AF recurrence, combining the identification of a metabolic signature of the arrhythmia and the patient, with a machine learning approach to aggregate conventional risk factors and metabolic biomarkers. A longitudinal clinical study will be conducted on patients scheduled for AF ablation, to monitor changes in their metabolic signature over 12 months, in parallel with arrhythmia progression. Using machine learning, the study team will establish and validate a classifier retrospectively stratifying patients with or without recurrent AF, and compare this method with canonical risk stratification. This will enable to consider personalized management of patients at risk of recurrence, with the aim of reducing human and economic costs.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years, all genders, and ethnic origins
* Free, informed, and written consent signed
* Person affiliated to or benefiting from a social security scheme

Exclusion Criteria:

* Age \< 18 years
* Lack of informed consent
* Gestating women (pregnancy test carried out as part of care for FA patients, contraception, or menopause for women in control groups)
* Persons under administrative or judicial protection
* Endocarditis or pericarditis in progress or within the 3 last months
* Active tumor pathology (benign or malignant)
* Chronic inflammation or autoimmune disease
* Chronic liver disease
* Myocardial infarction within the last 8 weeks
Efficacy of High-intensity Laser Acupuncture in Patients With Chronic, Non-specific Low Back Pain

The purpose of this study is to investigate the efficacy of high-intensity laser acupuncture on peak torque, power of trunk extensors and flexors, back pain, range of motion, function, and satisfaction in patients with chronic nonspecific low back pain (CNLBP).

Chronic nonspecific low back pain (CNLBP) is a persistent back pain that affects people of all ages and contributes to the global disease burden. Treatment focuses on reducing pain and its consequences. High-intensity laser therapy is a non-invasive, painless modality that can be easily administered for various conditions. It has been proven to significantly reduce pain, with anti-inflammatory, anti-edematous, and analgesic effects. Laser photobiomodulation (PBM) therapy is a non-invasive and painless method that stimulates cells, pain receptors, and the immune system and can cause vasodilation and analgesic effects. Acupuncture is a common complementary therapy that has been proven to treat musculoskeletal pain and enhance muscle strength, and high-intensity laser acupuncture (HILA) has been promoted as an alternative to traditional needle acupuncture. HILA, as a non-invasive treatment, combines the efficacy of high-intensity laser and acupuncture in musculoskeletal pain management. Due to a lack of research, this study will examine the effects of HILA on peak torque and power of the trunk extensors and flexors, back pain, range of motion, function, and satisfaction in patients with chronic non-specific low back pain.

Eligibility Criteria:
Inclusion Criteria:

1. The patients had CNSLBP with age from 20 to 40 years from both genders.
2. Patients will be referred from an orthopedist with diagnosis of chronic low back pain without underlying pathological causes.
3. The patients with chronic nonspecific low back pain more than 3months. Minimum pain intensity of 30 mm on the visual analogue scale (VAS) for pain, which ranges from 0 to 100 mm.
4. Patients with normal BMI ranges between 18.5:24.9 kg/m2.
5. The study populations must be willing to participate in the study

Exclusion Criteria:

1. Neurological, infectious diseases and systemic illness such as rheumatologic diseases,systemic lupus erythematosus, diabetes mellitus type I or II.
2. Psychiatric/mental deficit.
3. Patients who had a previous surgical history (within 6 months) will also excluded.
4. participation in other treatment within the previous 3 month.
5. Pregnancy.
6. History of spinal fracture, tumor, osteoporosis
7. use of medication, such as corticosteroids, anticonvulsants, and anti-inflammatory drugs that may affect the outcome of the study.
8. prior history of adverse effects to physical stimulation therapy.
9. significant physical or mental deficiencies preventing a clear understanding of the study procedure.
10. spinal stenosis, thyroid dysfunctions, obesity, pace-maker.
Analysis of the Relevance of Radiologic Parameters on the Outcome After Hip Arthroscopy

Joint-preserving surgery with arthroscopic techniques of the hip follows detailed radiological assessment including plain radiography of the hips and magnetic resonance arthrography (MRI). The purpose of this study was to compare features on radiography and MRI of the hip before surgery and assess their prognostic value on the outcome after surgery.

Hip arthroscopy is indicated for the treatment of a variety of pathologies of the hip, in patients without osteoarthritis. The diagnosis in patients with pain at the hip is made after history taking, clinical examination and radiological evaluation with plain radiography in a standardized technique and a magnetic resonance arthrography of the hip. The main indications for hip arthroscopy include CAM-type femoroacetabular impingement (FAI) necessitating bony decompression and chondro-labral tears necessitating arthroscopic repair or debridement. The purpose of this radiological non-interventional outcome study was to assess features on plain radiography and MRI in favor of good outcome after hip arthroscopy.

This department performed 810 hip arthroscopies in the years of 2013 till 2021. All of those patients underwent standardized radiological evaluation with radiography and MRI. Radiographical parameters are assessed by a resident with experience in musculo-sceletal radiology, intra- and inter-observer reliability has been assessed for each parameter. All arthroscopies have been performed by two experience senior orthopedic surgeons. Ethical board approval has been obtained to follow-up on those patients. Follow-up includes the patient-reported outcome assessment using the iHOT12 score and the modified Harris hip score. The clinical end-point is the time till total hip arthroplasty (THA), a registry analysis of the Tyrolean Arthroplasty registry (TAR) has been performed. Statistical analysis is performed using ANOVA and Fishers T-Tests, the level of significance is .05.

Eligibility Criteria:
Inclusion Criteria:

* Hip arthroscopy from 2013-2021 at this department.

Exclusion Criteria:

* Age below 18 years.
Surgical Treatment of Adult Trigger Finger

Trigger finger is a condition commonly treated with surgical intervention, yet no specific incision type has been associated with improved or worsened scar quality or outcome. Therefore, the investigators objective is to determine if the incision type may affect the results of operative treatment of trigger finger. Therefore, the goals of this study are as follows:

Primary Objective: To directly compare incision type (transverse vs. longitudinal) for trigger finger release with scar quality and patient satisfaction via a validated scar evaluation scale.

Secondary Objective: To directly compare incision type (transverse vs. longitudinal) for trigger finger release to patient outcome via a validated upper extremity outcome score.


Eligibility Criteria:
Inclusion Criteria:

* All patients over the age of 18 presenting to the four attending surgeons (Don Coleman, Douglas Hutchinson, Andrew Tyser, Angela Wang) through either the University of Utah Orthopaedic Center or the Veteran Affairs Hospital will be evaluated for possible inclusion into the study
* Patients who fail conservative treatment and elect to proceed with open surgical release of the A1 pulley will be offered the option of being included in the study.

Exclusion Criteria:

* Patients aged less than 18, previous failed surgical A1 pulley release, and patients receiving their care outside of the University of Utah Hospital system or the Veteran Affairs Hospital
* In addition, this study will evaluate trigger finger release; patients receiving treatment for trigger thumb will be excluded
Thiamine As Adjunctive Therapy for Diabetic Ketoacidosis

This is a randomized, double-blind, placebo-controlled trial to determine if administration of intravenous thiamine will lead to quicker resolution of acidosis in patients admitted to the hospital with diabetic ketoacidosis. The investigators will secondarily investigate whether thiamine improves cellular oxygen consumption, shortens intensive care unit (ICU) and hospital stay or decreases hospital resource utilization.

Thiamine (vitamin B1) is a water-soluble vitamin that plays a key role in aerobic glucose metabolism. Thiamine is a cofactor of pyruvate dehydrogenase (PDH), an enzyme that must be activated for entry into the Krebs Cycle for aerobic metabolism. PDH activity is reduced in thiamine deficient states, resulting in a shift in pyruvate metabolism to the anaerobic pathway. This leads to increased lactate production and acidosis. Thiamine loss in the urine, with consequent thiamine deficiency, is not uncommon in diabetes. The investigators' preliminary studies have found that thiamine deficiency in occurs in as many as 39% of patients with DKA, and that thiamine levels are inversely associated with lactate and acidosis. The investigator hypothesizes that treating DKA patients with intravenous thiamine will lead to faster resolution of acidosis and improved aerobic metabolism. The investigator's secondary hypothesis is that thiamine treatment will shorten stays in the ICU and hospital and lead to utilization of fewer hospital resources.

In this randomized, double-blind, placebo-controlled trial, patients admitted to the hospital with DKA who are enrolled in the study will be randomized to either intravenous thiamine (200mg in 0.9% saline) twice daily for two days or an identical volume of 0.9% saline on the same schedule. The investigator's primary outcome is change in bicarbonate over the 24 hours following enrollment, with measurements at 0, 6, 12, 18, 24 hours, using a linear mixed-effects model. Secondarily, patients will be stratified by Type I and Type II DM. Additionally, a pre-planned sub-analysis of thiamine deficient subjects will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Bicarbonate ≤15 mEq/L
* Anion gap \> 12 mEq/L
* Blood pH≤ 7.24 (if already obtained by clinical team)
* Urine ketones (qualitative) or serum ketones (β-hydroxybutyric acid) \> 3 mmol/L
* Enrollment within 6 hours of presentation

Exclusion Criteria:

* Current thiamine supplementation ≥ 6 milligrams per day (i.e., more than a multivitamin)
* Competing causes of severe acidosis including seizure, carbon monoxide poisoning, cyanide toxicity, cardiac arrest, liver dysfunction (specifically defined as known cirrhosis)
* Known allergy to thiamine
* Competing indication for thiamine administration as judged by the clinical team (e.g., significant alcohol use)
* Research-protected populations (pregnant women and prisoners)
* Patient enrolled previously in same study
* Code status of Do Not Resuscitate/Do Not Intubate (DNR/DNI) or Comfort Measures Only (CMO)
Effect Of Hydrocortisone Phonophoresis Versus Iontophoresis In Patients With Subacromial Impingement Syndrome

The purpose of this study will be to compare the efficacy of adding hydrocortisone phonophoresis or iontophoresis on pain, function, range of motion and shoulder external rotation isometric strength in patients with subacromial impingement syndrome.

Routine physiotherapy has been advocated was an effective treatment for SIS. However, there is lack of best exercise treatment and lots of studies are under consideration. According to published data focused on management of shoulder pain, it looks like that therapeutic exercise is not sufficient to treat SIS and it is compulsory to combine with other remedies to get the best results

Eligibility Criteria:
Inclusion Criteria:

1. All patients were diagnosed as unilateral SIS with stage II Neer classification \> 3 months.
2. Positive impingement sign (Neer's test or Hawkins-Kennedy test), / painful arc during active arm elevation, pain or weakness with resisted isometric external rotation or resisted scapular plane abduction with the humeral internal rotation (empty can test)
3. The age of patients ranged from 18 - 60 years old.
4. Both genders will be involved.
5. Shoulder pain scores more than 5 on a numeric rate scale for pain of 0- 10.
6. Failure to respond to conservative NSAID.

Exclusion Criteria:

1. Frozen shoulders.
2. Arthritis of the shoulder.
3. Shoulder instability.
4. Pregnant women.
5. A pacemaker.
6. Previous shoulder surgery.
7. History of dislocation of the shoulder.
8. Internal metallic fixation.
9. Malignancy.
10. Previous corticosteroid injection.
11. Rheumatoid arthritis
12. Partial or Full thickness tear of the rotator cuff.
13. Cervical radiculopathy.
14. Physiotherapeutic shoulder treatment within the last 3 months.
15. The patients will randomly be assigned into 3 equal groups, 20 patients for each group.
Short Term Evaluation of the Soothing and Re-epithelizing Activity of Three Topical Products and Relative Combinations

Aim of the study was to evaluate the soothing and re-epithelizing activity of a single application of topical products on experimentally induced erythema by skin stripping on the forearm (volar surface) of 20 healthy volunteers. In particular the activity of the following three cosmetic products and the relative combinations (cream and serum) were assessed: rejuvenating cream, rejuvenating serum, antioxidant serum


Eligibility Criteria:
Inclusion Criteria:

* Adult volunteers of both sexes, aged more than 18 years old
* Volunteers in a good general state of health in the Investigator opinion
* Volunteers not taking drugs or undergoing surgical procedure
* Volunteers who are giving a written informed consent.

Exclusion Criteria:

* Pregnancy (only for female subjects)
* lactation (only for female subjects)
* change in the normal habits in the last month
* participation in a similar study during the previous month
* known allergy to one or several ingredients of the products on trial
* insufficient adhesion to the study protocol
* dermatological disease
* clinical and significant skin condition on the test area (e.g. lesions, scars, malformations)
* diabetes
* endocrine disease
* hepatic, renal or cardiac disorder
* cancer
* topical drugs or surgical procedure on the test areas during the previous 3 months
* systemic corticosteroids
* aspirin or non-steroid anti-inflammatory drugs (FANS)
* diuretic drugs
* antibiotics and chemotherapics
* pshycotropic drugs
* retinoids
* psoralens
* cardiologic and vascular drugs
Two Doses of GHB04L1 for Pandemic Influenza Prophylaxis in Healthy Adults

This study evaluates safety, tolerability and immunogenicity of two doses of GHB04L1, a liquid formulation of the replication- deficient influenza A/Vietnam/1203/04(H5N1)-like ∆NS1 virus in healthy adults. Subjects are randomised at a ratio of 2:1 for GHB04L1 (6.8 log10 or 7.5 log10 TCID50/dose/volunteer) or placebo.

GHB04L1 is intended to provide a novel treatment approach for influenza virus H5N1 infection. Based on preclinical data from ferrets that demonstrated protection against challenge with wild-type virus following treatment with various dose levels of GHB04L1, vaccination with GHB04L1 might protect humans from influenza A (H5N1) virus infection.

Due to the lack of the NS1 protein, the ΔNS1 virus replicates efficiently in interferon-deficient cells but has lost its ability to grow in normal hosts and organisms. Immunisation with ΔNS1 mutant virus can cause only an abortive replication cycle in the nasal mucosa of vaccinated individuals. This allows development of replication-deficient intranasal vaccines with genetic stability of the attenuated phenotype and without virus shedding.

Eligibility Criteria:
Inclusion Criteria:

* Male or female healthy volunteers, 18-50 years of age
* Seronegative for H5N1 (with antibody titres \<1:10 detected in HAI assay)
* Seronegative for H1N1 (with antibody titres ≤1:20 detected in HAI assay)
* Written informed consent to participate in this study

Exclusion Criteria:

* Acute febrile illness (\>37.0°C)
* Positive influenza immunoassay at baseline
* Signs of acute or chronic upper or lower respiratory tract illnesses (sneezing, cough, tonsillitis, otitis, etc.)
* History of severe atopy
* Influenza vaccination 2006/2007 and/or later
* Known increased tendency of nose bleeding
* Volunteers with clinically relevant abnormal paranasal anatomy
* Volunteers with clinically relevant abnormal laboratory values Females with positive urine pregnancy test prior to vaccination
* Simultaneous treatment with immunosuppressive drugs incl. corticosteroids (≥ 2 weeks) within 4 weeks prior to study medication application
* Clinically relevant history of renal, hepatic, GI, cardiovascular, haematological, skin, endocrine, neurological or immunological diseases
* History of leukaemia or cancer
* HIV or hepatitis B or C seropositivity
* Volunteers who had undergone rhino or sinus surgery or surgery of another traumatic injury of the nose within 30 days prior to application of study medication
* Volunteers who had received antiviral drugs, treatment with immunoglobulins or blood transfusions or an investigational drug within four weeks prior to study medication application
* Volunteers who had received anti-inflammatory drugs 2 days prior to study medication application
* Volunteers who were not likely to cope with the requirements of the study or with a significant physical or mental condition that may interfere with the completion of the study