cyrilzakka/clinical-trials huggingface dataset:
Treatment of Acute Traumatic Laceration of the Olecranon and Prepatellar Bursa

Following a recent publication by the authors \[1\], there is no standardized treatment regime for the treatment of lacerations of the olecranon or prepatellar bursa, although primary bursectomy seems to be the most common treatment regime in Germany, Austria and Switzerland. The aim of this study is to prospectively follow patients who suffered from an acute traumatic laceration of the OB or PB treated, according to the local standards, either by bursectomy (Vie, AT) or bursal reconstruction and direct wound closure (Muc, GER).

\[1\] Baumbach et al. Evaluation of the current treatment concepts in Germany, Austria and Switzerland for acute traumatic lesions to the prepatellar and olecranon bursa. Injury (2012)

A fall onto the elbow or knee often results in a laceration of the olecranon (OB) and prepatellar bursa (PB), due to their exposed and superficial location. Although a common injury, the authors are not aware of any study dealing with this entity. In order to get a first idea on the treatment concepts currently used, the authors conducted a international online survey among orthopaedic and trauma surgeons in Germany, Austria and Switzerland \[1\]. The primary treatment approach of more than 70% of Austrian and German surgeons was bursectomy and immobilization, which was performed by less than 50% of Swiss physicians.

At the Departments of Trauma Surgery of the Medical University of Vienna and of the Medical University of Munich, two opposing treatment concepts are being practised. Whereas in Vienna a bursectomy is performed in case of traumatic laceration of the OB and PB, a primary bursal reconstruction is performed at the Medical University of Munich.

The aim of this study is to prospectively follow patients who suffered from an acute traumatic laceration of the OB or PB treated, according to the local standards, either by bursectomy (Vie, AT) or bursal reconstruction and direct wound closure (Muc, GER).

The Hypothesis of this study is, that there is no difference with respect to complications between bursectomy and bursal reconstruction in case of acute traumatic laceration of the OB and PB.

1. Baumbach et al. Evaluation of the current treatment concepts in Germany, Austria and Switzerland for acute traumatic lesions to the prepatellar and olecranon bursa. Injury (2012)

Eligibility Criteria:
Inclusion Criteria:

* Acute lacerations of the OB or PB (\<12h)
* Age 18 - 60 years
* Patient can read and understand German

Exclusion Criteria:

* Immunodeficient patients
* Severe dementia
* Chronic alcoholism
* Conditions affecting the neuromuscular- or musculoskeletal system
* Previous surgical interventions at the same joint
* Conditions affecting wound healing (including chronic alcoholism, insulin dependent diabetes
* Neurological diseases
* Patient is not available for follow-up visits
* Patient suspected to be non-compliant
* No major concomitant injuries
The Forgotten Role of Back Muscle Characteristics to Tailor Exercise Therapy for Recurrent Non-specific Low Back Pain

Patients with non-specific low back pain will be compared to healthy, age- and sex-matched controls to determine the most discriminating back muscle characteristics and to delineate possible phenotypes of patients with non-specific low back pain showing impaired proprioceptive postural control. Additionally, the group of patients with non-specific low back pain will receive a 16-week, high-load proprioceptive training program. The effects of this training program on the different back muscle characteristics and proprioceptive postural control will be evaluated.

The Back-to-Back study consists of a cross-sectional study and a proof-of-concept study. The cross-sectional study aims to gain more insight into the peripheral underlying mechanisms of impaired proprioceptive postural control in patients with non-specific low back pain. Macroscopic, microscopic, hemodynamic, and electrophysiological characteristics of the lumbar multifidus and erector spinae muscles will be compared between patients with non-specific low back pain and healthy, age- and sex-matched controls. The interrelatedness between these back muscle characteristics and the correlation with proprioceptive postural control will be examined. The most discriminating muscle characteristics will be determined based upon which phenotypes of patients with non-specific low back pain will be delineated. The proof-of-concept study aims to assess the effects of high-load proprioceptive training on back muscle characteristics and proprioceptive postural control in patients with non-specific low back pain.

Eligibility Criteria:
Inclusion Criteria:

Patients with non-specific low back pain:

* Aged 18-60 years
* Non-specific low back pain without radicular leg pain
* Mechanical low back pain with episodes of \<4 on the numerical pain rating scale and episodes of \>6 on the numerical pain rating scale
* Non-specific low back pain for three months or more
* Score of 20% or more on the Modified Low Back Pain Disability Questionnaire
* Informed consent to participate

Healthy controls:

* Aged 18-60 years
* No history of low back pain needing medical treatment or resulting in a limited activity level
* No low back pain in the previous six months
* Informed consent to participate

Exclusion Criteria:

* Pregnancy
* Previous trauma or surgery to the spine, pelvis or lower limbs
* Structural spinal deformity (e.g., scoliosis)
* Neurological, neuromuscular, respiratory or systemic disease
* Central sensitization: score of 50/100 or more on the Central Sensitization Inventory
* Specific vestibular or balance problems
* Acute lower limb or neck problems
* Body mass index of 30 kg/m² or more
Spinal Stimulation During Exercise in Heart Failure

The purpose of this proposal is to determine whether epidural spinal cord stimulation can modulate cardiovascular control during exercise in Heart Failure patients.

Forty Heart Failure (\>18 yrs. of age) will be recruited. The study will include a total of 2 visits. All experiments will take place at the Mayo Clinic; at the outpatient radiology for MRI screening, the Charlton Clinical Research Unit (CRU) for surgical suite for spinal cord stimulation placement and the Saint Mary's Hospital Clinical Research Unit for clinical exercise laboratory for the exercise protocol and overnight stay.

Study visit 1 will include eligibility screening, consenting process, completion of a health questionnaire and performance of a peak oxygen consumption (VO2) test. Additionally, subjects will undergo a screening lumbar MRI to ensure that there are no anatomical anomalies in or around the epidural area consistent with standard clinical practice for epidural stimulator lead placement associated with chronic pain syndromes.

Study visit 2 will include an overnight stay in the Saint Mary's Hospital Clinical Research Unit. Patients will check in to the CRU in the morning of day 1, visit 2. Prior to placement of stimulating electrodes an international normalized ratio (INR) will be checked to ensure safe clotting. An anesthesiologist will place the electrodes in the lumbar/thoracic epidural space in a manner that is standard for the clinical placement of temporary electrodes in humans. The participants will then transfer to the clinical exercise laboratory to start the exercise protocol. Participants will rest 15 minutes prior to starting exercise. Exercise will take place on a vertical bike where they will perform a submaximal cycling exercise at 30% of peak work for 29 minutes. Thigh cuffs will be placed on thigh bilaterally and inflated intermittently to pressures of 80m mmHg. After the testing is complete, participants will return to their room in the Clinical Research Unit for the rest of the day and sty over night.

On day two of visit two, participants will repeat the testing from day one with new randomization to determine reliability of testing performed on day one. After the exercise on day two of visit two, the spinal cord stimulator leads and radial arterial catheter will be removed.

Eligibility Criteria:
Inclusion Criteria, includes:

* Heart Failure patients with reduced ejection fraction:
* History of ischemic or idiopathic dilated cardiomyopathy (duration \> 1yr.) stable for \> 3mo and New York Heart Association Class I-III
* Not pacemaker dependent
* Body Mass Index ≤35
* Ejection Fraction \< 40%
* Current nonsmokers with \< 15 pack year history
* Able to exercise

Exclusion Criteria includes:

* History of cardiopulmonary disorders and dangerous arrhythmias
* Pregnant women
* Taking prescribed opioid medications or have had a fusion or laminectomy at L3 or above
* Patients with a recent drug-eluding stent
* History of spinal stenosis, lumbar radiculopathy, or peripheral neuropathy
* Must not currently be taking blood thinners or anticoagulant medications.
Positive Outcomes of the Supplementation With Lecithin-based Delivery Form of Curcuma Longa and of Boswellia Serrata in IBS

Small bowel dysbiosis (SBD), is a frequent finding in subjects with irritable bowel syndrome (IBS). The formula-tion in sunflower lecithin (Phytosome) of Curcuma longa and Boswellia serrata demonstrated beneficial effects on intestinal microbiota. The aim of this study was to evaluate the effect of a lecithin-based delivery formulation of Curcuma longa and of Boswellia serrata extracts (CUBO), on SBD in IBS subjects.


Eligibility Criteria:
Inclusion Criteria:

* age ranging from 18 to 70 years;
* diagnosis of moderate IBS according to Rome IV criteria;
* dysbiosis of the small bowel, defined by increased urinary indican values with normal values of urinary skatole;
* evidence of abdominal bloating and abdominal pain

Exclusion Criteria:

* normal values of urinary indican or increased values of urinary skatole ;
* subjects who were already on a low FODMAP diet (LFD) or other dietary prescription, such as lactose or gluten free diet in the last 6 months;
* insulin-dependent diabetes or seafood, nuts or soy allergies ;
* positive history of symptomatic diverticular disease, celiac disease, inflammatory bowel disease or microscopic colitis;
* colonic or small bowel or gallbladder surgery ;
* severe vomiting or bloody diarrhea ;
* liver disease (defined as altered values of liver function tests) or severe renal disease (defined as serum creatinine \>1.5 mg/dL) or treatment with antibiotics, excluding those for topical use, within the last three months
Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa

The purpose of this study was to demonstrate superiority of AL-60371 relative to Vehicle based on clinical cures at test-of-cure (TOC) for the treatment of acute otitis externa (AOE).

Participants or legal guardians completed a telephone diary twice daily to record assessments of ear pain, ear medication use, and impact of ear pain on sleep and other daily activities.

Eligibility Criteria:
Inclusion Criteria:

* At least 6 months of age.
* Clinical diagnosis of acute otitis externa (AOE) based on clinical observation and of presumed bacterial origin in at least one ear.
* Combined numerical score of ≥4 in at least one affected ear at the Day 1 exam for tenderness, erythema, and edema.
* Agree to refrain from water immersion of the ears during the conduct of the entire study.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Duration of signs or symptoms of AOE greater than 28 days in the affected ear(s) as reported by patient or parent/guardian.
* Presence of a tympanostomy tube or perforated tympanic membrane in the affected ear(s).
* Clinically diagnosed otic disease other than AOE (eg, malignant otitis externa) in the affected ear(s).
* Known or suspected ear infection of yeast, fungal or mycobacterial origin in the affected ear(s).
* Prior otologic surgery within 6 months of study entry in the affected ear(s).
* Known or suspected allergy or hypersensitivity to quinolones or other ingredients present in the medications to be used in the study.
* Patients who use ear plugs, head phones or ear buds and are unwilling to discontinue their use during the study period.
* Other protocol-defined exclusion criteria may apply.
Cytodiagnosis of Basal Cell Carcinoma and Actinic Keratosis Using Papanicolaou and May-grunwald-giemsa Stained Tissue Smear

The purpose of this study is to compare and evaluate the diagnostic performance of scrape cytology using two different cytological staining techniques, and to evaluate additional touch imprint cytology with that of histopathology of superficial basal cell carcinoma and actinic keratosis.


Eligibility Criteria:
Inclusion Criteria:

Histologically verified basal call carcinoma and actinic keratosis

Exclusion Criteria:

Morphea form of basal cell carcinoma. Pigmented form of basal cell carcinoma.
Clinical Study to Investigate the PK Profiles and Safety of CKD-385 in Healthy Volunteers Under Fed Conditions

Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers under fed conditions

A randomized, open-label, single dose, crossover study to investigate the pharmacokinetic profiles and safety of high-dose CKD-385 in healthy volunteers under fed conditions

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult aged more than 19 at the time of screening
2. Those who had 18.0kg/m² ≤ Body Mass Index (BMI) \< 30.0kg/m²

   # BMI=Weight(kg) / Height(m)²
3. Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings on a medical examination.
4. Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, urinalysis, serology), vital signs and ECG results at screening.
5. Those who have voluntarily given written informed consents to participate in the study and to comply with all the instructions, based on full understanding of the nature of the study after listening to detailed explanations.
6. Those who agree to double contraception method from the 1st dministration of the investigational product until 7 days after the last administration of investigational product.

Exclusion Criteria:

1. Those who has medical evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic or allergic diseases(except for simple dental history such as tartar, mpacted teeth, wisdom teeth).
2. Those with a medical history of gastrointestinal disorders(esophageal achalasia or esophagus stenosis, Crohn's disease) or gastrointestinal surgery(except for simple appendicitis surgery or hernia surgery or tooth extraction surgery) that may affect the absorption of drug.
3. Those who has a history of regular alcohol consumption in excess of 14 glasses/week for woman, 21 glasses/week for man within 1 months prior to screening.
4. Those who received investigational products or bioequivalence test drugs within 6 months before the first administration of clinical trial drugs.
5. Those who take drugs which may cause induction or inhibition of drug metabolism within 30 days before the first administration of investigational products.
6. Those who have taken any drugs that may affect the clinical trial within 10 days.
7. Those who donated whole blood within 2 months, or blood components within 2 week before first administration of investigational products.
8. Those who is unable to consume a high-fat meal provided during the study.
9. Those who are deemed insufficient to participate in this clinical study by investigators.
Glaukos® iStent Infinite Trabecular Micro-Bypass System in Subjects With Mild to Moderate Primary Open-angle Glaucoma

Prospective, multicenter, single-arm study of the iStent infinite in adult pseudophakic or phakic subjects with mild to moderate primary open angle glaucoma who have not failed conventional medical and surgical treatment


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary open-angle glaucoma
* Phakic or pseudophakic
* Age 35 years or older

Exclusion Criteria:

* Traumatic, uveitic, neovascular, angle-closure glaucoma or
* glaucoma associated with vascular disorders
* Active corneal inflammation or edema
* Retinal disorders not associated with glaucoma
Isokinetic Strengthening of Hip Muscles Effect on Pelvic Floor Muscles Function in Females With SUI

This study will be conducted to investigate the impact of isokinetic strengthening of hip muscles on pelvic floor muscles function in women experiencing stress urinary incontinence Does isokinetic strengthening of hip muscles impact pelvic floor muscles function in women experiencing stress urinary incontinence?


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with stress urinary incontinence
* age between 30 and 50 years

Exclusion Criteria:

* low back pain
* lower limb muscle pathology and/or joint degeneration
* cardiovascular, metabolic or pulmonary disease
* body mass index (BMI) \> 30 kg/m2.
The Image Characteristics of Adult Appendix on Computed Tomography

A retrospective analysis of CT images from adult patients who underwent scans for reasons unrelated to appendicitis. The study period will span from January 2010 to August 2024. Through this research, we hope to gain a comprehensive understanding of appendix positioning and compile definitive data on its most common locations.

The investigators conducted a retrospective analysis of CT images from adult patients who underwent scans for reasons unrelated to appendicitis. The study period will span from January 2010 to August 2024. Through this research, we hope to gain a comprehensive understanding of appendix positioning and compile definitive data on its most common locations.

Eligibility Criteria:
Inclusion Criteria:

CT of patients without appendicitis

Exclusion Criteria:

CT of patients with appendicitis
MR Imaging and MR Spectroscopy of HIV

The Center for Disease Control and Prevention estimates that 1,148,200 Americans aged 13 years and older are living with HIV infection, including 207,600 (18.1%) who are unaware of their infection. According to pathological data, central nervous system (CNS) involvement is commonly found during the early phase of infection. In vivo proton magnetic resonance spectroscopy studies of HIV-infected humans have demonstrated significant changes of metabolites observed in the brain N-acetylaspartate, creatine, choline, glutamate, glutamine and myo-inositol with varying changes in different brain regions. Diffusion tensor imaging (DTI) is a novel functional MRI technique which can be used to derive quantitative in vivo measurements of region-specific and diffuse brain alterations. DTI studies have demonstrated changes of mean diffusivity (MD) and fractional anisotropy (FA) in the various parts of brain. Diffusion abnormalities involving various regions of brain have also been observed in patients infected with HIV. One dimensional (1D) or two-dimensional (2D) magnetic resonance spectroscopic imaging (MRSI) technique has been used for many years to study the metabolites changes in HIV. MRI scan time necessary for the acquisition of high-resolution MRSI data with adequate spatial coverage may be prohibitively long for clinical exams. Thus, new imaging and bio-chemical characterization techniques are needed to allow repeated, non-invasive assessment of these processes in vivo. Since neuroinflammation is associated with increased brain water, diffusion tensor imaging (DTI) is sensitive to changes in white matter (WM) and inflammatory changes associated with HIV infections. Even though only single-voxel-based diffusion-weighted MRS has been previously investigated, altered diffusivity of non-water metabolites and its relationship with metabolic disturbance as well as structural and functional abnormalities in HIV has not been investigated. The brain apparent diffusion coefficient (ADC) changes of metabolites measured by the novel 3D MRSI technique will be correlated with the ADCs and fractional anisotrophy of water recorded by DTI and cell count to better understand the role of CNS involvement in HIV pathology.

This will be a multicenter prospective study. We will recruit ten (10) healthy participants aged 20 to 30 years to investigate the feasibility and test/retest reliability of the REPSI sequence. Twenty five (25) HIV+ patients will be recruited from the Division of HIV Medicine (Dr. Eric Daar) at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center (Torrance, CA). HIV+ patients will be transported to the UCLA Medical center for neuroimaging examination.

Eligibility Criteria:
Inclusion Criteria:

* HIV-infected between age of 20 and 65 years
* Consistently have plasma HIV RNA levels \<200 copies/mL for at least the last 12 months on a stable antiretroviral regimen with any changes made only for convenience, safety or simplicity.
* Able to provide informed consent.

Exclusion Criteria:

-HIV negative
Tow Techniques of Adductor Canal Block for Analgesia After Total Knee Replacement

This study compares the tow technique of continues adductor canal block for total knee replacement surgery. Half participants will receive catheterization at the entrance of the adductor canal, while the other half will receive catheterization at the middle point of the adductor canal.


Eligibility Criteria:
Inclusion Criteria:

* 18-80 years
* Knee-arthroscopy
* Written consent
* ASA I-III
* BMI 19-35

Exclusion Criteria:

* Unable to communicate with the investigators (e.g., a language barrier or a neuropsychiatric disorder).
* coagulopathy or on anticoagulant medication
* Allergic reactions toward drugs used in the trial
* History of substance abuse
* Infection at injection site
* Can not be mobilised to 5 meters of walk pre-surgery