cyrilzakka/clinical-trials huggingface dataset:
Investigation of the Perfusion of Gluteal Muscle in Patients With Intermittent Gluteal Claudication by Non-invasive MSOT

The objective of the proposed study is to define independent parameters for the diagnostic assessment of the perfusion situation of the gluteal muscle based on multispectral optoacoustic tomography (MSOT) in patients with gluteal claudication in Fontaine stage II (intermittent claudication) pre and post-intervention.

This is a monocentric, prospective study which aims to exanimate the optoacoustic signals in gluteal muscle after a exercise in patients with PAD in Fontaine stage II before and after the revascularisation to verify the change of MSOT by improved vascularization. MSOT data will be correlated with CCDS, ABI, treadmill test, subjectively perceived absolute walking distance in everyday life, PAD-related life quality (VASCUQOL-6) and TASC II classification in angiographic imaging (only in case angiographic imaging is available and independent from this study).

Patients with gluteal claudication in Fontaine stage II will be recruited during the consulting hours of the Department of Vascular Surgery, University Hospital Erlangen. Following detailed information about the study and after providing written consent, relevant clinical data will be collected from the electronical patient file, if available. In addition, a thorough anamnesis interview for relevant data and CCDS would be performed. Afterwards, the MSOT parameters will be recorded on gluteal muscles before and after a stepper exercise two minutes or until the occurrence of claudication pain in the gluteal muscle. The more affected side is examined. All data will be adequately pseudonymized in compliance with data protection regulations before they are used for statistical analysis. The duration of the study for participants will be max. 90 minutes. The angiographic imaging will be reviewed and analyzed.

Eligibility Criteria:
Inclusion Criteria:

• Patient with gluteal claudication in Fontaine stage II and corresponding stenosis (common iliac artery, internal iliac artery or distal aorta)

Exclusion Criteria:

* Patients with PAD in Fontaine stage I, III and IV or Rutherford category 0, 4, 5 and 6 or healthy volunteers with diabetes mellitus, chronic renal failure, claudication symptoms, abnormal ABI or non-palpable foot pulses
* People with age under 18
* Absence of written consent
* Safety concerns of the study physician (person with physical, mental or psychiatric conditions which, by the judgement of the study physician, would compromise the person's safety or the quality of the data, thereby rendering the person an ineligible candidate for the study
Investigating Bone and Skeletal Muscle Interaction in Men With Prostate Cancer

The overall goal of this pilot project is to test the hypothesis that a decline in muscle strength precedes the decline in bone strength in men undergoing androgen deprivation therapy (ADT) for prostate cancer. The investigators will measure changes in serum biomarkers involved in muscle-bone crosstalk, anatomic changes in muscle and bone structure and strength that could ultimately contribute to fractures. The findings from this research will inform design of interventions to reduce falls and hip fractures in patients undergoing ADT as well as application to broader populations of at risk patients.

Twenty-five men from urology clinic with prostate cancer will be recruited and enrolled prior to initiating ADT and studied at three time points. Baseline (before first does of ADT), and at approximately weeks 6 and 24 while receiving ADT for prostate cancer. Study measures will be the same during each of three data acquisition time points and include ascertainment of venous blood to determine serum biochemical markers of muscle and bone metabolic activity, MRI and CT imaging studies to assess muscle strength, volume, composition, bone volume, density and strength, and validated tests of muscle strength. Subjects will serve as their own controls.

Eligibility Criteria:
Inclusion Criteria:

• Dx with prostate cancer and planned ADT therapy

Exclusion Criteria:

* Contraindication to MRI
* Limited life expectancy
* Inability to participate in exercise testing
* Severe functional impairment
* Chronic kidney disease 4 or worse
* Hgb \< 9
* Use of anti-resorptive agent
* non-English speaking
* Bone metastasis
Penyagolosa Trail Saludable Women

This study has as main objective to asses different genetic, biochemical and physiological biomarkers affecting performance and health status in ultraendurance runners according to individual's sex.

Ultraendurance races has been shown to impact on several health-related biomarkers, and therefore they may have detrimental effects on runners' health. In this study, we aim to analyze the impact of running a 107,6 km mountain race in ultraendurance runners splitting our sample by individual's sex.

To do this, baseline measurements of the runners have been collected through stress tests and biochemical analyses of blood and urine samples. Indeed, a saliva sample was collected to isolated a genomic DNA sample of each runner.

During the race anthropometrical, ventilatory and strength data was collected in three different moments and after crossing the finish line. Indeed, after completed the ultraendurance mountain race, blood and urine samples were taken at the finish line, as well as 24h and 48h post-race.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults (\>18 years old)
* Volunteers should be finish at least one ultraendurance mountain race (\>60km).

Exclusion Criteria:

* Having heart disease
* Having kidney disease
* Taking a medication on an ongoing basis
Journey of Transformation Curriculum for Native American Youth

The investigators will conduct a waitlist control trial to test the efficacy of the Journey of Transformation-Native Youth Health Leadership Program (JOT) in terms of delaying or reducing tobacco and other substance use and improving sexual health.

This study assesses a new curriculum that will be available to students in the tenth grade. The lessons will include traditional storytelling and other Native American cultural arts activities (i.e., drum making, film making, field trips), as well as Traditional Ecological Knowledge (TEK) activities. This study also assesses how well the curriculum explains leadership skills, Native American cultural arts, the natural environment, and promotes healthy decision-making around health and relationships.

Participants are randomly assigned to a health class that starts the curriculum in the fall or to a health class that will start the curriculum in the winter. Participants will:

Week 1. Complete a 15-20- minute online survey about healthy relationships, drug use, youth leadership skills, and connecting with Native communities.

Weeks 1 - 3. Meet with a study educator up to two times to set goals around health, healthy relationships and how to reduce or avoid alcohol, tobacco, or other drug use.

Weeks 1 - 12 (months 1-3). As part of the class, attend up to ten health sessions on healthy behaviors and health promotion. Learn new skills around youth leadership, storytelling, and traditional health practices. The sessions will highlight connection to tribal traditions.

Month 3. Complete an online check-in survey via a link sent to participants' email address.

Month 6. Complete an online check-in survey via a link sent to participants' email address.

Month 12. Complete an online check-in survey via a link sent to participants' email address.

Optional after school activities:

Weeks 9 - 16 (months 3-4). Attend a once-a-month activity to help build leadership skills. Activities are between 1-2 hours after school and include drum making, film making, creating a storytelling vest that incorporates their own cultural symbols, and up to two outdoor field trips. The field trips are to places of cultural significance near the school and involve a 30-45 minute hike.

Week 16 (month 4). Meet with the study educator for a session to revise goals for health and community leadership.

Weeks 9 - 24 (months 3-6). Attend a 2-hour digital storytelling training and three monthly planning sessions to prepare for an optional digital storytelling leadership night. Stories can be about what participants have learned about health promotion, traditional health practices, and to celebrate their health leadership journey.

Week 25 (month 6). Attend the leadership night and present digital stories if participants would like. Help prepare a traditional feast and giveaway that will honor community culture and values.

Eligibility Criteria:
Inclusion Criteria:

* Attends an off-reservation boarding school in the tenth grade at time of enrollment

Exclusion Criteria

* None
Aerosol Particle Size and Breathing Pattern During Inhaled Furosemide

The study hypothesises that the variability in relief of air hunger with inhaled furosemide that is reported in previous studies can be explained by the breathing pattern adopted during the inhalation and the droplet size in the aerosol, both of which would influence the site of deposition of the aerosol in the lungs

Recent studies suggest that inhaling furosemide as a mist reduces air hunger in healthy volunteers in whom air hunger is induced experimentally in the lab. However, how much reduction varies among individuals. It is not known if the way the mist is breathed (slow/deep or fast/shallow) or the size of the droplets in the mist (large or small) can explain the variation in relief. Both of these factors can influence the site of deposition of the aerosol in the lungs

In this study the relief of air hunger (induced by hypercapnia and constrained ventilation) will be compared when furosemide is inhaled quickly or slowly, and when the mist has large or small droplets. 20 healthy volunteers will be recruited. After a practice session, the 'air hunger' test will be performed before and after 4ml of a 10mg/ml solution of furosemide (40mg). This will be repeated on 4 separate test days using a different method of inhaling the furosemide on each day.

Eligibility Criteria:
Inclusion Criteria:

- Healthy volunteers aged 18 and over

Exclusion Criteria:

* On any medication, including herbal medication (other than mild analgesics, vitamins and mineral supplements or, for females, oral contraceptives), whether prescribed or over-the-counter, in the two weeks prior to test sessions involving administration of furosemide or saline.
* Female participants who are pregnant, lactating or planning pregnancy over the course of trial
* A medical history of heart, kidney or liver disease/electrolyte disturbances/ immunosuppression/frequent fainting episodes/COPD/nasal polyps/Addison's/acute porphyria/significant prostatic symptoms/acute gout attack/life expectancy \<6months or history of allergic reaction to furosemide and/or any of the other ingredients of furosemide or amiloride, sulfonamides or sulphonamide derivatives, such as sulfadiazine or co-trimoxazole
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
* Have participated in another research trial involving an investigational product in the past 4 weeks.
Phase 1 Study of Anti-OX40 in Patients With Advanced Cancer

This study is designed to determine the safety and highest tolerated dose of anti-OX40 in patients with advanced cancer.

This study will evaluate the safety and determine the maximal tolerated dose of anti-OX40; evaluated the immune response to the study treatment; measure the pharmacokinetics of anti-OX40; monitor tumor regression, and identify the most biologically active dose of anti-OX40 to induce antigen-specific responses to a variety of immunogens.

Eligibility Criteria:
Inclusion Criteria:

* Patients with uncurable metastatic carcinoma, lymphoma, or sarcoma.
* ECOG performance status 0, 1, 2
* No active bleeding
* No clinical coagulopathy
* Anticipated lifespan greater than 12 weeks

Exclusion Criteria:

* Active residual toxicity from prior therapies
* Active Infection
* HIV positive
* Hepatitis B or C positive
* Pregnant or nursing women
* Requirement for oral steroids
* Brain metastases
* Presence or history of autoimmune disease
* Shellfish or tetanus allergy
* Splenomegaly
* Lymph nodes greater than 10 cm in maximal diameter
* Uncontrolled angina or class II or IV heart failure
Cross-sectoral Rehabilitation of Older High-risk Patients with Hip Fracture

The goal of this observational study is to learn about and monitor the cross-sectoral rehabilitation process in older high-risk patients treated for at fragility fracture of the hip.

The main questions aim to answer:

* how patients are doing up to one year after hip fracture surgery on different outcomes across the continuum of rehabilitation being offered
* what expectations, experiences and satisfaction patients have for the overall rehabilitation process after a hip fracture

Participants age 65 and above with home address in Frederiksberg municipality, living in own home, admitted and treated for at hip fracture at Department of Orthopedic Surgery, Bispebjerg Hospital, will be asked for participation.

In addition to primary and secondary outcome measures some of the patients will be asked to respond to a interviewer-based questionnaire, about their experiences of the rehabilitation offered during their hospital stay and at the temporary municipality-based 24-hour setting / or at home during the first couple of months. Furthermore, they will be interviewed about their expectations for rehabilitation in the municipality at time of discharge from the acute hospital.

Eligibility Criteria:
Inclusion Criteria:

Undergone surgery for hip fracture and admitted to department M1, Bispebjerg-Frederiksberg Hospital

Living in Frederiksberg municipality and being admitted from own home, or a 24 hour temporary setting in the municipality

Exclusion Criteria:

Living permanent in nursing home or is on the way to a permanent nursing home from a 24-hour setting.
EIT Assessment of Lung Volume and Tidal Distribution: A Comparison of Non-Invasive Ventilation Devices

This study is being done to further the investigators' knowledge of the EIT system and to see if measures between two non-invasive ventilation systems routinely used clinically are equivalent.

Mechanical ventilation is life-saving technology but it can also inadvertently induce lung injury and increase morbidity and mortality. There currently is not an easy method of assessing the impact ventilator settings have on the degree of lung inflation. Computed tomography (CT), the gold standard for visually monitoring lung function, can provide detailed regional information of the lung. Unfortunately, it necessitates moving critically ill patients to a special diagnostic room and involves exposure to radiation like an X-ray.

A technique introduced in the 1980's, electrical impedance tomography (EIT), can non-invasively provide similar monitoring of lung function, and without the exposure to radiation. This imaging technique applies small alternating currents of electricity to surface electrodes to construct cross-sectional images of the lung.

Over that past several decades EIT has moved from the research lab to commercially available devices that are used at the bedside. EIT has also been applied to study the effects of various devices used to provide non-invasive ventilation. EIT may prove useful to optimally adjust non-invasive ventilation settings to improve ventilation and oxygenation. One such EIT system is manufactured by Draeger Medical. It is available in Europe and Canada but is not yet FDA approved for use in the United States.

This study is being done with healthy volunteers to further the investigators' knowledge of the EIT system and to see if measures between two non-invasive ventilation systems routinely used clinically are equivalent.

As this is a preliminary study looking at the EIT system vs 2 other devices, outcomes measures may be modified as the study progresses.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older

Exclusion Criteria:

* Use of a cardiac pacemaker, an implantable cardioverter-defibrillator (ICD) or any other active implants
A Study to Evaluate the Safety and Efficacy of Ublituximab in Combination With Umbralisib for Participants Previously Enrolled in Protocol UTX-TGR-304

The purpose of this study was to provide the opportunity to the participants who progressed on treatment arm previously in the study UTX-TGR-304 (NCT02612311) to receive ublituximab (TG-1101) treatment in combination with umbralisib (TGR-1202).


Eligibility Criteria:
Inclusion Criteria:

* Prior treatment in clinical trial UTX-TGR-304
* Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

Exclusion Criteria:

* Participants refractory to ublituximab + TGR-1202
* Transformation of chronic lymphocytic leukemia (CLL) to aggressive Non-Hodgkin's Lymphoma (NHL) (Richter's transformation)
Efficacy of Epoetin Alfa in Patients With Friedreich's Ataxia

Friedreich's ataxia is a rare genetic disorder characterized by severe neurological disability and cardiomyopathy. Friedreich's ataxia is the consequence of frataxin deficiency. Although several drugs have been proposed, there is no available treatment. It was recently demonstrated that erythropoietin can increase the intracellular levels of frataxin in an in-vitro model.

The present project is aimed at testing the possible therapeutic approach of erythropoietin, which is an already available and commercialized drug. The investigators will perform both in-vitro and in-vivo tests, in order to asses its efficacy and safety in patients. The results will be useful to plan further clinical trials.

Friedreich ataxia (FRDA) is an inherited recessive disorder characterized by progressive neurological disability. FRDA is the consequence of frataxin deficiency. Although several drugs have been proposed for FRDA, there is no available treatment. Recently it was shown that recombinant human erythropoietin (rhu-EPO) administration increases frataxin expression in cultured human lymphocytes of FRDA patients. It is therefore of primary importance to test extensively rhu-EPO's ability in increasing frataxin levels in-vitro and in-vivo. In addition rhu-EPO is an already available and commercialized drug approved for the treatment of anaemia associated with chronic renal disease, heart failure and cancer. Towards this overall purpose, we will perform an acute clinical trial in FRDA patients with rhu-EPO and will assess its effect in-vivo on frataxin expression. In addition, rhu-EPO's safety in FRDA patients based on laboratory parameters and neurological indexes will be tested. The results will be useful to gain new insight in the role of rhu-EPO in FRDA, and in the future, it may be useful to plan further clinical trials.

Eligibility Criteria:
Inclusion Criteria:

* Molecular diagnosis of FA based on a homozygous GAA expansion within the FRDA with a triplet repeat sequence in the pathological range.
* Age \>18, \<50 years

Exclusion Criteria:

* Failure to meet one of the inclusion criteria
* Patients in treatment with Idebenone
* Wheelchair bound patients
* Significant renal, hepatic or haematological disease
* Positive history for arterial or venous thrombosis
* Acute diseases that might interfere with the study
* Positive history for arterial hypertension
* Present or programmed pregnancy
* Known hypersensitivity to study drug
* Other unacceptable concomitant medications (in particular agents thought to have a neuroprotective potential as tocopherol, amantadine, memantine, free radical scavengers).
Increasing Reporting of Intimidation of Medical Students With Simulation

Intimidation of medical students by health care professionals is a well-documented phenomenon. Raising awareness of what constitutes intimidation is a preferred method for preventing it through increased reporting. Simulation is a novel method of raising awareness of intimidation.

This is a randomised controlled trial comparing the effectiveness of simulation (involving actors), an educational video and no intervention, as adjuncts to group discussion, on students' ability to identify and report intimidation. Medical students from the University of Montreal in Montreal, Canada, will be recruited at the beginning of surgical clerkship. They will complete a standardized and validated pre-intervention questionnaire on their experience with intimidation consisting of multiple choice questions and short answers. They will be randomised to one of the three interventions lasting 70 minutes that will be followed by a 20-minute standardized discussion on intimidation with all students participating together. At the end of their surgical rotation, they will complete a similar post-intervention questionnaire with additional questions pertaining to the reporting of intimidation.

Differences in intimidation reporting after the intervention as well as a before and after comparison of the "Negative Acts Questionnaire" score will be studied.


Eligibility Criteria:
Inclusion Criteria:

* Medical students at the University of Montreal at the beginning of their surgical clerkship rotation.

Exclusion Criteria:

-
Transoral Robotic Surgery (TORS) for Oral and Laryngopharyngeal Lesions Using Da Vinci Robotic Surgical System

The purpose of this study is to conduct a pilot single-arm to assess transoral robotic surgery (TORS) for oral and laryngopharyngeal benign and malignant lesions using the Da Vinci Robotic Surgical System.

Patients are going to be evaluated in their usual regular clinical follow ups starting with preoperative first visit, 3 weeks, 3 months and 6 months postoperatively with a Quality of Life survey (Head and Neck Cancer Inventory, HNCI-QOLQ).

Eligibility Criteria:
Inclusion Criteria:

* Patient must present with indications for diagnostic or therapeutic approaches for benign and malignant diseases of the oral cavity or laryngopharynx (including the neoplastic lesions of the tongue, tongue base, retromolar trigone, tonsils, palate, posterior and lateral pharynx, glottic, supraglottic and subglottic larynx)
* Patients must have adequate transoral exposure of the oral cavity and laryngopharynx for TORS instrumentation

Exclusion Criteria:

* Unexplained fever and/or untreated, active infection
* Patient pregnancy
* Previous head and neck surgery precluding transoral/robotic procedures
* The presence of medical conditions contraindicating general anesthesia or transoral surgical approaches