cyrilzakka/clinical-trials huggingface dataset:
Diffusion Tensor Breast MRI (DTI)

The breast MRI is used in the preoperative scenario to evaluate the extension of a newly diagnosed breast cancer and to screen the contralateral breast. The scan consists of a series of images taken after the use of intravascular contrast media that may detect areas of enhancement that look malignant, but are actually benign tissue, producing a false positive result. The investigators aim to evaluate a novel MRI sequence of images that does not use contrast, diffusion tensor imaging (DTI). Addition of DTI sequence does not add significantly to the time of standard breast MRI exam. This novel technique provides improved detection of tissue microstructure and is able to differentiate malignant from benign tumor. Hence, the investigators hypothesize that DTI may decrease the false positive rate when compared with standard dynamic contrast-enhanced (DCE) MRI.


Eligibility Criteria:
Inclusion Criteria:

* Female of any race, ethnicity and lifetime risk.
* Eighteen years or older.
* Known recent diagnosis of a breast cancer and normal clinical breast exam of the contralateral side.
* Self-detected lump suspicious for breast cancer that it has not been biopsied yet.

Exclusion Criteria:

* Inability to understand the consent form
* Pregnant or nursing
* Currently taking tamoxifen, evista (raloxifene), or an aromatase inhibitor for adjuvant therapy or chemoprevention
* Physically unable to lie down on her belly for at least 10 minutes.
* Have had benign needle biopsy of the breast performed within 3 months, or breast surgery within 1 year prior to MRI exam.
Registry of Sarcoidosis Associated Pulmonary Hypertension (RESAPH)

Registry to follow patients with sarcoidosis associated pulmonary hypertension

This is a multi center registry of sarcoidosis associated pulmonary hypertension (SAPH). With this registry, the investigators will characterize the demographics, clinical course, hemodynamics, pulmonary physiology, and disease management of sarcoidosis associated pulmonary hypertension on the United States. The investigators will also compare these features to non-US sites.

Eligibility Criteria:
Inclusion Criteria:

* Patients with sarcoidosis as defined by the ATS/WASOG statement
* Patients with pulmonary hypertension as confirmed by right heart catheterization
* Patients willing to provide written informed consent

Exclusion Criteria:

* Unwillingness to provide assurance that they will complete the follow up visits for the study
Breakfast and Muscle Health in Children

One in every three children ages 2-19 years is overweight or obese. Although multifactorial in nature, obesity is primarily attributed to a mismatch between energy intake and energy expenditure (EE). Daily EE (DEE) can be partitioned between resting metabolic rate (RMR), EE associated with physical activity, and the thermic effect of food (TEF). RMR corresponds to the energy needed to sustain the body functions at rest and is also related to body composition (i.e., ratio of skeletal muscle mass to fat mass). Skeletal muscle mass is a large contributor to RMR; the more skeletal muscle mass, the higher the RMR (i.e., more energy expended at rest). In addition, muscle plays a central role in whole body protein metabolism and disrupted muscle metabolism is associated with the development of many common chronic diseases associated with obesity such as type 2 diabetes and cardiovascular disease. Although the contribution of disrupted muscle metabolism to chronic disease is well-established in older adults, the potential impact in children is unknown. The overall objective for this primary project application is to determine the role of breakfast protein consumption in improving energy metabolism, energy balance and skeletal muscle health in obese, school-aged children.


Eligibility Criteria:
Inclusion Criteria:

* Resides within Northwest Arkansas
* Age 8-12 years old
* BMI \>5th percentile
* All ethnicities

Exclusion Criteria:

* Food allergies
* Dietary restrictions
* Regularly skip breakfast (\> 5 times per week)
* Prescription medications
* Claustrophobic
* Fear of needles
* Classified as a picky eater by parent/guardian
Evaluation of a New Orange-Based Beverage Enriched With Polyphenols in Adult Humans

The purpose of this study is to evaluate the effects of a new orange juice-based beverage enriched in fiber and selected phenolic compounds (mainly flavanones) on features of metabolic syndrome and cardiovascular disease risk factors related to inflammation and antioxidant defense system in overweight and obese adult humans. This study hypothesizes that consumption of an orange juice-based beverage enriched in fiber and selected phenolic compounds (mainly flavanones)would improve lipid levels and lipid metabolism,blood pressure and the Homeostatic Model Assessment (HOMA) index.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) higher than 25 (overweight or obese) but lower than 40 (extreme obesity) or waist circumference higher than 94 cm for men and 80 cm for women,

and having altered at least two markers of MS namely:

* Hypertension (diastolic pressure higher than 85 mmHg but lower than 110 mmHg)
* Hyperglycemia (higher than 100 mg/dl but lower than 130 mg/dl)
* Elevated plasma triacylglycerol concentrations (higher than 150 mg/dl)
* Decreased plasma HDL-c levels (lower than 40 for men and 50 for women)
* Volunteers will be otherwise healthy and without taking any medication aiming to lower either blood lipids, blood pressure or blood glucose concentrations.

Exclusion Criteria:

* The presence of morbid obesity
* Blood pressure higher than 110 mmHg
* Plasma glucose levels higher than 130 mg/dl
* The use of any medication for the control of blood pressure or glucose or lipid metabolism
* Medical history of consumption of hypocaloric diet in the last year
* Disorders of the food conduct
* The presence of familiar dislipemias relatives of genetic character or the denial to take part in the study.
Penetrating Trauma Registry and Open Source Data

Penetrating injuries comprise roughly 30% of Methodist Health System (MHS) trauma patients. Firearm-related events have become more prevalent in the past few years. Active shooter events, mass casualties, assaults, and homicide are more commonplace which leads to an increase of trauma patients needing management of penetrating injuries.

Penetrating injuries comprise roughly 30% of Methodist Health System (MHS) trauma patients. Firearm-related events have become more prevalent in the past few years . Active shooter events, mass casualties, assaults, and homicide are more commonplace which leads to an increase of trauma patients needing management of penetrating injuries. On average, penetrating traumas only make up 14% of comparable center patient volumes. In spring 2022, we also were ranked 3/10 for our penetrating trauma outcomes with lower than expected mortality (TQIP Benchmarking Report). Together, as a Level 1 trauma center with above average penetrating injury volume we must take efforts to best understand the opportunities for our patients and disseminate those observations to the trauma community

Eligibility Criteria:
Inclusion Criteria:

* • Aged 16 years or older (National Trauma Data Standard for adult)

  * Penetrating injury or intent to cause penetrating injury

Exclusion Criteria:

* • Aged 15 years or younger

  * Prisoners, pregnant persons, or other protected population
  * Not involved in penetrating trauma
The Effect of Stomach Acid on Foscarnet

To see if ranitidine, by reducing stomach acidity, can enhance the effectiveness of foscarnet, by making foscarnet more available to the body.

Foscarnet is an antiviral compound. Laboratory studies have shown it to be active against HIV. However, only 12 - 22 percent of an oral foscarnet dose is absorbed by the body. Ranitidine suppresses gastric acid output, increasing gastric pH. Thus by increasing gastric pH (decreasing stomach acidity), less foscarnet is expected to be decomposed or broken down in the stomach. Thus, more foscarnet should be absorbed into the body.

Foscarnet is an antiviral compound. Laboratory studies have shown it to be active against HIV. However, only 12 - 22 percent of an oral foscarnet dose is absorbed by the body. Ranitidine suppresses gastric acid output, increasing gastric pH. Thus by increasing gastric pH (decreasing stomach acidity), less foscarnet is expected to be decomposed or broken down in the stomach. Thus, more foscarnet should be absorbed into the body.

Six asymptomatic HIV-infected males, or those with limited symptoms of early AIDS-related complex ( ARC ), will receive one dose intravenously of ranitidine in distilled water and one dose of placebo (distilled water alone), followed in 1 hour by foscarnet in oral solution. The order of ranitidine and placebo is randomized and the two foscarnet doses are separated by at least 72 hours. A nasogastric pH probe is placed on each morning of drug administration to monitor gastric pH.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Acetaminophen and sedatives.

Patient must be able to give informed consent.

Exclusion Criteria

Patients with the following are excluded:

* Unintentional weight loss in excess of 10 pounds or 10 percent of usual body weight within 2 years prior to study.
* Unexplained temperature above 38 degrees Celsius on more than 5 consecutive days or on more than 10 days in any 30 days in 2 years prior to expected study entry.
* Unexplained diarrhea defined by two or more stools/day for at least 14 days during a 120-day interval.

Prior Medication:

Excluded within 1 week of entry into study:

* Probenecid, aspirin, or diuretics.
"Effects of Passive Static Stretching of 30 Seconds Versus 60 Seconds on the Hamstring Flexibility in Adults With Hamstring Tightness.

This study is a randomised controlled trial and the purpose of this study is to determine the effects of Passive Static Stretching of 30 seconds versus 60 seconds on the Hamstring Flexibility in adults with Hamstring Tightness.

The study is conducted in Rehabilitation department of Fauji Foundation Hospital on the sample of 38 participants. Hamstring flexibility will be evaluated at the beginning by Active knee extension test.

The subjects will be randomized into two group by sealed envelope method. Baseline assessment would be done by using tools of SLR and modified knee extension test and then final assessment will be done after 4 weeks.

The purpose of this study is to determine the effects of passive static stretching on hamstring flexibility in adults with hamstring tightness" adults (age : 18-45 years ) by using

1. Goniometer
2. Straight leg raise (SLR)
3. Passive Hip Flexion Test(PHFT)
4. Active Knee Extension Test( AKET)
5. Modified Knee Extension Test(MKET) Data will be collected before and after the intervention protocol for each participant.

Data collection procedure:The subjects will be advised of the training session schedule following the baseline assessment. Pre and post intervention scores will be recorded.

Eligibility Criteria:
Inclusion criteria:

* Adults age ranging from 18-45 years
* Both males and females are included in the study
* Individuals with 90 degree hip flexion having a minimum reduction of 15 degrees in knee extension position.

Exclusion criteria :

* Old adults
* Individuals suffering from any acute or chronic co-morbidities of musculoskeletal, neurologic, cardiovascular or systemic origin
* Post-surgical cases
* Hamstring strain or any other dysfunction in past two years.
Pre-operative Localization of Ground Glass Solitary Pulmonary Nodules

Objectives: The main drawback of the hook-wire technique for locating ground glass nodules before video assisted thoracoscopic surgery (VATS) resection is the risk of the hook dislodging during single lung ventilation as the lung collapses. In order to reduce the friction of the thread in the wall, the investigators modified the technique by first positioning a catheter in the chest wall and introducing the carrying needle through the catheter. The objective was to evaluate the success rate and complications of this technique.

Material and Methods : the investigators retrospectively included all patients undergoing VATS resection of solitary lung nodules after localization using the sliding wire technique.


Eligibility Criteria:
Inclusion Criteria

- All patients who underwent VATS for pulmonary nodule resection in the thoracic surgery department of Nice University hospital after pre-operative hook-wire insertion using the sliding-wire technique

Exclusion criteria: None
Semaglutide and Physical Activity for Obesity and Multimorbidity

The aim of this observational study is to explore and describe changes in cardiometabolic health, physical activity, physical capacity, and wellbeing during interdisciplinary Semaglutide-based weight loss treatment in patients with severe obesity and multimorbidity.

This study is explorative and therefore does not include hypothesis testing.

This study is part of the project "Semaglutide and Physical Activity for Obesity and Multimorbidity: Co-designing Healthy Healthcare".

While this observational quantitative study aims to provide a comprehensive description of changes in patients' health and wellbeing during and after participation in weight loss treatment, the project also includes a qualitative interview study with a subset of patients from the same population to supplement and expand upon the quantitative findings. Additionally, a smaller subgroup of patients from the same population will eventually be invited to actively contribute to the collaborative development of a physical activity intervention in a co-design process, drawing on insights from the aforementioned studies.

Given its exploratory approach, the study is designed with a flat non-hierarchical outcome structure and multiple evenly valued outcomes measures. This will be reported evenly for all outputs of this research.

Eligibility Criteria:
Study participants are recruited from a particular interdisciplinary weight loss program based at Copenhagen University Hospital Hvidovre. Hence, the study uses the same set of inclusion criteria:

Inclusion criteria:

* Fulfilment of the Danish criteria for bariatric surgery:
* BMI ≥ 35 kg/m2
* Aged ≥ 18 years
* One or more obesity-related conditions (type II diabetes, resistant hypertension, sleep apnea, severe osteoarthritis of the lower extremities)
* One more comorbidities that prevent bariatric surgery

Exclusion criteria are:

* Unwillingness to participate in the study
* Inability to understand Danish
* Cognitive impairments

UPDATE 17.09.2024:

After initiating patient recruitment for the study on 15.02.2024, the project group identified discrepancies between the eligibility criteria and description of the study population as originally reported in the trial registration and those actually applied in the study. As a result, we adjusted both the eligibility criteria and description of the study population in the trial registration on 17.09.2024. These adjustments do not represent a change in the actual patient population but rather offer a more accurate and consistent description of their characteristics.
Assessment of the Rosacea Prevalence in the General Population

Multi-centre interventional cross-sectional prevalence study Assessment of the Rosacea Prevalence in the General Population.

Primary objective:

Assessment of the prevalence of rosacea in the general population per country using subject questionnaire and dermatologist diagnosis

Eligibility Criteria:
Part I

Inclusion Criteria:

The following subjects will be included in the study:

* Subjects aged 18 to 65 years old from the general population
* Subjects who are willing to complete the questionnaires

Part II

Inclusion Criteria:

The following subjects will be included in Part II of the study:

* Subjects who screened positive for rosacea during the first part of the study and selected by random method
* Subjects who gave their informed consent to participate in Part II of the study
Neurophysiology Biomarkers of Cognitive Impairment Associated with Deep Brain Stimulation

The study aims to investigate cognitive impairment associated with Deep Brain Stimulation (DBS) in Parkinson's Disease patients, with a focus on identifying neurophysiology biomarkers of DBS associated cognitive changes. Using neurophysiology data recorded during DBS surgeries and post-implantation, the research intends to identify biomarkers in order to optimize electrode placement, enhance programming, and ultimately minimize DBS-related cognitive side effects.


Eligibility Criteria:
Inclusion Criteria:

• Scheduled to undergo deep brain stimulation surgery under local anesthesia at Vanderbilt University Medical Center (Arm 1)

* Active deep brain stimulation system with implantable pulse generator capable of recording local field potentials (Arm 2)
* Diagnosis of Parkinson's disease as determined by a movement disorders specialist neurologist
* Age at least 18
* Able to participate in intraoperative testing
* English speaking

Exclusion Criteria:

* Age less than 18
* Not able to participate in intraoperative testing (ex unable to comprehend instructions or follow directions)
Trial on the Effects of Ultrasound Probe Position on Ultrasound-guided Nerve Blocks

Ultrasound has been used to guide a needle to inject local anesthetics around nerves. This is usually done in the same plane as the ultrasound beam in America and is known as an in-plane technique. When done correctly, the entire needle is visualized on the ultrasound screen as it approaches the nerves which are also seen on the same screen the entire time. The ultrasound probe can be held perpendicular or parallel to the shoulders of the person performing the in-plane technique. Our hypothesis is that holding the ultrasound probe perpendicular to the shoulder is superior to holding the probe parallel to the shoulder during an in-plane ultrasound guided regional anesthesia technique.

Right handed volunteers with no prior exposure to ultrasound techniques are used in this study. They will be randomly assigned to be shown an instructional video on how to perform an in-plane ultrasound guided needling technique on a realistic simulation target. The two videos are identical with the exception of the probe position. A blinded assessor will time the volunteers performance behind a screen and note the duration in which the needle is not visualized in the ultrasound screen.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Right handed
* Aged 18 to 55

Exclusion Criteria:

* Any person who has prior knowledge about ultrasound imaging or regional anesthesia
* Any person who has prior experience with laparoscopy or biopsy
* Any person who has problems with depth of field or simple hand eye co-ordination task
Altering Bone Microarchitecture and Mechanics by Off-label Pharmaceutical Intervention Following an Acute Knee Injury

The purpose of this study is to assess if a zoledronic acid injection can alter the trajectory of joint degeneration following an acute anterior cruciate ligament (ACL) injury.

After being informed about the study and potential risks and all participants giving written informed consent, this project will establish a cohort of young men and women who within six weeks have sustained an acute rupture of the ACL. The cohort is randomized into a control and treatment group, where the treatment group receives a zoledronic acid injection at baseline. The cohort will be followed radiographically with high resolution peripheral quantitative computed tomography (HR-pQCT), dual-energy computed tomography (DECT), digital radiography (X-Ray), bi-planar X-ray (EOS) and magnetic resonance imaging (MRI) for eighteen months to monitor the progression of joint changes and the effects of zoledronic acid.

Eligibility Criteria:
Inclusion Criteria:

* Clinical evidence of an acute unilateral ACL tear (full-thickness, complete tear) will be recruited. This age range is chosen to ensure participants have fully developed adult bone structures and to exclude participants with menopause as this could affect study results.
* Participants with combined ligament deficiencies (posterior cruciate, medial and/or lateral collateral) or meniscal injury will be included. Participants must be able to fully extend the knee while supported at the time of the baseline measurement in order to conduct the HR-pQCT scan.
* Participants with a serum calcium level in the normal range (2.1-2.55 mmol/L) and a creatinine level above 50 (reported as eGFR) will be included.

Exclusion Criteria:

* Individuals with contraindications to zoledronic acid (see below)
* Prior knee ligament and/or meniscus tears, and/or intra-articular fractures.
* Females who are pregnant or planning pregnancy within a year will not be eligible. The research team will recommend participants who are planning to become pregnant within the next five years to withdraw their participation.
* Individuals with knees larger than the CT scanner's circular field of view.
* Individuals with a history of disease and/or treatment affecting bone turnover in the past 12 months.
* Individuals with injuries or implants that are not MRI-safe.

Zoledronic acid is contraindicated for:

* Patients who are hypersensitive to this drug or to any ingredient in the formulation, or to any bisphosphonates or component of the container.
* Severe renal impairment with creatinine clearance \<35 mL/min and in those with evidence of acute renal impairment. For this study, participants with a creatinine clearance \<50 mL/min may be excluded.
* Non-corrected hypocalcaemia at the time of infusion.
* Pregnant and nursing mothers.
* Patients who are already taking another bisphosphonate (ex. for osteoporosis).
Mucinex® for Treatment of Filamentary Keratitis

It is a pilot study aimed to determine if oral Mucinex® is effective in reducing the amount of corneal filaments and improving symptomology in subjects with filamentary keratitis.

The study is aimed to determine if oral administration of Mucinex® is effective in reducing the amount of corneal filaments and improving symptomology in subjects with filamentary keratitis. Subjects will be instructed to take 600 mg tablets of extended release Mucinex® twice a day (total dose is 1.2 g/day) for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients with filamentary keratitis
* 18 years and older

Exclusion Criteria:

* Active ocular surface infection of any type
* Recent ocular surgery (\<30 days) history of nephrolithiasis as Mucinex® has been associated in rare cases of development of kidney stones
* Schirmer's test\<3mm
* History of hypersensitivity to Mucinex®
* Concurrent eye disease requiring immediate initiation of a new treatment (e.g. topical steroids) restriction for water intake can exacerbate the risk of nephrolithiasis.