cyrilzakka/clinical-trials huggingface dataset:
Use of a Self-Guided Mindfulness Mobile Application to Improve Pain Outcomes in Individuals With Knee Osteoarthritis

This study will investigate if mindfulness training via a smartphone mobile app is effective in improving OA-related knee pain.

The investigator's primary aim in this study is to determine if regular use of a mindfulness application improves pain outcomes in adults with knee osteoarthritis. The investigator's secondary aim is to determine if self-reported Healthcare-Related Quality of Life (HRQoL) scores predict response to mindfulness treatment in OA. The investigators hypothesize that the use of an mHealth intervention for mindfulness training may be an effective adjunct treatment of chronic knee osteoarthritis pain; specifically, that regular use of a mindfulness application will result in a statistically significant reduction in pain outcomes and improvement in physical function as determined by the KOOS scoring system. The investigators also hypothesize that those with lower baseline self-reported HRQoL scores are more likely to see a greater improvement in their pain and function with use of a mindfulness application than those with higher baseline scores.

Eligibility Criteria:
\*\*Patients must be able to get care at Nellis, Scott, or Travis Air Force Base (a military installation) in order to participate in this study\*\*

Inclusion Criteria:

* Male and female Active Duty members and DoD beneficiaries ages 18-74 years
* Meet criteria for symptomatic knee osteoarthritis according to the American College of Rheumatology (pain on more than half of the days of the past month during at least one of the following activities: walking, ascending or descending stairs, standing upright, or lying in bed at night)
* Demonstrate radiographic evidence of OA, with Kellgren and Lawrence (KL) Grade ≥1 as determined by Lead Site Investigator at each study location
* Must have access to a smartphone with enough memory to download the app My Water Balance or the Mindfulness app

Exclusion Criteria:

* Intra-articular corticosteroid injection in the 3 months prior to participation in the study.
* Intra-articular hyaluronic acid/PRP injection in the 6 months prior to participation in the study
* Medical condition contraindicating moderate aerobic exercise as determined by their physician
* History of knee surgery in the past 6 months or previous knee arthroplasty
* Inflammatory joint disease.
* Current Practice of Mindfulness
* Non-English-speaking
* Currently pregnant or planning pregnancy over the study period
* Enrollment in other clinical research study during the study period
* Inability to comply with treatment protocol, including participation in the Rx3 Home Exercise Program.
A Study to Assess How Vaborem® is Taking up in the Body and Tolerated in Paediatric Patients With Complicated Urinary Tract Infection

The goal of this clinical trial is to assess the pharmacokinetic (PK) and safety and tolerability of Vaborem ( fixed combination of meropenem and vaborbactam) in the paediatric population aged from 3 months to \< 18 years with complicated urinary tract infection (cUTI) including acute pyelonephritis (AP) in need of hospitalisation and intravenous (IV) antibiotic administration.

All participants will receive Vaborem IV every 8 hours to treat cUTI and/or AP for 10 up to 14 days; switch to stepdown oral antibiotic is allowed after a minimum of 3 days of Vaborem. PK sample collection will occur after at least 6 doses administration.

Participant's clinical conditions will be monitored during the entire duration of their hospitalization and during scheduled visit/s after the completion of the treatment.


Eligibility Criteria:
Main Inclusion Criteria:

* Written informed consent before initiation of any study-related procedures.
* Male or female, 3 months and \< 18 years of age, inclusive.
* Require hospitalization for cUTI/AP and a minimum of 3 days of IV antibiotic treatment for cUTI/API as per Investigator's judgement.Current or suspected cUTI or AP as indicated by the presence of clinical signs and symptoms, and complicating factors.

Main Exclusion Criteria:

* History of any moderate or significant hypersensitivity or allergic reaction to beta-lactam antibiotics or to any component of the investigational medical product.
* cUTI/AP that in the opinion of the Investigator is unlikely to respond to the study treatment.
* Creatinine clearance \<50 mL/min.
* In treatment with immunosuppressive agents, valproic acid, or probenecid.
A Dose Escalation Study of Adavosertib(MK1775) in Combination With 5-FU or 5-FU/CDDP in Patients With Advanced Solid Tumor (1775-005

The study evaluates safety of adavosertib in monotherapy, and in combination with 5-Fluorouracil (5-FU) alone or with 5-FU/cis-diamminedichloroplatinum (CDDP) in Japanese participants with solid tumor. The primary hypothesis is that adavosertib is safe and tolerable in participants with locally advanced or metastatic solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Parts 1 and 2-A: Patient must have a histologically or cytologically confirmed locally advanced or metastatic solid tumor failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist
* Parts 2-B and 3: Patient must have a histologically or cytologically confirmed locally advanced or metastatic esophageal, head and neck, or gastric cancer, and be a candidate of 5-Fluorouracil and Cisplatin regimen defined in this study
* Patient must have performance status of 0 or 1 on the ECOG Performance Scale

Exclusion Criteria:

* Patient who has had chemotherapy, radiotherapy, or biological therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to the first dose of study drug or who has not recovered from adverse events due to agents administered more than 4 weeks earlier
* Patient with a known primary central nervous system tumor
* Patient has known hypersensitivity to any of the components of the combination study therapy or its analogs
* Patient is receiving "alternative" cancer medications such as plant-derived products and their analogs with anti-tumor activity within 1 week prior to entering the study.
* Patient must not have prior radiation therapy to more than 30% of the bone marrow and must have recovered for at least 3 weeks from the hematologic toxicity of prior radiotherapy
Ultrasonography of the Neck: The Influence of Airway Devices on Vascular Topography in Pediatric Patients

Internal jugular venous catheterization is a challenging procedure in pediatric patients due to small size. Overlapping of the internal jugular vein (IJV) and common carotid artery (CCA) may jeopardize the success and increase the complication rate.However, the use of ultrasound as an assistance tool might be helpful to identify the relationship between the IJV and the CCA. Endotracheal intubation and insertion of laryngeal mask are the common options for the airway management during general anesthesia for central venous catheterization. In this observational study, the investigators aimed to investigate the impact of the laryngeal mask insertion or endotracheal intubation and the role of head rotation on the overlap of the IJV and CCA evaluated with ultrasound in pediatric patients undergoing any kind of surgical procedure.


Eligibility Criteria:
Inclusion Criteria:

* patients with American Society of Anesthesiologist status I-IV

Exclusion Criteria:

* patients with prior internal jugular vein catheterization or cardiovascular system anomaly
Pilot Study of How Children With Asthma Exacerbations Metabolize Prednisone

The objective of the investigators pilot study is to assess the pharmacokinetic profile of two corticosteroid drugs, prednisone and prednisolone, in children who present to the pediatric emergency department with an asthma exacerbation. The investigators hypothesis is that the pharmacokinetic profile in this population will be similar to healthy children and adults.

The standard of practice in treating children with asthma exacerbations is to give corticosteroid drugs early in the course of the exacerbation. These drugs decrease symptoms, provide faster time to recovery and improve of quality of life. However, there is 100% variability in a child's response to corticosteroids at a standard dose which is based on primarily on adult studies. The pharmacokinetic analysis or the process by which a drug is metabolized by the body is the first step to determine the proper dose.

Patients between the ages of 2 and 16 years with asthma exacerbations will be recruited from the pediatric emergency department. After the patients get the drugs, blood samples will be drawn over 8 hours to get the following parameters: maximum concentration reached in the body, the time for the drug to be eliminated from the body, how long the drug stays in the body, how much of the drug is found in the urine after it is given, and concentration of metabolites or breakdown products in urine and blood. These are the parameters needed to make the pharmacokinetic profile and is the first step towards appropriate dosing of these two medications for asthma exacerbations in children.

Eligibility Criteria:
Inclusion Criteria:

* patients aged 2 to 16 years
* acute asthma exacerbation requiring an oral corticosteroid (either prednisone or prednisolone)
* any "reactive airways disease" treated like asthma

\[Asthma is defined as at least 2 wheezing episodes and/or the patient has been treated with beta agonist and/or inhaled, oral or intravenous corticosteroids for the recurrent episodes of wheezing in the past\] \[Acute asthma exacerbation is defined as wheezing episode with any of the following symptoms: tachypnea, dyspnea, use of accessory muscles, or an increased need for short acting beta agonist prior to presentation to PED\]

Exclusion Criteria:

* any systemic corticosteroid use within 1 week of presentation to PED
* use of any other corticosteroid apart from oral prednisone or prednisolone for the current acute asthma exacerbation
* bronchiolitis
* underlying chronic medical condition other than asthma (ie: cystic fibrosis, nephrotic syndrome, epilepsy, etc)
* liver impairment (including elevated transaminases)
* renal impairment
* primary or secondary immunodeficiences
* concomitant immunosuppressive medication use
* IVIG use within 4 weeks
* need for assisted ventilation
Different Doses of Oral Melatonin Supplements in Chronic Kidney Disease (CKD)-Associated Sleep Disorders

The study will evaluate the safety and efficacy of melatonin supplementation in CKD and ESRD patients with sleep disorders to reduce sleep latency times, the number of apnea/hypopneic episodes, and prolong duration in rapid eye movement (REM) sleep in CKD and ESRD patients with sleep disordered breathing.

The study will look at the safety and efficacy of melatonin supplementation given to patients with chronic kidney disease and end stage renal disease who have sleep disorders to reduce sleep latency times, the number of apnea/hypopneic episodes, and prolong duration in rapid eye movement (REM) sleep in CKD and ESRD patients with sleep disordered breathing.

Eligibility Criteria:
Inclusion Criteria:

1. Patient age \> 18 and \<85 years of age
2. Patients with CKD or ESRD with eGFR \< 30 mls/min
3. If receiving hemodialysis, patients must be on treatment \> 3 months
4. Normal healthy controls must be without a known history of CKD and be willing to have formal PSG test and plasma melatonin measurements

Exclusion Criteria:

1. Patients receiving outpatient hemodialysis for \< 3 months
2. Patients with estimated GFR by Cockcroft Gault \> 30 mls/min
3. Patients receiving beta blocker therapy within one month of randomization
4. Patients receiving Nifedipine therapy within one month randomization
5. Patients on peritoneal dialysis
6. Patient with chronic home oxygen supplementation
7. Patients receiving chronic home CPAP therapy
8. Patients actively receiving outpatient sleep medications
9. Patients with diabetic gastroparesis unresponsive to medication
10. Patients with known pregnancy or unwilling to use contraception during the course of the study
11. Patients with a functioning renal allograft
12. Patient currently receiving long-term immunosuppressive therapy. Patients receiving low dose prednisone (10mg or less per day) will not be excluded from this trial
13. Unable to give informed consent
Phosphodiesterase-5 (PDE5) Inhibition and Pulmonary Hypertension in Diastolic Heart Failure

Prevalence of heart failure (HF) with left ventricular (LV) diastolic dysfunction and preserved ejection fraction (EF) (HFpEF) is increasing. Prognosis worsens with development of pulmonary vasoconstriction and hypertension (PH) and right ventricular (RV) failure. The investigators aimed at modulating pulmonary vascular tone and RV burden in HFpEF due to high blood pressure (HBP), by using the phosphodiesterase-5 (PDE5) inhibitor sildenafil.

Heart failure (HF) with preserved left ventricular (LV) ejection fraction (EF) (HFpEF) is a public health problem and a major topic in clinical cardiology. Its prevalence, in fact, is increasing and the outcome seems to be similar to that of HF with LV systolic dysfunction (LVSD). Pulmonary hypertension (PH) in HFpEF is highly prevalent and often severe and, like in LVSD (3), is a predictor of morbidity and mortality (4). Because of the thin wall and the distensibility, the right ventricle (RV) is much more vulnerable by an excessive afterload than by preload. The pulmonary circulation is a central determinant of RV afterload, and an increase in impendance to RV ejection, like occurring in LV dysfunction, can easily result in RV failure, tricuspid regurgitation, central venous pressure (CVP) rise. Development of RV failure is unanimously viewed as a predictor of poor prognosis but the underlying mechanisms have not been extensively investigated.

Because of the prevalence and clinical significance of PH secondary to HF, attenuation of the pulmonary vascular tone and of the RV hemodynamic burden has been suggested as a goal to be achieved with HF therapy. Attempts with endothelin receptor antagonists, or prostacyclin analogues, were basically unsuccessful. Experimental models and human studies, showing that in HF nitric oxide (NO) - dependent pulmonary vasodilatation is impaired and pulmonary vascular resistance elevation is at least in part due to pulmonary endothelial dysfunction, have suggested therapeutic strategies with agents that increase NO activity, like nitrates or phosphodiesterase - 5 (PDE5) inhibitors (12-14). The latter agents offer the double advantage of selectively dilating the pulmonary vessels and not producing tachyphylaxis.

In this 1-year duration study, the primary end-point was to probe whether pulmonary hemodynamics and RV performance in HFpEF with PH may be targets of PDE5 inhibition with sildenafil.

Eligibility Criteria:
Inclusion Criteria:

* LVEF \>50%
* sinus rhythm and stable clinical condition defined as no changes in therapeutic regimen, or hospitalization in the 6 months preceding recruitment.
* pulmonary artery systolic pressure \> 40 mm Hg,

Exclusion Criteria:

* Patients receiving nitrates
* A history of pulmonary disease
* Alternative causes of PH other than cardiac-related
* Renal failure (creatinine \> 2mg/dL)
* Anemia
* Pericardial disease
* Cardiac amyloidosis
Augmentation of Limb Perfusion With Contrast Ultrasound

Our laboratory has discovered that ultrasound (US) imaging together with clinically approved microbubble ultrasound contrast agents can augment limb tissue perfusion. These observations have been made in mice with and without peripheral artery disease (PAD), and also in humans where high power contrast enhanced ultrasound (CEU) was used to measure perfusion but was found also to augment perfusion by almost 2-fold. The latter human studies were performed with ultrasound protocols designed for perfusion imaging and not for flow augmentation. In this study, we will measure the degree to which limb perfusion is augmented with specific therapeutic CEU settings that are still within the FDA-approved limits with regards to US power and contrast dosing.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 y.o.
* For PAD subjects: known history of unilateral or bilateral PAD diagnosed by reduced ankle-brachial index or angiography and a Rutherford symptom class of 4-6.

Exclusion Criteria:

1. Major medical illness other than PAD affecting the limb (muscle disease, blood diseases that influence flow or rheology, severe heart failure \[NYHA class IV or LVEF \<30%\]).
2. Pregnant or lactating females
3. Hypersensitivity to any ultrasound contrast agent
4. Known atrial septal defect or large right to left shunt.
5. Hemodynamic instability (hypotension with systolic BP \<90 mm Hg, need for vasopressors)
6. Evidence for ongoing myocardial ischemia
7. For normal controls, any known structural non-arrhythmic cardiovascular disease (coronary artery disease, heart failure, moderate or greater valve disease).
Use of a Smartphone to Assess Balance and Provide Intervention to Older Adults at Home

Approximately one-third of older adults report one or more falls each year, with devastating physical, psychological, social, and financial consequences. Conventional gait analysis performed in a controlled laboratory environment can identify balance deficits, but unfortunately, such tools are bulky, time-consuming, and dependent on qualified technicians to properly collect and evaluate the data. Furthermore, these one-time gait and balance assessments cannot monitor changes in ambulatory strategies longitudinally and do not reflect performance in real-life environments, where falls commonly occur. While recent developments in smartphone-based evaluations have demonstrated great utility and accuracy in assessing gait performance, it is vital to evaluate participant compliance, ease-of-use, and feasibility of this technology using a smartphone in the home environment.

It is also paramount that interventions which improve balance be accessible to older adults. While four-week balance training routines have been shown to improve balance performance among older adults, it is unknown whether such interventions can be conducted remotely in a safe and compliant manner. Furthermore, the retention of balance function following intervention is unclear. Subsequently, the goals of this study are to evaluate technology that can both remotely monitor balance and prescribe intervention to older adults. With the current burdens on the health care system and the burgeoning population of older adults, it is essential that tools be provided to older adults that are easy to follow, attractive, and improve balance performance.

Therefore, the objective of this project is to investigate the utility of a valid, easily accessible, smartphone application to assess balance and provide personalized exercise for older adults as a stand-alone, field-based medical device. The aims of this proposal are to (1) utilize a smartphone application to longitudinally evaluate gait and standing balance over an 8-week period in the home environment among 30; and (2) determine the feasibility and efficacy of a smartphone application to promote exercise and evaluate gait changes for up to 2 months in this older adult population following a 4-week balance intervention. The long-term goal of this project is to provide a holistic home-based gait monitoring and intervention tool for integration in routine clinical care.


Eligibility Criteria:
Inclusion Criteria:

* Able to ambulate at least 10 meters without an assistive device.
* Cognitively intact based on scoring 18/22 or greater on the Montreal Cognitive Assessment (MOCA) - Blind.

Exclusion Criteria:

* Lower limb amputation
* Lower limb arthroplasty
* Visual impairment uncorrectable with lenses
* Uncontrolled hypertension or diabetes
* Neurological or musculoskeletal impairment
* Persistent symptoms of dizziness or lightheadedness
AMAZING PRAGUE (PRAGUE-12)

Aim of the project is to assess the long-time clinical impact of surgical ablation (MAZE procedure) on patients who suffer from atrial fibrillation but are indicated to a cardiac surgery for other predominant cardiac diagnosis (heart valve surgery, coronary revascularization or combined surgery). In recent years, those patients are more and more frequently indicated to some type of MAZE procedure, without the real benefit of this procedure for patients has been assessed with an enough large, randomized study. Even though it is well known, that MAZE procedures declines the early postoperative incidence of atrial fibrillation, convincing data about its mid-term and long-term impact on patients and about the appearance of recidives of atrial fibrillation in long-time horizon are still missing. Our hypothesis assumes, that MAZE procedure will significantly decrease the appearance of atrial fibrillation one year after the operation, without increasing mortality or incidence of serious postoperative complications in thirty postoperative days.


Eligibility Criteria:
Inclusion Criteria:

* indication to a cardiac surgery (coronary bypass, valve repair, others or combination of those)
* atrial fibrillation (paroxysmal, persistent or permanent) present or documented in last 6 month before the operation
* signed informed consent

Exclusion Criteria:

* rejection of signing the informed consent with randomization
* emergent surgery
Complications and Recurrences After Mohs Micrographic Surgery and Slow Mohs

Mohs micro-graphic surgery (Mohs) is a tissue-sparing, surgical treatment for different types of skin cancer (e.g. basal cell carcinoma, squamous cell carcinoma, lentigo maligna (melanoma). It is a procedure performed with frozen sections. Slow Mohs, a variant of micro-graphic surgery, is performed by formalin fixation and paraffin-embedded sections. Both in Mohs and Slow Mohs tumor margins are assessed to achieve complete removal. This study aims to investigate the clinical presentation and outcomes (i.e. complications and recurrence rates) in patients treated with Mohs or Slow Mohs in the dermatology department of the Maastricht University Medical Center+ in Maastricht, the Netherlands.


Eligibility Criteria:
Inclusion Criteria:

* patients with a cutaneous lesion with an indication for Mohs micrographic surgery or Slow Mohs
* patients who received a treatment with either Mohs or Slow Mohs between 1 july 2017 and 1 july 2023 at the dermatology department of the Maastricht University Medical Center+.

Exclusion Criteria:

* None.
Hypoallergenicity Evaluation of a New Extensively Hydrolyzed Formula

Infants/children with cow's milk allergy will take part in 2 double-blinded placebo-controlled food challenges (DBPCFC) of 2 extensively hydrolyzed formulas in random order. If both food challenges are passed, subjects will be asked to consume the Test formula in an at-home open challenge for 7 days.


Eligibility Criteria:
Inclusion Criteria:

* Born at term (\>36 weeks gestation)
* 2 months to \<4 years of age at enrollment
* Documented CMA within 6 months prior to enrollment
* Otherwise healthy
* Having obtained his/her legal representative's informed consent

Exclusion Criteria:

* Children consuming mother's milk at the time of inclusion and during the trial
* Any chromosomal or major congenital anomalies
* Chronic medical diseases (ie seizure disorders, chronic lung disease, heart problems (heart murmurs okay))
* Immunodeficiency
* Anaphylaxis to any food
* Receiving free amino acid formula
* Subject who in the Investigator's assessment cannot be expected to adhere to the study protocol
* Currently participating in another clinical trial