cyrilzakka/clinical-trials huggingface dataset:
Novel MRI Techniques on Evaluation of Lymphedema

In this project, the investigators aim to investigate the imaging approaches for breast cancer-related secondary lymphedema. The clinical study aims to optimize the conventional MRI methods for mapping lymphedema and assess the post-surgical therapeutic effects in longitudinal follow-up studies. Additionally, a normal imaging database of lymphedema MRI images will be established for future reference. For pre-clinical animal study, investigators aim to develop and integrate two novel MRI methods, including free water elimination diffusion MRI and diffusion kurtosis MRI techniques. By integrating clinical and pre-clinical studies, the investigators aim to establish a precise imaging tool for evaluating the therapeutic effects of lymphedema for following translational applications.

A total of three sub-projects will be conducted in this project. Sub-project 1 will establish a pre-clinical rat model for lymphedema and develop novel MRI methods, including diffusion kurtosis MRI and free water elimination diffusion MRI techniques, for mapping tissue characteristics of lymphedema. Sub-project 1 will be complemented with the clinical images provided by sub-project 2, yielding more information about the lymphedema. Sub-project 2 aims to optimize the clinical MRI methods for mapping lymphedema and quantitatively assess the severity of lymphedema. A normal imaging database will be established for reference. Sub-project 2 and sub-project 3 will be complementary in co-developing the image assessment of post-surgical therapeutic effect. Sub-project 3 will quantitatively evaluate the severity of lymphedema secondary to different kinds of axillary treatments by using the clinical MRI methods for establishing longitudinal monitoring and prediction approaches. It also focuses on the pre-surgical and post-surgical evaluation of lymphedema undergone supermicrosurgical technique by using the clinical MRI methods.

Eligibility Criteria:
Inclusion Criteria:

* adults with breast cancer related lymphedema

Exclusion Criteria:

* children younger than 20 years old
* pregnancy
* patients who have absolute contraindications regarding MRI scanning:

  1. The cardiac implantable electronic device (CIED) such as pacemakers, implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT) devices.
  2. Metallic intraocular foreign bodies.
  3. Implantable neurostimulation systems
  4. Cochlear implants/ear implant: bone-anchored hearing aid (BAHA) cochlear implant type can be scanned on a 1.5-tesla scanner only after the patient removes the battery. Cochlear implant wrapping scheduling must take place before the patient's MRI appointment.
  5. Drug infusion pumps (insulin delivery, analgesic drugs, or chemotherapy pumps): If possible, the patient has to remove the device.
  6. Catheters with metallic components (Swan-Ganz catheter)
  7. Metallic fragments such as bullets, shotgun pellets, and metal shrapnel
  8. Cerebral artery aneurysm clips
  9. Magnetic dental implants
  10. Tissue expander
  11. Artificial limb
  12. Hearing aid
Virtual SMAs in Lifestyle Approach for Type 2 Diabetes

This study protocol presents the design of a randomized pragmatic trial. This study aims to determine the effectiveness of virtual shared medical appointments (SMAs) lifestyle approach in improving glycaemic control, compared to usual care in type 2 diabetes (T2D) subjects.


Eligibility Criteria:
Inclusion Criteria:

* (1) be 18 years old or older
* (2) have a diagnosis of T2D with HbA1c ≥ 6.5% within the preceding 6 months
* (3) have body mass index (BMI) ≥ 25.0 kg/m2 within the preceding 6 months
* (4) have access to a camera and internet

Exclusion Criteria:

* unable to attend virtual SMAs for diagnosis of dementia or other cognitive impairment and any behavioral problem, which interferes with group participation and discussion
* not fluent in Portuguese, and unable to follow conversations, read instructions, and read in Portuguese
* being pregnant or planning a pregnancy in the next year
* attending a weight loss and/or physical activity counseling program
Patient's Perception of Treatment Outcome With Darifenacin by Patients With Overactive Bladder

This study will evaluate safety, efficacy and patient's perception of outcome after treatment with darifenacin (7.5 mg once daily (o.d.) with voluntary increase up to 15 mg o.d.) in patients with OAB who are dissatisfied with prior oxybutynin extended release (ER) or tolterodine extended release (ER) therapy.


Eligibility Criteria:
Inclusion Criteria:

* • Symptoms of OAB for at least six months prior to randomization

  * ≥ 8 micturitions on average/24 hours
  * ≥ 1 urgency episodes on average/24 hours
  * with or without UUIE

    * Patients dissatisfied with prior oxybutynin ER or tolterodine ER treatment. Patients must have been on either treatment for at least 1 week and up to 12 months preceding this study. It is required that either oxybutynin ER or tolterodine ER was the most recent OAB medication taken.
    * Patients without prior darifenacin treatment

Exclusion Criteria:

* • A mean daily urinary volume \>3000 mL or a mean volume voided/micturition of \>300 mL as verified in the micturition diary for two consecutive days prior to Baseline

  * Males with post-void residual (PVR) urinary volume \>200 mL at Baseline
  * Clinically predominant and bothersome stress urinary incontinence, as determined by the investigator
  * Urinary retention or clinically significant bladder outlet obstruction as determined by the investigator

Other protocol-defined inclusion / exclusion criteria may apply
Serum Uromodulin and DN Systematic Review and Meta Analysis

Several studies have investigated the association between the changes of serum uromodulin and diabetic nephropathy (DN). However, the results are still controversial. Hence, this meta-analysis aimed to evaluate the association of uromodulin with DN.


Eligibility Criteria:
Inclusion Criteria:

* Studies were included if they met the following criteria:

  1. serum level of uromodulin was determined;
  2. the samples were enrolled from diabetic patients;
  3. mean ± SD was reported for uromodulin between patients with and without DN;
  4. the level of albumin to creatinine ratio (ACR), glomerular filtration rate (GFR), or albumin excretion rate (AER) in patients with DN was determined

Exclusion Criteria:

* Studies were excluded according to the following criteria:

  1. duplicate studies;
  2. review articles;
  3. non original research articles;
  4. studies with insufficient data to extract;
  5. non-human research;
  6. studies that determined urine level of uromodulin.
Fed Study of Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg and Benicar HCT® Tablets 40 mg/25 mg

The objective of this study was to investigate the bioequivalence of Mylan's olmesartan medoxomil and hydrochlorothiazide 40 mg/25 mg tablets to Sankyo's Benicar HCT® 40 mg/25 mg tablets following a single, oral 40 mg/25 mg (1 x 40 mg/25 mg) dose administered under fed conditions.


Eligibility Criteria:
Inclusion Criteria:

* healthy, adult subjects, 18 years and older
* able to swallow medication

Exclusion Criteria:

* institutionalized subjects
* history of any significant disease
* use of any prescription or OTC medications within 14 days of start of study
* received any investigational products within 30 days prior to start of study
Feasibility of a Deep Learning-based Algorithm for Non-invasive Assessment of Vulnerable Coronary Plaque

The primary objective of this study is to assess the accuracy in terms of sensitivity, specificity, negative and positive predicted values of the DL-based algorithm with respect to correct identification of the plaque and associated vulnerability grade.

Data collected in this study will be used for technology development, scientific evaluation, education, and regulatory submissions for future products. This is a pre-market, open label, prospective, non-randomized clinical research study conducted at one site in Italy. The product being researched is the Deep Learning-based (DL) algorithm for non-invasive detection of vulnerable coronary plaque.

Eligibility Criteria:
Inclusion Criteria:

1. Patients referred for a clinically indicated CCTA and ICA with OCT imaging examinations;
2. Diagnosis of chronic coronary syndrome, known CAD, or stable angina; AND,
3. Patients with ACS that may undergo a CCTA and not refer directly to the Cath lab for revascularization procedures.

Exclusion Criteria:

1. Contradictions to contrast;
2. Contraindications for beta blocker;
3. BMI \>30;
4. High heart rate ≥75 BPM;
5. Atrial Fibrillation;
6. Arrythmia or irregular heartbeats;
7. Any prior coronary revascularization;
8. Presence of pacemaker or implantable cardioverter defibrillator; OR,
9. Patients with TAVI/TAVR.
Microfluidic-based Tactile Sensor in Cardiac Rehabilitation

This study will examine the impact of cardiac rehabilitation on blood vessel health using a newly developed microfluidic-based tactile sensor to assess blood vessel health. The participants will have their blood vessel health measured using a sensor that is placed on top of the skin over the artery before and after exercise (1, 3, 5, 10, 30 and 60 mins). The investigators will study these responses at the first session of cardiac rehabilitation and following 1 and 4 weeks of cardiac rehabilitation (sessions 3 and 6). The investigators will also collect some information from the medical record regarding: age, gender, body mass index, resting cardiovascular measures (heart rate, blood pressure etc), medications, reasons which qualified the participant into cardiac rehabilitation, blood tests related to heart or cardiovascular function, metabolic panel, lipid panel, echocardiogram results, recorded electrocardiogram, known vascular diseases, presence of implantable devices, Seattle Heart Failure Model data and cardiovascular measures and exercise workloads during cardiac rehabilitation.

The investigators will make the following research measurements (pre-exercise measurement and post-exercise measurement) on the first day of cardiac rehab, and following 1 and 4 weeks of cardiac rehabilitation.

Subjects will have their arterial pulse measured at the radial (wrist), carotid (neck) and temple (side of the head) arteries. The sensor will remain in place for 2-3 minutes while the recordings are made. Light pressure will be applied during this time. Blood pressure will also be obtained in the opposite arm.

The subject will then exercise on the modalities, intensity and duration designated by the staff in the Sentara Heart Hospital Cardiac Rehabilitation. It's important to note, that the normal standard of care will not change by the individual participating in this research study. The participants will follow standard physician ordered cardiac rehabilitation. The order of the modalities performed will be completed in the same order on the day of research testing in weeks 1 and 4.

After finishing the exercise, the subject will sit down for 1hr. The participant's pulse signals will be measured at 0-5min, 10min, 20 min, 30min and 1hr after exercise. Blood pressure will also be obtained from the opposite arm at the same time intervals.

The investigators will be collecting cardiac rehab data from each research day. This data will be entered into Redcap by the Sentara researchers.

The investigators will record from the most recent values/visits prior to start of cardiac rehab therapy, and this information will be entered into Redcap by the Sentara researchers.

The investigators will document at 1, 2 and 3 years from start of cardiac rehab, as to patient survival status.

Eligibility Criteria:
Inclusion Criteria:

* Age 45-70
* Subjects who qualify for cardiac rehabilitation via doctor's orders

Exclusion Criteria:

●Physical limitations which would preclude one from performing exercise.
Natural History in Primary Mitochondrial Myopathies

This is a longitudinal study in a cohort of patients with a genetic diagnosis of Primary Mitochondrial Myopathy to describe the natural history of the disease and identify clinical, biochemical, molecular, and radiological variables that allow evaluation of the severity and progression of the disease and may be useful in future clinical trials.

Mitochondrial Diseases (MD) are among the most frequent inherited metabolic diseases. Despite their high impact on patients, there are still no authorized drugs capable of modifying their clinical course. MD are clinically and genetically heterogeneous disorders, with muscular symptoms being one of their main manifestations. When muscular symptoms predominate, the disorder is classified as a Primary Mitochondrial Myopathy. In recent years, there have been significant advances in developing potential new treatments in this field. However, the absence of natural history studies makes the design and interpretation of clinical trials difficult and leads to long delays or even failures in the development of new treatments. The investigators propose to characterize in-depth a cohort of patients with Primary Mitochondrial Disorders due to mutations in the mitochondrial DNA (mtDNA) or in genes located in the nuclear genome (nDNA), from a clinical perspective but also a radiological, biochemical, and molecular point of view, and carry out a longitudinal follow-up of these parameters to identify those that are better correlated with severity and that allow measuring changes in the patient's clinical situation. With this objective, the investigators will analyze clinical variables (evaluation of motor function through manual force exploration, functional scales, and timed test, quality of life scales, serum biomarkers (growth differentiation factor 15 (GDF15) and fibroblast growth factor 21 (FGF21)), levels of heteroplasmy for cases harboring mtDNA mutations and mtDNA copy-number, and muscle magnetic resonance image of the lower extremities with quantification of fat replacement. All parameters will be evaluated at the beginning of the study and then annually during two years of follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Muscle symptoms: exercise intolerance and fatigue, myalgia, recurrent rhabdomyolysis, chronic progressive external ophthalmoplegia and/or muscular weakness
* Primary mtDNA mutation or pathogenic mutations in nDNA, especially in genes related to mtDNA maintenance such as TK2, POLG, TWNK and RRM2B, among others.

Exclusion Criteria:

* None
Costs, Effectiveness, QALYs, and Efficiency of Bioabsorbable Devices in Daily Clinical Practice

A multicenter, prospective, observational cohort study with clinical, quality of life, and economic evaluation to ascertain the quality-adjusted life years (QALYs) gained by patients with ischemic heart disease revascularized with Absorb in standard clinical practice in Spain. A before-after comparative analysis will be performed, so that each patient will act as his/her own control.

Economical evaluation study of the efficiency of Absorb in a cohort of patients with ischemic heart disease who have undergone revascularization with Absorb based on the criteria established according to standard clinical practice. A comparison group without Absorb cannot be used for ethical reasons. Thus, each patient will act as his/her own control, and a before-after comparison will be done. This is therefore a prospective, observational cohort study with concurrent data collection.

Primary objective:

* To assess utility (QALYs gained) in patients implanted Absorb in standard clinical practice conditions.

Secondary objectives:

* To assess effectiveness (clinical outcomes) in patients who undergo coronary revascularization with Absorb implantation.
* To assess costs (direct and indirect) derived from coronary revascularization with Absorb implantation.
* To assess efficiency in terms of cost/utility (cost per QALY gained) and cost/effectiveness (cost per MACE -major cardiac adverse events- free patient).

Eligibility Criteria:
Inclusion Criteria:

* Age ranging from 18 and 95 years.
* Both sexes.
* Coronary revascularization with Absorb for any of the following lesions: de novo, restenosis, segment ST elevation myocardial infarction (STEMI), chronic total occlusion (CTO), trunk, venous graft, or bifurcations.
* Informed consent signed before participation in the study is started.

Exclusion Criteria:

* Pregnant or nursing woman..
* Cardiogenic shock.
* Refusal to participate in the study.
Study of MR-based IGRT for Prostate Cancer

MR (Magnetic Resonance Imaging) - based IGRT (image-guided radiotherapy) for patients with prostate carcinoma.

Single arm, phase II study, MR (Magnetic Resonance Imaging) - based IGRT (Image-guided radiotherapy) of prostate cancer.

Primary endpoint: Grade 2+ GI (gastrointestinal) and genitourinary (GU) toxicity after 2 years.

Eligibility Criteria:
Inclusion Criteria:

* histologically proven prostate cancer
* indication for curative treatment
* ECOG performance scale 0-2
* Informed consent

Exclusion Criteria:

* contraindications for curative treatment
* age\<18year
* previous pelvic radiotherapy or prostatic treatment like TURP (transurethral resection of prostate), HIFU (high intensity focused ultrasound)
* serious comorbidity leading to inability for IGRT (image-guided radiotherapy)
* contraindications for MRI (Magnetic Resonance Imaging)
4 Weeks Treatment With Empagliflozin (BI 10773) in Japanese Type 2 Diabetic Patients (T2DM)

The objective of this trial is to evaluate the pharmacodynamics, pharmacokinetics, safety, and tolerability of once daily oral administration of BI 10773 administered for 28 days in Japanese patients with T2DM.


Eligibility Criteria:
Inclusion criteria:

1. Japanese male or female patients with T2DM treated with diet and exercise alone or with one hypoglycaemic drug other than glitazones.
2. Hemoglobin A1c (HbA1c) at screening (Visit 1)

   * For patients treated with 1 other oral antidiabetic drug: HbA1c between 6.5% and 9.0%.
   * For patients not treated with any antidiabetic drug: HbA1c between 7.0% and 10.0%.
3. Age between 20 and 70 years
4. Body mass index (BMI) between18.0 and 40.0 kg/m2
5. Signed and dated written informed consent before admission to the trial in accordance with the Good Clinical Practice (GCP) and the local legislation.

Exclusion criteria:

1. Antidiabetic treatment with insulin or glitazones within 3 months before obtaining informed consent or with more than 1 oral hypoglycaemic agent at the time of informed consent
2. Fasted blood glucose of \>240 mg/dL (\>13.3 mmol/L) or a randomly determined blood glucose level of \>400 mg/dL (22.2 mmol/L) on 2 consecutive days during wash-out period.
3. Myocardial infarction, stroke, or transient ischaemic attack within 6 months before informed consent.
4. Clinically relevant concomitant diseases other than T2DM, hyperlipidaemia, and medically treated hypertension before the first administration such as

   * Renal insufficiency (calculated estimated glomerular filtration rate \<60)
   * Cardiac insufficiency of New York Heart Association (NYHA) II-IV or other known cardiovascular diseases including hypertension of \>160/95 mmHg,
   * Neurological disorders (such as epilepsy) or psychiatric disorders
   * Acute or clinically relevant chronic infections (e.g., human immunodeficiency virus, hepatitis, repeated urogenital infections)
   * Any gastrointestinal, hepatic, respiratory, endocrine, or immunological disorder
5. Patients under treatment with any concomitant medication except for the following drugs at the time of informed consent.:

   * Statins.
   * Antihypertensives (diuretics not allowed)
   * alpha-Blockers for benign prostate hypertrophy
   * Occasional use of acetylsalicylic acid, ibuprofen, or paracetamol
6. Additional inclusion/exclusion criteria apply
Comprehensive Ultrasound Evaluation as a Predictor of Weaning

Several studies investigated the role of specific clinical predictors of weaning success, but it is determined by a combination of different aspects that can result in success or failure. Indeed, unresolved lung disease, cardiac dysfunction, loss of respiratory and core muscle strength can play a role in a failure weaning to mechanical ventilation (MV). The investigators hypothesized that a combined score that include heart, lung, and respiratory muscle ultrasound (US) evaluation could be able to predict the ability of weaning success. Furthermore, it will be described weather the days of MV before weaning trial may affect the relevance of each clinical variable evaluated.

Critically ill patients undergone at least 48 hours of MV and ready to spontaneous breathing trial (SBT) will be included in the study. The spontaneous breathing trial is performed in pressure support ventilation with a clinician-set positive end expiratory pressure (PEEP) ≤ 5 cm H2O and FiO2\< 40%. In addition to the parameters traditionally used for the evaluation of weaning (RSBI), the investigators will perform ultrasound evaluation of diaphragm, lung parenchyma, cardiac function, and the strength of the hand grip.

Investigators will evaluate the diaphragmatic parameters (thickening fraction,TF, and diaphragmatic displacement, DD) and TFmax (TF during forced breathing /TF during tidal respiration) to identify the inspiratory reserve. Weaning success is considered as liberation from MV within 72 hours.

Eligibility Criteria:
Inclusion Criteria:

* aged between 18 and 90 years
* Mechanical ventilation\> 48 h
* Reason for ICU admission: medical / surgical / trauma

Exclusion Criteria:

* age under 18
* diagnosis of neuromuscular disease
* tracheostomy
* terminal extubation
* pregnancy in progress -
* previous paralysis of the diaphragm or of a hemidiaphragm
* use of neuromuscular blocking drugs in continuous infusion in the 48 hours preceding the weaning attempt.
* Refusal to participate in the study
The Use of Bio-Oss Collagen for Sinus Augmentation Using the Transcrestal Approach.

To assess vertical bone height gain with Geistlich Bio-Oss Collagen used in conjunction with simultaneous implant installation in transcrestal approach sinus augmentation.

One of the most common situations in the posterior maxilla is reduced alveolar bone height as a result of tooth extraction and the following bone remodeling process, and maxillary sinus pneumatization. Lack of alveolar bone volume may compromise dental implant installation. Maxillary sinus augmentation is considered a very predictable solution for implant installation in limited amount of bone in the posterior maxilla. In general, there are two main maxillary sinus augmentation methods: the lateral approach and the transcrestal. In both methods, the idea is to expend the alveolar ridge in vertical direction on the expense of the maxillary sinus. Sinus augmentation using the transcrestal approach is a well known procedure which is being use for over 40 years. As time goes by, implant dentistry is evolving and improving, there is a constant progress in this field including new bone substitutes materials.

Geistlich Bio-Oss® Collagen - can improve the results obtained by sinus augmentation using the transcrestal approach, by better ease of use for the operator which makes it easier for the operator and the patient.

Study hypothesis: The vertical bone height gained by using Geistlich Bio-Oss Collagen in transcrestal approach sinus augmentation will be comparable to using Bio-Oss Collagen, with greater operator satisfaction and less intra-operative complications.

Eligibility Criteria:
Inclusion Criteria:

* Patients above the age of 18.
* Patients with edentulous ridge maximal height of 8mm≥ beneath the maxillary sinus.
* Patients with edentulous ridge minimal height of 3mm≤ beneath the maxillary sinus.
* Patients who need single implant placement at the posterior maxilla.
* Signed, well filled and dated informed consent form.

Exclusion Criteria:

* Inability to complete or understand the informed consent process.
* Pregnant women.
* Lactating women.
* Patients who use medications that affect bone metabolism such as IV bisphosphonates.
* Heavy smokers.
* Patients with chronic/acute sinus infections