cyrilzakka/clinical-trials huggingface dataset:
Deformation Imaging by Strain in Chronic Heart Failure Over Gliflozins: an Echocardiographic Register on Sodium-GLucose coTransporter-2 Inhibitors

It is an observational, cohort, prospective, multicentre, Italian, non-profit study, with the aim of evaluating the modification of conventional and advanced echocardiographic parameters, focusing on speckle tracking and three-dimensional echocardiography (optional), in patients with HFrEF after treatment with SGLT2i Dapagliflozin and Empagliflozin.

Participation in the study will last for approximately 18 months, and a total of 300 patients will be enrolled at the various Research Centers.

The enrolled patients will undergo a first evaluation in which the anamnestic, clinical and conventional and advanced echocardiographic data will be recorded. At this point, the patient will start SGLT2i.

After starting SGLT2i, a second evaluation will be carried out with a cardiological visit at 6 months, in which the same data listed above will then be recorded.

At the end of the evaluation, the clinical follow-up will be continued for the duration of 1 year, in number and frequency according to clinical indication.


Eligibility Criteria:
Inclusion Criteria:

1. Providing informed consent prior to any specific study procedure
2. Female or male outpatient patients \> 18 years
3. Have heart failure and left ventricular ejection fraction \<= 40%, according to the ESC definition
4. Already on therapy with an angiotensin converting enzyme (ACE) inhibitor or sacubitril / valsartan, a beta-blocker and mineralocorticoid receptor antagonist (MRA) and be initiated for treatment with SGLT2i for therapy optimization

Exclusion Criteria:

1. Involvement in study planning and / or conducting (applies to both investigator staff and study site staff)
2. Age \<18 years
3. For women only - ongoing pregnancy (confirmed with positive pregnancy test)
4. For women only - breastfeeding
5. Poor quality of echocardiographic images which compromises a correct speckle tracking analysis
6. Failure to sign informed consent.
7. Previous treatment with SGLT2i.
Patient Experiences Following Urinary Diversion as Part of Surgery for Advanced and Recurrent Rectal Cancer

The outcomes of patients who undergo radical surgery for locally advanced and recurrent rectal cancer have improved vastly, but there is a lack of emphasis on the quality-of-life outcomes of these patients. This study will assess the patient experience of having a stoma for urinary diversion as part of surgery for advanced pelvic malignancy. This will be assessed at regular intervals both before and after surgery with the goal of increasing awareness of patient beliefs and concerns with regards to their stomas and to devise interventions that will improve their quality-of-life.

Considerable progress has been made in the management of advanced and recurrent pelvic cancer over the last few decades. However, much emphasis has been placed on surgical and hospital-related outcomes. In recent years, there has been an increased focus on patient quality-of-life following major abdominopelvic surgery. However, there is a lack of updated evidence on how patients manage and perceive their stomas. Managing a stoma is a difficult task for patients and can adversely effect their quality-of-life. This study will investigate specifically the impact of managing a urostomy or ileal conduit. Patients will be contacted via an anonymized, opt-in SMS or email to answer a questionnaire, having previously been provided with a patient information leaflet. This will take approximately 5 minutes to complete and will be carried out just prior to and at 1, 3, 6, 9 and 12 months post-operatively. All of this data will be collated and published as part of a wider investigation in to patient quality-of-life following major abdominal and pelvic surgery. This study will be carried out in 35 countries.

Eligibility Criteria:
Inclusion Criteria:

* Histologically-proven advanced rectal cancer
* Has undergone urinary diversion/reconstruction
* Aged 18 years or older
* Able and willing to give written, informed consent
* Able to access email/internet

Exclusion Criteria:

* Strong evidence of metastatic or peritoneal disease
* Palliative exenteration
* Non-rectal origin of primary tumour
* Colonic obstruction
* Inability to answer online questionnaire
Open Label Study of Postmenopausal Women With ER and /or PgR Positive Breast Cancer Treated With Letrozole

To evaluate safety and efficacy (measured by clinical tumor response) of letrozole daily dose, 2.5 mg in postmenopausal patients with primary (untreated) breast cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Postmenopausal woman able to comply with the protocol requirements with primary invasive breast cancer, histologically confirmed by core needle biopsy, whose tumors are estrogen (ER) and / or progesterone (PgR) positive, defined by core biopsy immunohistochemistry with \> 10% positive malignant epithelial cells.
2. Clinical stage \*T2, T3, T4a,b,c, N0, 1 or 2, M0

   * Clinical stage T2 tumors which in the Investigators opinion would not be eligible for breast-conserving surgery.
3. Post menopausal status defined by one of the following:

   * No spontaneous menses for at least 1 year, in women \> 55 years.
   * Spontaneous menses within the past 1 year but amenorrhoeic in women ≤ 55 years (e.g. spontaneous or secondary to hysterectomy), and with postmenopausal gonadotrophin levels (LH y FSH levels \> 40 IU/L) or postmenopausal estradiol levels (\< 5 ng/dl) or according to the definition of "postmenopausal range" for the laboratory involved.
   * Bilateral oophorectomy. (Prior to the diagnosis of breast cancer).
4. Tumor measurable by clinical examination, mammography and ultrasound.

Exclusion Criteria:

1. Prior treatment with letrozole or tamoxifen.
2. Uncontrolled endocrine disorders such as diabetes mellitus, confirmed hypo- or hyperthyroidism, Cushing's Syndrome, Addison's disease (treated or untreated).
3. Patients with unstable, angina, or uncontrolled cardiac disease (e.g. Class III or IV New York Heart association's Functional Classification).
4. Patients with bilateral breast tumors
5. Patients who are eligible for breast conserving surgery
6. Evidence of inflammatory breast cancer or distant metastasis.

Other protocol-defined inclusion/exclusion criteria may apply.
Quit For Life (QFL): Smoking Cessation Among Chinese Smokers Living With HIV

The purpose of this two arm randomized clinical trial (RCT) is to test if a smoking cessation program called Quit for Life (QFL) which was developed by the investigators is effective for patients in China with HIV who smoke. This program is designed to suit the needs of people with HIV who smoke in China.

Eligible participants who provide consent will be randomized into either the QFL or the Control group.

The QFL group will receive a quit smoking program that lasts for 8 weeks with two parts-

1. 4 sessions with a trained counselor who will discuss the participants' smoking habits and strategies to help them quit.
2. Messages sent to the participants' cell phone using WeChat.

The Control group will not have sessions with a trained counselor or receive messages sent to their cell phone.

Both groups will be offered nicotine replacement therapy and a self-help guide with information about quitting smoking.


Eligibility Criteria:
Inclusion Criteria:

* HIV seropositive (by being at the HIV clinic and receiving care)
* Receiving ART treatment from the clinic (by being at the HIV clinic and receiving care)
* Smokes ≥ 5 cigarettes per day
* Able to speak and read in Mandarin Chinese
* Self-reported anticipate to receive ART treatment from the clinic for at least 9 months
* Own a cell phone
* Be willing to set a quit date within 1 month after baseline assessment

Exclusion Criteria:

* Self-reported using other smoking cessation program or medication
* Having a serious health problem that may make them unsuitable to stay in the study
Early Detection of Lung Cancer Via Bi-plane Correlation Chest Imaging

This project proposes a new method, Bi-plane Correlation Imaging (BCI), for improved detection of subtle lung nodules. In BCI, two digital radiographs of the chest are acquired within a short time interval from slightly different posterior projections. The image data are incorporated into an enhanced Computer-aided Diagnosis (CAD) algorithm in which nodules present in the thoracic cavity are detected by examining the geometrical correlation of the detected signals in the two views. The data are alos viewed stereoscopically for visual diagnosis. The expected high sensitivity/specificity of the method has the potential to change the current state of practice, perhaps leading to a preventive lung cancer screening program for high-risk populations, similar to the mammography screening program currently in place for breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Normal individuals
* Individuals with CT-confirmed subtle lung nodules.

Exclusion Criteria:

* Individuals with acute pulmonary abnormalities or those in poor health conditions will be excluded due to the potential impact on the results as well as difficulty of acquiring the images. Pregnant women will also be excluded to avoid the exposure of the fetus to radiation.
Weight Loss and CLOCK 3111T/C Polymorphism

The goal of this observational study is to investigate the relationship of CLOCK 3111T/C (rs1801260) gene variant with nutritional habits, nutritional status, chronotype, sleep quality, some biochemical parameters in overweight or obese individuals and to observe its effect on weight loss diet intervention. The main questions it aims to answer are:

* Is the frequency of carrying the CLOCK 3111T/C (rs1801260) gene risk allele different between individuals with normal body weight and those who are overweight or obese?
* Do those with the CLOCK 3111T/C (rs1801260) risk allele have a higher frequency of evening chronotype and a shorter sleep duration?
* Is the effect of CLOCK 3111T/C (rs1801260) gene alleles different on weight loss diet response in overweight or obese individuals? A questionnaire will be applied to the individuals in both groups (normal body weight and overweight/obese individuals) to evaluate their general characteristics, eating habits, adherence to Mediterranean diet, DASH and MIND. In addition, anthropometric measurements, 3-day food consumption record and 3-day physical activity record will be taken from individuals. CLOCK 3111T/C (rs1801260) gene variant analysis in whole blood, adiponectin and leptin hormones in serum samples will be studied. Participants those who are overweight/obese will be asked to follow a weight loss diet for 3 months.

Researchers will compare participants with normal body weight and those who are overweight or obese to see if there is a difference between the frequency of carrying the CLOCK 3111T/C (rs1801260) gene risk allele.


Eligibility Criteria:
Inclusion Criteria:

* Be in the 20-50 age range
* BMI in the range of 25-40 kg/m2 for the study group
* BMI of 18.5-24.9 kg/m2 for the control group

Exclusion Criteria:

* Those with type 1 diabetes
* Those with Type 2 diabetes who take insulin therapy or use oral diabetes medication
* Those who use drugs for weight loss
* Those with unstable cardiovascular disease
* Those with kidney or liver failure
* Presence of diagnosed malabsorption (celiac disease, Crohn's, ulcerative colitis)
* Those who have undergone bariatric surgery
* Those who are pregnant or breastfeeding
* Menopausal women
* Those who use corticosteroids
* Those with severe endocrine disorders (hypothyroidism, hyperthyroidism, hypopituitarism)
* Those with psychiatric or neurological disease
* Weight change of \>5% in the last 6 months
* Those with malignant tumors
* Those with eating disorders
* Shift workers
* Relatives
* People from different ethnic backgrounds
Evaluation of Visual Function and Driving Health Using Ocusweep in Patients Suffering From Wet Age-related Macular Degeneration

The aim is to study the use of Ocusweep system especially in driving health evaluation and compare the results produced by Ocusweep system to those of conventional devices. The main focus is in patients suffering from wet age-related macular degeneration. The study aims to find out how frequently these patients do not meet the European Union health criteria of safe driving and how Ocusweep finds these patients from a population of patients being treated in a busy medical retina clinic. The tests of Ocusweep system are compared against conventional visual field tests, contrast sensitivity tests, visual acuity tests and tests showing anatomical changes related to wet age-related macular degeneration (optical coherence tomography, fundus photography and fluorescein or indocyanine green angiography).


Eligibility Criteria:
Inclusion Criteria:

* Macular degeneration or other diagnosed or suspected macular disease

Exclusion Criteria:

* Pregnancy
* Mental disorder
* Dementia and Alzheimers disease
* Prisoners
Three-dimensional Virtual Imaging to Improve the Accuracy of Standard CT-based Nephrometric Scores: a Prospective Multicentric Observational Study

STUDY DESIGN:

prospective multicentric observational

SAMPLE SIZE OF THE STUDY:

The estimated number of patients to enroll in the multicenter study is at least 270 patients (statistically calculated referring to the results of a monocentric analysis including 101 patients with the same design, already performed by the Coordinator Center).

NUMBER OF CENTERS INVOLVED:

Considering a total number of patients enrolled of at least 270, number of Centers to be involved: 5.

STUDY PROCEDURES:

3D virtual model rendering

* CT-scan images sent in DICOM format to MEDICS (Turin, Italy) after anonymization.
* Dedicated online platform available to upload the anonymized CT images, after registration.
* CT imaging processing by bioengineers and 3DVM building within 72 hours
* 3D-PDF download from the same online platform

Nephrometric score assessment

* All CT-scans and their 3DVMsevaluation in order to assess surgical complexity, as classified by the PADUA nephrometry score and its relative PADUA risk category.
* For each Center:

  * assessment of the PADUA score on the basis of the CT-scans (2D-NS) by one urologist;
  * assessment of the PADUA score on the basis of the 3DVMs (3D-NS) by another urologist.

Surgical intervention and pathological assessment

* Dedicated expert surgeon for each Center performing NSS to all patients with the same surgical technique.
* Dedicated uro-pathologist for each Center performing the histopathological evaluations of the specimens.


Eligibility Criteria:
Inclusion Criteria:

* four-phase (unenhanced, corticomedullary, nephrographic and urographic phases) contrast enhanced CT-scan

Exclusion Criteria:

* evidence of anatomical abnormalities, like horse-shoe shaped or ectopic kidney.
* preoperative imaging inadequate to perform a 3DVM (such as those with a CT-scan with \>3 mm acquisition interval of the slices, or suboptimal difference of enhancement among the enhanced phases) or older than 3 months.
Clinical and Radiographic Assessment of Nano-Bioactive Glass Combined With I-PRF Scaffold in Vital Pulp Treatments in Mandibular Molars With Closed Apices

Clinical, Radiographic and pain assessment of Vital pulp treatment in patients suffering from irreversible pulpitis in mature permanent molars. Total pulpotomy is investigated using I-prf only vs I-prf mixed with Nano-bioactive glass.


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from Symptomatic irreversible pulpitis in mature mandibular molars only will be involved.
* Tooth should give positive response to cold test
* Haemostasias should be achieved after total pulpotomy
* The tooth is restorable and free from advanced periodontal disease, cracks and splits.
* Patients should be free from any systemic disease that may affect normal healing and predictable outcome.
* Patients who will agree to the consent and will commit to follow-up period.
* Patients with mature root apices
* Patients with no internal or external resorption and no periapical lesions
* Soft tissues around the tooth are normal with no swelling or sinus tract.

Exclusion Criteria:

* Patients with immature roots.
* Haemostasias after 10 minutes can not be controlled after total pulpotomy
* Patients with any systemic disease that may affect normal healing.
* Patients with periapical lesions or infections.
* Pregnant females.
* Patients who could/would not participate in a 6 months follow-up.
* Patients with fistula or swelling
* Patients with necrotic pulp.
* Patients with old age.
Inpatient Enrollment of Patient Portal App

This study aims to determine if inpatient enrollment into a patient communication app improves clinic follow-up of orthopedic trauma patients and improves survey completion rates after orthopedic trauma.

Follow-up in trauma is historically poor. As a result, outcomes from trauma are difficult to collect via surveys and are often significantly influenced by selection bias. Patient interaction apps like Patient Gateway are thought to facilitate greater participant involvement and adherence to treatment regimens. The investigators will explore if inpatient enrollment into Patient Gateway would improve clinic follow-up rates. Increasing follow-up rates could improve the quality of care delivered.

In addition, self-administered survey questionnaires are an important data collection tool in clinical practice, public health research and epidemiology. However, survey completion rates are typically poor in orthopaedic trauma.

With the evaluation of modern technology, electronic applications are being increasingly used in both hospital and personal settings. In outpatient clinics, questionnaires to measure outcomes and monitor quality of care are administered by staff members using hospital owned tablet devices. Recently, applications to complete these surveys on personal devices have been developed.

In a recent Cochrane review on the comparison of self-administered survey questionnaire responses collected using mobile apps versus other methods it was concluded that there are no data available on response rates. The investigators will attempt to address this question.

All Patient Gateway naïve patients aged 18 years or older able to consent for themselves and admitted to the hospital for an orthopedic condition with the need for outpatient follow-up will be invited to participate in this study. Exclusion criteria will be patients unable to consent for themselves, inability to communicate in English, and no possession of a smartphone.

Eligibility Criteria:
Inclusion Criteria:

* admitted to the hospital for an orthopedic condition with the need for outpatient follow-up
* able to consent for themselves

Exclusion Criteria:

* unable to consent for themselves
* inability to communicate in English
* no possession of a smartphone
Safety and Pilot Efficacy of AKB-9778 in Subjects With Diabetic Macular Edema

The purpose of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and pilot efficacy of multiple ascending dose levels of AKB-9778 given as subcutaneous injections daily for 28 days in patients with diabetic macular edema (DME).


Eligibility Criteria:
Inclusion Criteria:

The following is an abbreviated list of inclusion criteria:

* Adults between 18 to 80 years of age, inclusive
* Diagnosis of diabetes mellitus (type 1 or type 2)
* Decrease in vision determined to be primarily the result of DME in the study eye
* Definite Retinal thickening due to diffuse DME involving the center of the macula in the study eye
* Mean central subfield thickness of at least 325 µm by OCT in the study eye
* Early Treatment Diabetic Retinopathy Study (ETDRS) letter score BCVA ≤ 70 (20/40) in the study eye

Exclusion Criteria:

The following is an abbreviated list of exclusion criteria:

* Hemoglobin A1C (HbA1C) ≥ 11.5%
* History of any of the following in the study eye (however, the following are not exclusionary in the fellow eye):

  1. Panretinal scatter photocoagulation (PRP) or focal laser within 12 weeks prior to Screening
  2. Prior pars plana vitrectomy within 12 weeks prior to Screening
  3. Any ocular surgery within 12 weeks prior to Screening
  4. YAG capsulotomy within 7 days prior to Screening
  5. Prior intravitreal, subtenon, or periocular steroid therapy within 3 months prior to Screening or prior treatment with intravitreal anti-VEGF treatment within 1 month of Screening
Comparison Between the Ultrasound Guided Pericapsular Nerve Group Block and Anterior Quadratus Lumborum Block in Elderly Patients Undergoing Total Hip Replacement Surgeries: a Randomized Controlled Clinical Trial

The investigators hypothesis that PENG block will produce effective opioid sparing analgesia with enhanced motor recovery more than AQLB in elderly patients undergoing total hip replacement surgeries

Aim of the work:

The aim of this study is to compare analgesic efficacy and motor recovery of the ultrasound guided anterior quadratus lumborum block and the pericapsular nerve group block

Statistical Analysis:

Data will be coded and entered using the statistical package SPSS version 22. Categorical data will be expressed frequency and proportion and will be compared by Chi2. Numerical data will be summarized using mean and standard deviation. Comparisons between groups for normally distributed data will be done using analysis of variance (ANOVA), while for non-normally distributed numeric variable will be done by Krauskal Wallis test. P value less than or equal to 0.05 will be considered statistically significant. All test will be two tailed

Eligibility Criteria:
Inclusion Criteria:

* Both genders
* Type of surgery; unilateral elective total hip replacement.
* Physical status ASA I- III
* Age ≥ 65 Years.
* Body mass index (BMI): \> 20 kg/m2 and \< 35 kg/m2.
* Traumatic fracture hip through anterolateral approach.

Exclusion Criteria:

* Patient refusal.
* Patients with known sensitivity or contraindication to drugs used in the study (local anesthetics \& opioids).
* History of psychological disorders and/or chronic pain.
* Pre- existing peripheral neuropathies
* Coagulopathy.
* Infection of the skin at the site of needle puncture area.
* Active cardiac condition (unstable coronary syndromes, significant arrhythmias, severe valvular disease).
* Acute respiratory disease (active chest infection, respiratory failure).
* Advanced liver disease (increased liver enzymes \>3 folds) or severe kidney disease (creatinine \>2).
* long operative time more than 3 hours.
Injectable Lidocaine Versus Lidocaine/Tetracaine Patch for the Incision and Drainage of Skin Abscesses

Local anesthesia used for incision and drainage of abscesses is known to be painful.

We studied the analgesia provided by a lidocaine/tetracaine patch compared to injectable lidocaine during incision and drainage (I\&D) of skin abscesses.

Local injection of lidocaine provided similar analgesia compared to the lidocaine/tetracaine patch during I\&D of skin abscesses in the Emergency Department. Pain at presentation and following the procedure was similar in both groups.


Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years
* Skin abscess in need of incision and drainage (judged by treating physician)

Exclusion Criteria:

* Allergy to lidocaine or tetracaine
* Non-intact skin
* Unable/unwilling to provide informed consent