cyrilzakka/clinical-trials huggingface dataset:
Multimodal Analgesia in Children and Adolescents After the Ravitch Procedure and Thoracotomy

The study was performed in patients aged 6-18 years after the Ravitch procedure and thoracotomy. The primary aim of the study was to evaluate the efficacy and safety of pain control provided by the multimodal approach that involves the continuous infusion ropivacaine with fentanyl vs. bupivacaine with fentanyl through thoracic epidural catheter. Secondary aims were to identify the determinants of acute post-operative pain at rest, during deep breathing and coughing.

The subjects were randomized to the Ropivacaine/Fentanyl (RF) or Bupivacaine/Fentanyl (BF) group.

To perform a thoracic surgical procedure, all patients were premedicated with midazolam, and then, paracetamol, non-steroidal anti-inflammatory drugs, fentanyl, propofol, pancuronium or rocuronium (in children \< 10 years old) and suprane were used to introduce and maintain the anesthesia. Thoracic epidural catheters were placed following induction of anesthesia and endotracheal intubation.

Intraoperative analgesia was introduced by a single dose of lidocaine 2% (2 mg/kg). Then after 15 minutes, the patients from the RF group received ropivacaine 1% (1-3 mg/kg) and those from the BF group bupivacaine 0.5% (0.5-1 mg/kg). After 60 minutes 0.2% ropivacaine solution with fentanyl or 0.125% solution of bupivacaine with fentanyl was infused with the flow rate of 0.1 ml/kg/hr.

Depending on the allocation to the group, postoperative analgesia was continued either with 0.2% ropivacaine and fentanyl or 0.125% bupivacaine and fentanyl, based on the concentration and the flow rate described above. In addition, intravenous paracetamol was administered as standard every 6 hours (the maximum of 60 mg/kg daily) along with non steroidal anti-inflammatory drugs. In children \> 14 years of age, ketoprofen was injected at the dose of 1 mg/kg (the maximum of 200 mg daily) and in younger children ibuprofen (orally or rectally, up to 30 mg/kg daily) every 8 hours. Metamizol was given as a "rescue drug" (20 mg/kg).

Eligibility Criteria:
Inclusion Criteria:

* Elective thoracic surgery (thoracotomy or Ravitch procedure);
* Analgesia: continuous thoracic epidural analgesia.

Exclusion Criteria:

* American Society of Anesthesiologists physical status \>III;
* History of chronic pain or preoperative opioid use;
* Oncological treatment;
* Impaired verbal communication;
* Removal of epidural catheter \<24 h postoperatively;
* Lack of postoperative chest drainage.
Study for the Identification of a Score to Assess Intrapancreatic Fat Through Eco-Elastography and Its Correlation with Metabolic Syndrome and Insulin-Secreting Cells.

\*\*Brief Summary of the SPES Clinical Study\*\*

The SPES clinical study aims to evaluate the relationship between pancreatic fat accumulation (pancreatic steatosis) and metabolic health. Pancreatic steatosis has been linked to conditions like type 2 diabetes (T2D) and metabolic syndrome, but the underlying mechanisms and its impact on beta-cell function remain poorly understood.

The primary goal of this study is to develop a quantitative ultrasound elastography score to measure the degree of pancreatic steatosis and explore how this relates to pancreatic beta-cell function and key factors associated with the development of type 2 diabetes and metabolic syndrome.

A secondary goal is to categorize participants into four risk classes for type 2 diabetes based on their metabolic profiles and correlate these classes with the degree of pancreatic steatosis. This may provide insights into individual risk stratification for T2D and related complications.

The study will enroll 100 participants, aged 18 to 80, attending the Endoscopic Ultrasound Unit at the Fondazione Policlinico Universitario Agostino Gemelli in Rome. Participants will undergo endoscopic ultrasound for various clinical reasons, excluding those with pancreatic tumors, cystic fibrosis, or insulin-treated diabetes. Key inclusion criteria include controlled blood glucose levels (HbA1c \< 10% or fasting glucose \< 250 mg/dL) and the ability to understand and provide informed consent.

The study is interventional but does not involve drugs or medical devices. Participants will attend a visit where medical history, physical measurements (e.g., BMI, waist circumference, blood pressure), glucose tolerance tests, and blood work will be collected. This comprehensive approach aims to better understand the metabolic implications of pancreatic steatosis and its role in type 2 diabetes development.

The study will last 24 months, including the enrollment period. Findings may contribute to improved risk stratification, prevention, and management strategies for type 2 diabetes and related conditions.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 80 years
* HbA1c \<10% or fasting glucose \<250 mg/dL
* Ability to understand and provide informed consent regarding the procedures, data collection, and analysis.

Exclusion Criteria:

* Age \<18 years or \>80 years
* History of diabetes treated with insulin
* HbA1c \>10% or fasting glucose \>250 mg/dL
* Pancreatic diseases (solid tumors/secretory NETs/cystic fibrosis; non-secretory NETs and IPMN may be included)
* Previous pancreatic surgery
* Moderate anemia (Hb \<10 mg/dL)
* Severe liver failure (Child-Pugh C)
* Non-metabolic causes of NAPLD (e.g., corticosteroid therapy, antiretrovirals, gemcitabine, octreotide, history of hemochromatosis, malnutrition, HBV/HIV infections)
* Alcohol abuse (\>30 g/day of ethanol)
* Pregnancy and breastfeeding
* Inability to adequately understand informed consent and study procedures
Calcific Tendonitis Treatment: Barbotage vs. Barbotage With Cortisone Injection

The purpose of this study is to determine the efficacy of barbotage therapy by comparing the clinical and sonographic changes in patients that solely receive barbotage to patients receiving the standard of care, barbotage with cortisone injection.

Calcific tendonitis is a condition caused by calcium deposits building up in a person's muscles or tendons. If calcium builds up in an area, a person may feel pain and discomfort there. The purpose of this study is to determine the efficacy of barbotage therapy (injecting and washing the shoulder joint with saline) by comparing the amount of pain, shoulder function, and X-Rays in patients with calcific tendonitis that receive the standard of care, barbotage with cortisone injection, against barbotage with saline injection. Receiving barbotage without cortisone is therefore considered experimental.

Eligibility Criteria:
Inclusion Criteria:

* Must be at least 18 years of age and younger than 90 years of age
* Diagnosed with calcific tendonitis and ruled out other shoulder-related pathologies
* Failed 1st line therapy (physical therapy and cortisone injection)

  * Intention to receive barbotage with cortisone as standard of care
  * 3 or more months of shoulder pain
  * Finding of one or more calcifications ≥5 mm in size on either sonogram or radiograph, located on the supraspinatus tendon
  * Positive Hawkin's test or Neer's sign for impingement

Exclusion Criteria:

* Legally incompetent or mentally impaired (e.g. minors, Alzheimer's subjects, dementia, etc.)
* Osteoarthritis of the glenohumeral joint of the affected shoulder
* Previous surgery or barbotage to the affected shoulder
* History of prior allergic/hypersensitivity reactions related to the study medication
* Shoulder instability, glenohumeral arthritis, AC pathology, inflammatory arthropathy, fibromyalgia, frozen shoulder or cervical radiculopathy
* Sub-acromial injection with a corticosteroid or treatment by ESWT during the last 3 months before inclusion
* Younger than 18 years of age or older than 90
* Any patient considered a vulnerable subject
A Phase 2 Study of IW-3300 for the Treatment of Bladder Pain in Subjects With Interstitial Cystitis/Bladder Pain Syndrome

The aim of this study is to assess whether IW-3300 is safe and works for the treatment of interstitial cystitis/bladder pain syndrome (IC/BPS). The main question the study aims to answer is whether IW-3300 helps bladder pain and other symptoms (for example, bladder burning, pressure and discomfort). Subjects will be assigned to receive either the study drug or placebo by chance.

This is a Phase 2, randomized, placebo-controlled, parallel-assignment, 12-week, adaptive design study to evaluate the efficacy, safety, and tolerability of IW-3300 in subjects with IC/BPS. Subjects will be randomized 1:1:1 to IW-3300 100 µg, IW-3300 300 µg, or matching placebo administered as a rectal foam. The study has 4 periods, which are the screening (up to 30 days), pretreatment (up to 21 days), study treatment (12 weeks), and follow-up periods (2 weeks) which consists of 7 onsite study visits and 1 follow-up phone call. Subjects will administer the study drug at home for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with IC/BPS by a urologist or other clinician specializing in IC/BPS
* Chronic bladder pain associated with filling the bladder over the past 6 months
* Compliant with eDiary completion and meets weekly average daily score for bladder pain at its worst during the pretreatment period
* Has at least 1 of the following urinary symptoms over the past 6 months: nocturia ≥2 voids/night, daytime frequency \>8×day, urgency
* Body mass index (BMI) ≤40 kg/m2
* Willing to use a rectally administered product once daily for 12 weeks

Exclusion Criteria:

* Male subject has history of bacterial prostatitis or benign prostatic hyperplasia with active symptoms that are difficult to distinguish from IC/BPS
* Has a condition that can be a contraindication to using a rectal foam
* Has cancer under active treatment or a history of uterine, cervical, pelvic, colorectal, ovarian, or vaginal cancer
* Has a history of benign or malignant bladder tumors
* Has an active urinary tract infection or had ≥2 UTIs within the past 90 days
* Has an uncontrolled major psychiatric condition or has made a suicide attempt during the past 2 years
* Has a malabsorption syndrome
* Had surgery in the pelvic or abdominal region within the past 90 days or is planning pelvic or abdominal region surgical procedures before the end of the study
* Has received a cystoscopy with or without hydrodistension for diagnostic purposes (ie, not for pain relief) within the past 30 days or a cystoscopy with therapeutic hydrodistension (ie, for pain relief) within the past 90 days or is planning a cystoscopy for any reason before the end of the study
* Has history of pelvic irradiation or radiation cystitis, or drug-induced cystitis.
* Has a recent history of drug or alcohol abuse
Identification of Genetic Determinants for Treatment Resistance/Sensitivity and/or Toxicity in Adjuvant Setting for HER2 Positive Breast Cancer

This is a multicenter, non-randomized, prospective cohort study. The purpose of the study is to identify constitutional genetic factors associated with histological response, resistance or sensibility to treatment in human epidermal growth factor receptor 2 (HER2)-positive breast cancer. 9000 patients will be enrolled in this study. Blood samples will be collected after informed consent and inclusion in the study. Patients will be treated and followed according to the standards of their treating center. They will be followed every six months for five years.

The purpose of the SIGHER trial is to create a cohort of 9000 patients with HER2-positive breast cancer including detailed epidemiologic and treatment data. The distribution of constitutional genetic variants will be evaluated within groups of patients treated with different regimes of targeted therapies, identifying variants associated with histological response, as well as sensitivity or resistance to these therapies.

Blood samples will be collected in two 6ml ethylenediaminetetraacetic acid (EDTA) tubes after informed consent and inclusion in the study.

As the samples are received at the biological resource center, total blood will be aliquoted into a 500 µl tube and frozen at -80° C. DNA will be extracted using standard protocols. DNA will be stored in anticipation of genetic analyses. An aliquot of the DNA sample will be genotyped for a panel of high-density genetic markers covering the whole genome for genome-wide association studies.

Eligibility Criteria:
For inclusion in the study, patients must be affiliated to the national or local social security, and must meet all the following criteria:

Inclusion Criteria:

* Age ≥ 18 years
* Histological diagnosis of breast adenocarcinoma. Non-metastatic and operable.
* Current or prior treatment with one therapy targeting HER2 in adjuvant or neoadjuvant phase for the current breast cancer
* Given written informed consent

Exclusion Criteria:

* Patients not able to comply to the protocol assessments for geographic, social or psychological reasons
* Patients placed under judicial protection, guardianship, or supervision
* History of cancer in the 5 years preceding anti-HER2 therapy initiation
* Concomitant cancer (except for an other non metastatic cancer treated only with surgery)

Note : Patients are eligible at any time of the follow-up if the adjuvant or neoadjuvant chemotherapy started after 01/01/2019. Patients treated with trastuzumab, pertuzumab, neratinib or T-DM1 in a clinical trial are eligible in the SIGHER study.
Assessment of Walking-related Fatigability in Patients With Multiple Sclerosis.

The primary goal of this interventional study is to objectively examine the prevalence of walking-related performance fatigability, together with the psychometric properties of its measuring parameters. The secondary aim is to investigate the relation of other clinical symptoms to walking-related performance fatigability.

The following three research questions will be addressed:

1. How prevalent is walking-related performance fatigability and what are the psychometric properties of fatigability formulas in preparation of use as experimental outcome measure?
2. What are associated symptoms of walking-related motor fatigability and how long does this manifest?
3. What is the relationship between cognitive fatigability and walking-related performance fatigability?

participants perform two six-minute walking test (6MWT), with 3-5 days in between. Before and after the 6MWT, three screenings test (spasticity, muscle strength, balance) are executed and the participants have to indicate the severity of eleven possible symptoms (= symptom inventory, SI) on a VAS scale. These screening tests and SI are continued every 10 minutes for half an hour. During a third test session, participants perform a 6-minute vigilance alphabet test in rest and while doing a 6MWT to investigate the relationship between cognitive and motor fatigability.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 - 70 years
* Confirmed diagnosis according to the McDonald criteria
* Performed a 6MWT before, to ensure familiarization
* Able to walk independently or with unilateral support for 6 minutes without rest
* Signed the informed consent

Exclusion Criteria:

* Exacerbation or relapse within last 3 months before study
* Other neurological diagnosis, such as stroke and Parkinson
* MS-like syndromes, such as neuromyelitis optica
* Other medical condition interfering with walking ability (e.g. cardiac or respiratory diseases, arthritis and fibromyalgia)
Dosing and Tolerability of Deoxycholic Acid Vs. Polidocanol in the Treatment of Neurofibromatosis Type 1 Cutaneous Neurofibromas

This study will evaluate the tolerability and effectiveness of two treatments in Neurofibromatosis Type 1 Cutaneous Neurofibromas. These treatments are: Kybella and Asclera injection. Each patient will have a treatment and a control site.


Eligibility Criteria:
Inclusion Criteria:

1. Adult males and females ≥18 years of age
2. Have a diagnosis of NF1 based on germline genetic testing or by meeting ≥ 2 the following criteria:

   1. Family history of NF1
   2. Six or more light brown ("cafe-au-lait") spots on the skin
   3. Presence of two or more neurofibromas of any type, or one or more plexiform neurofibromas
   4. Freckling under the arms or in the groin area
   5. Two or more pigmented, benign bumps on the eye's iris (Lisch nodules)
   6. A distinctive bony lesion: dysplasia (abnormal growth) of the sphenoid bone behind the eye, or dysplasia of long bones, often in the lower leg
   7. Tumor on the optic nerve that may interfere with vision
3. Patients must be seeking treatment for cNF
4. Patients must have ≥ 6 paired cNF per modality (3 treated and 3 untreated). cNF should be visible and measure between 2-8mm in size. These must be in areas amenable to treatment and surveillance with digital photography.
5. cNF must be located on the trunk, arms or legs of the patient
6. Able and willing to comply with all visit, treatment and evaluation schedules and requirements
7. Able to understand and provide written informed consent

Exclusion Criteria:

1. Patients who are undergoing other treatment modalities or investigational agents for their cNF lesions
2. Individuals who cannot give informed consent or adhere to study schedule
3. Actively tanning during the course of the study
4. Adverse reactions to compounds of any external agent (e.g., gels, lotions or anesthetic creams) required for use in the study, if no alternative to the said agent exists;
5. Known allergy to injectable anesthetics, polidocanol or deoxycholic acid
6. Those with acute thromboembolic diseases
7. Those with bleeding abnormalities or those who are currently being treated with antiplatelet or anticoagulant therapy
8. Those with dysphagia
9. Women who are pregnant
10. Any condition which, in the Investigator's opinion, would make it unsafe (for the participant or study personnel) to treat the participant as part of this research study
Implantable Loop Recorders in Post-atrial Fibrillation (AF) Ablation: RPAF-A

This is a randomized pilot study, of post pulmonary vein isolation (PVI) patients to determine the clinical utility of the Implantable Loop Recorder. These type of patients either are monitored with weekly transtelephonic monitoring (TTM) or implantable loop recorder (ILR). The Medtronic Reveal XT loop recorder will be implanted at the time of the PVI or at the 3-4 month PVI follow-up visit and patient care will be managed based on randomization to a blinded or unblinded group. Outcome measures will be compared to aid in decision making regarding anticoagulation and overall post ablation clinical management.

This is a randomized pilot study, of post pulmonary vein isolation (PVI) patients to determine the clinical utility of the Implantable Loop Recorder. The Medtronic Reveal XT implantable Loop Recorder is a market released device indicated for patients with clinical syndromes or situations at increased risk of cardiac arrhythmias, and patients who experience transient symptoms that may suggest a cardiac arrhythmia. These type of patients either are monitored with weekly transtelephonic monitoring (TTM) or implantable loop recorder (ILR). Neither approach has been shown to be superior. As both approaches are currently being performed based on physician preference, the investigators propose to study and compare both approaches in a randomized fashion for evidence based practice. The Medtronic Reveal XT loop recorder will be implanted at the time of the PVI or at the 3-4 month PVI follow-up visit and patient care will be managed based on randomization to a blinded or unblinded group. Outcome measures will be compared to aid in decision making regarding anticoagulation and overall post ablation clinical management.

Eligibility Criteria:
Inclusion Criteria:

* atrial fibrillation
* Chads score \> or equal to 1

Exclusion Criteria:

* contraindication for ILR
* life expectancy less an 12 months
* pregnant women
* existing cardiac rhythm management (CRM) device
Stem Cell Therapy for Patients With Vascular Occlusive Diseases Such as Diabetic Foot

Mesenchymal stem cells with multidirectional differentiation potential,autologous stem cell transplantation into ischemic foot, make its differentiation to form new blood capillary, improve and restore the local blood flow.


Eligibility Criteria:
Inclusion Criteria:

* the age of 30-78 years old, men and women there is no limit.
* in accordance with the ministry of health in higher medical colleges and universities teaching material the sixth edition of the annals of diabetic foot diagnostic criteria.
* with severe lower limb ischemia (defined as the resting state of ankle brachial index (ABI) 0.4-0.85, accompanied by resting or intermittent toe line.
* treatment on a voluntary basis, and sign the informed consent.

Exclusion Criteria:

* with severe heart, liver, kidney, lung function failure or general condition is very poor can't tolerate the stem cell transplant.
* clear over the past five years tumor markers in patients with malignant disease and blood levels increased significantly.
* the prodrome of acute infectious diseases.
* participated in clinical subjects within three months before test.
* adherence is poor, can not complete the course.
Mucociliary Clearance Techniques for Acute Bronchiolitis

To assess the efficacy of mucociliary clearance techniques in non-hospitalised infants with a first episode of mild to moderate acute bronchiolitis.


Eligibility Criteria:
Inclusion Criteria:

* Medical diagnosis of first episode of acute Bronchiolitis.
* Acute Bronchiolitis with mild (ESBA score = 1-4) or moderate (ESBA score =5-9) severity according to the ESBA.
* Informed consent signed by parents or legal guardians.

Exclusion Criteria:

* Infants previously diagnosed with chronic respiratory disease.
* Previous episodes of wheezing.
* Presence of any type of contraindication to receive Respiratory Physiotherapy treatment.
Stroke Prevention in Atrial Fibrillation Patients Between 2004 and 2020

Prevention of thromboembolic complications is an important part in the management of patients with atrial fibrillation (AF). European and American guidelines recommend the use of non-vitamin K antagonist oral anticoagulants (NOACs) over therapy with vitamin K antagonists (VKA) in most AF patients. The number of patients treated with NOACs has increased significantly during the last few years. In the primary randomized controlled trials leading to their approval, compared to warfarin, NOACs were shown to be either noninferior or superior for stroke prevention in AF, with similar or reduced rates of bleeding, especially intracranial haemorrhage.

The aim of this study was to assess the frequency of oral anticoagulants using, espescially apixaban, dabigatran, and rivaroxaban, and the predictors of their prescription in a group of hospitalised patients with AF.


Eligibility Criteria:
Inclusion Criteria:

- non-valvular atrial fibrillation

Exclusion Criteria:

* valvular atrial fibrillation
* death during hospitalization