cyrilzakka/clinical-trials huggingface dataset:
MRI-Guided Biopsy of Recurrent Prostate Cancer After Radiotherapy

In this study we will test a new procedure to guide needle biopsies into the prostate gland based on MRI. This study will be conducted in patients who may have recurrence of their cancer in the prostate gland after radiation therapy in order to map out the location of the recurrence. Using this technique, we will be able to measure the accuracy of MR images in identifying the site of tumour recurrence.

This study involves the technical development and clinical testing of a novel technique for magnetic resonance imaging (MRI) guided prostate biopsy in a 1.5T horizontal bore scanner using a dedicated interventional table. We primarily hypothesize that the integration of diagnostic and interventional MRI enables needle biopsy targeting to foci of tumor recurrence after radiotherapy, and will enable a determination of the diagnostic accuracy of MRI in mapping sub-sites of tumor recurrence after radiotherapy. RELEVANCE TO PUBLIC HEALTH: Patients with recurrence of their prostate cancer after radiotherapy currently face difficult choices. Standard second line treatments target the entire prostate gland and are associated many side effects. This study will directly improve the detection, spatial delineation, and characterization of prostate cancer persistence after radiotherapy. If anatomic patterns of disease persistence are found across patients, radiation delivery techniques will be suitably modified, which may translate to improved cure rates. Importantly, this study will establish a procedural platform for MRI-guidance of minimally invasive local salvage therapies. By precisely focusing salvage therapy to sites of tumor persistence within the prostate gland, side effects may be reduced in the future.

Eligibility Criteria:
Inclusion Criteria:

* Biochemical failure \> 18 months after definitive external beam radiotherapy (ASTRO definition - revised version 2006: rise by 2 ng/mL or more above the nadir PSA)
* PSA \<20 prior to initial course of external beam radiotherapy
* PSADT \>3 months at failure
* Age ≥ 18 years
* ECOG performance status 0 or 1 with \>10 year life expectancy
* Fit for local anaesthesia
* Informed consent:

Exclusion Criteria:

* Contraindications to MRI
* Severe claustrophobia
* Bleeding diathesis and anti-coagulative therapy that cannot be temporarily ceased precluding brachytherapy
* Previous brachytherapy
* Active hormonal therapy
* Radiologic evidence of LN or distant metastases
* Other urinary or medical conditions deemed by the PI or associates to make the patient ineligible for MRI-guided prostate biopsy.
* Contraindications to endorectal coil, surgically absent rectum, severe hemorrhoids or previous colorectal surgery
* Contraindications to conscious sedation
* Contraindication to IV Gadolinium administration
* latex allergy
Electromyographic (EMG) Biofeedback Training in Zone I-III Flexor Tendon Injuries

Aim: The aim of the study was to investigate the effect of electromyographic (EMG) biofeedback training applied in addition to early passive motion protocol on electrical muscle activity (EMA) and functional status in zone I-III flexor tendon injuries.

Materials and Methods: Cases who underwent surgery for flexor tendon injuries in zone I-III were included in this prospective randomized controlled trial. Cases were randomly divided into two groups of 11 cases each by block randomization. In the first group, EMG biofeedback training was applied in addition to the early passive motion method (modified Duran protocol), while the second group was followed only by early passive motion method. The treatment program was performed by the same physiotherapist three times a week, for 12 weeks. At the postoperative 5th, 12th and 24th weeks, joint range of motion (ROM) and EMA were evaluated, and the Michigan Hand Outcome Questionnaire (MHQ) was administered to the patients. The grip strength at 12th and 24th weeks were also assessed. The Mann-Whitney U Test was used to compare the two groups.


Eligibility Criteria:
Inclusion Criteria:

* Being olunteer,
* No history of neurological, orthopedic, rheumatologic disease or trauma in the related extremity,
* No history of neuropathy due to a metabolic disease (diabetes, etc.),
* Incision of at least one of the FDS or FDP tendons,
* At least one of the FDS or FDP tendons repaired within 2 weeks after the injury,
* No communication problems.

Exclusion Criteria:

* \<18 years of age,
* Pregnancy,
* Thumb flexor tendon cuts,
* Digital nerve injury,
* Accompanying fracture, joint capsule injury or skin loss,
* Crush injury,
* Patients with pacemakers,
* Patients with cardiac arrhythmias,
* Epilepsy.
The Analysis of Factors Influencing the Vd of Imipenem in Septic Shock Patients

The study measures the plasma concentrations of imipenem in septic shock patients and non-septic shock patients and observes hypoalbuminemia and the impact of the severity of critical illness on Vd

Severe sepsis and septic shock are major causes of mortality in intensive care unit(ICU) patients.Correct and adequate antibiotic coverage is essential but can be complex as a result of fluid resuscitation, hypoalbuminemia, organ dysfunction, the application of extracorporeal support modalities and the impact of critical illness on pharmacokinetics(PK).Such changes will significantly distort the normal anti-biotic PK profile, resulting in drug exposure that is markedly different from the 'healthy volunteer.'The apparent volume of distribution is one of important PK parameters.Vd determines the loading dose. This review article considers these issues in detail, summarizing the key changes in antibiotic Vd in the critically ill, and providing general suggestions how to optimization of antibiotic dosing to manage Vd challenges.50 patients who receives the theapy of imipenem are included in this study.Whether hypoalbuminemia, organ dysfunction, the application of extracorporeal support modalities and the impact of critical illness on Vd will be evaluted.

Eligibility Criteria:
Inclusion Criteria:

1. age between 18 years old and 80 years old;
2. Admitted to the ICU;
3. Patients diagnosed as septic shock requiring the therapy of imipenem(0.5g q6h or 1.0g q8h;

Exclusion Criteria:

1. Patient participated in another interventional trial before enrollment
2. Allergy, hypersensitivity or a serious reaction to imipenem;
3. Pregnancy.
4. patients with ECMO and(or)CRRT.
5. tumors.
Prevention of Pressure Ulcer on the Sacrum

The aim of the present study was to assess whether the application of a multilayered dressing made of hydrocellular polyurethane foam conformed to the sacral area (MSP) in addition to standard preventive care reduces the rate of pressure ulcer (PU) and their severity in population at risk admitted in acute care Hospital.


Eligibility Criteria:
Inclusion Criteria:

* Patients at risk to develop Pressure Ulcer (Braden scale \<17)
* without sacrum Pressure Ulcer
* Patients or legal guardians who give their consent to take part in the study

Exclusion Criteria:

* Patients with known allergy to the product being tested or dermatological diseases that prevent the use of topical products
Multicenter, National, Observational, Prospective, Real-life Study Evaluating the Performance of 2% Aqueous Eosin in Children With Diaper Rash

This study is being conducted to provide updated clinical data on safety and performance (demonstrated previously for CE marking under the Medical Devices Directive) Cooper Aqueous Eosin 2%. This is an observational study conducted under real-life conditions and as part of post-marketing surveillance activity for a device that has been on the market for a long time and a well-established technology, in accordance with the Medical Devices Regulations 2017 /745 (MDR) and MDCG 2020-6 guidelines.

The study will be a multicenter, national, observational, prospective study, with a 7-day follow-up (+/- 2 day). 60 patients are scheduled.


Eligibility Criteria:
Inclusion Criteria:

* Children under 24 months
* With diaper rash for which a prescription for 2% aqueous eosin in a 50 ml vial is made
* SSDDS score \>= 3/6
* Not requiring hospitalization
* Written consent of one of the parents
* Affiliated with social security
* Acceptance of one of the parents to participate in a visit on day 7 in the office or, in case of impossibility, with video/internet consultation or with consultation by phone and sending a photo in this case by the parent(s).

Exclusion Criteria:

* Antibiotic therapy in progress or prescribed on day 0, or other local therapeutic topicals prescribed on day 0
* Children with wounds or likely to be allergic to 2% aqueous eosin or to one of the components of 2% aqueous eosin.
* Ongoing diarrhoea (change in the consistency of stools (loose or watery) and / or an increase in the number (≥ 3 stools / day).
A Study to Reduce Persistent Post-mastectomy Pain Using Opioid-free Anesthesia

In 230 patients undergoing mastectomy, the investigators will compare opioid-free anesthesia (OFA) versus conventional opioid-based anesthesia in terms of chronic pain. The enrolled patients will be randomly assigned into two groups with 1:1 ratio. Chronic pain will be evaluated at 1 year after mastectomy based on the Breast Cancer Pain Questionnaire (BCPQ). Baseline pain sensitivity test and psychologic evaluation will be done before operation.

Study population

1. All of patients will undergo mastectomy with or without immediate breast reconstruction.
2. 230 patients will be enrolled.

Intervention

1. OFA group will be sedated using dexmedetomidine and lidocaine.
2. Conventional opioid anesthesia group will be sedated using remifentanil.

Pain screening

1. Breast Cancer Pain Questionnaire (BCPQ)
2. Pain-detect, HADS, EQ-5D, PHQ-15 (somatic symptom), PCS (pain catastrophizing), BFI (big five inventory), HAM-A\&D, Pressure algometry (Pain sensitivity), Quantitative sensory test (pinprick)

Eligibility Criteria:
Inclusion Criteria:

* All of patients will undergo mastectomy with or without immediate breast reconstruction.

Exclusion Criteria:

* Previous history of breast surgery
* Allergy to drug
* Other cancer history
* Underlying psychologic disorder
* Patients with chronic pain requiring pain killers
* Baseline SpO2 \<95%
* Left ventricular EF \<40%
* Bradycardia as HR \<50 bpm
* BMI \>35kg/m2
* Pregnant woman
The COMBO CAD Study

Implementation of clinical strategies based on optical diagnosis of \<5 mm colorectal polyps may lead to a substantial saving of economic and financial resources. Despite this, 84.2% of European endoscopists reported not to use such strategies - also named as leave-in situ and resect- and-discard - in their practice due to the fear of an incorrect optical diagnosis.

Indeed, accuracy of optical diagnosis is operator-dependent, and values reported in the community setting are below the safety thresholds proposed for its incorporation in clinical practice.

Artificial intelligence (AI) is being increasingly explored in different domains of medicine, particularly those entailing image analysis. As optical diagnosis involves subitaneous processing of multiple images, searching for specific visual clues, and recognizing well-defined visual patterns, AI systems has the potential to help endoscopists in distinguish neoplastic from non-neoplastic polyps, making the characterization process more reliable and objective. Computer-Aided-Diagnosis systems aiming at characterization are called CADx.

Preliminary data on CADx showed a high feasibility and accuracy of AI for optical diagnosis of colorectal polyp, and initial experiences in clinical practice confirmed preliminary results.

To assess the potential benefit and risk of AI-assisted optical diagnosis with standard colonoscopy, we exploited two new Computer-Aided-Diagnosis systems (CAD-EYE® Fujifilm Co., and GI-Genius® Medtronic) that provide the endoscopist with a real-time polyp characterization without the need of optical magnification.


Eligibility Criteria:
Inclusion Criteria:

- All patients aged 40 or older undergoing a colonoscopy for gastrointestinal symptoms, fecal immunohistochemical test positivity, primary screening or post-polypectomy surveillance

Exclusion Criteria:

* subjects with personal history of CRC, or IBD.
* Subjects affected with Lynch syndrome or Familiar Adenomatous Polyposis.
* patients with inadequate bowel preparation (defined as Boston Bowel Preparation Scale \< 2 in any colonic segment).
* patients with previous colonic resection.
* patients on antithrombotic therapy, precluding polyp resection.
* patients who were not able or refused to give informed written consent.
Patient Satisfaction Study of Single-Use Autoinjector for the Delivery of Pre-Filled Avonex Syringe

Determine patient satisfaction with the single-use autoinjector for the delivery of pre-filled Avonex syringe.


Eligibility Criteria:
Inclusion Criteria:

* Must be using liquid AVONEX® to treat MS. In addition, the subject must be on liquid AVONEX® for 12 weeks prior to the Screening Visit.
* Must have a BMI of 19 to 28 kg/m², inclusive, and a minimum body weight of 50 kg at Screening.
* Must be able to physically demonstrate use of the device and be able to self-administer all injections.
* Must be English speaking.
* Must be able to understand and comply with the protocol.

Exclusion Criteria:

* Abnormal screening or screening blood tests determined to be clinically significant by the investigator for: white blood count (WBC) or differential, platelet count, hemoglobin, serum creatinine, bilirubin, alanine transaminase (ALT) aspartate transaminase (AST), prothrombin time (PT).
* Known sensitivity to dry natural rubber.
* Treatment with other agents to treat MS symptoms or underlying disease as specified in the protocol.
* History of severe allergic or anaphylactic reactions.
* History of intolerance to acetaminophen (paracetamol), ibuprofen, naproxen, and aspirin that would preclude the use of at least one of these during the study.
* Serious local infection

Other inclusion and exclusion criteria apply as per Biogen Idec Protocol
Eight-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms Associated With Menopause

This is an exploratory 8-week, multicenter, double-blind, randomized, placebo-controlled study of Brisdelle (paroxetine mesylate) Capsules 7.5 mgin subjects with moderate to severe postmenopausal vasomotor symptoms (VMS), defined as follows:

* Moderate VMS: Sensation of heat with sweating, able to continue activity
* Severe VMS: Sensation of heat with sweating, causing cessation of activity

Eligible subjects will be entered into a 1-week observation period followed by a 1-week run-in period. Following completion of the run-in period, eligible subjects will be randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo in a 1:1 ratio. Study drug will be administered once daily at bedtime. Symptom assessment questionnaires will be administered at baseline and at Day 28 and Day 57 visits.

Eligibility Criteria:
Inclusion Criteria:

1. Female, \>40 years of age
2. Reported more than 7-8 moderate to severe hot flashes per day (average) or 50-60 moderate to severe hot flashes per week for at least 30 days prior
3. Spontaneous amenorrhea for at least 12 consecutive months
4. Amenorrhea for at least 6 months and meet the biochemical criteria for menopause
5. Bilateral salpingo-oophorectomy \>6 weeks with or without hysterectomy

Exclusion Criteria:

1. History of hypersensitivity or adverse reaction to paroxetine mesylate
2. Use of an investigational study medication within 30 days prior to screening or during the study
3. Concurrent participation in another clinical trial or previous participation in this trial
4. Family of investigational-site staff
How is Physical Activity Level and Educational Expectations of Patient With Knee Osteoarthritis : Epidemiological Study in Spa Therapy

The primary purpose is to evaluate the level of physical activity in patients with knee osteoarthritis in a spa treatment and doing epidemiological study about this patient.

Explain the physical activity level of knee osteoarthritis by socio-demographic, clinical variables, barriers and facilitators of regular physical activity practice, fears and beliefs about their condition, functional limitations and physical inactivity.

Eligibility Criteria:
Inclusion Criteria:

* Patients, male or female, aged 50 to 75 years.
* Patients with knee pain reported to osteoarthritis
* Patient affiliated to a social security scheme (beneficiary entitled)
* Patient registered spa

Exclusion Criteria:

-
The Direct III Post Market Study

The primary objective of this multicenter, single-arm, observational study is to evaluate the feasibility of a systematic direct stenting strategy with the Svelte SLENDER IDS Sirolimus-Eluting Coronary Stent-on-a-Wire Integrated Delivery System (SLENDER IDS) in an all-comers, real-world population.

In this post-market study, the population will include real-world subjects who are intended to be treated, with SLENDER IDS as standard therapy. Follow-up contacts post procedure will be made for clinical assessments at hospital discharge, 1, 6 and 12 months.

This study is designed as a prospective, multi-center, single-arm, observational all-comers clinical study to collect ongoing safety and efficacy of SLENDER IDS and to determine the feasibility of a direct stenting strategy in an all-comers population. A minimum of two hundred fifty (250) subjects will be treated at up to 20 sites in Europe.

Review of safety data and risks to subjects will be monitored by an independent Clinical Events Committee (CEC) at pre-specified enrollment milestones.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is ≥ 18 years old;
2. Subject has symptomatic heart disease due to coronary artery lesions of length \< 28 mm and a reference vessel diameter 2.5 - 4.0 mm.
3. Subject is intended to be treated with PCI and implantation of SLENDER IDS as part of his/her standard treatment
4. Subject or subject's legal representative understands the study requirements and the treatment procedures and provides written informed consent before any study specific tests or procedures are performed.

Exclusion Criteria:

1. Subject is unable to receive anti-platelet and/or anti-coagulant therapy;
2. Subject is allergic to sirolimus, PEA III Ac Bz, cobalt, chromium, nickel or tungsten;
3. The subject is judged to have lesions preventing complete inflation of an angioplasty balloon or proper placement of a coronary stent, including chronic total occlusions.
4. Subject is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential, based on the standard of care for the cath lab);
5. Subject is participating in another investigational drug or device clinical trial that the investigator feels would interfere with the subject's participation in this study.
Rapid Hepatitis C Elimination Trial- A Pilot Study of Daclatasvir/Asunaprevir/BMS-791325 With or Without Ribavirin To Treat Hepatitis C Virus

The purpose of this study is to determine whether treatment with Daclatasvir/Asunaprevir/BMS-791325, with or without ribavirin, for 8, 6, or 4 weeks is feasible for the treatment of genotype 1a chronic hepatitis C in patients without cirrhosis.


Eligibility Criteria:
Inclusion Criteria:

* Subjects chronically infected with HCV genotype 1a
* HCV RNA ≥ 10,000 IU/mL at screening
* Treatment-naïve subjects with no previous exposure to an interferon formulation (ie, IFNα, pegIFNα), ribavirin (RBV), or HCV direct acting antiviral (DAA; protease, polymerase inhibitor, etc.)

Exclusion Criteria:

* Evidence of cirrhosis
* Liver or any other organ transplant
* Current or known history of cancer within 5 years prior to enrollment
* Documented or suspected hepatocellular carcinoma (HCC)
* Not eligible for sofosbuvir + pegylated interferon + ribavirin therapy
Combined Biofeedback With Virtual Reality in the Treatment of Pediatric Headache

The objective of the study is to examine the effect of combined treatments (biofeedback with virtual reality) for pediatric chronic headache.

Chronic headache is a common symptom in children. Pharmacologic treatment has only a limited productivity and several known adverse reactions. Despite the frequency and chronicity of pediatric headache, validated treatment paradigms are currently inadequate.

Biofeedback is a medical treatment in which physiologic markers like heart rate, breathing rate, EMG, EEG, or electrodermal activity are measured and displayed back to the patient. The patient can then attempt to modulate physiology to achieve a certain feedback goal,such as slowing heart or breath rate, or relaxing certain muscles. Numerous psychophysiologic studies have been conducted that examine the effect of biofeedback alone on physiology as well as various clinical conditions. Clinical trials for chronic headaches have found that biofeedback was more effective in the treatment of headache when compared to pure drug therapy.

A number of recent distraction interventions for acute pain in children and adolescents have employed virtual reality technology in conjunction with either a passive distraction stimulus, such as a movie, or an interactive distraction activity, such as a computer game. However, the actual benefit of VR technology over and above the benefits of the distracting stimulus that is experienced through the VR equipment has not been adequately tested in children.

The objective of this study is to combine virtual reality with biofeedback in order to increase the effectivity of both techniques in decreasing chronic headache frequency and pain degree in the pediatric population.

Eligibility Criteria:
Inclusion Criteria:

* 9-18 years old children suffering from chronic headache diagnosed by pediatric neurologist
* Exclusion of Other disorders causing chronic headache

Exclusion Criteria:

* Children younger than 9 years or olde than 18.
* Children who do not fulfill headache criteria as described in the International Headache Society
* Children who were not examined by a certified pediatric neurologist
Blood Draw Study for Liver Transplant Patients

The purpose of this study is to see what a lab test will show and if there is a way to predict which patients will be more likely to have rejection after receiving a liver transplant.

The purpose of this study is simply to see what the new oligonucleotide microarrays will show when comparing the the different patient groups. The results of this study will be one of the first steps In exploring the potential use of this new test.

Eligibility Criteria:
Inclusion Criteria:

* Received a liver Transplant

Exclusion Criteria:

* Received Multiple Organ Transplant
Comparative Effectiveness of Emergency Ultrasound Guided Management of Pediatric Soft Tissue Infections

To examine the effect of Point-of-Care Ultrasound (POCUS) management guidance on pediatric skin and soft tissue infections treatment failure rate, as well as emergency department process outcome.


Eligibility Criteria:
Inclusion Criteria:

* history and examination findings consistent with possible abscess or cellulitis per the treating clinician.
* minimal lesion diameter for inclusion is 1cm.

Exclusion Criteria:

* suspected soft tissue infections involving or near mucosal membranes (e.g. perirectal, peritonsillar, vulvovaginal areas)
* facial lesions
* paronychia or felon
* parent or patient refusal of consent
* unsuitable subjects deemed by treating clinicians.