cyrilzakka/clinical-trials huggingface dataset:
Observational Study of Fostamatinib as Second Line Therapy in Adult Patients With Immune Thrombocytopenia (ITP) and Insufficient Response to a Prior Therapy

Evaluate patient characteristics, treatment patterns, clinical outcomes and safety of fostamatinib as second-line therapy in real-world clinical practice, for the treatment of ITP in adult patients who have an insufficient response to prior therapy (steroids ± immunoglobulins).

Evaluate patient characteristics, treatment patterns, clinical outcomes and safety of fostamatinib as second-line therapy in real-world clinical practice, for the treatment of ITP in adult patients who have an insufficient response to prior therapy (steroids ± immunoglobulins).

Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to provide written informed consent
2. Diagnosis of ITP in adult patients (≥ 18 years of age) with an insufficient response to steroids ± immunoglobulins and requiring a change in therapy
3. For Cohort 1, intent to initiate fostamatinib at enrollment as change in therapy
4. For Cohort 2, currently undergoing treatment with fostamatinib as second line therapy for at least 12 weeks, with the intent to continue, at the time of enrollment

Exclusion Criteria:

1. Any prior ITP therapy/treatment other than steroids ± immunoglobulins (e.g. rituximab, thrombopoietin receptor agonists (TPO), splenectomy)
2. Participation in any interventional study during the course of this study
3. Lack of historical platelet counts, at time of fostamatinib initiation for those entering Cohort 2
4. Pregnant and/or nursing
Lidocaine-prilocaine Cream on IUD Insertion Pain

The purpose of the investigators' study was to evaluate whether cervical lidocaine-Prilocaine cream will improve pain scores compared to placebo. The investigators hypothesized that lidocaine-Prilocaine cream will reduce the insertion pain.

IUD can cause pain and discomfort in several ways: Use of the tenaculum to grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions including measuring uterine depth, inserting the IUD insertion tube, and removing the tube; and placement of the device in the uterus.

To minimize the discomfort and the hazards of an IUD insertion, several measures have been proposed including NSAIDs, anxiolytics, and local anesthetics in the form of intracervical gel, cervical and para-cervical block, but there have not done enough studies about their effectiveness. According to the review published in the Cochrane, non-steroidal anti-inflammatory drugs and misoprostol are not effective on reducing an IUD insertion pain. Many trials have been done about effectiveness of lidocaine gel in reducing pain during IUD insertion and only one of those trials showed positive effect of 2% lidocaine gel, while others failed.

Lidocaine 2.5% and Prilocaine 2.5% Cream, is an emulsion in which the oil phase is a eutectic mixture of Lidocaine and Prilocaine cream in a ratio of 1:1 by weight. This eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as liquid oil rather than as crystals. Its absorption of from the genital mucosa is more rapid and onset time is shorter (5 to 10 minutes) than after application to intact skin. After a 5 to 10 minute application of Lidocaine-Prilocaine cream to female genital mucosa, the average duration of effective analgesia was 15 to 20 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Women not taken analgesics or anxiolytics in the 24 hours prior insertion
* Women not taken misoprostol prior to IUD insertion
* No contraindication to or history of allergic reaction to lidocaine
* Women who will accept to participate in the study

Exclusion Criteria:

* Lidocaine allergy
* Any contraindication to IUD placement
Mechanical Insufflator-exsufflator in Patients After Video-assisted Thoracoscopic Operations With One-lung Ventilation

Postoperative pulmonary complications (PPC) are a common problem in patients undergoing surgery using one-lung invasive ventilation. Major pulmonary complications such as atelectasis, bronchospasm, and pneumonia can lead to respiratory failure. PPC are the main cause of mortality in the postoperative period in patients after thoracic surgery. The study aimed to compare the effectiveness of using a mechanical insufflator-exsufflator after video-assisted thoracoscopic surgery using one-lung ventilation to reduce postoperative pulmonary complications as compared to standard therapy.

Postoperative pulmonary complications (PPC) are a common problem in patients undergoing surgery using one-lung invasive ventilation. Major pulmonary complications such as atelectasis, bronchospasm, and pneumonia can lead to respiratory failure. PPC are the main cause of mortality in the postoperative period in patients after thoracic surgery. The incidence of PPC ranges from 5% to 80%. Patients undergoing thoracic surgery are usually at high risk. Most often these are elderly people with concomitant diseases. Most of these patients are smokers, have occupational exposures, and are therefore at even greater risk of developing pulmonary complications. Part of their problem is due to poor baseline pulmonary function. Improving mucus production in the postoperative period using a mechanical insufflator-exsufflator may help reduce the incidence of complications.

Eligibility Criteria:
Inclusion Criteria:

* Video-assisted thoracoscopic surgery using one-lung ventilation
* Age 18-65 years Forced expiratory volume in one second (FEV1) 60% of predicted or more
* Absence of pronounced bronchial secretion before surgery
* Written informed consent.

Exclusion Criteria:

* Age less than 18 and more than 65 years
* Presence of pneumothorax 6 hours after surgery on radiography
* Pulmonary hemorrhage of any intensity
* Unstable hemodynamics
* Forced expiratory volume in one second (FEV1) is less than 60% of predicted during preoperative examination
* The scope of the operation is more than a lobectomy
* Bilateral and combined operations
* Mechanical ventilation after surgery for more than 6 hours
* Anesthesia risk according to American Society of Anesthesiologists (ASA) 4 and 5 points
A Multi-site Randomized Controlled Trial Comparing Regional and General Anesthesia for Effects on Neurodevelopmental Outcome and Apnea in Infants

The primary purpose of the GAS study is to determine whether different types of anesthesia (Regional versus General) given to 720 infants undergoing inguinal hernia repair results in equivalent neurodevelopmental outcomes. The study also aims to describe the incidence of apnea in the post-operative period after both regional and general anesthesia for inguinal hernia repair in infants. This study is important as it will provide the greatest evidence for safety or toxicity of general anesthesia for human infants.

This is a prospective, observer blind, multi-site, randomized, controlled, equivalence trial. The general anesthesia group will receive sevoflurane (intervention drug) for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg per kg) administered via caudal or ilioinguinal nerve block. The airway can be maintained with a face mask, laryngeal mask or endotracheal tube, with or without neuromuscular blocking agents.

The regional group will have no sedative agent. The regional blockade may be with spinal alone, spinal block with caudal block, spinal with ilioinguinal block or caudal alone. The maximum dose of 2.5 mg per kg of bupivacaine can be used.

Eligibility Criteria:
Inclusion Criteria:

* Any infant scheduled for unilateral or bilateral inguinal hernia repair (with or without circumcision)
* Any infant whose gestational age is 26 weeks or more (GA = 182 days)
* Any infant whose post-menstrual age is up to 60 weeks (PMA = 426 days)

Exclusion Criteria:

* Any child older than 60 weeks post-menstrual age
* Any child born less than 26 weeks gestation
* Any contraindication to general or spinal/caudal anesthesia (for example: neuromuscular disorder or coagulopathy)
* Pre-operative ventilation immediately prior to surgery
* Congenital heart disease that has required ongoing pharmacotherapy
* Known chromosomal abnormality or any other known acquired or congenital abnormalities (apart from prematurity) which are likely to affect development
* Children where follow-up would be difficult for geographic or social reasons
* Families where English is not the primary language spoken at home
* Known neurological injury such as cystic periventricular leukomalacia (PVL), or grade 3 or 4 intra ventricular hemorrhage (ICH) (+/- post hemorrhage ventricular dilation)
* Previous exposure to volatile anesthesia or benzodiazepines as a neonate or in the third trimester in utero.
Effects of Immunonutrition in Patients Undergoing Pancreaticoduodenectomy

The purpose of this study is to determine whether immunonutrition is effective on surgical site infection and Th1/Th2/Th17 differentiation in patients undergoing pancreaticoduodenectomy

Perioperative immunonutrition is reported to improve the incidence of postoperative infectious complication in patients with gastrointestinal surgery. It has also been recognized that Th1/Th2 balance shifts toward Th2 by surgical stress. On the other hand, the change of Th17 status after surgery has not been established. Furthermore, The change of Th1/Th2 balance and Th17 status with immunonutrition on pancreaticoduodenectomy have not been reported yet.

Objective of this study is to investigate the effects of perioperative immunonutrition on incidence of postoperative infectious complication, Th1/Th2 balance and Th17 status after pancreaticoduodenectomy.

Eligibility Criteria:
Inclusion Criteria:

* patients underwent pancreaticoduodenectomy

Exclusion Criteria:

* age younger than 18 years or older than 75 years
* preoperative chemotherapy or radiation
* ongoing infection
* diabetes mellitus
* gastrointestinal obstruction
* respiratory dysfunction
* cardiac dysfunction
* hepatic dysfunction
* renal failure
* history of recent immunosuppressive or immunological diseases
* preoperative evidence of widespread metastatic disease
Budesonide for Prevention of Acute Gastrointestinal GVHD Following Allogenic Stem Cell Transplantation

The purpose of this study is to determine whether orale budesonide is effective in the prevention of acute gastrointestinal graft-versus-host disease (GVHD) following allogenic stem cell transplantation.

The purpose of this study is to determine whether orale budesonide is effective in the prevention of acute gastrointestinal graft-versus-host disease (GVHD) following allogenic stem cell transplantation.

Eligibility Criteria:
Inclusion Criteria:

* planned allogenic stem cell or bone marrow transplantation
* HLA identity (max. 1 mismatch)
* standard GVHD prophylaxis with cyclosporin A or tacrolimus combined with MTX, +/- ATG or Campath1H
* written informed consent

Exclusion Criteria:

* history of allogenic transplantation
* in vitro T-cell depleted transplant
* pretreatment with budesonide within the previous 4 weeks
* known intolerance to budesonide
* gastrointestinal infections
* portal hypertension
* concomitant infectious diseases
* liver cirrhosis, impaired liver function
* severe mental disorder
* lack of compliance
* drug or alcohol abuse
* pregnancy, lactation
* childbearing potential without effective contraception
Real Time Tissue Characterisation Using Mass Spectrometry REI-EXCISE iKnife Study

REI-EXCISE is a multicentre, prospective, non-randomised feasibility study, aimed to evaluate the diagnostic accuracy of rapid ionisation mass spectroscopy using an iKnife device. The iKnife will collect vapour, a by-product of surgery, which will pass through the mass spectrometer machine for analysis in order to evaluate what is "normal" and what is "cancerous" breast tissue.

There is an urgent need to address high rates of close or positive margins and re-operative breast cancer surgery, which commonly results from the inability of the surgeon to rapidly and reliably evaluate resection margin status intra-operatively.

This study therefore seeks to address this problem by aiming to develop a method for near real time, in vivo intra-operative tissue classification that may be used by breast surgeons as an intelligent knife (or "iKnife") to better guide oncological margin control. The method known as Rapid Evaporative Ionisation Mass Spectrometry (REIMS) technology uses mass spectrometric and chemometric analysis of the tissue specific ionic content of the surgical diathermy smoke plume for the rapid identification of dissected breast tissues.

There are no additional treatment interventions as part of REI-EXCISE. The main study procedures are breast conserving surgery using the REIMS iKnife for mass spectral analysis of each surgical margin and correlation between the results of a software recognition algorithm that capitalised on the spectral data (i.e. iKnife margin = positive / negative) with conventional histopathological assessment. False positive iKnife data will be further interrogated with digital droplet polymerase chain reaction and imprint cytology assessment.

Eligibility Criteria:
Inclusion Criteria:

* BCS for ductal carcinoma in situ (B5a)
* BCS for invasive ductal carcinoma (B5b)
* BCS for invasive lobular carcinoma (B5b)
* B3 lesions undergoing surgical excision

Exclusion Criteria:

* Pregnant or lactating
* 18 years or younger
* Diagnostic excision biopsy for classical lobular carcinoma in situ (LCIS) (current practice is that classical LCIS at a surgical resection margin would not mandate wider excision)

Or if the patient is diagnosed with

• Non-epithelial breast tumour (phyllodes, lymphoma)

Note on patients receiving Neo-adjuvant Chemotherapy (NACT):

Patients selecting to receive NACT will be eligible for participation. However, the data for patients receiving NACT will be analysed separately as a pre-planned subgroup and these patients will not contribute data to the n=35 patients with positive margins required for this feasibility trial. Data from NACT cases have not been used to generate the validated multispectral database since eccentric fibrosis made the histological analysis more complex, which limited the number of patients in whom tissue was available for research.
Effectiveness of a Combined Pressure and Silicone Intervention for Hypertrophic Scar Treatment

Pressure therapy (PT) and silicone therapy are recommended as first-line non-invasive treatments HS, yet the effectiveness of the combination of these two treatments through an RCT trial has not been established yet. This study aims to examine the effectiveness of the combination of adequate pressure therapy and silicone gel sheeting implemented by Smart Scar Care Pad (SSCP) + Smart Pressure Monitored Suit (SPMS) versus conventional Pressure Garment (PG in the management of severe HS in adult. It is hypothesized that the combination of adequate pressure therapy and silicone gel sheeting will demonstrate its superiority in improving scar parameters than conventional pressure garment therapy.


Eligibility Criteria:
Inclusion Criteria:

* The Vancouver Scar Scale (VSS) will be used to screen candidates for the study.10 Isolated scars with a total score of 4 or higher and the score of each item equal to or greater than 1 will be included.
* The scar size should also reach 2\*2 cm2 or above to allow adequate area for assessment tool attachement.
* Consenting adult's age between 19 to 60 years old who is able to provide written consent, cooperative, and good compliance with treatment.

Exclusion Criteria:

* the HS area have an open wound or infection;
* the HS have been treated with steroid injections or other intervention (such as traditional Chinese medicine or laser therapy) prior to the study;
* the patients have a medical condition that might affect wound healing (e.g., diabetes mellitus or another serious medical problem);
* the patients with comorbidities that might affect their compliance to treatment: such as severe scar contracture at adjacent area that might be scheduled for reconstructive surgery.
Evaluation of the SmartBx System for Breast Biopsy

Performance evaluation of a novel, semi-automated device and method for needle core biopsy download compared to standard methods in terms of:

3. Biopsy core length obtained (i.e. collecting all tissue fragments) 4. Biopsy core yield (i.e. percent of tissue loss during the pathologic processing)

Examination procedure:

* Biopsy cores will be collected from the breast during US guided biopsy procedure.
* The number of cores taken will be decided per the physician discretion according to the clinical demand.
* Additional two biopsy core will be taken the SmartBx cassette. Since the SmartBx cassette holds two biopsies together, two consecutive cores will be collected using the SmartBx.
* samples will be photographed for measurements in 2 steps during the process:

  1. On the needle notch \[A\].
  2. On the glass slide \[B\].
* Standard tissue fixation, processing of the samples in paraffin will be performed unchanged per the pathology laboratory protocols.
* Embedding of the biopsy cores taken with the SmartBx will be embedded using the SmartBx mold and tamper.
* Standard staining and histology analysis will be preformed to the sectioned samples, unchanged per the pathology protocols.

  • Analysis will be preformed to the histological results, and a comparison between the standard procedures samples to the SmartBx samples will be performed in terms of -
* Biopsy core length obtained (i.e. collecting all tissue fragments)
* Biopsy core yield (i.e. percent of tissue loss during the pathologic processing)

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Planned for breast biopsy procedure.
* Signed informed consent.

Exclusion Criteria:

o Patient's unwilling to participate.
Evaluation of Improved Preparation Time to a Coverage in Patients With Acute Wounds by Use of VistaCare® Versus Dressings

Primary objective:

Demonstrate that in patients with acute leg wounds with skin defect, VistaCare® accelerates the formation of a quality granulation tissue and reduces preparation time to a cover gesture.

Secondary objectives:

* Evaluate the success of hedging gesture
* Assess the quality of the bud by colorimetry
* Assess tolerance
* Collect medical and economic data on the care of patients included
* Evaluate the quality of life of patients
* Assess patient comfort
* Evaluate the ease of use for the caregiver


Eligibility Criteria:
Inclusion Criteria:

* Man or woman
* Age from 18 to 65 inclusive
* Patient with acute or leg sores (s), traumatic, with skin defect with or without external fixators and without exposure to fine fabrics (functional tendon, artery, vessel, bone, osteosynthesis material ...). These wounds may be burns, deep second degree only.
* Patient having no associated pathology
* Patient has given its written consent, lighting, dated and signed
* Patient affiliated to a social security scheme
* Voluntary Patient and able to comply with the protocol requirements
* Patient whose wound is located below the knee
* Patient whose wound date of less than 2 weeks
* A patient whose wound has a minimum area of 10 cm2
* Patient whose wound does not require surgical debridement after inclusion (if surgical debridement is necessary, it must be performed before inclusion in the study)

Exclusion Criteria:

* Pregnant or breastfeeding women
* Women of childbearing potential not using effective contraception (combined hormonal, IUD) and failing achieving a pregnancy test and getting the result before starting treatment
* Patients do not speak and do not read French
* Patient with one or more risk factors such as smoking more than 5 cigarettes a day, diabetes, autoimmune disease
* Patients with such treatment during or within one month prior to inclusion in the study: corticosteroids, topical corticosteroids at the immunosuppressive wound or radiotherapy
* A patient whose wound is located at a place not compatible with the use of VistaCare®
* Patient with traumatic wound leg with exposure to some tissues (functional tendon, artery, vessel, bone, osteosynthesis material ...)
* Patient with general signs of infection (temperature, lymphangitis, osteitis proven)
* Patient with a bleeding wound
* Patient with a burn to a stage other than deep second degree
* Patients with a wound whose area is less than 10 cm2
* Patient with a plague of nontraumatic leg
* Previous participation in this trial
* Patient in exclusion period from another clinical trial or participated in a clinical trial in the month before inclusion
* Patient whose wound is more than 2 weeks
* Patient whose wound was treated by hyperbaric chamber
Multicenter Registry on Microvascular Dysfunction - Searching a New Ach Spasm Definition

The MICRO-SNAPE registry will collect data from patients undergoing investigation of microvascular dysfunction and coronary spasm in Europe and North America.

Microvascular dysfunction is an important determinant of patients´quality of life and prognosis, which however remains poorly classified. Given the high burden of disease and the severity of the functional impairment in these patients, the lack of a clear understanding and diagnosis has a potentially large clinical importance. It is therefore important to better describe the phenotype of these patients. The MICRO-SNAPE registry will allow investigating these associations. Patient data as collected during the local clinical practice and at the operator's discretion, will be retrospectively entered in this non-interventional registry in anonymous form.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent combined measurements of coronary pressure and flow in at least 1 native coronary artery in response to endothelium dependent and independent vasodilators.

Exclusion Criteria:

* Hemodynamic instability
* Age \<18 years