cyrilzakka/clinical-trials huggingface dataset:
Restore-B: A Trial Comparing Prepectoral Implant-based Breast Reconstruction With and Without Mesh

The goal of this feasibility randomised controlled clinical trial (RCT) is to compare mesh-assisted to no-mesh pre-pectoral implant based immediate breast reconstruction in women undergoing mastectomy for treatment of breast cancer or for risk reduction of an inherited breast cancer risk.

The main questions it aims to answer are:

* To determine the feasibility of a definitive RCT comparing the clinical and cost- effectiveness of no- mesh versus mesh- assisted pre-pectoral breast reconstruction.
* To determine if it is possible to collect data to inform a future economic analysis on the use of mesh in breast reconstruction.

Participants will be randomly allocated to have their breast reconstruction either with the use of mesh or without the use of mesh prior to the start of the operation. Participants will be blinded to their allocation until day 90 post operatively. Participants will be asked to have medical photography and to complete a short quality of life questionnaire before and after surgery at 90 days prior to finding out their allocation.

Trial Design:

Restore-B is a prospective, multicentre parallel 2-armed single-blinded randomised controlled feasibility trial comparing no-mesh to mesh- assisted immediate implant-based prepectoral breast reconstruction surgery.

Patients will be randomised 1:1 to either the intervention surgery (no- mesh) arm or the control arm surgery (mesh-assisted).

Planned Trial Period:

The overall period of the trial is:

12 months recruitment, 3 months follow-up and 6 months data analysis and final reporting of results.

Trial Participants:

Women over 18 years old eligible for elective immediate prepectoral implant-based breast reconstruction with mesh for cancer treatment or risk reduction surgery

Intervention:

Immediate prepectoral implant-based (implant or expander) breast reconstruction without surgical mesh (ADM or synthetic).

Comparator:

Immediate prepectoral implant- based (implant or expander) breast reconstruction with surgical mesh (ADM or synthetic) (standard of care).

Eligibility Criteria:
Inclusion Criteria:

* Women \> 18 years
* Participant is able and willing to give informed consent for participation in the trial
* Eligible for immediate prepectoral implant-based breast reconstruction with implant or expander with mesh (biologic or synthetic) for cancer treatment or risk reduction surgery.
* In the Investigator's opinion, can comply with all trial requirements.

Exclusion Criteria:

The participant may not enter the trial if any of the following apply:

* Participant is pregnant, lactating or planning pregnancy during the trial
* Patient refusal
* Delayed breast reconstruction post simple mastectomy
Effectiveness of the Eko Digital Stethoscope in Capturing Infant ECGs

When a newborn is diagnosed with tachyarrhythmia, they are generally started on medical therapies, most commonly a beta-blocker, while being observed in an inpatient setting. In most academic institutions, current practice is to provide parental teaching on use of a stethoscope to auscultate their child when there is suspicion for distress, in addition to requiring cardiopulmonary resuscitation (CPR) classes. Fortunately, newer technologies have emerged that allow for capture of cardiac rhythm that may provide a buffer between the infant and the emergency room.

Tachyarrhythmias which would prompt an emergent call to the pediatric cardiologist following the child, along with simultaneous transportation towards the nearest, preferably pediatric, emergency room. In reality, parental caregivers may be blinded by their personal anxiety in caring for their child with a tachyarrhythmia, and their interpretation or ability to count their child's heart beats may not be accurate. This in turn, can result in unnecessary calls and visits to the emergency room which increase their utilization in addition to piling onto the already astounding cost of healthcare in the United States. Fortunately, newer technologies have emerged that allow for capture of cardiac rhythm that may provide a buffer between the infant and the emergency room. Eko manufactures a digital stethoscope with 1-lead electrocardiogram (ECG), the DUO, which pairs with a mobile application that allows the clinician to further engage with the device during and after a clinical visit. The application enables the clinician to visualize the sounds and electrical signals coming from the device in real time.

Currently, the DUO is cleared for use on patients greater than or equal to 10 kg. This device may have additional clinical utility in pediatric patients \<10 kg when used by either a physician or a parent/caregiver at home for remote patient monitoring. The CORE 500 may also have clinical utility in this patient population.

Eligibility Criteria:
Inclusion Criteria:

* Age \<1 year
* No previous diagnosis of arrhythmia
* Parent/caregiver can provide informed consent
* Parent/caregiver can speak and understand simple English

Exclusion Criteria:

* Age ≥ 1 year
* Patient has a pacemaker or implantable cardioverter defibrillator (ICD)
* Parent/caregiver is unwilling or unable to provide informed consent
* Parent/caregiver is unable to speak and understand English
Epinephrine Dose: Optimal Versus Standard Evaluation Trial

The objective of this randomized controlled trial is to evaluate the effectiveness of a low cumulative dose of epinephrine compared to a standard cumulative dose of epinephrine during resuscitation from ventricular fibrillation (VF) or ventricular tachycardia (VT) in adult out-of-hospital cardiac arrest (OHCA) patients.

This study is designed as a prospective, multicentre, single-blinded randomized controlled trial (RCT) where eligible OHCA patients are randomized to receive a low cumulative dose of epinephrine (low dose epinephrine, up to 2mg total) or a standard cumulative dose of epinephrine (standard dose epinephrine, up to 6mg total) in a 1:1 fashion.

Eligible OHCA patients will be treated by paramedics who will initiate cardiopulmonary resuscitation (CPR) and the delivery of defibrillation shocks per paramedic agencies' treatment protocols. After one defibrillation and when feasible, paramedics will establish peripheral intravenous (IV) access, and patients will be randomly allocated to either the low dose or standard dose treatment arm. Epinephrine doses (according to treatment assignment) will be administered every 3-5 minutes, based on current guidelines and paramedic protocols, until the first return of spontaneous circulation (ROSC) is achieved or if resuscitation has been terminated by the base hospital physician. Other medications (e.g. antiarrhythmics, magnesium, beta blockers) and interventions (e.g. intubation) may be interposed as required. Follow-up will take place using a combination of administrative databases (e.g. the Discharge Abstract Database and the National Ambulatory Care Reporting System) and telephone interviews.

This RCT will evaluate a fundamental change in the treatment of OHCA. The investigators hypothesize that a low cumulative dose of epinephrine will improve patient survival to hospital discharge compared to a standard cumulative dose of epinephrine. Please feel free to contact epidose@unityhealth.to for further information.

Eligibility Criteria:
Inclusion Criteria:

* Out-of-hospital cardiac arrest treated by paramedics
* Initial recorded cardiac rhythm of VF or pulseless VT, or, AED shock on first analysis administered or witnessed by EMS (paramedic or fire)
* Established intravenous vascular access

Exclusion Criteria:

* Known or apparent age \<18 years
* Initial recorded cardiac rhythm of VF or pulseless VT, or, AED shock on first analysis administered or confirmed by paramedics
* Cardiac arrest due to an obvious non-cardiac primary cause (e.g. blunt or penetrating trauma, exsanguination, burns, drug overdose, drowning, anaphylaxis, sudden asphyxiation, etc.)
* Administration of intramuscular, endotracheal tube, or intraosseous epinephrine
* Prisoners or persons in police custody
* Known allergy or sensitivity to epinephrine
AntiPhospholipid Syndrome Low-molecular-weight Heparin Pregnancy Loss Evaluation: The Pilot Study

The APPLE pilot trial is a feasibility study that is a multicentre, open-label, randomized controlled trial. Pregnant women with antiphospholipid syndrome (APS) and a history of late (≥10 weeks gestation) or recurrent early (2 \<10 weeks) pregnancy loss will be recruited.

Eligible and consenting subjects will be assigned to one of two study arms: open-label low-molecular-weight heparin (LMWH) prophylaxis until 37 weeks gestation AND low-dose aspirin (ASA) daily until delivery, or open-label low-dose aspirin daily from randomization until delivery.

The purpose of this pilot trial is to determine the feasibility of conducting a multicenter randomized full trial evaluating antepartum prophylaxis with ASA versus LMWH/ASA in women with confirmed APS and a history of late or recurrent early pregnancy loss.

Given the large sample size needed to adequately power a large multicenter trial that assesses the efficacy of ASA alone versus LMWH/ASA, the investigators first need to determine if it is possible to meet minimum recruitment rates needed for a full multicenter trial. If the pilot feasibility trial is successful, then the secondary outcomes collected will be used in the analysis of the full multicenter trial.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed pregnancy;
* 18 years or older;
* Two or more unexplained pregnancy loss before the 10th week of gestation, AND/OR one or more unexplained pregnancy loss at or beyond the 10th week of gestation;
* One or more APS laboratory criteria present, according to the revised Sapporo criteria;

Exclusion Criteria:

* Greater than 11 weeks +6 days gestational age at time of randomization;
* Indication(s) for prophylactic or therapeutic-dose anticoagulation;
* Contraindication to heparin or aspirin;
* Received 7 or more doses of LMWH;
* Previous participation in the trial;
* Geographic inaccessibility;
* Refused consent.
Sufentanil Bispectral Index Elderly

We compared BIS values during propofol stepwise induction with or without concomitant sufentanil in patients ≥ 65 years .

Bispectral index (BIS) is widely used to estimate the depth of anesthesia. In clinical studies, a large variability of BIS has been observed. Several factors may be responsible for this inconsistency. We were able to show that in elderly patients (average age 78 years) receiving increasing doses of propofol alone a BIS values at loss of consciousness (LOC) were about 30% higher compared with young patients (average age 35 years). We showed also that in young patients (average age 48 years) the BIS values at LOC were significantly higher in those receiving sufentanil concomitantly with propofol compared with those who had received propofol alone. It remains unknown, however, whether these data from young surgical patients are applicable to a population of elderly patients. It may be argued that in the elderly receiving propofol, the impact of advance age was so important that any addition of an opioid would not further disturb the sedation-monitor balance. Alternatively, it may be expected that in the elderly receiving an opioid added to propofol the impact of both drugs on sedation will be additive and that previous observations from younger patients will be further exaggerated. The impact of advance age and presence or absence of sufentanil during propofol induction on BIS values at LOC was investigated in this trial.

Eligibility Criteria:
Inclusion Criteria:

- Age ≥65 years

Exclusion Criteria:

* History of heart disease
* History of renal disease
* History of psychiatric
* Obesity
* Allergy to propofol or sufentanil
Safety and Pharmacology Study of SNX-5422 in Subjects With Refractory Hematological Malignancies

Hsp90 is a chemical in the body that is involved int he promotion of cancer. SNX-5422 is an experimental drug that blocks Hsp90.

SNX-5422 is a prodrug for SNX-2112. Correlation has been observed between Hsp90 client protein level changes and functional effects in cells in in vitro studies of SNX-2112, supporting inhibition of Hsp90 as the mechanism of action for this compound. SNX-5422 has demonstrated significant antitumor activity in mouse xenograft models of human tumors, including breast (BT474, MX-1), colon (HT29), prostate (PC3), and melanoma (A375) with multiple oral dosing regimens. Pharmacokinetic (PK) studies in mice, rats, and dogs have shown high bioavailability of SNX-2112 following oral administration of SNX 5422. In mouse xenograft studies, SNX-2112 was selectively retained in tumor tissue compared with other tissues. This study will employ critical risk management features including the use of the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03, which provides a scale for consistently grading the severity of AEs, toxicity criteria analyses for dose escalation, frequent laboratory and clinical observations, correlation of AEs with plasma concentrations of SNX-5422 and SNX-2112, monitoring of the QTc interval at appropriate time points, and a conservative dose-escalation scheme.

Eligibility Criteria:
Inclusion Criteria:

* Males or non-pregnant, non-breastfeeding females 18 years-of-age or older with histologically confirmed non-Hodgkins lymphoma, without known or clinically suspected CNS involvement, that is refractory to available therapy or for which there is no available therapy.
* No more than 4 prior lines of systemic anti-cancer therapy and no prior bone marrow transplant or stem cell transplant within 12 months of dosing, and no prior allogeneic transplant.
* Karnofsky performance score ≥60
* Life expectancy of at least 3 months.
* Adequate baseline laboratory assessments

Exclusion Criteria:

* Currently receiving anticancer therapy or have received anticancer therapy within the past 28 days or 5 half-lives of the anticancer therapy
* The need for treatment with medications with clinically-relevant metabolism by the cytochrome P450 (CYP) 3A4 isoenzyme within 3 hours before or after administration of SNX-5422
* At increased risk for developing prolonged QT interval, including hypokalemia or hypomagnesemia, unless corrected to within normal limits prior to first dose of SNX-• Chronic diarrhea.
* Gastrointestinal diseases or conditions that could affect drug absorption, including gastric bypass.
* Gastrointestinal diseases that could alter the assessment of safety, including irritable bowel syndrome, ulcerative colitis, Crohn's disease, or hemorrhagic coloproctitis.
* History of documented adrenal dysfunction not due to malignancy.
* Seropositive for human immunodeficiency virus (HIV) or hepatitis C virus (HCV).
* History of chronic liver disease
Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms

The purpose of the study is to assess the safety and effectiveness of the GORE® EXCLUDER® Conformable AAA Endoprosthesis to treat an infrarenal aneurysm located in the abdominal aorta. Performance of the GORE® EXCLUDER® Conformable AAA Endoprosthesis will be judged by separate performance goals.

The study design is a prospective, nonrandomized, international, multicenter study comprised of two parallel substudies. The total subject population is 175 subjects with 80 subjects assigned to the Short Neck Substudy and 95 subjects to the High Neck Angulation Substudy.

This clinical study will include up to fifty-six sites in the US. Each enrolled subject will undergo periodic follow-up evaluations involving physical exams and contrast-enhanced computed tomography (CT) scans at specific, protocol-defined intervals for a period of five years following the GORE® EXCLUDER® Conformable AAA Endoprosthesis implant. Each Substudy will be evaluated and reported independently from each other according to the Safety and Effectiveness Endpoints. No comparative analyses between these substudies are planned.

Eligibility Criteria:
Inclusion Criteria:

1. AAA meeting any of the following criteria:

   * Maximum diameter ≥50 mm
   * Rapid growth (\>5 mm in a 6 month period)
   * Non-ruptured AAA presenting with clinical symptoms
2. Adequate anatomy to receive the GORE® EXCLUDER® Conformable AAA Endoprosthesis, including:

   * Adequate iliac / femoral access
   * Infrarenal aortic neck diameter 16-32 mm
   * Infrarenal aortic neck length ≥10 mm
   * Aortic neck angle ≤ 90˚
   * Distal iliac artery seal zone ≥10 mm
   * Iliac artery diameter 8-25 mm
3. An Informed Consent Form (ICF) signed by Subject
4. Male or infertile female
5. Able to comply with Protocol requirements including following-up
6. Life expectancy \> 2 years
7. Age ≥ 21 years

Exclusion Criteria:

1. Mycotic or ruptured aneurysm
2. Known concomitant thoracic aortic aneurysm which requires surgical intervention
3. Renal insufficiency defined as creatinine \> 2.5 mg/dL or patient undergoing dialysis
4. New York Heart Association (NYHA) class IV
5. Aneurysmal, dissected, heavily calcified, or heavily thrombosed landing zone(s)
6. Severely tortuous or stenotic iliac and / or femoral arteries
7. Patient has body habitus or other medical condition which prevents adequate delineation of the aorta
8. Participating in another investigational device or drug study within 1 year of treatment
9. Systemic infection which may increase the risk of endovascular graft infection
10. Known degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome
11. Planned concomitant surgical procedure or major surgery within 30 days of treatment date
12. Known history of drug abuse
13. Known sensitivities or allergies to the device materials
Prehabilitation Plus ERAS vs ERAS in Gynecological Surgery

Prospective, interventionist, controlled and randomized study to test the effectiveness of multimodal prehabilitation protocol in patients who will undergo gynecological surgery.

Prospective, interventionist and randomized controlled trial in a 1: 1 ratio, open to the multidisciplinary team but blind to surgeons and anaesthesiologists. The aim is to test the effectiveness of a multimodal prehabilitation protocol in patients with diagnosed or suspicious gynaecological cancer, who will undergo gynaecological surgery.

The multidisciplinary prehabilitation program will be applied to the intervention group. For the group participating in the prehabilitation and for the control group, the protocol and specific recommendations for gynecological cancer defined by the Enhanced Recovery After Surgery (ERAS®) guidelines will be applied.

Eligibility Criteria:
Inclusion Criteria:

* Patients who sign the Informed Consent Form, indicating that they understand the study procedures and their purpose;
* Women aged between 18 and 80 years old;
* Gynecological surgery performed by laparotomy;
* Patients with Eastern Cooperative Oncology Group Performance Status of at least 2 (ECOG ≤2);
* Preoperative schedule that allows prehabilitation intervention for 2 to 3 weeks

Exclusion Criteria:

* Patients under 18 or older than 80 years old;
* ECOG ≥3;
* Significant comorbidities, such as: neurological or musculoskeletal disorder, heart disease and / or respiratory failure that prohibit physical exercise;
* Limitation of locomotion preventing the patient to perform physical exercises;
* Cognitive deterioration or patients with psychiatric disorder that prevents adherence to the program;
* Emergency or urgency surgeries;
* Surgeries by minimally invasive approach (laparoscopy or robotics);
* Vulvectomy or soft tissue surgery without abdominal approach;
* Minor gynaecological surgeries such as conizations;
* Surgeries performed together with other specialties, in which the gynecology team is not primarily responsible for postoperative care;
* Non-adherence of the patient in the intervention group to the preoperative prehabilitation program.
* If surgery is performed 21 days after the last day of the prehabilitation program, for any reason
Post-Stroke Improvement of Motor Function

Open-label clinical study where all new patients presenting with cerebrovascular accidents and consenting to treatment are given intravenously a new combination of medications. Patients are evaluated neurologically with NIHSS scores before treatment administration and at 1 month after the first treatment. Further evaluations at 6 months after treatment by NIHSS and Barthel scores are ongoing

Patients with cerebrovascular accidents (CVA), ischemic (including those with hemorrhagic transformation), are given a new combination of medications which aims to improve neuronal survival, stimulate mitochondrial genesis and the formation of new synapses. This combination is given as an intravenous perfusion with a 2-hr duration and consists of vitamins B1, B6, B12, C, Actovegin, etc.

Before treatment a NIHSS score is given. Each patient receives 3-4 such perfusions in 1 month and afterwards another NIHSS score is obtained.

Patients are monitored afterwards and those who show improvements receive more such treatments, and new NIHSS and Barthel scores are obtained.

Patients are grouped on the basis of the time interval between CVA occurence and first treatment:

* Group 1: 0-35 days
* Group 2: 36-100 days
* Group 3: 101-360 days Improvement of motor function is compared using NIHSS scores between groups, and between literature and groups

Eligibility Criteria:
Inclusion Criteria:

* adults with CVA
* agreeing to treatment in person or by proxy signing of Informed Consent Form
* available for NIHSS evaluation

Exclusion Criteria:

* allergy to any of the substances administered
* scheduled for surgery or other procedures
* not available for NIHSS evaluation after at least 48 hours from treatment