cyrilzakka/clinical-trials huggingface dataset:
Rescue Stenting in the Severe Atherosclerotic Stenosis After the Failure of Intravenous Thrombolysis

Intravenous (IV) recombinant tissue plasminogen activator is the standard of care for patients with acute ischemic stroke (AIS) who present to the hospital within 4.5 hours of symptom onset. However, IV thrombolysis, even bridging thrombolysis (combining intravenous thrombolysis and mechanical thrombectomy) has limited efficacy among patients who had occlusive lesions associated with highgrade arterial stenosis requiring revascularization to improve neurological deficits. The investigators evaluated whether rescue stenting results in good outcomes among patients after the failure of intravenous thrombolysis and bridging thrombolysis.

Stroke is the second most common cause of death worldwide, with an annual mortality rate of approximately 5.5 million. Depending on the timing of presentation, intravenous (IV) administration of recombinant tissue plasminogen activator can be an effective treatment, but is most effective when used between 3 and 4.5 hours of symptom onset. Bridging thrombolysis, which describes the combination of IV thrombolysis and mechanical thrombectomy, can lead to long-term functional independence after 90 days with higher recanalization success rates than IV thrombolysis alone without increased risk. The HERMES meta-analysis of fve trials (MR CLEAN, ESCAPE, REVASCAT, SWIFT PRIME, and EXTEND IA) indicated the potential benefits of mechanical thrombectomy (MT) in case of proximal circulation occlusions. The recanalization failure rate of this treatment, defined as a modified Thrombolysis in Cerebral Ischemia (mTICI) score of 2a or worse, remained high, ranging from 13% to 29%, and most patients experienced poor clinical outcomes. Permanent stent placement has been suggested as a potential approach for achieving successful recanalization, which is the goal of endovascular therapy in the early management of acute ischemic stroke (AIS). However, the risk of intracranial hemorrhage associated with the combined use of IV thrombolysis and a loading dose of dual antiplatelet therapy (DAPT) increases when rescue stenting is applied. The investigators hypothesize that stent deployment might serve as a feasible treatment for large artery occlusion after the failure of intravenous thrombolysis and bridging thrombolysis.

Eligibility Criteria:
Inclusion Criteria:

* Acute ischemic stroke who underwent rescue stenting for large vessel occlusions underlying severe atherosclerotic stenosis after the failure of intravenous alteplase therapy.
* Absence of intracranial hemorrhage.

Exclusion Criteria:

* Premorbid modified Rankin Scale (mRS) ≥ 2
* Initiation to rescue stenting beyond 24 hours after symptom onset
Safety Study of a Melanoma Vaccine (GVAX) With or Without Cyclophosphamide in Patients With Surgically Resected Melanoma

The primary objective of this study is to evaluate the safety and feasibility of administering an allogeneic GM-CSF-secreting lethally irradiated whole melanoma cell vaccine ("melanoma GVAX"), alone or in combination with low dose cyclophosphamide (CPM), for the adjuvant treatment of patients with surgically resected stage IIB-IV melanoma. Secondarily, the investigators will assess in vitro correlates of anti-melanoma immunization by melanoma GVAX, including serological and cellular immune responses in patients treated with either the vaccine alone or the vaccine given with low dose CPM.


Eligibility Criteria:
Inclusion Criteria:

* Any patient age ≥18 years with melanoma of cutaneous or mucosal origin, and with clinicopathologic stage IIB, IIC, III or IV that has been completely resected
* Patients must be able to provide informed consent.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Life expectancy of at least 6 months.
* Adequate hematologic function.
* Adequate renal function
* Adequate hepatic function
* Patients of both genders must agree to practice effective birth control during the study period and for at least 4 weeks after the last treatment.

Exclusion Criteria:

* Patients whose primary site of melanoma is ocular.
* Are undergoing or have undergone in the past 4 weeks any systemic treatment for melanoma.
* Are undergoing or have undergone in the past 2 weeks any surgery or focal radiation therapy.
* Have active systemic infections, coagulation disorders (including therapeutic anticoagulation), or other major medical or psychiatric illnesses.
* Are known to be positive for hepatitis B surface antigen, anti-Hepatitis C Virus or anti-Human Immunodeficiency Virus (HIV) antibody (because of possible immune effects of these conditions).
* Documented history of autoimmune disease, for example, systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerulonephritis, or vasculitis.
* Any form of primary or secondary immunodeficiency. This would include hereditary disorders such as ataxia-telangiectasia or Wiskott-Aldrich syndrome, or acquired immune deficiencies such as following bone marrow transplantation.
* Requirement for systemic steroid therapy or immunosuppressive therapy.
* Have received any type of cancer immunotherapy, including but not limited to interleukin-2, interferon alfa or melanoma vaccines.
* Have been diagnosed with another invasive cancer within the past 3 years.
* Radiographic evidence of melanoma recurrence.
* Pregnant or lactating women.
* Known or suspected hypersensitivity to GM-CSF, pentastarch, hetastarch, corn, Dimethyl sulfoxide, fetal bovine serum or trypsin (porcine origin).
Study on Efficacy and Safety of CaReSR-1S to Repair Cartilage Defects of the Knee

The purpose of this trial is to investigate the safety and effect of CaReS-1S to repair knee cartilage defects.

CaReSR-1S is a sterile, ready for use round implant based on a dense matrix of native Collagen type I. It is indicated for the defect filling of focal, full layer and clearly defined knee and ankle cartilage defects of longest diameter 1.1-2.2cm. The fixation of CaReSR-1S is made for all sizes with fibrin glue, whereas the 11 mm implants also allow a press-fit anchoring due to the elasticity of the implant.

The physical nature of the CaReSR-1S allows the in-growth of healthy chondrocytes, as well as progenitor cells from the surrounding healthy tissue.

Eligibility Criteria:
Inclusion Criteria:

1. Aged from 18 to 55 years old;
2. Diagnosed with isolated knee cartilage defects in condyles of femur by arthroscopy, and the longest diameter is 1.1-2.2cm. The degree of the cartilage defects is Outerbridge IV degree or III degree but approximate to IV degree;
3. Outerbridge degree of cartilage in the other articular facet ≤Ⅱ;
4. Normal lower limb mechanical force line (varus or valgum \< 5°);
5. Skeletal mature;
6. 18Kg/M2 ≤ BMI ≤ 30Kg/M2;
7. Agree to sign the informed consent form;
8. Can cooperate in a post-operative rehabilitation program.

Exclusion Criteria:

1. Superficial cartilage defects;
2. Concomitant with subchondral bone defect;
3. Varus or valgum \> 5°;
4. Serious meniscus injury;
5. Fractures around the knee;
6. Cannot join in the post-operative rehabilitation program;
7. The contralateral lower-limb cannot stand weight-bearing;
8. A history of knee surgery within 6 months;
9. Secondary arthritis affecting cartilage;
10. Serious arthrocleisis;
11. Undergoing clinical trial;
12. Serious illness of the heart, lung, and other vital organs;
13. Liver function test equal to two times or greater than the upper normal limits; serum creatinine equal to two times or greater than the upper normal limit;
14. Have a contagious disease;
15. Allergic to the agents;
16. Lactating or pregnant women;
17. Serious neuropathy or mental disease;
18. Be addicted with drug or alcohol.
Quality of Life in Neoadjuvant Versus Adjuvant Therapy of Esophageal Cancer Treatment Trial

The purpose of this study is to compare the results of preoperative chemotherapy and radiation followed by surgery to surgery followed by postoperative chemotherapy and radiation for esophageal cancer.

Patients will be randomized to neo-adjuvant or adjuvant treatment. Quality of life questionnaires will be completed every 2 months up to 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Histologically documented squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (\> 20 cm from the incisors) or gastroesophageal junction are included.
* No distant metastases (M0).
* Patients will be stratified by stage (clinical N0 versus clinical N1), and surgeon.
* Patients with tumours within 3 cm distal spread into gastric cardia as detected by esophagogastroscopy.
* Resectable mediastinal nodes are eligible.
* No prior chemotherapy for this malignancy.
* No prior radiotherapy that would overlap the field(s) treated in this study.
* Patients with other malignancies are eligible only if \> 5 years without evidence of disease or completely resected or treated non-melanoma skin cancer.
* Age \> 18 years and able to tolerate tri-modality therapy at the discretion of the treating thoracic surgeon, medical and radiation oncologists. Tumours must be resectable after assessment by the thoracic surgeon.

Exclusion Criteria:

* Cancers of the cervical esophagus (\< 20 cm are excluded).
* Tumours that have \> 3 cm of spread into cardia of the stomach are considered gastric cancers and are ineligible.
* Patients with biopsy (by endoscopic ultrasound, laparoscopy, or laparotomy ) proven metastatic supraclavicular nodes are ineligible.
* Patients with biopsy proven metastatic celiac nodes are ineligible.
Management of Malignant Pleural Effusions Using an Indwelling Tunneled Pleural Catheter and Non-Vacuum Collection System

In this study, the investigators will collect data on patients who are using the Aspira system as part of their clinical care for the management of recurrent pleural effusion. Data will be collected on patient demographics, placement of the pleural catheter, palliation of dyspnea, complication rates, and rates of spontaneous pleurodesis.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, at least 18 years of age, inclusive
* Subject has a symptomatic malignant pleural effusion requiring intervention. For an effusion to be defined as malignant, at least one of the following must be true

  * There is cytological confirmation of pleural malignancy
  * The effusion is an exudate (per Light's criteria Pleural fluid protein/Serum protein \>0.5, Pleural fluid LDH/Serum LDH \>0.6, or Pleural fluid LDH \>2/3 the upper limit of normal) in the context of histocytologically proven malignancy elsewhere, with no other clear cause for fluid identified
* Subject is able to provide informed consent
* Subject has sufficient pleural fluid to allow safe insertion of an indwelling tunneled pleural catheter as determined by the PI
* Subject is able to perform home drainage of the pleural effusion or has sufficient resources (family member, caregiver, home health).

Exclusion Criteria:

* Subject is pregnant
* Subject has evidence, in the opinion of the PI, of either ongoing systemic or pleural infection
* Subjects with uncorrected coagulopathy
Enteral Nutrition in Infants With Ileostomy

This study is a prospective, single center, practical, and observational open clinical study.

Infant enterostomy is one of the emergency surgeries in pediatric gastroenterology. The most common underlying conditions during infancy include necrotizing enterocolitis, intestinal necrosis, intestinal perforation, and congenital gastrointestinal malformations. Necrotizing enterocolitis also serves as a major cause of short bowel syndrome in infants. Infants with small bowel stoma leading to short bowel syndrome face a higher incidence of complications compared to adults. Additionally, small intestinal stomy inevitably come with various complications such as infection, electrolyte imbalance, nutrient deficiencies, and malnutrition.

Currently, both domestic and international studies have shown that breast milk is the preferred choice for infant nutrition. The benefits of breastfeeding have been widely reported. For postoperative infants with digestive tract surgery, breast milk's immunoglobulins and prebiotics can help promote beneficial gut bacteria and bioactive proteins (such as lactoferrin, lysozyme, and lipoproteins), growth factors that facilitate intestinal adaptation and maturation processes while enhancing feeding tolerance and preventing infections or inflammatory disorders.

However, according to literature reports on clinical practice operations after digestive tract surgery even if early breastfeeding was initiated in 88% of cases; only 44% of infants were still being breastfed at discharge. This is due to feeding intolerance following breastfeeding which manifests as gastric retention, abdominal distension, diarrhea etc., not only delaying growth but also prolonging hospital stay while causing other adverse clinical outcomes. Some discharged infants who started breastfeeding experienced diarrhea and dehydration leading to readmission. Clinically speaking this issue has often been addressed by substituting feeds with enteral nutrition preparations (deep hydrolyzed formulas or free amino acid formulas).

The objective of this study is to assess the impact of enteral nutrition, which involves selecting appropriate preparations and human breast milk based on the child's intestinal tolerance, on growth and developmental outcomes in children following enterostomy. Additionally, we aim to investigate its effects on postoperative intestinal permeability, stoma output, gut microbiota and metabolites, sepsis incidence, colitis occurrence as well as bile stasis.

Eligibility Criteria:
Inclusion Criteria:

* After birth, infants aged 0-6 months (including neonates) undergo small bowel ostomy for various reasons.

Exclusion Criteria:

* Primary liver and kidney dysfunction, congenital multiple malformations and chromosomal abnormalities.
The Analysis of Skin Temperature by Long Wave Infrared Imaging to Determine Its Effectiveness as a Predictor of Tissue Injury

Long-wave infrared imaging can be used to identify skin temperature changes associated with underlying tissue changes. We want to determine if the use of Long Wave infrared Imaging is as effective as the Braden Score in predicting nosocomial pressure ulcers.

The Trillennium Medical Imaging system will be used to gather skin temperature data on 100 subjects. The subjects will be enrolled from Duke North floors 8100 or 8300 in a prospective controlled trial. All eligible patients who have signed a consent form will be assessed using the Long Wave Infrared imaging.

Subjects eligible for this study who have signed a consent form will be scanned on bilateral heels and sacrum. Subjects with ulcers on those areas will also be scanned due to the fact that they are at a high risk of developing additional pressure ulcers. The intent is not to capture images of the existing ulcer, but to focus on areas that could potentially develop into additional pressure ulcers. The subjects who already have an ulcer will only be scanned on non ulcerated tissue. The areas of interest must be off-loaded for 3 minutes from any pressure in order to acclimate to ambient temperature. The device will be held approximately 36 inches from the area of interest in order to obtain an image. The subjects will be assessed within 24 hours of admission and every 24 hours until discharge or they develop a pressure ulcer. The subject's routinely recorded Braden scores (By on the floor nursing staff) will also be captured in order to effectively compare the effectiveness of the Imaging system. The nurse conducting the imaging will also record a Braden score.

All subjects will be included in the trial unless they refuse to participate or are incapacitated to the degree that imaging becomes unreasonable.

Eligibility Criteria:
Inclusion Criteria:

* To be admitted to 8100 or 8300 and be willing to participate in the study

Exclusion Criteria:

* Unwillingness to participate
Acute Kidney Injury Biomarkers: Diagnosis and Application in Pre-operative Period of Liver Transplantation

Acute kidney injury (AKI), is a common complication of patients undergoing liver transplantation. Timing and definition of AKI, usually based on serum creatinine, have been inaccurate and inconsistent.

We hypothesized that the pattern of novel biomakers elevation could be a prognostic tool to provide information on the risk of progression of AKI, the need for RRT and mortality.


Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years
* Reception liver transplantation

Exclusion Criteria:

* CKD stage 4 / 5
* Combined organ transplants
* Patients receiving dialysis before liver transplant operation
HCR vs. CABG Study

The purpose of the study is to find out if hybrid coronary revascularization (HCR) and coronary artery bypass grafting (CABG) procedure outcomes are similar. HCR is a combination of surgery and catheter procedures to open up clogged heart arteries. CABG is a surgical procedure to open up clogged heart arteries.

Currently, it is not clear how the outcomes of hybrid coronary revascularization (HCR) compare with other treatments. The purpose of the study is to find out if HCR and coronary artery bypass grafting (CABG) procedure outcomes are similar. HCR is a combination of surgery and catheter procedures to open up clogged heart arteries. CABG is a surgical procedure to open up clogged heart arteries.

This study will collect information about the medical care participants receive during their planned procedure. No new testing or procedures will be done. Participants will have only the tests or procedures already planned by their doctor. The investigators will look at how well participants do after the procedure by assessing the outcomes of interest 30 days after surgery and, potentially, one year after surgery (funding dependent).

Eligibility Criteria:
Inclusion Criteria:

* Able to give informed consent
* Have multi-vessel coronary artery disease (CAD) involving the Left Anterior Descending (LAD) artery
* Have a clinical indication for revascularization
* Are a candidate for either HCR or CABG or both
* Anatomy suitable for HCR shall include

  1. Multi-vessel CAD involving the LAD and/or
  2. LAD disease and involvement of a major diagonal artery, both of which require revascularization

Exclusion Criteria:

* Prior cardiac operations
* Severe left ventricular dysfunction with ejection fraction (EF) \< 30%
* Patients with chest radiation
* Body mass index (BMI) \> 35
* Severe peripheral vascular disease (PVD)
* Acute ischemia requiring emergent traditional coronary artery bypass graft (CABG)
Perineal Consequences of Twin Pregnancies According to Mode of Delivery

This is an ancillary study to the "JUMODA" (National Prospective and Comparative Study on the Mode of Delivery of Twins) study: please see NCT01987063.

The main objective of this study is to investigate the role of the mode of delivery (vaginal versus cesarean) as a risk factor for the occurrence of urinary incontinence at 3 months post-delivery in primiparous women delivering twins after 34 weeks of pregnancy.

The secondary objectives of this study are to compare the following elements between primiparous mothers giving birth to twins vaginally versus by caesarean section after 34 weeks of pregnancy (comparisons will be made at 3 months ant at 12 months post-partum):

A. Diagnosis, type and severity of urinary incontinence via the ICIQ-UI questionnaire

B. Urinary, anorectal and perineal symptoms via the PFDI-20 questionnaire

C. Quality of life related to urinary, anorectal and pelvic floor symptoms via the PFIQ-7 questionnaire

D. Sexuality via the PISQ-12 questionnaire

E. General quality of life via the SF-12 questionnaire

Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is available for 12 months of follow-up following delivery
* The patient was included in the JUMODA study
* Primiparous
* Birth of 2 live children after 34 weeks of pregnancy

Exclusion Criteria:

* Adult patient under guardianship
* Patient under judicial protection
* It proves impossible to correctly inform the patient
* Birth occurring before 34 weeks of pregnancy
* Birth not resulting in 2 living children
MONITORING OF ATTENTION ACCORDING TO FATIGUE IN THE HEALTHY SUBJECT

To develop an easy-to-use measurement tool for monitoring fatigue and alertness, particularly in sleep-deprived subjects.

Objective and primary endpoint:

Demonstrate that the NaoX measurement tool detects sleep deprivation in medical residents performing medical shifts.

The primary endpoint is the detection of a significant decrease in Coefficient Alpha Attenuation (CAA) between the pre- and post-sleep deprivation measurements.

The data analysis will be blinded to the measurement.

Secondary endpoints and objectives :

Demonstrate a link between the Alpha Attenuation Coefficient (AAC) measured by the NaoX measurement tool and the vigilance tests.

Endpoint: significant increase in PVT (Psychomotor Vigilance Task) time associated with a significant decrease in Alpha Attenuation Coefficient (AAC).

Demonstrate a link between the Alpha Attenuation Coefficient (AAC) measured by the NaoX measurement tool and the state of fatigue experienced.

Endpoint: significant increase in Karolinska Sleepiness Scale (KSS) score associated with a significant decrease in Alpha Attenuation Coefficient (AAC).

Experimental scheme:

3 cycles of 2 recordings with the NaoX measurement tool associated with a self-questionnaire and vigilance tests (approximately 30 minutes per recording), carried out before and after a night shift by a medical resident.

Population targeted:

Medical residents performing night shifts of at least 12 hours.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers.
* Male, female.
* Medical residents.
* Aged between 24 and 34 years.
* Doing emergency, intensive care or "inside" shifts.
* Working in a health institution.
* No history of epilepsy.
* No background treatment that could have an impact on the EEG (electroencephalogram) data (type: benzodiazepines, anti-epileptics).
* No significant change in background treatment during the study, if any.
* Affiliation to the social security system.
* Informed volunteer who has signed a consent form.

Exclusion Criteria:

-
Impact of Prewarming on Perioperative Body Core Temperature and the Outcomes of Cytoreductive- and Major Open Abdominal Surgery: A Randomised Trial

The primary purpose of this study is to determine whether a prewarming period of at least 30 minutes during induction of general and combined epidural anesthesia reduces the core temperature drop normally occuring in patients undergoing cyto-reductive and major abdominal surgery. In addition the effect of prewarming on intra and postoperative body core temperature will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18
* elective cytoreductive or major abdominal surgery caused by ovarian cancer, primarily or secondary

Exclusion Criteria:

* age \< 18
* refusal participate in study
* pregnant or breast-feeding women
* cardiac ejection fraction \< 30%
* terminal renal insufficiency requiring dialysis
* severe pulmonary disease (Gina-Classification\< 3)
* neurological and/or psychiatric disease
* patient is placed in an institution due to court order
* lack of language skills/understanding
* employee of Charité Berlin
* alcohol addiction
* refusal of epidural anesthesia or failure to insert epidural catheter
* participation in other perioperative, invasive studies which prohibit further study inclusion