cyrilzakka/clinical-trials huggingface dataset:
Value of Percutaneous Cholangioscopy After Placement of a Percutaneous Transhepatic Biliary Drainage

In a prospective study the investigators perform repeated cholangioscopies in all patients that received percutaneous transhepatic biliary drainage (PTBD) for a variety of malignant and benign diseases. Endoscopic findings and their correlation with clinical features will be recorded prospectively. The impact on clinical decision will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

PTBD with at least 14 French in diameter

Exclusion Criteria:

missing informed consent
Neoadjuvant Treatment in Rectal Cancer With Radiotherapy Followed by Atezolizumab and Bevacizumab (TARZAN)

In this study, patients with resectable rectal cancer will receive radiotherapy, followed by neoadjuvant bevacizumab and atezolizumab

38 patients with resectable rectal cancer will be enrolled. All patients will be treated with radiotherapy followed by bevacizumab and atezolizumab.

Eligibility Criteria:
Inclusion Criteria:

* signed informed consent
* patients age 18 years and older
* histologically confirmed adenocarcinoma of the rectum
* intermediate risk rectal cancer or low risk distal rectal cancer

Exclusion Criteria:

* evidence of metastatic disease
* prior radiation therapy for disease under study
* prior treatment with CD137 agonists or immune checkpoint blockade therapies
* current or recent use of acetylsalicylic acid
* history of clinically significant cardiac or pulmonary dysfunction pregnancy or breastfeeding
* significant auto-immune disease
Vasculopathy, Inflammation and Systemic Sclerosis

It is a study of basic research with mechanistically objectives and including clinical biological samples.

Systemic sclerosis (SSc) is a rare and severe disease characterised by a fibrotic process and an incompletely elucidate physiopathology. Several shared featured have been identified between SSc and another autoimmune disease, the systemic lupus erythematous (SLE) as an interferon-alpha signature, the role of platelets and the polymorphism of OX40 ligand (OX40L). In SLE, OX40L has been shown highly linked to the active form of the disease, was increased by the CD40L of platelets and induced the CD8 cytotoxicity while inhibiting the suppressive functions of regulator T lymphocytes. The third main factor of the SSc physiopathology apart from autoimmunity and fibrosis is the vasculopathy with an important role of endothelial cells (EC). They turned out to be half-professional antigen presenting cells and can modulate the adaptive immunity.

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 75.
* SSc diagnosed according to the American College of Rheumatology (ACR) criteria.
* With skin manifestations since less than 10 years.
* Localised sclerosis (LSc) diagnosed, morphea type.

Exclusion Criteria:

* Age inferior to 18 or upper than 75.
* Skin manifestations since more than 10 years.
* Haemostasis diseases (independent from treatments).
* Stem cell transplant.
* Immunosuppressive treatments in the last 6 months.
* Associate autoimmune disease.
Changes of Right and Left Cerebral Oxygen Saturation and Blood Flow During Nephrectomy in Lateral Decubitus Position

The purpose of this study is to determine changes of right and left cerebral oxygen saturation and blood flow during nephrectomy in lateral decubitus position.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (ASA physical status I and II) aged between 20-65 yrs

Exclusion Criteria:

* Cardiovascular, renal, hepatic disease, or communication failure
Outreach: A Programme for Timely Treatment of Critically Ill Patients in a University Hospital

The identification of patients with potential early organ failure is the key in preventing admission or readmission to a critical care facility. The primary goal of the Outreach Project is to ensure that all patients with threatening organ failure receive appropriate and timely treatment in a suitable area; avoid admission to the intensive care unit (ICU); and share ICU skills by a partnership in education. The objectives of the study are to determine whether the introduction of an intensive care unit based medical emergency team, responding to hospital-wide preset criteria of physiologic instability, will decrease the number of predefined serious adverse events (SAEs) and to investigate the effects on quality of life and costs in a general surgery population.

Study Hypothesis: The Outreach intervention will decrease the number of predefined serious adverse events; increase quality of life; and decrease costs.

DESIGN: A multi centre longitudinal intervention trial with a before and after design in a university hospital.

The INTERVENTION consists of three parts:

1. The introduction of a hospital-wide intensive care unit based medical emergency team to evaluate and treat patients deemed at risk for developing an adverse outcome.
2. Education and training of ward staff in the recognition and basic management of patients developing a critical illness.
3. The development of an intensive care (nurse and physician staffed) consultancy service for general wards.

STUDY POPULATION: The population for this study consists of patients undergoing major general surgery with an admission stay of more than 48 hours. It includes patients undergoing central or peripheral vascular surgery, major oncological surgery, lung surgery, major abdominal surgery and trauma surgery.

MEASUREMENTS AND OUTCOMES: In total, 1500 patients will be included. (750 Patients in the control period and 750 patients in the intervention period). Measurements include the incidence of Serious Adverse Events, HRQoL (Quality of life EQ-5D), costs of care and ICU logistics.

TIME-SCHEDULE: Data collection starts January 1, 2006 and stops no later than three months after the inclusion of 1500 patients or April 1, 2008. The final report of the study will be in December 2008.

Eligibility Criteria:
Inclusion Criteria:

* Major general surgery.
* Admitted to the hospital 48 hours after surgical intervention

Exclusion Criteria:

* Not able to communicate in the Dutch language.
* Younger than 18 years old.
* Pregnancy
Feasibility Evaluation of CPAP in the Treatment of Obstructive Sleep Apnea Synchrone in the Acute Phase of Stroke

This project is focused on the treatment of obstructive sleep apnea in the acute phase of stroke. Stroke is a frequent pathology with a high morbidity and mortality rate. Although it has now been proved that obstructive sleep apnea syndrome (OSAS) is a risk factor of stroke, on the other hand, there is evidence that 50 to 70% of patients in the acute phase of stroke have obstructive sleep apnea (OSA) based on an apnea-hypopnea index (AHI) of ≥ 10. OSA is associated with worse functional outcomes and higher mortality in the post-stroke period. Profound hemodynamic fluctuations and hypoxia generated by sleep apnea are likely to aggravate cerebral ischemia, particularly in the acute phase of stroke in the potentially reversible ischemic penumbra. Continuous Positive Airway Pressure (CPAP) is the primary treatment for obstructive sleep apnea.

Yet, to our knowledge, there have been very few studies aimed at demonstrating the value of CPAP in the treatment of obstructive sleep apnea in the acute phase of stroke. Only one randomised trial has provided the means to document neurological improvement at mid term (1 month) in a targeted population.

Before undertaking a comparative study evaluating the efficacy of CPAP in the acute phase of ischemic stroke, it is worth evaluating the feasibility and tolerance of introducing CPAP at the very early stage of ischemic stroke. Therefore, the purpose of our study is to evaluate the feasibility of CPAP in the treatment of OSA in the acute phase of ischemic stroke.


Eligibility Criteria:
Inclusion Criteria:

* - Clinical presentation of ischemic stroke confirmed by imaging (CT or MRI brain scan)
* less than 24 hours from onset of symptoms
* admitted to the Neurovascular unit of the Emergency Hospitalisation Department of 'Hôpital Nord' of the university hospital of Saint-Étienne
* presenting obstructive sleep apnea syndrome (defined as an apnea-hypopnea index (AHI) of ≥ 10 and \> 50% of obstructive events)
* written consent of patient

Exclusion Criteria:

* Concussion (Coma Glasgow Score \<12)
* Comprehension aphasia
* Uncontrollable confusion and agitation
* History of dementia
* History of ischemic stroke with neurological damage
* History of hemorrhagic stroke
* History of epilepsy
* Cerebrospinal fluid leak, recent cranial surgery or head injury
* Serious bullous lung disease
* Hypoxic pulmonary disease
* Pleurisy or pneumothorax requiring draining
* Respiratory distress requiring mechanical ventilation
* Oxygen therapy prior to stroke
* Non-invasive ventilation therapy prior to stroke
* Hypotension
* Dehydration
* Hypersalivation
* Vomiting
* Pregnancy, parturients, breast feeding
* Absence of consent
Prospective i-FactorTM Analysis Fusion Rate and Quality of Life

Adult spinal deformity surgery is a complex procedure that involves many risks and complications. Bone grafts and bone substitutes are essential to achieve fusion and manage stability in spinal surgery.

Autologous bone has been considered the "gold-standard" for obtaining a spinal fusion. However, the source from which to obtain it is limited. Furthermore, the problems of bone quality in patients with osteoporosis and the morbidity have forced the orthopedic community to seek other options.

I-Factor ™ Bone Graft (Cerapedics, Inc., Westminster, CO) is a compound formed by peptide P-15 bound to an anorganic bone mineral of bovine origin that is composed of porous and smooth hydroxyapatite (ABM) particles.

In the literature there are no articles which identify bone formation with the i-Factor ™ graft in more than 4 instrumented levels, therefore the development of this study will allow assessing the fusion rate and quality of life of patients, which could lead to an improvement in the management and decision-making of surgical procedures, as well as better control of healthcare spending


Eligibility Criteria:
Inclusion Criteria:

* Patients of legal age.
* Patients diagnosed with adult deformity, whether due to scoliosis, imbalance, thoracolumbar curves, etc. In which the minimum number of levels to be instrumented is 5, that is, 4 intervertebral discs.
* Patients who provide their informed consent in writing. (In the event that the patient's circumstances do not allow him to grant consent, this may be provided by the legal representative).
* Present radiological tests, computed tomography and / or magnetic resonance imaging prior to surgery.
* The implants used in the surgery are Cobalt Chrome bars and Titanium screws and interbody cages.

Exclusion Criteria:

* Patients who are expected to be unavailable for follow-up.
* Patients with mental disabilities that make it difficult for them to fill in the questionnaires.
* Patients who have had other types of implants placed, other than Cobalt Chrome bars and Titanium screws and interbody cages.
* Patients who are going to have cemented and / or expansive screws, Peek boxes or another type of material other than Titanium.
* Underlying neurological or neuromuscular disease.
* Underlying inflammatory or tumor disease.
Sizing of the PERCEVAL® Sutureless Aortic Valve Prosthesis Using the CT: a Feasibility Study

This study is to analyse if the size of the valve can be determined with a preoperative CT scan of the heart in order to prepare the valve preoperatively to save time.

Patients with severe aortic stenosis undergo aortic valve replacement (AVR). One approach to reduce trauma and operation time is the implantation of a sutureless valve to reduce aortic cross-clamp time due to the missing necessity of suturing the valve. Until now, sizing of the valve was determined intraoperatively using the measuring devices provided by the product manufacturer. Due to the implantation mechanism, the valve has to be collapsed after determination of the size. This is consuming time and can seriously delay the procedure.

This study is to analyse if the size of the valve can be determined with a preoperative CT scan of the heart in order to prepare the valve preoperatively to save time.

Eligibility Criteria:
Inclusion Criteria:

* Implantation of a Sorin Perceval ® sutureless valve
* availability of preoperative CT scan

Exclusion Criteria:

* denial of consent
* missing preoperative CT scan
* bad quality of preoperative CT scan
A Reduction in C-section Rates Using the Hem-Avert Perianal Stabilizer

A REDUCTION IN C-SECTION RATES USING THE HEM-AVERT® PERIANAL STABILIZER.

This study is being conducted to evaluate an existing FDA approved device called the HEM-AVERT® Perianal Stabilizer for its efficacy in reducing Cesarean births and/or reducing the second stage of labor.

Eligibility Criteria:
Inclusion Criteria:

* Subject is scheduled for vaginal delivery.
* Subject is willing and able to comply with the study plan as indicated by understanding and signing the Subject Informed Consent Form.
* Subjects' pre-natal examination indicates that this is to be a single birth delivery.

Exclusion Criteria:

* Subject's scheduled for vaginal delivery with anticipated complications.
* Subject is unable to understand and sign the informed consent form.
* Subject does not deliver at study facility (hospital).
Study to Assess Long-term Effectiveness of Zomacton® and Treatment Adherence in Patients With Growth Hormone Deficiency or Ullrich-Turner Syndrome

Assessment of long-term effectiveness of ZOMACTON in treatment of Growth Hormone Deficiency or growth retardation due to Ullrich-Turner Syndrome and assessment of compliance and adherence, optionally with the aid of an electronic app or patient diary.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients (\< 18 years) with growth hormone deficiency or growth retardation due to Ullrich-Turner-Syndrome
* Patients already receiving or who have been prescribed Zomacton® de novo according to its German label; the decision to prescribe Zomacton® was made independently from participation and prior to enrollment in this study.
* Patient and their parents (or legal representatives) who are willing and able to provide signed informed consent for use of their personal data.

Exclusion Criteria:

* Participation in an interventional clinical study within the last 30 days prior to baseline visit or during the follow-up period
Clinical Outcomes of Robotic Myomectomy

To identify the predictors of perioperative outcomes in women who receive robotic myomectomy

Uterine myoma is the most common gynecological tumor. Current surgical management was inclusive of conventional abdominal myomectomy, laparoscopy-assisted myomectomy, robotic-assisted myomectomy. The aim of this study was to identify the predictors of perioperative outcomes in women who receive robotic myomectomy

Eligibility Criteria:
Inclusion criteria

* \>20 years old women
* women who received robotic myomectomy
Immediate Implant Placement With Immediate Professionalization in Aesthetic Area

Immediate implant placement with immediate professionalization in the maxillary esthetic zone using mixture of allograft and xenograft vs xenografts to augment the jumping gap

Implant placement in fresh extraction sockets in conjunction with appropriate guided bone regeneration has many benefits, which ultimately affect the total treatment plan. The immediate placement of implants provides significant advantages, including fewer surgical procedures, shorter treatment time, and improved esthetics. The goals of osseous replacement are maintenance of contour, elimination of dead space, and reduce postoperative infection, provide good support for dental implant and enhance bony and soft tissue healing. allograft bone has gold standard over other augment techniques including favorable bone quality and minimal bone resorption.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with badly broken teeth in upper esthetic zone indicated for extraction, presence of at least 4 mm of bone beyond the root apex to guarantee implant primary stability, implant placement within the alveoli confines.
* Both sexes.
* No intraoral soft and hard tissue pathology.
* No systemic condition that contraindicate implant placement.

Exclusion Criteria:

* Presence of fenestrations or dehiscence of the residual bony Walls after extraction.
* Heavy smokers more than 20 cigarettes per day .(24)
* Patients with systemic disease that may affect normal healing.
* Psychiatric problems
* Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.
Evaluation of Gixam's Efficacy Predicting Pre-cancerous Colorectal Polyps and Colorectal Cancer

This is a prospective, single arm, multi-center clinical investigation aim to demonstrate the efficacy of Gixam in predicting the presence of premalignant colorectal polyps and colorectal cancer (CRC) in a fecal immunochemical test (FIT) positive population.

1. Average risk persons eligible for CRC screening that have received a positive FIT outcome in the past 6 months and are scheduled for a screening colonoscopy at one of the participating centers will be offered to participate in the study.
2. Following the informed consent process, subjects will undergo the Gixam test.

   1. A subset of 50 subjects will participate in the repeatability assessment. They will undergo three (3) repetitive Gixam tests one after the other, by the same operator.
   2. Both the subject and the endoscopist will be blinded to the Gixam outcome
3. All subjects will thereafter undergo a standard of care HD-WL colonoscopy procedure.
4. All resected and retrieved lesions will be sent separately for histopathological evaluation.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects aged ≥50 - ≤80 years.
2. Able to provide a signed informed consent.
3. Underwent FIT screening within the past 6 months with a positive result.
4. Scheduled for a FIT positive screening colonoscopy at investigational site.

Exclusion Criteria:

1. Has undergone colonoscopy within the past nine (9) years, except for a failed colonoscopy due to poor bowel preparation, which must have been performed within the past year without therapeutic intervention.
2. Personal history of CRC.
3. Family history of CRC, defined as having one or more first-degree relatives (parent, sibling, or child) with CRC at any age.
4. Subject has a diagnosis or medical / family history of any of the following conditions, including:

   * Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP and Gardner's syndrome),
   * Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome"),
   * Other hereditary cancer syndromes including but are not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Neurofibromatosis, or Familial Hyperplastic Polyposis.
5. Subject has a diagnosis or personal history of inflammatory bowel disease (IBD) including chronic ulcerative colitis, and/or Crohn's disease, and/or IBD-undefined.
6. Subjects with the disability to extend their tongue.
7. Subjects with tongue piercing.
8. Dental visit in the 7 days prior to the Gixam test.
9. Intake of pro-biotics over the past 3 months pre-Gixam test.
10. Subject has any condition that in the opinion of the Investigator should preclude participation in the study.
Efficacy and Safety Study of Adalimumab in Treatment of Hidradenitis Suppurativa

A study to evaluate the safety and efficacy of treatment with adalimumab in adults with moderate to severe hidradenitis suppurativa (HS).

The clinical trial identifier is PIONEER I. The purpose of this study is to evaluate the safety of adalimumab and to determine how well it works in the treatment of adults with moderate to severe HS. HS is a chronic skin disease that creates red, swollen, painful bumps which can break open to combine and form tunnels in the skin and scars. Sometimes these bumps can heal themselves quickly and sometimes they will become much worse and create sores that heal with multiple combined scars, or areas that do not heal. In this study, approximately 300 adults will be enrolled at treatment centers worldwide. Subject participation in this study will be up to 50 weeks. There will be a screening period, which will last from 7 to 30 days, and a study treatment period of up to 36 weeks. Study visits occur at Screening, Baseline, and Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32 and 36 (or sooner if subject leaves the study before Week 36). The study is divided into two treatment periods. The first period (Period A) will last 12 weeks and the second period (Period B) will last up to 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Adults must have a diagnosis of HS for at least 1 year prior to Baseline.
* HS lesions must be present in at least two distinct anatomical areas, one of which must be at least Hurley Stage II or Hurley Stage III.
* Subject must have stable HS for at least 60 days prior to Screening visit and at Baseline visit.
* Subject must have experienced an inadequate response to at least a 90-day treatment of oral antibiotics for treatment of HS.
* Subject must have a total AN count of greater than or equal to 3 at baseline.

Exclusion Criteria:

* Subject was previously treated with adalimumab or another anti-tumor necrosis factor (anti-TNF) therapy (e.g., infliximab or etanercept).
* Subject received any oral antibiotic treatment for HS within 28 days prior to Baseline.
* Subject received oral concomitant analgesics (including opioids) for HS-related pain within 14 days prior to Baseline visit.
* If entering the study on concomitant oral analgesics for non-HS related pain:

  * Subject on opioid analgesics within 14 days prior to Baseline visit;
  * Subject not on a stable dose of non-opioid oral analgesics for at least 14 days prior to the Baseline visit ("as needed" is not considered a stable dose).
microRNAs Role in Pre-eclampsia Diagnosis

Pre-eclampsia is one of the most threatening pregnancy complications. So far neither a secure, competent therapy for PE nor effective biomarkers for a premature discovery has been achieved.The aim of our study was to identify miRNAs 136, 494 and 495 genes expression in exosomes of peripheral blood compared to umbilical cord mesenchymal stem cells conditioned media released exososomes in patients with PE, as valuable markers for PE early prediction.


Eligibility Criteria:
Inclusion Criteria:

To have an uncomplicated pregnancy:

1. gestational age at venipuncture between 20 - 42 weeks
2. no medical, obstetrical, or surgical complications
3. absence of labor at the time of venipuncture
4. delivery of a normal term (≥ 37 weeks) neonate whose birth weight was between the 10th and 90th percentile for gestational age

Exclusion Criteria:

Patients with chronic hypertension, renal disease, and fetuses affected with congenital anomalies were excluded
Buddy Taping Compared to Splint Immobilization for Displaced Paediatric Finger Fractures

Fracture immobilization with Buddy taping is not inferior to Splint immobilization for non-displaced extra-articular paediatric finger fractures. However, whether the same applies for reduced finger fractures is unclear.

Displaced fractures will be reduced in the paediatric ED by Emergency physicians. After fracture reduction, fracture immobilization will either be done with a Splint immobilization or a fingertaping. After 4 and 21 days, clinical and radiographic controls will take place at the Hand surgery outpatient clinic.

Eligibility Criteria:
Inclusion Criteria:

* extraarticular displaced finger fractures of the proximal or middle phalanges

Exclusion Criteria:

* fractures of the thumb
* fractures that are open, instable, pathologic or multifragmented
* multiple fractures of the Hand
* phalangeal neck fractures
* presentation later than 5 days after the injury