cyrilzakka/clinical-trials huggingface dataset:
Assessment of Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Crohn's Disease and Ulcerative Colitis Patients´ Adherence Attitudes to Maintenance Therapy With a Scheduled Adalimumab Treatment in Routine Clinical Practice

The purpose of this non-interventional, multicenter, post-marketing observational study (PMOS) was to assess rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), plaque psoriasis (PS), Crohn's disease (CD) and ulcerative colitis (UC) patients' adherence attitudes (beliefs) to maintenance therapy with adalimumab monotherapy or combination therapy with methotrexate (in participants with RA) and to investigate whether there were correlations between such beliefs and adherence to maintenance treatment.

Adalimumab was prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication. The assignment of a participant to an adalimumab-containing regimen was decided in advance and was to be current practice. The prescribing of adalimumab was clearly separated from the decision to include the participant in the study. Participants were observed for a maximum of 12 months, with a total of 5 study visits (Screening = Visit 1).

Eligibility Criteria:
Inclusion Criteria:

* Participants ≥18 years of age with rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), plaque psoriasis (PS), Crohn´s disease (CD), or ulcerative colitis (UC)
* Participants must fulfill international and national guidelines for the use of a biologic disease-modifying antirheumatic drug (bDMARD) in RA, PsA, AS, PS, CD, or UC (chest X-ray and interferon gamma release assay (IGRA) or purified protein derivative (PPD) skin test negative for tuberculosis)
* In addition one of the following criteria must be fulfilled:

  1. unsatisfactory DMARD response defined as treatment failure with at least two DMARDs including methotrexate in participants with RA or PsA
  2. unsatisfactory nonsteroidal anti-inflammatory drug (NSAID) response in participants with AS
  3. unsatisfactory response to prior bDMARDs in participants with RA, PsA, or AS
  4. unsatisfactory response to, contraindication to, or intolerance to other systemic therapy including cyclosporine, methotrexate, or psoralen with ultraviolet A light (PUVA) in participants with PS
  5. unsatisfactory response despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or intolerance or medical contraindications for such therapies in CD
  6. unsatisfactory response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or intolerance to or medical contraindications for such therapies in UC

Exclusion Criteria:

* Participants who are not covered in the latest version of the adalimumab Summary of Product Characteristics (SPC) for the syringe and pen
* Participants currently enrolled in another study program or clinical trial
* Participants who have been treated with adalimumab before
0.05 Versus 0.1 mg Spinal Morphine for Reducing Morphine Requirement After Vaginal Hysterectomy

This study aims to compare the efficacy of 0.05 mg and 0.1 mg spinal morphine in reducing postoperative morphine requirement in patients undergoing vaginal hysterectomy with/without anterior and posterior vaginoplasty.


Eligibility Criteria:
Inclusion Criteria:

* Female ASA physical status 1-3
* Undergoing vaginal hysterectomy with/without anterior and posterior vaginoplasty
* Be able to operate patient-controlled analgesia (PCA)

Exclusion Criteria:

* Allergy to the study drugs
* History of bleeding tendency
* Infection at the back
* Refuse to spinal anesthesia
* History of CAD or CVA
Goblet Cell Degranulation Produced by Intranasal Tear Neurostimulator (ITN) in Dry Eye Disease

The purpose of this study is to evaluate goblet cell degranulation following acute use of the Intranasal Tear Neurostimulator in participants with dry eye.


Eligibility Criteria:
Inclusion Criteria:

* Capable of giving verbal and signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
* Have not worn contact lenses for at least 7 days prior to the screening visit and are willing to forego the use of contact lenses for the duration of the study
* The participant should be literate, able to speak English, and able to complete questionnaires independently

Exclusion Criteria:

* Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the investigator, may lead to clinically significant increased bleeding
* Nasal or sinus surgery (including history of application of nasal cautery) or significant trauma to these areas
* Cardiac demand pacemaker, implanted defibrillator or other implanted electronic device
* Corneal transplant in either or both eyes
* Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study
* Women who are pregnant, planning a pregnancy, or nursing throughout the study
Hematopoietic Stem Cell Transplantation for Patients With Thalassemia Major: A Multicenter, Prospective Clinical Study

The only curative therapy for thalassemia major remains the replacement of the defective erythropoiesis by allogeneic hematopoietic stem cell transplantation(allo-HSCT). We conduct a prospective multicenter study to evaluate the efficacy of allo-HSCT in the treatment of thalassemia major.

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is one of the established curative option for thalassemia major (TM). Previous study has predicted that more than 90% of TM patients can survive after allo-HSCT with a thalassemia-free survival (TFS) in around 80% of them.The purpose of this study is to evaluate the efficacy of allo-HSCT in the treatment of thalassemia major.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with thalassemia major.
2. Indication of hematopoietic stem cell transplantation.
3. A cardiac ejection fraction of \>50%; normal pulmonary function tests and pulmonary examination results; and normal kidney function.

Exclusion Criteria:

1. Aspartate aminotransferase levels \> 4-fold the upper limit of the normal range for our institution's lab criteria;
2. Uncontrolled bacterial, viral or fungal infections;
3. Any other restriction for transplantation.
A Clinical Study Evaluating the Safety and Efficacy of BinD19 Treatment in R/R ALL and Lymphoma Subjects

This is a single arm, open-label, uni-center, phase I/II study to determine the safety and efficacy of an experimental therapy called BinD19 cells in patients with B-cell acute lymphoblastic leukemia or lymphoma, who are chemo-refractory, relapsed after allogeneic SCT, or are otherwise ineligible for allogeneic stem cell transplant.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects with CD19+ B cell malignancies in patients with no available curative treatment options (such as autologous or allogeneic SCT) who have limited prognosis (several months to \< 2 year survival) with currently available therapies will be enrolled.
* CD19+ leukemia or lymphoma
* Not eligible for allogeneic SCT because of age, comorbid disease, or lack of available family member or unrelated donor
* Follicular lymphoma, previously identified as CD19+:
* Disease responding or stable after most recent therapy (chemotherapy, MoAb, etc)
* ECOG result is 0, 1 or 2.
* With normal heart, liver and kidney functions.
* Negative serum antibody for EBV, CMV, HBV, HCV, HIV and syphilis.
* Negative in pregnancy test （female subject only).

Exclusion Criteria:

* ECOG result is 3, 4 or 5.
* Pregnant or lactating women
* Uncontrolled active infection
* Active hepatitis B or hepatitis C infection
* Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary
* Previously treatment with any gene therapy products
* HIV infection
* Enrolled to other clinical study in the last 4 weeks.
* Subjects with systemic auto-immune disease or immunodeficiency.
* Subjects with CNS diseases.
* Subjects with secondary tumors.
* Subjects with tumor infiltration in liver, brain or GI tract.
Remote Ischemic Preconditioning in High Risk Cardiovascular Surgery Patients

Remote ischemic preconditioning (RIPC) occurs when a tissue (ex. heart) becomes less vulnerable to an ischemic insult if a remote tissue (ex. arm) has had previous exposure to a period of ischemia and reperfusion. A beneficial effect of RIPC has been demonstrated in several randomized studies in patients undergoing cardiac and vascular surgery, as well as interventional cardiac procedures such as angioplasty. They have shown improvements in cardiac, renal, neurologic and respiratory function. Most have focused on surrogate outcomes, such as biochemical markers of cardiac and renal function in low-risk patients. No trials have investigated only high-risk patients or been designed to detect clinical outcomes.

This study is a randomized-controlled trial powered to detect clinical events in a high-risk cohort undergoing cardiovascular surgery. Patients will be randomized to RIPC (exposed to cycles of inflation of a blood pressure cuff on the upper arm prior to undergoing surgery) or control (no ischemic stimulus).

The investigators hypothesize this population will demonstrate lower rates of adverse ischemic events. The investigators also intend to sample biochemical markers to better elucidate the mechanism of RIPC and generate hypotheses for future studies and interventions. Post-operatively the investigators will monitor for adverse clinical outcomes including cardiac, renal, pulmonary and neurologic injury.

RIPC is simple, inexpensive and easily reproducible and there have been no reports of adverse consequences. Post-operative ischemic events such as stroke, myocardial infarction, cardiac, renal and respiratory failure affect patient survival and quality of life, and represent a sizeable financial burden to health care. If beneficial effects of RIPC are demonstrated, it will be widely applicable to the entire population of cardiac and vascular patients resulting in a widely-implemented change in practice.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing either cardiac or vascular surgical procedures and are deemed to be at increased risk of suffering adverse ischemia-related events (judged by pre-operative evidence of clinical ischemic conditions, pre-operative screening indicating cardiovascular disease or undergoing higher-risk surgery).

Exclusion Criteria:

* Will not include emergency cases, patients with known vascular disease (ex. arterial occlusive disease, arterio-venous shunts) or neurologic disease affecting the upper limb and patients unable to give informed consent.
Evaluation of Consistency of StaphVAX Manufacturing Lots

This study answers a U.S. Food and Drug Administration requirement for evaluation in people of the consistency of manufacturing of a vaccine. Subjects are randomized to one of three lots of vaccine. The antibodies in the blood measure the immunogenicity of each lot of vaccine, and typical vaccine safety information is also collected.


Eligibility Criteria:
Inclusion Criteria:

* healthy,
* written informed consent,
* negative serum pregnancy test if appropriate,
* expect to comply with protocol procedures and schedule

Exclusion Criteria:

* known HIV,
* immunomodulatory drugs,
* malignancy (other than basal cell or squamous cell carcinoma, carcinoma in situ of the cervix, or early stage prostate cancer),
* active infection in the 2 weeks prior to study injection,
* serious S. aureus infection within the last 3 months prior to injection,
* use of investigational drugs, vaccines or devices within the prior 30 days,
* hypersensitivity to components of StaphVAX
Impact of Propofol Versus Sevoflurane on Incidence of Postoperative Delirium in Elderly Patients After Spine Surgery

Postoperative delirium in older adults is a common and costly complication after surgery. Propofol and sevoflurane are commonly used anesthetics to maintain sedation during spine surgery, and have different sedative and anti-inflammatory effects. The aim of this trial will be compare the impact of propofol versus sevoflurane on incidence of postoperative delirium in elderly patients after spine surgery.

Spine surgery is the third most common surgical procedure in older patients. With the increasing number of older patients undergoing spinal surgery, the risk of delirium after spinal surgery is currently expected to increase. The pathophysiological mechanisms of delirium remain poorly understood, leading models include neurotransmitter imbalance and neuroinflammation. Among precipitating factors, drugs (especially sedative hypnotic agents and anticholinergic agents), surgery, anesthesia, high pain levels, anemia, infections, acute illness, and acute exacerbation of chronic illness are the most commonly reported. Propofol and sevoflurane are commonly used anesthetics to maintain sedation during spinal surgery, and induce unconsciousness through different mechanisms. Meanwhile, previous studies have found that propofol and sevoflurane have different anti-inflammatory effects. Given their different sedative and anti-inflammatory effects, propofol and sevoflurane may have different effects on postoperative delirium. There are many studies to explore the effects of propofol and sevoflurane on postoperative delirium, but the conclusions are controversial. Therefore, a randomized, controlled, double-blind clinical study was designed to compare the impact of propofol and sevoflurane on delirium after spine surgery in elderly patients.

Eligibility Criteria:
Inclusion Criteria:

1. age ≥65 years and ≤90 years;
2. scheduled to undergo surgery for spinal, under general anaesthesia;
3. American Society of Anesthesiology (ASA) I-III;
4. agree to participate, and give signed written informed consents.

Exclusion Criteria:

1. family history or history of malignant hyperthermia;
2. History of propofol or sevoflurane allergy;
3. demonstrated cognitive impairment on the modified Mini-Mental State Examination (score, \<24of 30 or \<20 of 30 if the patient's education year was less than 6 years or\<17 if the patient is Illiterate);
4. planned postoperative intubation or transferred to ICU;
5. severe visual or auditory handicap;
6. prior diagnoses of neurologic diseases or mental disorders (e.g., stroke, Parkinson's disease, dementia, schizophrenia, or depressive illness)
7. take anticholinergic drugs or other drugs acting on the central nervous system for a long time before operation
8. participating in other clinical studies in recent 3 months
Fusion Imaging for EVAR With Mobile C-arm

Fusion imaging is a technique that facilitates endovascular navigation but is only available in hybrid rooms. The goal of this study is to evaluate the feasibility of fusion imaging with a mobile C-arm in a conventional operating room through the use of an angio-navigation station.

The study include all patients who underwent an aortic stent graft procedure in a conventional operating room with a mobile flat-panel detector (Cios Alpha, Siemens) connected to an angio-navigation station (EndoNaut, Therenva). The intention is to perform preoperative 3D CT/perioperative 2D fluoroscopy fusion Imaging using an automatic registration process. Registration is considered successful when the software was able to correctly overlay preoperative 3D vascular structures onto the fluoroscopy image. For EVAR, contrast dose, operation and fluoroscopy time were compared to those of a control group drawn from the department's database who underwent a procedure with a C-arm image intensifier.

Eligibility Criteria:
Inclusion Criteria:

Patients eligible for endovascular treatment of aneurysm disease of the aorta. Procedure performed in a conventional operating room equipped with a mobile flat-panel detector (30´30 cm) (Cios-Alpha, Siemens®, Munich, Germany) and a floating table.

Patients who received written and verbal information about the protocol and did not object to participating in the trial.

Exclusion Criteria:

Patients who also required a conventional surgical revascularisation procedure or who required an endovascular revascularisation procedure in another site.

Patients who underwent MR angiography during preoperative evaluation. Non-analysable CT angiogram (no or poor injection). Procedure performed in a hybrid room or in an operating room not equipped with a mobile flat-panel detector.
Biodegradable Biliary Stent for Post Operative Cystic Duct Leakage

Endoscopic sphincterotomy and temporary stenting is a routine treatment for post cholecystectomy cystic duct leakage. The draw back is that the plastic stent need to be removed later in a second intervention. Our studies with animal models have demonstrated that biodegradable biliary stent is at least as good as conventional plastic stent to heal that kind of leakage. In this pilot study the biodegradable biliary stent is inserted endoscopically to patients with confirmed cystic duct leakage to demonstrate the efficacy in human setting.


Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed post cholecystectomy cystic duct leakage requiring endoscopic treatment
Persons With Disabilities Generating Quality Metrics

No standard way exists to measure the quality of medical care or independent living long-term services and supports provided to persons with disabilities. This project will: provide a broader picture of how consumers with disabilities define care and care quality; measure the value of using consumers' expertise in developing, collecting, and assessing quality measures; and use this information to assist One Care providers in improving care delivered to their enrollees

The aims of the project are as follows:

1. To work with persons with significant physical disabilities and serious and persistent mental illness to develop two new approaches to assess quality of care:

   Approach #1: We will survey enrollees about their experiences in One Care and their thoughts about the care they receive. This survey will also ask One Care enrollees about how they manage their care and what self-direction means to them. The survey will be called the Persons with Disabilities Quality Survey (PDQ-S), and it will be available in English and Spanish versions.

   Approach #2: Enrollees in One Care will provide information about their perceptions of care quality to a trained team of persons with disabilities who will report the information to One Care care teams. The goal of the activity is to support quality improvement in One Care through hearing the consumer's voice. This is called YES Health - Your Experience: Speak up for better health care.
2. We want to test how providing consumer informed and consumer directed quality information to One Care providers affects One Care quality.
3. We want to improve the ability of One Care enrollees to manage their own health care and to recognize and report quality problems

Eligibility Criteria:
Inclusion Criteria:

* One Care enrollee
* Permanent physical disability and/or serious mental illness
* Seen at designated practice site
* English or Spanish speaking

Exclusion Criteria:

* Persons with an intellectual or a developmental disability
Manual Lymphatic Drainage in Women Undergone to Thigh Lifting

This study will investigate the subcutaneous tissue changes in the lymphedema found after thigh surgery, by circumferential measure of thr thighs and by magnetic resonance imaging verifying the effects of postoperative lymphatic drainage.

Patients will be invited to participate in the study, divided into two groups, and randomized to treatment by wwww.randomization.com, where 10 patients will participate in the study group(20 legs) and 10 control group patients(20 legs). Total of 40 legs. Then, the evaluation will be performed on preoperative time, consisting of physical examination and circumferential measures. Others measurements will be taken im postoperative time and confirmed by magnetic resonance.

Eligibility Criteria:
Inclusion Criteria:

* Female patients
* Age between 30 and 60 years old
* Bariatric Surgery Capella Previous Type
* Stabilization of weight loss for 1 year or more
* Patients with a body mass index less than or equal to 30 kg/m2

Exclusion Criteria:

* Pregnancy, childbirth or breastfeeding for less than 1 year
* Presence of uncontrolled systemic disease
* Other disease that require surgical interventions
* Lymphatic or venous pathologies in advance
* Patients over 110 kg
* Patients with a body mass index(BMI) greater than 30 kg/m2
* Patients who has undergone plastic surgery of the thighs
Fluid Balance Neutralization During CRRT (Continuous Renal Replacement Therapy)

Fluid overload is associated with increased mortality in critically ill patients with acute kidney injury. Fluid balance controlled is associated with improved outcome in observational studies, and is deemed safe in interventional trials.

The objective of the study is to keep fluid balance neutral by matching the net ultrafiltration rate to fluid inputs in patients with vasoplegia, and treated with continuous renal replacement therapy (CRRT), while insuring its security using advanced hemodynamic monitoring with continuous cardiac output monitoring.


Eligibility Criteria:
Inclusion Criteria:

* Patient 18 yo or more, affiliated to a social security system
* Treated with vasopressors for acute circulatory failure
* With KDIGO stage 3 acute kidney injury
* Treated with continuous renal replacement therapy for less than 24 jours
* Monitored with a calibrated continuous cardiac output device

Exclusion Criteria:

* Treatment by ECMO (extracorporeal membrane oxygenation)
* Active hemorrhage necessitating transfusion
* Maintenance dialysis or renal graft recipient
* Switch to intermittent hemodialysis is scheduled in the next 72 hours
* Acute cerebral stroke complicated by coma and under mechanical ventilation
* Acute fulminant hepatitis
* Postural maneuver (passive leg raising or Trendelenburg) cannot be performed (amputation, inferior vena cava obstruction)
* Pregnancy or lactating
* Withdrawal or limitation of care
* Moribund patient
* Patient under protective measures/wardship
* Inclusion in another trial whose main outcome is cumulative fluid balance, or whose intervention targets hemodynamic physiology, fluid balance or net ultrafiltration.
* Patient previously enrolled in the same study
Improving Childhood Immunization

Specific Aim: To improve childhood immunization rates by utilizing automated Electronic Health Record-derived provider-specific performance feedback reports, coupled with automated Electronic Health Record-derived trigger alerts.

Hypothesis: The automated Electronic Health Record-derived provider-specific performance feedback reports will result in a 50% decrease in unimmunized children ages 0-13 years of age, when coupled with automated Electronic Health Record-derived trigger alerts, compared with trigger alerts alone.


Eligibility Criteria:
Inclusion Criteria:

* all pediatric resident providers in Harriet Lane Clinic at Johns Hopkins University

Exclusion Criteria:

* none