cyrilzakka/clinical-trials huggingface dataset:
Australasian Nanoparticle-mediated Magnetically Enhanced Diffusion for Ischemic Stroke

Rapidly restoring blood flow to the brain in patients with stroke caused by a blocked blood vessel in the brain is the key to reducing disability. Current treatments often leave small blocked arteries that cannot be safely opened with mechanical clot removal devices. Furthermore, stagnant flow limits access of clot-dissolving medication to the clot. This trial tests iron nanoparticles (similar to iron infused to replace low body stores but injected directly into the brain artery upstream of the blockage) combined with an external rotating magnet that draws the nanoparticles towards the clot, overcoming stagnant blood flow. The aim is to bring fresh blood which contains naturally-occurring clot-dissolving substances, and any clot-dissolving medication that may be circulating, to the surface of the clot with the aim of restoring blood flow to the brain. The trial will recruit up to 30 patients. All will receive injection of nanoparticles via an angiogram (small tube inserted into a leg or arm artery and fed up into the brain artery under Xray control). The procedure takes 30min and the degree of success in opening the artery at the end of procedure is the primary outcome, combined with an absence of symptomatic brain bleeding at 24h.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with ischemic stroke within 24 hours of the time they were last known to be well
* Patient's age is ≥18 years
* Legal requirements for consent as per local legislative requirements are satisfied.
* Distal medium vessel intracranial arterial occlusion visible on CT-angiography, MR-angiography or catheter digital subtraction angiography (DSA) in the middle cerebral, anterior or posterior cerebral artery. The occlusion may be primary or secondary (ie following initial mechanical thrombectomy of a large vessel occlusion)

Exclusion Criteria:

* Intracranial hemorrhage (ICH) identified by CT or MRI
* Rapidly improving symptoms at the discretion of the investigator
* Pre-stroke mRS score of ≥ 3 (indicating functional dependence)
* Frank hypodensity in \>1/3 of the affected arterial territory on non-contrast CT
* CT Perfusion ischemic core volume \> 100 ml
* Known automated implantable cardiac defibrillator, pacemaker, cerebral aneurysm clip, cochlear implant, cranial neurostimulator or other device implant that is incompatible with the external magnetic field
* Known allergy or sensitivity to iron
* Known hemochromatosis, or known liver disease such as cirrhosis.
* Known aortic dissection
* Suspected septic embolization
* Contra indication to imaging with contrast agents
* Pregnant or lactating women
* Any terminal illness such that patient would not be expected to survive more than 6 months
* Current participation in another investigational drug or device treatment study
* Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
Treatment of Fecal Incontinence by Injection of Autologous Muscle Fibers Into the Anal Sphincter

Aim:

To investigate efficacy and safety in a new treatment with injection of autologous muscle fibers into the anal sphincter in patients with fecal incontinence.

Method:

Patients with fecal incontinence after obstetric anal sphincter rupture will be included. After inclusion, they will be offered 3 months of pelvic floor muscle training. If the patients after completion of pelvic floor muscle training still suffer from fecal incontinence, the patients will be offered treatment with autologous muscle fiber injection into the anal sphincter. The patients will be followed one year after the injection. The autologous muscle fibers are harvested at the patients leg muscle, cut into small pieces and injected into the anal sphincter. A small part of the fibers are used for analysing number of muscle stem cells and thereby the regenerative potential of the sample.

The study is a pilot study.


Eligibility Criteria:
Inclusion Criteria:

* fecal incontinence
* Wexner score \>= 9 or affected quality of life.
* Understanding and speaking danish
* Informed consent

Exclusion Criteria:

* Ongoing pregnancy
* Delivery in the last 12 months
* colostomy
* chronic inflammatory bowel disease (mb. crohn, colitis ulcerosa)
* improvement after pelvic floor muscle training in an extent that makes autologous muscle fiber injection unnecessary.
Evaluation of the Online Chronic Disease Self-Management Project at Group Health

The purpose of this study is to learn if Group Health members who participate in the online chronic disease self-management program will experience improved health outcomes, improved health care utilization, and lower costs.

We will pilot an evidence-based online program for chronic disease self-management that is modeled after the widely-replicated in-person Chronic Disease Self-management Program (CDSMP) developed at Stanford University.

The online CDSMP is an internet-based intervention for people with one or more chronic conditions. It is built on self-efficacy theory and is structured around a formal curriculum that emphasizes problem solving, decision making, and confidence building in weekly sessions over six weeks. The curriculum addresses generic topics and skills that are relevant to managing any chronic condition.

The program is structured around three components: 1) password-protected, interactive web-based instruction; 2) web-based bulletin board discussion groups to enable participatory learning and interaction; 3) and a reference book, Living a Healthy Life with Chronic Conditions, that contains the program content and supplemental information. It is facilitated by two trained lay moderators, at least one of whom has a chronic condition.

Piloting the online CDSMP allows Group Health to learn about and maximize the program's impact in the Group Health system before launching a full-scale program. Since web-based interventions are increasingly recognized as holding promise in health care, our learnings and recommendations will likely be applicable beyond this innovation. The pilot provides GH the opportunity to explore the following about the online CDSMP and web-based tools, in general:

1. Impact of the online CDSMP on participants' psychosocial and health status, health behaviors, and health service utilization
2. Efficient processes for incorporating the online CDSMP into existing operations through use of PDCA cycles
3. An understanding of demographic characteristics of members who are more likely to participate in an online self-management program than an in-person program
4. Effective recruitment and retention strategies
5. Feasibility of sustaining the program without external funding
6. Recommendations for successful implementation of future innovations that utilize web-based media, social networking technology, etc.

Eligibility Criteria:
Inclusion Criteria:

* Group Health member
* Have access to Group Health enhanced online services
* one or more chronic conditions or a caregiver of someone who fits that criteria
* 18 years of age or older

Exclusion Criteria:

* Not a Group Health member
* No access to Group Health enhanced online services
* No chronic conditions and not a caregiver of someone with a chronic condition
* Under 18 years of age
A Study of LY2140023 in Schizophrenia Patients With Prominent Negative Symptoms

The purpose of this study is to determine whether LY2140023, when added to standard-of-care antipsychotic treatment, will improve negative symptoms.

The primary objective of this study was to test the hypothesis that treatment with LY2140023 compared to placebo, when added to a fixed dose of a standard of care (SOC) antipsychotic, would demonstrate significantly greater reduction of negative symptoms, as assessed by the 16-item Negative Symptom Assessment scale (NSA-16), in patients with schizophrenia. Patients included in this study were concurrently receiving 1 of 4 second generation antipsychotics (SGAs): aripiprazole, olanzapine, risperidone, or quetiapine.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of schizophrenia
* Participants must have been receiving monotherapy treatment for at least 3 months prior to study entry with one of 4 atypical antipsychotic medications (aripiprazole, olanzapine, risperidone, quetiapine)
* Disease symptoms must meet a certain range as assessed by the clinician
* Participants must have evidence of prominent negative symptoms of schizophrenia (for example blunted affect, emotional withdrawal, or motor retardation)
* Participants must be considered reliable, have a level of understanding sufficient to perform all tests and examinations required by the protocol, and be willing to perform all study procedures
* Participants must be able to understand the nature of the study and have given their informed consent

Exclusion Criteria:

* Participants who are actively suicidal
* Participants who are pregnant or nursing
* Participants who have had electroconvulsive therapy (ECT) within 3 months of screening or who will have ECT at any time during the study
* Participants with uncorrected narrow-angle glaucoma, history of or current seizure disorder, uncontrolled diabetes, certain diseases of the liver, renal insufficiency, uncontrolled thyroid condition or other serious or unstable illnesses
* Participants with Parkinson's disease, psychosis related to dementia or related disorders
* Participants with known Human Immunodeficiency Virus positive (HIV+) status
visuALL Field Analyzer (vFA) Compared to Standard Humphrey Automated Perimetry

To determine age-adjusted reference values of the visuALL Field Analyzer (vFA) retinal sensitivity and to assess the repeatability of the measured values and compare them with those measured by a Standard Automatic Perimetry (SAP).

Standard Automatic Perimetry (SAP) is the gold standard test for the evaluation of central and peripheral retinal sensitivity to light for detection and monitoring optic nerve diseases such as glaucoma. The current device has its own limitation such as positioning for the duration of the test which makes is hard for older patients especially those with back or other musculoskeletal diseases, artifact of the corrective lenses used to accommodate the patients refractive errors, etc.

Several devices have been developed since the advent of the Octopus Perimeter 3-5 and the Humphrey Field Analyzer (HFA), in an effort to improve the test reliability and patient comfort.

The main goal of this study is to evaluate the repeatability of a novel psychophysical platform that takes advantage of a Head Mounted Device (HMD) with eye tracking capabilities. Other objectives of this study include the development of an initial reference database and comparison of the measured parameters with HFA.

Eligibility Criteria:
Inclusion Criteria:

* age 21 to 80 years
* Healthy subjects with no eye diseases, normal appearing optic nerve and retina, intraocular pressure less than 19 millimeters mercury and normal standard automatic perimetry (SAP).
* mild glaucoma subjects with less than -6 mean deviation
* moderate glaucoma subjects with -6 to -12 mean deviation

Exclusion Criteria:

* spherical refraction outside ± 3.0 diopters and cylinder correction outside 2.0 diopters
* Unreliable SAP (false positives, fixation losses and false negatives greater than 25% and/or observable testing artifacts)
* Unreliable visuALL Field Analyzer (vFA) (greater than 25% false positive, excessive fixation losses)
* SAP abnormality with pattern loss consistent with neurologic and/or other ocular diseases than glaucoma
* Intraocular surgery in study eye (except non-complicated cataract or refractive surgery performed more than 6 months before enrollment and without posterior capsule opacification)
* History of systemic condition known to affect visual function
* History of medication known to affect visual function
Aflibercept in Patients With Pigment Epithelial Detachments (PED)

Uncontrolled single site non randomized non interventional study to determine the safety and efficacy of intravitreal injections of Aflibercept in patients with recent vision loss due to retinal pigment epithelial detachment secondary to AMD


Eligibility Criteria:
Inclusion Criteria:

* Patients with vascular PED due to AMD
* Male or female patients with the age \> 50 years
* Angiographic and via OCT ensured PED ≥ 200 µm in the eye for treatment
* Written informed consent
* Best corrected visual acuity (ETDRS-Visus): 24 - 73 letters within

Exclusion Criteria:

* Patients that do not fulfill the a. m. inclusion criteria
* Patients which have been treated with steroids or with verteporfin via photodynamic therapy or focal lasercoagulation treatment until 3 months before,
* Anti VEGF therapy until 1 month before screening
* Patients with other retinal vascular diseases including diabetic rethinopathia or retinal vein occlusion
* Other ocular operative procedurs 3 months before Screening
* Anamnesis of non controlled glaucoma
* Active or intraocular Inflammation or Inflammation of ocular adnexa
* Subfoveal fibrosis within study eye
* Larger surgical interventions 1 month before Screening
* Anamnesis of serious cardiovascular diseases or stroke 6 months before srceening
* Allergy of components of the study medication
* Patients which might be not compliant
* Patients participating at another clinical trial at the same time
* Pregnancy, breastfeeding, women in child-bearing years without using a safe contraception method
* Chronical alcohol- or drug abuse within the last year
* lack of capacity and/or knowledge of German language
* Neurologic disease i. e. multiple sclerosis
Pancreaticogastrostomy Versus Pancreaticojejunostomy With Dunking Technique After Pancreaticodudenectomy: A Prospective Randomized Comparative Study

To compare between the outcomes of pancreaticogastrostomy and pancreaticojejunostomy with dunking technique after Pancreaticodudenectomy in the treatment of operable periampullary malignancies.

Pancreaticoduodenectomy remains the treatment of choice for periampullary malignancies. Advances in pancreatic surgery techniques and perioperative care have led to reduced mortality rates for Pancreaticodudenectomy \[1\]. However, morbidity after pancreatic resection remains high, with 30-60% of patients experiencing complications following surgery, mainly as a result of leak and subsequent fistula from the pancreatic anastomosis \[2\].The leakage of the pancreatic anastomosis remains the most serious problem as it is the major cause of morbidity after pancreaticoduodenectomy, and also contributes significantly to prolonged hospitalization \[5\]. For this reason, surgeons have always directed their efforts at reducing the rate of pancreatic fistula through the introduction of new and effective methods of construction of the pancreatic anastomosis \[6\]. Various techniques have been described for joining the pancreatic stump either with the jejunum or with the stomach, with or without internal or external drainage of the pancreatic duct. Recently, new prospective randomized studies have demonstrated the advantage of pancreaticogastrostomy over pancreaticojejunostomy in reducing the incidence of pancreatic fistula \[3\]; however, none of these techniques has proved to be superior in minimizing postoperative mortality and morbidity \[4\]. One of the difficulties of pancreatic reconstruction after pancreaticoduodenectomy is the presence of soft pancreas which leads to high risk of fistula so dunking technique was raised \[8\]. But few researches or papers have focused on its efficacy and even fewer papers have discussed dunking in pancreaticogastrostomy and pancreaticojejunostomy, So this is the interest of our study to compare between the efficacies of these two techniques.

Eligibility Criteria:
Inclusion Criteria:

* All cases of resectable periampullary carcinomas (cancer head of pancreas, ampullary carcinoma, distal cholangiocarcinoma and second part of duodenum adenocarcinoma) that are surgically fit according to ASA.

Exclusion Criteria:

* 1. Surgically unfit cases according to ASA 2. Locally advanced irresectable cases
* Abutment or encasement of coeliac trunk
* Encasement of SMA less than 180 degree of its axis
* Encasement of portal/SMV more than 180 degree of its axis or infiltration segment too long more than 2.5 cm that the remaining segment will not coapts after resection.

  3. Metastatic disease
Remote Endarterectomy Versus Suprageniculate Femoropopliteal Bypass

The objective of this study is to compare remote superficial femoral artery endarterectomy with suprageniculate bypass surgery in the treatment of long occlusions of the superficial femoral artery. The study hypothesis is that patency rates are comparable and therefore the minimal invasive remote superficial femoral artery endarterectomy can be considered in patients presenting with a long occlusion of the superficial femoral artery.

Different strategies exist in the treatment of chronic long occlusions of the superficial femoral artery and yet we still suffer a significant percentage of restenosis, re-occlusions and even major amputations, reason for continuous development of new techniques. One such technique is the recently developed minimal invasive remote endarterectomy, which shows promising patency rates and possibly less complications with earlier recovery. A more experienced and the most implemented technique is the suprageniculate femoropopliteal bypass graft, which, when using the saphenous vein, has proved durable. A randomized trial comparing both modalities was lacking so far, what makes the objective of this study a comparison of patency rates between those 2 techniques in a randomized fashion.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with Fontaine IIB, III, IV ischemia
* Long (\>10 cm) occlusion of the superficial femoral artery, with patent popliteal artery and at least 1 patent crural vessel
* Atherosclerotic disease

Exclusion Criteria:

* Previous operations on the superficial femoral artery
* Radiation therapy groin/leg region
* Diameter superficial femoral artery \< 4 mm
* Contrast allergy
Outcomes of RV Dysfunction in Acute Exacerbation of Chronic Respiratory Diseases

Observational study in patients with chronic respiratory diseases (chronic obstructive pulmonary diseases, bronchiectasis, interstitial lung diseases, neuromuscular diseases, obesity-hypoventilation syndrome...) admitted in intensive care unit for acute respiratory failure. The main objective is to determine the prevalence of right ventricular (RV) dysfunction in this population and to analyze the impact of such a complication on outcomes (survival at day-28, duration of non-invasive or mechanical ventilation, duration of hospital stay). RV function will be assessed by echocardiography at admission, after 3 days and at discharge. Plasma NT-proBNP and troponin levels will be collected.

Observational study in patients with chronic respiratory diseases (chronic obstructive pulmonary diseases, bronchiectasis, interstitial lung diseases, neuromuscular diseases, obesity-hypoventilation syndrome...) admitted in intensive care unit for acute respiratory failure.

Inclusion Criteria:

* Chronic respiratory disease (COPD, ILD, OHS...)
* Admission in ICU for acute respiratory failure
* Patient's non-opposition

Exclusion Criteria:

* Patients \< 18 year-old
* Protected patients
* Pregnant women The main objective is to determine the prevalence of right ventricular (RV) dysfunction in this population and to analyze the impact of such a complication on outcomes (survival at day-28, duration of non-invasive or mechanical ventilation, duration of hospital stay). RV function will be assessed by echocardiography at admission, after 3 days and at discharge. Plasma NT-proBNP and troponin levels will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Chronic respiratory disease (COPD, ILD, OHS...)
* Admission in ICU for acute respiratory failure
* Patient's non-opposition

Exclusion Criteria:

* Patients \< 18 year-old
* Protected patients
* Pregnant women
A Study to Assess the Effect of YM150 for Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery

The purpose of the study is to evaluate the efficacy and safety of the oral dose of YM150 for prevention of venous thromboembolism (VTE) in patients undergoing major abdominal surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients after a major abdominal surgery
* Written informed consent obtained

Exclusion Criteria:

* Subject has history of symptomatic deep vein thrombosis and/or pulmonary embolism
* Subject has a hemorrhagic disorder and/or coagulation disorder
* Subject has had clinically important bleeding occurred within 90 days prior to the screening visit
* Subject has an active bacterial endocarditis
* Subject has uncontrolled severe or moderate hypertension, retinopathy, myocardial infarction or stroke
* Subject is receiving anticoagulants/antiplatelet agents
* Subject has a thrombocytopenia
* Body weight less than 40 kg at the screening
Pre-operation Chemo and Antibody Therapy Followed by Surgical Resection and Adjuvant Chemoradiation for Gastric Cancer

This study intends to evaluate the feasibility and treatment efficacy of adding an antibody blocking the epidermal growth factor (EGF) pathway to a neoadjuvant approach with proven efficacy developed at New York University.

The overall objective of this study is the development of definitive treatments for patients with locally advanced gastric cancer. To this end, this trial is evaluating the feasibility and treatment efficacy of adding an antibody blocking the EGF pathway to a neoadjuvant approach with proven efficacy developed at New York University (NYU). The combination of Irinotecan and Cisplatin has been shown to be synergistic and active against gastric carcinoma. This trial therefore builds upon NYU previous experience with the neoadjuvant administration of Irinotecan combined with Cisplatin as well as the reported enhanced activity of Irinotecan, Cisplatin and External beam radiation when combined with Cetuximab to develop a novel neoadjuvant and adjuvant approach for the treatment of gastric and gastro-esophageal junction (GEJ) cancers. The program includes: 1) systemic combination of Irinotecan, Cisplatin and Cetuximab used as an induction, 2) followed by potentially curative gastrectomy or GEJ resection, and 3) post-operative chemoradiation as reported in the Intergroup study with the addition of Cetuximab.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have signed an approved informed consent.
* must have histologically documented untreated gastric/GEJ carcinoma (clinical stage T3 N0 or T4, or any T with N1-N3 M0)
* Patients with tumor tissue available for assessment of EGF receptor status by immuno-histochemistry (IHC).
* Patients with Performance Status 0-2.
* Patients, 18 years and older, must either be not of child bearing potential or have a negative pregnancy test within 7 days of treatment. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
* Bone marrow function: absolute neutrophil count (ANC) at least 1,500/ul; platelets at least 100,000/ul.
* Renal function: creatinine not greater than 1.5 x institutional upper limit of normal (ULN).
* The PT and PTT should be within the range of normal values
* Hepatic function: bilirubin not greater than 1.5 x ULN; aspartate aminotransferase (AST) not greater than 2.5 x ULN.

Exclusion Criteria:

* Acute hepatitis or known HIV.
* Active or uncontrolled infection.
* Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, and congestive heart failure.
* Prior therapy that affects or targets the EGF pathway.
* Prior allergic reaction to chimerized or murine monoclonal antibody therapy or documented presence of human anti-mouse antibodies (HAMA).
* Any concurrent chemotherapy not indicated in the study protocol or any other investigational agent(s).