cyrilzakka/clinical-trials huggingface dataset:
A Feasibility Study of the Surpass Aneurysm-Embolization System in Intracranial Arteries

The purpose of this study is to evaluate safety and performance of the Surpass Aneurysm-Embolization System.


Eligibility Criteria:
Inclusion Criteria:

* Subject understands the nature of the procedure and provides written informed consent.
* Subject is willing to return to the investigational site for the thirty day and six month follow-up evaluations.
* Age 18 years to 80 years.
* Subject with a non-ruptured saccular, or fusiform intracranial aneurysm arising from a parent vessel with a diameter of \> 2mm and \< 6mm.

Exclusion Criteria:

* Pregnancy
* Enrollment in another trial
* Allergy or contraindication to aspirin, clopidogrel, heparin, local or general anesthesia
* History of life threatening allergy to contrast dye.
* Major surgery within previous 30 days or planned in the next 90 days after enrollment date.
* Severe neurological deficit that renders the patient incapable of living independently
* Dementia or psychiatric problem that prevents the patient from completing required follow up
* Co-morbid conditions that may limit survival to less than one year
* Subject with anatomy not appropriate for endovascular treatment due to severe intracranial vessel tortuosity or stenosis, or intracranial vasospasm not responsive to medical therapy.
* Subject with an intracranial mass (tumor (except meningioma), abscess, or other infection), or is undergoing radiation therapy for carcinoma or sarcoma of the head or neck region.
* Subject has a history of bleeding diathesis or coagulopathy, international normalized ratio (INR) greater than 1.5, or will refuse blood transfusions.
* Subject has a serum creatinine level greater than 2.0 mg/dL (within 7 days of procedure) which the investigator determines restricts the use of contrast agents.
* Subject has a previously implanted intracranial stent associated with the symptomatic distribution within the past 12 weeks prior to enrollment date
* Stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to enrollment date
* Subject has a previously implanted carotid stent associated with the symptomatic distribution within the past 12 weeks prior to enrollment date
* Subject has uncontrolled atrial fibrillation or known cardiac disorders likely to be associated with cardioembolic symptoms.
* Subject had a subarachnoid hemorrhage within 12 weeks prior to the enrollment date.
* Subject with resistance to ASA and/or Clopidogrel.
* Subject with two or more aneurysms in associated distribution - unless the device is used to treat both aneurysms.
* Subject has a non-treated arteriovenous malformation (AVM) in the territory of the target aneurysm.
* Target aneurysm is expected to require more than one device.
Pharmacokinetic Study of Antibiotics in Patients Assisted by Extracorporeal Membrane Oxygenation (PHARMECMO)

The PHARMECMO study is a pilot, prospective, pharmacokinetic study, conducted in a cardiac surgery intensive care unit of 18 beds. Optimization of antibiotic therapy for extracorporeal membrane oxygenation (ECMO) patients remains a pharmacological challenge. Clinical studies suggest that individualized dosing strategies and therapeutic drug monitoring could facilitate the achievement of adequate antibiotic concentration. The objective of this pilot study was to observe the pharmacokinetic characteristics of commonly used antibiotics in intensive care for patients treated with extracorporeal membrane oxygenation.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Extra corporeal membrane oxygenation treatment
* Parenteral antibiotherapy for known or suspected sepsis
* Informed consent

Exclusion Criteria:

* Refusal of participation
* Pregnancy
* Burned patient
* Steady state conditions not reached
* Non-intravenous administration of antibiotherapy
Treatment and Outcome of Early Onset Bipolar Disorder

This study will compare the effectiveness in the maintenance of continuing adjunctive atypical antipsychotic medication compared to traditional mood stabilizer(s) alone in the maintenance treatment of adolescents with bipolar disorder.

In children and adolescents, bipolar disorder is often accompanied by symptoms such as hallucinations, delusions, or paranoia that require acute treatment with a combination of an atypical antipsychotic medication and a mood stabilizer. It is not known if it is necessary to continue treatment with the atypical antipsychotic medication after the child's symptoms have remitted.

Participants in this study are treated with lithium, divalproex (Depakote), and one of the following atypical antipsychotic medications: olanzapine (Zyprexa), risperidone (Risperdal) or quetiapine (Seroquel) for at least 24 weeks. Participants who have already begun combination therapy with at least one of the mood stabilizers and atypical antipsychotic medications listed above are also encouraged to enroll in this study. After participants have been on combination therapy for at least 24 weeks they will then be randomly assigned to one of two groups. The first group will continue to receive active mood stabilizer and atypical antipsychotic medication. The second group will receive active mood stabilizer and placebo. Participants are assessed weekly and followed for up to 18 months.

Eligibility Criteria:
Inclusion criteria:

* Have a diagnosis of Bipolar I Disorder;
* Have had aggressive and/or psychotic features (delusions, hallucinations and/or thought disorder) during the most recent manic episode;
* Is willing to be treated or is already being treated with the combination of mood stabilizer(s) (lithium or Depakote) and an atypical antipsychotic medication (Abilify, Geodon, Risperdal, Seroquel, or Zyprexa);
* Live in the NY Metropolitan area;
* Able to attend weekly to biweekly office visits

Exclusion Criteria:

* Medical contraindication to treatment with lithium and divalproex
* Seizure disorder
* Pregnancy
* Unwillingness to use acceptable methods of birth control if sexually active
* IQ less than 70
* Substance-induced mood disorder or mood disorder due to a general medical condition
* Prior experience with re-emergence of psychotic features or severe aggression within 6 months of antipsychotic medication discontinuation under circumstances similar to those in the study
* Potentially lethal suicide attempts or infliction of serious injury upon someone during most severe bipolar episode
* High risk for running away or truancy
Ultrasound-assisted Thoracic Epidural Catheter Insertion

The aim of the present study is to access the success rate of ultrasound-guided thoracic epidural catheter insertion, using fluoroscopy.

Thoracic epidural anesthesia has been associated with reduced acute postoperative pain for a wide variety of surgical procedures. It has also been associated with reductions in perioperative cardiac stress, chronic post-thoracotomy pain, and improvements in postoperative pulmonary function. Although a variety of methods can be used to confirm the position of the epidural needle in the epidural space, a blind technique and fluoroscopic guided approach are a widely used method. A thoracic epidural block is a relatively more difficult procedure than procedures used in other regions, because the spinous process of the thoracic vertebra is longer than that of the lumbar vertebra, and the area through which the needle can approach the epidural space is relatively smaller due to an acute angle and larger distance between the skin and the epidural space. Therefore, the success rate of thoracic epidural intervention is only about 68% under a blind technique due to inadequate position of the needle tip, misplacement, occlusion, and migration of the catheter.

Although fluoroscopic guided thoracic epidural intervention is the safest and most accurate method to identify the correct anatomical structures and confirm the epidural space with contrast medium, its use is limited because of the difficulty of using fluoroscope and the burden of radiation exposure. As the use of ultrasound has become popularized and universal, it has been widely used in regional anesthesia and analgesia, has continuously replaced the modality such as a blind technique and fluoroscopic guidance. Ultrasound-guided thoracic epidural catheter insertion was also recently investigated, and then it was conducted successfully in 15 cases of thoracic and upper abdominal surgery. Moreover, it showed several advantages including lowering the number of needle passes and increasing the success rate. However, it has not yet been studied how accurately the catheter is located in the thoracic epidural space during thoracic epidural catheter insertion using real-time ultrasound. Although it is possible to speculate the success of the thoracic epidural catheterization clinically, the identification of the location of the catheter is only possible under fluoroscopic guidance. Therefore, in the present study, we aimed to confirm the success rate of ultrasound-guided thoracic epidural catheter insertion, using fluoroscopy with contrast medium.

Eligibility Criteria:
Inclusion Criteria:

* Patients who will undergo upper abdomen or thoracic surgery
* Scheduled for thoracic epidural catheter insertion
* 20 ≤ age \<80
* When obtaining informed consent voluntarily

Exclusion Criteria:

* Allergy to local anesthetics and contrast dye, and steroid
* Use of anticoagulants or antiplatelet medication, coagulopathy
* Infection at the insertion site
* Neurological or psychiatric disorders
* Prior spine instrumentation
* Pregnancy
Lipoarabinomannan (LAM) Enzyme-Linked Immunosorbent Assay (ELISA) in Diagnostics of Childhood Tuberculosis (TB)

In children, it remains quite difficult even in developed countries, to prove a diagnosis of Tuberculosis (TB). New means for diagnosis of this disease are currently being researched. One candidate test is Lipoarabinomannan ELISA from Urine, which has shown good sensitivity of up to 80% in adults.

Our study aims to evaluate this test in the diagnosis of children with TB.

Among candidate new diagnostics for TB, a test for mycobacterial Lipoarabinomannan (LAM) excretion in urine has shown promising results in one Tanzanian study: The sensitivity for detecting TB culture-positive patients was 80.3%. Of 103 healthy volunteers, only one gave a false positive result (Boehme, 2005).

Until now, there are only data concerning this test for diagnosis of adult disease. For evaluation of routine use in children in countries like Malawi, we are starting a prospective study. Children 0-14 years of age with suspected TB will be investigated using TB culture as the gold standard. In sputum samples, microscopy will be done. Simultaneously, LAM Elisa from the patient´s urine will be done.

Eligibility Criteria:
Inclusion Criteria:

* age 0-14 years
* suspicion of active TB or TB contact

Exclusion Criteria:

* no informed consent
A Study of LY2875358 in Participants With MET Positive, Advanced Gastric Cancer

The main purpose of this study is to evaluate the effectiveness of LY2875358 in participants with MET diagnostic positive (+), advanced gastric or gastroesophageal junction (GEJ) cancer.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of a histopathologically or cytologically confirmed local and/or advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma which is unresectable
* Have received 2 regimens of prior chemotherapies for gastric or GEJ adenocarcinoma
* Have the presence of measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
* Have consent to provide a tissue sample for pre-screening
* Determined to be MET diagnostic positive based upon testing of a tumor sample obtained at any time before enrollment
* Have discontinued all previous treatments for cancer, including chemotherapy and radiotherapy, for at least 3 weeks before enrollment and have recovered from the acute effects of therapy
* Have adequate organ function
* Male participants: must agree to use a reliable method of birth control and to not donate sperm during the study and for at least 4 months following last dose of study drug or country requirements, whichever is longer
* Female participants: are women of child-bearing potential who test negative for pregnancy ≤14 days before enrollment based on a serum pregnancy test and agree to use a reliable method of birth control during the study and for 4 months following the last dose of the study drug and must also not be breastfeeding
* Have a performance status of ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale
* Have an estimated life expectancy, in the judgment of the investigator, of at least 12 weeks

Exclusion Criteria:

* Are currently enrolled in, or discontinued within the last 21 days from, a clinical trial involving an investigational product or non-approved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
* Have previously completed or withdrawn from this study or any other study investigating LY2875358
* Have an active fungal, bacterial, and/or known viral infection
* Have a history of New York Heart Association class ≥3, unstable angina, myocardial infarction (MI) in 6 months prior to study drug administration
* Have symptomatic central nervous system (CNS) malignancy or metastasis
* Have previous or concurrent malignancies
* Have received a liver transplant, or have liver cirrhosis with a Child-Pugh Stage of B or C
* Have corrected QT interval (QTc) of \>470 millisecond (msec) on screening electrocardiogram (ECG)
* Have received previous treatment with any hepatocyte growth factor (HGF)/MET targeting therapeutics
* Have a history of radiation therapy involving more than 25% of the bone marrow. Previous radiation therapy is allowed but should have been limited and must not have included whole pelvis radiation
Safety and Effectiveness of Resistance Exercise Training in Patients With Pompe Disease.

The purpose of this research study is to determine if exercise will help improve muscle strength, endurance, and quality of life in individuals with Pompe disease. This is a research study to further define the outcome of patients with Pompe disease treated with a combined diet and exercise therapy.

Eligibility: Subjects that are age 16 years or older, have been diagnosed with Pompe disease by genetic testing, and are showing symptoms such as muscle weakness

Time Commitment:

The study will last for 8 months. This study consists of a baseline visit of and return visits at week 9, week 16, week 24, and week 32. At the week 9 visit the subject will be given an individualized exercise plan which will be carried out over the next 24 weeks. The subject will be asked to return for three more visits at week16, week 24 and week 32. The 24 week training period will involve 3 workouts a week approximately 15-30 minutes each. It will also involve a breathing exercise that the subject can do at home twice daily for 10-15 minutes per session. The study visits will include the exercise plan, physical exam, blood draw and questionnaires.

Anticipated Benefits:

The possible benefits include a delay in progression of muscle weakness. The knowledge gained from this study will help researchers understand the effect of exercise on the disease. This may eventually lead to new forms of prevention of symptom onset in the future.

Eligibility Criteria:
Inclusion Criteria:

1. Able to fully consent to the protocol.
2. Physically able to perform resistance exercises for 12 weeks.
3. Patients with a confirmed diagnosis of Pompe disease.
4. Age 16 years to 75 years.
5. Currently receiving ERT.
6. Patient on ERT for at least 1year.

Exclusion Criteria:

1. Patients with no confirmed diagnosis of Pompe disease, either by GAA enzyme deficiency from any tissue and/or molecular testing revealing two GAA gene mutations
2. Unable to walk or cycle
3. Unable to consent to the study/ procedures
4. Women who are pregnant or breastfeeding
5. Heart disease
6. Patients with any metal inside their body such as metallic clips used for vascular repairs and/or implanted devices such as cardiac pacemakers which would prevent them from doing the MRI.
A Study of Glaucoma or Ocular Hypertension in Patients Within the United States

Safety and efficacy study comparing between fixed combination latanoprost-timolol and its component parts.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral or bilateral primary open angle glaucoma, capsular glaucoma, pigmentary glaucoma or ocular hypertension.
* Patients currently on IOP reducing therapy: IOP greater than or equal to 25mmHg (Ltwo IOP determinations at pre-study separated by at least one hour) OR Patients without IOP reducing therapy: IOP greater than or equal to 30mmHg (two IOP determinations at pre-study separated by at least one hour).

Exclusion Criteria:

* History of acute angle closure or closed/barely open anterior chamber angle.
* Current use of contact lenses.
* Ocular surgery or argon laser trabeculoplasty (ALT) within three months prior to pre-study visit.
* Ocular inflammation/infection occurring within three months prior to pre-study visit.
* Hypersensitivity to benzalkonium chloride or to any other component of the study drug solutions.
* Other abnormal ocular condition or symptom preventing the patient from entering the study, according to the investigator's judgement.
* Patients with conditions in which treatment with B-blocking agents are contraindicated: cardiac failure, sinus bradycardia, second and third degree atrio-ventricular block.
* Patients with conditions in which treatment with B-blocking agents are contraindicated: bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary disease.
* Inability to adhere to treatment/visit plan.
* Have participated in any other clinical study within one month prior to pre-study visit.
Study of Genetic and Molecular Defects in Primary Immunodeficiency Disorders

OBJECTIVES: I. Identify the molecular defects responsible for primary immunodeficiency disorders.

II. Explore the mutations within each syndrome to better understand the genetics of these disorders.

III. Study the function of the Wiskott-Aldrich syndrome proteins (WASP). IV. Design methods to identify carriers and for prenatal diagnosis. V. Explore new avenues for therapy.

PROTOCOL OUTLINE: Patients are studied systematically to determine the extent of their immune deficiency and to confirm a specific diagnosis. Patients with a known immunodeficiency syndrome are studied in detail to identify the gene mutation, to assess the effect of the mutation on the gene product, and to establish cell lines for further in vitro assessment of the genetic defect. The function of Wiskott-Aldrich syndrome proteins (WASP) in hematopoietic cells is studied.

Family members of patients with X-linked disorders are studied to identify carrier females.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

Primary immunodeficiency disease, e.g.: Leukocyte adhesion deficiency syndrome Wiskott-Aldrich syndrome X-linked agammaglobulinemia X-linked hyper IgM syndrome
Somatosensory Assessment and Rehabilitation of Allodynia (SARA)

This pilot study will test a new therapy, somatosensory rehabilitation, for the painful sensitivity experienced by persons with nerve injuries and/or complex regional pain syndrome (CRPS). Several methods for measuring pain and sensitivity that emphasize the person's evaluation of their own symptoms and the impact of these symptoms on their daily activities will also be tested to make sure they are consistent and accurate.

Previous research has suggested one of the assessments may also be used to assist in the identification of CRPS: this simple test will be evaluated to see if it can accurately identify persons with this disorder (for which there is currently no diagnostic test). Together, this will improve treatment of CRPS through early, accurate diagnosis and the ability to measure important changes in this painful condition, and set up future studies for this new rehabilitation treatment method.

We will test four groups: persons with CRPS of one upper extremity, persons with recent hand fractures (\<12 weeks) or peripheral nerve injuries with residual sensory deficits at the time of the study, and healthy normal volunteers with a battery of assessments for CRPS, including a technique to precisely localize and quantify static mechanical allodynia.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of a) Complex Regional Pain Syndrome or b) Peripheral Nerve Injury or c) recent hand trauma without peripheral nerve injury in a single upper extremity confirmed by physician or medical record.
* Participant and most responsible physician give consent to exclusive focus on somatosensory rehabilitation for the duration of the trial (6 months). The participant may continue any oral medications but any planned use of topical medication, injections or IV medication in the affected limb is contra-indicated. Use of these modalities in an emergency situation would of course take priority.

Exclusion Criteria:

* History of cardiac or vascular disease or known sensitivity to sympathetic stress or cold intolerance or medically unstable
* Confounding diagnoses: whiplash, nerve root compression, metabolic diseases such as diabetes or thyroid problems, and/or peripheral neuropathy
* Open wounds on testing sites
* Unable to provide informed consent
Optimised Post-discharge Care in Older Patients After Surgery for Colon Cancer (ERAS 3.0)

The purpose of the study is to investigate whether an extended program (ERAS 3.0) initiated hospital discharge, can improve recovery in elderly, frail patients who have undergone surgery for colon cancer.

The study is a randomised controlled trial with two groups: an intervention group receiving the ERAS 3.0 program and a control group recieving standard care. The ERAS 3.0 program includes a comprehensive geriatric health assessment, dietary counseling from a dietitian, and instructions on training and physical activity. These activities will take place in the participant's homes after hospital discharge. Data will be collected at multiple time points: at the hospital, 12 days post-discharge (at the outpatient clinic), and at 1 and 3 months post discharge in the participants' homes.


Eligibility Criteria:
Inclusion Criteria:

* Age 65+
* Clinical Frailty Scale preoperative score 4-7
* Nutritional Risk Screening tool (NRS 2002) \> 3
* Elective colonic resection
* No stoma planned
* Minimally invasive surgical approach (laparoscopic or robotic)
* Patients discharged to own home
* Informed consent to participate

Exclusion Criteria:

* Stoma creation during index surgery
* Conversion to laparotomy
* Major complications following surgery (Clavien-Dindo \>3a)
* Participation in other randomised trials in conflict with the protocol and end- points of the ERAS 3.0 project
* Discharged with tube feeding and parenteral nutrition (partially or completely)
* Known food allergies to dairy or any other ingredient contained in the nutrition package
* Incapable of providing informed consent
* Discharge to 24-hour municipal rehabilitation facility
* All conditions including psychological, geographical, and social factors that could hinder adherence to the trial protocol
* Neoadjuvant radio- or chemotherapy