cyrilzakka/clinical-trials huggingface dataset:
Sonographic Visibility of Breast Biopsy Marker Clips Up to 4 Weeks After Placement

The purpose of this study is to determine how long collagen based marker clips remain visible by ultrasound after placement in suspicious breast lesions and if collagen based marker clips can be reliably identified in the operating room and serve as effective guidance for surgical removal of high risk or malignant breast lesions.

Many breast cancers and other breast lesions are discovered as a palpable abnormality by patients or their providers during a breast exam. Diagnostic imaging and biopsy of these lesions may reveal high-risk or malignant findings. These palpable lesions can be removed in the operating room by the surgeon using touch as guidance. However, there are many lesions discovered by screening examinations that surgeons cannot palpate. When this occurs, a radiologist will percutaneously place a wire or wires at the site of the breast lesion using sonographic or mammographic guidance. The surgeon then uses the wires as a guide for complete and successful resection of the lesion.

New marker devices have been developed that are sonographically visible. They consist of the standard mammographically visible metallic clip surrounded by a sonographically visible collagen plug. It is hypothesized that radiologists and surgeons can effectively localize the clip with intra-operative ultrasound and then resect the lesion. If so, the pre-operative wire localization procedure could be eliminated. This could improve the patient experience while saving time and money by reducing the number of invasive procedures from 3 (biopsy, wire-localization and operation) to 2 (biopsy and operation).

Eligibility Criteria:
Inclusion Criteria:

* Patients with suspicious breast lesions that have undergone biopsy and marker clip placement within 28 days (4 weeks) of pre-operative consultation visit.
* Patients or their legal representative must be able to provide written informed consent.
* Patients must be over 18 years old.

Exclusion Criteria:

* Under the age of 18 years
* Unable to give written informed consent
* Patients will be excluded if the clip was placed more than 4 weeks prior to their pre-operative appointment or wire-localization.
Safety Study of CTA018 Injection to Treat Stage 5 Chronic Kidney Disease

This study will investigate the levels of CTA018 in the body over time (pharmacokinetics, PK) in patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT), undergoing regular hemodialysis. This study will also investigate the safety and effects of different strengths of CTA018, on parathyroid hormone (PTH) levels.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index between 18 and 35
* On maintenance hemodialysis three times per week
* Serum iPTH value greater than or equal to 300 pg/mL and lower than or equal to 1000 pg/mL
* Adjusted or total serum calcium value greater than or equal to 8.4 mg/dL and lower than 10.0 mg/dL
* Serum phosphorus value greater than or equal to 2.5 mg/dL and lower than or equal to 5.5 mg/dL
* Serum 25-hydroxyvitamin D level greater than or equal to 15 ng/mL
* Willing and able to discontinue vitamin D and/or bone metabolism therapy for at least 2 weeks prior to administration of Study Drug, and the length of study

Exclusion Criteria:

* On bisphosphonates for at least three months prior to first dose of Study Drug
* Currently taking cytochrome P450 3A inhibitors and/or inducers
* Abnormal liver functions
Breast Screening - Risk Adaptive Imaging for Density

BRAID is a randomised, multi-centre study assessing the impact of supplementary imaging in the detection of breast cancer in women participating in the UK national breast screening programme who have dense breast tissue.

Breast density is a measure of the amount of fibroglandular tissue and is a risk factor for breast cancer. Women with extremely dense breasts are at 4-fold increased breast cancer risk compared to women with 'fatty' breasts. High breast density reduces the sensitivity of mammography increasing the probability of the test missing a cancer. Women with dense breasts have their cancers found when the cancer is larger as they present with interval cancers or their cancers are not detected until the next screening round at a later stage.

The UK national breast screening programme (NHS BSP) offers all women aged 50-70 screening with 3-yearly mammograms. It aims to reduce breast cancer mortality by 20% by detecting small cancers thereby reducing the number of late stage diagnoses. However only 53% of the cancers being detected are small (\<15mm). This is partly due to masking of cancers by dense breast tissue.

This trial addresses how best to screen women with dense breasts for breast cancer. BRAID will randomise women whose recent screening normal mammogram shows that they have dense breasts to either standard of care (no supplementary imaging) or supplementary imaging with abbreviated MRI (ABB-MRI), automated whole breast ultrasound (ABUS) or contrast enhanced spectral mammography (CEM). These imaging techniques have been shown to be more sensitive than mammography at detecting cancers in dense breast tissue. Our hypothesis is that more cancers will be detected at an earlier stage with supplemental imaging.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to give written informed consent
* Willing and able to comply with the scheduled study visits, tests and other procedures
* Female
* Screening mammogram that is either normal or being recalled for assessment
* Increased breast density identified on current screening mammogram examination (BIRADS C or D)

  * If BIRADS C the reporting radiologist should use clinical judgement as to eligibility, there should be a high chance of a cancer being masked in this participant
  * All BIRADS D will be eligible
* Aged 50-70 and eligible for 3-yearly NHS breast screening

Exclusion Criteria:

* Known BRCA carrier or ≥50% risk of being a carrier
* Unable to give informed consent
* Breast implant(s)
* Unable to be followed-up for the study duration
* Current participation in another interventional breast screening trial (Including but not limited to MyPeBS)
* Participated in part A of the BRAID study
* Pregnant or breast feeding
Modified TAP (Transverse Abdominis Plane) Block in Colorectal Surgery

Single Blind, Randomized Controlled study to see if TAP Block with Exparel provides better pain relief than TAP Block with bupivicaine. Differences in Pain Scale, Length of Stay, and Total Narcotic use in the hospital will be evaluated.

Subjects recruited into the study will undergo surgery as scheduled. During the procedure they will receive a TAP Block with one of the pain medications. TAP Block in the experimental arm will be performed with 20 mL (266mg) of liposomal bupivacaine with 25 mL (5 mg/mL) of bupivacaine diluted in 55 mL of normal saline. The control arm will have a TAP Block performed with 30 mL (5mg/mL) of bupivacaine diluted in 70 mL of normal saline. These doses are consistent with prior studies of TAP Block with liposomal bupivacaine. Subjects will be monitored for pain as per standard of care and will be given pain medication as needed.

Subject Recruitment and Screening Patients will be recruited from the Ochsner Colorectal Surgery Clinic at the time of a preoperative visit.

Study Procedures

Screening \& Baseline Visit After obtaining informed consent the subjects relevant medical and surgical history will be documented. Demographics and vitals will be documented. Current use of pain medication will be recorded. A physical exam will be performed.

Day of Surgery Routine vital signs will be obtained preoperatively. During the operation subject will receive a TAP Block containing their randomized local injection mixture as described above. Following surgery the subject will recover the PACU and pain medication will be provided on demand. Initial postoperative vital signs and pain scores will be obtained at this time.

Post-Operative Course Postoperatively subject will have regularly scheduled vital signs and pain scores obtained, and recorded for study use. Narcotic and non-narcotic pain medication will be provided on demand; dosages will be recorded for study use. Subjects will be followed until they are discharged at which time study participation will be complete.

Eligibility Criteria:
Inclusion Criteria:

* Patients age 18-75 years undergoing planned laparoscopic colon or rectal resection

Exclusion Criteria:

1. Patients younger than 18 or older than 75 years old
2. Pregnant women
3. Patients who have taken steroids or other immunomodulators within the last 6 months
4. Patients on home narcotics
5. Patients allergic to Exparel or bupivacaine
Evolution of Two Cohorts of Children (Univentricular and Bi-ventricular Heart) After Strapping of the Pulmonary Artery

Pulmonary artery strapping is a surgical technique aimed at providing a palliative treatment to newborns suffering from congenital heart defects, characterized by an increase in blood flow and pulmonary blood pressure.

The intervention consists of placing a band around the pulmonary artery. This band causes an artificial stenosis, therefore inducing a reduction of the pulmonary arterial pressure. It acts as a first step, preparing the ground for a future definitive repair intervention.

It is mainly used in the context of septal defects, atrio-ventricular canal defects or uni-ventricular hearts.

The complications linked to strapping include, among others, the erosion of the band in the artery lumen, its migration and the obstruction of the pulmonary artery, a pulmonary valvular insufficiency, the obstruction of the coronary artery and an ineffective strapping.

The early mortality rate of pulmonary artery strapping after 1980 varies between 1.8% and 13.6%, while strapping readjustment rates oscillate around 20%. It is assumed that the mortality is linked to the nature of the cardial malformation (uni-ventricular or bi-ventricular) rather than the procedure itself.

This retrospective study aims to evaluate the intra-hospital and extra-hospital mortality rate of pulmonary artery strapping, as well as the readjustment rate within two groups of patients: those benefiting from an uni-ventricular cardiac reparation and those benefiting from a bi-ventricular cardiac reparation. The aim is to determine the short term mortality rate of the intervention and the incidence of complications within the hospital, within the two groups.


Eligibility Criteria:
Inclusion Criteria:

* All patients treated with pulmonary artery strapping between 2005 and 2016 at the Queen Fabiola Children Hospital

Exclusion Criteria:

* Outdated indications
Shamrock Versus Lumbar Ultrasound Trident - Ultrasound Guided Block of the Lumbar Plexus

The main objective of the trial is to complete a double-blinded randomized controlled trial of a lumbar plexus block with the Shamrock technique versus the Lumbar Ultrasound Trident technique by estimating the time of performance of lumbar plexus blocks in healthy volunteers.

Secondary objectives include a) estimates of number and depth of needle injections, distance of injection site from the midline, minimal electric nerve stimulation to trigger muscular response and the type of response, and volunteer discomfort during block injection, b) measurements of plasma lidocaine and mean arterial blood pressure, c) examinations of sensory block of the dermatomes T8-S3 and motor block of the femoral nerve, the obturator nerve, the hip abductor muscles, and the hamstring muscles, d) success rate of lumbar plexus block, e) perineural and epidural distribution of local anesthetics added contrast visualized on magnetic resonance imaging (MRI) scanning, and f) cost-effectiveness for the Shamrock technique versus the Lumbar Ultrasound Trident Technique for lumbar plexus block in healthy volunteers.

The hypothesis is that the Shamrock technique is faster to perform than the Lumbar Ultrasound technique, and that the success rate of the Shamrock technique is equal to or higher than the Lumbar Ultrasound Trident technique.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Age ≥ 18 years
* Volunteers who have given their written and oral consent to participate in the study after fully understanding the content and the limitations of the protocol
* Normal healthy volunteer (American Society of Anesthesiology (ASA) Classification I)

Exclusion Criteria:

* Volunteers not able to cooperate for the study
* Volunteers not able to understand Danish
* Daily use of analgesics
* Allergy against the medicines used in the study
* Drug abuse (according to the investigator's judgement)
* Alcohol consumption larger than the recommendations of the Danish National Board of Health
* Volunteers in whom nerve blocks are not possible due to technical reasons
* Volunteers who meet any contraindication for MRI including claustrophobia
* Volunteers who are incompetent, i.e. surrogate consent is not accepted
Analysis of HBV-Specific Immune Response in Patients With HBeAg Negative Chronic Hepatitis B Treated With Pegasys (Peginterferon Alfa-2a (40KD)) - Immunology Sub-Study of ML18253

This study will evaluate immune responses in patients with HBeAg-negative chronic Hepatitis B treated with Pegasys (peginterferon alfa-2a). Eligible patients will have been randomized in study ML18253 to receive Pegasys 180 mcg subcutaneously for 48 or 96 weeks. Sample collection period for each patients will occur in the first 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients 18-55 years of age
* Chronic HBeAg negative hepatitis B
* Liver disease consistent with chronic hepatitis documented by liver biopsy within 18 months prior to enrollment
* Participation in study ML18253.

Exclusion Criteria:

* Interferon-based or any systemic anti-HBV therapy \</= 12 months prior to first dose of study drug
* Antiviral, anti-neoplastic, or immunomodulatory treatment \</= 12 months prior to first dose of study drug
* Nonresponders to previous interferon therapy and resistant to lamivudine
* Co-infection with hepatitis A, C or D, or with human immunodeficiency virus (HIV)
* Hepatocellular cancer
* Compensated (Child A, score 6) or decompensated liver disease (Child B or C)
* History or evidence of medical condition associated with chronic liver disease other than HBV
Precision TMS Treatment Guided by Personalized Brain Functional Sectors (pBFS) for ASD

This study will evaluate the efficacy and safety of pBFS-guided TMS treatment for the core symptom in autism spectrum disorder children, adolescents and young adults.

Autism spectrum disorder is a neurodevelopmental disorder characterized by impaired social communication and repetitive behaviors. Broad cognitive control function deficit in ASD suggested cognitive control function as a potential phenotype and treatment target. Using the personalized Brain Functional Sectors (pBFS) technique, investigators could precisely identify individualized brain areas underlying cognitive control function based on the task free functional MRI data. The tailored TMS intervention target to cognitive control function network which located in the left dorsal lateral prefrontal cortex (DLPFC) will be selected for each participant by a blinded researcher.

The participants will be equally randomized to the active iTBS to the cognitive control function network, and sham iTBS at a ratio of 2:1. Each participant will receive 5 days of treatment per week for 12 weeks. Functional MRI data under sedation will be collected pre-and post-treatment. Three behavioral evaluations will be taken pre-treatment, after 8-weeks treatment and after 12-weeks treatment.

Eligibility Criteria:
Inclusion Criteria:

* Nearest age 6-30 years old
* Have the diagnosis of autism spectrum disorder
* ADOS-2 score is higher than the ASD cut-offs
* Capacity to follow the study procedures, including fMRI scan under sedation, assessment, and rehabilitation training
* Participant's parent or other legal guardian give informed consent

Exclusion Criteria:

* Current or history of psychotic disorders, such as schizophrenia, schizoaffective disorder, bipolar disorder
* Severe self-injury or suicidal behavior presented in the last one year
* Severe visual, auditory, or motor disability that interferes with any study procedure
* Current or history of seizure
* Known severe physical diseases, such as congenital heart defect, traumatic brain injury
* Metal implantations, which are contradicted by MRI or TMS, such as artificial cardiac pacemakers, stents, cochlear implants
* Received TMS, tCS, FUS, or other neuromodulation treatment in the last 3 months
* Currently participating in other clinical trials
Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia

RATIONALE: Vaccines made from a person's white blood cells may make the body build an immune response to kill cancer cells.

PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have chronic myelogenous leukemia.

OBJECTIVES:

* Determine the feasibility of vaccination with autologous heat shock protein 70 in patients with chronic phase chronic myelogenous leukemia.
* Determine the toxicity of this vaccination in these patients.

OUTLINE: Patients undergo leukapheresis to obtain peripheral mononuclear cells (PMNCs). Heat shock protein 70 (HSP70) is derived from the autologous PMNCs. Patients receive HSP70 intradermally once weekly for 8 weeks.

Patients are followed for 2 weeks.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of chronic phase chronic myelogenous leukemia

  * Philadelphia chromosome positive
* Peripheral blast count no greater than 10%
* No molecular remission
* Less than 3 years since initial diagnosis
* No anticipation of requirement for bone marrow or stem cell transplantation for 6 months

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-1

Life expectancy:

* Not specified

Hematopoietic:

* Hemoglobin at least 10 g/dL
* Platelet count at least 20,000/mm\^3

Hepatic:

* Bilirubin less than 2.0 times upper limit of normal (ULN)
* Transaminase less than 2.0 times ULN

Renal:

* Creatinine less than 2.0 mg/dL

Other:

* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception
* No significant active infection requiring hospitalization
* No other serious illness or significant behavioral or psychological problem that would preclude study involvement

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* See Disease Characteristics
* Prior interferon alfa allowed
* No concurrent interferon alfa

Chemotherapy:

* Prior cytarabine or other cytotoxic agents allowed
* No concurrent cytarabine or other cytotoxic agents
* Concurrent hydroxyurea allowed

Endocrine therapy:

* No concurrent corticosteroid therapy

Radiotherapy:

* Not specified

Surgery:

* Not specified

Other:

* No concurrent immunosuppressive medications
* Concurrent imatinib mesylate allowed
Taiwan Cohort - Chronic ThromboEmbolic Pulmonary Hypertension Registry

The diagnosis of chronic thromboembolic pulmonary hypertension (CTEPH) is difficult for numerous reasons and is related with a poor prognosis. In Taiwan, the incidence of CTEPH and its clinical features are unknown. This study aims at evaluating the prevalence, clinical characteristics, and management of CTEPH in a Taiwanese cohort.

Primary objective:

- To investigate the geodemographics of CTEPH in Taiwan

Secondary objectives:

* To characterize the demographics and clinical presentation of patients with CTEPH
* To describe the real-world management and treatment outcome of patients with CTEPH
* To identify the risk factors of CTEPH
* To assess the relationship between risk factors/patients' characteristics and clinical outcomes for CTEPH
* To evaluate the prognosis of CTEPH in Taiwan using survival assessment


Eligibility Criteria:
Inclusion Criteria:

1. Right heart catheterization (RHC) results that are in line with both of the following haemodynamic levels:

   Mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg at rest AND Pulmonary arterial wedge pressure (PAWP) ≤ 15 mmHg
2. Confirmation of CTEPH diagnosis by one of the following as recommended by standard guidelines:

   At least 1 (segmental) perfusion defect(s) in ventilation-perfusion (V/Q) / perfusion scan OR Pulmonary artery obstruction seen by multidetector computed tomography (MDCT) angiography or conventional pulmonary cineangiography.
3. Presence of pulmonary hypertension or evidence of pulmonary thromboembolism after at least 3 months of anticoagulation treatment.

Exclusion Criteria:

* not written informed consent
* not meet inclusion criteria
A Compassionate Case Study to Assess the Hypotensive Efficacy of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Glaucoma Patients With Uncontrolled Intraocular Pressure to Avoid Surgical Intervention

A. To evaluate the ocular hypotensive efficacy of the rho-kinase Inhibitor (AR-12286 0.5% and 0.7%) ophthalmic solutions in open-angle glaucoma patients with uncontrolled IOP who are facing surgical intervention. Patients will be treated for 6 months in this initial trial.

B. To evaluate the efficacy of AR-12286 in enabling treated patients to delay or avoid the necessity of surgical intervention.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with open-angle glaucoma.
2. IOP above the target range or visual field progression with use of maximum standard drug therapy.
3. Have given written informed consent, prior to any investigational procedures.
4. Ability to attend for the 6-month duration of treatment.

Exclusion Criteria:

1. Angle-closure glaucoma
2. Eyes having had previous incisional glaucoma surgery
3. Known hypersensitivity to any component of the formulation (benzalkonium chloride, etc.), or to topical anesthetics.
4. Ocular medication of any kind within 30 days of base-line visit, with the exception of ocular hypotensive medications and/or lubricating drops for dry eye (which may be used throughout the study).
5. Any abnormality preventing reliable applanation tonometry of the treated eye.
6. Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study.
7. Participation in any investigational study within the past 30 days.
8. Inability to perform reliable visual field testing.
9. Unwilling to sign the consent form approved by the Institutional Review Board (IRB) of the New York Eye and Ear Infirmary.
10. Self-reported poor compliance to treatment.
11. Reluctance to return for scheduled follow-up visits.
12. Patients not able to understand the nature of the study.