cyrilzakka/clinical-trials huggingface dataset:
Optical Coherence Tomography in Tissue Samples From Women Undergoing Mastectomy for the Treatment or Prevention of Breast Ductal Intraepithelial Neoplasia

RATIONALE: New diagnostic procedures, such as optical coherence tomography, may be effective in finding tumor cells.

PURPOSE: This clinical trial is studying optical coherence tomography in tissue samples from women undergoing mastectomy for the treatment or prevention of breast ductal intraepithelial neoplasia.

OBJECTIVES:

* To design and construct a portable forward imaging optical coherence tomography (OCT) needle probe.
* To compare OCT imaging of ex-vivo breast tumor tissue sections with histology to form the basis of an image library for in-vivo work.
* To initiate development of an OCT needle probe that is capable of acquiring core biopsy samples.

OUTLINE: Breast tissue samples are obtained during mastectomy and analyzed ex-vivo by optical coherence tomography (OCT) and by histopathological examination. Once routine pathological evaluation and tissue sampling are completed, OCT imaging is performed using a portable forward imaging needle probe that is inserted through the ducts of the tissue sample. OCT images of the surface of the closest margin to the tumor (if present) as well as images of the duct(s) in the nipple areola complex (after dilation) are obtained. Images of a cross section of the tumor (after the sample has been sliced by the pathologist) are also obtained. The OCT images are then correlated with tissue histology. The images are used to create a correlation histology-OCT atlas for the evaluation of subsequent images and for future reference.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Undergoing mastectomy at the City of Hope Breast Center for the treatment or prevention of breast ductal intraepithelial neoplasia

PATIENT CHARACTERISTICS:

* Fertile and/or pregnant patients allowed

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Prospective Randonmized Comparison of Needlescopic Versus Conventional Laparoscopic Adrenalectomy

The study is a prospective radonmized comparison between needlescopic adrenalectomy and conventional laparoscopic adrenalectomy for benign adrenal tumors less than 5 cm. The operative success rate, operative time, intraoperative blood loss, intraoperative or postoperative complication, postoperative pain, postoperative hospital stay, convalescence, and wound cosmesis were compared.

Needlescopic instruments, defined as those with a diameter of no more than 3 mm. They result in smaller incisions than conventional 5- to 12-mm instruments, and thus better cosmesis. It may further reduce postoperative pain, hospital stay, and recovery time.

All operations were performed with the lateral transperitoneal approach. A 12-mm port was created near the umbilicus for a 30-degree telescope, and another two(for left lesions) or three (for right lesions) 2-mm working ports (Tyco Healthcare, Norwalk, Connecticut, USA) were created along the ipsilateral subcostal region. Careful dissection was done with the use of a 2-mm hook or scissors electrocoagulator. The adrenal vein of the lesion side was isolated and controlled with a 2-mm mini-bipolar coagulation apparatus (Tyco Healthcare) for a long segment. The vein was then transected closer to the adrenal gland, leaving the coagulated stump at the renal vein or vena cava as long as possible, even when a short right adrenal vein was encountered. Then the adrenal gland with the tumor was dissected from its surrounding tissues after several tiny vessels were transected with the needlescopic instruments mentioned above. The specimen was put into a retrieval bag and removed through the umbilical port.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Benign Adrenal Tumors

Exclusion Criteria:

* Suspected adrenal malignancy clinically
* Bilateral adrenal disease
* Pregnant female
Histologic Assessment of the Difference Between 18F-2-fluoro-2-deoxy_D-glucose Positron Emission Mammography(PEM) and Magnetic Resonance Imaging (MRI) of the Breast

Positron Emission Mammography (PEM) is a newly developed imaging examination of the breast that uses a radioactive glucose based tracer, which is a form of sugar attached to a low radiation agent, to detect cancer cells. The radioactive glucose based tracer is called fluorodeoxyglucose (FDG), and it is FDA approved. A PEM scanner is able to better detect cancer cells within the breast, more than a regular PET scanner. The PEM scanner is also FDA approved. This type of imaging may be able to see the breast cancer before it could be seen with mammograms and may be as good as or better than breast MRI.

The purpose of this study is to compare the value of FDG Positron Emission Mammography (PEM) with contrast enhanced Magnetic Resonance Imaging (MRI) of the breast for patients with breast cancer. This study will also perform special pathology test to compare the FDG PEM and contrast enhanced breast MRI images with the results from the standard of care breast surgery. This may teach us more about the biology of each breast tumor.


Eligibility Criteria:
Inclusion Criteria:

* Female patients with recently diagnosed invasive or in situ breast cancer by core needle biopsy or FNA (confirmed at MSKCC) prior to enrollment.
* Patients planning treatment with mastectomy at MSKCC.
* Patients 21 years old or older.
* Patients who had or are having a breast MRI within 30 days or less of PEM.
* Patients who had or are having a digital mammogram.

Exclusion Criteria:

* Patients who are pregnant or breast feeding.
* Patients with prior radiation therapy or endocrine therapy.
* Patients who had a prior lumpectomy.
* Patients who are diabetic.
* Patients with moderate to end stage kidney disease.
* Patients who have a contraindication to MRI (i.e. pacemaker, metallic implants, etc).
User-Friendly Spirometer and Mobile App for Self-Management and Home Monitoring of Asthma Patients

The primary goal of this proposal is to use an in-home, smartphone-enabled, hand-held spirometer to determine the FEV1% predicted ranges that predict the Yellow Zone threshold.

The study hypothesizes that objective lung function tracking at-home, using a portable spirometer in addition to conventional symptom monitoring (in which asthmatic patients self-report and track their own symptoms), will result in more reliable detection of exacerbation in children 6-15 years old with asthma.

This is a 44-week, single arm, blinded nonrandomized trial to determine clinically relevant ranges in FEV1% predicted that correlate with the Yellow Zone of the Asthma Action Plan.

A total of 100 pediatric subjects (between the ages of 6 and 15 years old) with physician-diagnosed mild or moderate persistent asthma treated on controller therapy will be enrolled from the ED, Inpatient Units, Pulmonary Medicine Clinic, and Allergy/Immunology Clinic at UCSF Benioff Children's Hospital San Francisco.

Primary Specific Aim

To determine the FEV1% predicted changes that correspond with a change from the Green to Yellow Zone.

The primary outcome will be Yellow Zone episodes, as identified by the occurence of any of the following:

Symptom Diary score \> 4 ATAQ score \> 1

Secondary Specific Aim

To determine the FEV1% predicted changes that correspond with a change from the Yellow to Red Zone.

The secondary outcome will Red Zone episodes, as identified by the occurence of any of the following:

ED or Urgent Care visit Administration of systemic (oral, IM, or IV) corticosteroids Hospitalization

Eligibility Criteria:
Inclusion Criteria:

1. Physician-diagnosed mild or moderate persistent asthma
2. On controller therapy \[inhaled corticosteroid (ICS), ICS + leukotriene receptor antagonist (LTRA), or ICS + long-acting beta agonist (LABA)\] for at least the previous six months
3. At least one severe exacerbation requiring systemic corticosteroids in the previous year
4. Baseline FEV1 \>/= 70% predicted for age, gender, and height according to published reference standards
5. Parental consent and the child's assent

Exclusion Criteria:

1. Chronic obstructive respiratory disorder other than asthma (e.g., cystic fibrosis, primary ciliary dyskinesia)
2. Severe persistent asthma, as evidenced by any of the following:

   * 3 hospitalizations
   * 6 severe exacerbations in the previous year on chronic oral corticosteroid therapy daily symptoms
3. Inability to perform acceptable spirometry
4. History of collapsed lung
5. History of syncope with forced exhalation
6. Not owning an iOS™ device (e.g., iPhone®, iPod®, or iPad®)
7. Lacking access to wireless local area networking (Wi-Fi™)
Study for Patients With Non Small Cell Lung Cancer (NSCLC)

This is a randomized study to assess the efficacy and safety of chemotherapy with platin compared to chemotherapy without platin.

Randomized Phase II design, multicenter study, to assess the efficacy and safety of combined chemotherapy with Paclitaxel and Carboplatin versus a platinum free chemotherapy with Paclitaxel and Vinorelbine, within the combination therapies there are two different dosing intervals, which will be assessed as well (4 Arm study).

Eligibility Criteria:
Inclusion Criteria:

* Chemotherapy naive patients with histologically confirmed NSCLC stage III and IV

Exclusion Criteria:

* New York Heart Association (NYHA) III or IV
* Brain metastases
* Neurotoxicity Grade 2 or greater
18F-DCFPyL PET/MRI in Regional Nodal&Distant Metastases Detection in Intermediate &HR Prostate Cancer

The purpose of this research study is to see if patients' tumor can be identified by 18F-DCFPyL PET/MRI scan. The radioactive study agent, 18FDCFPyL, combined with PET/MRI scan may be able to identify smaller tumors than the standard of care contrast-enhanced CT or MRI scan.

This is an expanded access study with a total of 100 participants with newly diagnosed intermediate or high-risk prostate cancer scheduled to undergo prostatectomy and lymph node dissection.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is older than 18-year-old
2. Biopsy proven prostate adenocarcinoma
3. Planned prostatectomy with lymph node dissection
4. Intermediate to high-risk disease (as determined by elevated Prostate-specific antigen (PSA) \[PSA\>10\], T-stage \[T2b or greater\], Gleason score \[Gleason score \> 6\] or other risk factors)
5. Able to provide written consent
6. Karnofsky performance status of ³50 (or Eastern Cooperative Oncology Group (ECOG) /World Health Organization (WHO) equivalent)

Exclusion Criteria:

1. Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy including focal ablation techniques (HiFu)
2. Androgen deprivation therapy or other neoadjuvant treatments prior to PET imaging surgery
3. Metallic implants (contraindicated for MRI)
Dexamethasone Solution and Dexamethasone in Mucolox™

Topical steroid therapy is considered the first line of treatment for Oral Inflammatory Ulcerative Diseases with current treatment regimens requiring multiple application or rinses daily. Using Mucolox™ as a vehicle to deliver topical dexamethasone to the oral mucosa has the potential to effectively prolong contact time between the medication. The primary objective of this study is to determine the clinical efficacy and tolerability of compound dexamethasone at 0.5 mg/5 mL in Mucolox™ for the treatment of Oral Inflammatory Ulcerative Diseases as measured by a reduction in oral symptoms between patients treated with compounded dexamethasone 0.5mg/5ml solution in Mucolox™ (group A) and patients treated with topical commercial dexamethasone 0.5mg/5ml solution only (group B). and mucosa, leading to improved clinical outcomes due to the need for less frequent application.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older.
* Patients with symptomatic biopsy proven Oral Inflammatory Ulcerative Diseases (worst VAS sensitivity score ≥ 7 over the last week).
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Patients already on topical or systemic steroids.
* Inability to comply with study instructions.
* Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements.
* VAS sensitivity score \< 7.
* Pregnant women. A urine pregnancy test will be performed for women of child bearing potential.
* Allergy to fluconazole.
Effect of a High Intensity Interval Training in Older Adults With Coronary Artery Disease

A study comparing 2 groups: interval training and control group. Interval training group will perform a physiotherapy program based in exercises, at a high intensity, and stretching of muscles at the end. Control group will not perform any physiotherapy program. Several parameters will be evaluated at baseline, 2 months and 6 months: anxiety, depression, functional capacity, blood pressure, lipid profile, physical activity, ecc.

A study comparing 2 groups: high intensity interval training and control group. Interval training group will perform a two-month physiotherapy program based in exercises, at a high intensity, and stretching of muscles at the end. Intensity will be established based on Borg scale and an effort test.

Control group will not perform any physiotherapy program, but will have usual care with medication.

Several parameters will be evaluated at baseline, 2 months and 6 months: anxiety, depression, functional capacity, blood pressure, lipid profile, physical activity, ecc.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed of coronary artery disease
* Discharged from hospital, less than 2 months

Exclusion Criteria:

* Not able to move by themselves
PK/PD Study of Gan & Lee Insulin Aspart Injection vs. US & EU NovoLog®/NovoRapid® in Healthy Males

Primary objective:

To demonstrate pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of Gan \& Lee Insulin Aspart Injection with both EU-approved NovoRapid® and US-licensed NovoLog® (Reference Products) in healthy male subjects

Secondary objectives:

To compare the PK and PD parameters of the three insulin aspart preparations

To evaluate the single dose safety and local tolerability of the three insulin aspart preparations


Eligibility Criteria:
Inclusion Criteria:

1. Signed and dated informed consent obtained before any trial-related activities. Trial-related activities are any procedures that would not have been done during normal management of the subject
2. Healthy male subjects
3. Age between 18 and 64 years, both inclusive
4. Body Mass Index (BMI) between 18.5 and 29.0 kg/m\^2, both inclusive
5. Fasting plasma glucose concentration \<= 5.50 mmol/L (100 mg/dL) at screening
6. Considered generally healthy upon completion of medical history, physical examination, vital signs, ECG and analysis of laboratory safety variables, as judged by the Investigator

Exclusion Criteria:

1. Known or suspected hypersensitivity to investigational medicinal products (IMPs) or related product
2. Previous participation in this trial. Participation is defined as randomized
3. Use of other investigational drugs within five half-lives for enrolment or receipt of any medicinal product in clinical development within 30 days before randomization in this trial, whichever is longer
4. History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
5. Clinically significant abnormal values for haematology, biochemistry, coagulation, or urinalysis as judged by the Investigator
6. Increased risk of thrombosis, e.g subjects with a history of deep leg vein thrombosis or family history of deep leg vein thrombosis, as judged by the Investigator
7. A positive result in the alcohol and/or urine drug screen at the screening visit
8. Positive to the screening test for Hepatitis Bs antigen or Hepatitis C antibodies and/or a positive result to the test for HIV-1/2 antibodies or HIV-1 antigen
9. Blood donation or blood loss of m ore than 500 mL within the last 3 months
Gender Dysphoria and Transition

Persons with gender dysphoria present the difficulties of access to health care. Little time is devoted to education of health professionals about the care of transgender persons. According to the proposal of the French Ministry of Social Affairs and Health there is a need to increase knowledge in this area and to improve the care of transgender people including prevention and screening.

Similarly, little is known about social and medical needs of the transgender population.

This project proposes to illustrate gender dysphoria through testimonies of transgender people with the aim to increase the investigator's understanding aout the needs and the desires of this population and to describe the process of medical and social transition.


Eligibility Criteria:
Inclusion Criteria:

* Person affiliated to a social security system
* Person having received complete information on the organisation of the research and having signed the informed consent
* Person having carried out a prior clinical examination adapted to the research
* Age\> 18 years
* Diagnosis of gender incongruence (dysphoria) according to the international classification of diseases, revision 11

Exclusion Criteria:

* Severe, uncontrolled psychiatric or somatic illness
* Substance and alcohol addiction
* Pregnancy
Femoral Triangle + IPACK Blocks for ACL Reconstruction Analgesia

An adequate balance between analgesia and motor function is an essential requirement to facilitate functional recovery and early discharge after anterior cruciate ligament (ACL) reconstruction surgery.

Proximal nerve blocks (i.e. femoral and sciatic nerve blocks) are associated with optimal analgesia, but they can cause muscle weakness, interfering with rehabilitation and increasing the risk of falls .

A recent randomized controlled trial concluded that, compared to mid-and distal ACB, a distal femoral triangle block (FTB) is associated with lower opioid consumption and improved postoperative analgesia for ambulatory ACL reconstruction.

In ACL reconstruction surgery there are other potential sources of pain not covered by a FTB, such as intra-articular structures (menisci, cruciate ligaments), posterior knee capsule and the graft donor site.

Evidence supporting the addition of an IPACK block to a FTB has been studied for patients undergoing total knee replacement, nonetheless, there is no trial analyzing the analgesic contribution of IPACK to a FTB in the context of ACL reconstruction surgery.

In this multicentric trial, the investigators set out to analyze the analgesic benefit of adding an IPACK block to a FTB.


Eligibility Criteria:
Inclusion Criteria:

* Patient scheduled to undergo anterior cruciate ligament reconstruction under general anesthesia with ipsilateral autologous graft.
* Age between 18 and 65 years
* American Society of Anesthesiologists classification 1-3
* Body mass index between 19 and 35 (kg/m2)

Exclusion Criteria:

* Adults who are unable to give their own consent
* Pre-existing neuropathy (assessed by history and physical examination)
* Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50)
* Renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
* Hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
* Allergy to local anesthetics (LAs), morphine or tramadol
* Pregnancy
* ACL revision surgery
* Contralateral graft or any type of allograft
* Chronic pain syndromes requiring opioid intake at home
Prasugrel With Lower Dose - Loading Dose

Although prasugrel, recently available thienopyridine derivative, exhibits rapid and potent platelet inhibition, concerns of low on-treatment platelet reactivity have been suggested especially in East Asian ethnicities. The investigators compared the effect of lower loading dose of prasugrel with conventional loading dose of clopidogrel and prasugrel.

Although clopidogrel together aspirin has been a backbone of anti-platelet therapy in coronary artery disease patients, clopidogrel has several limitations. It has delayed onset of peak concentration and pharmacodynamic inter-patient response variability resulting in high on-treatment platelet reactivity (HPR). Those demerits are known to be associated with adverse cardiovascular outcomes.

Prasugrel has a more effective metabolism pathway than clopidogrel and exhibits more rapid and potent platelet inhibition. Recent guidelines recommend prasugrel as a first line antiplatelet agent or put precedence over clopidogrel for the patients with acute coronary syndrome. However, there have been concerns of different pharmacodynamic and pharmacokinetic response to prasugrel in East Asian ethnicities.

In addition, lower loading dose of prasugrel exhibited more potent pharmacodynamic effect than clopidogrel 600 mg with comparable efficacy compared to conventional loading dose of prasugrel in healthy Korean subjects.

The investigators compare the antiplatelet effect of lower loading dose of prasugrel 30 mg with conventional loading dose of clopidogrel 600 mg and prasugrel 60 mg in Korean coronary artery disease patients undergoing elective coronary angiography.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 and 80 years
* Stable or unstable angina
* Planned to undergo elective coronary angiography

Exclusion Criteria:

* Previous history of transient ischemic attack or stroke
* Intracranial neoplasm
* Uncontrolled malignant disease
* History of antiplatelet or anticoagulation treatment within 1 month
* Contraindication to the study drug
* Bleeding diathesis
* Hemoglobin \< 10 g/dl
* Platelet count \< 100,000/mm3
* Significant renal insufficiency (glomerular filtration rate \<60 mL/min/1.73 m2)
* Significant hepatic impairment (Serum liver enzyme or bilirubin \> 3 times normal limit)
* Body weight \< 50 kg