cyrilzakka/clinical-trials huggingface dataset:
CT-based Radiomics of ALN pCR (ypN0) in Breast Cancer Undergoing NAC

This is a prospective, single-center, non-randomized, non-controlled observational study.

Almost 55-62% of patients with triple-negative or human epidermal growth factor receptor 2 (HER2) positive, node-positive breast cancer achieve an axillary pathologic complete remission (pCR) after neoadjuvant chemotherapy (NAC). To avoid surgery post-NAC, it is paramount to accurately identify patients who achieve pCR in axillary lymph node (ALN). We found that patients with normal-appearing lymph nodes on computed tomography (CT) based radiomics of the axilla after chemotherapy had a lower risk of developing residual nodal disease. However, the features of CT-based radiomics for pCR ALN following NAC has not been established yet. This study aimed to assess the performance of CT-based radiomics in evaluating the response and predicting pCR of metastatic lymph nodes after NAC in breast cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* Triple-negative or HER2-positve invasive breast cancer with axillary lymph node metastasis by confirmed by fine needle aspiration or core needle biopsy.
* Underwent computed tomography for assessment of axillary lymph node status before and after neoadjuvant chemotherapy.
* Attend the study voluntarily, sign the informed consent.

Exclusion Criteria:

* Contradiction for adjuvant chemotherapy.
* Contradiction for proceeding surgery.
Nuclear Matrix and Cancer: Proteomic and Genomic Analyses Using Microarray in Cells Obtained Via Thoracocentesis

Accurate characterization of malignant cells obtained via thoracocentesis is of paramount importance in the management of cancer patients. The identification of novel biomarkers may in that regard considerably improve the diagnostic approach of these pleural effusions, guide therapeutic decisions, particularly with respect to targeted therapies, and offer helpful prognostic information. Nuclear anomalies represent the cornerstone of the cytologic and/or histopathologic diagnosis of malignant cells. The nuclear matrix is a fundamental constituent of the nuclear architecture via its interaction with the nuclear membrane, but is also directly involved with DNA and RNA processing. Prior studies have suggested that in some cancers, the lamins, a major constituent of the nuclear matrix, have different patterns of expression or nuclear localization that could potentially have prognostic implications. Our project aims at studying the constituents of the nuclear matrix of malignant cells isolated for pleural fluid in patients with metastatic disease, both of bronchogenic or non-bronchogenic origin, which, to our knowledge, has not yet been done. Both proteomic (localization by immunofluorescence and expression by Western-Blot) and genomic (microarray, CGH type) analyses will be undertaken to identify microrearrangements in the genes of interest. The primary aim is to identify specific biomarkers to more accurately characterize malignant cells in metastatic pleural disease.


Eligibility Criteria:
Inclusion Criteria:

* sign consent approval
* patients with metastatic disease, both of bronchogenic or non-bronchogenic origin
* 50% or more of malignant cells

Exclusion Criteria:

* patients with tumoral treatment during thoracocentesis
* 50% or less of malignant cells
A Brief Multimedia Program Affects Parents' Attitudes Toward Physical Punishment

The American Academy of Pediatrics recommends that parents receive anticipatory guidance about how to discipline their children as part of the well child visit. However, physicians provide counseling only 25-40% of the time. In regard to the type of discipline, the AAP recommends that primary care providers encourage parent to use non-physical forms of discipline and discourage parents from using physical punishment. Educational resources are needed to help physicians routinely provide these important anticipatory guidance messages. In this study, consecutive parents were exposed to routine anticipatory guidance messages before the well child visit with the physician. After the clinic visit, parents were invited to participate in a research study to assess their attitudes about physical punishment and other discipline strategies. The key research question of this study is: Can a brief multimedia program (i.e. Play Nicely program) affect parents' attitudes about the use of physical punishment? The time frame of the study was June through August of 2010. Data was collected immediately after the clinic visit and 2-4 weeks post clinic visit.

Note: Because of a poor follow up rate with the 2-4 week phone call, this effort to collect follow up data was unsuccessful.

Eligibility Criteria:
English and Spanish speaking parents of 6-24 month old children presenting for a primary care visit in the Vanderbilt Pediatric Primary Care Clinic.
Anti-osteoporosis Medication Monitoring and Management Service

BACKGROUND:

One-year adherence to oral anti-osteoporosis medication (AOMs) was only about 30%. In recent years, efforts have been made to change the delivery of these medications from oral form to injection form every, 3, 6 or 12 months to increase adherence. However, both patients and providers are sometimes confused about the multiple choices. Also, patients may receive extra medications if providers did not keep tract of their previous AOM uses or patients may changes providers. There were urgent needs to provide AOM monitoring and management services to improve cares.

OBJECTIVES:

To establish a anti-osteoporosis medication management service at National Taiwan University Hospital and its BeiHu Branch.

METHODS:

Participating physicians will select those eligible for services and refer to study coordinators. Study coordinators will conduct baseline assessments on osteoporosis/fracture risks, record medical conditions, AOMs, provide educations on osteoporosis, fracture, sarcopenia, fall, medications, nutrition, and exercise. They also arrange return clinic visit, telephone reminder and follow up for patients, and communicate with providers on regular bases. the investigators plan to enroll 500 patients with 18-month follow up for each.


Eligibility Criteria:
Inclusion Criteria:

* Age \>=50 and one of the below
* Newly prescribed with AOMs
* Recent change of AOMs
* Poor adherence to AOMs
* Participating physicians feel that the service will benefit the patient in overall osteoporosis and medication managements.

Exclusion Criteria:

* Life expectancy less than 2 years or can't be assessed for communication problems
* patient in our fracture liaison service or other medication clinical trials
Varenicline or Nicotine Patch in Promoting Smoking Cessation Among Current Smokers

This pilot clinical trial studies varenicline or nicotine patch in promoting smoking cessation among current smokers. Varenicline or nicotine patch may help people stop smoking

PRIMARY OBJECTIVES:

I. To determine if mail delivery of 12 weeks of varenicline results in improved smoking cessation outcomes relative to nicotine replacement therapy (NRT) in 300 smokers.

II. To determine if delivery of varenicline is cost-effective as compared to nicotine patch.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo general smoking cessation counseling and receive varenicline orally (PO) twice daily (QD) on days 1-28. Courses repeat every 28 days for up to 12 weeks.

ARM II: Patients undergo general smoking cessation counseling and receive nicotine patch continuously for 12 weeks.

After completion of study treatment, patients are followed up at 4 months.

Eligibility Criteria:
Inclusion Criteria:

* Cigarette smokers who call the New York State Smokers' Quitline requesting assistance with quitting smoking
* State that they are under the care of a primary care physician
* Are eligible for receipt of pharmacotherapy by mail using the standard NRT criteria
* Speak English
* Answer "no" to the following 3 questions:

  * "Have you ever been diagnosed with or treated for a mental health problem like major depression, bipolar disorder, dysthymia, or schizoaffective disorder?"
  * "Have you ever had serious thoughts of killing or hurting yourself, ever have any intention or plan to carry out these thoughts, or actually attempted to kill yourself?"
  * "Is there any reason that you cannot use varenicline/Chantix?"

Exclusion Criteria:

* State that they are not under the care of a primary care physician
* Are not eligible for receipt of pharmacotherapy by mail using the standard NRT criteria
* Do not speak English
* Answer "yes" to the question, "have you ever been diagnosed with or treated for a mental health problem like major depression, bipolar disorder, dysthymia, or schizoaffective disorder?"
* Answer "yes" to the question, "have you ever had serious thoughts of killing or hurting yourself, ever have any intention or plan to carry out these thoughts, or actually attempted to kill yourself?"
* Answer "yes" to the question, "is there any reason that you cannot use varenicline/Chantix?"
* Are women who are currently pregnant
* Report that they are unwilling to receive or take varenicline on screening
AOT and ICT for Hemiplegia

A new rehabilitative approach, called AOT, based on the recent discovery of mirror neuron system (MNS), has been used with promising results on the Upper Limb (UL) function in some studies in children with Cerebral Palsy (CP).The purpose of the present trial is to provide evidence by a RCT that AOT is an effective rehabilitation tool in Children with Unilateral CP (UCP) and that its effects are greater than standard care. Assisting Hand Assessment is chosen as primary outcome measure and a sample size of 10 per group is required. The rehabilitation lasting 3 weeks will be provided at home by an ICT platform able to deliver, manage, monitor and measure a personalized AOT.

A waitlist control, evaluator-blinded, randomized trial (RCT) will be conducted according to CONSORT guidelines. Each participant will be randomized to either:

1. Immediate intervention group (Experimental group). Children will receive immediately the system for 3 weeks.
2. Waitlist delayed intervention (Control group). Children will continue standard care for 3 weeks and then will receive the system as the Experimental group.

As such, all participants will receive the AOT training. The system will provide an in-home, individualized, intensive treatment based on the AOT. The system will be delivered at home and the children will perform a 60-minute training session 5 days a week for 3 consecutive weeks. For the Immediate intervention group, follow-up assessment (outcome measures) will be conducted before (T0) and post-intervention at 3 weeks (T1), and then 8 and 24 weeks after T1(T2 and T3). For the Waitlist group, the assessments will be conducted before T0 and 3 weeks after (T1) the standard care, then they will follow the same timeline of the first group (T1 plus, after the AOT intervention) and 8 and 24 weeks after T1 Puls (T2 and T3). The primary endpoint will be T1. Clinical assessments will be administered by a therapist blind to group assignment in each center. Scoring of videotaped clinical outcome measures will be performed by therapists blind to group allocation and assessment order.

Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of spastic UCP
* age between 15 and 20 years
* predominant spasticity at upper limb upper limb
* minimal ability to grasp and hold objects, also passively, with affected hand (House functional classification score 2 or more)
* sufficient cooperation, cognitive and communicative understanding to perform assessments and participate in the intervention
* subjects and parents able to commit to the intensive therapy program for a period of 3 weeks

Exclusion Criteria:

* Children who had sustained previous orthopedic surgery or botulinum toxin A injection in the UL within 6 months prior to study entry were excluded.
Effect of White Light on Fatigue Levels in Patients With Gynecological Cancer

White light therapy is one of the non-pharmacological methods in the management of fatigue. Cancer-related fatigue (CRF) is a persistent, subjective sense of physical, emotional, and/or cognitive tiredness or burnout. It is associated with cancer or cancer treatment from the first diagnosis until the end of life that is not proportional to recent physical activity.

It was founded that 10,000 Lux bright white light administered in the morning hours reduced fatigue by 17% in patients with cancer and that the mean fatigue scores of patients decreased from 30.37 to 9.48 compared to before the light administration. According to NCCN (2020), white light of 10,000 Lux can be applied for 30-90 minutes in the morning hours to regulate sleep and manage fatigue in the post treatment period as well as in cancer patients receiving active treatment. However, studies on this subject consist of small sample groups, and more studies are needed to identify the risks and benefits of the application and to determine the optimal application time and duration. The present study was aimed to evaluate the effect of white light on the fatigue levels of patients with gynecological cancer who were treated with chemotherapy. The patients with high levels of fatigue in every dimension were selected so as to have a homogeneous group. The research hypotheses were determined as follows:

H0: White light has no effect on fatigue levels in patients with gynecological cancer.

H1: White light reduces fatigue levels in patients with gynecological cancer.


Eligibility Criteria:
Inclusion Criteria:

* had a normal state of consciousness,
* had no communication disorders, did not work in the night shift,
* had a general fatigue level score of ≥1 according to the Brief Fatigue Inventory

Exclusion Criteria:

* had natural/artificial lenses,
* used medication that causes photosensitivity (tetracycline, doxycycline, nalidixic acid, voriconazole, amiodarone, hydrochlorothiazide, naproxen, piroxicam, chlorpromazine)
* had a change in their treatment plan in the last 6 weeks were not included in the study
A Study to Evaluate the Safety of Long-term Treatment With Siltuximab in Patients With Multicentric Castleman's Disease

The purpose of this study is to evaluate the long-term safety of siltuximab in patients with multicentric Castleman's disease (MCD).

This is an open-label (all people know the identity of the intervention), multicenter (study conducted in multiple sites), non-randomized (patients are not assigned by chance to treatment groups), Phase 2b study. Up to 75 patients with MCD will be eligible for the study, the majority of whom will be on active therapy with siltuximab at the time of enrollment. Patients will be either siltuximab-naive or have not progressed on siltuximab in the opinion of the investigator. Duration of disease control and survival will be assessed. Data collection for patients who discontinue treatment will be limited to survival, occurrence of malignancies, and subsequent therapies for MCD, which will be assessed twice per year until the patient has been lost to follow up or has withdrawn consent for the study, whichever occurs first. An interim analysis will be conducted (no later than 2 years after the start of enrollment) to further evaluate the benefit and safety of long-term treatment with siltuximab in patients with MCD. A data will occur at 6 years after the start of enrollment and for those patients remaining on treatment after the data cutoff, data collection will be limited to pregnancies and serious adverse events (SAEs), including information on study agent administration and concomitant medications associated with an SAE. Safety evaluations for adverse events, clinical laboratory tests, vital signs, and physical examination will be performed throughout the study. The end of study is the date of the last assessment for the last patient.

Eligibility Criteria:
Inclusion Criteria:

* Has multicentric Castleman's disease
* Have previously been enrolled in Study C0328T03 or CNTO328MCD2001 (either treatment arm)
* Have had their last administration of study treatment (siltuximab or placebo) less than 6 weeks (window of plus 2 weeks) prior to first dose
* Patients must not have had disease progression while receiving siltuximab. For those patients originally assigned to placebo in the CNTO328MCD2001 study, patients who have received less than 4 months of siltuximab following crossover will also be eligible
* Have adequate clinical laboratory parameters within 2 weeks prior to the first dose of siltuximab for this study

Exclusion Criteria:

* Unmanageable toxicity, an adverse event, progression of disease, or withdrawal of consent as reason for discontinuing treatment from previous sponsor-initiated siltuximab study
* Vaccination with live, attenuated vaccines within 4 weeks of first dose of this study
* Known unmanageable allergies, hypersensitivity, intolerance to monoclonal antibodies, to murine, chimeric, human proteins or their excipients
Avastin for Post-photocoagulation Macular Edema

to evaluate the efficacy of a single intravitreal bevacizumab (IVB) injection, 0.1mL (2.5mg), against panretinal photocoagulation (PRP)-induced macular thickening and visual disturbance in patients with severe nonproliferative diabetic retinopathy (NPDR) and proliferative diabetic retinopathy (PDR) and good vision


Eligibility Criteria:
Inclusion Criteria:

* Patients with Proliferative retinopathy or severe non-proliferative retinopathy
* BCVA of 20/63 or better (56 ETDRS letters
* No history of Macular Edema
* Central Retinal Thickness of 250mics or more

Exclusion Criteria:

* Previous treatment.
* Other ophthalmic diseases. history of Nephropathy, heart diseases and pregnancy
* Media opacities
Measure of Cerebrospinal Fluid (CSF) Pressure Variation With Patient Positioning

This is a study looking at pressure changes in the fluid that surrounds the spine when a person is positioned in 2-3 different ways.

Volunteers who need a myelogram of their spine as part of their routine medical care are being asked to be in this study. A myelogram is an imaging study with x-rays after an agent is put into the spine that shows spinal fluid on the x-ray. It requires insertion of a needle into the cerebrospinal fluid (CSF) inside the spine. CSF is a bodily fluid that bathes the brain, spinal cord, and nerve roots. This study is being conducted to measure CSF pressure changes with different patient positioning.

We are motivated to do this research study to better treat patients who develop a spinal fluid leak during a myelogram or other spine procedure. The tissue that holds the cerebrospinal fluid (CSF) is called the dura. During surgery or other procedures, the dura can develop a tear. Dural tears can result in a leakage of CSF. CSF leaks are a recognized complication of spinal surgery. Currently, there is no evidence on whether or not a specific postoperative spine position is beneficial, especially for cervical (neck spine) CSF leaks. The process of dural healing after a dural tear is influenced by CSF pressure. High CSF pressure may inhibit dural healing. We want to find the patient position (sitting, lying down, or reclining) that reduces the CSF pressure the most. To do this, we want to attach a pressure monitor to the needle that is normally placed in the spine for a myelogram and measure the CSF pressure.

Eligibility Criteria:
Inclusion Criteria:

* Need a lumbar or cervical myelogram as part of routine care.

Exclusion Criteria:

* Not needing a myelogram in the cervical or lumbar spine.
Reducing Chemical Exposures in Nail Salons

In this intervention study, the investigators engage Vietnamese American nail salon owners to train workers within their salons on how to reduce workplace chemical exposures. The long-term goal of the study is to reduce toxic chemical exposures in nail salons and promote worker health and safety in this vulnerable worker population.

The primary hypothesis is that there will be a significantly greater reduction in measured levels of air contaminants among workers in the intervention group than in the comparison group. The primary outcome of interest is workplace chemical exposure reduction.

In addition, the secondary hypotheses are:

1. The proportion of workers who have increased knowledge of workplace chemical exposure reduction (WCER) will be significantly greater in the intervention group than in the comparison group.
2. The proportion of workers who report having modified behavioral and environmental factors that facilitate WCER will increase significantly more in the intervention group than the comparison group.
3. The proportion of workers with decreased work-related health problems will be greater in the intervention group than the comparison group.

As part of the secondary analyses, the investigators will also examine whether changes in knowledge and behavior are associated with workplace chemical exposure reduction and also whether changes in workplace chemical exposure are associated with improved health. The specific aims are to:

1. Enhance existing workplace chemical exposure reduction (WCER) education materials and survey instruments that target Vietnamese nail salon owners and workers.
2. Implement an owner-to-worker intervention to administer the WCER education materials.
3. Evaluate the effectiveness of the owner-to-worker WCER intervention for:

   1. reducing the primary outcome of measured personal levels of air contaminants (e.g., toluene, methyl methacrylate, methyl ethyl ketone, and total volatile organic compounds) in workers;
   2. influencing the secondary outcomes which include:

   i) increasing worker knowledge of WCER

   ii) modifying behavioral and environmental factors that promote WCER

Eligibility Criteria:
Inclusion Criteria:

* Nail salon workers and owners who speak and/or write Vietnamese

Exclusion Criteria:

-