cyrilzakka/clinical-trials huggingface dataset:
Behavioral Intervention Study for Better Breast and Cervical Cancer Control for Korean American Women

The long-term goal of this study is to build a sustainable,community-based outreach program using Korean American community health workers (CHWs) to promote breast and cervical screening among Korean American women, thereby reducing related morbidity and mortality. The study is designed to determine the effectiveness of a health literacy-focused tailored breast and cervical cancer control intervention delivered by CHWs.

The investigators hypothesized that, compared to KA women in the delayed intervention group, KA women who receive a health literacy-focused CHW intervention will demonstrate: (1) higher levels of adherence to screening for breast and cervical cancer, (2) greater levels of health literacy, (3) higher levels of breast and cervical cancer knowledge, and (4) improve decisional balance.

Despite considerable progress in U.S. cancer control over the past 20 years, certain ethnic minority groups continue to experience significant health disparities. Recent immigrants including Korean Americans (KA), face an unequal cancer burden related to the significant language and cultural barriers they face in attempting to navigate the U.S. healthcare system. KA women have the second highest incidence of cervical cancer nationally and are experiencing rapid increases in breast cancer incidence. Not only are their breast and cervical cancers diagnosed at significantly later stages than those of whites, but they are also the least likely racial/ethnic group to receive early breast and cervical cancer screening.

This community-based behavioral intervention is designed 1) to evaluate, in a randomized controlled trial, the effects of our health literacy-focused cancer control intervention, delivered by trained CHWs, on the primary outcomes: mammography and Papanicolaou(Pap)test screening adherence, in a sample of 360 KA women, 2)to test the effects of the proposed intervention on the secondary outcomes: level of health literacy, breast and cervical knowledge, and decisional balance, in the KA sample.

Eligibility Criteria:
Inclusion Criteria:

1. age 21-65 years
2. self-identified as a KA woman
3. no mammogram and Pap test within the last 18 months
4. able to read and write Korean or English
5. willing to provide written study consent
6. willingness to provide written consent to allow the researchers to audit medical records for mammography and Pap test use.

Exclusion Criteria:

1. Potential participants with a cancer diagnosis, an acute and/or terminal condition
2. Psychiatric diagnosis (e.g., schizophrenia or cognitive impairment), or other conditions
3. Women who have undergone hysterectomy
An Open-Label Study to Assess the Long-term Safety of AXS-05 in Subjects with Dementia of the Alzheimer's Type, ADVANCE-2 and ACCORD-2 Extension Study

The primary objective of this open-label extension trial is to evaluate the long-term safety of AXS-05 for the treatment of Alzheimer's disease agitation in subjects that participated in ADVANCE-2 and ACCORD-2.

This is a multi-center, open-label extension trial to evaluate the long-term safety of AXS-05 in subjects with Alzheimer's disease (AD) agitation that wish to continue to receive AXS-05 given completion of ADVANCE-2 (AXS-05-AD-304) and ACCORD-2 (AXS-05-AD-303).

Eligibility Criteria:
Inclusion Criteria:

* Completed the treatment period in Study AXS-05-AD-304 or exited from Study AXS-05-AD-303 due to study completion.
* Caregiver is willing to communicate with site personnel, comply with all required study procedures, and oversee administration and compliance with the subject's study treatment.

Exclusion Criteria:

* Caregiver is unwilling or unable, in the opinion of the Investigator, to comply with study instructions.
* Subject is hospitalized in a mental health facility (e.g., psychiatric hospital or ward), living in a nursing home, or living alone.
* Any concurrent medical condition that might interfere with the conduct of the study, confound the interpretation of study results, or endanger the subject's well-being.
* Initiation of a new medication since enrolling in AXS-05-AD-304 and/or AXS-05-AD-303 which may pose a safety risk when taken concurrently with AXS-05.
Supine MRI in Breast Cancer Patients Undergoing Upfront Surgery or Receiving Neoadjuvant Therapy

This research study involves the use of a common breast imaging modality (magnetic resonance imaging, 'MRI') and is investigating its role in evaluating surgical decision making for breast cancer when it is performed with the patient in a new position (lying on one's back) as opposed to in the standard position (lying on one's stomach).

The procedure involved is called a supine breast magnetic resonance imaging (MRI).In this study, the investigators are evaluating the value of supine MRI in surgical decision making for women with breast cancer either undergoing upfront surgery or for those anticipating surgery after receiving neoadjuvant therapy.

The purpose of this study is to assess the value of supine breast MRI as a new imaging method to assist in surgical treatment planning. It is possible that the use of supine breast MRI will help your doctor see the size and location of tumors more accurately

Eligibility Criteria:
Inclusion Criteria:

* Participants must be female
* Participants must have a pre-operative standard mammogram with or without ultrasound.
* Participants must have biopsy confirmed and clinical stage I, stage II, or stage III non-inflammatory breast carcinoma. If biopsy was done at an outside hospital, pathology will be reviewed at (BWH, BWFH)
* Patient must meet standard MRI guidelines and be able and willing to undergo MRI
* Participants must be candidates for definitive local therapy with breast conserving therapy or deemed as potential candidates following NAT (this takes into account tumor to breast size ratio appropriate for BCT, and the ability to undergo standard radiation therapy post-operatively).
* Study participants will be restricted to those aged ≥18 years old. This age group is selected because it encompasses the majority of women likely to receive neoadjuvant therapy
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Participants with a known BRCA 1 or 2 mutation.
* Participants with a known Li-Fraumeni or Cowden's Disease.
* Participants with prior mantle radiation.
* Participants with inflammatory breast cancer or multi-centric disease
* Participants who are pregnant.
* Participants who are already enrolled in a conflicting investigational trial
* Participants with known active collagen vascular disease.
* Participants with prior history of ipsilateral breast carcinoma treated with BCS and radiation therapy.
* Patients who have biopsy confirmed multi-centric disease.
* Participants who are unable to undergo MRI because of documented contra-indications for contrast-enhanced MRI, including but not limited to renal failure
* Participants who exceed the weight limit for the operative surgical table, 350 lbs or who will not fit into the 60 cm diameter bore of the MRI scanner.
An Intervention Study to Assess the Role of the Built Environment on Physical Activity and Active Transportation to School in Children and Youth

The purpose of this study is to evaluate if changes to the built environment influence physical activity and active transport to school in children and youth.


Eligibility Criteria:
Inclusion Criteria:

* Student is in grade 4 - 10 at start of study (fall 2012), or grade 4 at any of the subsequent study years (2013-2015).
* Student's parent(s) or guardian(s) provide(s) consent.

Exclusion Criteria:

* Student is not in grade 4 - 10 at start of study (fall 2012).
* Student's parent(s) or guardian(s) do(es) not provide consent.
* Student cannot read or write in English.
ctDNA-MRD in Stage IIIB-C NSCLC Patients Treated With Induction Chemoimmunotherapy

The goal of this observational study is to explore whether ctDNA-MRD dynamic monitoring can more effectively predict the therapeutic effect of induction chemoimmunotherapy followed by surgery or non-surgical treatment for stage IIIB-C driver-negative NSCLC in the MDT model, so as to accurately guide clinical diagnosis and treatment.

This study is a single-center, observational, non-interventional, prospective study. 50 patients diagnosed with stage IIIB-C driver-negative NSCLC receiving induction chemoimmunotherapy will be planned to be enrolled in the study. Pre-treatment biopsy tissues of enrolled patients will be collected for next-generation sequencing (NGS) of institutionally-developed 1021-gene panel, and personalized detection panel will be customized based on NGS testing results. Patients will be received induction chemoimmunotherapy followed by surgery or non-surgical treatment in the MDT model and ctDNA-MRD testing will be performed at prespecified time points. For patients who received surgery following induction therapy, peripheral blood will be collected in baseline, 1 day before the third cycle of neoadjuvant therapy, 1 day before surgery, 3 days after surgery and landmark time and pulmonary venous blood will be collected intraoperatively. For patients who received non-surgical treatment following induction therapy, peripheral blood will be collected in baseline, 1 day before the third cycle of neoadjuvant therapy, 1 day before non-surgical therapy and landmark time. All included patients will be regularly followed up for at least 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Histopathology or cytology confirmed the non-small cell lung cancer
* Age ranging from 18 to 75
* Agree to participate in this study and sign an informed consent form
* Treatment-naive tumor
* Driver gene negativity
* According to the American Joint Committee on Cancer (AJCC) eighth edition of the Lung Cancer Staging Manual, the clinical stage is stage IIIB-C potentially resectable tumor
* The Eastern Cooperative Oncology Group (ECOG) performance status (PS) score is 0-1

Exclusion Criteria:

* Patients who cannot understand the content of the experiment and cannot cooperate, and those who refuse to sign the informed consent form
* Small cell lung cancer
* Driver gene positivity
* Tumor directly invades esophagus, heart, aorta, diaphragm, trachea, or carina, or is considered unresectable even following induction therapy
* Patients with solid organ or blood system transplantation
* Previous use of recombinant cytotoxic T-lymphocyte associated antigen 4 (CTLA-4), programmed cell death 1 (PD-1), or programmed cell death ligand 1 (PD-L1) immune checkpoint inhibitors
* Patients with interstitial lung disease
* Patients with acute or chronic infectious disease
* Pregnant and lactating women
* Patients who have undergone other clinical drug trials
Study of Fecal Bacteria in Early Diagnosis of Colorectal Cancer

The aim of the study is to identify and verify one or more gut bacteria of which the abundance in feces may help to early diagnosis colorectal cancer.

Gut microbiota is closely related to human gut neoplasm. According to recent statistics, the abundance of FN (Fusobacterium Nucleatum) is connected with the development and progression of CRCs (colorectal cancers). Subsequent research shows identifying multiple microbial-specific genes in human feces using qPCR (quantitative Polymerase Chain Reaction) may help diagnosis of early stage colorectal cancer. Currently little is known about the relationship between single abundance of specific gut microbiota and colorectal cancer in different stage. Moreover, finding early-stage CRCs is still of great challenge partially due to precancerous diseases like colorectal adenoma which remain difficult to differentiate from early-stage CRC under endoscope. Conventional clinic methods predicting CRCs largely depend on serum CEA (serum Carcino Embryonic Antigen) and OB(fecal occult blood test), which lack of adequate sensitivity and specificity especially in early stage CRCs. The investigators' work focuses on the abundance of gut microbiota in feces from people with colon neoplasm and its comparison with classical indicators such as CEA and OB, aiming to reveal and testify its potential role on assisting diagnosis of CRCs in different stage as a none-invasive cost-effective method.

Eligibility Criteria:
Inclusion Criteria:

* Patients age from 40 to 85 years old
* Patients with endoscopic or pathological confirmed healthy, adenoma, inflammation, early or late stage of colorectal cancer
* Patients with valid CEA(carcino embryonic antigen) and OB(occult blood) test result in 1 year before or after the coloscopy or surgery

Exclusion Criteria:

* Patients with history of colorectal cancer
* Patients with long term use of antibiotics or probiotics
* Patients with uncontrolled diabetes, hypertension or hepatitis
* Patients with a history of subtotal gastrectomy or partial bowel resection
* Patients who are not able to cooperate
* Patients with medical conditions who are not appropriate to participate the study
* Patients who are taking aspirin, NSAIDs (nonsteroidal antiinflammatory drugs), COX2(cyclo-oxygen-ase 2) inhibitors.
Surgical APGAR Score and Modified Surgical APGAR Score

In this study we aimed to define a new modified SAS is to predict the incidence of postoperative complication and mortality in major abdominal and orthopedic surgery. We also identify the effectivity of this modified scoring system composed of the duration of operation in addition to the three intraoperative parameters of SAS.


Eligibility Criteria:
Inclusion Criteria:

* Subject has major surgery
* More than 18 years

Exclusion Criteria:

* Pregnant
* Younger than 18
Point of Care Ultrasound to Predict Intensive Care Unit Admission of Patients Presenting With Sepsis to the Emergency Department

The FloPatch device will be applied to 150 septic patients in the emergency department before they receive fluid resuscitation. This study will assess whether initial FloPatch measured volume-responsiveness and volume of fluids used will predict a composite outcome of mortality, intensive care unit admission, or rapid response team activation. The development of fluid unresponsiveness throughout the initial fluid resuscitation will be assessed and its association with the composite outcome will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Emergency department patient
* 18+ years old
* Systolic blood pressure less than 100mmHg
* Respiratory rate greater than 22 breaths per minutes
* Temperature greater than 38 degrees Celsius or less than 36 degrees Celsius
* Heart rate greater than 90 beats per minute

Exclusion Criteria:

* Already intubated prior to emergency department arrival
* Ventilator-dependent
* Patients transferred from another hospital
* Pregnancy
Prediction of Safe Discharge From ICU

Patients who have an increased need for monitoring or therapy during their stay in hospital are typically admitted to an intensive care unit. This is characterized by a large number of diagnostic and therapeutic options. If this additional effort is no longer necessary, then typically in most hospitals patients are transferred to wards with a lower presence of nurses and physicians and reduced provision of extensive monitoring and therapeutic procedures such as organ replacement procedures.

However, deintensification of medical and nursing care requires that previously monitored and partially supported bodily functions are restored to the point where further monitoring is no longer necessary. For this reason, transfer from an intensive care unit to the normal inpatient area is only possible if the patient in question has neither an increased need for monitoring nor an increased need for therapy. If this is not the case, then there is a risk of life-threatening conditions in the normal ward, which can sometimes occur very quickly. However, the need for further monitoring, or for continued intensive medical therapy, cannot be easily assessed. There is no laboratory value or clinical examination method that can be used to estimate beyond doubt whether a patient's condition could worsen if he or she is transferred to the normal ward. For this reason, the decision to transfer is made on the basis of the individual assessment by the attending physician. Although this is based on the synopsis of a wide variety of examinations and laboratory findings, it is therefore subject to large interindividual variations. Thus, the personal experience of the evaluating physician has a considerable influence on the decision for or against a transfer to the normal inpatient area.

In this respect, the decision to deintensify therapy, i.e. to transfer patients from intensive care units to the normal care area, is challenging:

The assessing physician has to make a prediction from the combination of the available findings under time pressure whether a transfer to the normal inpatient area is possible without endangering the patient. In this situation, it would be desirable to have an automated warning system that could describe the success of the transfer with sufficient accuracy in the presence of specific laboratory constellations. In the best case, such an approach would prevent dangerous transfers, but at the same time reduce unnecessary lengths of stay in the ICU. Machine learning methods seem particularly suited to support such a decision.


Eligibility Criteria:
Inclusion Criteria:

* All adult patients that were treated in intensive care units at the Kepler University Hospital in Linz, Austria in the period 2010-01-01 to 2019-10-31.

Exclusion Criteria:

* None.
Revaccination With Pollinex® Quattro

The purpose of this non interventional study (NIS) was to observe the efficacy of Pollinex® Quattro as a short-term revaccination in patients who have already been successfully desensitized at least five years ago against grass-pollen but developed a recurrent allergy.

The increasing prevalence of allergies represents a major problem for the health care system. Approximately 500 million people are suffering worldwide from allergic rhinitis (AR). Allergic rhinitis is a Type 1 hypersensitive disorder, initiated by IgE antibodies. Whereas seasonal allergic rhinitis (SAR) is caused by different allergens found outdoors such as grass, tree and weed pollen, perennial allergic rhinitis (PAR) is caused by allergens that are mainly found indoors such as dust mites, mould or animal hair.

Specific immunotherapy (SIT) presently constitutes the only causal therapy available and is common practice. SIT is indicated in cases of IgE-mediated allergic diseases and includes two forms of treatment options: subcutaneous (SCIT) and sublingual immunotherapy (SLIT). Both therapies aim to train the immune system not react to supposed pathological allergens, but instead to develop tolerance to them.

Even though allergy vaccinations have been applied for a century, the commonly used SCIT requires up to 90 injections over three to five years. Pollinex® Quattro is currently the only ultra-short term medicinal product which requires only four preseasonal injections. The immunological effect associated with Pollinex® Quattro shows an increase of allergen-specific IgG antibodies and a decrease of allergen-specific IgE antibodies as well as a shift from a Th2 to a more Th1 type-immune reaction. Previous studies on the therapeutic efficacy of Pollinex® Quattro have come to a positive conclusion in regards to tolerability and decrease of allergic symptoms. As an ultra-short course SCIT, Pollinex® Quattro might decrease the number of noncompliance and withdrawal for revaccination in patients that have already undergone an intensive immunisation therapy.

In this non-interventional study, patients who were treated with Pollinex® Quattro and patients who decided to use anti-allergic drugs for the treatment of their grass pollen allergy were compared due to their allergic symptoms in the grass pollen season from May to July. For this purpose, the rhinoconjunctivitis and asthmatic symptoms as well as the use of concomitant medication were documented in a dia

Eligibility Criteria:
Inclusion Criteria:

* Adults and children from the age of 12 years on, who are diagnosed with recurrent seasonal allergic rhinitis (SAR) caused by grass pollen.

A previous specific immunotherapy finished at least five years ago had to be successful.

Exclusion Criteria:

* Contraindications according to the patient information leaflet
Outcomes of Early Laparoscopic Cholecystectomy in Cases of Acute Cholecystitis

Laparoscopic cholecystectomy is the most common laparoscopic surgery performed in the world. The initial treatment of acute calculus cholecystitis includes GIT rest, intravenous fluid, correction of electrolyte imbalance from repeated vomiting, good analgesia, and intravenous antibiotics. Following this treatment, patients with uncomplicated disease are managed on outpatient basis and are called for elective laparoscopic cholecystectomy after a period of 6-8 weeks.

Elective laparoscopic cholecystectomy has become the gold standard for treatment of symptomatic gallstones. However, in the early days, acute cholecystitis was a contraindication of laparoscopic cholecystectomy, and patients with acute cholecystitis were managed conservatively and discharged for re-admission in order to have elective surgery performed for the definitive treatment.

Early laparoscopic cholecystectomy, within 72 hours of presentation,has been advocated because of shorter hospital stay, decreased financial costs and reduced readmission rates. Previously cited reasons against early laparoscopic cholecystectomy include the increased technical difficulties, increased risk of conversion to an open procedure (6-35 % in some studies) and increased risks of biliary complications such as bile leaks and common bile duct (CBD) injuries when operating on an inflamed gallbladder with edematous planes and distorted anatomy.


Eligibility Criteria:
Inclusion Criteria:

* Any patient presented by Acute cholecystitis fit for lap cholecystectomy .

Exclusion Criteria:

* Patients unfit for laparoscopic surgery such as patients with significant medical illness (ASAgrade more 3), pancreatitis and common bile duct stones
RESOLUTE ONYX Post-Approval Study

To observe the continued performance of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in a real-world more-comer population.


Eligibility Criteria:
Key Inclusion Criteria

* Symptomatic coronary artery disease including subjects with chronic stable angina, silent ischemia, and acute coronary syndromes including non-ST elevation and ST-elevation myocardial infarction
* Subject is an acceptable candidate for treatment with a drug eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, manufacturer's Instructions for Use, and the Declaration of Helsinki

Key Exclusion Criteria

* Unprotected left main disease
* Subjects with planned PCI of three vessel disease