cyrilzakka/clinical-trials huggingface dataset:
A Clinical Study to Explore the Efficacy and Safety of Hyperbaric Oxygen in the Neoadjuvant Treatment of Hormone Receptor Positive Breast Cancer Patients

The goal of this study is to explore the efficacy and safety of hyperbaric oxygen in the neoadjuvant treatment of hormone receptor positive breast cancer patients


Eligibility Criteria:
Inclusion Criteria:

1. understood the study process, volunteered to participate in this study and signed an informed consent form
2. Patients with histopathologically confirmed diagnosis of initial unilateral primary invasive breast cancer, occult breast cancer, Inflammatory breast cancer and eczema-like carcinoma are excluded.
3. Female, aged ≥ 18 years and ≤ 60 years.
4. Patients who meet the inclusion criteria of neoadjuvant therapy to receive neoadjuvant therapy for breast cancer (locally advanced breast cancer (AJCC Stage III, except T3N1M0), or operable, but do not meet the conditions of breast conservation or axillary preservation (Stage IIA-IIB and T3N1M0).
5. Hormone receptor-positive breast cancer (Luminal/HER2-low (IHC 2+/FISH-negative)).
6. ECOG performance status 0-1.
7. LVEF ≥ 55 per cent
8. Adequate bone marrow functional reserve: white blood cell count ≥ 3.0 x 109/L, neutrophil count ≥ 1.5 x 109/L; platelet count ≥ 100 x 109/L; haemoglobin ≥ 90g/L;
9. AST, ALT ≤ 2.5 times the upper limit of normal value, alkaline phosphatase ≤ 2.5 times the upper limit of normal value, total bilirubin ≤ 1.5 times the upper limit of normal value; serum creatinine ≤ 1.5 times the upper limit of normal value
10. For non-menopausal or non-surgically sterilised female patients: consent to contraception during treatment and for at least 7 months after the last dose of study treatment

Exclusion Criteria:

1. have contraindications to hyperbaric oxygen therapy: lung disease (severe chronic obstructive airway disease, herpetic lung disease, acute or chronic lung infections, uncontrolled asthma, untreated pneumothorax), previous history of middle ear surgery, middle ear disease (eustachian tube dysfunction\\recurrent vertigo), eye disease (retinal detachment).
2. Previous hyperbaric oxygen therapy.
3. Distant metastases, including lymph node metastases in the contralateral breast and mediastinum.
4. Malignancy other than radically treated basal or squamous cell carcinoma of the skin or CIS of the uterine cervix within the last two years.
5. Pregnancy or lactation.
6. Uncontrolled hypertension, cardiac, hepatic, renal related diseases or other medical or psychiatric disorders.
7. Major surgical procedures unrelated to breast cancer within 4 weeks prior to randomisation, or patients who have not fully recovered from such surgical procedures.
8. Serious or uncontrolled infections that may interfere with study treatment or assessment of study results, including but not limited to active hepatitis virus infection, human immunodeficiency virus (HIV) antibody positivity, pulmonary infection, or other infections.
Abridge AI Pilot Test

We are piloting a new technology (Abridge) that uses artificial intelligence to listen to clinician-patient office visits and then document the interaction in the electronic health record.

This study will evaluate pilot implementation of the Abridge Artificial Intelligence (AI) Platform (Abridge) in UCHealth clinics. Abridge licenses will be deployed to 116 physician and advanced practice clinicians to accomplish the following goals:

1. Determine if Abridge meaningfully impacts clinician documentation time and burnout or stress
2. Determine whether to scale Abridge beyond the pilot

We will evaluate clinician experiences using Abridge, particularly with regard to documentation time and clinician burnout or stress. Study findings will explore value added in integrating Abridge into clinician practice, and guide decision-making for entering into a commercial agreement with Abridge. This pilot will also inform best practices for scaling Abridge to a broader user base across UCHealth outpatient practices.

Eligibility Criteria:
Inclusion Criteria:

-clinician (physician, advance practice professional, or licensed mental health professional) employed by UCHealth

* See clinic patients at least three half-day sessions per week. (Half-day sessions seeing or supervising patients with residents and fellows will NOT count toward the weekly total. Half-day sessions seeing patients with a medical student CAN count toward the weekly total, however, Abridge can only capture conversations where you are physically present with patients.)
* Own an iOS smartphone and be willing to download and use the Epic Haiku smartphone app during clinic visits

Exclusion Criteria:

* Trainees including residents and fellows
* PT/OT, ED, maternal/fetal, pediatric, dental, eye specialties
Ligation of Inter-sphincteric Fistula Tract for Management of Anal Fistula

After abscess formation, an anal fistula is a common consequence, with crypto-glandular infection being the most commonly accepted causative cause. The goal of this study was to see how well closure of the inter-sphincteric fistula tract affects the outcome of trans-sphincteric fistula surgery. Patients with perianal trans-sphincteric fistulas who underwent ligation were studied prospectively. All patients had the identical anesthetic approach, followed by the operation with two years' follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Men and women with trans-sphincteric peri-anal fistulas (according to magnetic resonance fistulogram) of crypto-glandular source with no previous fistula surgery

Exclusion Criteria:

* Individuals with recurrent fistulae or had specific pathology, like Crohn's disease.
Effect of Different Stretching Techniques

The aim of this study is to investigate the effect of proprioceptive neuromuscular facilitation (PNF) and static stretching techniques on the balance and functional capabilities of children diagnosed with diplegic cerebral palsy (CP).

The aim of this study is to investigate the effect of proprioceptive neuromuscular facilitation (PNF) and static stretching techniques on the balance and functional capabilities of children diagnosed with diplegic cerebral palsy (CP). The study consisted of a group of sixteen children, ranging in age from 8 to 16 years, who were diagnosed with bilateral hip flexor contracture and diplegic cerebral palsy. These children were classified according to the Gross Motor Function Classification System (GMFCS) levels I to III. The children were randomly divided into PNF and static stretching groups. Stretching techniques were applied 2 days a week for 4 weeks, with 6 repetitions in each session. The study assessed various parameters, including hip extension range of motion (ROM), muscle tone intensity based on the Modified Ashworth Scale, hip flexor shortness as determined by the Thomas Test, the time up and go (TUG) test, balance using the Pediatric Berg Balance Scale, and functional status evaluated through the Gilette Functional Walking Assessment Questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* A clinical diagnosis of CP;
* Age ranging from 6 to 18 years;
* No recent administration of Botulinum Toxin to the lower extremity muscles in the last 6 months;
* An IQ score of 70 or above;
* A Gross Motor Function Classification System (GMFCS) value of 1, 2 or 3;
* Presence of hip flexion contracture;
* Willingness to participate in the study

Exclusion Criteria:

* Concomitant diagnoses aside from CP,
* Presenting with muscle tone ratings of 3 or 4 in the hip muscles according to the Modified Ashworth Scale (MAS),
* Who had undergone tendon lengthening surgery to increase hip flexion
Different Bowel Preparations in CT Colonography: is Diet Necessary? A Randomized Controlled Trial

The aim of this study is to compare a new regimen of reduced bowel preparation that does not include low fiber diet with another reduced bowel preparation including low-fiber diet.

Bowel preparation should be safe and well tolerated by patients, particularly in a screening setting. For this reason, limited bowel preparations have been extensively investigated. Usually, they combine the use of low-fibre diet and faecal/fluid tagging. The ingestion of a positive contrast agent (either barium, iodine or a combination of the two),needed to differentiate stool or fluid residues from true colonic lesions, is now considered mandatory. A low-fibre diet has the aim of improving residue homogeneity and facilitates tagging; however, there aren't significative evidences at support. The aim of this study is to compare a new regimen of reduced bowel preparation that does not include low fiber diet with another reduced bowel preparation including low-fiber diet. Primary outcome is the overall quality of bowel preparation.

Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic patients (Screening Patients)
* Symptomatic patients unwilling to undergo optical colonoscopy (Symptomatic Patients)
* Patients with a previous incomplete optical colonoscopy.

Exclusion Criteria:

* Allergy to Macrogol
* Cognitive behavioral deficits
The Association of Costimulatory Molecules and PPAR-polymorphisms With Autoimmune Thyroid Disease in Taiwan

Autoimmune thyroid disease is the most common organ-specific autoimmune disease. AITD include Graves' disease and Hashimoto's thyroiditis. Although the pathogenesis of AITD remains unclear, it is generally thought that the mechanisms of the disease is a complex disease in which susceptibility genes and environmental triggers act in concert to initiate the autoimmune response to the thyroid.

The initial step of thyroid autoimmunity is the activation of T cells. The activation of T cell requires two signals: firstly, thyroid follicular cells or antigen presenting cells binds to T cell receptor through antigenic HLA complex. Secondly, the activation of T cells is also required the interaction of costimulatory molecules between thyroid follicular cells and immune cells, including CTLA-4, CD 40, CD28, ICOS. PPAR- is a kind of intranuclear transcription factor, associated with adipogenesis and inflammation. Some reports showed that PPAR- polymorphism may have a protective effect from Graves' ophthalmopathy.

The goal of the study is to investigate the relationship among SNP and mRNA of costimulatory molecules and PPAR- , serum cytokine including TNF- and sIL-2R, and clinical characteristics in AITD patients. From the study, we hope to clarify the role of costimulatory molecules and PPAR- polymorphism in AITD.

Autoimmune thyroid disease is the most common organ-specific autoimmune disease. AITD include Graves' disease and Hashimoto's thyroiditis. Although the pathogenesis of AITD remains unclear, it is generally thought that the mechanisms of the disease is a complex disease in which susceptibility genes and environmental triggers act in concert to initiate the autoimmune response to the thyroid.

The initial step of thyroid autoimmunity is the activation of T cells. The activation of T cell requires two signals: firstly, thyroid follicular cells or antigen presenting cells binds to T cell receptor through antigenic HLA complex. Secondly, the activation of T cells is also required the interaction of costimulatory molecules between thyroid follicular cells and immune cells, including CTLA-4, CD 40, CD28, ICOS. PPAR- is a kind of intranuclear transcription factor, associated with adipogenesis and inflammation. Some reports showed that PPAR- polymorphism may have a protective effect from Graves' ophthalmopathy.

The goal of the study is to investigate the relationship among SNP and mRNA of costimulatory molecules and PPAR- , serum cytokine including TNF- and sIL-2R, and clinical characteristics in AITD patients. From the study, we hope to clarify the role of costimulatory molecules and PPAR- polymorphism in AITD.

Eligibility Criteria:
Inclusion Criteria:

* Autoimmune thyroid patients
* patients who cut Nodular Goiter in Wanfang Hospital

Exclusion Criteria:

* none
Cardioversion of Atrial Fibrillation Accompanied by Chronic Heart Faliure

The purpose of this study is to explore the efficacy of low energy cardioversion on atrial fibrillation accompanied with chronic heart failure treated with HTEA or usual medicine.

The purpose of this study is to explore the efficacy of low energy (30J) cardioversion on atrial fibrillation accompanied with chronic heart failure treated with HTEA or usual medicine.

Eligibility Criteria:
Inclusion Criteria:

* congestive heart failure accompanied by atrial fibrillation.

Exclusion Criteria:

* Valvular heart diseases.
CheckED Yourself Study

During adolescence, the most common causes of morbidity and mortality are related to risky behaviors. The American Academy of Pediatrics recommends that adolescents be screened for these behaviors during primary care visits, but many adolescents do not receive the recommended risk behavior screening and counseling, in part because they are infrequently seen in primary care. The objective of this study is to evaluate if the electronic health screening tool, which includes an electronic health assessment with integrated personalized feedback, reduces risk behaviors in adolescents seen in the Emergency Department (ED).

Adolescents and their parents (if participant is under the age of 18 years) will be approached and invited to participate in the study during their Emergency Department (ED) visit. Following consent, adolescents will be randomized to the intervention or control group. A tablet computer will be provided to the participants for use during their baseline assessment in the ED. The CheckED Yourself App will be pre-loaded on the tablet. The CheckED Yourself App (eHA-IPF) is an innovative electronic health screening tool with integrated personalized feedback about risk behaviors. The CheckED Yourself App (eHA-IPF) will be divided into an assessment about risk behaviors and a personalized feedback portion. Participants will be randomized to a control or intervention group at the time of consent. Those in the intervention group will receive both parts of the CheckED Yourself App, while the control group will receive only the assessment with no feedback.

Those in the Intervention arm will complete the health risk behavior assessment and receive integrated personalized feedback from the CheckED Yourself App (eHA-IPF), and those in the control group will complete the health risk behavior assessment only. Participants will complete the questionnaire at some point during their ED visit and prior to discharge.

Follow-up assessments will be completed at 1-day and 3 months post ED visit via an online survey. Reminders for the 1-day and 3-month follow-ups will be sent via email or text message. The 1-day assessment will focus on adolescent-reported motivation to make a health behavior change, the content of the ED visit including what, if any, risk behaviors their ED provider discussed with the participant, and satisfaction with care in the ED. The 3-month assessment will include a re-assessment of risk behaviors.

Eligibility Criteria:
Inclusion Criteria:

* 13-18 years of age
* Ability of patient and parent of patient \<18 years old to fluently speak and read English
* Has email address and/or cell phone

Exclusion Criteria:

* Inability to independently complete the assessment due to intellectual disability
* Acute cognitive impairment due to injury and/or intoxication
* Administration of IV sedation or pain medications during Emergency Department visit
* Presenting to the Emergency Department due to a psychiatric or mental health complaint
* Emergency Department visit results in hospital admission
Retrospective Observational Study About Long-term Effect of Fampridine in Patients With Multiple Sclerosis

Mobility problems in multiple sclerosis (MS) is a frequent symptom. It might appear in almost 93% of patients in the first 15 years of the disease, being a clear problem for their normal living. Nevertheless, therapeutic options for this symptom are few and optimal for only some patients.

The mechanism of action of fampridine has a direct effect on mobility and it´s based on voltage-dependent potassium channels functioning, causing an improvement of conductivity of action-potential in neurons. This is why nowadays is the only approved drug to treat walking and mobility problems in MS. Results obtained after Phase III randomized clinical trials proved improvement in walking ability measured using the Timed 25 Walking Feet test (T25WF).

There are few studies regarding fampridine effects on symptoms different from mobility. The ENABLE Phase VI study found the first data related with the long-term impact of this treatment in physical and psychological function in patients according to their own perception. Results from this study indicated that, after one year of treatment, patients perceived a sustained benefit in their health, both physical and psychologically.

Eligibility Criteria:
Inclusion Criteria:

* patients with multiple sclerosis with fampridine treatment

Exclusion Criteria:

* none
Chronic Lung Disease and COVID-19: Understanding Severity, Recovery and Rehabilitation Needs

This is study is comprised of three approaches. First, the investigators will conduct a retrospective cohort study to determine factors associated with COVID-19 severity and complications and understand COVID-19 outcomes, including all-cause mortality, post-discharge events, and impacts of rehabilitation services (third aim). The second aim is a mixed-method study and follows COVID-19 patients with repeated surveys to determine patient-reported functional outcomes, health recovery, and rehabilitation needs after COVID-19. The investigators will recruit patients and their informal caregivers for interviews to assess their function and rehabilitation needs.

The long-term consequences of COVID 19 are not well understood, particularly in the Veteran population. This study will describe and quantify the long-term consequences of COVID-19, including impairment in physical and psychosocial function and health-related quality of life. Additionally, it will determine the impact of chronic lung disease (CLD) and other comorbidities on severity and recovery after COVID-19 infection and the association of social determinants of health with severity and recovery.

Initially, a retrospective national cohort of VA patients who test positive with SARS2 will be identified. Baseline clinical history will be analyzed with outcomes that include severity of COVID 19, all-cause mortality, and post-discharge events.

Subsequently, a mixed methods, prospective cohort study will include both qualitative (interview) and quantitative components (surveys). The investigators will identify patients with COVID-19 and recruited for qualitative interviews following hospital discharge or diagnosis. Patient caregivers will also be eligible to participate in study interviews. Interviews will occur once at various times ranging 2 weeks to 1 year since a patient's COVID-19 diagnosis. Surveys will be completed at 3 time points, 2-8 weeks after diagnosis or discharge to home, and then 6 months and 12 months later. Surveys will include the EQ-5D-5L profile for health-related quality of life, and the WHODAS 2.0 score for a global assessment of overall physical and psychosocial function. Investigators will also identify a comparator cohort of patients who have been diagnosed with lower respiratory tract infection (LRTI) in the setting of a negative COVID-19 test. Surveys will be administered at the same interval and analysis will determine if COVID-19 has different and more severe health impacts than other causes of lower respiratory tract infection.

Eligibility Criteria:
Inclusion Criteria:

* (Patients in COVID-19 cohort) VA patients diagnosed with COVID-19 through a positive PCR (Polymerase Chain Reaction) or antigen SARS-CoV-2 test conducted in VA
* (Caregivers) Providing caregiving to VA patients diagnosed with COVID-19
* (Patients in LRTI cohort) VA patients diagnosed with LRTI and tested negative for COVID-19 (through PCR and/or antigen test)

Exclusion Criteria:

* Cognitive limitations that preclude the ability to communicate and obtain informed consent
* Language barriers
Docetaxel in Treating Women With Ovarian Epithelial or Primary Peritoneal Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating women who have ovarian epithelial cancer or primary peritoneal cancer that has not responded to previous treatment.

OBJECTIVES:

* Determine the activity of docetaxel in women with platinum resistant, refractory ovarian epithelial or primary peritoneal serous cancer.

OUTLINE: Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive a minimum of 6 courses of therapy, including 2 courses beyond CR.

PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed ovarian epithelial or primary peritoneal serous cancer that is resistant to platinum therapy
* Platinum resistance as defined by one of the following:

  * Relapse within 6 months of platinum based chemotherapy
  * Residual disease after completion of platinum based chemotherapy
  * Disease progression while receiving platinum based chemotherapy
  * Marker only relapse (CA-125 elevation) and measurable disease
* Bidimensionally measurable disease on exam or CT scan

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Sex:

* Female

Performance status:

* ECOG 0-2

Life expectancy:

* Greater than 2 months

Hematopoietic:

* WBC at least 3,000/mm3
* Absolute neutrophil count at least 1,500/mm3
* Platelet count at least 100,000/mm3

Hepatic:

* Bilirubin no greater than upper limit of normal (ULN)
* SGPT or SGOT no greater than 1.5 times ULN
* Alkaline phosphatase no greater than 2.5 times ULN

Renal:

* Creatinine no greater than 1.5 mg/dL

Cardiovascular:

* Acceptable cardiac exam
* No active cardiac ischemia

Pulmonary:

* Acceptable pulmonary exam
* No active pulmonary infection or compromise

Other:

* Not pregnant or nursing
* No severe peripheral neuropathy (grade 2 or greater)
* No other significant psychiatric or medical conditions that would interfere with compliance
* No other malignancies within the past 3 years, except:

  * Limited basal or squamous cell skin cancer
  * Carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No prior cytokine therapy

Chemotherapy:

* See Disease Characteristics
* At least 3 weeks since prior chemotherapy for ovarian epithelial or peritoneal serous cancer
* Prior paclitaxel allowed
* No prior docetaxel
* At least 3 years since prior chemotherapy for other disease

Endocrine therapy:

* Not specified

Radiotherapy:

* No prior pelvic radiotherapy

Surgery:

* Not specified