cyrilzakka/clinical-trials huggingface dataset:
Effects of Chemotherapy on Intestinal Bacteria in Patients With Newly Diagnosed Breast Cancer

This pilot research trial studies the effects of chemotherapy on intestinal bacteria/organisms (microbiota) in patients newly diagnosed with breast cancer. Change in intestinal microbiota may be associated with weight gain in patients treated with chemotherapy. Weight gain has been also associated with cancer recurrence. Examining the types and quantity of bacterial composition in the stool of breast cancer patients treated with chemotherapy may help determine whether body weight and composition are associated with changes in the intestinal microbiota and allow doctors to plan better treatment to prevent weight gain and possibly disease recurrence.

PRIMARY OBJECTIVES:

I. To examine the transitory and longer lasting effects of chemotherapy on the gut microbiota.

SECONDARY OBJECTIVES:

I. To examine the relationship between body composition and gut microbiota before and after chemotherapy.

II. To examine the relationship between blood estrogen levels and gut microbiota before and after chemotherapy.

TERTIARY OBJECTIVES:

I. To examine the relationship between changes in the gut microbiota by pre-treatment body mass index (BMI) (normal - BMI \< 25 kg/m\^2, overweight - BMI \>= 25-\< 30 kg/m\^2, and obese- BMI \>= 30 kg/m\^2) and by changes in body composition in relation to chemotherapy.

OUTLINE: Patients are assigned to 1 of 3 groups.

GROUP A: Patients undergo collection of stool samples at baseline (before surgery), at 1 week before initiation of adjuvant chemotherapy (after surgery), and at 1 and 4 months after completion of adjuvant chemotherapy.

GROUP B: Patients undergo collection of stool samples at baseline (after surgery), at 1 week before initiation of adjuvant chemotherapy, and at 1 and 4 months after completion of adjuvant chemotherapy.

GROUP C: Patients undergo collection of stool samples at baseline, 1 month after completion of neoadjuvant chemotherapy (before surgery), and at 1 and 4 months after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed ductal carcinoma in situ or invasive breast cancer (stage I, stage IIA, stage IIB, and stage IIIA breast cancer)
* A treatment group including surgery followed by standard treatment of adjuvant chemotherapy such as doxorubicin and cyclophosphamide followed by paclitaxel, docetaxel and cyclophosphamide, or a treatment group including neoadjuvant chemotherapy followed by surgery at the Norris or LAC+USC Medical Center
* Women of child-bearing potential agree to pregnancy test to confirm she is not pregnant
* Provide informed consent

Exclusion Criteria:

* Metastatic, recurrent, synchronous or metachronous breast cancer
* History of other cancers (other than non-melanoma skin cancer)
* History of autoimmune celiac or inflammatory bowel disease
* Past bariatric surgery
* Current or recent pregnancy or nursing (within past 12 months)
* Past treatment with chemotherapy
* Recent use (within past month) of more than 3 days of antibiotics use
* Current use of probiotic supplements
Pre-operative Physiotherapy to Prevent Post-operative Complications

The purpose of this study is to assess the roll of pre-operative chest physiotherapy, in addition to the usual care given after major abdominal surgery, in the prevention of post-operative respiratory complications.


Eligibility Criteria:
Inclusion Criteria:

* Major abdominal surgery

Exclusion Criteria:

* Respiratory Disease
* Pregnancy
* Mental Disease
* Dementia
* Alzheimer's Disease
Aerobic Exercise on PETCO2 Response in Coronary Artery Disease Patients

The purpose of the present study was to evaluate: 1) the effects of continuous exercise training and interval exercise training on end-tidal carbon dioxide pressure (PETCO2) response during graded exercise test in patients with coronary artery disease; and 2) examine the effects of exercise training modalities on the association among PETCO2 at ventilatory anaerobic threshold (VAT) and indicators of ventilatory efficiency and cardiorespiratory fitness in patients with coronary artery disease.

End-tidal carbon dioxide pressure (PETCO2) is a noninvasive index considered to be a good indicator in evaluating the ventilation/perfusion relationship in patients over a wide range conditions. Variations in PETCO2 have been shown to reflect changes in both cardiac output and pulmonary blood flow in animals and humans under constant ventilation. In this regard, it has been shown that patients with cardiac disease have an abnormally low PETCO2 during exercise, especially those with an impaired response of cardiac output during exercise

Eligibility Criteria:
Inclusion Criteria:

* was stable coronary artery disease diagnosed by coronary angiography

Exclusion Criteria:

* unstable angina pectoris,
* complex ventricular arrhythmias,
* pulmonary congestion and
* orthopaedic or neurological limitations to exercise
Use of PRF in Treatment of Dry Socket.

The aim of the study is to evaluate the influence of PRF application in case of alveolar osteitis.

The main objective was to compare the effects of using two different methods in the treatment of dry socket (alveolar osteitis), which is a postoperative complication of dental extraction. The first was Nipas, applied, if dry socket was diagnosed following a tooth extraction. In case of subsequent extraction of homonymous tooth and reoccurrence of dry socket, patients were treated with application of PRF.

Eligibility Criteria:
Inclusion Criteria:

* no known medical history of abnormal platelet counts,
* patients with symmetric teeth qualified for extraction,

Exclusion Criteria:

* patients treated previously for existing dry socket,
* patients allergic to acetylsalicylic acid ,
* systemic diseases,
* pregnancy,
* lactation,
* drugs known to affect the number or function of platelets,
* abnormal platelet counts,
His-pacing and AV-node Ablation vs. Pulmonary Vein Isolation for Atrial Fibrillation

Objective To investigate if conduction system pacing ((CSP) i.e. atrioventricular node ablation + His bundle pacing or Left Bundle Branch pacing) is as good as (or better than) atrial fibrillation ablation with pulmonary vein isolation for older patients (70-85yrs) with symptomatic atrial fibrillation and at least moderately dilated left atrium.

Patient population:

90 patients aged 70-85 years with atrial fibrillation, referred to either AV node ablation or pulmonary vein isolation.

Primary endpoint:

Improvement in health-related quality of life as measured by the physical component summary (PCS) of the well-validated SF-36 form, at one year after AV node ablation + CSP or AF ablation.

Secondary endpoints:

Physical performance measured by 6-minute walk test, biochemical markers of heart failure (NT-ProBNP), frequency of complications, left ventricular systolic and diastolic function, and left atrial size evaluated after 12 months. Arrhythmia specific symptoms and anxiety will be measured with the ASTA and HADS questionnaires. Arrhythmia symptom correlation between subjective and objective findings. After three years, clinical endpoints will be evaluated regarding overall survival, and risk of heart failure hospitalization or death. The cost of the treatments will be compared, and estimated cost per quality adjusted year of life will be calculated, based on the EQ5D questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Indication for invasive treatment of symptomatic atrial fibrillation according to current guidelines
* LVEF \>35%
* Age 70-85 years
* Persistent atrial fibrillation, or paroxysmal atrial fibrillation with at least moderate enlargement of the left atrium (≥42ml/m2)
* Chronic and well-tolerated treatment with anticoagulants (either non-vitamin K oral anticoagulant or vitamin K antagonist)
* Willingness to participate, to understand the instructions and fill out the questionnaires, and ability to sign informed consent

Exclusion Criteria:

* Chronic atrial fibrillation with \>1 year duration
* BMI \>40kg/m2
* Hypertrophic cardiomyopathy
* Severe heart failure with symptoms ≥ NYHA class IIIb
* Heart amyloidosis
* Cardiac sarcoidosis
* Recent (\<3 months) myocardial infarction
* Significant heart valve disease (pronounced insufficiency or stenosis)
* Pacemaker or ICD treatment ongoing, or current pacemaker indication
* Congenital heart disease that required surgical correction
* Comorbidity that is assessed significantly affect the patient's quality of life over the next year, or 3-year survival
A Comparison of Nasal Versus Oral Fiberoptic Intubation in Children

There are two routes in which a fiberoptic intubation can be performed - oral and nasal. In general, nasal intubation by any conventional method may be the preferred choice for certain procedures such as intra-oral surgeries, or for anatomical reasons such as limited mouth opening. If nasal intubation is not indicated or preferred, then oral intubation is usually performed.

This study is looking to explore whether or not the nasal route significantly improves the ease and time for successful fiberoptic intubation compared to the oral route in children less than or equal to 2 years of age. This study will also examine if operator experience influence time to tracheal intubation with either route?

The investigators hypothesize that the nasal route of fiberoptic intubation will be faster than the oral route, for both the trainee and the expert, and that there will be minimal differences between experts and trainees with nasal fiberoptic intubation.

The goal of this prospective randomized study is to compare the effect of nasal fiberoptic intubation versus oral fiberoptic intubation in children less than 2 years of age. Other factors that will be assesed include operator experience, the ease and time for fiberoptic grade of laryngeal view, time for fiberoptic tracheal intubation, and complications.

This study is looking to explore whether or not the nasal route significantly improves the ease and time for successful fiberoptic intubation compared to the oral route in children less than or equal to 2 years of age. While also asking, will operator experience influence time to tracheal intubation with either route?

The investigators hypothesize that the nasal route fiberoptic intubation will be faster than the oral route, for both the trainee and the expert, and that there will be minimal differences between experts and trainees with nasal fiberoptic intubation.

Eligibility Criteria:
Inclusion Criteria:

* Healthy children ASA I to III
* Patients less than or equal to 2 years of age
* Patients with scheduled surgeries in which endotracheal intubation is part of their general anesthetic plan

Exclusion Criteria:

* Children with ASA IV or V
* Children with active respiratory infection, pulmonary disease, a known history of difficult mask ventilation, high suspicion of difficult airway (secondary to congenital syndromes for example), and significant airway abnormalities
A Portal-based Advance Care Planning Intervention Among Community-Dwelling Persons Living With Cognitive Impairment

The purpose of this research is to examine the feasibility of using a patient portal based advance care planning (ACP) tool to improve ACP discussions and documentation in persons living with cognitive impairment in outpatient primary care.

The goal of this study is to explore whether sending a portal-based ACP tool (called ACPVoice) paired with a motivational message within the patient portal before a routine primary care physician visit can improve ACP discussions and documentation within the electronic health record among persons living with cognitive impairment in outpatient primary care.

Eligibility Criteria:
Inclusion Criteria:

* Age 65 years old and older
* Diagnosis of recognized or probable mild cognitive impairment or mild dementia or elevated eRADAR score
* Completed visit with their primary care provider (PCP) within the past 12 months and have upcoming PCP visit in next 6 months
* Have an active patient portal account

Exclusion Criteria:

* Lives in a long-term care facility
* Severe vision impairment/blindness (as they need to be able to read portal messages)
* Enrolled in hospice
* Lacks decisional capacity as deemed by PCP
High Flow Nasal Cannula (HFNC) Initiation Flow Rate Study

The investigators propose an open label, non-blinded, single center randomized controlled feasibility study to find the optimal initial HFNC flow rate in children less than 12 months old with clinically diagnosed moderate to severe bronchiolitis. This feasibility study is projected over December 2020 to April 2023. The study is consisted of 3 arms, comparing HFNC therapy at 1 L/kg/min, 1.5 L/kg/min, and 2 L/kg/min (20 L/min max). Moderate to severe bronchiolitis is defined clinician's assessment for the need for ICU level of care.

The primary outcome is treatment response to HFNC therapy defined by RDAI/Respiratory Assessment Change Score (RACS) ≥ 4 at 4 hours of therapy. Secondary outcome measures comprise of treatment failure requiring an escalation of care during the first 24 hours of HFNC therapy, duration of HFNC and simple nasal cannula therapy, duration of simple nasal cannula therapy, hospital and PICU length of stay (LOS), time to treatment failure, and adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Patients less than 12 months of age
* Clinical signs of moderate to severe bronchiolitis defined by American Academy of Pediatrics
* Requires ICU level of care by clinicians' discretion
* Requiring HFNC support

Exclusion Criteria:

* Infants who required immediate need for respiratory support such as non-invasive positive pressure ventilation (NIPPV) or invasive ventilation
* Congenital heart disease,
* Immunocompromised state
* Upper airway obstruction
* Chronic lung disease
* Bronchopulmonary dysplasia,
* Home oxygen therapy requirement
* Acute trauma patients
* Baseline craniofacial malformations
* Admitted to the neonatal or cardiac ICUs
* Patients who are admitted to the floor
Support Program for Adoption of Cancer Screening Interventions at a Rural Community-Based Organization

This pilot trial study uses a structural support program for adoption of cancer screening interventions at a rural community-based organization. Rural communities face unique barriers in implementation of evidence-based interventions due to a lack of infrastructure, community capacity, and expertise as academic and research centers are often clustered in urban areas. The support program may help a rural community-based organization select, adapt, and implement cancer prevention and control evidence-based interventions.

OUTLINE:

Community-based organizations participate in the support program, consisting of 2 half-day training workshops over 2 weeks, and 30-minute bi-weekly consultations in order to adapt and implement the cancer screening intervention for community members.

After completion of study, participants are followed up at 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Objective II COMMUNITY-BASED ORGANIZATION: Located in the Yakima Valley of Washington State
* Objective II COMMUNITY-BASED ORGANIZATION: Serve community members who are 18 and older
* Objective II COMMUNITY-BASED ORGANIZATION: Willing to commit to the 6-month program
* Objective II PARTICIPANTS: Receiving services from the recruited community-based organization
* Objective III PARTICIPANTS: Not up-to-date for breast, cervical, and colorectal cancer screening according to current U.S. Preventive Services Tasks Force (USPSTF) guidelines. The current USPSTF recommendations for breast, cervical, and colorectal cancer are:

  * Breast Cancer Screening: Women ages 50-74 should be screened for breast cancer with mammography every 2 years.
  * Cervical Cancer Screening: Women ages 21-29 should be screened for cervical cancer every 3 years with cervical cancer cytology alone. For women ages 30-65, the USPSTF recommends screening every 3 years with cervical cytology alone, every 5 years or every 5 years with high risk human papillomavirus (hrHPV) testing in combination of cytology.
  * Colorectal Cancer Screening: Individuals ages 50-75 should be screened for colorectal cancer with guaiac-based fecal occult blood tests (gFOBT) or fecal immunochemical test (FIT) once a year, or colonoscopy every 10 years (USPSTF approves additional screening tests, but these are the most commonly used).
* Objective III PARTICIPANTS: If the community-based organization selects breast cancer screening, we will recruit women ages 50-74.
* Objective III PARTICIPANTS: If the community-based organization selects cervical cancer screening, we will recruit women ages 21-65.
* Objective III PARTICIPANTS: If the community-based organization selects colorectal cancer screening, we will recruit women and men ages 50-75.
* Objective III PARTICIPANTS: Average risk for breast, cervical, or colorectal cancer
Primary Pain Palliation in Bone Metastases Treated With Magnetic Resonance-guided Focused Ultrasound

Magnetic Resonance guided Focused Ultrasound (MRgFUS) has demonstrated to be effective for pain control through thermally-induced cell death and periosteal denervation caused by cortical heating relative to acoustic energy absorption. There is also evidence that a high intensity focused ultrasound beam can penetrate through the cortical bone to the medullary space, producing thermal necrosis of cancer tissue. However, little is known about the potential effects of MRgFUS as first line therapeutic modality for pain palliation in skeletal metastases.

Our hypothesis sought to assess the clinical performance of MRgFUS primary treatment of painful bone metastases and determine the potential of this technique for local tumor control.

Unlike previous studies, in which patients were enrolled for MRgFUS treatment because of the failure of other therapies, our study will be conducted in patients not previously treated with EBRT to the targeted lesion.

This is an important new feature, especially given the advantages of MRgFUS, such as lack of ionizing radiation, the ability to conduct treatment on an outpatient basis and the possibility to repeat the treatment as necessary.

Eligibility Criteria:
Inclusion Criteria:

* the presence of a known primary cancer and bone metastases confirmed by two or more imaging modalities;
* exhaustion or refusal of all other pain palliation methods including EBRT;
* confirmation of MRgFUS treatment feasibility at a preliminary MR planning examination (presence of an adequate acoustic window between the transducer, skin and target lesion and absence of bowel loops across the planned ultrasound path)

Exclusion Criteria:

* general contraindication to MR imaging (including pacemaker, ferromagnetic devices or implants)
* general contraindication to gadolinium-based contrast agents (intolerance and/or clinically proven chronic renal failure)
* general contraindication to general/epidural anesthesia or deep sedation
Magnetic Resonance Imaging (MRI) of Pulp Regeneration

The present study was conducted to test whether pulp-like tissue can be regenerated in mature teeth with closed apex? And whether the size of the apical diameter affects the success of REPs? And whether Magnetic resonance imaging (MRI) can be used to quantitatively assess the vitality of the regenerated pulp-like tissue.

Regenerative endodontic procedures via blood clot were done on 18 mature anterior necrotic teeth with periapical lesions. The teeth were randomly assigned into two groups according to the size of the apical diameter of the rotary files used for instrumentation.

In the test group, rotary instrumentation was done using Pro-taper Next till size X3, while in the control group, instrumentation was done till size X5.

Calcium hydroxide was used as an intracanal medication for 1-2 weeks. Calcium hydroxide was then washed away using 1.5%NaOCl, followed by induction of blood using pre-curved K-fi;e #25 2mm past the radiographic apex. Biodentine was then used as a cervical plug over the blood clot followed by resin-modified glass ionomer cement and composite resin as coronal restoration.

MRI was used to assess the vitality of the regenerated pulp-like tissue, where the signal intensity of the regenerated pulp-like tissue was measured after 3,6 and 12 months follow up and compared to the normal contralateral teeth. In addition, sensibility tests using cold test and electric pulp testing were used to assess vitality of regenerated pulp-like tissue after 3,6,9 and 12 months. Cone beam computed tomography (CBCT) was also used to assess the healing of the periapical lesion after 12 months.

Eligibility Criteria:
Inclusion Criteria

* Upper anterior mature teeth with single canals.
* Necrotic teeth
* Presence of periapical lesion.

Exclusion Criteria:

* Presence of systemic diseases.
* Presence of stainless steel wires o brackets
* Vital immature teeth with open apex
High Risk Adult T-cell Leukemia/Lymphoma (ATLL-HR) and Allogeneic Transplant

Patients are recruited at diagnosis or at relapse of ATLL-HR in French Caribbean islands and Guyana. They all receive Zidovudine and Pegylated Interferon (ZPI). For patients younger than 65 years old, an allogeneic donor is searching out. Patients included at relapse and with lymphoma clinico-biological subtype also receive chemotherapy (CT). Responses are assessed during ZPI+/-CT and eligible patients (depending on age, comorbidities and response criteria) receive allogeneic transplant. Patient follow-up is planned for 3 years old


Eligibility Criteria:
Inclusion Criteria:

* Patient \>18 years old and ≤ 75 years old, with ATLL-HR who signed informed consent.

Exclusion Criteria:

* Pregnant or nursing women are not eligible; neither are women of childbearing potential unless using effective contraception as determined by the patient's physician.