cyrilzakka/clinical-trials huggingface dataset:
Effects of Pulmonary Diseases and Their Treatment on Cardiac Function

While the bidirectional relationship between the lung and the right heart are well studied, the cardiopulmonary interactions between the lung and the left heart are largely unresearched and not well understood. However, in recent years, there is a growing evidence that partially explains the bidirectional interaction between COPD and left heart. Systemic inflammation with multiorgan involvement is thought to play a role in COPD as a systemic disease. Some therapeutic approaches to COPD also appear to influence these cardiopulmonary interactions. While understanding these interactions is very important for clinicians, scientific data are scarce. Cardiac magnetic resonance imaging (cardiac MRI) is the gold standard for assessing cardiac function and dimensions as well as myocardial inflammation. Despite this excellent suitability of cardiac MRI for the assessment of cardiovascular function, only few studies have investigated cardiac function and myocardial structure in patients with pulmonary disease using cardiac MRI. Such a study is therefore very important for understanding the effects of pulmonary disease and its management on the heart.

The objective is to determine cardiac function in patients with pulmonary disease and to analyze the cardiovascular effects of the treatment of the pulmonary disease.

Specifically, the following will be studied:

* Using cardiac MRI: Cardiac function and volumes and indications of myocardial fibrosis and edema in patients with chronic pulmonary disease at the time of first diagnosis.
* the vascular function of pulmonary arteries in these patients, also using cardiac MRI
* the relationship between pulmonary function parameters and cardiac dysfunction to identify patients at increased risk, if applicable.
* Echocardiographic assessment of left heart including strain analysis.
* the course of these cardiovascular parameters (using cardiac MRI and echocardiography) 3-6 months after initiation of guideline-based therapy for pulmonary disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic lung disease requiring treatment (COPD, asthma, or pulmonary fibrosis).
* Age \> 18 years
* Informed consent to participate in the study will sign

Exclusion Criteria:

* Individuals who are not fully capable of giving consent and understanding the nature, significance and scope of the study.
* Patients with contraindications to MRI examination (eg, pacemaker, severe claustrophobia) or to contrast medium use (severe renal insufficiency or glomerular filtration rate \<30 ml/min, known gadolinium contrast medium allergy)
* Patients with atrial fibrillation or other significant cardiac arrhythmias that interfere with cardiac MRI
* Pregnancy and lactation
Prophylactic Mesh Reinforcement for Stoma Closure

n the current work we are aiming to compare between the mesh-reinforced stoma closure and the anatomical closure in terms of the risk of developing surgical site incisional hernia (SSIH),incidence of surgical site infection , post-operative Pain and Hospital stay

Intestinal stomas are used to divert intestinal content as a treatment option. Faecal flow is diverted from the site of the pathology by bringing the end or a loop of bowel through the anterior abdominal wall; any segments of the colon can be used, as well as the distal part of the ileum. A stoma may be temporary or permanent according to the condition. Temporary stomas are usually followed by elective stoma closure 6-8 weeks after. Though considered a relative safe procedure, studies reported high morbidity rates following stoma closure with different complications.

Incisional hernia following stoma closure occurs in up to 30% of patients. Incisional hernia affects quality of life, in regards to pain, physical function, ability to work, and cosmoses. Other serious complications due to bowel obstruction with incarceration or strangulation can occur which may necessitate reoperation. Mesh-reinforced stoma closure shown to decrease the incidence of surgical site incisional hernia (SSIH) with low complications risk. Though there is a debate about its efficacy due to lake of data ,and doubt to use a mesh in contaminated wounds due to fear of wounds complications which may necessitate mesh extraction or longer hospital stay make it hard for many surgeons to use Mesh-reinforced stoma closure.

In the current work we are aiming to compare between the mesh-reinforced stoma closure and the anatomical closure in terms of the risk of developing (SSIH),incidence of surgical site infection ,post-operative Pain and Hospital stay

Eligibility Criteria:
Inclusion Criteria:

* Patients who are fit for aesthesia.
* Patients with temporary double barrelled and simple loop ostomy
* Patients older than 16 years old

Exclusion criteria:

* Patients with end ostomy
* Infected stomas
Double Blind Study to Evaluate the Efficacy of Collagenase Histolyticum in the Treatment of Lipoma

The purpose of this study is to determine whether collagenase is effective in reducing the surface area of a subcutaneous benign lipoma.

This study will evaluate the safety and efficacy of a Food and Drug Administration (FDA) approved drug (XIAFLEX) in the treatment of lipoma (fatty tumors). The fat in the lipoma is like normal fat except that it is enclosed in a balloon-like structure which is made of collagen (fibrous tissue). Treatment of the lipoma with an injection of XIAFLEX (a protein that breaks down collagen fibers) may dissolve the collagen/fibrous strands thereby decreasing the size of the lipoma or removing it. Each subject must have two lipomas; one lipoma to be treated with placebo and one lipoma to be treated with study drug, both to be observed similarly throughout the trial.

Eligibility Criteria:
Inclusion Criteria:

* 18-75 years of age, of either sex or any race
* Clinical history of at least 2 lipomas for at least one year
* Lipomas diagnosed as benign
* Two lipomas on distinctly separate parts of the body, or on the torso if 30 cm apart, with easily definable edges
* Each lipoma is a single mass with easily definable edges
* Lipomas are 5 to 24 cm squared
* Women of childbearing potential must use an acceptable method of birth control

Exclusion Criteria:

* Lipomas on the head, neck, hand or foot, or female breast
* Women who are nursing or pregnant
* Multi-lobular lipomas
* Subjects who have received an investigational drug within 30 days before receiving the first dose of study drug in this study
* Subjects with a known allergy to collagenase or any of the inactive ingredients in XIAFLEX
* Subjects with uncontrolled diabetes, hypertension, or thyroid disease, or any medical condition that would make the subject unsuitable for enrollment
* Subjects having prior treatment or trauma of the lipoma that could interfere with study assessments
* Subjects with a history of connective tissue diseases, rheumatological diseases
* Subjects taking anticoagulants or planning to receive anticoagulants (except for lo dose aspirin and over-the-counter nonsteroidal anti-inflammatory drugs) within 7 days of injection of study drug
Irinotecan in Treating Patients With Metastatic or Inoperable Thyroid Cancer

RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well irinotecan works in treating patients with metastatic or inoperable thyroid cancer.

OBJECTIVES:

Primary

* Determine the response rate in patients with metastatic or inoperable locoregional medullary thyroid cancer treated with irinotecan.

Secondary

* Determine the safety and tolerability of this drug in these patients.

OUTLINE: Patients receive irinotecan IV on days 1 and 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Response is assessed after completion of 4 courses. Patients achieving complete response (CR) or partial response (PR) receive 2 additional courses beyond CR or PR. Patients who have stable disease receive up to 12 total courses.

PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.

Eligibility Criteria:
Inclusion

* Histologically confirmed medullary thyroid cancer
* Metastatic or inoperable locoregional disease
* Measurable disease by CT scan
* 18 years and over
* ECOG PS 0-1

Adequate lab functions including:

* Granulocyte count \> 1,000/mm\^3
* Platelet count \> 100,000/mm\^3
* Bilirubin \< 1.5 mg/dL
* ALT and AST \< 2.5 times upper limit of normal
* No unstable or uncompensated hepatic disease
* Creatinine clearance \> 60 mL/min
* No unstable or uncompensated renal disease
* Negative pregnancy test
* More than 3 months since prior biologic therapy
* More than 3 months since prior chemotherapy
* No prior radiotherapy to \> 25% of bone marrow
* More than 3 months since prior radiotherapy
* Recovered from prior oncologic or other major surgery
* More than 30 days since prior non-approved or investigational drugs

Exclusion:

* Patients with elevated calcitonin levels as the only measurement of disease are not eligible
* Unstable or uncompensated cardiovascular disease
* Unstable or uncompensated respiratory disease
* Pregnant or nursing
* Diarrhea ≥ grade 2 (antidiarrheals allowed)
* Other severe or uncontrolled systemic disease
* Other malignancy within the past 5 years except squamous cell or basal cell skin cancer or cervical cancer
* Illness that would preclude study participation
* Significant clinical disorder or laboratory finding that would preclude study participation
Comparison Study of the Effect of Enema in Anal Surgery

To evaluate whether receiving enema before anal surgery or not affects the postoperative recovery and complications.

For patients undergoing anal surgery, some of them receive enema as doctors' preference before the surgery in consider to lower postoperative complications e.g. infection, while others do not. These choices are often determined by surgeons' personal preference according to their experiences due to lack of evidence from researches. Hemorrhoidectomy and fistulotomy are the most common two types of surgery in colon and rectal surgery division in Shuang Ho hospital, where top three quantities of hemorrhoidectomy in Taiwn have been performed.Therefore, we conducted a randomized controlled trial to evaluate the benefits of enema before anal surgery and possible waste of medical resources.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent hemorrhoidectomy, including circular stapled hemorrhoidopexy (PPH) and conventional hemorrhoidectomy
* Patients who underwent fistulotomy or fistulectomy

Exclusion Criteria:

* Emergency surgery
* Surgery other than circular stapled hemorrhoidopexy (PPH) and conventional hemorrhoidectomy, e.g., rubber band ligation, injection treatment, and cryosurgery
* Complicated fistulectomy, e.g., requiring surgical drainage and seton placement
* Other types of anal surgery, e.g., anal fissure and colorectal cancer
* Liver cirrhosis
* Coagulation dysfunction
* Bedridden
* Human immunodeficiency virus infection
Gentle Warriors Academy Healthy Marriage and Responsible Fatherhood Program Evaluation

The purpose of this descriptive study is to explore whether there is an association between participation in the Gentle Warriors Academy and improvements in outcomes related to parenting, co-parenting, and parental well-being. Participants are surveyed at program entry, program exit, and 12 months following program enrollment, and changes in participant attitudes and behaviors are assessed over time.

This study is a descriptive evaluation of the Gentle Warriors Academy program offered to fathers in the Atlanta metropolitan area. Program participants are informed about the study and asked to provide consent to participate in the evaluation of the program. Consenting participants complete surveys at program enrollment, program exit, and 12 months after program enrollment, and survey data is used to determine if the program is associated with short-term and long-term changes in attitudes and behaviors among participants. Changes in parenting attitudes and parental well-being are assessed by comparing survey answers before and after participating in 26 hours of the Next Level Fatherhood primary curriculum. Changes in behaviors related to parenting and co-parenting are assessed from program entry to 12 months post-enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Adult (age 18-55)
* Father/father figure
* With children under age 16
* Reside in Metro Atlanta area

Exclusion Criteria:

* Minor (under the age of 18)
* Not a father/father figure
* Children older than 16 years old
* Reside outside of Metro Atlanta area
Individualized Patient Decision Making for Treatment Choices Among Minorities With Lupus

The study will compare the efficacy of the usual education materials to individualized computerized decision guide on decision conflict of patients with lupus nephritis making treatment decisions regarding immunosuppressive therapies.

The proposed study, a randomized controlled trial \[RCT\], will evaluate methods to assist minority lupus patients (African-Americans and Hispanics) to make shared decisions for the management of their lupus nephritis considering what is the best for them. We have developed an individualized patient decision guide that is culturally sensitive since it was developed solely based on the values, beliefs and preferences of minority patients. We will test the effectiveness of individualized decision aids in African-American and Hispanic lupus nephritis patients in a 2-arm randomized trial including 200 patients. We hypothesize that use of decision-aid will be associated with reduction in decisional conflict and more informed choice compared to usual care group (American College of Rheumatology \[ACR\] lupus pamphlet; co-primary effectiveness outcomes), both clinically meaningful and patient-centered outcomes. We chose the low-literacy decisional conflict scale as our primary outcome, since it is a validated measure, and the most commonly used outcome measure in decision aids RCTs. We use informed choice as a co-primary outcome, since this is conceptually most immediate to the intervention. It will measure whether in those with knowledge of risks and benefits of immunosuppressive drugs, patient values are concordant with their choice of immunosuppressive drug. Secondary outcomes include patient involvement in decision-making (concordance on control preference scale) and patient-physician communication (Interpersonal Processes of Care (IPC) score and analysis of audiotaped physician-patient Interaction (using the Active Patient Participation Coding Scheme (APPC)). Since we planned to recruit patients with current lupus nephritis flare (making current decision for an immunosuppressive drug) and with past lupus nephritis flares (making the same decision for a future lupus nephritis flare), two secondary outcomes (control preference scale for concordance of preferred and real role in deciding about immunosuppressive drugs and the audiotaped physician-patient interaction about immunosuppressive drugs) will be analyzed only in patients with current lupus nephritis flare, a subset of the entire cohort.

Eligibility Criteria:
Inclusion Criteria:

* adult female lupus nephritis patients, currently having a flare of lupus nephritis and considering change or initiation of an immunosuppressive medication (current flare) or had had flare of lupus nephritis in the past and at risk for a future lupus nephritis flare (future flare)

Exclusion Criteria:

* male; lupus but no lupus nephritis; change in lupus immunosuppressive treatment already made for current flare; end stage renal disease on dialysis; renal transplant or candidate for a renal transplant
Evaluation of Patients in Chest Pain in the Emergency Room

The primary objective of this feasibility study is to determine whether it is possible to conduct a study of the ClearView scan among patients under evaluation for acute cardiovascular events, as well as give insight into the performance of the ClearView scoring algorithm with respect to this patient population. The EPIC™ scan is a bio-electrographic tool that may assist the health care provider in rapid assessment of the systemic origin of the patient's presenting symptom(s). The EPIC ClearView is a potentially valuable resource that may benefit an emergency department (ED) by offering expedited "chest pain" etiologic differentiation capabilities. The subsequent results have the potential to include more rapid "chest pain" patient diagnosis and appropriate disposition of non-cardiac chest pain (rule out MI); optimized precious resource expenditure (nursing, physician, inpatient or observation bed, etc.); lower costs to facility, patient and insurance company; and greater patient satisfaction rates due to decreased ED wait time.


Eligibility Criteria:
Inclusion Criteria:

1. Sex: Male or Female
2. Age range: 18 to 85
3. Chief complaint upon admission to the ED: chest pain
4. The patient or legal representative is able to understand and provide signed consent for the procedure.
5. Every effort will be given to balance subjects by gender, age, and race.

Exclusion Criteria:

1. Patients \< 18 years in age or \> 85 years in age.
2. Inability or unwillingness to provide informed consent.
3. Patients with pacemakers or another electrical device, such as an automatic internal cardiac defibrillator, implanted somewhere in their body.
4. Patients connected to an electrical device that cannot be removed (i.e. monitor).
5. Pregnant women.
6. Patients currently undergoing therapy for cancer of any kind.
7. Patients missing all or part of any of their fingers.
8. Patients with hand tremors or involuntary oscillations ("shaking") of the hands that prevent clear imaging.
Sickle Cell Disease Biofluid Chip Technology (SCD BioChip)

'Sickle-shaped' anemia was first clinically described in the US in 1910, and the mutated heritable sickle hemoglobin molecule was identified in 1949. The pathophysiology of SCD is a consequence of abnormal polymerization of sickle hemoglobin (HbS) and its effects on red cell membrane properties, shape, and density, and subsequent critical changes in inflammatory cell and endothelial cell function. Our goal is to understand the impact of CMA abnormalities in SCD, by interrogating a number of recognized interactions in a range of clinical phenotypes.

To date, correlative studies in SCD, by us and others, have range between clinical reports, based on tests, interventions, and chart review of individuals or groups of individuals and, at the other extreme, identification of functional gene polymorphisms based on population studies. The investigators wish to augment these studies through a systematic examination of cellular membrane properties and activation status. Of hematologic disorders, SCD may be unusually susceptible to such an examination.

Novel biofluidic chip technology can investigate surface characteristics that are typically measured with conventional techniques, such as fluorescent activated cell sorting (FACS), immunohistochemistry, or microscopic imaging methods. In FACS, cells of interest are isolated, extensively processed, incubated with a fluorescent-labeled antibody and sorted by optical recognition. In the proposed SCD biofluidic chip (SCD biochip), the interrogating antibody coats the microchannel surface and captures the cell population(s) of interest, without processing, incubation, or in vitro manipulation. The SCD biochip can also quantitate cellular adherence to experimental biological surfaces that are comprised of subcellular components. The SCD biochip is technically simple and experimentally flexible, whereby the population of interest is retained on the chip and quantitated in situ. The microchip system allows retrieval of viable isolated cells for potential downstream processing, analysis, and in vitro culture.

Eligibility Criteria:
Inclusion Criteria

* Male or female ≥12 years of age at the time of consent (enrollment).
* Documentation Sickle Cell Disease, including HbSS or compound heterozygus HbSC- or HbSβ- thalassemia diagnosis as evidenced by one or more clinical features.
* Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.

Exclusion Criteria

* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
Implementation of Vascular Care Team to Improve Medical Management of PAD Patients

This study intends to evaluate the efficacy of a multidisciplinary vascular care team utilizing an intensive guideline-based lipid reduction program in improving risk factor modification as measured by LDL-C reduction at 12 months in patients with peripheral artery disease (PAD). An additional objective is to understand the potential reach and impact if this program were extended across the University of Colorado Healthcare (UC Health) System.

Patients with PAD and elevated LDL-C who are cared for at the University of Colorado (UC) and who provide consent will be randomized 1:1 to Intervention A, a vascular care team approach including pharmacy and healthcare provider assistance with medication adherence, versus Intervention B consisting of standard care augmented with a single consultation with a Vascular Medicine physician who will provide the treating doctor with a personalized risk assessment for the patient and a summary of the 2018 American College of Cardiology (ACC)/American Heart Association (AHA) Guideline on Management of Blood. In order to investigate the efficacy of the CPC Endpoint Quality Intervention Program (EQuIP), subjects will additionally be randomized 1:1 to an investigative site conducted Six-Minute Walk Test or an EQuIP team led Six-Minute Walk Test. Quality of Life data will be collected from all subjects. There will also be an observational cohort (registry) to understand current practice patterns and outcomes in a non-interventional PAD population within the UC Health system in order to assess the potential impact of Intervention A after conclusion of the randomized study.

Eligibility Criteria:
Inclusion Criteria:

1. Documented lower extremity atherosclerotic PAD with recommended goal LDL-C \<70 mg/dL by the ACC/AHA Management of Blood Cholesterol Guidelines
2. Receiving care at CU Anschutz
3. Screening/baseline LDL-C ≥70 mg/dL without change in lipid lowering therapy within the last 30 days prior to LDL-C draw.
4. Able to provide informed consent and willing to participate

Exclusion Criteria:

1. Unwilling or unlikely to remain in the UC Health system through 1 year follow up (12 months after randomization)
2. Life expectancy \< 12 months
3. Fasting triglycerides \>400 mg/ml at screening
4. End-stage renal disease (eGRF\<15 mL/min/1.73m2 and/or renal replacement therapy)
5. History of nephrotic syndrome
6. Clinical evidence of severe liver disease or another medical condition for which lipid lowering therapy may be contraindicated
7. Current enrollment in another investigational device or drug study with unapproved devices or therapies or with therapies that would impact lipid levels or lipid therapy
8. Any other condition that in the opinion of the investigator would make the subject unable to comply with the protocol