cyrilzakka/clinical-trials huggingface dataset:
Diastology-Guided Management of Decompensated Heart Failure

More than 30% of people hospitalized with decompensated heart failure return to the hospital within 90 days. Emerging evidence suggests that hemodynamic monitoring with guided management may enhance prognosis and management. Hemodynamic monitoring with echocardiography using diastology and an evidence-informed therapeutic protocol have the potential to achieve this aim in a minimally invasive manner.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years at the time of enrolment
2. Decompensated heart failure with reduced ejection fraction (≤40%)
3. Sinus rhythm without conduction abnormalities (second-degree Mobitz II, third-degree, permanent pacemaker)
4. Written informed consent from either the patient or a substitute decision maker

Exclusion Criteria:

1. Mitral annular calcification (at least moderate or severe)
2. Moderate or severe aortic or mitral valvular heart disease, or history of prosthetic mitral valve
3. Atrial fibrillation or flutter
4. History of non-diagnostic echocardiogram
5. Hemodialysis
Endostapler Hemostasis Study

The goal of this prospective, multi-center, post-market study is to measure AEON™ Endostapler performance with the EASY/THICK MODE feature for laparoscopic bariatric surgery against the Echelon Flex™ Powered Stapler system from Ethicon. Stapler performance will be evaluated primarily by incidence and degree of staple line bleeding through a third-party blinded primary outcome evaluator. The study will include 60 total consecutive cases of individuals undergoing a planned laparoscopic sleeve gastrectomy (LSG). The LSG procedure will be performed according to institutional standard-of-care and all subjects will undergo standard preoperative evaluation as well as post-operative care. Relevant data will be collected using the Data Collection sheet which should be filled out following each procedure by a member of the surgical or nursing team.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing planned laparoscopic sleeve gastrectomy with signed surgery consent form
* Informed consent for study obtained and signed from each subject

Exclusion Criteria:

* Planned open surgical approach
* Prior bariatric operation (i.e. revisional bariatric surgery)
* Use of staple line reinforcement material (buttress)
* Patients taking anticoagulants
* Patients under the age of 18 on the date of the surgery
Study of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-biologic DMARDS (Disease Modifying Antirheumatic Drugs) Who Have an Inadequate Response to Anti-TNF Therapy

The purpose of this study is to summarize the safety and tolerability of abatacept during 6 months of combined treatment with one or more of the background non-biologic disease modifying anti-rheumatic drugs (DMARDs) approved for rheumatoid arthritis (RA) in subjects with active RA. Secondary objectives assessed the clinical efficacy of combination treatment, including disease activity, physical function, and quality of life outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Completed double-blind portion of the IM101064 study.
* Rheumatoid arthritis (RA) for greater than 1 year from the time of initial diagnosis
* American College of Rheumatology (ACR) functional class I, II, III
* Subjects currently or previously received an anti-TNF therapy at an approved labeled dose for at least 3 months

Exclusion Criteria:

* Subjects with active vasculitis of a major organ system (except subcutaneous rheumatoid nodules)
* History of cancer within the last 5 years (other than non-melanoma skin cell cancers cured by local resection)
ONTAK® in Treating Patients With Advanced Breast Cancer That Did Not Respond to Previous Treatment

RATIONALE: ONTAK may be able to help reduce the type of cells that prevent other types of immune cells from attacking the breast cancer cells.

PURPOSE: This phase I/II trial is studying the safety of ONTAK and its possible side effects to see how well it works in treating patients with advanced breast cancer that did not respond to previous treatment.

PRIMARY OBJECTIVES:

I. To evaluate the safety of ONTAK infusion in patients with advanced refractory breast cancer.

II. To evaluate the effect of ONTAK administration on peripheral blood T-regulatory cells.

SECONDARY OBJECTIVES:

I. To evaluate the incidence of IL-2R expression in tumor samples and investigate the correlation of tumor IL-2R expression and tumor response to ONTAK therapy.

II. To evaluate levels of circulating sIL-2R before and after ONTAK therapy. III. To evaluate the effect of ONTAK on endogenous tumor specific immunity. IV. To evaluate the potential anti-tumor effects of ONTAK in patients with advanced refractory breast cancer.

OUTLINE:

Patients receive ONTAK IV over 1 hour on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced stage refractory breast cancer
* Progressive or relapsed disease following standard therapy
* Patients must have measurable disease that can include, but is not limited to bone; specifically, patients must have measurable extraskeletal disease that can be accurately measured in at least one dimension as \>= 20 mm with conventional CT techniques or \>= 10 mm with spiral CT scan; measurable (bi-dimensional) chest wall disease will also be allowed
* Patients must be at least 14 days out from last cytotoxic chemotherapy; patients on bisphosphonates are eligible
* White blood cell count (WBC) \> 3.0 THOU/ul
* ANC \> 1.0 THOU/ul
* Platelets \>= 100 THOU/ul
* Serum creatinine =\< 2.0 mg/dL or creatinine clearance (calculated) \>= 60 ml/min
* ALT/AST =\< 2.0 x upper limit of normal
* Total bilirubin =\< 1.5 x upper limit of normal
* Albumin \>= 3.0 g/dL
* Subjects must have a Performance Status Score (ECOG Scale) =\< 2
* Subjects must have recovered from major infections and/or surgical procedures and, in the opinion of the investigator, not have a significant active concurrent medical illness precluding protocol treatment
* Men and women of reproductive ability must agree to contraceptive use during the study and for 1month after ONTAK treatment is discontinued

Exclusion Criteria:

* Prior treatment with ONTAK (DAB389 IL-2) or DAB486 IL-2
* Known history of hypersensitivity to diphtheria toxin or IL-2
* Active autoimmune disease
* Known history of pulmonary disease except controlled asthma
* History of or pre-existing, cardiovascular disease as defined by New York Heart Association (NYHA) Class III-IV categorization
* Pregnant or breast-feeding women
Evaluate Inflammation Caused by Gingivitis in Adults

The purpose of this study is to compare the anti-inflammatory efficacy of a dentifrice


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be adult males or females 18 to 60 years old
* Subjects must be able and willing to follow study procedures and instructions
* Subjects must have generalized, moderate plaque-associated gingivitis as determined by the Investigator or designee during the screening examination
* Subjects must present with at least 20 teeth in the functional dentition, excluding third molars
* Each subject must have at least four teeth with probing depths of 4-5 millimeters and at least 30% of sites bleeding to gentle probing

Exclusion Criteria:

* Subjects who have chronically used (two weeks or more) Total (Triclosan/Copolymer) dentifrice within 6 months prior to enrollment
* Subjects with gross oral pathology, including widespread caries or chronic neglect, extensive restoration, pre-existing gross plaque and calculus, or soft or hard tissue tumor of the oral cavity
* Subjects with periodontitis as indicated by periodontal pocketing 6 millimeters at screening
* Subjects with a history of early onset periodontitis or acute necrotizing ulcerative gingivitis
* Subjects with concomitant endodontic or periodontal therapy other than prophylaxis within 6 months prior to enrollment
* Subjects with orthodontic appliances or removable partial dentures
* Subjects chronically treated (two weeks or more) with any medication known to affect inflammation or periodontal status or (aspirin, nonsteroidal anti-inflammatory drugs, steroids, statins, phenytoin, calcium antagonists, cyclosporin and coumadin) within one month of the screening examination. All other medications for chronic medical conditions should be initiated at least three months prior to enrollment
* Subjects who currently smoke or who report using tobacco products within one year of screening.
* Subjects who have been treated with antibiotics for medical or dental reasons within 3 months prior to enrollment
* Subjects having clinically significant or unstable organic disease; subjects having compromised healing potential such as those with diabetes mellitus or connective tissue disorders; subjects having heart murmurs, histories of rheumatic fever, valvular disease or prosthetic joint replacement necessitating antibiotic prophylaxis
* Female subjects who report being pregnant
* Subjects who use hormonal contraceptives must have started the method 30 days prior to the screening examination.
* Subjects with active infectious diseases such as hepatitis, human immunodeficiency virus or Tuberculosis
* Subjects diagnosed with human immunodeficiency virus (HIV) or subjects that are immunocompromised as determined by the Investigator
* Medical condition which precludes not eating/drinking for approximately 8 hours.
High Risk Breast Clinic: Protocol for Women at Increased Risk for Developing Breast Cancer

The overall goal of this project is to develop an integrative system of breast cancer risk assessment based on epidemiologic and biologic risk variables, as well as to develop or refine risk biomarkers which may be useful in predicting and monitoring response to prevention interventions.

1. To correlate established risk biomarkers such as cytomorphology obtained from random periareolar fine needle aspiration ( RPFNA), mammographic breast density, serum bioavailable estradiol and IGF-1/IGFBP-3 with each other and with 5-10 year Gail risk estimates. Where available, and with appropriate safe guards to maintain status for breast cancer susceptibility genes may be included.
2. To determine the relative predictive value of established risk biomarkers for the development of DCIS and/or invasive cancer.
3. To evaluate potential new breast tissue-based biomarkers including Ki-67, PCNA, ER, COX-2, aromatase, methylation of key tumor suppressor genes (i.e., RAR, p16, etc), proteomic patterns in RPFNA and nipple aspirate fluid (NAF), as well as NAF hormone levels, and correlate them with other risk biomarkers listed in 1.
4. To determine the prevalence of polymorphisms of a panel of genes important in hormone and xenobiotic metabolism as well as DNA repair and correlate these polymorphisms with established risk biomarkers listed in 1, as well as with development of DCIS and invasive cancer.
5. To maintain contact with this initially identified cohort of high risk women, acquire demographic data, biologic specimens and data and follow them prospectively for the development.

Eligibility Criteria:
Inclusion Criteria:

* women with at least 2 times the normal risk of developing breast cancer
* between the ages of 30-65 (or within 10 years of youngest age at diagnosis in first degree relative)
* greater than six months from ingestion of antihormonal therapy
* greater than 1 year from pregnancy, lactation, or chemotherapy
* willing to have a mammogram within six months prior to RPFNA
* willing to discontinue NSAIDS or herbal supplements
* willing to have blood drawn

Exclusion Criteria:

* no metastatic malignancy of any kind
* no breast implants or tram flap reconstructions
* no radiation to both breasts
* no women who have a current mammogram or clinical breast exam suspicious for cancer
Dose-Finding, Safety, Pharmacodynamic Effect Study of Sodium Nitrite Inhalation Solution in Normal, Healthy Volunteers

This study is designed to investigate the safety and tolerability of AIR001 Inhalation Solution when administered under conditions of hypoxia and to identify dose levels of drug resulting in a reduction in pulmonary arterial pressure under these hypoxic conditions.


Eligibility Criteria:
Inclusion Criteria:

* Normal male and female volunteers
* Age 18-55
* Demonstrate a rise in pulmonary artery pressure to low inspired oxygen concentration (a normal response to breathing a low level of oxygen)

Exclusion Criteria:

* Significant medical illnesses
* Risk factors for pulmonary hypertension
* G6PD or Cytochrome B5 Reductase deficiencies
* History of any form of altitude sickness
* Current prescription or over the counter medication use
Reducing the Effects of Active Surveillance Stress, Uncertainty and Rumination Thru Engagement in Mindfulness Education

We propose to examine the efficacy of couples-based mindfulness-based stress reduction (MBSR) on positive and negative psychological responses to active surveillance (AS) and AS adherence, with a sample of men on AS and their spouses.

The current study proposes to examine the efficacy of couples-based mindfulness-based stress reduction (MBSR) on positive and negative psychological responses to active surveillance (AS) and AS adherence, with a larger, more geographically representative sample of men on AS and their spouses. We will compare the MBSR intervention condition (Group A) with a health promotion and wellness condition (Group B) in a sample of prostate cancer patients and their spouses. We will evaluate its efficacy on self-reported measures of positive and negative psychological responses to AS.

PRIMARY AIM Examine longitudinal change in positive and negative psychological responses to AS between groups over time.

SECONDARY AIM Observe the relation between positive and negative psychological responses to AS and AS adherence between groups over time.

THIRD AIM Explore dyadic factors on positive and negative psychological responses to AS and AS adherence between groups over time.

Eligibility Criteria:
Inclusion Criteria:

* Must be diagnosed with prostate cancer and on active surveillance within the past 36 months (or the spouse or significant other of someone with prostate cancer on active surveillance)
* Must be at least 18 years of age
* Must be able to read, write, speak and understand English
* Must be able to perform basic activities of daily living (as determined by referring physician)
* Must be cognitively intact and free of serious psychiatric illness (as determined by referring physician)
* Must have access to the internet and ability to locate the assessment URL and/or ability to use a touchscreen keypad on a tablet device
* Must be willing to commit to the 8-week MBSR or Health Promotion course, which includes attending weekly, 2.5 hours classes over an 8 week period, a half-day retreat between week 6 and 7 , and daily homework assignments
* Must be willing to complete study assessments

Exclusion Criteria:

* Unable to provide consent
* Bedridden, or physical debilitation such that study participation would not be feasible or would create undue hardship
Effect of Ramosetron on Bowel Motility After Gynecological Surgery

Ramosetron is effective in preventing postoperative nausea and vomiting. Several studies reported that ramosetron is also effective treatment of irritable bowel syndrome. The investigators examine the effect of ramosetron on postoperative bowel motility.

Ramosetron, a new potent and long-acting selective 5-HT3(5-hydroxytryptamine3) receptor anatagonist, is effective for preventing postoperative nausea and vomiting. Also several studies reported that ramosetron is effective treatment of diarrhea-predominant irritable bowel syndrome because it inhibits the accelerated colonic transit, abnormal colonic water transport, defecation abnormality, and the lowered colonic perceptual threshold by corticotrophin-releasing hormone, There is no study about the effect of ramosetron used for preventing postoperative nausea and vomiting on postoperative bowel motility. In this study, the investigators examine the effect of ramosetron on postoperative bowel motility.

Eligibility Criteria:
Inclusion Criteria:

* 20-70 yrs of age
* ASA(American Society of Anesthesiologists) physical status class I or II
* Scheduled for gynecological laparoscopic surgery

Exclusion Criteria:

* Allergic to study drugs
* Antiemetics or steroids use within 24 hrs prior to surgery
* Dependence upon opioids
* Insulin dependent Diabetes Mellitus
* Cardiovascular or pulmonary disease
* Renal or hepatic insufficiency
* BMI\>=35kg/m2
* History of motion sickness or PONV
* Cigarette smoker
* Conversion to open laparotomy from laparoscopic surgery
* Pregnants
GW823093C For The Treatment Of Type 2 Diabetes Mellitus

This study was designed to find dose response and as extension in treatment of GW823093C.


Eligibility Criteria:
Inclusion criteria:

* Type 2 diabetes mellitus.
* Managed by diet therapy or receiving treatment with oral anti-diabetic monotherapy (excluding TZD (Thiazolidinediones))

Exclusion criteria:

* Patients who have metabolic disease judged by investigator as a clinically significance
* Serious cardiovascular disease or serious hepatic disease
Evaluation of Pulmonary Doppler Signals in Patients With Systemic Sclerosis(SSc)

Doppler signals can be recorded from the lung parenchyma by means of a pulsed Doppler ultrasound system incorporating a special signal processing package- the Transthoracic Parametric Doppler (TPD) (Echosense Ltd., Haifa, Israel). Systemic sclerosis patients often develop pulmonary vascular disease leading to pulmonary hypertension. The TPD system may provide important insight into pulmonary blood vessels characteristics by the LDS (Lung Doppler Signals) signals that are related to pulmonary hypertension. The TPD performance in detecting PAH in SSc patients will be assessed in the study.


Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to give signed informed consent prior to enrollment
2. Male or female, ≥ 18 years of age
3. Diagnosis of SSc according to 2013 ACR/EULAR SSc Classification Criteria (van den Hoogen 2013): Score ≥ 9.
4. Patients with RHC data available from measurement within 3 weeks prior to TPD assessment
5. No change in or initiation of PAH specific therapy between the last RHC and TPD

Exclusion Criteria:

1. People unable or unwilling to give informed consent.
2. PCWP or LVEDP \> 15 mmHg
3. Any PH etiology outside Group 1 (Dana Point, 2008)
4. Pregnant women
5. Patients having severe chest wall deformity
Effects of a Cognitive Gait Dual Task With Smartglasses in Stroke Patients

The aim of this study is to find out to determine changes in gait, dual-task interference, cognition, and fall scores during a cognitive walking dual task on a treadmill while wearing augmented reality-based smartglasses in stroke patients.

Before the experiment, the investigators measure the subjects general characteristics, gait, cognition, dual-task interference, and fall risk. This will be done 3 times a week for 30 minutes for 4 weeks.

Group 1 will perform a cognitive task with smart glasses and a gait task on a treadmill at the same time. The training will consist of 10 minutes of treadmill walking without incline, followed by 5 minutes of rest, followed by 10 minutes of treadmill walking with incline, followed by 5 minutes of rest.

Group 2 will perform only treadmill walking without the cognitive task. Same as the experimental group: 10 minutes without treadmill incline, followed by 5 minutes rest, followed by 10 minutes treadmill incline, followed by 5 minutes rest.

At the end of the 4-week training program, the investigators will measure walking ability, cognitive performance, dual-task interference, and fall risk as assessed before the experiment.


Eligibility Criteria:
Inclusion Criteria:

* Participants have hemiplegia from a stroke
* Able to walk 10 meters independently without assistive devices
* Stable health to participate in the study protocol and interventions

Exclusion Criteria:

* Have comorbidities or disabilities other than stroke that may interfere with gait training
* Have an uncontrolled medical condition for which exercise is contraindicated.
* Have a neurological or orthopedic condition that may interfere with the study
Comparison of Clinical and Serological Differences Among Juvenile, Adult, and Late-onset Systemic Lupus Erythematosus

Systemic lupus erythematosus (SLE) is a heterogeneous autoimmune disease with a highly variable presentation and course. It can affect virtually every organ of the body and many symptoms may be observed. Skin, musculoskeletal, hematologic, and serological involvement are most commonly observed. Some patients show predominately hematologic, renal, or central nervous system manifestations.

Studies have reported that juvenile-onset SLE patients tend to have a more aggressive presentation and course, with higher rates of organ involvement and lower life expectancy than adult-onset SLE patients. Late-onset SLE patients tend to have a more insidious onset of disease and tend to have less major organ involvement and more benign disease course. However, they have a poorer prognosis than patients who developed SLE before the age of 50 years, because of the generally higher frequency of comorbid diseases and higher organ damage, due to aging and longer exposure to ''classical'' vascular risk factors.

Aims of the Study:

To compare clinical and serological differences among juvenile, adult, and late-onset systemic lupus erythematosus in a cohort of SLE patients in our hospital.

Methods:

All patients will be subjected to the following:

1. Thorough medical history of the patients
2. Full clinical examination including:

   1. General examination and vital signs.
   2. Complete rheumatological examination.
   3. SLE disease activity index SLEDAI (ref).
   4. SLICC damage index (ref).
3. Routine investigations (complete blood picture, erythrocyte sedimentation rate and liver functions).
4. Renal investigations:

   1. Kidney functions
   2. Urine analysis
   3. 24 hours protein in urine and/or A/C ratio
   4. Renal biopsy if indicated.
5. ANA test.
6. ANA profile for the most common 19 autoantibodies by immunoblot.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria:

1. Patients diagnosed as SLE( Systemic lupus erythematosus )according to EULAR / ACE (European League Against Rheumatism /American College of Rheumatology )
2. Age juvenile SLE ( Systemic lupus erythematosus )was defined as a diagnosis below the age of 18 years, and those diagnosed between 19 and 50 years of age were classified as adult SLE ( Systemic lupus erythematosus ), late onset SLE was defined as a diagnosis at more than 50 years of age).
3. Patients with a disease duration of more than 6 months

Exclusion Criteria:

* Exclusion criteria:

  1. Patients with had other autoimmune diseases, such as rheumatoid arthritis, systemic sclerosis, mixed connective tissue disease , overlap syndrome or primary Sjogren's syndrome ,but not secondary Sjogren's syndrome or secondary antiphospholipid syndrome .
  2. Patients who are not willing to be involved in the study
Using Breath Metabolites to Determine Specific Virus Infection in Asthmatic Patients

Respiratory virus infections cause a majority of asthma exacerbations in the fall to spring months. Current diagnostic platforms for respiratory viruses have limitations including cost, availability, and invasiveness. The use of noninvasive breath collection to analyze breath metabolites may be used to differentiate virus-infected asthmatics from other causes of acute asthma exacerbations.


Eligibility Criteria:
Inclusion Criteria:

* Asthma, Age ≥12, Symptoms/signs of an early asthma exacerbation, Ability to provide exhaled breath condensate (EBC) x15 min, Body mass index (BMI) ≥18

Exclusion Criteria:

* Chronic lung diseases other than asthma (e.g., chronic obstructive pulmonary disease \[COPD\], lung cancer, fibrotic lung disease, etc.), Smoking in the past 7 days, Eating or non-clear liquids \<4 hrs prior to EBC collection, Pregnancy