cyrilzakka/clinical-trials huggingface dataset:
Breathe 2 Project 3: Comprehensive Chronic Care

This study will evaluate Comprehensive Chronic Care (CCC), a healthcare treatment approach designed to increase smoking treatment engagement and abstinence among primary care patients who smoke. This research will compare CCC with Standard of Care (SC) on the following outcomes: abstinence at 18 months (primary outcome), treatment reach, and cost-effectiveness. Participation in the study will last 18 months.

This project is a 2-arm randomized controlled trial (RCT) designed to evaluate whether Comprehensive Chronic Care (CCC), relative to Standard Care (SC), increases smoking abstinence and treatment use in primary care patients who smoke. The aims are as follows:

* Primary Aim

  * Aim 1: To determine whether Comprehensive Chronic Care (CCC), relative to Standard Care (SC), significantly improves biochemically confirmed 7-day point-prevalence smoking abstinence at 18 months post-enrollment.
* Secondary Aims

  * Aim 2: To determine the effects of CCC relative to SC on: cost-effectiveness and 7-day point-prevalence smoking abstinence at 6- and 12-months (biochemically confirmed) post-enrollment.
  * Aim 3: To compare CCC with SC on cessation treatment use over 18 months of treatment access.

Comprehensive Chronic Care (CCC) provides ongoing proactive outreach designed to provide support and information about evidence-based smoking treatment, with access to individually validated treatments that are appropriate for patients who are: 1) unwilling quit but willing to reduce; 2) ready to quit; and 3) recovering from an unsuccessful quit attempt.

Standard Care (SC) involves one offer of cessation treatment per year (8 weeks of nicotine patch plus referral to the tobacco quit line).

Eligibility Criteria:
Inclusion Criteria:

* On smoking registry at a participating clinic OR report current smoking at a clinic visit
* Smoked cigarettes every day in the past 30 days (with or without other forms of tobacco or nicotine)
* Able to participate in informed consent activities (e.g., reports understanding the nature of the study and consent)
* Able to speak and read English.

Exclusion Criteria:

* Activated healthcare power of attorney or cognitive impairment that would preclude informed consent.
Twenty-five-year Experience With the Medtronic-Hall Valve Prosthesis

Background-:. The Medtronic-Hall (MH) valve was developed and for the first time implanted in Oslo in 1977. A total of 1,104 patients received this valve at Rikshospitalet-Radiumhospitalet HF in the period 1977-87. In the present study we followed all 816 patients undergoing aortic valve replacement (AVR) over a 25-year period.

The Medtronic-Hall (MH) tilting valve disk was first implanted in Oslo in June 1977. From 1977 through 1987, the valve was used as the only valve of choice and inserted in a total of 1,104 consecutive patients at our department.

The MH valve is made of a single piece of titanium with no welds. The disk is made of tungsten impregnated graphite with a carbon pyrolytic coating. The tungsten renders the disk radiopaque. In the aortic position the maximal opening is 75˚. A central aperture in the disk allows free rotation. The valve is rotatable in the sewing ring. The sewing ring is made of Teflon. Aortic sizes are 20-31 mm (outer diameter).

The initial clinical results were published in 1979 (1). The cohort of patients has been followed-up and analysed at 5, 10 and 15 years (2-5). In the present study we report our 25-year follow-up data for the 816 patients undergoing aortic valve replacement (AVR) with special reference to survival, functional status, valve-related complications and the impact of concomitant surgery.

Eligibility Criteria:
Inclusion Criteria:

* All patients with aortic valve replacement 1977-87
The Use of Magnetic Endoscopic Imaging for Improving Quality Indicators in Outpatient Colonoscopy

Colonoscopy is an important procedure for diagnosing and treating diseases of the colon. In Canada, up to 13% all colonoscopies do not examine the full colon and are therefore incomplete. Incomplete colonoscopies happen for a number of reasons but are often due to twists and turns in the colon that make the colonoscopy difficult to perform and uncomfortable for the patient.

This randomized study is being done to test a new colonoscopy system called the Scope Guide that shows an exact 3-dimensional picture of how the colonoscopy is positioned in the patient's abdomen.

We hypothesize that the use of the Scope Guide for colonoscopy will improve measures of colonoscopy quality including rate of complete examination, patient comfort, polyp detection rate, insertion time, amount of sedation required, and need for abdominal compression.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be over the age of 18 presenting for out-patient colonoscopy to the endoscopy unit at the VG Site.

Exclusion Criteria:

* Inability or unwillingness to provide written informed consent.
* Previous incomplete or difficult colonoscopy (i.e. independent indication for use of Scope Guide).
* Colonoscopist not participating in trial.
* Current pregnancy.
* Cardiac pacemaker or any other type of implantable stimulator.
* Previous colectomy, hemicolectomy, segmental colon resection, or ileocecal resection.
Radiofrequency Identification Technology in Locating Non-palpable Breast Lesions in Patients Undergoing Surgery

This pilot clinical trial studies radiofrequency technology in locating non-palpable breast lesions in patients undergoing surgery. Placing a miniature radiofrequency tag or microchip in the breast lesion before surgery and using a handheld device to guide doctors during surgery may improve surgical outcomes in patients with non-palpable breast lesions.

PRIMARY OBJECTIVES:

I. Evaluate the feasibility of utilizing a new Federal Drug Administration (FDA)-cleared radiofrequency tag for localization of non-palpable breast lesions and provide preliminary data for a larger study.

OUTLINE:

Patients undergo mammogram or ultrasound for image-guided placement of the radiofrequency tag within 30 days of surgery and then undergo radiofrequency-guided localization during surgery.

After completion of study, patients are followed up within 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Able to give written informed consent to participate in the study
* Able to read and write English
* Patients with breast lesions that are non-palpable that require surgical removal
* Lesions and/or clip targetable with image guidance

Exclusion Criteria:

* Multicentric breast cancer
* Stage IV breast cancer
* Pregnant or lactating females
UT-15C SR in the Treatment of Critical Limb Ischemia

This study will evaluate UT-15C sustained release tablets in subjects experiencing ischemic lower limb rest pain related to advanced peripheral arterial disease. Rest pain is one of the primary management issues of severe arterial occlusive disease and may lead to amputation when the pain becomes intolerable and unresponsive to narcotic analgesia. Rest pain also impacts the quality of sleep and mobility with frequent interruptions in sleep and decreased mobility. Treprostinil sodium (Remodulin®) has been studies in several small open-label studies and has been shown to be safe as well as an effective agent for ischemic rest pain when given by subcutaneous or intravenous delivery. However, these forms of administration have patient convenience limitations, including the need for an infusion device and associated pain at the site of infusion with subcutaneous delivery. UT-15C may allow patients suffering from CLI to benefit from the simplicity of an oral dosage form

This study is an eight week, two center, open-label study assessing the tolerability, safety, and efficacy of oral UT-15C sustained release tablets in subjects with CLI and ischemic lower limb rest pain, with or without an ischemic wound present. Conventional therapy should be continued without changes over the course of the study for all subjects.

Group 1: The first ten subjects to enroll in the study will be assigned to receive an initial dose of 1mg. The dose will be titrated upward every seven days, depending on tolerability, to a maximum dose of 4mg/day .

Group 2: The last ten subjects to enroll in the study will be assigned to receive an initial dose of 1mg. The dose will be titrated upward every seven days, depending on tolerability to a maximum dose of 8 mg/day .

Eligibility Criteria:
Inclusion Criteria:

1. Have an ankle systolic pressure ≤ 60 mm/Hg OR ABI ≤ 0.60 OR toe systolic pressure ≤ 60 mm/Hg OR an arteriogram showing at least one level of occlusion of lower extremity arteries.
2. Have been taking analgesics to control ischemic rest pain for at least two weeks at Baseline.
3. Have signed an appropriate consent for participation in this study.
4. If female, be physiologically incapable of childbearing or practicing acceptable methods of birth c

Exclusion Criteria:

1. Have had a vascular surgery or other vascular procedure to treat their CLI within 30 days prior to study entry.
2. Have a planned or scheduled vascular surgery or endovascular procedure.
3. Be currently taking any investigational drugs for CLI.
4. Have received prostaglandins such as PGE1, epoprostenol (Flolan®), or any other prostacyclin (PGI2) or prostacyclin analog in the past 30 days.
5. Be hemodynamically unstable or have acute renal failure, cardiac failure or pulmonary failure.
6. Have a diagnosis of Stage IVb (Fontaine) or Stage 6 (Rutherford scale) Critical Limb Ischemia due to documented peripheral arterial disease
7. Have an unhealed incision(s) from a toe or transmetatarsal amputation at Baseline.
8. Have any wound with significant gangrene or exposed tendons.
Novel Equations for Estimating Lean Body Mass in Patients With Chronic Kidney Disease

Simplified methods to estimate lean body mass (LBM), an important nutritional measure representing muscle mass and somatic protein, are lacking in non-dialyzed patients with chronic kidney disease (CKD).

Objective: We developed and tested a reliable equations for estimation of LBM in daily clinical practice.

Two cross-sectional data sets were derived from outpatients with CKD stage 3-5 in Peking University First Hospital.Two equations for estimating LBM based on midarm muscle circumference (MAMC) or hand grip strength (HGS)were developed and validated in CKD patients with dual-energy x-ray absorptiometry (DEXA) as referenced gold method. Demographic data, comorbidity, and other clinical variables were also recorded.

Eligibility Criteria:
Inclusion Criteria:

* non-dialyzed patients with CKD stage 3-5
* clinical stable
* a willingness to be examined with all measurements being taken simultaneously.

Exclusion Criteria:

* systemic infections, acute cardiovascular events, operations, trauma, active hepatitis or tumor
* severe edema within one month prior to the study
* chronic infections, connective tissue disease, hyper- or hypothyroidism, amputations or pregnancy,
* taking immunosuppressive agents and anti-inflammatory medication chronically
Identification of Asthma Phenotypes in Severe Asthmatics

Asthma is a heterogenous disease. Different patients have different presentations, course of disease and response to treatment.

The investigators would like to study our population of more severe asthma and find out about their profile - demographic, clinical and inflammatory.

Asthma is a heterogeneous disorder presenting with many phenotypes. Most asthmatics have mild to moderate disease. However, 5-20% of asthmatics belong to the "Difficult-to-treat" or more severe group and they account for 50-80% of asthma health care costs. In a tertiary hospital like Singapore General Hospital, most of our asthmatics belong to the more severe group. They have more frequent healthcare visits, hospitalizations, medication use and higher risks of death.

There is currently no local data on the phenotypic profile of our patients. Asthma phenotypes which have been identified include those related to triggers ( eg. drugs such as aspirin or NSAIDS, environmental allergen, occupational allergens or irritants, exercise) or clinical physiological phenotypes ( eg. severity-defined, exacerbation-prone, chronic airflow limitation, steroid-resistant, age -of -onset) or inflammatory phenotypes ( eg. eosinophilic, neutrophilic, pauci granulocytic, mixed). With better understanding of their phenotypes, treatment can then be individually tailored to improve their asthma control and reduce future risks.

We aim to improve the understanding of this group of asthmatics such that better treatment approaches can be developed in the future. This is not a clinical trial. Its purpose is to gather information ranging from demographic data, medical history to responses to simple routine questions, to lung function, inflammation, allergy and blood testing results. The data are analyzed to improve our understanding of the clinical and inflammatory phenotypes ( or profiles) in this group of patients.

Eligibility Criteria:
Inclusion Criteria:

1. Difficult-to-treat severe asthma
2. Treatment-resistant severe asthma patients who are partially or poorly controlled despite high dose inhaled corticosteroids ( ICS) or a high-dose ICS and long acting- beta-2- agonist combination ( LABA) and frequent or chronic use of systemic corticosteroids or
3. Treatment-resistant severe asthma who are well-controlled on the highest level of recommended treatment to maintain control (high dose ICS or combination of high-dose ICS with other medications such as LABA, theophylline, montelukast, systemic corticosteroids, anti-Ig E, etc.
CSPPT- Chronic Kidney Diseases Study

The purpose of this trial is to confirm that enalapril maleate and folic acid tablets is more effective in preventing renal function decline among the patients with primary hypertension when compared to enalapril maleate.

Elevated blood concentration of homocysteine (Hcy) has been suggested as a modifiable, independent risk factor for coronary artery disease, stroke, and deep vein thrombosis. Prevalence of hyperhomocysteinemia and folic acid deficiency in China are significantly higher than those in Europe and USA. The investigators' preliminary research demonstrated that blood concentration of Hcy was negatively correlated to estimated glomerular filtration rate (eGFR), a key index of kidney function. However, the question as to whether Hcy-lowering therapy with folic acid can reduce the risk of chronic kidney disease(CKD) remains to be answered.

This study, exploiting the hypertensive population of CSPPT trial (ClinicalTrials.gov register number: NCT00794885), is intended to compare the effects of enalapril maleate and folic acid tablets versus enalapril maleate in preventing renal function decline among the patients with primary hypertension. The results from this trial may have the potential to transform current clinical and public health findings into practice in the prevention of chronic kidney disease(CKD) in China.

Eligibility Criteria:
Inclusion Criteria:

* BP≥140/90 mmHg in both of the two screening visits or currently under anti-hypertension treatment;
* 45-75 years old;
* Successful determination of methylenetetrahydrofolate reductase (MTHFR) C677T genotype;
* For pre-menopausal women, agreed to use contraceptives during the trial;
* Signed the written informed consent.

Exclusion Criteria:

* Having a history of stroke;
* Having a history of myocardial infarction;
* Having a history of physician diagnosed heart failure;
* Post- coronary revascularization;
* Severe somatic disease such as cancer;
* Secondary hypertension;
* Congenital or acquired organic heart diseases;
* Contraindicated to angiotensin-converting enzyme inhibitor (ACEI);
* Having a history of ACEI adverse effects;
* Currently long-term use of folic acid or vitamin B12 or vitamin B6;
* Pregnant or child breastfeeding women;
* Severe mental disorders;
* Lab tests indicating abnormal liver or kidney function;
* Unwilling to participate the trial;
* Unwilling to change the current antihypertensive treatment.
Comparison Study of Narrow Band Imaging Versus White Light Resection in Patients With Bladder Tumors/Cancer

The purpose of this study is to compare the recurrence rate at 1 year following Narrow Band Imaging and trans-urethral resection of bladder tumor with White Light and TURB in patients with non-muscle invasive bladder cancer.

Currently bladder tumors are diagnosed visually with standard cystoscopy that uses white light, or light that is generated encompassing the entire visual spectrum. Some tumors such as carcinoma in situ may not be visible using white light and require patients to undergo random bladder biopsies in order to find the cancer. Recently the development of photodynamic agents have been shown to enhance these procedures to accomplish better resection and identify over-looked tumors. However, these methods often require the instillation of dyes into the bladder as well as specialized cystoscopes. Narrow band imaging (NBI) is now available which uses a special filter to limit the light to only certain wavelengths which allows the identification of areas of increased vascularity or abnormalities without the need for dyes. NBI has been investigated in gastro-intestinal disease and found to be beneficial. Early reports in urology suggest that this technology may reduce the number of tumors that are missed which could impact the recurrence rate of bladder tumors, but this is not known at this time.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for treatment of primary or recurrent non-muscle invasive bladder cancer
* Patients greater than 18 years of age
* No tumors in the upper tract (kidneys or ureters)
* No previous pelvic radiation

Exclusion Criteria:

* Gross hematuria at the time of resection making visualization with NBI not possible
* Participation in other clinical studies with investigations drugs concurrently or within 30 days.
* Pregnancy
* Conditions associated with a risk of poor compliance or unwilling to follow up
Pulse Oximeter Accuracy During Stable Hypoxia Plateaus

This project aims to test the accuracy of pulse oximeters in the range of arterial HbO2 saturations from 100% down to 70%.

This project aims to test the accuracy of pulse oximeters in the range of arterial HbO2 saturations from 100% down to 70%. This is done by comparing the pulse oximeter reading during brief, steady state hypoxia plateaus with a gold-standard measurement of blood oxyhaemoglobin saturation.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged \>= 18 and \< 50.
* Subject in good general health with no evidence of any medical problems.
* Subject is fluent in both written and spoken English.
* Subject has provided informed consent and is willing to comply with the study procedures.

Exclusion Criteria:

* Subject is obese (BMI \> 35).
* Subject has a known history of heart disease, lung disease, kidney, or liver disease.
* Diagnosis of asthma, sleep apnea, or use of CPAP.
* Subject has diabetes.
* Subject has a clotting disorder.
* Subject has hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation.
* Subject has any other serious systemic illness.
* Subject is a current smoker.
* Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators would interfere with the sensors working correctly.
* Subject has a history of fainting or vasovagal response.
* Subject has a history of sensitivity to local anesthesia.
* Subject has a diagnosis of Raynaud's disease.
* Subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).
* Subject is pregnant, lactating, or trying to get pregnant.
* Subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures.
* Subject has any other condition, which in the opinion of the investigators would make them unsuitable for the study.
The TOSCA Registry: Hormonal and Metabolic Deficiencies in Chronic Heart Failure

The objective of this study is to determine whether the presence of metabolic alteration and anabolic deficiencies in patients with chronic heart failure are able to identify a subset of patients with poor outcome.

Despite the effectiveness of the neurohormonal model to explain the progression of heart failure and the many insights that it provided for the development of new therapies, there is increasing clinical evidence that suggests that our current models fail to completely explain the disease progression. Thus, neurohormonal models may be necessary but not sufficient to explain all aspects of disease progression in the failing heart. There is evidence suggesting that in heart failure there is a metabolic imbalance characterized by the predominance of the catabolic status over the anabolic drive.

Aim of this registry is to determine the prevalence of hormone/metabolic deficiencies in heart failure patients and to look for possible association with clinical variables. Moreover, enrolled patients will be followed up for a mean of 2,5 years in order to collect outcome data including all-cause mortality, cardiovascular mortality, hospitalizations.

This is a multi-center observational study involving several Italian Department of Cardiology, Endocrinology, Internal Medicine

Eligibility Criteria:
Inclusion Criteria:

* patients of either sex affected by CHF, secondary to ischemic or idiopathic dilated cardiomyopathy
* left ventricle ejection fraction 40% or less

Exclusion Criteria:

* severe liver disease
* serum creatinine levels \>2.5 mg/dl
* history of active cancer with life expectancy below 1 year
* acute coronary syndrome in the previous 6 months
Pilot Study to Evaluate Escitalopram in Obsessive-compulsive Disorder

This study will determine the safety and effectiveness of escitalopram (Lexapro)in treating obsessive-compulsive disorder (OCD) symptoms.

OCD is a chronic and disabling disorder for which Selective Serotonin Reuptake Inhibitor(SSRI) drugs can be effective. The purpose of this study is to evaluate the effects of an SSRI, escitalopram, in OCD patients.

This study will last 16 weeks and will comprise 2 phases. Phase 1 is an open label in which all participants will receive daily escitalopram for 8 weeks. Those who have responded to treatment at the end of the 8 weeks will be randomly assigned to either continue or discontinue their treatment for an additional 8 weeks. Those who do not respond to treatment at the end of Phase 1 will discontinue the study and be offered three free visits with a study clinician or referred elsewhere for treatment, based on the their preference. Study visits are made at baseline, and at Weeks 1, 2, 4, and 8 in Phase 1 and Weeks 12 and 16 in Phase 2.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of OCD
* A minimum score of 16 on the Yale Brown Obsessive-Compulsive Scale (YBOCS) at both the screening and baseline visits

Exclusion Criteria:

* Lifetime history of psychosis or cognitive dysfunction due to a general medical condition or substance use
* A primary diagnosis of another Axis I psychiatric disorder
* Alcohol or other substance abuse or dependence within the last 6 months
* Unstable medical condition
* Clinically significant laboratory abnormality
* Failure of a previous 10-week trial of citalopram of at least 40 mg/day or escitalopram 20 mg/day
* Active suicidality
* History of violent behavior in the past year or current risk of serious violence
* A history of sensitivity to citalopram or escitalopram
* Use of other investigational drugs within 30 days of baseline or other psychotropic drugs or herbs within 14 days of baseline (28 days for fluoxetine)
* Need for concurrent psychotherapeutic intervention
* Pregnant or lactating females.