cyrilzakka/clinical-trials huggingface dataset:
Prospective Evaluation of Heart Failure Patients With Central Sleep Apnea

Central sleep apnea (CSA) has been associated with increased mortality and primarily occurs in patients with heart failure (HF). The primary purpose of this study is to document the natural progression of moderate to severe CSA in heart failure patients.

This trial is a prospective, non-randomized observational study in heart failure patients with moderate to severe central sleep apnea (CSA).

Eligibility Criteria:
Inclusion Criteria:

* Subject is willing and able to comply with this protocol and has signed an IRB/MEC approved informed consent (as well as Privacy Protection Authorization in the United States)
* Age is greater than or equal to 18 years
* Known recent history of sleep disordered breathing of predominantly central origin, as evidenced by an overnight PSG with EEG and at least 4 hours of recording that was conducted within 60 days of enrollment and demonstrating the following characteristics:
* AHI greater than or equal to 20
* greater than or equal to 50% of classified events of a central nature
* less than 20% of the total AHI comprised of obstructive apnea events
* Diagnosed chronic heart failure, with medications optimized and stable for at least 30 days prior to the screening PSG, or since the date of the earliest test used for baseline, whichever is longer. Optimal medications include: beta blockade, ACE-I or ARB and diuretics unless contraindicated or not considered medically necessary.

Exclusion Criteria:

* Current or intended use of any mask-based therapy for central sleep apnea
* Baseline oxygen saturation less than or equal to 90% on a stable FiO2
* Severe Chronic Obstructive Pulmonary Disease (COPD) (per GOLD classification system)
* History of cerebrovascular accident (CVA), myocardial infarction (MI), coronary artery bypass grafting (CABG) surgery, or percutaneous coronary intervention (PCI), or any cardiac ablation procedure within the 3 months prior to the study
* Unstable angina
* History of primary pulmonary hypertension
* Currently enrolled in a non-observational (ie, interventional) clinical study that could confound the results of this study
* If subject has an implanted cardiac resynchronization device (CRT), it must have been implanted at least 3 months before enrollment; any other device must have been implanted at least 30 days prior to enrollment
* Life expectancy of less than 6 months
CARE Study: Cancer, Asian Americans, and Relationship Enrichment

The overarching goal of the current study is to reduce the burden Asian American patients may feel are on their caregivers by designing and testing the feasibility and efficacy of a positive activity intervention designed to increase a sense of autonomy, competence, and connectedness, each of which have been shown to be associated with psychological benefits according to self-determination theory.

This study will introduce two new positive activities, household contribution and outside contribution, which have been specifically created for AA cancer patients and have not been previously investigated. These interventions have been developed with consideration of culture-related challenges, Hofstede's concept of collectivist cultures, and self-determination theory. This study will be the first randomized controlled trial to assess the impact of these new positive activities on Asian-American cancer patients.

Eligibility Criteria:
Inclusion Criteria for Patients:

1. self-identifies as Asian American or Asian
2. males or females ages 21-80 years
3. within 1 year of any cancer diagnosis or stage 4 cancer diagnosis
4. actively undergoing surgery or systemic therapy (e.g., chemotherapy, radiation, immunotherapy) or within the past 6 months,
5. able to identify a caregiver (e.g., spouse) who lives in the same household or see at least 3 times per week
6. able to read, write, and speak English (i.e., English proficient; EP) or Mandarin/simplified Chinese.

Exclusion Criteria for patients:

1. life expectancy less than 6 months in the opinion of the primary physician
2. inability to stand or walk on their own or other physical limitations that preclude them from participating (3+ on ECOG performance status),
3. major thought disorder (e.g., schizophrenia or bipolar \[patient records or self-disclosure\]).

Inclusion Criteria for Caregivers:

1. identifies as Asian American or Asian,
2. patient considers them to be caregiver
3. English proficient or Mandarin Chinese proficient
4. access to computer/phone, internet, and web browser.

Exclusion Criteria for Caregivers:

1. unwilling or unable to participate in the study for any reason,
2. under the age of 18.
Omacor and Cardiovascular Risk Factors in HIV Patients on HAART Treatment

The purpose of this study is to evaluate the effect of Omacor 4g/day on blood lipid parameters and on the function and stiffness of blood vessels in HIV infected patients on Antiretroviral Therapy (HAART)

Results from recent studies show increasing numbers of Ischemic Heart Disease (IHD) incidents among patients on HAART treatment (Highly Active Antiviral Therapy). Three elements have received special attention:

1. the immunodeficient effects of the HIV infection itself may influence the progression of arteriosclerosis
2. the higher levels of risk behaviour in this group of patients (i.e. high prevalence of smokers in this group)
3. The HAART treatment itself increases plasma levels of cholesterol, LDL cholesterol and triglycerides, resulting in HIV related lipodystrophy.

The cardioprotective effects of n-3 PUFAs are well established both through epidemiological studies and through small and large clinical trials. Clinical trials have shown positive effects of n-3 PUFA on plasma triglycerides, and statistically significant reductions in cardiovascular death and sudden cardiac death. Moreover n-3 PUFAs have been shown to have beneficial effects on endothelial function. Based on the above rationale it is expected that Omacor (Omega-3-acid ethyl ester 90) will have positive effects on risk factors related to Ischemic Heart Disease in HIV patients on HAART treatment.

Approximately 50 patients will be randomized to Omacor 4 grams/day or placebo. Treatment period is 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Man/women \> 18 years of age
* Documented HIV infection
* On active treatment with HAART for at least 3 months.
* Written informed consent. This implies that the patient can read and understand Danish or English

Exclusion Criteria:

* Age \< 18 years
* Malign disease
* Patients assessed as not cooperative
* Patients planning to be pregnant or who are already pregnant or breast feeding.
* Patients who have been taking fish oil capsules prior to randomization. However, patients who have discontinued fish oil supplements at least 8 weeks prior to the first visit will be included
* Patients allergic to fish proteins
* Statin treatment that has been ongoing for less than three months, or a change in statin treatment dose within the last three months
PROFILE - Evaluation of QoL and PRO Outcomes in Patients Taking Fingolimod

Multi centre, prospective, non interventional study in 200-240 UK relapsing remitting multiple sclerosis patients. Patients will complete questionnaires at baseline, 3, 6 and 12 months.

Multi centre, prospective, non interventional study in 200-240 UK relapsing remitting multiple sclerosis patients assessing the change in QoL and PRO outcome measures from baseline to 12 months after starting fingolimod. Patients will complete 4 questionnaires at baseline (prior to first fingolimod dose), then repeat them at 3, 6 and 12 month intervals via post.

Eligibility Criteria:
Inclusion Criteria:

Patients prescribed Gilenya within the EU licence No previous exposure to Gilenya Patient's HCP considers patient able to complete study questionnaires Patient is between 18-55 years of age -

Exclusion Criteria:

There are no exclusion criteria for this study.

-
The Neurocognitive Sub-study of Encore1

The purpose is to investigate whether HIV and HIV medication can affect certain areas of brain function. This study will look at possible changes in brain function including memory, concentration and thought processes to see if there are any differences between the two doses of efavirenz used in the Encore1 study and also the level of efavirenz in the blood


Eligibility Criteria:
Inclusion Criteria:

* All subjects entering into the main study protocol at participating centres will be eligible to enter this sub-study.

Exclusion Criteria:

* Existing neurological brain disease
* Recent (\<6months ) head injury
* Current major depression or psychosis
* Current alcohol abuse
* Intended use of recreational drugs during study period
* Uncontrolled medical conditions deemed to potentially interfere with cognitive function (e.g. uncontrolled diabetes, pyrexial illness, uraemia etc)
Efficacy and Safety of Ciclesonide (CIC) Administered Twice Daily in Pediatric Patients With Asthma.

Primary objective: To demonstrate the efficacy of ciclesonide, compared to placebo, at 80 μg twice daily (BID) or 40 μg BID for 12 weeks in patients with persistent asthma.

Secondary objective: To assess the safety and tolerability of ciclesonide.


Eligibility Criteria:
Inclusion Criteria:

* History of persistent bronchial asthma for at least 3 months prior to screening;
* For patients with persistent bronchial asthma and being treated with a controller therapy: Documented use of an inhaled steroid or Singulair® 5mg once daily;
* For patients with persistent bronchial asthma and not being treated with controller therapy: Patients may have documented use of a reliever therapy such as albuterol/salbutamol or may be untreated;
* Morning Peak Expiratory Flow (AM PEF) of ≤90% of predicted values from the in-clinic spirometry after a 6 hour withhold of albuterol/salbutamol;
* Only patients aged between 6 to \<12 years must have a forced expiratory volume in one second (FEV1) of ≥50% to ≤85% of predicted normal after a 6 hour withhold of albuterol/salbutamol

Exclusion Criteria:

* Nocturnal awakenings for asthma which require treatment with albuterol/salbutamol for 4 or more nights out of the last 7 days of the screening period;
* Use of more than 8 puffs/day of albuterol/salbutamol on 3 or more consecutive days within the last 7
* Upper or lower respiratory tract infection within 4 weeks prior to screening and during screening period;
* History of life-threatening asthma, including a history of significant hypercarbia (pCO2 \>45 mmHg), prior intubation, respiratory arrest, or seizures as a result of an exacerbation of asthma;
* More than 3 in-patient hospitalization or emergency care visits due to asthma exacerbations in the year prior to screening;
* Use of injectable or oral corticosteroids within one month prior to screening, or more than 3 bursts) within 6 months prior to screening;
Frequency of Common Medical Conditions in People With and Without HHT

Hereditary Hemorrhagic Telangiectasia (HHT) affects 1 in 5,000 people. The purpose of this study is to provide data regarding the frequency of common health conditions and the tolerability of therapies in HHT by using a questionnaire.

This will be filled in by both people with HHT, and controls who will be members of the general population without HHT.

The questionnaire has been designed primarily for web based entry, but can also be circulated in paper format on request

Hereditary Hemorrhagic Telangiectasia (HHT) affects 1 in 5,000 people, usually causing nosebleeds, skin blood spots, and/or anemia as a result of bleeding from the nose or gut. The majority of people with HHT also have abnormal blood vessels (arteriovenous malformations) in internal organs such as the lungs, liver and brain. Management of this multisystem disorder is highly challenging.

The Lead Applicant has spent 20 years working on this rare disease, and identified multiple areas where more evidence is required to assist clinicians and patients with this lifelong condition. A particular issue is what happens when people with HHT have other common medical conditions such as asthma, cancer, diabetes, or heart disease. Do they have the same pattern of problems as the general population? Can they use the same drugs? Are further safeguards needed? For these important questions, current advice can only be based on theoretical considerations and anecdotal data.

The ultimate goal of this study is to use information derived from a questionnaire to provide evidence to assist clinicians treating people with HHT.

Data will be entered from April 2012. Data will be analysed on average 6-8 months after entry.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 or over.
* Capacity to fill in a questionnaire.

Exclusion Criteria:

* Age under 18
* Unable to fill in a questionnaire
Hypoglycemia: Physician and Patient Perspectives

The purpose of this study is to assess the burden of hypoglycemia and identify unmet need related to the management of hypoglycemia among Type 2Diabetes Mellitus (T2DM) patients on OADs and/or insulin. This is an observational study which will identify patients with T2DM in an administrative claims database and will link claims data with results of patient and physician surveys concerning hypoglycemia.


Eligibility Criteria:
Inclusion Criteria:

* T2DM claims diagnosis (algorithm-based) with at least 2 pharmacy claims for an antidiabetic drug
* at least 1 HbA1c test recorded during the identification period
* continuous enrollment in the health plan for at least 12 months prior to survey date

Exclusion Criteria:

* Type 1 Diabetes Mellitus
* pregnancy or gestational diabetes
Prokinecitine in Acute Myocardial Infarction

The study aims to investigate the presence of a substance in the blood called prokinecitine, which is released by the heart when a heart attack occurs. Several venous blood samples at the arm are withdrawn at admission, H6, H12, H24, H48 and H72 in order to measure the concentration of this substance in the blood. The usefulness of this new blood marker is going to be determsined to seek if it would be of help to better diagnose or estimate the gravity of heart infarction after a heart attack.


Eligibility Criteria:
Inclusion Criteria:

* Patients with acute St elevation myocardial infarction of less than 6 hours
* Age\>18 y/o

Exclusion Criteria:

* Previous myocardial infarction
* LBB, RBB
* Renal Insuffiency MDRD\<30 mL/min
* Patient with Pace-Maker or ICD.
Studying Biomarkers in Blood Samples From Patients With Invasive Cervical Cancer

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors predict how well patients will respond to treatment.

PURPOSE: This research study is looking at biomarkers in blood samples from patients with invasive cervical cancer.

OBJECTIVES:

Primary

* To develop a serum proteomic profile for cervical cancer using banked pre-treatment serum specimens from patients with invasive cervical cancer and to determine if this serum proteomic profile has possible utility in cervical cancer prognosis.

Secondary

* To develop a serum proteomic profile for cervical cancer using banked post-treatment serum specimens from these patients and to determine if this serum proteomic profile has possible utility in cervical cancer prognosis.

OUTLINE: This is a multicenter study.

Banked serum specimens are used to generate proteomic profiles.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed invasive adenocarcinoma, squamous cell carcinoma, or adenosquamous cell carcinoma of the cervix

  * Stage IIB, III, or IVA disease
* Eligible and evaluable for GOG-0191
* Pre- and/or post-treatment serum specimens available for proteomic analysis

PATIENT CHARACTERISTICS:

* Patient has given consent to allow their specimen(s) to be used for future cancer research

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Efficacy & Safety of Single Dose Alprostadil Cream (2 Concentrations Enhancer) to Vehicle in Men w/Erectile Dysfunction

The purpose of this study is to assess the safety \& efficacy of a single dose of alprostadil cream with 2 concentrations of WC3036 compared to vehicle alone in men with erectile dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* Male subject aged 40 or older of any race
* History of ED (erectile dysfunction) of at least 3 months duration defined as inability to attain \& maintain an erection of the penis sufficient to permit satisfactory sexual intercourse
* Completed and signed informed consent prior to any study related procedures

Exclusion Criteria:

* History/presence any significant disease that Investigator feels will interfere with course of the study
* Anatomic deformity of penis
* History/presence alcoholism or drug abuse/dependence within past 2 years (discretion of Investigator)
* Participation in investigational study drug trial within 30 days prior to randomization
Evaluation of Safety and Efficacy of NvisionVLE® Imaging Low Profile System in Patients With Bile Duct Disease

A previous study evaluating the NvisionVLE® Imaging Low Profile System revealed the system to be feasible and safe for use in bile duct. The study also revealed a potential to better define abnormalities, target sampling and therapy when utilizing the NvisionVLE® Imaging Low Profile System. This study will further evaluate the safety and efficacy of the NvisionVLE® Imaging Low Profile System in patients with bile duct diseases.

The primary objective of this retrospective and prospective study is to acquire additional data to further evaluate the safety and efficacy of the NvisionVLE® Imaging Low Profile System in patients with bile duct disease. The secondary objective will be to provide a tool for participating physicians to collect imaging data, clinical utility data, and other clinical data such as demographics, pathology, and treatment surveillance results for patients who have undergone an examination of the bile duct with the NvisionVLE® Imaging Low Profile System. Specific aims include completing a multi-center registry to further evaluate the safety and efficacy of the NvisionVLE® Imaging System Low Profile System and developing a tool from the NvisionVLE® Imaging Low Profile System data to better define abnormalities, target sampling and therapy in patients with bile duct disease.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Undergone ERCP with NvisionVLE® Imaging Low Profile System at MDMC between 10/15/2017 and 10/15/2019.

Exclusion Criteria:

* Below 18 years of age
* Did not undergo ERCP with NvisionVLE® Imaging Low Profile System at MDMC
Freeze-dried Live Attenuated Measles/Rubella Combined Vaccine (Schwarz FF-8 Strain/TO-336 Strain) Specified Drug-use Survey of Vaccinees After the Second Vaccination

The purpose of this survey is to assess the safety of freeze-dried live attenuated measles and rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) (freeze-dried live attenuated measles and rubella combined vaccine "Takeda") in terms of the occurrence of unknown/known adverse drug reactions and factors that may influence the safety of vaccinees after the second vaccination.

This survey was designed to assess the safety of freeze-dried live attenuated measles and rubella combined vaccine (Schwarz FF-8 strain/TO-336strain) (freeze-dried live attenuated measles and rubella combined vaccine "Takeda") in terms of the occurrence of unknown/known adverse drug reactions and factors that may influence safety after the second vaccination.

Freeze-dried live attenuated measles and rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) is dissolved in 0.7 mL of accompanying reconstitution fluid (water for injection \[Japanese Pharmacopoeia\]), wherein a 0.5-mL portion is typically administered subcutaneously as a single dose.

In addition, freeze-dried live attenuated measles and rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) should be used in accordance with the "Regulations for Vaccination" and the "Guidelines for Routine Vaccination."

Eligibility Criteria:
Inclusion Criteria:

-

Vaccinees who meet both of the following conditions \[1\] and \[2\]:

1. Vaccinees who have a prior history of receiving measles and/or rubella vaccination and who received freeze-dried live attenuated measles and rubella combined vaccine "Takeda" as the second vaccination
2. Vaccinees whose guardians are able to participate in a questionnaire survey on the health status of vaccinees after vaccination with freeze-dried live attenuated measles and rubella combined vaccine "Takeda"

Exclusion Criteria:

* None
Diagnostic and Therapeutic Applications of Microarrays in Heart Transplantation

Demonstrate the impact of the Molecular Microscope Diagnostic System as the standard of care for heart transplant patients.

The current standard for biopsy-based diagnoses of rejection of heart transplants is the ISHLT classification from 2004, which represents a widely-used international consensus, based on morphological criteria of the cellular infiltrate within the myocardial specimen system with certainties and some arbitrary and blurred parameters. Recent data-driven approaches using molecular and conventional technologies indicate that this system produces incorrect diagnoses with potential harm to patients due to inappropriate treatment. To address this unmet need and improve diagnostics in the area of organ transplantation, the Alberta Transplant Applied Genomics Centre (ATAGC, University of Alberta) has developed a new diagnostic system - the Molecular Microscope® Diagnostic System (MMDx) that interprets biopsies in terms of their molecular phenotype, and combines the molecular and histopathological features of transplant biopsies, plus clinical and laboratory parameters, to create the first Integrated Diagnostic System. The MMDx developed first in kidney transplant biopsies because phenotypes are well established, will now be adapted to heart transplant endomyocardial biopsies (EMBs). The present study will develop a Reference Set of EMB, adapt the MMDx system to assess and report EMBs; and validate and refine this system in 900 unselected prospectively collected for clinical indications and a standard of care EMBs from North American and European Centers. In addition to demonstrating the real-time feasibility and potential value of this System in patient care, the study will develop and optimize a transparent and user-friendly reporting format to communicate this information to clinicians and obtain detailed feedback to improve its utility. We refine now our MMDx system using a new type of analysis (see primary outcome) and the resulting MMDx report. Currently, INTERHEART recruited 1912 biopsies from 1279 patients.

Eligibility Criteria:
Inclusion Criteria:

* biopsy for clinical indications

Exclusion Criteria:

* no consent
* pregnant women
Individualized Neurodevelopmental Treatment

The purpose of the study was to evaluate this therapeutic intervention by expressing functional level with valid quantitative data.

The intervention lasted 6 weeks. There were 3 sessions per week. At each session there was a part of standard physical therapy program and there was also a part with emphasis on dynamic balance exercises.

Eligibility Criteria:
Inclusion Criteria:

* spastic tetraplegia

Exclusion Criteria:

* vision problems
Clinical Evaluation of Working Length Determination by Electronic Apex-Locator or Radiography on Adequacy of Final Working Length

Accurate length determination of root canal is essential in root canal therapy. Radiography has been the conventional method for this measurement but recently several in-vitro studies have shown that new generations of Electronic Apex locators are as accurate as radiography in length determination. It is hypothesized that the latest generation of Electronic Apex locator can produce acceptable results as radiography when used for length determination.


Eligibility Criteria:
Inclusion Criteria:

* All the patients who are referred for Root Canal Therapy

Exclusion Criteria:

* Blocked Canals
* Open Apexes