cyrilzakka/clinical-trials huggingface dataset:
Canadian Registry of ICD Implant Testing Procedures

To document practices in Canadian ICD implant centres around defibrillation therapy efficacy testing.

To document types of defibrillation testing (DFT) procedures are in current use in Canada, rates of use an dno use of DFT testing, medical indications for non use of DFT testing, rate of successful testing of first lead configuration, rates and types of complications from DFT testing, costs of implant procedures and the costs associated with DFT testing, short term outcomes of patients with different types of implant procedures.

Eligibility Criteria:
Inclusion Criteria:

* Receiving a Guidant ICD system, including replacements

Exclusion Criteria:

* New epicardial lead(s) implanted, included in another cardiovascular trial (may be in the ELECTION Study)
A Study to Investigate the Effect of a New Postural Bio-feedback Device on Low Back Pain

A postural bio-feedback device worn by subjects for 4-10 hours a day for 6 days spread across 6 weeks for the sub acute low back pain group and for 8 days spread across 10 weeks for the chronic group. The device records movement and muscle activity data relating to the lower back. Bio-feedback is delivered to the subject as an audible tone, visual cue or vibration and aims to prompt the subject to alter their posture or position in line with recommendations given by the treating practitioner. Four small sensors are adhered to the lower back and send data wirelessly to a data logger carried in the pocket by the subject (the size of a small mobile phone).


Eligibility Criteria:
Inclusion Criteria:

1. Subject provides informed consent
2. Age between 18 and 65 years of age
3. At least moderate intensity low back pain (LBP) and/or back related leg pain, as defined by a QVAS score \> 3 (Carragee, Spine 2000).
4. Initial QVAS score of \> 3 out of 10
5. Subjects must be assessed by the practitioner as Sub Acute (3 to 12 weeks post onset of low back pain (LBP) or Chronic (\> 12 weeks post onset of low back pain (LBP).

Exclusion Criteria:

1. Lower back surgery within previous twelve (12) months.
2. Females who are pregnant.
3. Subjects with a severe hearing impairment.
4. Evidence of non mechanical contributing cause for lower back pain e.g. neoplasm, infection, fracture, inflammatory disorder.
5. Preceding chronic neurological changes (Sub Acute group only).
6. Implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator)
7. Nerve block, spinal injection or anesthetic procedure for the treatment of lower back pain within 12 months of the study.
8. Significant medical abnormalities or conditions that in the opinion of the Practitioner would interfere either with the ability to complete the study or the evaluation of the investigational device's safety and efficacy.
9. Recent history of a significant medical-surgical intervention that in the judgment of the Practitioner would interfere either with the ability to complete the study or the evaluation of the investigative device's safety and efficacy.
10. Known allergic skin reaction to tapes and plasters.
11. Subject who is currently enrolled in an investigational drug or device study.
Developing a Down Syndrome Health Instrument

Although over 200,000 individuals with DS live in the United States, studies to date have focused on outcomes apart from health. The foundation for this proposal is based on the need to accurately measure health of all individuals - specifically, with DS - and the dearth of available tools for this population. Creating such an instrument will provide a barometer of the current state of health for DS and hold use in future research. In this project, I propose to create an instrument that directly assesses health in DS - the Down syndrome Health Instrument (DHI). More specifically, the aims of this proposal are: 1. To conduct focus groups among caregivers, individuals with DS, panels of experts on DS and primary care physicians, and cognitive interviews to refine a conceptual model of health for DS and create an item pool, 2. To administer the DHI and establish internal validity, reliability, and external validity of the DHI for use in clinical research, and 3. To test the usability of the DHI in two pilot settings: research and clinical. This instrument will measure patient-reported health in DS for the first time and allow measurement of health as an outcome which is not currently possible in this population. This can identify gaps in care, then direct and optimize interventions that will improve care.


Eligibility Criteria:
Inclusion Criteria:

* Primary caregiver of an individual with DS (individual with DS age: \<22 years)
* Caregiver age: ≥18 years
* Fluent in written and spoken English
* Able to read and provide informed consent

Exclusion Criteria:

* Physical or mental condition of caregiver that would prohibit self-administration of questionnaire
* Mosaic Down syndrome: based on medical record review. If caregiver is uncertain or mosaicism is unknown, we will request additional records.
Ultrasound and Exercises in Knee Osteoarthritis

The aim of this investigation is to compare the effects of continuous (CUS) and pulsed (PUS) ultrasound associated with a program of exercises on pain, range of motion, muscle strength, functionality, mobility and activity in patients with knee osteoarthritis. Participants were randomized into five groups: Group I (in the first month, continuous ultrasound was applied), Group II (in the first month, pulsed ultrasound was applied), Group III (in the first and second month, the continuous ultrasound was applied), Group IV (in the first and second month, the pulsed ultrasound was applied) and Group V (patients received only exercise sessions for eight weeks).

Strong evidence suggests that joint exercises reduce pain and disability in patients with osteoarthritis. There is evidence that exercise is responsible for muscular strengthening and better flexibility, improved global function as well as better performance in activities of daily living (ADL).

There are two modes of US, continuous and pulsed. Continuous US (CUS) generates thermal effects by stimulating the process of tissue regeneration, changing cell membrane permeability and increasing intracellular calcium, while pulsed US (PUS) mainly produces non-thermal effects to increase tissue metabolism, enhance fibrous tissue extensibility and elevate pain threshold

Eligibility Criteria:
Inclusion Criteria:

To be included in the study, participants needed to suffer knee osteoarthritis with osteoarthritis levels 2 - 4 according to Kellgren-Lawrence grade12, be aged between 50 and 75 years and suffer knee pain and functional disability for at least three months, according to the criteria of the American College for Rheumatology (ACR)13. Participants from both genders were included. The Kellgren and Lawrence grading of knee osteoarthritis is as follows: none (0), doubtful (1), minimal (2), moderate (3) and severe (4).

The ACR criteria of knee osteoarthritis are as follows:

* Using history and physical examination: knee pain and three of the following - over 50 years old; less than 30 minutes of morning stiffness; bone tenderness; bone enlargement; no palpable warmth of synovial.
* Using history, physical examination and radiographic findings: knee pain and one of the following - over 50 years old; less than 30 minutes of morning stiffness; crepitus on active motion; and osteophytes.
* Using history, physical examination and laboratory findings: knee pain and five of the following - over 50 years old; less than 30 minutes of morning stiffness; bone tenderness; bone enlargement; no palpable warmth of synovial; crepitus on active motion; ESR \<40 mm/h; rheumatoid factor \<1: 40; synovial fluid sign of osteoarthritis.

Exclusion Criteria:

* Participants were excluded if they had cancer, diabetes, symptomatic hip osteoarthritis, or used antidepressants, anti-inflammatory medications or anxiolytics during six months prior to enrollment.
Use of mHealth to Increase Physical Activity for Patients Recently Hospitalized With Acute Heart Failure

The aim of this trial is to determine if a mobile application that promotes physical exercise in the follow-up of patients recently hospitalized with acute heart failure can improve exercise capacity after 6 months and physical activity levels compared to the standard follow-up.

A randomized clinical trial will be conducted with 100 consecutive patients aged +18 years, hospitalized for acute decompensated heart failure in a tertiary referral hospital who own a mobile phone compatible with MyPlan and access to Wi-Fi or mobile data. At discharge, patients will be randomly assigned in two groups; the intervention group will be followed with a smartphone application to promote physical activity, whereas the control group will take responsibility in their adherence to exercise recommendations. Main study variables will be functional capacity after 6 months, which will be evaluated using the six minute walking test, and physical activity levels, using the International Physical Activity Questionnaire (IPAQ). The study will be analyzed using the intention-to-treat principle. The project has been authorized by the local committee for ethics in clinical research.


Eligibility Criteria:
Inclusion Criteria:

* Aged +18 years
* Hospitalized for acute decompensated heart failure in a tertiary referral hospital
* Owning a mobile phone compatible with MyPlan and access to Wi-Fi or mobile data (either the patient or the caregiver)

Exclusion Criteria:

* NYHA IV patients
* Currently listed for heart transplant
* Left ventricular assist device recipient
* Ventricular arrhythmia within prior 6 months
* Uncontrolled arterial hypertension or resting heart rate \>100 bpm
* Acute myocarditis or pericarditis
* Severe aortic stenosis
* Hypertrophic obstructive cardiomyopathy
* Advanced AV block
* Muscle-skeletal or neurologic disease preventing to perform study procedures
* ACS within prior month
* Severe lung disease
* Moderate or severe cognitive impairment
* Unable/unwilling to consent
* Projected life expectancy \<6 months
* Clinical judgment concerning other safety issues
Impact of Hospital Admission on Patients With Dementia

People with dementia have complex medical, social, and psychological needs and can be exacerbated by physical illness and the complex relationships between health care systems, patients and their families or caregivers. They are a vulnerable and fragile population that differs significantly from the population without dementia. Therefore, the investigators propose the following objectives: 1. To describe the evolution of dementia patients admitted during the study period in two hospitals in the Basque Health Service-Osakidetza and complications associated with such admissions. 2. To compare with a control group (matched by type of pathology, age and sex and adjusting for other clinical variables (severity of dementia ...) the patient's condition before and after admission, in terms of quality of life, dependency, instrumental activities of daily living and severity of dementia. 3. To compare the length of stay, complications, mortality rate, the degree of dependency and quality of life of patients with dementia compared to those without dementia, matched by groups of pathologies, gender and age.


Eligibility Criteria:
Inclusion Criteria:

* For the patients with dementia cohort, the inclusion criteria were: (a) Being patient aged over 75 years; (b) having been diagnosed with dementia according to the Diagnostic and Statistical Manual for Mental Disorders-IV (American Psychiatric Association, 1994) by any of the psychiatrists; (c) having received inpatient treatment by the time of the study in the hospital//with an unplanned medical admission to any medical speciality in the Galdakao-Usansolo Hospital (d) agreeing to participate voluntarily and providing written informed consent. Patients with dementia were included if a caregiver agreed to participate voluntarily. Caregiver is defined as any person who cares for a needy person in his or her direct environment on a regular basis and more or less as a matter of course. The caregiver is related (family, friend...) to the person receiving care and is not a professional caregiver (Shoenmakers et al., 2010).
* For the cognitive intact patients cohort, the inclusion criteria were patients without dementia admitted in the hospital by the time of the study, matched with patients with dementia, after controlling for age, gender and types of pathologies.

Exclusion Criteria:

* Patients with dementia (or caregivers) were excluded if they did not provide inform consent.
* The exclusion criteria for patients without dementia were disorders interfering with psychometric assessment, or not given written informed consent.
A Study to Compare Efficacy and Safety of CT-P17 With Humira in Patients With Active Rheumatoid Arthritis

This is a Phase III Study to Compare Efficacy and Safety of CT-P17 with Humira in Patients With Active Rheumatoid Arthritis

CT-P17, containing the active ingredient adalimumab, is a recombinant humanized monoclonal antibody that is being developed as a similar biological medicinal product to Humira. The purpose of this study is to demonstrate similar efficacy and safety of CT-P17 and Humira in patients with moderate to severe rheumatoid arthritis when co-administered with methotrexate.

Eligibility Criteria:
Inclusion Criteria:

* Patient is male or female aged 18 to 75 years old, both inclusive.
* Patient has had a diagnosis of rheumatoid arthritis according to the 2010 American College of Rheumatology(ACR)/EULAR classification criteria for at least 24 weeks prior to the first administration of the study drug .

Exclusion Criteria:

* Patient who has previously received investigational or licensed product; biologic or targeted synthetic disease-modifying antirheumatic drugs for the treatment of rheumatoid arthritis and/or a tumor necrosis factor (TNF) α inhibitor for any purposes.
* Patient who has allergies to any of the excipients of study drug or any other murine and human proteins, or patient with a hypersensitivity to immunoglobulin products.
Study of Genes and the Environment in Patients With Prostate Cancer Residing in the East Anglia, Trent, or West Midlands Regions of the United Kingdom

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This study is looking at genetic susceptibility and the interactions between genes and the environment in patients with prostate cancer.

OBJECTIVES:

* To obtain epidemiological information and biological material on a population-based series of prostate cancer cases.
* To identify novel cancer susceptibility genes by comparison of genotype frequencies in cases with the corresponding frequencies in large control series.
* To estimate the age and sex-specific risks associated with variants in predisposition genes.
* To evaluate interactions between polymorphisms in predisposition genes and potential lifestyle risk factors.

OUTLINE: This is a multicenter study.

Patients complete a detailed epidemiological questionnaire, including information on education, occupation, smoking habits, alcohol consumption, height, weight, family history of cancer, and past medical history.

Blood samples are collected from patients. DNA is extracted from these blood samples and from samples collected from cancer-free control participants in MREC-SEARCH-CONTROL as well as from additional controls through the European Prospective Investigation of Cancer (EPIC) study (a population based study of diet and health based in Norfolk, East Anglia). DNA samples are analyzed for polymorphisms of low penetrance cancer susceptibility genes.

In addition to the prostate cancer patients recruited for this study, patients with breast, ovarian, endometrial, colorectal, bladder, kidney, pancreatic, brain and esophageal cancer, malignant melanoma, and lymphoma cancer are recruited in the following related clinical trials: MREC-SEARCH-BREAST, MREC-SEARCH-OVARIAN, MREC-SEARCH-ENDOMETRIAL, MREC-SEARCH-COLORECTAL, and MREC-SEARCH-CANCER.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of prostate cancer within the past 5 years
* Identified through the cancer registry serving any of the following geographic regions of the United Kingdom:

  * East Anglia
  * Trent
  * West Midlands

PATIENT CHARACTERISTICS:

* Identified by the patient's general practitioner as fit to contact for this study
* No serious mental illness or retardation

PRIOR CONCURRENT THERAPY:

* Not specified
A Phase I Study to Evaluate the Safety and Drug Allergy of HLB3-002 in Healthy Volunteers

Part I) multi-center, randomized, double-blind, placebo controlled

Part II) multi-center, randomized, double-blind, placebo controlled


Eligibility Criteria:
Inclusion Criteria:

\[Part I\]

1. Healthy volunteers aged 19 years or older at the time of screening (Visit 1).
2. Subjects with intact skin at the site of administration, without tattoos, acne, dermatitis, pigmentation, or lesions that could interfere with the administration of the investigational drug and allergy testing.

\[Part II\]

1. Subjects who tested negative on the drug allergy assessment after Part 1 intradermal administration.
2. For women of childbearing potential, a negative pregnancy test (serum-hCG) at baseline visit (V5).

Exclusion Criteria:

\[Part I\]

1. Subjects with the following comorbidities or conditions:

   * Acute fever exceeding 37.5°C within 1 week prior to the baseline (Visit 2).
   * Symptoms of an acute illness within 2 weeks prior to the baseline (Visit 2).
   * Immune disorders that may affect the immune system (e.g., flu, cancer, HIV).
   * Chronic urticaria, dermographism.
   * Clinically significant diseases affecting the liver, kidneys, gastrointestinal system, cardiovascular system, respiratory system, endocrine system, immune system, psychiatric/neuropsychiatric system, hematologic system, or oncology.
   * Clinically significant blood pressure abnormalities.

     * Hypertension: Systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg.
     * Hypotension: Systolic blood pressure ≤90 mmHg and/or diastolic blood pressure ≤60 mmHg.
2. Subjects who have smoked more than 10 cigarettes per day within 4 weeks prior to the screening (Visit 1).
3. Subjects who have participated in another clinical trial and received investigational drugs or medical devices within 6 months prior to the baseline (Visit 2).
4. Other subjects deemed inappropriate for participation in this clinical trial by the investigator.

\[Part II\]

1) Subjects with the following comorbidities or conditions:

* Acute fever exceeding 37.5°C within 1 week prior to the baseline (Visit 5).
* Symptoms of an acute illness within 2 weeks prior to the baseline (Visit 5).
* Clinically significant diseases affecting the liver, kidneys, gastrointestinal system, cardiovascular system, respiratory system, endocrine system, immune system, psychiatric/neuropsychiatric system, hematologic system, or oncology.
* Clinically significant blood pressure abnormalities.

  * Hypertension: Systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg.
  * Hypotension: Systolic blood pressure ≤90 mmHg and/or diastolic blood pressure ≤60 mmHg.
Investigation of the Changes of Brain Structure and Function in Premature Ejaculation Patients and the Effects of Dapoxetine on Central Neural Activity in Premature Ejaculation Patients

Lifelong premature ejaculation (LPE) is a common male sexual dysfunction with a high prevalence in global. Up to now, the etiology of LPE remains unclear. In recent years, dapoxetine, a highly potent serotonin-transporter inhibitor, has been used for treating premature ejaculation. However, the underlying mechanism of dapoxetine was unknown. Recently, with widespread use of neuroimaging techniques, like positron emission tomography and magnetic resonance imaging (MRI) in basic science, researchers can acquire human data on cerebral base of human sexual behavior, not only in normal subjects but also in patients with sexual dysfunction. Therefore, in order to further understand the biological mechanism of LPE and the brain targets of dapoxetine, the present study would investigate the brain changes of LPE and the effect of dapoxetine on brain activation by using MRI technology.


Eligibility Criteria:
Inclusion Criteria:

* right-handed male Chinese volunteers
* intravaginal ejaculatory latency time within 1 min
* premature ejaculation diagnostic tool score \>11 for patients, but \<5 for each control.
* patients who never received dapoxetine hydrochloride or other SSRI drugs

Exclusion Criteria:

* smokers
* had medical，neurological or psychiatric disorders
* had alcohol, nicotine, or drug abuse
* received any treatment at least 2 weeks before the experiment
Screening and Interventions in an Acute Care Setting

The purpose of this study is to: 1) evaluate the reliability and validity of EMS screening for depression and cognitive impairment and 2) to develop a pilot ED intervention program to address the needs of older adults found to be at risk for depression and cognitive impairment.

Many older adults (age over 64) have undetected health problems and lack basic prevention measures. Failure to identify and treat these conditions can lead to unnecessary morbidity and mortality and a decreased quality of life. Traditional screening and intervention programs, usually based in primary care providers' offices, have been insufficient, particularly in medically underserved populations. Alternate sites for screening and intervention have begun to receive attention and may hold promise.

The emergency medical services (EMS) system is a unique, community-wide system that can be used to perform in-home evaluations to uniformly screen large numbers of vulnerable older adults during emergency responses. The emergency department (ED) is the entry point for access to medical and social services for many patients. Recent programs have used the EMS system to screen patients or the ED to screen and intervene with mixed results, but little has been done to rigorously evaluate an integrated program of EMS screening that leads to focused ED interventions that promote the health of older adults. This proposed project builds upon the principal investigator's preliminary work and unique resources in Rochester, NY to develop and evaluate a program of EMS screening and ED interventions to help community-dwelling older adults with unmet needs. Specifically, this study aims to:

1. Implement an EMS screening program to identify community-dwelling older adults' unmet needs during emergency responses, identifying patients with needs related to depression and dementia.
2. Evaluate the test-retest reliability and concurrent criterion validity of EMS screening for depression and cognitive impairment.
3. Develop and refine an EMS and ED intervention program that addresses the needs of older adults found by EMS to be at risk for depression and cognitive impairment.

Upon completion, this study will have demonstrated the reliability and validity of EMS screening for these conditions and will have proposed an EMS and ED based intervention program template that can be applied to these and a wider range of geriatric disorders.

Eligibility Criteria:
Inclusion Criteria:

* age 65 or older, cared for by participating EMS providers

Exclusion Criteria:

* too ill to participate, not transported to participating hospitals