cyrilzakka/clinical-trials huggingface dataset:
Oxford Niaspan Study: Effects of Niaspan on Atherosclerosis and Endothelial Function

AIM 1 will test the hypothesis that elevation of high-density lipoprotein (HDL) through treatment with Niaspan will accelerate the regression of atherosclerotic plaque in patients with established atherosclerosis. The investigators will therefore study patients with atherosclerosis in the aorta and carotid artery. Plaque quantification will be with magnetic resonance imaging (MRI).

AIM 2 will assess the ability of Niaspan to improve endothelial function in patients with coronary artery disease and type II diabetes mellitus, who typically have low high-density lipoprotein cholesterol (HDL-C), and high risk of cardiovascular events.

Patients will be randomised to receive either Niaspan 2000mg each night or placebo. Niaspan will be commenced at 375mg daily and increased to 500mg then to 750, and 1000mg daily at weekly intervals. After 4 weeks the dose will be increased to 1500mg daily and, after a further one month, the study dose of 2000mg daily2 will be instigated. Immediately before randomization (to exclude patients unable to tolerate MRI because of claustrophobia), and 6 and 12 months after commencing treatment participants will undergo MR examination.

Eligibility Criteria:
Inclusion Criteria:

* Aim 1: Carotid or peripheral arterial disease and HDL \<1mmol/L
* Aim 2: Coronary artery disease, type II diabetes and HDL \<1mmol/L

Exclusion Criteria:

The following will constitute exclusion criteria:

* Inability to provide informed consent,
* Known intolerance of a study drug,
* Use of niacin or a fibrate at time of screening,
* AST or ALT elevated above normal range at time of screening
* Use of oral nitrates or nicorandil
* Uncontrolled or newly diagnosed diabetes mellitus
* Symptomatic heart failure or heart failure requiring treatment with diuretics
* Fasting triglycerides \> 500mg/dL \[5.65mmol/L\]
* Patients with acute coronary syndromes, active peptic ulcer disease,
* Active gout,
* Standard exclusions for MRI will apply, i.e. pacemakers, implantable defibrillators, metal implants or embedded metallic fragments of any kind.
Effects of Different Exercises Interventions in Post-menopausal Women

This study will compare different exercise training protocols on health parameters of postmenopausal women. The hypothesis is that short duration high intensity interval training will promote different effects of long duration moderate intensity training.

Exercise load control still not a consensus as to the most effective strategy for improving health parameters in postmenopausal women. In this way, the volunteers will perform anthropometric and body composition assessments, climacteric symptoms and sleep quality evaluations, blood pressure reactivity, resting blood pressure and heart rate and ambulatorial blood pressure monitoring, before and after 12 weeks of training.

Eligibility Criteria:
Inclusion Criteria:

* being postmenopausal (amenorrhea of at least 12 months and \[FSH\]\> 40 mlU/ml); be controlled hypertension; not to undergo drug treatment with β-blockers; not make use of sex hormone therapies; do not present physical problems or cardiovascular complications that prevent the performance of physical exercises; present attestation of a cardiologist proving that they are able to perform physical exercises.

Exclusion Criteria:

* Do not attend the collection site on the day and time programmed more than once in the acute phase of the study; missing more than 2 consecutive sessions or 6 alternates in the chronic phase of the study; unable to perform the proposed training protocols; change in drug therapy during the intervention.
Cognitive Remediation Plus Aerobic Exercise in Schizophrenia Treatment

Cognitive remediation (CR) and aerobic exercise have separately shown promising results in schizophrenia cognitive improvement, despite this, the impact in improving functionality is still limited. Aerobic exercise increases Brain Derived Neurotrophic Factor (BDNF) levels, promoting neuronal and cognitive plasticity, which can maximize the impacts of CR. The aim of this randomized controlled trial is to study the efficacy of a 3-month intensive program that combines CR plus physical exercise comparing it to cognitive remediation plus a control activity.

Cognitive remediation (CR) and physical exercise have separately shown promising results in schizophrenia cognitive improvement, despite this, the impact in improving functionality is still limited. Physical exercise increases Brain Derived Neurotrophic Factor (BDNF) levels, promoting neuronal and cognitive plasticity, which can maximize the impact of CR. The aim of this project is to study the efficacy of an intensive program (3 months) that combines CR and physical exercise by a randomized controlled trial where 74 patients with chronic schizophrenia will be randomized to two groups: 1) CR plus physical exercise; 2) CR plus control activity (health promotion). Primary outcome measures will be cognitive performance, functional outcome, negative symptoms and BDNF levels. Measures will be blindly assessed at baseline, at 3 months follow up and at 15 months follow up. The investigators expect that: i) the CR plus physical exercise will be superior to CR plus control activity in improving cognition, functional outcome, negative symptoms and in increasing BDNF levels in the short and medium term (3 and 15 months); ii) changes in BDNF levels after the CR plus physical exercise will be an adequate biomarker of the cognitive improvement obtained with this treatment.

Eligibility Criteria:
Inclusion Criteria:

1. A diagnosis by Diagnostic and Statistical Manual of Mental Disorders of schizophrenia or schizoaffective disorder with a minimum of 10 years illness evolution/duration;
2. Between 28 and 60 years of age;
3. Clinically stable (no changes in psychotropic medication in the previous months, except for benzodiazepines)
4. Sufficient acculturation and fluency in the Spanish language to avoid invalidating research measures of thought, language, and speech disorder or of verbal cognitive abilities;
5. Low physical activity, as measured by International Physical Activity Questionnaire, IPAQ;
6. Signed informed consent

Exclusion Criteria:

1. Evidence of a known neurological disorder (e.g., epilepsy) or significant head injury;
2. Evidence of substance use disorder within the previous 3 months;
3. mental retardation, i.e. premorbid intelligence quotient less than 70;
4. Electroconvulsive therapy in previous 6 months.
5. Somatic illnesses that contraindicate physical exercise.
Pilot Study Based on Technology Solutions for Hypertension Care

The goal of this clinical trial is to understand whether the adoption of digital solutions by healthcare professionals and patients improves the management of patients with high blood pressure.

The main questions it aims to answer are:

* are these digital solutions feasible and well accepted by patients?
* can these solutions, compared to standard care, allow a better hypertension control in patients with high blood pressure?

Participants randomised to one of the two intervention arms will be asked to adopt the digital solutions that include a smartphone app and 2 devices for blood pressure and body weight measurement that will be connected to the app.

Researchers will compare patients randomised in the two intervention groups with patients randomised to standard care (control group)

The study falls within the scope of the HSMonitor project, a pre-commercial tender for the development of telematics solutions aimed at optimising patient health status and disease management. Specifically, the aim of this study is to test whether the adoption of HSMonitor solutions by healthcare professionals and patients improves the management of patients with high blood pressure.

This will be a randomised controlled trial where patients with hypertension will be randomised either to one of the two digital solutions or to standard care.

The present pilot study is planned to be carried out within the framework of the EU project HSMonitor - Pre-commercial Procurement of innovative ICT-enabled monitoring to improve health status and optimize hypertension care (Grant Agreement Nr. 856698).

The two solutions are referred to as:

* Solution 1 - HSmartBPM (developed by a supplier consortium led by GNOMON)
* Solution 2 - HyperHealth (developed by a supplier consortium led by TECH4CARE)

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with essential hypertension (\>140/90 mmHg or normal BP with antihypertensive treatment)
* Basic ICT knowledge and ability to access the internet at home and on mobile devices
* aged 18+
* ability to provide written informed consent, giving informed consent.
* written informed consent

Exclusion Criteria:

* inability to consent
* chronic renal replacement therapy (haemodialysis, peritoneal dialysis or transplantation) or if, at baseline, there is a history of active malignancy within the last five years
* pregnancy
* illiterate
* younger than 18 years
* being a prisoner
* being institutionalized
* the patient is mentally or psychiatrically ill
* the patient has barriers to understand the implications of participation to the study
* the patient is critically ill or dying
* the patient is extremely poor
* the patient has a learning disability
* the patient is sedated or unconscious
* the patient is a refugee with no permanent permission to stay
* the patient does not have a good command of the language
* the patient has problems in cognitive, juridical, and deferential dimensions
Effect of Diet and Exercise in Breast Cancer Survivors

This study seeks to see if a 12-week diet and exercise program improves exercise ability, energy level, and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* ER/PR/HER2neu negative breast cancer
* at least 3 months after end of treatment
* BMI at least 25

Exclusion Criteria:

* stage IV cancer
Prediction Model for Delayed Extubation of Tracheal Intubation in Patients With Maxillofacial Space Infection After Abscess Incision and Drainage Surgery

Retrospective exploration of the risk factors associated with mechanical ventilation and tracheal extubation twenty-four hours after abscess incision and drainage surgery in patients with maxillofacial space infection.

1. Retrospective exploration of the risk factors associated with mechanical ventilation and tracheal extubation after 24 hours of abscess incision and drainage in patients with maxillofacial space infection.
2. Prediction model: Based on the identified risk factors, establish a model to predict the risk of tracheal intubation withdrawal 24 hours after abscess incision and drainage surgery in patients with maxillofacial space infection.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old (actual age of the patient)
* Patients diagnosed with maxillofacial space infection upon admission

Exclusion Criteria:

* Serious errors or omissions in key demographic information and medical records
The Effect of Precise Aerosol Inhalation Nursing on Sputum Excretion in Elderly Patients With Lung Surgery

Comparing the effects of different kinds of aerosol inhalation nursing programs on effective sputum excretion in elderly patients with lung surgery.

Based on the traditional oxygen aerosol inhalation treatment, this study will improve it. In the process, precise body position care, time control, observation and treatment, evaluation, etc. will be used to form a precise aerosol inhalation care plan. To explore the effect of this program on effective sputum excretion in elderly patients undergoing lung surgery.

Eligibility Criteria:
Inclusion Criteria:

* ①The patient underwent thoracoscopic lung surgery; ②There was no obvious pulmonary infection before the operation; ③Good audiovisual function, no communication barriers, able to cooperate with nebulized inhalation operation; ④Patients informed consent to this study.

Exclusion Criteria:

* ①Patients with mental illness; ②Acute COPD; ③Serious complications or failure of important organs after operation.
Drug Eluting Stent Registry of Thrombosis

Multicenter, case-control study, to collect data regarding incidences of late and very late drug-eluting stent thrombosis with the aim of identifying trends and possible correlates of stent thrombosis.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age
* Case Subjects: patients who have experienced definite late or very late drug-eluting stent thrombosis
* Control Subjects: patients who underwent drug-eluting stent implantation at the same facility and in the same time period as a matched Case Subject, and have not experienced drug-eluting stent thrombosis.

Exclusion Criteria:

* Patients not meeting the above Inclusion Criteria
A Comparative Study: Non-Surgical Spinal Decompression and Spinal Manipulative Therapy- Utilizing a Quantifiable Musculoskeletal Functional Assessment Risk Analysis Tool (MSDR®) in Patients With Chronic Low Back Pain

To administer the MSDR® (Musculoskeletal Disorder Reporting) instrument to document the musculoskeletal profile of patients with chronic low back pain, a prospective, non-randomized, multicenter treatment trial


Eligibility Criteria:
Inclusion Criteria:

* Must have Informed Consent Signed
* Lumbar Disc Herniations under 5mm without Sequestered Fragments
* Lumbar Disc Bulging
* Lumbar Degenerative Disc Disease (mild and moderate severity)
* Non-pregnant Females and Males suffering from Chronic Low Back Pain from 18 to 65 years of age
* Segmental Dysfunction Secondary to Dyskinesia
* Unresolved Nerve Entrapment Syndrome
* Patients must be able to comply with study protocol
* Joint Fixation Syndrome
* Premenopausal Female Patients, excluding patients who have undergone a hysterectomy, oophorectomy, or tubal ligation, must have one of the following methods of contraception and must have a negative serum or urine b-HCG pregnancy test performed within 48 hours before initiating protocol specified treatment.

Exclusion Criteria:

* Contraindications to Spinal Manipulative Therapy
* Lumbar Canal Stenosis resulting in significant neurological comprimise
* Any Spinal Cord Compression resulting in significant neurological comprimise
* Cauda Equina Syndrome
* Infection
* Osteomyelitis

  -\>65 years of age
* History of Back or Neck Surgery
* Acute Arthritis
* Signs or Symptoms of Arterial Aneurysm
* History of Active Cancer with Bone Metastasis
* Widespread Staphyloccal and/or Strepococcal Infection
* Acute Gout
* Serious unstable medical illness such as cardiovascular, renal, respiratory, endocrine, gastrointestinal, or psychiatric.
* Unstable Spondylosis, Spondylolisthesis, or Spondylolysis
* Prior adverse experience with Spinal Manipulation Therapy
* Uncontrolled Diabetic Neuropathy
* Gonorreal Spinal Arthritis
* Tuberculosis to the Bone
* Maligancy with Metatasis to Bone
* Excessive Spinal Osteoporosis
* Osteomalacia
* Ankylosis
* Syphlitic Articular or Peri-Articular Lesions
* Active Low Back Injury Resulting from a Motor Vehicle Accident or Work Related Injury
GIC-102, Intravenous Allogeneic NK Cells, in Subjects With Advanced Solid Cancers and R/R Hematologic Malignancies

This is a first-in-human trial to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor effects of GIC-102 in patients with advanced solid tumors, relapsed/refractory non-hodgkin lymphoma, and multiple myeloma.

This is a first-in-human, open-label, non-randomized, dose-escalation and expansion phase 1/2a trial to determine the safety profile and identify the maximum tolerated dose of GIC-102 in patients with advanced solid tumors, relapsed/refractory non-hodgkin lymphoma, and multiple myeloma.

This study will comprise two phases.

* GIC-102 monotherapy dose escalation Phase
* GIC-102 monotherapy dose expansion phase

GIC-102 is an "off-the-shelf" allogeneic natural killer cells isolated from non-HLA-related healthy donor. Natural killer cells are innate immune cells that show strong cytolytic function against physiologically stressed cells such as tumor cells and virus infected cells.

Eligibility Criteria:
Inclusion criteria:

1. At least 19 years of age
2. Advanced solid tumors, relapsed/refractory non-hodgkin lymphoma, and multiple myeloma
3. At least one measurable or evaluable lesion
4. Eastern Cooperative Oncology Group performance status 0 or 1
5. A life expectancy of 12 weeks or more
6. Acceptable hematological function, kidney, and liver function
7. Subjects who sign on an informed consent form willingly

Exclusion Criteria:

1. Clinically significant cardiovascular disease within 24 weeks
2. Primary malignant tumor other than the indications for this study
3. The following diseases

   1. Severe infection or other uncontrolled active infectious disease requiring administration of systemic antibiotics or antivirals within 4 weeks
   2. The New York Heart Association class III/IV
   3. Active hepatitis B virus or hepatitis C virus infection
   4. Human immunodeficiency virus positive
   5. Clinically significant symptoms or uncontrolled central nervous system metastasis
4. Previously been diagnosed with immunodeficiency or need systemic corticosteroids or other systemic immunosuppressants within 2 weeks or require administration of systemic immunosuppressants during the study
5. Received chemotherapy other than pre-conditioning within 4 weeks
6. Underwent major surgery within 4 weeks prior or minor surgery within 2 weeks
7. Hypersensitivity reactions to the study drug or excipients
8. Hypersensitivity to cyclophosphamide or fludarabine
9. Have received allogeneic cell therapy within 6 months or autologous stem cell therapy within 4 weeks
10. Have previously received an allogeneic tissue/solid organ transplant
11. Have administered other investigational drug or applied other investigational medical device within 4 weeks
12. Pregnant or lactating female subjects
13. Male subjects who did not agree to use contraception or to maintain abstinence
Comparison of a Novel Transperineal Targeted Fusion Biopsy System to Conventional Transrectal Targeted Fusion Biopsy

This study is designed as a randomized control trial which intends to determine if transperineal (TP) targeted biopsy is not inferior to transrectal (TR) targeted biopsy for diagnosis of clinically significant prostate cancer while comparing post-procedural infection rates between the two techniques. The study will also look to compare patient reported pain scores related to the procedure, rates of other minor complications (e.g. bleeding, urinary retention) and procedure time.

The expected sample size at The Ottawa Hospital is 360 men.

Patients undergo mp-MRI, at the discretion of the treating Urologist, when they are referred to the Cancer Assessment Clinic for their initial visit with a risk factor for prostate cancer (e.g. abnormal digital rectal exam \[DRE\] or elevated prostate serum antigen \[PSA\] level). Performing an mp-MRI in a man with risk factors for prostate cancer prior to an initial biopsy has become the standard of care for diagnosis of prostate cancer based on two large multi-center randomized control trials.

At the second visit, which is standard of care, the Urologist (or delegate \[Resident, Fellow\]) will discuss targeted biopsy and will introduce the trial design obtaining informed consent to participate. If consent is obtained, the patient will be randomly assigned to receive either the standard transrectal (TR) ultrasound guided targeted fusion biopsy or the novel transperineal (TP) targeted fusion biopsy system which has also been preliminarily validated as being accurate for detection of significant prostate cancers at targeted biopsy.

Patients will be notified regarding which method of targeted biopsy will be employed at time of scheduling.

Both the TR and TP biopsies will be conducted in existing biopsy rooms in The Ottawa Hospital (TOH) and will employ a brief 30-minute post-procedural observation period at which point the patient is required to urinate prior to discharge. Level of pain will be recorded by the ultrasound technologists during the 30 minutes observation period as well.

This study aims to compare ultrasound guided transrectal and transperineal targeted fusion biopsy for diagnosis of prostate cancer in abnormalities detected on MRI for the purpose of reducing or completely eliminating the risk of serious infection associated with the transrectal approach.

Eligibility Criteria:
Inclusion Criteria:

* MRI positive - abnormal area detected
* Patient re-evaluated in the TOH Prostate CAC (Cancer Assessment Centre) for planning of targeted biopsy
* Signed Consent

Exclusion Criteria:

* MRI negative - no abnormal area detected
* Patient with a prior diagnosis of prostate cancer enrolled in active surveillance
Arterial Stiffness and Atrial Fibrillation

Researchers are trying to determine whether arterial stiffness detected by ultrasound can predict outcomes in the development and recurrence of atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

* All patients with persistent AF, scheduled for electrical cardioversion

Exclusion Criteria:

* Unable to provide informed consent.
* Patients with intramural thrombus or other conditions that preclude the performance of electrical cardioversion.
* Patients with prior carotid stents.
Pediatric Nasal Mask Usability Study

The purpose of the study is to demonstrate the effectiveness of a pediatric mask in treating obstructive sleep apnea (OSA) in a pediatric population.

Obstructive sleep apnea (OSA) is a condition in which there is partial or complete collapse of the upper airway during sleep. Features of OSA include snoring to upper airway resistance, which could be mild to severe. While OSA has been studied extensively in an adult population, research indicates that OSA is prevalent in a pediatric population as well, though the options for treatment are not as varied as that for the adult population. The study seeks to determine if a mask made for a pediatric population effectively treats their OSA.

Eligibility Criteria:
Inclusion Criteria:

* 2-7 years of age
* Diagnosis of OSA
* Current PAP therapy user
* Current nasal mask user

Exclusion Criteria:

* Recent sinus surgery
* Allergies to mask material
* Current seasonal allergies that could interfere with therapy
* History of clinically significant epistaxis in past 6 months
* Upper airway surgery less than 60 days before study entry
Study 08-114 Open-label Extension of Study 08-110 - A Multi-Center Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis Lung Disease (P08642)

The purpose of this study is to obtain data on the potential of long-term treatment with denufosol to improve the clinical course of CF lung disease in patients with mildly impaired lung function and to provide CF patients who completed study 08-110 continued access to denufosol.


Eligibility Criteria:
Inclusion Criteria:

* Completed Study 08-110

Exclusion Criteria:

* A female patient will not be eligible for the study if she is of childbearing potential and is pregnant, lactating, and/or not practicing an acceptable method of birth control (e.g., abstinence, hormonal or barrier methods, partner sterilization, or intrauterine device).
* Have a condition that might affect compliance with study procedures