cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180mg When Added to PCSK9 Inhibitor Therapy

The purpose of this study is to determine if bempedoic acid (ETC-1002) 180mg added to PCSK9 inhibitor (evolocumab) therapy is effective and safe in patients with elevated LDL cholesterol.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years or legal age of majority depending on regional law
* Fasting, calculated LDL-C at screening ≥160 mg/dL and following PCSK9i therapy ≥70 mg/dL
* Men and nonpregnant, nonlactating women

Exclusion Criteria:

* Heterozygous (HeFH) or Homozygous (HoFH) Familial Hypercholesterolemia
* Total fasting TG ≥500 mg/dL
* Renal dysfunction or a glomerulonephropathy; eGFR \<30 mL/min/1.73 m2
* Known cardiovascular disease (CVD), peripheral arterial disease (PAD), or cerebrovascular disease (CD)
* History of type 1 or type 2 diabetes
* Uncontrolled hypertension
* Uncontrolled hypothyroidism
* Liver disease or dysfunction
* Gastrointestinal conditions or procedures (including Lap-Band® or gastric bypass)
* History of hematologic or coagulation disorders
* History of malignancy (except non-metastatic basal or squamous cell carcinoma of the skin and cervical carcinoma in situ)
* Unexplained creatine kinase (CK) \>3 × ULN
* Use of a cholesterylester transfer protein (CETP) inhibitor in the last 12 months prior to screening, such as: anacetrapib, dalcetrapib, or evacetrapib
* Pregnant or breast feeding, or planning to become pregnant during treatment and/ or within 30 days after the end of treatment
Effects of Intermittent Pneumatic Compression on Recovery of Cyclists

This study aims to assess the recovery kinetics of road cyclists following a fatigue protocol (30 time trial).


Eligibility Criteria:
Inclusion Criteria:

* Road cyclists competing nationally

Exclusion Criteria:

* Injured athletes
Endoscopic Ultrasound Guided Colorectal ESD and Traditional Colorectal ESD Surgery

A prospective randomized controlled study protocol between endoscopic ultrasound guided colorectal ESD and traditional colorectal ESD surgery

This study compare and analyze the efficiency of endoscopic ultrasound guided colorectal ESD surgery with traditional colorectal ESD surgery, in order to guide colorectal ESD operations.

Eligibility Criteria:
Inclusion Criteria:

* Cases in our hospital who require colorectal ESD surgery
* Colorectal lesions（laterally spreading tumor）.

Exclusion Criteria:

* Laterally spreading tumor but not nodular mixed type(LST-G-M)
* Patients who have participated or are currently participating in other clinical trials within the first 4 weeks of enrollment;
Preliminary Efficacy and Safety Study of Oral Nepadutant in Infant With Colic Not Responding to Conventional Treatment

This phase IIa study is designed as a multi-centre, single country, randomised, double-blind, placebo controlled study in three parallel groups, with the aim to evaluate the efficacy and safety of Nepadutant given at two oral doses once daily for seven days in comparison to placebo in the treatment of infantile colic.

Infant colic is a functional gastrointestinal disorders which affects up to the 30% of the infant population; it is primarily characterised by excessive inconsolable crying starting without any apparent cause and lasting for several hours per day.

Current non pharmacological interventions (e.g. message, restriction in maternal diet in breast-feeding infants) and pharmacological treatments (simethicone, antimuscarinic drugs) are largely unsatisfactory.

In animal models, Nepadutant reverse the exaggerated intestinal motility and sensitivity, induced by different stimuli, without producing inhibitory effects on these functions at baseline, suggesting that Nepadutant could have a therapeutic effect with no interference on physiological gastrointestinal transit.

This phase IIa study is designed to evaluate the efficacy of Nepadutant paediatric oral solution given once daily at two doses in comparison to placebo.

The experimental clinical phase encompasses the following periods:

* Screening period (no study medication) to be done 7 to 4 days prior to randomisation
* Treatment period, lasting seven days with once daily administration
* Post treatment period, lasting seven days A safety follow-up visit will be performed approximately 1 month after the first administered dose.

Eligibility Criteria:
Inclusion Criteria:

* Healthy infants with diagnosis of infant colic according to the following modified Wessel criterion "paroxysm of irritability, fussing or crying that start and stop without obvious cause for \>3h/day, \>3 days/week for one week"
* Age ≥ 6 weeks and \< 4 months
* No adequate response to conventional pharmacological or non-pharmacological treatment alternatives for infant colic
* Infants exclusively breast-fed.
* Normal growth
* Willingness to refrain from use of antimuscarinic drugs, simethicone, dimethicone or antiacids during the study period

Exclusion Criteria:

* Clinical evidence of allergies or other diseases which may cause crying and/or fussiness or may interfere with absorption or clearance of the drug.
* Suspect of gastroesophageal reflux disease (GERD)
* Formula fed or mixed fed infants.
The Effect of Raltegravir on HIV Decay During Primary and Chronic Infection

The purpose of this study is to measure the decay characteristics of HIV in the blood of patients after taking a combination of anti-HIV drugs, which includes a new class of anti-HIV drug, an integrase inhibitor. This study explores how this new combination of therapy reduces virus in various compartments of the body and immune system.

The study is an open-label study of 3-years duration. This study will be conducted at 4 study sites in Sydney, Australia. Sixteen participants will be recruited comprising 8 participants diagnosed with primary HIV infection (Cohort A) and 8 individuals with chronic HIV infection (Cohort B). All patients must be antiretroviral therapy (ART) naïve and will commence a regimen of combination ART consisting of tenofovir disoproxil fumarate and emtricitabine (TDF/FTC; Truvada) plus the integrase inhibitor, raltegravir. Subjects will be followed for three years with intensive quantification of both plasma RNA and cell associated DNA viral species.

Eligibility Criteria:
Inclusion Criteria:

* Age at least 18 years.
* Provision of written, informed consent.
* Screening plasma HIV RNA \> 10,000 copies/mL.
* Screening CD4+ T lymphocyte count \> 100 x 10\^6)/L.
* No previous antiretroviral therapy.
* Haemoglobin \> 115 g/L (female) or \> 130 g/L (male).
* Absolute neutrophil count \> 1 x 10\^9/L.
* Platelet count \> 100 x 10\^9/L
* Serum bilirubin \< 1.5 x ULN.
* Serum alkaline phosphatase \< 3 X ULN.
* Serum aspartate aminotransferase (AST) \< 3 X ULN.
* Serum alanine aminotransferase (ALT) \< 3 X ULN.
* Creatinine clearance \> 50mL/min (Creatinine clearance (mL/min) =140 - age x weight creatinine Multiply the result by 1.2 for men).

Cohort A: Primary HIV infection:

Documented acute or early infection diagnosed by:

Acute infection:

\< 3 bands on Western Blot and any one of: i. positive p24 antigen ii. positive proviral DNA

Early infection:

i. Positive detuned or BED ELISA result OR ii. Previously negative serology within 6 months of confirmed positive serology.

Cohort B: Chronic HIV infection:

Documented HIV-infection of at least 12 months duration.

Exclusion Criteria:

* Pregnancy or breastfeeding.
* Receipt of investigational products within 1 month of study entry.
* Receipt of any of the following within 6 months of study entry:

  * interferon alpha or gamma
  * oral corticosteroids (inhaled or topical corticosteroids are permitted)
  * cyclosporin
  * alkylating agents
  * other immunosuppressive agents
  * rifampin
  * phenytoin
  * phenobarbital
* Documented genotypic (IAS 2007) resistance to tenofovir or emtricitabine from any HIV drug resistance test.
* Any medications contraindicated with Truvada or raltegravir.
* Significant intercurrent illnesses apart from HIV infection such as viral hepatitis (diagnosed by core hepatitis B antigen and/or positive hepatitis B PCR or positive hepatitis C PCR) or any other condition which in the opinion of the investigator would compromise participation in the study.
* History of non-traumatic osteoporotic fracture.
The Effect of a Reduced Noise Environment on the Response Time of the Anesthesia Provider

This project will investigate whether reduction in ambient light and elimination of noise during induction and emergence from anesthesia influences the response time of the anesthesia provider to auditory and visual alarms when compared to a standard operating room. In addition, the investigators will assess the cumulative level of noise exposure that providers experience during the perioperative period.


Eligibility Criteria:
Inclusion Criteria:

* Anesthesia providers that have agreed to participate.

Exclusion Criteria:

* none
Effects of n-3 Polyunsaturated Fatty Acids and Antioxidants on Postprandial Hyperlipidemia and Vascular Function in Men

Diet has long been used as a way to provide enough nutrients to an individual in order to meet metabolic requirements. However, recent scientific advancements have suggested that beyond meeting nutrition needs, diet may also be health promoting through the modulation of various body functions. In a way, the role of nutrition has evolved from hunger satisfaction and maintenance of body integrity to the promotion of a state of well-being and prevention of important chronic diseases such as cancer, diabetes and cardiovascular disease (CVD). In recent years, n-3 polyunsaturated fatty acids (PUFA) have attracted much attention as consumption of a n-3 PUFA rich diet has been reported to reduce CVD risk. However, n-3 PUFA are also highly susceptible to free radical damage and therefore could be unable to fully exert their health benefits under an oxidative stress condition. The general objective of the present application is to investigate the mechanisms by which n-3 PUFA improve cardiovascular health in abdominal obesity and explore the potential of dietary antioxidants to modulate these effects in individuals at high risk of oxidative stress. For that purpose, we plan to study the changes in fasting and postprandial plasma lipoprotein-lipid levels, markers of lipid and lipoprotein oxidation, inflammation and endothelial dysfunction following 12 weeks of n-3 PUFA supplementation with or without low-calorie cranberry juice cocktail (as a source of antioxidants) in a group of 160 men. We feel that the present study will broaden our understanding of the physiological mechanisms underlying the beneficial effects of consuming unsaturated fatty acids and give further insights on the role of antioxidants in preserving and potentiating these cardiovascular health benefits.


Eligibility Criteria:
Inclusion Criteria:

* Waist circumference \> 90 cm
* Fasting triglycerides \> 1.7 mmol/L
* No use (ever) of medications for the treatment for dyslipidemia or hypertension

Exclusion Criteria:

* Alcohol consumption \> 1 drink per day i.e \~15 g of alcohol/day or the equivalent of 1 beer (12 oz or 341 mL), 1 glass of wine (4 oz or 125 mL) or 1 ounce (30 mL) of liquor.
* Chronic use of supplements (vitamins, minerals or flavonoids)
* Body mass index \> 35 kg/m2
* Chronic diseases: CHD, diabetes, etc.
* Smokers (1 or more cigarette/day)
* Dyslipidemia secondary to renal insufficiency, hypothyroidism or others
* Any prior or current use of medications known to affect lipoprotein-lipid metabolism (e.g. statins, fibrates), endothelial function (hypotensive drugs). Use (ever) of anticoagulant drugs (e.g. warfarin) because of possible detrimental interaction with the consumption of cranberry juice. Current or recent (\<2 weeks) use of anti-inflammatory drugs Note: If for any reason, a subject would have to go an any of these drugs during the protocol, they would be automatically dropped from the study.
The Impact of Nursing Delirium Preventive Interventions in the Intensive Care Unit

Delirium is a common disorder in Intensive Care Unit (ICU) patients and is associated with serious short- and long-term consequences. This study focuses on a program of standardized nursing and physical therapy interventions to prevent delirium in the ICU, and determines the effect of the program on the number of delirium-coma-free days in 28 days and several secondary outcomes in a multicenter randomized controlled trial.

Delirium is a common disorder in Intensive Care Unit (ICU) patients and is associated with serious short- and long-term consequences, including re-intubations, ICU readmissions, prolonged ICU and hospital stay, persistent cognitive problems, and higher mortality rates. Considering the high incidence of delirium and its consequences, prevention of delirium is imperative. This study focuses on a program of standardized nursing and physical therapy interventions to prevent delirium in the ICU, called UNDERPIN-ICU (nUrsiNg DEliRium Preventive INterventions in the ICU).

Objective: To determine the effect of the UNDERPIN-ICU program on the number of delirium-coma-free days in 28 days and several secondary outcomes, such as delirium incidence, the number of days of survival in 28 and 90 days and delirium-related outcomes.

Design and Setting: A multicenter stepped wedge cluster randomized controlled trial.

Methods: Eight to ten Dutch ICUs will implement the UNDERPIN-ICU program in a randomized order. Every two months the UNDERPIN-ICU program will be implemented in an additional ICU following a two months period of staff training. UNDERPIN-ICU consists of standardized protocols focusing on several modifiable risk factors for delirium, including cognitive impairment, sleep deprivation, immobility and visual and hearing impairment.

Participants: ICU patients aged ≥ 18 years (surgical, medical, or trauma) and at high risk for delirium, E-PRE-DELIRIC ≥35%, will be included, unless delirium was detected prior ICU admission, expected length of ICU stay is less then one day or when delirium assessment is not possible.

Eligibility Criteria:
Inclusion Criteria:

* aged ≥ 18 years
* surgical, medical or trauma patients
* admitted to one of the participating ICUs
* at high risk for delirium (\>35% determined with the E-PRE-DELIRIC prediction tool)

Exclusion Criteria:

* delirious before ICU admission
* an ICU stay \< one day
* reliable assessment for delirium is not possible due to: sustained coma; serious auditory or visual disorders; inability to understand Dutch; severely mentally disabled; serious receptive aphasia.
Circulating BDNF in Patients With Atrial Fibrillation Undergoing Catheter Ablation or Exercise Training

The main purpose of this project is to determine the impact of atrial fibrillation interventions (catheter ablation and exercise training) on circulating BDNF concentrations in patients with atrial fibrillation. It also seeks to determine if there is a relation between circulating BDNF concentrations and mental health (depression severity, quality of life and symptoms) among those undergoing interventions for atrial fibrillation catheter ablation or exercise training.

The main purpose of this project is to determine the impact of atrial fibrillation interventions (catheter ablation and exercise training) on circulating BDNF concentrations in patients with atrial fibrillation. It also seeks to determine if there is a relation between circulating BDNF concentrations and mental health (depression severity, quality of life and symptoms) among those undergoing interventions for atrial fibrillation catheter ablation or exercise training. Using a pre-post study design, the investigators will explore interventions in two subsets of patients at the opposite end of the atrial fibrillation clinical spectrum. Arm 1: patients with paroxysmal atrial fibrillation will undergo catheter ablation (n=100). Arm 2: patients with permanent or persistent atrial fibrillation will perform exercise training 2 times weekly for 12 weeks (n=100). Total sample size will be 200 participants. All measurements will be performed at baseline and follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects must be either currently enrolled in the OPPORTUNITY trial (NCT02602457) or have paroxysmal atrial fibrillation and be scheduled to undergo catheter ablation (for the first time) through the electrophysiology clinic at the University of Ottawa Heart Institute.
2. Subjects must be willing and able to provide a blood sample.
3. Subjects must be willing and able to provide informed consent.

Exclusion Criteria:

1. Subject is not either currently enrolled in the OPPORTUNITY trial (NCT02602457) or scheduled to undergo catheter ablation (for the first time) through the electrophysiology clinic at the University of Ottawa Heart Institute for paroxysmal atrial fibrillation.
2. Subjects with congestive heart failure with heart failure admission in the past 3 months.
3. Subjects with a cerebrovascular accident in the past 3 months
4. Subjects with severe dementia.
5. Subjects with a history of severe psychiatric illness (e.g., schizoaffective disorder, bipolar disorder, or schizophrenia).
6. Subjects with an active infection or inflammatory condition.
7. Subjects who are pregnant, lactating or planning to become pregnant during the study period.
8. Subject is unable to read or understand English or French.
9. Subject is unable to provide informed consent.
Assessment of Rosacea Patients' Clinical Trial Experiences

Taking part in medical trials usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups.

This study will admit a wide range of data on the clinical trial experience of Rosacea patients to determine which factors prevail in limiting a patient's ability to join or finish a trial.

It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future Rosacea patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient is at least 18 years of age
* Diagnosis of Rosacea
* Ability to understand the study procedures, benefits and risks, and sign a written informed consent document.

Exclusion Criteria:

* Inability to perform regular electronic reporting
* Women who are pregnant, intend to become pregnant, or are lactating
* Enrolled in another research study
Study for the Prediction of Active Rejection in Organs Using Donor-derived Cell-free DNA Detection

This is a multi-center prospective study designed to collect blood samples from transplant patients in order to improve Natera's method for determining allograft rejection status using the donor-derived cell-free DNA analysis, called Prospera.

This is a multi-center prospective study designed to collect blood samples from transplant patients in order to improve Natera's method for determining allograft rejection status using the donor-derived cell-free DNA analysis, called Prospera.

Subjects who have had an organ transplant, who present at the clinic for a standard of care visit or consent for an extra research blood samples to be taken by mobile phlebotomy, meet the study's eligibility criteria and are willing to participate in this research, will be consented and enrolled in this study.

Subjects will provide at least one blood sample at study enrollment and up to three optional follow-up blood samples at future visits. Relevant medical data will also be collected for each patient enrolled.

Urine samples may also be collected at the above described time-points.

Up to 500 subjects over the age of 2 worldwide who meet the study eligibility criteria are expected to be enrolled in this study. The study includes adult, pregnant, and pediatric subjects.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be 2 years old or older at the time of enrollment
* Subject or Legally Authorized Representative is willing and able to sign the informed consent form (and assent form, if applicable), prior to participation in any study-related procedures.
* Subject has received at least one organ transplant prior to enrollment.

Exclusion Criteria:

* Pediatric subjects under 2 years old
* Subject received donor organ from an identical twin
Social Isolation and Loneliness in Older People

Although psychotic disorders such as schizophrenia usually present in late adolescence or early adulthood, research suggests that a substantial subset of people are diagnosed for the first time after the age of 60. This condition is referred to as 'very late-onset schizophrenia-like psychosis' (VLOSLP). People with VLOSLP are thought to experience high levels of social isolation, yet there has been little research systematically examining this. Additionally, little is known about how lonely people with VLOSLP feel, or how this group relate to and perceive other people.

This study aims to examine levels of social isolation and loneliness in patients with VLOSLP. The investigators also aim to explore aspects of social cognition in relation to VLOSLP.

A case-control study design will be used to examine the relationship between VLOSLP, loneliness, social isolation and social cognition. The case group will be people diagnosed with a non-organic psychotic disorder after age 60. The comparison group will be those aged 60 and above in contact with mental health services for a mental health difficulty, except from a psychotic disorder or dementia.


Eligibility Criteria:
Cases

Inclusion criteria:

* Aged 60 and above.
* Diagnosed with a psychotic disorder after age 60.

Exclusion criteria:

* Diagnosed with a psychotic disorder before age 60.
* Dementia diagnosis.
* Mild cognitive impairment diagnosis.
* Clear organic cause for psychosis.
* Does not speak English to the degree needed to engage with study materials.
* Mental health problems too severe to fully engage with the study.
* Other medical or psychosocial factor that could limit ability to fully engage with study materials, such as severe intellectual disability or imminently life-limiting illness.

Controls

Inclusion criteria:

* Aged 60 and above.
* Diagnosed with any mental health disorder except from a psychotic disorder, dementia, or severe depression.

Exclusion criteria:

* Diagnosed psychotic disorder, drug-induced psychosis or organic psychosis.
* Dementia diagnosis.
* Mental health problems too severe to fully engage with the study.
* Does not speak English to the degree needed to engage with study materials.
* Other medical or psychosocial factor that could limit ability to fully engage with study materials, such as severe intellectual disability or imminently life-limiting illness.
Study of B013 and Nab-Paclitaxel for Locally Advanced or Metastatic Triple Negative Breast Cancer

This Phase II/III study assessed the efficacy, safety, pharmacokinetics, and immunogenicity of B013 administered with nab-paclitaxel in participants with locally advanced or metastatic triple negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC).


Eligibility Criteria:
Inclusion Criteria:

1. Women or men aged 18 -75 years
2. Locally advanced or metastatic triple negative breast cancer (TNBC)
3. No prior chemotherapy or targeted systemic therapy for inoperable locally advanced or metastatic TNBC
4. ECOG performance status of 0 or 1
5. Patient must have measurable or evaluable disease as defined by RECIST v1.1. Measurable lesions will be confirmed by radiographic imaging (CT or MRI)

Exclusion Criteria:

1. Previous treatment is eligible.
2. Spinal cord compression not definitively treated with surgery and/or radiation prior to study entry
3. Known central nervous system (CNS) disease
4. Uncontrolled pleural effusion, pericardial effusion, or ascites Patients
5. Uncontrolled tumor-related pain prior to study entry
6. The patient has a history of another malignancy within 5 years prior to study entry, except adequately treated non-melanotic skin cancer, carcinoma in situ of the cervix or Papillary carcinoma of the thyroid
7. Pregnancy or lactation