cyrilzakka/clinical-trials huggingface dataset:
Cardiovascular Outcome Study to Evaluate the Effect of Obicetrapib in Patients With Cardiovascular Disease

This study will be a placebo-controlled, double-blind, randomized, phase 3 study in participants with Atherosclerotic Cardiovascular Disease (ASCVD) who are not adequately controlled despite maximally tolerated lipid-lowering therapy.

This study will be a placebo-controlled, double-blind, randomized, phase 3 study to evaluate the effect of 10mg Obicetrapib in participants with Atherosclerotic Cardiovascular Disease (ASCVD) who are not adequately controlled despite maximally tolerated lipid-lowering therapy to reduce the risk of cardiovascular death, myocardial infarction, stroke and non-elective coronary revascularization. The PREVAIL Study

Eligibility Criteria:
Inclusion Criteria:

* Males \& females ≥ 18 years age.
* Established ASCVD including:
* Coronary artery disease
* Cerebrovascular disease
* Peripheral Artery disease
* On maximally tolerated lipid-modifying therapy
* Fasting LDL-C ≥ 55 mg/dL
* Fasting triglycerides \< 400 mg/dL
* Estimated glomerular filtration rate ≥ 30 mL/min

Exclusion Criteria:

* New York Heart Association class III or IV heart failure or left ventricular ejection fraction \< 30%
* Have been hospitalized for Heart Failure within 5 years prior to screening
* Had non-fatal MI, non-fatal stroke, non-elective coronary revascularization and/or hospitalization for unstable angina or chest pain within past 3 months prior to screening
* Uncontrolled hypertension
* Diagnosis of homozygous familial hypercholesterolemia (HoFH)
* Active liver disease
* HbA1c ≥10%
* Thyroid Stimulating Hormone (TSH) \> 1.5 times upper limit normal
* Creatine kinase \> 3 times upper limit normal
* History of malignancy with surgery in past 3 years
* History of alcohol or drug abuse within past 5 years
* Received treatment with investigational product or device within past 30 days excluding Coronavirus treatment or vaccine
* Known allergy to study drug
* Participated in previous obicetrapib trial
* Taking gemfibrozil within 30 days screening
Does Virtual Reality Improve Symptom Burden in Dialysis Patients?

The goal of this clinical trial is to investigate the use of virtual reality therapy in dialysis patients. The main question it aims to answer is: Does virtual reality improve symptom burden in dialysis patients and improve their mental wellbeing? Over a period of one month, one virtual reality therapy session of 30 minutes will be performed during each regular hemodialysis session. Since we will conduct a monocentric, crossover randomized controlled trial, the participants act as their own control group.

Hemodialysis is a lifesaving therapy for patients with end stage kidney disease but comes with a high burden of physical and emotional symptoms that lower quality of life in dialysis patients. Dialysis mediated complications such as drops in blood pressure, nausea and muscle cramps results in refusal and a negative perception of this treatment. In dialysis patients, treatment-related burden results in deterioration in health related quality of life. During the past few years, Virtual reality (VR) has become more affordable and found its way into households as entertainment electronics but stepwise also into medicine. VR enables the user to view, interact and be immersed in a multisensory 3D virtual world. The aim of the current study is to reduce dialysis-related burden of symptoms by using virtual reality therapy during regular dialysis sessions and thereby improve quality of life among dialysis patients.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years;
* in treatment with thrice-weekly hemodialysis sessions;
* regular hemodialysis duration of three to five hours
* having no visual impairment
* having no acoustic deficit
* patient must be capable of speaking and understanding German or English
* no signs of cognitive impairment
* patient oriented in time and space
* being able to give informed consent as documented by signature

Exclusion Criteria:

* diagnosis of epilepsy
* current pregnancy
Evaluation of Patients With Systemic Sclerosis Without Specific or Associated Autoantibodies

Systemic sclerosis (SSc) is a complex systemic autoimmune disease with variable phenotype and prognosis. Autoantibodies are important diagnostic biomarkers in SSc. More than 90% of patients with SSc had anti-nuclear antibodies. Autoantibodies specific to SSc (anti-topoisomerase I antibodies, anti-centromeres, anti-RNA polymerase III, anti-Th/To, anti-fibrillarin, anti-NOR90) or associated with overlap syndromes (anti-RNA polymerase III antibodies -PM/Scl, anti-KU, anti-U1RNP, anti-TRIM21) are detected in most patients. Excluding anti-TRIM21 antibodies, autoantibodies are usually mutually exclusive and are associated with distinct phenotypes.

Around 5 to 10% of patients with SSc have no autoantibodies detectable with routine biological tests. Recently, new autoantibody specificities have been described in SSc (anti-eIF2B, anti-RuvBL1/2, anti-BICD2, anti-U11/U12 RNP antibodies).

"Seronegative" patients could represent new specificities of autoantibodies (unknown or not currently routinely evaluated) associated with different phenotypes of the disease.

Primary objective is to compare the phenotype of patients with systemic sclerosis with or without detectable specific or associated autoantibodies.

Secondary objectives are:

* to determine homogeneous groups of patients with systemic sclerosis without detectable specific or associated autoantibodies
* to compare the phenotype of patients with systemic sclerosis without detectable specific or associated autoantibodies according to anti-nuclear antibodies status


Eligibility Criteria:
Inclusion Criteria:

* Patient with systemic sclerosis defined according to ACR/EULAR 2013 classification criteria
* Patient with a minimum follow-up of 3 years since the diagnosis of systemic sclerosis
* Patient evaluated for the following systemic sclerosis specific and/or associated autoantibodies: anti-topoisomerase I, anti-centromere, anti-RNA polymerase III (RP155 and RP11), anti-Th/To antibodies , anti-fibrillarin, anti-NOR90, anti-PM/Scl, anti-KU, anti-U1RNP and anti-SSA antibodies (independently of antinuclear antibodies status)

Exclusion Criteria:

* Patient with equivocal results for one or more systemic sclerosis specific and/or associated autoantibodies
* Patient initially negative but with a positive result for systemic sclerosis specific and/or associated autoantibodies during follow-up
H1N1sw Vaccine in Adult Transplant Recipients

The trial investigates the efficacy of the adjuvanted H1N1 influenza vaccine Focetria(R) in immunocompromised adults who have undergone solid organ or bone marrow transplantation. It is expected that when administered twice the vaccine fulfills all serological efficacy criteria required for the elderly population age 60 years and older.


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects 18-60 years of age who have undergone prior renal, cardiac, liver, lung, or bone marrow transplantation for any reason, more than 3 months prior to enrolment
* Patients able to visit the outpatient clinic with a life expectancy of at least one year
* Patients who receive any immunosuppressive treatment currently taken to prevent organ rejection

Exclusion Criteria:

* Individuals who received any vaccine within 30 days prior to study entry
* Individuals who received a H1N1 vaccination less than 6 months prior to the study
* Influenza diagnosed by a physician within 4 months prior to the study start
* Pregnant or lactating females
* History of an anaphylactic (i.e. life-threatening) reaction to any of the components of the vaccines, including egg and chicken proteins, ovalbumin, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB)
Efficacy Study of a Bioelectric Dressing to Treat Skin Graft Donor Site Wounds

The purpose of this study is to determine whether the use of a bioelectric wound dressing is effective in the healing of skin graft donor site wounds.


Eligibility Criteria:
Inclusion Criteria:

* Wounds resulting from skin graft
* Split thickness wound
* Wound size greater than 2x2 cm
* Wounds must be ≥5 cm away from all other wounds
* Participant agrees to participate in follow-up evaluation
* Participant must be able to read and understand informed consent, and sign the informed consent

Exclusion Criteria:

* Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study
* Participant is to receive another topical antimicrobial agent other than the study dressing
* Participant with sensitivity or adverse reactions to silver or zinc
* Pregnancy or nursing an infant or child
* Immunosuppression
* Active or systemic infection
* Peripheral vascular occlusive disease
* Collagen vascular disease
* Connective tissue disease
* Participant undergoing active cancer chemotherapy
* Chronic steroid use
* Decision impairment
Verification Protocol for the Cloud DX Vitaliti Continuous Vital Signs Monitor (VERDICT-2)

The VERDICT-2 verification study will examine the accuracy of the Cloud DX Vitaliti Continuous Vital Signs Monitor (Model: CVSM-1A) in an ambulatory context with healthy participants. The objective is to determine the accuracy of continuous non-invasive vital signs metrics including respiration, pulse rate, oxyhemoglobin saturation (SpO2), core temperature, heart rate, and cNIBP against standard comparator devices guided by consensus standards.

Effective postoperative care is faced with several challenges- patients experience major complications following surgery, which often require re-hospitalization or utilization of healthcare services (i.e., emergency room visits) once discharged into the community. New remote automated monitoring (RAM) technologies that enable data integration, synthesis, and real-time alerts to clinicians have the potential to transform postoperative care, similar to how intraoperative care has evolved.

The Cloud DX Vitaliti Continuous Vital Signs Monitor (Model: CVSM-1A) is a continuous vital sign monitor intended to measure vital metrics including systolic and diastolic blood pressures (via ECG/ photoplethysmography \[PPG\]), pulse (via PPG), respiration rate (via impedance respiration waveform), core body temperature (via infrared sensor), and blood oxygen saturation levels (via PPG) of an adult individual using non-invasive techniques.

The VERDICT-2 verification study will examine the accuracy of the Vitaliti CVSM in an ambulatory context with healthy participants.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Healthy participant (no known significant health problems)
3. Provide informed consent to participate

Exclusion Criteria:

1. Active smoker
2. Recent exposure to carbon monoxide
3. Have unexplained shortness of breath at rest
4. Pregnant
5. Hearing aid/Cochlear Implant
6. Current arrhythmia
7. ICD/Pacemaker
8. Current respiratory disease/infection
9. Significant body tremors/shaking
10. Epilepsy
11. History of unexplained fainting/syncope
12. Have any disorder that prohibits placement of the device (i.e., skin rash/abrasion, open or infected sore)
13. Cerebrospinal Fluid Shunt
14. Unable to ambulate, stand, or lay in supine position
15. Allergy to adhesive
16. Unable to understand or speak English
Phase II Neoadjuvant ER+/PgR + Arimidex +/- Iressa Study

The purpose of this study is to compare the changes in a proliferation biomarker in subjects receiving Anastrozole or Anastrozole/ZD1839 combination.


Eligibility Criteria:
Inclusion Criteria:

* Measurable (stage I-IIIB) non meta static non inflammatory breast cancer
* Patients must post menopausal women who in the opinion of investigator would be likely to benefit from endocrine therapy. Postmenopausal patients are defined as:
* Natural menopause with last menses \> 1 year ago,
* Radiation induced oophorectomy with last menses \> 1 year ago,
* Serum FSH and LH levels clearly in the postmenopausal range for the institution.
* Bilateral oophorectomy

Exclusion Criteria:

* Other current or previous (to last 5 years) malignancies, other metastases, abnormal blood chemistry, lung/ heart/kidney/liver abnormalities,
* Hormonal treatment within the last 2 weeks, previous hormonal treatment for invasive cancer
18F-mFBG PET Imaging in the Evaluation of Pheochromocytoma

The aim of this study is to evaluate the diagnostic performance and tumor burden of 18F-metafluorobenzylguanidine (18F-MFBG) positron emission tomography (PET) in patients with pheochromocytoma.

Pheochromocytoma highly expresses norepinephrine transporter (NET) which is targeted by function alanalogue of norepinephrine, 123/131I-MlBG. However, low spatial resolution of 123/131I-MlBG and inaccurate attenuation correction of single photon emission tomography (SPECT/CT) will affect the image quality of MlBG SPECT and lead to poor diagnosis of small lesions. In addition, 123l-MlBG imaging is usually performed at 24h after injection, while 131I-MlBG is performed at 48h or even 72h after injection. The procedure is complicated and takes a long time, which limits clinical application. 18F-labeled MFBG is an ideal tracer to show the expression of NET. Preliminary data show that 18F-MFBG imaging is safe and has favorable biodistribution and kinetics with good targeting of lesions. Patients can undergo PET 0.5 hours after injection without special preparation. Our study will assess the safety profile, image quality and evaluate the diagnostic performance and tumor burden of 18F-MFBG. Patients with suspected or histologically confirmed pheochromocytoma will be enrolled in this study.

Eligibility Criteria:
Inclusion Criteria:

* 1) Aged 30-80 years old, primary school or above, with a regular caregiver; 2) Clinically diagnosed patients with pheochromocytoma; 3) Can provide informed consent, can understand and comply with the study requirements.

Exclusion Criteria:

* 1) Patients with serious primary diseases such as heart, brain, liver, kidney and hematopoietic system; 2) Uncontrolled hypertension or high-risk BP (i.e., systolic BP \> 180 mmHg or diastolic BP \> 110 mmHg); 3) Patients with mental disorders or primary affective disorders; 4) Unable to understand and adhere to the study protocol or provide informed consent; 5) Contraindications to PET imaging (including pregnant women, lactating women, and women of childbearing age with recent childbearing plans, etc.); 6) Allergy to imaging agents; 7) Patients who were unable to cooperate with PET scanning, such as hypoglycemia, severe pain or tremor.
Serial Changes in sTREM-1 During Ventilator-associated Pneumonia (VAP)

Triggering receptor expressed on myeloid cells (TREM)-1 is a recently described molecule that plays an important role in myeloid cell-activated inflammatory responses. The aim of this study was to investigate the evolutional change of soluble TREM-1 (sTREM-1) in bronchoalveolar lavage (BAL) fluid of clinically diagnosed ventilator-associated pneumonia (VAP) and its correlation with response to treatment and outcome.

A prospective, interventional study conducted between August 2006 and August 2007 in MICU in Mackay Memorial Hospital, 35 patients with clinically diagnosed VAP were investigated. sTREM-1 was measured in BAL samples using ELISA at the onset, 4th - 5th and 7th - 9th day of clinical diagnosis of VAP.Of these 35 patients, 27 had positive BAL culture. The sTREM-1 levels in BAL fluid were measured and compared between patients with positive BAL culture and negative BAL culture. Serial changes in sTREM-1 levels were evaluated in relation to patient outcome.

Eligibility Criteria:
Inclusion Criteria:

* adult patients (older than 18 years)with clinically suspected VAP

Exclusion Criteria:

* mechanically ventilated patients post cardiopulmonary resuscitation
* patients with end stage diseases with life expectancy less than 3 months
* patients with solid or hematology transplantation
* patients on immunosuppressive agents
Co Morbid Attention Deficit and Hyperactivity Disorder(ADHD) and Developmental Co Ordination Disorder (DCD)

This study aims to establish and present the prevalence figures and demographics of the co-morbidity of ADHD and DCD.

It further aims to design an exercise intervention, to be utilised in the management of the symptoms of both conditions.

Furthermore, it aims at establishing the efficacy of this exercise intervention, when compared with the current and most commonly used intervention, that is: neurostimulant drugs.

This study is an experimental design, having three phases. The study looks at children, aged 8 to 9, in remedial units or LSEN classes, in and around Durban, Kzn, SA; who have been diagnosed with ADHD/ADD.

Phase 1: Teachers of the children identified with ADHD/ADD, will be asked to complete a modified teacher Conner's rating, to confirm the diagnosis of ADHD/ADD. The parent will then be asked to complete a DCD questionnaire (DCDQ) to give the PI an idea of whether co-ordination difficulties exist. The PI will then administer a Motor Assessment Battery for Children (MABC) to confirm the diagnosis of DCD. From the scores derived from the 3 above tests, co-morbidity will be diagnosed. The prevalence figures of co-morbidity will be calculated and presented. Demographics of prevalence figures will be given: Gender, Population group, average age.

Phase 2: The exercise intervention will be designed, drawing from the literature and similar interventions already used in various publications.

This programme will be validated by experts (Physiotherapists and O.Ts from special needs schools) and when 70% consensus is reached on all aspects of the programme, the final version will be drafted.

Phase 3: The children found to have both conditions, in co-morbidity, will be assigned to one of 4 groups, according to parental choice, medical advice from paediatricians, GPs etc and an intervention a child is already on.

The four groups will be: medication, exercises, medication plus exercises and a control group. The intervention designed in phase 2 will be administered to the two groups opting for the exercise intervention, for a minimum of 8 sessions. The 3 pre intervention scores (Conner's, DCDQ and MABC) will be derived from phase 1, post intervention scores will be done 6 months after completion of the intervention, as it is stipulated by the rules of the MABC that the test may not be repeated sooner. The pre and post intervention scores will be compared to calculate improvement and average improvement within each group, will be calculated, to establish which intervention or combination of interventions, is the most effective.

Eligibility Criteria:
Inclusion Criteria:

* Age 8 to 9, diagnosed with ADHD, in remedial unit or LSEN class, in mainstream school in Durban Kzn SA.

Exclusion Criteria:

* Any child having an obvious physical disability, neurological condition, musculoskeletal condition, psychiatric disorder or genetic disorder.

Any child below age 8 and above age 9.
Aspirin Twice Daily in Diabetic Patients With Coronary Artery Disease

The aim of the study is to evaluate platelet function variations according to the delay since last aspirin intake (12 vs 24 hours)in a population of diabetic patients with previous Coronary Artery Disease.

We have previously demonstrated that there was a time-dependant efficacy of aspirin on platelet function. In this study, we investigate platelet function (fundamental research) according to the delay since last aspirin intake (12 vs 24 hours)in a population of diabetic patients with previous Coronary Artery Disease routinely treated with aspirin. In order to eliminate any variation linked to a cumulative dose effect of aspirn, platelet function is assessed 24 hours after a single 150 mg aspirin intake or 12 hours after a 75 mg aspirin intake given twice per day (corresponding to the same total dose of 150 mg /day). Light transmission aggregometry triggered by arachidonic acid 0.5mg/mL (LTA-AA) is the main endpoint of the study (intensity and velocity of agregation following exposure to arachidonic acid 0.5 mg/ml).

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes mellitus
* documented coronary artery disease
* treatment with aspirin for at least 7 days before randomization
* one of the following additional criteria defined from our previous study9: current smoking, hs-CRP \> 4mg/L, fibrinogen \> 4g/L and/or platelet count \> 270 103/mm3

Exclusion Criteria:

* oral anticoagulants, heparin, thrombolytic agents, non-steroidal anti-inflammatory drugs, prasugrel
* family or personal history of bleeding or thrombophilic disorders
* platelet count \> 600x103/mm3 or \< 150x103/mm3
* hematocrit \> 50% or \< 25%
* creatinine clearance \< 30mL/min
* low compliance before enrollment
* cancer considered not in remission or those having undergone major surgery within the month prior to enrollment.
Impact of NANO-PSO on Cognition in Older Adults with Mild to Moderate Cognitive Impairment

The objective of this randomized, triple-blind, placebo-controlled clinical trial is to compare NANO-PSO therapy against placebo in improving cognitive abilities in older adults with mild to moderate non-vascular cognitive impairment over six months of treatment. The primary questions it aims to answer are:

• Does NANO-PSO therapy improve cognitive abilities in older adults with mild to moderate non-vascular cognitive impairment over six months of treatment compared to placebo?

The researchers will compare NANO-PSO therapy against placebo to see if it benefits the cognitive abilities of geriatric patients.

Participants will be required to:

* Consume two capsules of NANO-PSO or placebo daily in the morning for six months.
* Be evaluated monthly by phone to identify potential risks and ensure adherence to the treatment.
* Be evaluated in person at 90 and 180 days of treatment.
* The patient or primary caregiver must maintain a log to confirm daily dose consumption and will have a direct communication line with the attending physicians in case of questions about ingestion or possible adverse reactions.
* At the end of the final patient evaluation, a quality questionnaire will be administered.


Eligibility Criteria:
Inclusion Criteria:

* Patients attended at the Hospital Español.
* Patients of any gender who are 60 years or older.
* Patients presenting with mild to moderate cognitive impairment.
* Meet the diagnostic criteria for \&#34;probable dementia\&#34; of the National Institute on Aging and the Alzheimer's Association (NIA-AA) (2011).
* Meet the criteria for the typical variant of Alzheimer's disease, specifically a specific clinical phenotype.
* Progressive and gradual change in memory functions reported by the patient or the informant for at least 6 months.
* Objective evidence of a hippocampal-type amnesic syndrome, based on significant impairment in the performance of episodic memory tests with established specificity for AD.
* Subjects are primary and secondary school graduates and have the ability to complete cognitive capacity tests and other specified tests in the program.
* Total score on the Hachinski Ischemic Scale (HIS) ≤ 4.
* Patients who sign the informed consent.

Exclusion Criteria:

* Patients with known allergy to any component of the NANO-PSO capsule (e.g., fish).
* Patients with short bowel syndrome, bariatric surgery, or gluten reaction that may affect intestinal absorption.
* Patients in palliative care with a life expectancy of less than 6 months according to the NECPAL scale.
* Patients with terminality criteria established in the comprehensive palliative care management guide of Mexico.