cyrilzakka/clinical-trials huggingface dataset:
How Does Antiretroviral Therapy Affect Coronary Atherosclerosis: a Serial CT Study

Combined antiretroviral therapy (cART) is thought to promote coronary artery disease via a number of mechanisms: abnormal lipid profiles, endothelial dysfunction, hypertension, insulin resistance and renal impairment are the main pathological mechanisms driving atherosclerosis as a consequence of cART. An association between protease inhibitors and increased cardiovascular disease risk has been shown in many large cohort trials.

CT Coronary Angiography (CTCA) is now widely used to assess for the presence of atherosclerosis, typically in patients presenting with chest pain. This imaging technique allows visualisation of the coronary arteries and quantification of any atherosclerotic disease that may be present. This technique is being increasingly used as a surrogate for cardiovascular disease risk.

HART CT is an open label, prospective, randomised-control pilot study to investigate the feasibility of performing a future appropriately powered multi-centred randomised control trial using CT based outcome data as a surrogate for cardiovascular disease risk.

Participants will be randomised to either continue their usual cART or switch to Biktarvy (a fixed dose combination of bictegravir, emtricitabine and tenofovir alafenamide). A baseline CT scan will be performed. If there is any evidence of atherosclerosis a further CT scan will be performed at the end of the study (approximately 48 weeks). This will allow quantification of any change in coronary artery plaque burden or characteristic. Participants will be also followed up for any changes in metabolic health.


Eligibility Criteria:
* HIV positive
* Undetectable viral load on cART which contain protease inhibitors (duration \>6 months at eligibility visit)
* Age\>40 years
* Stable cART
* No previous documented cardiovascular disease
* No contraindication to study drug
* Ability to give informed consent
* Willingness to comply with all study requirements
* No symptoms of overt cardiovascular disease

A definition of stable cART is no change to the medication regime in the preceding 6 months.

Well controlled hypertension is considered acceptable for recruitment.

Exclusion Criteria:

* Active liver disease (previously diagnosed)
* Renal disease eGFR \<30
* Any ongoing infection
* Significant ionising radiation in preceding 12 months
* Known or suspected cardiovascular disease
* High dose statin therapy (Atorvastatin 20mg or more, Rosuvastatin 20mg or more)
* Pregnancy or planned pregnancy
* Breast feeding
* Allergy to iodine based contrast agent
* Known drug resistance to NRTI or Integrase
* Any contraindication to BIC/FTC/TAF
* Current enrolment onto another CTIMP.

Significant ionising radiation should not exceed \>25mSv from medical sources. A definition of cardiovascular disease includes documented angina, previous myocardial infarction or previous coronary revascularization.
Study to Investigate Safety and Tolerability Single Ascending Doses of AZD4017

The primary aim of this study is to investigate the safety and tolerabilty of AZD4017 when given as single oral ascending doses to healthy volunters. This will be done by comparing the effect of AZD4017 to placebo. The study will aslo investigate the absorption, distrubution and disappearance of AZD4017 in the body. Information about plasma concentrations of AZD4017 vs time after dose intake will also be collected. The future indication for AZD4017 is planned to be Type 2 Diabetes Mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed written and dated informed consent
* BMI between 19 and 30 kg/m2
* Subjects must be willing to use barrier methods of contraception

Exclusion Criteria:

* History of any clinical significant disease
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product
* History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
* Laboratory blood sample result showing elevated liverenzymes (ASAT, ALAT) and muscle enzymes (CK).
Mindfulness Based Stress Reduction: Supportive Treatment for Adult Patients With Cancer and Their Partners

The main purpose of this study is to evaluate the effects of the Mindfulness Based Stress Reduction (MBSR) training program that is offered in the investigator hospital, more specifically on quality of life, coping strategies and partner relationship by using questionnaires. To asses the possible impact of this treatment on the latter domain, partners of the patients with a cancer diagnosis are invited to join the training program.

Patients with breast cancer often experience anxiety, depression, stress and reduced quality of life. As such, there is an increased interest in the implementation of the Mindfulness-Based Stress Reduction program as an additional supportive treatment. MBSR is a structured group program that aims at reducing stress levels by enhancing awareness of the present moment in combination with a non-judgemental attitude.

The study evaluates the effects of an 8-week MBSR program on quality of life, mood, depression, stress and coping skills in breast cancer patients.

Breast cancer patients of the Breast Clinic of the Universitair Ziekenhuis Brussel participate in the MBSR program. Before and after the training program patients filled out questionnaires evaluating quality of life, coping skills, emotional functioning, stress and aspects of mindfulness.

Eligibility Criteria:
Inclusion Criteria:

For patients:

* Cancer diagnosis
* Between the age of 18 until 70
* Dutch speaking

For partners:

* between the age of 18 until 70
* dutch speaking

Exclusion Criteria:

for patients and partners:

* Ongoing radiation therapy
* Psychiatric disorders
* Previous experience with mindfulness or meditation related techniques
* Pregnancy
* No or insufficient understanding of the Dutch language
A Pilot Study on the Feasibility Study of a Novel Virtual Reality (VR)-Based Post-stroke Hemineglect Evaluation System

The normal value of the new virtual reality (VR)-based hemineglect evaluation system is obtained and its validity is checked by whether there is a difference in the evaluation results between normal people, stroke patients with hemineglect, and stroke patients without hemineglect. And, the usability of the virtual reality-based hemineglect evaluation system is confirmed.

This pilot study included 50 stroke patients with right hemisphere lesion and 25 healthy people.

The normal value for each item is determined based on the result value for each item of the virtual reality (VR)-based hemineglect evaluation system in normal people.

It is checked whether there is a difference in the results measured using the VR-based hemineglect evaluation system in normal persons, stroke patients with hemineglect, and stroke patients without hemineglect.

Structural validity is confirmed by examining the correlation between the measured values of the virtual VR-based hemineglect evaluation system and Korean Version of Modified Barthel Index (K-MBI), Mini Mental State Examination (MMSE), and Behavioral Inattention Test-Conventional (BIT-C) in stroke patients with hemineglect.

Check the required time and test stability of the evaluation using the VR-based hemineglect evaluation system.

Eligibility Criteria:
Inclusion Criteria:

(Stroke patients)

* Right handed
* Patients with first onset stroke, with right brain lesions confirmed by imaging tests (MRI, CT)
* Onset of stroke more than 1week (Normal people)
* Right handed
* Who has no problem in identifying objects with wearing VR head gear.

Exclusion Criteria:

(Stroke patients)

* Patients with unilateral neglect due to other causes.
* Patients with neurological diseases other than stroke (Parkinson's disease, Alzheimer's disease, etc.)
* Patients with severe cognitive impairment.
* Patients with underlying diseases or medical history that may cause visual impairment.

(Normal people)

* Who has a neurological disease such as stroke, traumatic brain injury, Parkinson's disease, or Alzheimer's disease.
* Who has a severe cognitive impairment.
* Who has a underlying diseases or medical history that may cause visual impairment.
Rocuronium vs Cis-atracurium: Do Rocuronium Still 'ROCKS' In Coronary Artery Bypass Grafting

The current trend in most cardiac surgeries was to use rocuronium as it provides faster recovery in train-of-four ratio compared to other aminosteroid non-depolarising neuromuscular blocker. However, as most cardiac centres' standard of care does not perform any neuromuscular monitoring nor antagonism of neuromuscular blockade effect, residual neuromuscular blockade could potentially be the key to delayed extubation. As such, Cis-atracurium's organ-independent Hofmann elimination could be in favour.


Eligibility Criteria:
Inclusion Criteria:

* All patients that undergo general anaesthesia for CABG surgery requiring neuromuscular blockade of either rocuronium or cis-atracurium

Exclusion Criteria:

1. Recent history of pulmonary infection four weeks before surgery
2. Exposed to both neuromuscular blockade within 24 hours perioperatively
3. Patients intubated or on tracheostomies pre-operatively
4. Any missing or incomplete data
Correction of Exercise-induced Desaturation by Acute Oxygen Supply and Exercise Responses in COPD

In the literature, the effects of acute oxygen administration on exercise tolerance and related symptoms have often appeared to be contradictory. Some investigations have reported benefits from acute oxygen supply during exertion, including increased exercise performance, reduced dyspnea, and better cardiorespiratory adaptations, whereas other studies have reported no improvement. Recently, we advanced then the hypothesis that some patients would be non-responders and even worsen under oxygen treatment. The preliminary results confirmed our hypothesis since we demonstrated that while 56% of the patients were improved with supplemental oxygen, 16% were non-responders and 28% were negative-responders (decreased performance and increased dyspnea during endurance exercise with supplemental oxygen). However, this was a pilot study offering preliminary insights and tentative conclusions that must be confirmed in a larger case series.

The aims of this retrospective study was :

1. To confirm on cohorte and with clinical test (the 6-minute walking test - 6WT) the deleterious responses to acute oxygen supplementation in LTOT (long terme oxygenotherapy treatment) and non-LTOT patients who exhibit exercise desaturation.
2. To identify the predictive factors among the clinical data (i.e., anthropometric, spirometric and gazometric data) and/or functional data recorded during rehabilitation program

During this study, a retrospective data collection will be carried out using the informations contained in the medical folders of patients admitted in our centers for pulmonary rehabiliation program.

We will select patients who meet the following criteria:

A) patients having two 6WT early in their program B) who desaturate (SpO2 \<90% for 3 consecutive min) during the first 6WT and who will have been properly corrected with a supply of oxygen during the second walk test.

The analyzed parameters will be distance and dyspnea during the tests

Eligibility Criteria:
Inclusion Criteria:

* Obstructive airflow limitation defined by FEV1/CVF \< 70% and FEV1 \< 80 %
* Patients with or without long terme oxygenotherapy
* Patients exhibited during the first test, an exercise-induced desaturation, defined by SaO2 \< 90% for 3 consecutive minutes during the 6-minute walking test in the air condition for non-LTOT or with the flow normally recommended during exercise for LTOT patients (i.e., flow rate of rest + 1L/min)
* Patients with no desaturation during the test with oxygen supply

Exclusion Criteria:
MORPHEE : Mechanisms of Cell Death Induced by Extracorporeal Photochemotherapy

The objective of this study is to describe the type of cell death induced by extracorporeal photochemotherapy, depending on the cell type, using a panel of complementary analysis techniques.

Extracorporeal photochemotherapy (ECP) is a cell therapy used for its immunomodulation and tolerance induction capabilities. Its main indications are the control of graft-versus-host (GVH) disease in hematopoietic cell allografts, treatment and control of rejection in solid organ transplantation and the treatment of cutaneous T-cell lymphoma. Data on the mechanisms of action of ECP remains very patchy. This lack of data limits the discussion on therapeutic regimens by disease.

ECP consists of repeated apheresis sessions to collect leukocytes from the patient. The cells are then photosensitized, irradiated with UVA and reinjected into the patient in a closed circuit. In the context of GVH, induced cell death would stimulate the expansion of regulatory cells (Treg), restore a Th1/Th2 balance and decrease Th17 polarization. The ECP also allows the expansion of Treg in solid organ transplantation. Conversely, ECP would restore or activate an antitumor immune response in cutaneous T lymphoma.

The type of cells collected and treated would play a major role in the effects obtained. However, these hypotheses must be consolidated, in particular by detailing the initial role of cell death. Several questions remain, on the chronology of cell death in the different treated subpopulations, on the uptake by phagocytes, but especially on the type of cell death induced according to the cell type (necroptosis, apoptosis, pyroptosis, autophagy). The data generated will allow for validation or detail of the mechanisms of resolution of the inflammation and/or the anti-tumour effect observed.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Treated with ECP for at least 1 month, for control of GVHD in hematopoietic cell allograft (acute or chronic GVHD), treatment and control of cellular or humoral rejection in solid organ transplantation (heart, lung, kidney) or in the treatment of cutaneous T-cell lymphoma

Exclusion Criteria:

* Subjects with limited legal capacity.
* Subjects judged by the investigator to be unlikely to comply with study procedures
* Subjects with no social security coverage.
* Pregnant women.
* Subjects still in the exclusion period of another study, or according to the national registry of clinical trial participants.
Oxygen Partial Pressure After Breast Cancer Surgery

Hypoxia and reduced oxygen partial pressure is commonly occurring after abdominal surgery. This study aims to investigate whether similar changes also occur after breast cancer surgery.

Inclusion: 60 women undergoing breast cancer surgery. Exclusion: Dementia or cognitive impairment that makes it impossible to participate in the study.

Arterial blood gas and lung function are undertaken before surgery and the day after surgery

Postoperative hypoxia complicates 30% - 50% of abdominal surgeries. People at particular risk for postoperative pulmonary complications including severe hypoxia are those who undergo abdominal surgery, emergency surgery or have a respiratory failure due to chronic lung disease. The cause of postoperative hypoxia and reduced lung function is unknown. Previous studies report that arterial partial pressure (PaO2) decreased by an average of 2 kilopascal after abdominal surgery, while carbon dioxide partial pressure (PaCO2) was unchanged and vital capacity decreased by 35%. The effect of breast cancer surgery on oxygen and carbon dioxide partial pressure and lung function has to the best of the investigators knowledge not been investigated. This study aims to investigate possible changes in oxygen partial pressure, carbon-dioxide partial pressure and vital capacity after breast cancer surgery.

Design: Prospective cohort study participate in studies. Method: Blood gas measurements and Lung function (Vital capacity and FEV1) The day before surgery, the day after surgery and at follow-up.

Power analysis: There is a need to investigate 27 patients if the mean (SD) difference is 0.5 (1) kilopascal. Due to drop-outs the investigators calculate a need to include up to 60 patients.

Eligibility Criteria:
Inclusion Criteria:

• Women scheduled for surgery because of breast cancer.

Exclusion Criteria:

• Dementia or cognitive impairment that makes it impossible to participate in the study.
Observational Study of the Prognosis in Treated Arterial Hypertension

Observational study of life time prognosis for persons medically treated for arterial hypertension, according to current WHO-guidelines.


Eligibility Criteria:
Inclusion Criteria:

hypertension according to WHO-defined criteria

Exclusion Criteria:

age \< 18 years

pregnancy
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CCX168 in Healthy Participants

The primary objective of this study will be to evaluate the safety and tolerability of single and multiple oral doses of CCX168, over a range of dose levels, in healthy male and female participants.


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants, aged 19-45 years inclusive, who are in generally good health, whose body mass index is 19 to 29 kg/m\^2;
* Willing and able to give written Informed Consent and to comply with the requirements of the study protocol;
* Negative result of the human immunodeficiency virus screen, the hepatitis B screen, and the hepatitis C screen;
* Judged to be healthy by the Investigator, based on medical history, physical examination (including ECG), and clinical laboratory assessments. Participants with clinical laboratory values that are outside of normal limits and/or with other abnormal clinical findings that are judged by the Investigator not to be of clinical significance may be entered into the study, and
* Female participants of childbearing potential, and male participants with partners of childbearing potential, may participate if adequate contraception is used during, and for at least the four weeks after, any administration of study medication.

Exclusion Criteria:

* Women who are pregnant, breastfeeding, or have a positive serum pregnancy test at Screening and/or on Study Day -1;
* Expected requirement for use of any medication (with the exception of continuing use by female participants of hormonal contraceptives in accordance with a regimen that has been stable for at least the three months prior to Screening) during the study period;
* History within the three months prior to study entry of use of tobacco and/or nicotine containing products;
* History within one year prior to study entry of illicit drug use;
* History of alcohol abuse at any time in the past;
* History of any form of cancer;
* Consumed alcoholic beverages, or any food or drink containing grapefruit or grapefruit juice within 24 hours of screening;
* History or presence of any medical condition or disease which, in the opinion of the Investigator, may place the participant at unacceptable risk for study participation;
* Donated or lost more than 350 mL of blood or blood products within 56 days prior to Screening, or donated plasma within 7 days of randomization;
* Participant's hemoglobin less than 12 g/dL (or less than 7.45 mmol/L);
* Participated in any clinical study of an investigational product within 30 days prior to randomization;
* Participant has any evidence of hepatic disease; aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transpeptidase, alkaline phosphatase, or bilirubin \> 1.5 x the upper limit of normal;
* Participant has any evidence of renal impairment; serum creatinine \> 1.5 x upper limit of normal, and
* Participant's urine tested positive at Screening and/or on Study Day -1 for any of the following: opioids, amphetamines, cannabinoids, benzodiazepines, barbiturates, cocaine, cotinine, or alcohol (Breathalyzer test allowed for alcohol).
Is the BAT Inhibition Able to Replace Sting Challenges? (BATIRS)

Insect venom allergy is the major cause for severe allergic reactions in Europe. Wasps and honeybees are responsible for the majority of these allergic reactions. Symptoms range from generalized skin symptoms (wheals, swellings) to respiratory or cardiovascular problems such as asthma, dizziness, loss of consciousness, or cardiac arrest. The regular administration of insect venom ('venom immunotherapy') over up to 5 years is a well-established therapy, providing long-term protection from further systemic sting reactions in the majority of patients. However, there is no laboratory test which is able to identify patients who will still react to an insect sting. The only reliable method available is stinging patients with living insects ('sting challenges'). The key issue is that only few centers in Europe perform sting challenges and many patients have no access to these tests. Therefore, it is of utmost importance to find a method which is able to identify patients who are still at risk for future allergic sting reactions.

The inhibition of the basophil activation test (BAT) could be a potential method to monitor the effectiveness of immunotherapy. Basophils are cells which are activated in acute allergic reactions. The basophil activation of blood donors with vespid venom allergy can be measured after adding sera from allergic patients undergoing immunotherapy. In a preliminary study we found that the activation of basophils could be inhibited in all patients treated with vespid venom, however, results must be confirmed in a larger study.

In this study, a total of 219 patients with vespid venom allergy will be included. Those patients who are receiving or who have already finished venom immunotherapy will be sting challenged and blood samples will be taken to perform BAT inhibition experiments. At the same time, donors with confirmed vespid venom allergy, who have not undergone immunotherapy, will be recruited for a blood donation, which is necessary for the BAT inhibition tests.

If results of the preliminary study could be confirmed, the BAT inhibition will facilitate monitoring the effectiveness of venom immunotherapy and patients would benefit from an early detection of lacking tolerance and consequently from the increased venom dose preventing future life threatening systemic sting reactions.


Eligibility Criteria:
Inclusion Criteria:

* Legally competent male and female subjects who are currently treated or who have been treated with vespid venom immunotherapy
* Age ≥18 and ≤70 years
* Written consent of the participant after being informed

Exclusion Criteria:

* Pregnancy
* Autoimmune disease
* Uncontrolled cardiovascular disease
* Uncontrolled asthma