cyrilzakka/clinical-trials huggingface dataset:
Is There a Difference in Flicker Induced Vasodilatation Between Smokers and Non-Smokers?

Habitual smoking is associated with an increased risk of coronary artery disease, cerebral and peripheral vascular disease, including ocular diseases like age-related macular degeneration or diabetic retinopathy. Data of a recent study performed in the investigators lab revealed abnormal choroidal blood flow regulation in chronic smokers as compared to age-matched non-smoking subjects during isometric exercise. However, no information is yet available about the regulation of retinal vascular tone in habitual smokers.

Thus, in the current study, the investigators set out to investigate whether the regulation of retinal vessels diameters is affected in habitual smokers. It has been shown in several reports that stimulation with diffuse luminance flicker, increases retinal arterial and venous diameters, indicating for the ability of the retina to adapt to changing metabolic demands. In the current study we use this effect as a tool to investigate whether the flicker induced vasodilatation is affected in habitual smokers. This would indicate for an impaired vascular regulation process in smokers.


Eligibility Criteria:
Inclusion Criteria:

* 24 subjects aged between 18 and 35 years, nonsmokers (since at least 2 years)
* 24 subjects aged between 18 and 35 years, smokers (at least 10 cigarettes/day since 2 years)
* Body mass index between 15th and 85th percentile
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, ametropy \< 3 dpt.

Exclusion Criteria:

* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of study drugs
* Blood donation during the previous 3 weeks
* Ametropy \>= 3 dpt
Sulphate Accumulation in Prostate

This study evaluates whether a broccoli intervention (≥ 4 weeks) will result in differences in tissue sulphate levels in men scheduled for prostate biopsies. Comparisons will be made between participants randomised to the broccoli-rich diet and those randomised to the non-intervention arm.

Epidemiological studies provide evidence for a negative correlation between prostate cancer and intake of cruciferous vegetables such as broccoli. Preliminary data from ongoing intervention trials carried out at the IFR suggest that dietary changes can directly influence the metabolic profile of prostate tissue. The most significant result observed to date is that of sulphate accumulation within the prostate. The additional sulphate is likely to drive synthesis of 3'-phosphoadenosine-5'-phosphosulfate, a universal sulphate donor, a process which would consume energy from ATP. A significant rise in levels of both ADP and phosphate has also been observed in prostate tissue from these studies, supporting the potential depletion of cellular ATP. Interestingly, the data indicate that the extent of ADP accumulation is negatively correlated with prostate cancer progression.

The investigators now propose to undertake a two arm parallel un-blinded study to test the hypothesis that a short-term intervention with broccoli soups will lead to the accumulation of sulphate and ADP in prostate tissue. A potential increase in glutathione metabolites indicating a change in redox status, and therefore functional status, of specific genes involved in tumour suppression (PTEN) will also be investigated.

Furthermore, the investigators aim to determine whether the accumulation of sulphate and ADP is specific to the prostate gland through the metabolic analyses of both prostate and non-prostate tissues.

Eligibility Criteria:
Inclusion Criteria:

* Males
* Scheduled for TPB as part of routine investigation or staging for prostate cancer
* Aged 18-80 years
* BMI between 19.5 and 35 kg/m2
* Smokers and non-smokers

Exclusion Criteria:

* Those regularly taking 5α-reductase inhibitors or testosterone replacement medicines
* Those on warfarin treatment
* Those diagnosed with diabetes
* Those diagnosed with or suspected to be high-risk for human immunodeficiency virus (HIV) and/or hepatitis
* Those allergic to any of the ingredients of the broccoli soups
* Those taking dietary supplements or herbal remedies which may affect the study outcome. Please note that some supplements may not affect the study and this will be assessed on an individual basis
* Those that are unable to understand English or give informed consent
* Parallel participation in another research project that involves dietary intervention
* Any person related to or living with any member of the study team
The Effect of Music on Delirium, Pain, Need of Sedation, Anxiety and Vital Parameters

The purpose of this study is to test the effect of a twice daily, 60-minute, nurse initiated, music listening intervention on patients followed in the ICU with MV support as compared to patients who receive care as usual and ear plugs.

Delirium is an acute disorder of consciousness and cognitive function that occurs frequently in critical care settings. Many critically ill patients (e.g., up to 80% of patients) experience ICU delirium due to underlying medical or surgical health problems, recent surgical or other invasive procedures, medications, or various noxious stimuli (e.g., underlying psychological stressors, mechanical ventilation \[MV\], noise, light, patient care interactions, and drug-induced sleep disruption or deprivation). Delirium contributes to adverse outcomes such as increased mortality and morbidity, longer length of ICU stays, prolonged MV, costlier hospitalizations, and cognitive impairment after hospital discharge. The Society of Critical Care Medicine (SCMM) Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU (PADIS) recommend non-pharmacological interventions of preventing delirium and other symptoms. Music, which is one of the non-pharmacological applications, is one of the cognitive-behavioral treatment methods applied in the field of ICU as in many other fields. Music is easy method to apply and has no side effects and contributes to physical, psychological, emotional and spiritual healing. In the literature, it is seen that music intervention studies applied to patients followed in the ICU mostly focus on the effects on anxiety, pain, non-invasive ventilation tolerance, and stress response (heart rate, blood pressure, respiratory rate). The relationship between intensive care delirium and all these symptoms (pain, agitation, anxiety, stress response, etc.) and their interaction with each other have been clarified in the light of evidence-based guidelines and studies. Therefore, the aim of this study is to examine the effects of music applied to patients followed in the ICU with MV support on delirium, pain, need for sedation, anxiety and vital parameters.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years,
* Admitted to the ICU as of the start of the study and planned to be followed up in the ICU for at least 24 hours,
* Needing invasive MV for at least 24 hours,
* Pre-deliric score \> 20%
* At least one positive delirium according to CAM-ICU,
* GCS score \> 8,
* RASS score ≥ -3,
* Hemodynamically stable,
* CPOT score ≥ 3

Exclusion Criteria:

* Hearing or vision problems,
* Diagnosed with psychiatric illness,
* Diagnosed with dementia,
* Having acute neurological injury,
* Alcohol/drug poisoning
* Hemodynamically unstable and treated with high-dose inotropic/vasopressor medication,
* Pregnant,
* Planned to be followed in ICU for less than 24 hours,
* Does not need MV,
* GCS score ≤ 8,
* RASS score \< -3,
* Patients referred from another ICU
Collection of Gingival Crevicular Fluid From Periodontitis Patients

To collect GCF (gingival crevicular fluid) samples from diseased patients suffering only from gingivitis and/or periodontitis.


Eligibility Criteria:
Inclusion Criteria:

* Be aged 18 to 65 years inclusive
* Have a minimum of 20 natural uncrowned teeth (excluding 3rd molars) present
* Give written informed consent
* Be in good general health
* No known history of allergy to personal care/consumer products or their
* ingredients, relevant to any ingredients in the test products as determined by the
* dental/medical professional monitoring the study

Exclusion Criteria:

* Medical condition which requires pre-medication prior to dental visits/procedures
* Advanced periodontal disease
* 5 or more decayed, untreated dental sites
* Diseases of the soft or hard oral tissues
* Orthodontic appliances
* Abnormal salivary function
* Use of prescription drugs.
* Use of antibiotics one (1) month prior to or during this study
* Use of any over the counter medications other than analgesics
* Erratic use of vitamin supplements
* Pregnant or breastfeeding.
* Participation in another clinical study in the month preceding this study
* Allergic to common dentifrice ingredients
* Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
Prescription Event Monitoring in Patients With Benign Prostatic Hyperplasia (BPH)

Study to evaluate the safety profile of Secotex® in the improvement of the symptoms of Benign Prostatic Hyperplasia in real clinical practice


Eligibility Criteria:
Inclusion Criteria:

* Patients of any age with a diagnosis of symptomatic Benign Prostatic Hyperplasia (BPH)
* Patients with symptoms, that according to physician require medical treatment to improve quality of life
* Patients could be naive to treatment or could be on treatment with other drugs but have not responded adequately to treatment

Exclusion Criteria:

* Patients with known hypersensitivity to Tamsulosin, or any other component of the product
* Patients with a history of orthostatic hypotension or severe liver failure
Evaluation of Patients Treated With HMG-CoA Reductase Inhibitors to Reach Cholesterol Target Values

This study is non-interventional study of patients who are treated with any HMGCoA reductase inhibitors (rosuvastatin, simvastatin,atorvastatin and fluvastatin) available in Bosnia and Herzegovina for at least 6 months. Data collection for each patient will take place at a single visit. The investigators will complete Case Report Form (CRF) with patient's demographic, the presence of the factors for high cardiovascular risk, current treatment, cholesterol value as well as with further treatment decision.

Non-interventional study to assess reaching of cholesterol target values in patients treated with HMG-CoA reductase inhibitors in Bosnia and Herzegovina

Eligibility Criteria:
Inclusion Criteria:

* Patients, treated with one HMG-CoA reductase inhibitors for at least 6 months without changing the dose for the last 4 weeks at least
* All patients must sign informed consent form

Exclusion Criteria:

* Patients who have not signed the Informed Consent Form
* Patients with contraindication for the treatment with HMG-CoA reductase inhibitors as per SmPC approved in Bosnia and Herzegovina
Assessment of Oxygen Delivery as an Early Predictor of Postoperative Pulmonary Complications During One-lung Pulmonary Ventilation in Thoracic Surgery. A Pilot Study

This is a simple descriptive pilot study where 60 patients undergoing One-lung ventilation (OLV) for \> 120 minutes during esophagectomy will be enrolled to see if the Flo Trac® system can identify hypoxemia earlier than the standard of care monitoring.

One-lung ventilation (OLV) is necessary to facilitate surgical exposure in thoracic surgery. OLV can lead to hypoxemia due to the collapse of the non-dependent lung with potentially increased atelectasis in the dependent lung. Hypoxemia, the low oxygen level in the blood, during OLV can be detected by a decrease in arterial hemoglobin oxygen saturation (SaO2) measured by pulse oximetry (SpO2%). Although the incidence of hypoxemia during OLV is currently considered less than 4%, SaO2 is not well correlated to the oxygen supply to the tissues, determined by oxygen delivery (DO2), thus normal values of SaO2 can be associated with abnormal values of DO2 and on the contrary, hypoxemic values of SaO2 can be associated with normal values of DO2. Hypoxemia in patients with cardiovascular, cerebrovascular and/or pulmonary disease leads to an increased risk of complications related to low oxygen supply.

Postoperative pulmonary complications (POPCs) can lead to increased perioperative morbidity and mortality, increased incidence of admission to an intensive care unit, prolonged hospital stay and increased medical cost.

To the best of our knowledge, there are no studies in thoracic surgery, including esophagectomies, where intraoperative Oxygen Delivery (DO2) or DO2 index (DO2i) is used as a strategy for early detection of POPCs. There are also no studies that have determined the critical level of DO2 and DO2i or Percentage of Oxygen Extraction (O2ER) and Percentage of Oxygen Extraction index (O2ERi) in thoracic surgery associated with POPCs.

The aim of this study is to determine if the use of DO2 and DO2i as a continuous non-invasive monitor of oxygen supply to the tissues during OLV, may help us determine the critical DO2 and DO2i to predict POPCs.

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 18 years
* Esophagectomy surgery requiring one-lung ventilation for \> 120 minutes

Exclusion Criteria:

* Severe heart disease (LVEF (Left ventricle ejection fraction) \<50%) and/or Heart failure with CI (cardiac index) \<2.5 l/min/m2 or need of vasopressors and/or ionotropic support
* Genetic alterations of hemoglobin
* Pregnant patients
* History of severe restrictive lung disease (such as pulmonary fibrosis with minimal FEV1 of \<75% or COPD/emphysema with minimal FEV1 of \<50%) which may affect inflation/deflation times
* Trauma patients requiring VATS/thoracotomy
* Patient with recent mechanical ventilation support (2 weeks)
The Effect of Ischaemic-Reperfusion in Man - A Bradykinin Dependent Pathway

Heart attacks are usually caused by a blood clot blocking an artery supplying blood to the heart. Current treatments are designed to relieve this blockage as quickly as possible to minimize damage to the heart muscle. However in restoring the supply of blood local damage known as "ischaemia-reperfusion injury" may occur. The aim of this study is to assess how clot forming and clot dissolving pathways are affected during this process, and examine the role of a natural inflammatory hormone, bradykinin. This will help the investigators to understand the mechanism by which ischaemia-reperfusion injury may occur and to devise new treatments for heart attacks.


Eligibility Criteria:
Inclusion Criteria:

* healthy males between 18-65 years of ages
* non-smokers

Exclusion Criteria:

* any concurrent illness or chronic medical condition
* concurrent use of vasoactive medication
* smoking history
18F-S16 PET/CT in Healthy Volunteers and Patients With Neurodegenerative Dementia

This is an open-label dynamic whole-body PET/CT (positron emission tomography/computed tomography) study for investigation of radiation dosimetry, plasma pharmacokinetics, biodistribution, safety and diagnostic performance of 18F-S16 in healthy volunteers and patients with neurodegenerative dementia.

For interests in clinical translation of 18F-S16, an open-label dynamic whole-body PET/CT study was designed to investigate safety and diagnostic performance of 18F-S16 in patients with neurodegenerative dementia. A single dose of nearly 370 MBq 18F-S16 will be intravenously injected into healthy volunteers and patients with neurodegenerative dementia. Visual and semiquantitative method will be used to assess the PET/CT images. Changes of blood pressure, pulse, respiration, temperature, routine blood and urine tests, serum alanine aminotransferase, albumin, and creatinine, and any adverse events will be collected from the subjects. Adverse events will also be observed in the subjects.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with Neurodegenerative Dementia
2. Males and females, ≥40 years old
3. They rely on a combination of neurologic examination and neuropsychological assessment with a battery of tests. Clinical diagnosis was established by sophisticated neurologists.

Exclusion Criteria:

1. Females planning to bear a child recently or with childbearing potential
2. Renal function: serum creatinine \>3.0 mg/dL (270 μM/L)
3. Liver function: any hepatic enzyme level more than 5 times upper limit of normal.
4. Known severe allergy or hypersensitivity to IV radiographic contrast.
5. Patients not able to enter the bore of the PET/CT scanner.
6. Inability to lie still for the entire imaging time because of cough, pain, etc.
7. Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc.
8. Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the investigator, may significantly interfere with study compliance.
Schizophrenia and the Gut Microbiome

In a sample of 20 inpatients with a DSM-IV-TR/DSM 5 diagnosis of schizophrenia or schizoaffective disorder, investigators propose to conduct a prospective, 2 week observational trial to collect gastrointestinal stool samples in order to characterize the microbiota in people with schizophrenia and examine its variability over time. Participants may elect to participate for an additional two weeks, during which they will receive the prebiotic, oligofructose-enriched inulin (FOS), in order to examine its effects on the relative preponderance of butyrate-producing bacteria in the gut microbiome. Investigators will use an inpatient sample in order to standardize meals, exercise and environmental mediators. This is considered a feasibility, pilot study in order to apply for future grant funding. Investigators will recruit patients from the Treatment Research Program inpatient unit, Maryland Psychiatric Research Center, University of Maryland School of Medicine.


Eligibility Criteria:
Inclusion Criteria:

1. DSM-IV-TR /DSM 5 diagnosis of schizophrenia or schizoaffective disorder;
2. Age 18-64 years;
3. currently hospitalized for at least 7 days
4. currently treated with an antipsychotic, with no dose changes in last 14 days
5. ability to participate in the informed consent process, as determined by a score of 10 or greater on the Evaluation to Sign Consent

Exclusion Criteria:

1. Gastrointestinal disorders, including, but not limited to Crohn's Disease, Irritable Bowel Syndrome, Celiac Disease,
2. Organic brain disorder, including cerebrovascular accident; epilepsy; traumatic brain injury, Loss of consciousness (LOC) for more than 30 minutes
3. Mental retardation
4. Antibiotic or immune therapy within the last three months
5. Prebiotic or probiotic treatment within the last three months
6. Inability to understand English
7. Inability to cooperate with study procedures
8. Pregnant women
9. Prisoner status
10. For MRI ONLY Contraindication for MRI scanning (e.g. metal in body, pacemaker).
Revascularization in Patients Undergoing Transcatheter Aortic Valve Implantation

The aim of this study is to evaluate the effect of routine FFR-guided complete revascularization with PCI compared to conservative management in patients with concomitant coronary artery disease who are undergoing TAVI.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Severe aortic valve stenosis and selected for TAVI by a multi-disciplinary Heart Team
3. At least one stenosis with FFR ≤ 0.80 or diameter stenosis \> 90% in a coronary artery ≥ 2.5 mm in diameter

Exclusion Criteria:

1. Life expectancy \< 1 year due to other severe non-cardiac disease
2. Severe renal failure with estimated glomerular filtration rate \< 20 ml/min
3. No PCI-eligible coronary artery stenosis, but rotablation is allowed
4. Admitted with a new acute coronary syndrome (ST-elevation myocardial infarction (STEMI) or non-STEMI) within 14 days
5. Significant stenosis in left main stenosis or ostial left anterior descending artery (LAD) + ostial left circumflex artery (LCx))
6. Only stenoses with thrombolysis in myocardial infarction grad \< 3
7. Potential pregnancy
8. Known allergy towards P2Y12 receptor antagonists, heparin or contrast medium
9. More than one chronic total occlusion (CTO)
Adductor Canal Block for Medial Compartment Knee Arthroplasty

This study will evaluate the affects of a single injection ultrasound-guided adductor canal block for patients undergoing robotic-assisted (MAKOplasty) medial UKA (unicompartmental knee arthroplasty). Specifically, this study will compare the adequacy of postoperative analgesia provided by the adductor canal block with that provided by single injection lumbar plexus blockade. The working hypothesis is that the analgesia provided by the adductor canal block will be equivalent to the analgesia provided by the lumbar plexus block. The primary outcome will be a comparison of verbal numerical pain scores at rest and with movement over the first 24 hours following nerve blockade.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-85
* Undergoing unilateral robotic-assisted (MAKOplasty) medial compartment knee arthroplasty at Wake Forest University Baptist Medical Center.
* Must give written informed consent for anesthesia including subarachnoid blockade and peripheral nerve blockade of both the lumbar plexus and adductor canal.
* Must consent to the performance of a sham block at the site to which they are not randomized.
* Must also be reliable to give accurate verbal pain scores postoperatively.

Exclusion Criteria:

* Contraindication to adductor canal blockade or lumbar plexus blockade (including significant coagulation abnormalities)
* History of opioid addiction or current chronic pain therapy for pain other than at the surgical site that is being treated with high-dose opioids (extended release opioids or \> 40mg oxycodone equivalents per day)
* Allergy to study medications
* Failure to adequately place either the adductor canal or lumbar plexus blocks.
* Patients who decline or have a contraindication to subarachnoid blockade will also be excluded from the study.
* Pregnancy.