cyrilzakka/clinical-trials huggingface dataset:
Anti-inflammatory Effects of Caffeine in Chronic Obstructive Pulmonary Disease (COPD) Subjects

Nowadays it has become evident that a chronic systemic inflammation is present in patients suffering from chronic obstructive pulmonary disease (COPD).

The role of the nuclear enzyme poly(adenosine diphosphate-ribose)polymerase (PARP) as a key mediator within these systemic inflammatory processes as well as in COPD associated exercise intolerance and muscle weakness could recently been identified. The attenuating effect of dietary ingredients with PARP inhibiting activity on systemic inflammation was supported by data from in vitro and in vivo studies, from other groups as well as from our own lab. We identified several caffeine metabolites as potent inhibitors of the most abundant PARP-isoform PARP-1 in-vitro, in animal models as well as in ex-vivo experiments with whole blood from COPD patients.

However, clinical data with respect to their anti-inflammatory effects in COPD patients are currently not available for none of these substances. Therefore, the current clinical pilot study is intended to establish for the first time clinical data (proof of principle) on the anti-inflammatory potential of caffeine metabolites.


Eligibility Criteria:
Inclusion Criteria:

* COPD GOLD stage II (50% ≤ FEV1\< 80%)
* CRP plasma levels ≥ 3 mg/l
* BMI \> 20 kg/m2 and \< 30 kg/m2
* Diastolic blood pressure (DBP)=60-90 mmHg, Systolic blood pressure (SBP)=100 150 mmHg

Exclusion Criteria:

* Physical and/or mental disease or major surgery in the present or the past that might limit participation in or completion of the study
* Reported current or previous metabolic (e.g. diabetes), cardiovascular and/or renal diseases
* Known presence of a carcinoma
* Acute and/or chronic inflammatory condition such as arthritis, arthrosis, chronic colitis, etc. during three months before entry of the study
* Respiratory tract infection or exacerbation of COPD for at least 8 weeks prior to the start of the study
* Change in treatment regime of the COPD subjects for at least 8 weeks prior to the start of the study
* Use of laxatives, anti-diarrhoeal drugs and any other medication that can influence the uptake of the investigational products and/or influence their metabolism during the trial
* During the month prior to the start of the study and during the study the use of antibiotics and/or local and systemic steroidal (glucocorticoids) and non-steroidal anti-inflammatory drugs (NSAID)
* Abnormal constant dietary eating habits and a coffee consumption of less than 3 cups per day (i.e. a usual daily intake of \<400 mg caffeine).
Safety and Efficacy of BAY1192631 in Japanese Patients With Methicillin-resistant Staphylococcus Aureus (MRSA) Infections

The aim of this study is to see the efficacy and safety of BAY1192631 in Japanese patients with methicillin-resistant staphylococcus aureus (MRSA) (skin and soft tissue infections (SSTI) and SSTI-related bacteremia).


Eligibility Criteria:
Inclusion Criteria

* Suspected or confirmed Methicillin-resistant Staphylococcus aureus (MRSA) infection
* Japanese Male and female patients aged 18 years or above
* Diagnosis of Skin and soft tissue infection with MRSA either suspected or confirmed as the major cause of infection, with/without SSTI (skin and soft tissue infection)-derived MRSA bacteremia suspected

Exclusion Criteria:

* Having received any systemic antibacterial potentially effective against MRSA for \>/=24 hours within 3 days prior to the first infusion of a study drug, or having received/expected to receive the medication within 24 hours prior to the first infusion, unless antibacterial therapy for \>/=72 hours proves to be ineffective on or lack appropriate potency (resistant) to MRSA.
* Moribund clinical condition such as death likely within the first 3 days of a study drug treatment
* History of significant allergy or intolerance to linezolid or BAY1192631
* Known or suspected human immunodeficiency virus (HIV) infection with a CD4+ T-cell count \< 200/μL
* Chronic treatment with immunosuppressive drugs
* Active tuberculosis or non-tuberculous mycobacteriosis which need medical treatments
* Current or anticipated neutropenia with neutrophil count \< 1,000/ mm\^3
* Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) \>/= 8 times the upper limit of reference range OR moderate to severe hepatic disease with Child Pugh score \>/=10.
Hypertension and Retinal Microvascular Dysfunction

Hypertension is a worldwide health care burden that affects the structure and function of the macro- and microcirculation. Non-invasive vascular biomarkers are essential to timely diagnose end organ damage to improve cardiovascular (CV) risk stratification and medical decision making. The "Hypertension and retinal microvascular dysfunction" (HyperVasc) trial will investigate macro- and microvascular impairments in hypertensive patients and healthy controls to investigate hypertension-induced end organ damage by using gold-standard methods as well as newly developed and unique retinal microvascular biomarkers. Additionally, this trial will investigate the reversible effects of an eight weeks supervised and walking based high-intensity exercise intervention on blood pressure as well as macro- and microvascular health, compared to a control group with standard physical activity recommendations. Secondary outcomes will be cardiorespiratory fitness, physical activity, microalbuminuria, hypertensive retinopathy, and classical cardiovascular risk marker. The results of the HyperVasc trial will improve the understanding of hypertension-induced vascular impairments and will push the development of non-invasive vascular biomarker to screen end organ damage in general CV risk stratification.


Eligibility Criteria:
Inclusion Criteria:

* Men and Women between 40 and 70 years of age
* hypertension (≥90 mmHg diastolic or ≥140 mmHg systolic BP during 24h monitoring or hypertensive medication) or normal blood pressure (≤85 mmHg diastolic and ≤130 mmHg systolic BP during 24h monitoring and no hypertensive medication).

Exclusion Criteria:

* Any cardiovascular (CV) medication (accept for hypertensive medication in the hypertensive group)
* history of CV, pulmonary, or chronic inflammatory disease
* active smoking status
* any chronic eye disease.
Clinical Validation Study for Optimization of Anemia MAnagement in Hemodialysis Patients With End Stage Kidney Disease Using the Dialysis Anemia TReatmenT Model

This is a human subject research study conducted in patients undergoing dialysis treatment with darbepoetin alfa at Intermountain Utah Dialysis and Intermountain Medical Center Dialysis Services. The purpose is to test a dose recommendation algorithm that may reduce hemoglobin variability and drug cost.

Hemoglobin cycling is an outcome of treating long-term dialysis patients for anemia using erythropoiesis-stimulating agents (ESAs), and represents a conundrum for practitioners. While patients with low hemoglobin levels suffer from anemia, high hemoglobin levels may lead to blood clots and subsequent health risks. The current protocol for ESA dosing often results in suboptimal dosing that leads to hemoglobin cycling, which can have a negative impact on patient survival. To this end, we have developed a personalized method for ESA dosing that controls anemia in dialysis patients that is similar to the commercial product sold by PhySoft. Our method, the Dialysis Anemia Treatment Model, uses a mathematical model for erythropoiesis that takes each patient's physiology into account, predicting the optimal dose of ESA for that patient to prevent hemoglobin cycling. The goal of this computer-aided approach is to reduce hemoglobin cycling and the amount of drug used by predicting optimal doses to keep the patient's hemoglobin within the desired range. This is a human subject research study to validate the model in the clinic and demonstrate that it is able to minimize hemoglobin cycling in patients and reduce the amount of ESA drug administered.

Eligibility Criteria:
Inclusion Criteria:

* Males and females (≥ 18 years of age) with End Stage Kidney Disease undergoing in-center hemodialysis
* 150 days of hemoglobin readings and Aranesp doses without a hospitalization relevant to the condition of anemia

Exclusion Criteria:

* Inflammation as characterized by ferritin levels greater than 1000 ng/mL
* Patients with active cancer
* Patients with PTH greater than 1,000 pg/mL
* Active GI Bleed
* Hospitalization relevant to ESRD in last 150 days or during study
* Patients receiving Procrit rather than Aranesp.
A Drug-drug Interaction Study of S-892216 Coadministered With Carbamazepime to Healthy Adult Participants

The primary objective of this study is to investigate the effect of multiple-dose administration of carbamazepine on the pharmacokinetics of S-892216 in healthy adults.


Eligibility Criteria:
Key Inclusion Criteria:

* Overtly healthy as determined by medical evaluation including medical history, medical examination, laboratory tests, vital sign measurements, and 12-lead electrocardiogram, at screening and on admission or participants whose laboratory values exceed the institutional reference range but deemed not clinically significant by the investigator in consideration of safety.
* Body mass index ≥18.5 and ≤32.0 kilograms/meter squared.

Exclusion Criteria:

* This study will not enroll participants with Asian ancestry, defined as individuals who have 1 or more Asian grandparent, due to significant increase of risk for carbamazepine-related serious dermatologic reactions almost exclusively in these populations.
* Presence or history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological, or ophthalmological (that is, increased intra-ocular pressure) disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data per the investigator's assessment.
* History of adverse hematologic reaction to any drug, or a history of bone marrow depression.
* History or family history of severe cutaneous reactions including toxic epidermal necrolysis and Stevens-Johnson Syndrome.
* Prior carbamazepine use that was discontinued for tolerability or adverse events, including a clinically significant decrease in platelets, white blood cells, or hemoglobin.

Note: Other protocol-defined inclusion/exclusion criteria may apply.
Comparison of FDG PET and Bone Scintigraphy/Labelled Leukocyte/Gallium Scintigraphy in Diabetic Foot Osteomyelitis

Diabetic foot osteomyelitis is a common and serious complication of diabetes. While the diagnosis of soft tissue infection can be made with simple physical examination in most cases, bone involvement can be harder to diagnose, often requiring medical imaging. In addition to conventional radiological examinations (x-ray and MRI) nuclear medicine procedures can also provide important physiological information in these patients. These procedures include triple phase bone scan combined with Gallium scintigraphy or a combination of labelled leukocyte scintigraphy and bone marrow scintigraphy using sulfur colloid. These procedure, while they provide useful physiological information, are time consuming, generally requiring at least 2 separate image acquisition on separate days, and can be costly.

18F-FDG is a glucose analog that can be used for PET imaging. In addition to its application in oncology, the literature has shown that FDG can be used to investigate a wide variety of inflammatory and infectious conditions, including diabetic foot infections.

The aim of this study is to compare the usefulness of FDG PET imaging versus "conventional" nuclear medicine (either bone scan and Gallium scintigraphy or labelled leukocytes and sulfur colloid scintigraphy) in patient with suspected diabetic foot osteomyelitis.


Eligibility Criteria:
Inclusion Criteria:

* Diabetic patient with suspected diabetic foot osteomyelitis referred for nuclear medicine examination (bone scan and Gallium or labelled leukocytes).
* Being treated or followed by a physician at CHUM

Exclusion Criteria:

* Pregnant woman
* Breastfeeding patient
* Claustrophobia/patient unable to complete imaging procedure
Web-based Ultra-brief Intervention for Heavy Drinkers Trial

The purpose of the study is to determine whether a web-based ultra-brief intervention, consisting of personalized normative feedback or standardized self-help material, is effective in lowering self reported alcohol use in heavy drinkers.

Background and purpose:

The Danish national board of Health has awarded funds for two studies that will test methods that can be used for effective and early detection of heavy drinkers. The study will be carried out in 12 Danish municipalities in 2008. The study is part of the 'Diet, Smoking, Alcohol and Exercise' nationwide health study of the Danish population. It takes place in 13 municipalities in 2007 and 2008.

The purpose of the study is to determine whether a web-based ultra-brief intervention, consisting of personalized normative feedback or standardized self-help material, is effective in lowering self reported alcohol use in heavy drinkers.

Design:

The experiment is designed as a randomized controlled trial, where heavy drinkers will be allocated to either:

A) an intervention group receiving web-based personalized normative feedback (PFI) B) an intervention group receiving web-based self-help material (SHM) C) a control group receiving nothing.

After 6 and 12 months there will be follow-up and the participants will receive a questionnaire with questions about their alcohol consumption (internetbased and paper).

Eligibility Criteria:
Inclusion Criteria:

* Participants must be invited to the Danish 'Diet, Smoking, Alcohol and Exercise' nationwide health study.
* Participants must have a weekly alcohol consumption above the recommended Danish limits (168 grams of alcohol for women, 252 grams of alcohol for men).

Exclusion Criteria:

* Weekly alcohol consumption less than 168 grams of alcohol for women and 252 grams of alcohol for men.
* Participants who have not informed their email address.
DBS of the MLR for Gait and Balance Disorders in PD Patients

Gait and balance disorders represent the main motor disability in advanced Parkinson's disease. These symptoms are less or unresponsive to levodopa treatment and are considered to be a contraindication for deep brain stimulation of the subthalamic nucleus. Falls and freezing of gait are responsible for high morbidity (fractures, residential health care) and increased significantly mortality. The pathophysiology of gait and balance disorders is still poorly understood, but recent data obtained in animals and humans suggest that a degeneration of cholinergic neurons of the pedunculopontine nucleus (PPN), within the mesencephalic locomotor region, could play a crucial role. In line with this hypothesis, low-frequency stimulation of the pedunculopontine area, thought to increase the activity of the remaining cholinergic PPN neurons, has been proposed to alleviate gait and balance disorders in advanced PD patients. Here, the efficacy of deep brain stimulation of the mesencephalic locomotor region will be tested in 12 PD patients in a randomized, double-blind, cross-over, controlled study.


Eligibility Criteria:
Inclusion Criteria:

* age below 71 years
* severe form of Parkinson's Disease with disease duration \> 5 years
* presence of gait and/or balance disorders unresponsive to levodopa treatment,
* \> 40% decrease in others motor symptoms with levodopa treatment
* health insurance
* give signed informed written consent

Exclusion Criteria:

* dementia (Mattis Dementia Rating Scale \< 129, MDRS),
* ongoing psychiatric disturbances,
* surgical contraindications
* significant brain lesions detected on MRI.
Assessment of Efficacy and Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation

The purpose of this study is to evaluate the effect and safety of NKTR-118 treatment of opioid-induced constipation in patients with non-cancer-related pain, including those patients that have inadequate response to laxative therapy (LIR).


Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent prior to any study-specific procedures.
* Men and women who are between the ages of ≥18 and \<85 years.
* Self-reported active symptoms of OIC at screening (\<3 SBMs/week and experiencing ≥1 reported symptom of hard/lumpy stools, straining, or sensation of incomplete evacuation/anorectal obstruction in at least 25% of BMs over the previous 4 weeks); and Documented confirmed OIC (\<3 SBMs/week on average over the 2-week OIC confirmation period.
* Receiving a stable maintenance opioid regimen consisting of a total daily dose of 30 mg to 1000 mg of oral morphine, or equianalgesic amount(s) of 1 or more other opioid therapies for a minimum of 4 weeks prior to screening for non-cancer-related pain with no anticipated change in opioid dose requirement over the proposed study period as a result of disease progression.
* Willingness to stop all laxatives and other bowel regimens including prune juice and herbal products throughout the 2-week OIC confirmation period and the 12-week treatment period, and to use only bisacodyl as rescue medication if a BM has not occurred within at least 72 hours of the last recorded BM.

Exclusion Criteria:

* Patients receiving Opioid regimen for treatment of pain related to cancer.
* History of cancer within 5 years from first study visit with the exception of basal cell cancer and squamous cell skin cancer.
* Medical conditions and treatments associated with diarrhea, intermittent loose stools, or constipation.
* Other issues to the gastrointestinal tract that could impose a risk to the patient.
* Pregnancy or lactation.
Lutonix DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries

To assess the safety and efficacy of the Lutonix Drug Coated Balloon (DCB) for treatment of stenosis or occlusion of native below-the-knee arteries.


Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant female ≥18 years of age;
* Rutherford Clinical Category 3, 4 \& 5;
* Life expectancy ≥ 1 year;
* Significant stenosis (≥70%)
* A patent inflow artery;
* Target vessel(s) diameter between 2 and 4 mm;
* Target vessel(s) reconstitute(s) at or above the ankle

Exclusion Criteria:

* Pregnant or planning on becoming pregnant;
* History of stroke within 3 months;
* History of MI, thrombolysis or angina within 30 days of enrollment;
* Planned major amputation (of either leg)
* Prior major amputation if amputation occurred less than one year prior to enrollment and if patient is not independently ambulating;
* GFR ≤ 30 ml/min per 1.73m2;
* Acute limb ischemia;
* In-stent restenosis of target lesion
Effects of Suboptimal CPAP Therapy on Symptoms of Obstructive Sleep Apnoea

Obstructive sleep apnoea (OSA) is a highly prevalent sleep-related breathing disorder. The most effective treatment for OSA is continuous positive airway pressure (CPAP). CPAP therapy has been shown to significantly reduce subjective sleepiness and blood pressure in patients with symptomatic OSA. Its effectiveness tends to depend on its nightly usage and a commonly held view is that CPAP should be used for at least 4h/night. However, previous studies have estimated that a considerable proportion of CPAP users fail to achieve this. In addition, there is inadequate evidence to support this apparent threshold effect and so it is unclear whether such patients actually benefit from treatment or whether they could be withdrawn from CPAP, thus substantially reducing health care costs, or encouraged to increase their nightly usage of CPAP.

The aim of the proposed project is to study the effect of CPAP withdrawal on subjective sleepiness in OSA patients using CPAP for less than 4h/night on average. We hypothesize that two-week CPAP withdrawal in patients with 3-4h/night use will lead to a return of OSA-related symptoms. This trial will better establish the minimum level of CPAP adherence which could generally be regarded as effective in reducing OSA-related symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Objectively confirmed OSA (at the time of original diagnosis) with an oxygen desaturation index (ODI, ≥4% dips) of ≥15/h and an ESS of \>10.
* Currently ≥15/h oxygen desaturations (≥4% dips) during an ambulatory nocturnal pulse oximetry performed at the end of a 4-night period without CPAP.
* Eligible patients must have been treated with CPAP for more than 12 months with a mean compliance between 3 and 4h/night. Apnoea-hypopnoea index (AHI) must be less than 10 with treatment (according to CPAP machine download data).

Exclusion Criteria:

* Previous ventilatory failure (awake PaO2\<9.0kPa or arterial PaCO2\>6kPa).
* Unstable, untreated coronary or peripheral artery disease, severe arterial hypertension (\>180/110mmHg).
* Previously diagnosed with Cheyne-Stokes breathing.
* Current professional driver.
* Age \< 20 or \> 75 years at trial entry.
Study of SPG302 in Adult Participants With Mild-to-Moderate Alzheimer's Disease (AD)

This phase 2 study will evaluate the safety, tolerability, clinical efficacy, pharmacokinetics, and pharmacodynamics of SPG302 in adult participants with mild-to-moderate AD.

This is a phase 2, multicenter study to assess the safety, tolerability, CNS effects, pharmacokinetics, pharmacodynamics and clinical efficacy of SPG302 in adult participants with mild-to-moderate AD. The study will consist of 2 parts:

Part A: Placebo-controlled, randomized, safety and preliminary efficacy cohort with daily dosing for 28 day cycles

Part B: a randomized expansion cohort of daily dosing for 28 day cycles

Eligibility Criteria:
Inclusion Criteria:

* Age 45-85
* Diagnosis of mild to moderate AD
* Clinical laboratory values within normal range or \< 1.5 times ULN
* If receiving AD-specific treatment, have been on stable dose for ≥ 3 months prior to first dose of study drug.
* Life expectancy of \>2 years
* Able and willing to provide written informed consent

Exclusion Criteria:

* Any physical or psychological condition that prohibits study completion
* Known cardiac disease
* Active or history of malignancy in the past 5 years
* Serious infection that will not be resolved by first day of study intervention.
* History of clinically significant CNS event or diagnosis in the past 5 years.
* Acute illness within 30 days of Day 1
* History of suicidal behavior or suicidal ideation
* History of chronic alcohol use or substance abuse in the last 5 years
* HIV, hepatitis B and/or hepatitis C positive
* Vaccines within 14 days
* Receipt of investigational products within 30 days
* Blood donation within 30 days
* Pregnant or breastfeeding