Participants will receive lactose placebo tablets, encapsulated in opaque capsules, and will be asked to take one capsule daily for seven days at night-time, by mouth

Participants will receive 20mg atorvastatin tablets, encapsulated in opaque capsules, and will be asked to take one capsule daily for seven days at night-time, by mouth

Healthy

Atorvastatin 20mg

Lactose placebo

Riccardo De Giorgi

7-day Atorvastatin and Emotional Processing

The Effect of Seven-Day Atorvastatin Administration on Emotional Processing, Reward Processing, and Inflammation in Healthy Volunteers

Faces representing varying degrees [from "neutral" (0%) to "full prototypical emotion" (100%) of basic emotions (happiness, fear, anger, disgust, sadness, surprise)] are displayed on the screen and participants are asked to quickly and correctly classify them. Accuracy and reaction times on positive vs negative stimuli are compared between those receiving drug and placebo.

Faces acting as positive or negative emotional stimuli (happy or fearful facial expressions) are presented together with a matched neutral face. One is presented above and one below a central fixation point. Subsequently, a probe appears behind one of the two faces and participants are asked to quickly indicate the position of the probe. Accuracy and reaction times on positive vs negative stimuli are compared between those receiving drug and placebo.

Words describing positive and negative personality characteristics are presented, and participants are asked to quickly indicate whether they would like or dislike being described with the presented word. Accuracy and reaction times on positive vs negative stimuli are compared between those receiving drug and placebo.

After a delay from the Emotional categorisation task, participants are asked to recall and write down as many words as possible from it. Accuracy in recall of positive vs negative stimuli are compared between those receiving drug and placebo.

The original personality descriptors in the Emotional categorisation task, plus an equal number of matched distractor words, are presented, and participants are asked to indicate whether they recognise it from the Emotional categorisation task. Accuracy and reaction times on positive vs negative stimuli are compared between those receiving drug and placebo.

During a computer-based task, participants are instructed to learn and select which images are associated with wins rather than losses. Accuracy and reaction times are assessed and compared between those receiving drug and placebo.

Changes in high sensitivity-C Reactive Protein (hs-CRP) from baseline to seven-day, comparing those receiving drug and placebo

To comply with the General Data Protection Regulation (GDPR) and the new Data Protection Act, personal data will be deleted as soon as possible after it is no longer needed for the study.
Screening information: For volunteers who do not wish to be contacted for future studies, screening information (including contact details) will be stored for up to one year of completing study analyses, and then destroyed by shredding. Contact details may be retained after the end of the study for participants who have agreed to be contacted for future studies.
Consent forms: Consent forms will be kept for 10 years after the end of the study, and then destroyed by shredding.

University of Oxford

Wellcome Trust

Participants will be randomised, in a double-blind fashion, to either placebo or atorvastatin. The randomisation code will be drawn up by a researcher not involved in the study using an online randomisation tool (https://www.sealedenvelope.com/simple-randomiser/v1/lists).

The atorvastatin drug and the placebo will be encapsulated in identical capsules. Participants will not be aware of the treatment that they will be receiving; neither will the researcher. Allocation of treatments will be recorded on a Randomisation List, which will be updated when each new participant enters the randomised phase. The list will be held by a scientist uninvolved in the study.

Patients will receive two cycles of Placebo (NaCl solution) at an interval of three months.
Each cycle will consist of intravenously administered (within 3-5 seconds) Placebo twice weekly on days 1, 4, 8 and 11.

Patients will receive two cycles of Bortezomib (Velcade®) at an interval of three months.
Each cycle will consist of intravenously administered (within 3-5 seconds) Bortezomib 1.3 mg/m2 twice weekly on days 1, 4, 8 and 11.

Late Rejection of Renal Transplant

Antibody-mediated Rejection

Bortezomib

Placebo

Medical University of Vienna, Department of Nephrology and Dialysis

Bortezomib in Late Antibody-mediated Kidney Transplant Rejection

Bortezomib in Late Antibody-mediated Kidney Transplant Rejection (BORTEJECT Study)

Peripheric venous blood samples (4ml) will be obtained after 0, 6, 12, 18 an 24 months to assess the change of eGFR slopes over time.
In case of loss of follow-up the GFR is assumed to be 0ml/min.

Peripheric venous blood samples (10mL) will be obtained after 0, 6, 12, 18 and 24 months to assess DSA levels by Luminex® technology.
Maximum and sum of MFI of DSA
Number of DSA
Broadness of sensitization (virtual PRA)

Survival will be assessed after 12 and 24 months after randomization

Graft loss will be assessed after 12 and 24 months after randomization with or without re-transplantation

Cr-EDTA GFR will be assessed by measuring the clearance of a defined peripheric administered dose of Chromium-51 EDTA according to a standard protocol.

Protein excretion (protein/creatinine ratio) will be measured in 24h urine at 0, 6, 12, 18 and 24 months after randomization.

Diagnosed at protocol biopsy after month 24 after randomization or whenever clinically indicated

Acute AMR score (0-9)
Sum of:
Glomerulitis 0, 1, 2, 3
Peritubular capillaritis 0, 1, 2, 3
C4d in peritubular capillaries 0, 1, 2, 3

Chronic AMR score (0-9)
Sum of:
Transplant glomerulopathy 0, 1, 2, 3
Peritubular capillary basement membrane lamellation 0, 1, 2, 3
Chronic vasculopathy 0, 1, 2, 3

Farsad Eskandary

Farsad Eskandary, MD

Medical University of Vienna

Medical University Innsbruck

Subjects in the DPAEP group will undergo a structured weight loss for approximately 6 months, followed by approximately 6 months of weight maintenance, as well as 12 months of aerobic exercise. This intervention stresses a personalized program emphasizing activities that are meaningful to and are tailored to individual participants; provides consistent contact between the participants and research staff; and allows monitoring of activity levels using questionnaires, actigraphy, monitoring of heart rate, direct and telephone contact. Participants dietary and physical activity goals as assessed by the dietician and trainer will be discussed at face-to face meetings to re-establish these goals. These programs will be tailored to meet the realistic goals of the individual participant. The program stresses aerobic exercise, rather than other types of exercise interventions, as aerobic exercise appears to correlate best with improved autonomic function.

The SC group will be assigned an interventionist assessor. This assessor will meet with the subjects during their orientation meeting and will be provided guidelines and a weight loss and physical activity target to achieve by the end of the program at their orientation meeting. Participants will contacted approximately weekly during the approximate 12 month period.

Diabetes

Neuropathy

Impaired Glucose Tolerance

Structured weight loss or weight maintenance and aerobic exercise intervention for 12 months or standard of care weight and exercise management

lifestyle modification

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Improving Autonomic Function and Balance in Diabetic Neuropathy

This is a cardiac autonomic measure that will be carried out using clinical equipment in the autonomic laboratory at the site. The measurement requires placing electrodes near the heart similar to an EKG.

This outcome measure assesses changes in trunk positioning using a standardized, validated test.

This outcome assesses sweat gland nerve fiber density, which is proposed as a sensitive neuropathy pathology biomarker.

VA Office of Research and Development

Multiple Sclerosis

Multiple Sclerosis Center Carmel Medical Center

Observational Study for Assessment of the Effect of Fampyra on the Manual Function of Persons With Multiple Sclerosis

Scores of hand function tests before treatment with Fampyra and at several timepoints after treatment initiation will be compared.

Assessment of daily function before treatment with Fampyra and 4 months after initiation of treatment will be compared.

Improvement in patient manual function after 1 to 4 months of initiation of treatment with Fampyra will be compared to patient improvement in ambulation over the same period of time.

common cold/nausée

7-day Atorvastatin and Emotional Processing

Bortezomib in Late Antibody-mediated Kidney Transplant Rejection

Improving Autonomic Function and Balance in Diabetic Neuropathy

Observational Study for Assessment of the Effect of Fampyra on the Manual Function of Persons With Multiple Sclerosis

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