rifaximin 550 milligrams (mg) orally twice daily for 3 months

Alzheimer's Disease

Rifaximin (Xifaxan, Salix Pharmaceuticals, Bridgewater, N.J.) (See Package Insert) is a drug that is approved by the FDA for use in humans for the treatment of Hepatic Encephalopathy, Traveler's Diarrhea and Irritable Bowel Syndrome. It is commercially available. It will be used in accordance with approved labeling as pertains to dosage and administration for Hepatic Encephalopathy, contraindications and warnings. However, it will be used investigationally in this trial as rifaximin is not FDA approved for the treatment of Alzheimer's Disease.

Rifaximin 550 milligrams (MG)

Duke University Medical Center

Trial of Rifaximin in Probable Alzheimer's Disease

Pilot, Single Center, Open, Trial of Rifaximin in Probable Alzheimer's Disease

Done at Baseline, 3 month and 5 month visits. ADAS-Cog is a widely used cognitive endpoint in AD clinical trials and changes on this scale, over time, are considered clinically meaningful. ADAS-11 range is 0-70 with higher scores indicating worse performance. Errors from 11 items are added to generate the total score.

Collected at every visit and follow-up phone visits. A rare side effect of Rifaximin is diarrhea caused by clostridium difficile. This is a very serious form of diarrhea that can be fatal if not treated. The investigators will be following the patients closely during treatment and for 2 months following treatment to see if the patient has any signs or symptoms of this diarrhea. If a patient does develop clostridium difficile diarrhea, they will be promptly treated.

Done at Baseline, 3 month and 5 month visits. When brain tissue is damaged, it releases substances (serum neuronal markers) into the blood, such as Neurofilament Light. The investigators will be looking for the amount of these serum neuronal markers to decrease after three months of Rifaximin treatment, indicating less brain tissue damage.

The investigators will be looking for changes in the amounts of the following pro-inflammatory markers:
Interleukin (IL) 1 beta, IL 2, IL 4, IL 5, IL 6, IL 8, IL 10, IL 13, Tumor necrosis factor - alpha

The study drug, Rifaximin, is an antibiotic. It changes the mixture of bacteria in the colon. The investigators will analyze the types of bacteria that are in the patient's colon. The microbiome variables the investigators will use standard FDR correction to examine nominal significance of change from baseline. The investigators will be assessing the Escherichia, shigella, pseudomonas, bacteroides, eubacterium and Faecalibacterium.

Assessed at every visit. The patients will be followed closely to see if they are tolerating the drug, Rifaximin. The of the number of side effects would indicate that the patient may not be tolerating the drug. Most of these side effects are minor and include headache, nausea, vomiting, tiredness. A potentially fatal side effect would be the development of clostridium difficile diarrhea. The investigators will be following the patients closely during treatment and for 2 months following treatment to see if the patient has any signs or symptoms of this diarrhea. If a patient does develop clostridium difficile diarrhea, they will be promptly treated.

Change from baseline global cognitive scores at month 3). Global cognitive performance will be assessed by a psychometrician using the (MMSE). It is a brief cognitive questionnaire with a maximum score of 30 points. MMSE range is 0-30 with lower scores indicating worse performance. The number of correct answers is added to generate the total score.

Safety will be measured through adverse events as reported by the subjects

Clinically significant deviations from the baseline on CBC will be considered an AE and clinically significant

Clinically significant deviations from baseline to month 3 in blood pressure.

Clinically significant deviations from baseline to month 3 in pulse.

Clinically significant deviations from the baseline on Chemistry values as defined as Creatine, blood urine nitrogen, electrolytes and sodium potassium chloride results will be considered an AE.

Clinically significant deviations from the baseline on LFT will be considered an AE.

Clinically significant deviations from the baseline on clinically significant and newly emergent C Difficile infection will be considered.

Duke University

Bausch Health Americas, Inc.

Placebo

Pregabalin: On the day of the surgery, 1hour + 15 minutes before the surgery starts, the subject will receive either 300mg of pregabalin or a similarly packaged placebo. On post operative day one, 150 mg of pregabalin or placebo will be given in two doses 12hrs apart.

Pregabalin

Total

Sex: Female, Male

Region of Enrollment

The primary objective of this study is to evaluate the role of three doses of pregabalin on intra and postoperative (48hrs) opioid requirements in patients undergoing fusion of two or more vertebrae.

Postoperative Opioid Requirement

evaluate pain using the visual analog scale (VAS) pain score at two hrs post-op, the morning following surgery 24 hours and 48 hours post-op

Pain Using the Visual Analog Scale (VAS) Pain Score

Find the incidence of 48 hours post operative nausea and vomiting in the target population

Incidence of 48 Hours Post Operative Nausea and Vomiting

48 hours post operative headache, dizziness, sedation and blurred vision

Post Operative Cognitive Function

Measure the level of pre-operative anxiety using the visual analog scale (VAS)

Pre-operative Anxiety

To measure the level of overall anesthesia satisfaction among the two groups at discharge.

Anesthesia Satisfaction

Overall Study

Dr.Singh Nair

Spinal Fusion

On the day of the surgery, 1hour + 15 minutes before the surgery starts, the subject will receive either 300mg of pregabalin or a similarly packaged placebo. On post operative day one, 150 mg of pregabalin or placebo will be given in two doses 12hrs apart.

placebo

Montefiore Medical Center

Evaluating the Role of Pregabalin in Reducing Opioid Requirement in Spinal Fusion Surgeries of Two or More Vertebrae

Double Blinded, Randomized, Placebo Controlled Study in Evaluating the Role of Pregabalin in Reducing Opioid Requirement in Spinal Fusion Surgeries of Two or More Vertebrae

Singh Nair

Assistant Professor

2 capsules Theramine twice daily with one ibuprofen-like placebo once daily.

Two capsules Theramine twice daily with Ibuprofen 400mg once daily.

Two Theramine-like placebo twice daily and one ibuprofen 400mg.

Chronic Low Back Pain

Theramine two capsules twice daily for 28 days.

Theramine (A medical food)

Theramine two capsules twice daily and ibuprofen 400mg once daily for 28 days.

Theraprofen

Ibuprofen

Targeted Medical Pharma

A Double Blind Placebo Study to Determine the Effectiveness of Theramine on the Management of Chronic Back Pain

The primary efficacy outcome will be the change from baseline in awakening stiffness and pain subscale scores obtained from the Roland-Morris Lower Back Pain.

The primary efficacy outcome will be the change from baseline in awakening stiffness and pain subscale scores obtained from the Visual Analog Scale Evaluation.

Functionality outcomes obtained from the Oswestry Low Back Pain Scale

Percent change in c-reactive protein levels from baseline to Day 28.

Percent change in Il-6 level from baseline to Day 28.

Change in amino acid turnover rate from baseline to Day 28.

The patients in the placebo group received equal numbers of identical looking placebo 2 h before operation

Patients in the gabapentin group received two capsules of gabapentin 300 mg (Neurontin®, Pfizer) at 2 h before operation.

Pruritus

Gabapentin

Songklanagarind Hospital

Gabapentin for Prophylaxis Intrathecal Morphine-Induced Pruritus

Gabapentin for Prophylaxis Intrathecal Morphine-Induced Pruritus After Orthopedics Surgery

the incidence of pruritus during the 24 h follow-up period

The difference of onset time and severity of pruritus in the gabapentin and placebo groups

serotonin/ödem

Trial of Rifaximin in Probable Alzheimer's Disease

Evaluating the Role of Pregabalin in Reducing Opioid Requirement in Spinal Fusion Surgeries of Two or More Vertebrae

A Double Blind Placebo Study to Determine the Effectiveness of Theramine on the Management of Chronic Back Pain

Gabapentin for Prophylaxis Intrathecal Morphine-Induced Pruritus

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