Sjogren's Syndrome

National Institute of Dental And Craniofacial Research (NIDCR)

The Functioning of Immune and Hormonal Systems in Patients With Sjogren's Syndrome and in Healthy Volunteers

Basal and Stimulated Somatostatin Plasma Levels in Patients With Primary Sjogren's Syndrome and in Control Subjects

National Institute of Dental and Craniofacial Research (NIDCR)

Potassium citrate x 7days Off therapy x 7 days 500 mL low calorie orange juice beverage x 7 days 1000 mL low calorie orange juice beverage x 7 days Return to potassium citrate therapy Litholink urine collection to be performed after each 7 days treatment

500 mL low calorie orange juice beverage x 7 days 1000 mL low calorie orange juice beverage x 7 days Off therapy x 7 days Potassium citrate x 7days Continue on potassium citrate therapy Litholink urine collection to be performed after each 7 days treatment

Kidney Calculi

Kroger low calorie orange juice beverage will be consumed for 7 days followed by a 24 hour urine collection with Litholink to see if urine alkalization similar to potassium citrate can be achieved

Kroger low calorie orange juice beverage

Indiana University Health Methodist Hospital

Indiana University Health Physicians Urology

A Dietary Source of Potassium Citrate to Resolve Hypocitraturia and Aciduria in Patients With Kidney Stones

A Dietary Source of Potassium Citrate to Resolve Hypocitraturia and Aciduria in Patients With a History of Nephrolithiasis

The primary endpoint of interest will be the changes in urinary citrate while consuming Kroger low calorie orange juice beverage compared to potassium citrate therapy.

The primary endpoint of interest will be the changes in urinary pH while consuming Kroger low calorie orange juice beverage compared to potassium citrate therapy.

Tim Large

Principal Investigator

Indiana University

Group 1 kcit x 7 days ↓ Litholink on day 7
↓ off therapy x 7 days
↓ OJ 500 ML + 1.5L water /day x 7 days
↓ Litholink on day 7
↓ OJ 1000 ML + 1L water /day x 7 days
↓ Litholink on day 7 Return to kcit therapy
Group 2 OJ 500 ML + 1.5L water /day x 7 days ↓ Litholink on day 7
↓ OJ 1000 ML + 1L water /day x 7 days
↓ Litholink on day 7
↓ off therapy x 7 days
↓ kcit x 7 days
↓ Litholink on day 7 Continue on kcit therapy

25 patients after elective colorectal surgery will be given 100 mg caffeine citrate orally diluted in 50 ml apple flavored water three times per day starting on the morning of postoperative day 1 after surgery until flatus will occur for the first time or to a maximal period time of 7 days, whichever comes earlier.

25 patients after elective colorectal surgery will be given 50 ml apple flavored water three times per day starting on the morning of postoperative day 1 after surgery until flatus will occur for the first time or to a maximal period time of 7 days, whichever comes earlier.

Postoperative Ileus

Caffeine Citrate

Water

Ref 11. Mayo Clinic staff. Caffeine content for coffee, tea, soda and more. [Accessed March 14, 2017]

Hadassah Medical Organization

Does Caffeine Enhance Bowel Recovery After Colorectal Surgery?

The time in hours from end of surgery to first flatus.

The time in hours from end of surgery to first bowel movement.

The time in hours from end of surgery to first solid meal tolerated (the first time the patient is able to eat any food requiring chewing, without vomiting or going back to liquid diet)

The postoperative hospital stay is the number of hours from surgery until discharge. The criteria for hospital discharge include stable vital signs with no febrile morbidity for ≥24 hours, passage of stool, toleration of a solid diet and the absence of other complications.

After a baseline polysomnography (PSG), subject will receive 100 mg of trazodone 30 minutes prior to their 2nd PSG and will receive 100mg Placebo 30 minutes prior to their 3rd PSG.

After a baseline polysomnography (PSG), subject will receive 100 mg of placebo 30 minutes prior to their 2nd PSG and will receive 100mg trazodone 30 minutes prior to their 3rd PSG.

Sleep Bruxism

TMJ Pain

Chronic Pain

Sleep Disorder

BASELINE PSG Patient has to sleep over at the hospital (sleep lab). The technician will place several sensors on your scalp, temples, chest and legs to record all the data needed for your evaluation. You will be monitored throughout the duration of the test (approximately 6 hours). Brain waves, eye movements, chin muscle tone, breathing patterns, snoring, heart rate, blood pressure, blood oxygen level, body position and muscle activity will be recorded.

polysomnography

100 mg trazodone or placebo given once 30 minutes prior to 2nd PSG

Trazodone

placebo per os 30 minutes prior to 2nd PSG

Placebos

2nd psg, done 1 week after baseline. Patient has to sleep over at the hospital (sleep lab). The technician will place several sensors on your scalp, temples, chest and legs to record all the data needed for your evaluation. You will be monitored throughout the duration of the test (approximately 6 hours). Brain waves, eye movements, chin muscle tone, breathing patterns, snoring, heart rate, blood pressure, blood oxygen level, body position and muscle activity will be recorded.

100 mg trazodone per os 30 minutes prior to 3rd PSG

100 mg placebo per os 30 minutes prior to 3rd PSG

placebos

3rd PSG, done 2 weeks after baseline. Patient has to sleep over at the hospital (sleep lab). The technician will place several sensors on your scalp, temples, chest and legs to record all the data needed for your evaluation. You will be monitored throughout the duration of the test (approximately 6 hours). Brain waves, eye movements, chin muscle tone, breathing patterns, snoring, heart rate, blood pressure, blood oxygen level, body position and muscle activity will be recorded.

CHUM

Accuracy and Efficacy of Trazodone (Desyrel) on Sleep Quality and Pain Management of TMD Patient

Stabilisation de la qualité du Sommeil Chez le Sujet en Douleurs Orofaciales Chroniques - étude expérimentale en chassé croisé : Trazodone/ Placebo

Based on visual analysis of these parameters:
Sleep stage shifts: change from deeper to lighter sleep stage (stage 2, 3&4, REM toward stages 1 or 2); measured as number/hour.
Awakening: presence of alpha and beta electroencephalography (EEG) activities, with rise in submental/chin muscle tone, lasting>10s; measured as number/hour.
Movement arousal: an EEG pattern or awakening associated with major body movement; measured as number/hour.
Microarousal (MA): abrupt shift in EEG frequency lasting more than 3s and less than 10, excluding spindles and K-complexes; measured as number/hour.
Heart rate rapid fluctuations: acceleration of heart beat within 15s recorded by 2 electrodes at thoracic positions. Measured as number/hour.
Presence and severity of abnormal values will be determined based on AASM recommended cutoffs. For value reference in TMD women participants, see Dubrovksy et al 2014. We hypothesize all these parameters would decrease in Trazodone group.

Based on visual analysis of these parameters:
Sleep duration: from time in bed to wake as estimated by EEG (minutes) Sleep efficiency: % time asleep/time in bed (time in minutes) Sleep fragmentation: index of all above criteria (point 1) number/hour Sleep latency: from light off to first sign of sleep on EEG (minutes). REM sleep latency: from sleep onset (on EEG) to first REM sleep stage (minutes).
Presence and severity of abnormal values will be determined based on AASM recommended cutoffs. For references of values in TMD women participants, see Dubrovksy et al 2014. We hypothesize that sleep duration and efficiency will improve in Trazodone group, while sleep fragmentation, sleep latency, and REM sleep latency will decrease.

Measured with a numerical rating scale (0 to 10) were 0 is poorest possible sleep quality and 10 is the greatest possible sleep quality

Measured with a numerical rating scale (0 to 100) were 0 is no pain and 100 is the most intense pain imaginable.

cola/headache

The Functioning of Immune and Hormonal Systems in Patients With Sjogren's Syndrome and in Healthy Volunteers

A Dietary Source of Potassium Citrate to Resolve Hypocitraturia and Aciduria in Patients With Kidney Stones

Does Caffeine Enhance Bowel Recovery After Colorectal Surgery?

Accuracy and Efficacy of Trazodone (Desyrel) on Sleep Quality and Pain Management of TMD Patient

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