Each patient will undergo mastectomy(ies) if immediate reconstruction is being performed, followed by uni- or bilateral abdominally based free flap harvest, microsurgical anastomoses, and flap inset. If randomized to the ketorolac intervention group, then the participant will receive 30 mg of intravenous (IV) ketorolac tromethamine. The anaesthetist will give participants their first study drug intravenously at the conclusion of surgery. The participant will then continue to receive their assigned drug every 6 hours for 72 hours, for a total of 13 doses. Patients all receive 1:1 care from nursing staff in the early postoperative period, and their nurse will administer all drugs given on the surgical ward.

Each patient will undergo mastectomy(ies) if immediate reconstruction is being performed, followed by uni- or bilateral abdominally based free flap harvest, microsurgical anastomoses, and flap inset. If randomized to the control group the patient will be given a sham IV medication. The sham medication will be normal saline at the same volume as ketorolac, which corresponds to 3 ccs. The anaesthetist will give participants their first study drug intravenously at the conclusion of surgery. The participant will then continue to receive their assigned drug every 6 hours for 72 hours, for a total of 13 doses. Patients all receive 1:1 care from nursing staff in the early postoperative period, and their nurse will administer all drugs given on the surgical ward.

Breast Cancer Female

Ketorolac Tromethamine

Normal Saline

Ketorolac for Analgesia followiNG Autologous Breast RecOnstructiOn

recorded in days beginning post operative day number one

Total narcotic consumption over first 72 hours converted to morphine equivalence

Total surgical drain output over first 72 hours

Any hematoma requiring management in the operating room

Any infection requiring antibiotics, or flap complications requiring management in the operating room

Joey Corkum

Physician

Nova Scotia Health Authority

Osteoporosis in Post-menopausal Women

Whole body vibration

GP Office Dr. Baumann

X-pert Med GmbH, MUC

X-pert Med GmbH, Jena

Sportmedizin Stockach

Sophien- und Hufeland- Klinikum GmbH

Safety and Efficacy of Whole-body Vibration as add-on Treatment of Osteoporosis in Post-menopausal Women

Multicentered, Randomized Study of Safety and Efficacy of Whole-body Vibration as add-on to Standard Pharmacological Treatment of Osteoporosis in Post-menopausal Women

1. Changes in markers of bone formation (N-terminal propeptide of type-1 procollagen - P1NP) and bone resorption (cross links of N-terminal telopeptide of type 1 collagen - N-Tx) from baseline to week 6

Changes in Fall Risk (Tinetti Mobility test) from baseline to week 6

Changes in low back pain (100 mm VAS) from baseline to week 6

Dr. med. habil. Matthias Rother

X-pert Med GmbH

All Groups

Sex/Gender, Customized

Region of Enrollment

Adverse Events assessed in accordance with CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0.

Number of Participants Experiencing Serious Adverse Events Including But Not Limited to Hospitalizations, Deaths Related to Treatment, or Other Incapacitating Conditions.

Response and progression will be evaluated in this study using measurements from the MRI/CT scans. Measurements will be made of the image slice with the largest cross sectional area. Two orthogonal measures will be made to determine maximal AP and lateral dimensions. Progression of disease will be defined as a greater than 25% increase of largest cross sectional area by two orthogonal measurements, taking as reference the smallest sum recorded since the treatment started or the appearance of one or more new lesions.

Hydroxyurea: Hydroxyurea inhibits DNA synthesis by inhibition of ribonucleotide diphosphate reductase and is a well-known drug used for the treatment of a number of tumor types including head and neck tumors and chronic myelogenous leukemia. It has also been used as an adjuvant for antiretroviral treatment for patients with HIV and as a treatment for polycythemia vera, essential thrombocythemia and sickle cell disease.
Verapamil: Verapamil is another commonly used medication. It is used for the treatment of angina, hypertension, supraventricular arrhythmias, and migraine prophylaxis. Dosing with standard verapamil is 80-120 mg pox three times a day but the sustained release form can be given 120-480mg once or twice each day.

All Participants

Median Progression-free Survival Rates of the Treatment Population.

Overall Study

Dr. Randy Jensen

Cancer

Brain Cancer

Meningioma

Hydroxyurea inhibits DNA synthesis by inhibition of ribonucleotide diphosphate reductase and is a well-known drug used for the treatment of a number of tumor types including head and neck tumors and chronic myelogenous leukemia. It has also been used as an adjuvant for antiretroviral treatment for patients with HIV and as a treatment for polycythemia vera, essential thrombocythemia and sickle cell disease.

Hydroxyurea

Verapamil is another commonly used medication. It is used for the treatment of angina, hypertension, supraventricular arrhythmias, and migraine prophylaxis. Dosing with standard verapamil is 80-120 mg pox three times a day but the sustained release form can be given 120-480mg once or twice each day.

migraine disorders/phosphatase

Ketorolac for Analgesia followiNG Autologous Breast RecOnstructiOn

Safety and Efficacy of Whole-body Vibration as add-on Treatment of Osteoporosis in Post-menopausal Women

Combination of Hydroxyurea and Verapamil for Refractory Meningiomas

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