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Property:Exclusion criteria

From CAMIH

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H
Clinical stage T3 or T4, Gleason score ≥ 8, serum PSA ≥ 20 ng/mL, other prior surgery for prostate cancer, concurrent participation in another clinical trial which would require approval upon entry to this trial, gastrointestinal disorders such as inflammatory bowel disease, reflux and peptic ulcers and any adverse reaction to curcumin  +
History of hepatitis, alcohol abuse and other significant medical or psychiatric condition; took 5-alpha reductase inhibitors, antiandrogens, or luteinizing hormone-releasing hormone agonists  +
History of diabetes, history of peripheral neuropathy resulting from other causes, or seizure disorder; receiving any of the following medications used to treat CIPN were excluded: vitamin E, glutamine, gabapentin, nortriptyline, amitriptyline or duloxetine hydrochloride (HCL), and other nutritional supplements used to treat CIPN  +
History of diabetes, history of peripheral neuropathy resulting from other causes, or seizure disorder; receiving any of the following medications used to treat CIPN were excluded: vitamin E, glutamine, gabapentin, nortriptyline, amitriptyline or duloxetine hydrochloride (HCL), and other nutritional supplements used to treat CIPN  +
Evidence of rapid terminal decline, recent traumatic injury, or hospitalization within the 2 weeks, skin diseases: acute psoriasis, eczema, severe bruises, skin infection or ulceration, open wound, recent burn or fracture, inflammatory conditions: acute rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis, Reiter’s syndrome, cardiovascular conditions: history of deep vein thrombosis, phlebitis, angina, a pacemaker, recent discontinuation(less than 2 weeks) of physiotherapy that included massagetherapy, fever (recent temperature >102◦within past 24hours), or currently prescribed anticoagulant medication (e.g., Coumadin, Heparin, or derivative substances).  +
Uncontrolled diabetes; uncontrolled eating disorders; acquired immunodeficiency syndrome, active lupus or scleroderma; known allergy to pure aloe; inability to complete the screening and informed consent procedures before receiving a total of 10 Gy of radiation  +
Patient were asked to refrain from large quantities of resveratrol-containing foods and drinks such as peanuts, grapes, mulberries and alcohol within 48 h of scheduled PK collection days, and the day of surgical resection.  +
I
Adequate vitamin D levels; hypercalcemia, osteoporosis, stage IV kidney disease or myocardial infarction within the past year  +
J
Known hypersensitivity reaction to vitamin D or calcium com-pounds, known comorbidities affecting the vitamin D/calcium balance or bone health, concomitant vitamin D supplementation  +
Ongoing use of tube feedings or parenteral nutrition; edema or ascites; treatment with adrenal corticosteroids (except for short-term dexamethasone during the time of chemotherapy), androgens, progestational agents, or other appetite stimulants within the previous month; brain metastases; insulin-requiring diabetes; pregnancy or lactation or unwillingness to use oral contraceptives; anticipated alcohol or barbiturate use during the study period; poorly controlled hypertension or congestive heart failure; history of thromboembolic disease; mechanical obstruction of the alimentary tract, malabsorption, or intractable vomiting  +
Patients with history of allergy to systemic opioids, substance use disorder, coagulopathy, chronic opioid use, sleep apnea, and analgesic use within 24 h  +
Current use of at least 600 IU/day of supplemental vitamin D or high-dose calcium therapy within the prior 6 month and any prior cancer or other significant diseases that could hamper the participant’s safety or preclude the benefit of vitamin D supplementation  +
Cancers affecting the oral cavity; radiotherapy to the floor of the mouth; major psychiatric or cardiovascular disorders; epilepsy; renal or hepatic impairment; pregnant, lactating, or not using adequate contraception; therapies expected to confound the study outcome (epidural analgesia within 48 hours of screening; palliative radio-, chemo-, or hormonal therapy within two weeks of screening; CBs within seven days of randomization); use of levodopa, sildenafil, or fentanyl; hypersensitivity to CBs  +
K
Known pregnancy or lactation; history of intolerability to emzyme preparations or to the passive ingredients ; arterial closures and/or flow-off disorders at the ill arm and/or contra lateral arm; connate lmphatic oedema; treatment with venoactive drugs such as Rutosides, Bioflavonoides, Aescin, ets.; treatment with NSAIDs; contraindication for lymphatic drainage; participation in any clinical study in the last 30 days; simultaneous participation in any other clinical trial  +
Unwillingness to participate in the study, vaginal infection, estrogen therapy in the last 8 weeks, idiopathic vaginal bleeding, and disease recurrence based on the diagnosis recorded in the patient’s file  +