Vitamin C (ascorbic acid) 500 mg/capsule. Ingestion of 2 capsules (1000 mg) daily for 12 months.

Placebo capsule. Ingestion of 2 capsules daily for 12 months. Placebo will be prepared as capsules that look and taste identical to the vitamin C supplement capsules. The content of the placebo is lactose, potato starch, gelatin, magnesium stearate, and talc.

Myelodysplastic Syndromes

Chronic Myelomonocytic Leukemia-1

Cytopenia

Monotherapy with oral vitamin C supplementation to elevate plasma vitamin C level to the upper end of the physiological range.

Vitamin C (ascorbic acid)

Placebo

Nordic Council of Ministers (2012). Vitamin C. In Nordic Nutrition Recommendations (NNR) (Copenhagen), pp. 465-473

University of Southern California

Rigshospitalet

Herlev Hospital

Epigenetics, Vitamin C, and Abnormal Blood Cell Formation - Vitamin C in Patients With Low-Risk Myeloid Malignancies

Epigenetics, Vitamin C, and Abnormal Hematopoiesis - Role of Vitamin C in Epigenetic Regulation in Hematopoiesis Sub-Study on CCUS, Low-Risk MDS, and CMML-0/1

Mean change from baseline to 12 months in mutant allele burden as measured by the variant allele frequency (VAF) and number of mutations.

Mean change from baseline to 3 months in global 5-hmC/5-mC measured in hematopoietic stem cells is compared between the vitamin C group and the placebo group. In addition, the mean change from baseline in 5-hmC/5-mC at 12 months is compared between participants in the vitamin C arm with baseline plasma vitamin C level in the normal range vs. participants in the vitamin C arm with baseline plasma vitamin C level below the normal range.

Mean change from baseline to 12 months in 5-mC at promoters/enhancers/long terminal repeats, and other regulatory genomic regions of tumor suppressors/methylated driver genes/genes involved in hematopoietic development.

Mean change from baseline to 12 months in methylated histone H3 lysine at position 9 at promoters/enhancers/long terminal repeats, and other regulatory regions of tumor suppressors/methylated driver genes/genes involved in hematopoietic development.

Mean change from baseline to 12 months in plasma cytokine levels (e.g., IL-6, S100A9, etc.).

Mean change from baseline to 12 months in mRNA levels of tumor suppressor genes, oncogenes, epigenetic regulators, cytokines, and genes involved in hematopoietic development.

Mean change from baseline to 3 months in mRNA levels of tumor suppressor genes, oncogenes, epigenetic regulators, cytokines, and genes involved in hematopoietic development.

Number of serious adverse events and treatment-related adverse events as assessed by CTCAE v5.0. Adverse events, that are not considered serious or related to vitamin C intake, will not be recorded.

Percentage of participants with baseline plasma vitamin C level below the normal physiological range.

Mean change from baseline to 12 months in global 5-hmC/5-mC measured in hematopoietic stem cells is compared between the vitamin C group and the placebo group. In addition, the mean change from baseline in 5-hmC/5-mC at 12 months is compared between participants in the vitamin C arm with baseline plasma vitamin C level in the normal range vs. participants in the vitamin C arm with baseline plasma vitamin C level below the normal range.

Kirsten Grønbæk

Professor, MD, DMSc

Rigshospitalet, Denmark

Van Andel Research Institute

Imperial College London

University of Copenhagen

Zealand University Hospital

Technical University of Denmark

Prospective, randomized, placebo-controlled trial.

Randomization performed by the independent provider of study medication (Glostrup Pharmacy).

Diet modification - nortriptyline and then if necessary topiramate

Diet Modification topiramate and then nortriptyline if necessary

Migraine Disorders

The nortriptyline will be given in an escalating fashion, starting at 25 mg PO qhs for 2 weeks, followed by 50 mg PO qhs for 2 weeks, and finally 75 mg PO qhs. Patients will be encouraged to use the lowest effective dose and to self-titrate their medication.

nortriptyline

Topiramate dosing will be 25 mg PO qhs for 1 week, followed by 25 mg BID for 1 week, followed by 25 mg in the morning and 50 mg qhs for 1 week, and finally 50 mg BID

Topiramate

Saint Louis University

Trial of Nortriptyline and Topiramate in the Initial Treatment of Vestibular Migraine

A Prospective Randomized Cross-over Trial of Nortryptyline and Topiramate in the Initial Treatment of Vestibular Migraine.

Changes in Migraine Specific Quality of LIfe (MSQ) and Dizziness Handicap Inventory (DHI) between groups

Anthony A. Mikulec, MD

Associate Professor

St. Louis University

Patients will receive ESWL and no medication

Patients will receive silodosin after ESWL

Kidney Stones

silodosin

Extra-corporeal shock wave lithotripsy

Tamsulosin

Albert Einstein Healthcare Network

Differential Effect of Silodosin Versus Tamsulosin on Stone Clearance After Extra-corporeal Shock Wave Lithotripsy

Differential Effect of Silodosin Versus Tamsulosin on Stone Clearance After ESWL

The primary endpoint of this study is the clearance rate of kidney stones. That is, in what period of time does the patient achieve clearance, is stone free and has all residual stones gone. This outcome measure will be measured in days.

Analgesic use, number of pills of pain medication

Residual stones remaining, based on imaging

need for re-treatment. Either the patient will need another ESWL, or hospitilization

need for intervention. Either ESWL again or hospitilization and further procedures such as laser lithotripsy, percutaneous nephrolithotomy, open surgery

steinstrasse clearance. Whether or not stone clearance is achieved or not

need for hospitalization. either yes or no

Richard Harkaway

PRINCIPAL INVESTIGATOR

Acute Schizophrenia

niacinamide

pyridoxine

ascorbate

Beersheva Mental Health Center

Treatment of Acute Schizophrenia With Vitamin Therapy

The Treatment of Acute Schizophrenia With High Dose Niacinmide Plus Ascorbate Plus Pyridoxine Plus Centrum Forte vs. Centrum Forte Only as an Add-On to Risperidone and Dietary Counseling

kidney calculi/diarrhea

Epigenetics, Vitamin C, and Abnormal Blood Cell Formation - Vitamin C in Patients With Low-Risk Myeloid Malignancies

Trial of Nortriptyline and Topiramate in the Initial Treatment of Vestibular Migraine

Differential Effect of Silodosin Versus Tamsulosin on Stone Clearance After Extra-corporeal Shock Wave Lithotripsy

Treatment of Acute Schizophrenia With Vitamin Therapy

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