In three combined drugs used in nasopharyngeal carcinoma, the valproic acid and valganciclovir administration will be followed by indication to find the maximum tolerance dose of gemcitabine.

Nasopharyngeal Carcinoma

Gemcitabine will be administrated 600~1250 mg/m^2 intravenously according to the body surface area at day 1 and day 8 in a 28 day-treatment cycle. The treatment cycle of 28 days will be repeated maximum 6 times. The first dose level of gemcitabine will be started at 800 mg/m^2. If no subject suffered the dose limit toxicity, 1000 mg/m^2 and even 1250 mg/m^2 will be started by order. If subjects suffered the dose limit toxicity in 800 mg/m^2, the 600 mg/m^2 will be started.

Gemcitabine

Valproic acid will be administrated orally by the fixed dose 12.5 mg/kg/day according to instructions from day 1 to day 14 in one treatment cycle. The treatment cycle of 28 days will be repeated maximum 6 times.

Valproic acid

Valganciclovir will be administrated orally by the fixed dose 1350 mg/day (creatinine clearance rate ≥ 60 mL/min) or 900 mg/day (creatinine clearance rate ≥ 40 mL/min and < 60 mL/min) from day 9 to day 15 in one treatment cycle. The treatment cycle of 28 days will be repeated maximum 6 times.

Valganciclovir

Chang-Gung Memorial Hospital, Linkou

Study of Cytolytic Viral Activation Therapy (CVAT) for Recurrent/Metastatic Nasopharyngeal Carcinoma

Phase I Study of Cytolytic Viral Activation Therapy (CVAT) for Recurrent/Metastatic Nasopharyngeal Carcinoma

According to Worst Toxicity CTCAE v4.03 Grade and FDA indication of gemcitabine, the dose limiting toxicity (DLT) of this trial was determined in the first treatment cycle and DLTs were defined as ≥1 of the following effects attributable to the study drug and requiring discontinuation or a significant dose reduction in the study drug(s):
≥Grade 4 neutropenia >5 days;
≥Grade 4 thrombopenia lasting ≥7 days;
≥Grade 3 anemia;
≥Grade 3 neutropenic fever with a single temperature of >38.3 degree C or a sustained temperature of ≥ 38 degree C for more than one hour;
any ≥Grade 3 non-hematologic toxicity with exception of nausea and vomiting, alopecia, drug-related fever;
≥Grade 3 serum creatinine;
bone marrow and renal function didn't recover to CTCAE Grade ≤ 1 of baseline at the Day 1 of the 2nd treatment course, the treatment can be postponed less than 2 weeks. DLT was recognized when the delayed duration was more than 2 weeks.

The plasma EB virus DNA load will be check by real-time quantitative polymerase chain reaction (PCR). These data will be collected every months when subjects enter this trial and finish their final treatment cycle one weeks, 3 months, and/or 6 months later. These data will be used to supplementary data for tumor status assessment.

Chang Gung Memorial Hospital

TTY Biopharm

REP 2139-Ca is the calcium chelate complex formulation of REP 2139.
Zadaxin is thymosin alpha 1
Pegasys is pegylated interferon alpha 2a
Patients initially receiving REP 2139-Ca with no Grade 3 adverse events at week 20 are eligible to transition to combination therapy with Zadaxin if serum HBV DNA is > 2000 copies / ml.
After 10 weeks of REP 2139-Ca / Zadaxin combination therapy, patients not experiencing a measurable improvement in serum antiviral response can further transition to combination therapy with REP 2139-Ca and Pegasys.

Hepatitis B, Chronic

REP 2139-Ca is administered weekly at 250 or 500mg doses by slow IV infusion.

REP 2139-Ca

Zadaxin is administered twice weekly (1.6mg) by subcutaneous injection

Zadaxin

Pegasys in administered once weekly by subcutaneous injection with dose escalation to 180ug / week.

Pegasys

Farabi General Hospital

Therapeutic Safety and Efficacy of REP 2139 (REP 9AC') in HBV Infected Patients

To record side effects, symptoms and adverse effects of exposure to REP 2139-Ca in monotherapy and when combined with Zadaxin and / or Pegasys.

To assess antiviral activity of REP 2139-Ca in monotherapy and when combined with Zadaxin and / or Pegasus including serum HBsAg, HBeAg, anti-HBsAg antibodies, anti-HBeAg antibodies and HBV DNA.

Replicor Inc.

Individuals with Freeman-Sheldon, Sheldon-Hall, distal arthrogryposis type 1, or distal arthrogryposis type 3

Blood samples will be taken but no retention is expected.

Arthrogryposis

Craniofacial Abnormalities

Completed during the clinical examination and exercise test by the researchers, lactate, glucose, and free and total adenosine triphosphate blood levels are determined at rest and during exercise.

Lactate, Glucose, and Adenosine Triphosphate Blood Levels

During exercise, heart and lung function are monitored for changes caused by exercise, which increases the body's need for oxygen and puts extra demands on the heart. In this study, testing is done using a cycle ergometer and conducted according to the standardised exponential exercise protocol (STEEP).

Physiological Stress Test

Evaluated before clinical examination, it is a checklist of medical problems.

Functional Enquiry Form

Completed during the clinical examination by the researchers, it is a structured approach to evaluation of muscles, joints, arms, thighs, and legs.

Strength, Joint ROM, Girth and Length Measurements

Completed during the clinical examination by the researchers, it is a structured approach to a full physical examination (minus breasts, genitalia, or rectum).

Study Physical Examination

Completed during the clinical examination by researchers, it is a structured approach to evaluation of a person's walking.

Observational Gait Analysis

Completed during the clinical examination by the researchers, it is a general evaluation of mental health status.

Mental Health Interview

Freeman-Sheldon Research Group, Inc.: Organisational website. Includes organisation information and scientific and lay information on Freeman-Sheldon syndrome and related conditions.

Freeman-Sheldon Research Group, Inc. Headquarters

Study of Resting and Exercising Body Functioning in Freeman-Sheldon Syndrome and Related Conditions

Freeman-Sheldon Syndrome Evaluation and Diagnosis in Clinical Settings (FSS-EDICT) I: a Case-Control, Cross-Sectional Study of Baseline and Stress Physiology Parameters

Increased heart rate, measured electrocardiographically, is used as an index of cardiovascular strain imposed by needs during exercise and exaggerated by Freeman-Sheldon and related conditions.

Oxygen consumption, measured by ventilation of expired oxygen, is used as a measure of physiological strain imposed by metabolic needs during exercise and exaggerated by Freeman-Sheldon and related conditions.

Increased non-invasive arterial blood pressure rate is used as an index of cardiovascular strain imposed by needs during exercise and exaggerated by Freeman-Sheldon and related conditions.

Decreased ability of the lungs to move air, measured by forced expiration, is used as an index of strain imposed by Freeman-Sheldon syndrome and related conditions.

Decreased saturation of peripheral oxygen, measured by pulse oxymetry, is used as a measure of physiological strain imposed by metabolic needs during exercise and exaggerated by Freeman-Sheldon and related conditions.

Increased respiratory rate, measured by plethysmograph, is used as a measure of physiological strain imposed by metabolic needs during exercise and exaggerated by Freeman-Sheldon and related conditions.

Heart rhythms, monitored by electrocardiograph, are used as an index of cardiovascular strain imposed by needs during exercise and exaggerated by Freeman-Sheldon and related conditions.

Increased core temperature, measured as oesophageal temperature, is used as a measure of physiological strain imposed by metabolic needs during exercise and exaggerated by Freeman-Sheldon, related conditions, and malignant hyperthermia.

Decreased adenosine triphosphate, measured as capillary blood level, is used as a measure of physiological strain imposed by metabolic needs during exercise and exaggerated by Freeman-Sheldon and related conditions.

Increased perceived exertion, measured using the Borg scale, are used as an index of fatigue.

Increased muscle rigidity, evaluated by clinical examination and patient self-report, is used as an indicator of malignant hyperthermia, when increased core temperature, heart rate, and respiratory rate are present.

Functional and health-related quality of life, measured with the Medical Outcomes Trust Short Form (36) Health Survey (SF-36), is used as a general prediction of expected physical exercise capacity.

Lactic acid, measured by capillary blood level, is used as a measure of physiological strain imposed by metabolic needs during exercise and exaggerated by Freeman-Sheldon and related conditions.

Glucose, measured by capillary blood level, is used as an index of physiological strain, together with lactic acid and adenosine triphosphate capillary blood levels, imposed by metabolic needs during exercise and exaggerated by Freeman-Sheldon and related conditions.

Body composition, measured by calliper, together with direct indices of physiological strain, is used to determined metabolic disease burden of Freeman-Sheldon syndrome and related conditions.

Decreased hand grip strength, measured by a hand dynamometer, is used as an index of physiological strain imposed by Freeman-Sheldon and related conditions

We do not intend to share any individual participant data.

Freeman-Sheldon Research Group, Inc.

8 subjects to receive vaccine (10 mcg) alone on Days 0, 29 and 59.

8 subjects to receive vaccine (10 mcg) with 250 mcg of adjuvant on Days 0, 29 and 59.

8 subjects to receive vaccine (10 mcg) with 500 mcg of adjuvant on Days 0, 29 and 59.

4 subjects to receive normal saline (placebo) on Days 0, 29 and 59.

Bacterial Sepsis

CPG 7909 is a synthetic oligodeoxynucleotide used as an adjuvant and administered at 2 different dosages: 250 mcg and 500 mcg.

CPG 7909

J5-OMP vaccine 10 mcg to be administered with and without CpG 7909 adjuvant 250 or 500 mcg, intramuscularly on Days 0, 29 and 59.

J5-OMP Vaccine

Placebo

University of Maryland Medical System - General Clinical Research Center (GCRC)

Detoxified J5 Core Glycolipid/ Group B Meningococcal Outer Membrane Protein Vaccine for Gram-negative Bacterial Sepsis Administered With and Without Synthetic CPG Oligodeoxynucleotide 7909 Adjuvant

A Randomized, Partial-Blinded, Placebo-Controlled, Phase I Safety and Immunogenicity Study in Healthy Subjects of Detoxified J5 Core Glycolipid/ Group B Meningococcal Outer Membrane Protein Vaccine for Gram Negative Bacterial Sepsis Administered With and Without Synthetic CPG Oligodeoxynucleotide 7909 Adjuvant

cytosine/febre

Study of Cytolytic Viral Activation Therapy (CVAT) for Recurrent/Metastatic Nasopharyngeal Carcinoma

Therapeutic Safety and Efficacy of REP 2139 (REP 9AC') in HBV Infected Patients

Study of Resting and Exercising Body Functioning in Freeman-Sheldon Syndrome and Related Conditions

Detoxified J5 Core Glycolipid/ Group B Meningococcal Outer Membrane Protein Vaccine for Gram-negative Bacterial Sepsis Administered With and Without Synthetic CPG Oligodeoxynucleotide 7909 Adjuvant

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