0

NCT00000726

Cytomegalovirus Retinitis

283

1

NCT00000726

Immunologic Deficiency Syndromes

28099

2

NCT00000726

Acquired Immunodeficiency Syndrome

48294

3

NCT00000726

Retinitis

9843

4

NCT00000726

Communicable Diseases

28178

0

NCT00000726

Foscarnet

529

1

NCT00000726

Phosphonoacetic Acid

2823

2

NCT00000179

Trazodone

656

3

NCT00000179

Haloperidol decanoate

502

4

NCT00000179

Haloperidol

502

NCT06207370

21

NCT01306058

46

NCT00513604

48

NCT00924001

48

NCT00301509

61

NCT00000102

United States

NCT00000105

United States

NCT00000116

United States

NCT00000117

United States

NCT00000119

United States

00002007-b79a-468c-8976-5f7df5949f71

NCT03246529

All

0

18 Years

78 Years

No

Inclusion Criteria: 1. Histologically confirmed Multiple Myeloma prior to enrolment and randomization. 2. At least 1 week (7 days) from last induction cycle of combination/multi-agent cyto-reductive chemotherapy (e.g., KRD [carfilzomib, lenalidomide, dexamethasone] or VRD (e.g., bortezomib, lenalidomide, dexamethasone) or last single agent chemotherapy (e.g., lenalidomide, pomalidomide, bortezomib, dexamethasone, etc.) prior to the first dose of G-CSF for mobilization. 3. Eligible for autologous hematopoietic stem cell transplantation according to the Investigator's discretion. 4. The subjects should be in first or second CR (including CR and SCR) or PR (including PR and VGPR). 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 6. Adequate organ function at screening as defined as below: 1. Hematology: - White blood cell counts more than 2.5 x 10^9/L - Absolute neutrophil count more than 1.5 x 10^9/L 2. Platelet count more than 100 x10^9/L Renal Function: • Glomerular Filtration Rate (GFR) value of ≥15 mL/min/1.732 calculated by Modification of Diet in Renal Disease (MDRD) equation 3. Hepatic function: - Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤ 2.5 x ULN - Total Bilirubin ≤ 2.0 x Upper Limit Normal (ULN) unless the subject has Gilbert disease 4. Coagulation test: - International Normalized Ratio (INR) or Prothrombin Time (PT): ≤1.5 x ULN unless subject is receiving anticoagulant therapy, as long as PT or Partial Thromboplastin Time (PTT) is within therapeutic range of intended use of anticoagulants - Activated Partial Thromboplastin Time (aPTT): ≤1.5 x ULN unless subject is receiving anticoagulant therapy, as long as PT or PTT is within therapeutic range of intended use of anticoagulants 7. Male subjects must agree to use an adequate method of contraception starting with the first day of G-CSF administration through 30 days after the last dose of study drug. 8. Patients must have a signed study informed consent prior to entering the study. Exclusion Criteria: 1. Previous history of autologous or allogeneic-Hematopoietic Cell Transplantation (HCT). 2. Failed previous Hematopoietic Stem Cell (HSC) collections or collection attempts. 3. Taken any of the listed below concomitant medications, growth factors or stimulating agents within the designated washout period: 1. Dexamethasone: 7 days; 2. Thalidomide: 7 days; 3. Lenalidomide: 7 days; 4. Pomalidomide: 7 days; 5. Bortezomib: 7 days; 6. Carfilzomib: 7 days; 7. G-CSF: 14 days; 8. Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) or Neulasta®: 21 days; 9. Erythropoietin or erythrocyte stimulating agents: 30 days; 10. Eltrombopag, romiplostim or platelet stimulating agents: 30 days; 11. Carmustine (BCNU): 42 days/6 weeks; 12. Daratumumab: 28 days; 13. Ixazomib: 7 days. 4. Received >6 cycles lifetime exposure to thalidomide or lenalidomide. 5. Received >8 cycles of alkylating agent combinations. 6. Received >6 cycles of melphalan. 7. Received prior treatment with radioimmunotherapy (e.g., radionuclides, holmium). 8. Received prior treatment with venetoclax. 9. Plans to receive maintenance treatment within 60 days post-engraftment (e.g., lenalidomide, bortezomib, pomalidomide, thalidomide, carfilzomib, etc.) 10. Has received a live vaccine within 30 days of the planned start of G-CSF administration. Seasonal flu vaccines that do not contain live virus are permitted. 11. Known active central nervous system (CNS) metastases or carcinomatous meningitis. 12. A history of allergic reactions attributed to compounds of similar chemical or biologic composition to BL-8040, G-CSF, or other agents used in the study. 13. Has an active infection requiring systemic therapy or uncontrolled infection. 14. Has a known additional malignancy that is progressing or requires active treatment. 15. Has an underlying medical condition that would preclude study participation. 16. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment. 17. O2 saturation < 92% (on room air). 18. Personal history or family history of Long QT Syndrome or Torsade de Pointes. 19. History of unexplained syncope, syncope from an uncorrected cardiac etiology, or family history of sudden cardiac death. 20. Myocardial infarction, coronary artery bypass grafting (CABG), coronary or cerebral artery stenting and /or angioplasty, stroke, cardiac surgery, or hospitalization for congestive heart failure within 3 months or greater than Angina Pectoris Class >2 or New York Heart Association (NYHA) Heart Failure >2. 21. ECG in screening showing QTcF > 470 msec, and/or PR > 280 msec,. 22. Mobitz II 2nd degree Atrioventricular (AV) Block, 2:1 AV Block, High Grade AV Block, or Complete Heart Block, unless the patient has an implanted pacemaker or implantable cardiac defibrillator (ICD) with backup pacing capabilities. 23. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. 24. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 25. Is pregnant or breastfeeding, or expecting to conceive within the projected duration of the trial, starting with the screening visit through 30 days after the last dose of study drug. 26. Has a known history of HIV (HIV 1/2 antibodies) 27. Has known active Hepatitis B (e.g., Hepatitis B Surface Antigen [HBsAg] reactive) or Hepatitis C (e.g., Hepatitis C Virus [HCV] RNA [qualitative] is detected). 28. Untreated or unsuccessfully treated Hepatitis B or C.

00003d89-d1ea-432e-9863-5bcd91e204e4

NCT01756560

All

0

18 Years

75 Years

No

Inclusion Criteria: - age 18-75, no contraindication to regional anesthesia Exclusion Criteria: - peripheral neuropathy

00005b5c-7a71-4602-a7fa-89d453a5decd

NCT00193258

All

0

18 Years

No

Inclusion Criteria: To be included in this study, you must meet the following criteria: - Metastatic or unresectable clear cell renal carcinoma confirmed by biopsy - Previous nephrectomy is required - Maximum of 1 previous systemic regimen for metastatic disease. - Able to perform activities of daily living with minimal assistance - Measurable disease - Adequate bone marrow, liver and kidney - Written informed consent. Exclusion Criteria: - Age < 18 years - Treatment with more than 1 previous systemic regimen - History of heart attack within 6 months - Clinically significant cardiovascular disease - Moderate to severe vascular disease. - Active brain metastases. - History or evidence by physical examination of brain tumor - Seizures not controlled with standard medical therapy - history of stroke or other serious disorders of the nervous system - Clinical history of coughing or vomiting blood within the past 3 months. - PEG tubes or G tubes - Chronic therapy with NSAIDS or other platelet inhibitors - Proteinuria - Nonhealing wound, ulcer, or long bone fracture - Clinical evidence or history of a bleeding disorder - Requiring full dose anticoagulation with coumadin - Receiving chronic steroid therapy - Significant medical conditions. - Tumors other than clear cell - History of stroke within 6 months. - History of abdominal fistula,perforation,or abscess within 6 months. Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

0000a853-07b6-42bf-b37a-74ac0019e8d7

NCT05443984

All

0

19 Years

No

- Inclusion Criteria: Subjects must satisfy all the following criteria. 1. Male or female, ≥ 19 years of age at the time of obtaining consent 2. Subjects who had experienced heartburn and regurgitation within 7 days prior to the screening visit, those whose severity and frequency of symptoms fall under the following (1) or (2) ⑴ Subjects who have experienced mild or more severe heartburn or regurgitation at least twice a week ⑵ Subjects who have experienced moderate or more severe heartburn or regurgitation at least once a week 3. Endoscopically confirmed grade A or higher erosive esophagitis as defined by †LosAngeles classification within 15 days, prior to randomization 4. Subjects who fully understand this study and voluntarily signed on the informed consent form - Exclusion Criteria: Subjects may not satisfy any of the following criteria. 1. Subjects who can't undergo endoscopy 2. Medical History º Subjects who have warning symptoms of the malignant gastrointestinal tract such as odynophagia, severe dysphagia, bleeding, weight loss, anemia, or bloody stool. (except negative result for malignancy by endoscopy) º Subjects with eosinophilic esophagitis (except negative result by esophageal biopsy) º Subjects who have esophageal stenosis, gastroesophageal varices, Barrett's esophagus, active gastric ulcer, gastrointestinal bleeding, or malignant tumor confirmed by EGD º Zollinger-Ellison syndrome patients º Subjects diagnosed with primary esophageal motility disorder, irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), or suspected with IBS in the last 3 months and with a current history of the disease including pancreatitis º Subjects who have a history of gastric acid suppression surgery, gastrointestinal or esophageal surgery (except appendectomy, cholecystectomy, polypectomy) º Subjects with a history of clinically significant hepatic, renal, cardiovascular, respiratory, endocrine, urinary, neuro-psychiatric, hemato-oncologic disorder º Subjects who have a history of malignant tumor in 5 years at the time of screening. However, excluding subjects with malignant gastrointestinal cancer regardless of the period. 3. Laboratory Test Screening laboratory test showing any of the following abnormal laboratory results: º ALT or AST > 2.0 x ULN º ALP or GGT > 2.0 x ULN º Total bilirubin > 2.0 x ULN º eGFR<70 mL/min/1.73 m2 (CKD-EPI formula) º Positive result for Serological test (HBsAg, HCV Ab, HIV Ab, Syphilis reagin test) º Clinically significant ECG abnormalities 4. Allergy and drug hypersensitivity º Known hypersensitivity to the active ingredient or excipients of the investigational product º Clinically significant allergies (except mild allergic rhinitis) or hypersensitivity history to drugs. (Aspirin, antibiotics, etc.) 5. Prohibited medication and therapy º Subjects who take gastric acid suppressant like P-CAB, PPI within 2weeks prior to EGD of screening procedure º Subjects who take medication (antacids, prokinetics, H2RA, etc.) related to reflux esophagitis more than 2times within 1week prior to EGD of screening procedure º Subjects who need to take medication (aspirin, NSAIDs, etc.) that may cause an ulcer, during the study period º Subjects who are on or need to be on the medications which categorized as contraindicated in this clinical trial. However, subjects who are on the contraindicated medications can participate in the trial after the washout period of 2 weeks. If five times of the half-life of the contraindicated medications exceeds 2 weeks, the washout period will be set as five times of the half-life. 6. Pregnant and lactating women 7. Contraception Subjects who do not agree to use medically acceptable methods of contraception during the period study 8. Subjects with clinically significant psychiatric disorder and a history with a drug and alcohol abuse. 9. Subjects who are judged unsuitable to participate in the study in the opinion of the investigator

00012e02-17e3-4bd5-95bc-ce17b49e8423

NCT04163419

All

0

18 Years

No

Inclusion Criteria: 1. Patients must have a confirmed diagnosis schwannomatosis by fulfilling either clinical or molecular diagnosis. 2. Age ≥ 18 years. Patients < 18 years are excluded since the safety profile of tanezumab in this population has not been determined. 3. ECOG performance status ≤2 or Karnofsky ≥60% 4. Participants must have normal organ and marrow function as defined per the full protocol 5. The subject's weight must be≥ 45 kg at Screening. 6. The subject must be willing to avoid prohibited pain medications (including non-steroidal anti-inflammatory drugs) throughout the duration of the study except as permitted per Protocol. 7. Subject must have moderate to severe pain secondary to schwannomatosis, defined as Score ≥5 on the Numeric Rating Scale-11 (NRS-11) at Screening. 8. Subject must have failure, intolerance, or contraindication to at least three standard of care therapies: - Documented history indicating that NSAID therapy has not provided adequate pain relief or subject is unable to take NSAIDs due to contraindication or inability to tolerate. - Documented history indicating that opioid treatment has not provided adequate pain relief or subject is unwilling to take opioids, or unable to take opioids due to contraindication or inability to tolerate - Documented history indicating that neuropathic pain medications, such as gabapentin, pregabalin, or others, have not provided adequate pain relief or subject is unable to take these treatments due to contraindication or inability to tolerate. 9. Female subjects of childbearing potential and at risk for pregnancy (e.g., not abstinent) must agree to use 2 highly effective methods of contraception throughout the study and for 112 days (16 weeks) after the last dose of assigned subcutaneous study medication. Exclusion Criteria: 1. Subjects with any of the following criteria: evidence of bilateral vestibular schwannomas on imaging, a known germline pathogenic NF2 mutation, a first-degree relative who meets diagnostic criteria for NF2, or have schwannomas limited to a previous radiation field. 2. Subjects with intracranial meningioma associated with cerebral edema on neuroimaging. Note: presence of intracranial meningioma itself is not an exclusion criterion. 3. Subjects who have had surgery, chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) for treatment of a painful schwannomatosis-related tumor prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. 4. Participation in other studies involving investigational drug(s) (Phases 1-4) within 30 days (or 90 days for biologics) before Screening and/or during study participation. 5. Subjects receiving anticoagulation to treat an underlying medical condition. 6. Subject has a history of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG fusion protein. 7. The subject's pain is related to a non-schwannomatosis cause such as prior cancer therapy, infection, bowel obstruction/perforation, spinal cord compression, or fracture or impending fracture of weight bearing bone. 8. The subject has a diagnosis of malignancy in the last 3 years (except for Gleason 6 prostate cancer, basal cell carcinoma or carcinoma in situ). 9. Use of concurrent adjuvant analgesics such as serotonin norepinephrine reuptake inhibitors (SNRI), tricyclic antidepressants, anticonvulsant medication, or muscle relaxants (unless the drugs were started at least 30 days prior to Screening and are maintained at a stable dose). 10. Use of concurrent analgesic non-steroidal anti-inflammatory drugs (NSAIDs, including selective COX-2 inhibitors) unless the subject is expected to be able to discontinue these medications at least 2 weeks prior to treatment. Note: Subjects who take daily low dose aspirin (≤ 325 mg as per local prescribing practice) therapy for cardiovascular prophylaxis are not excluded from participation. 11. Diagnosis of osteoarthritis of the knee or hip as defined by the American College of Rheumatology (ACR) combined clinical and radiographic criteria; Radiographic criteria will be assessed by the Central Reader. 12. Use of concurrent corticosteroids (except for inhaled or topical corticosteroids as needed for management of ongoing pulmonary or dermatologic conditions) 13. Subjects considered unfit for surgery, defined as Grade >3 on the American Society of Anesthesiologists (ASA) physical classification system for surgery or subjects who would not be willing to undergo joint replacement surgery if required. 14. Subjects with symptoms and radiographic findings (i.e. joint space narrowing, osteophytes) consistent with osteoarthritis in the shoulder. 15. History of significant trauma or surgery to a major joint (e.g. hip, knee or shoulder) within one year prior to Screening. 16. A history of osteonecrosis or osteoporotic fracture (i.e., a subject with a history of osteoporosis and a minimally traumatic or atraumatic fracture). 17. Radiographic (x-ray) evidence of any of the following conditions as determined by the central radiology reviewer at Screening: 1) rapidly progressive osteoarthritis, 2) atrophic or hypotrophic osteoarthritis, 3) subchondral insufficiency fracture, 4) spontaneous osteonecrosis of the knee (SPONK), 5) osteonecrosis, or 6) pathologic fracture. 18. Subjects who have evidence of orthostatic hypotension based upon replicate orthostatic blood pressure measurements at Screening. 19. Subjects with a total impact score of >7 on the Survey of Autonomic Symptoms (SAS) at Screening. 20. Diagnosis of a transient ischemic attack in the 6 months prior to Screening or diagnosis of stroke with residual deficits (e.g., aphasia, substantial motor or sensory deficits), that would preclude completion of required study activities. 21. History, diagnosis, or signs and symptoms of clinically significant neurological 22. Subjects with a past history of carpal tunnel syndrome (CTS) with signs or symptoms of CTS in the one year prior to Screening. 23. Subject with a history of significant alcohol, analgesic, or narcotic substance abuse within the six months prior to Screening. 24. Subject who, in the judgement of the investigator, is expected to require a surgical procedure during the duration of the study. 25. Previous exposure to exogenous nerve growth factor or to an anti-nerve growth factor antibody. 26. Subjects who are investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the Investigator, or subjects who are Pfizer employees directly involved in the conduct of the trial 27. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 28. Pregnant females; breastfeeding females; females of childbearing potential not using two (2) methods of highly effective contraception or not agreeing to continue two (2) methods of highly effective contraception for 112 days (16 weeks) after last dose of investigational product. 29. Any subject who, in the judgement of the investigator, is deemed inappropriate for participation in the study.

0

NCT00000726

NCT00000726

primary

1

NCT00000726

ACTG 015

org_study_id

2

NCT00000726

FDA 20D

external

3

NCT00000726

10991

external

4

NCT00001302

NCT00001302

primary

00001893-473d-4d35-b0d6-019d54c53460

d177da34-5f45-4231-914e-a81b486a64f2

00003aab-b2ea-43dc-b89d-ac18b3901e92

5b79b5d8-68c8-42e1-8ac9-6e98964b75ba

00004f13-b15b-49c7-b4b2-fbdd9d414d52

2d3be8b8-26c6-4732-bd87-1a5495d1fde0

00004f13-b15b-49c7-b4b2-fbdd9d414d52

3852a4f1-ee82-4717-9674-24b885150288

00004f13-b15b-49c7-b4b2-fbdd9d414d52

45ef5f15-0334-4179-94d4-6e78b5ab1b8c

00001893-473d-4d35-b0d6-019d54c53460

NCT02992015

drug

Gemcitabine

Participants receive a one time IV dose of gemcitabine prior to having standard of care surgery.

00003aab-b2ea-43dc-b89d-ac18b3901e92

NCT05605899

biological

Axicabtagene Ciloleucel

A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells

00004f13-b15b-49c7-b4b2-fbdd9d414d52

NCT03055936

drug

Carbidopa

Carbidopa 12.5 mg or 25 mg or 65 mg

00007903-41bc-4943-9299-e78ae1330a1b

NCT02424305

drug

LEO 43204 gel 0.018%

00007a6a-0c46-446e-b660-d7a5078d4125

NCT00124748

drug

Imatinib mesylate

Imatinib is packaged in bottles as 100mg and 400mg tablets

223653

00001893-473d-4d35-b0d6-019d54c53460

441

336188

00003aab-b2ea-43dc-b89d-ac18b3901e92

14009

227729

00004f13-b15b-49c7-b4b2-fbdd9d414d52

190

192356

00007903-41bc-4943-9299-e78ae1330a1b

16027

21518

00007a6a-0c46-446e-b660-d7a5078d4125

619

0

2e37e858-4b10-4024-a1d3-6b098eb85d42

Elavil

1

1bcac8d4-8e28-40f9-8823-542aeaa25058

elavil plus prozac

2

7045ffaa-6662-4c28-8337-343637f3b492

Subutex

3

7045ffaa-6662-4c28-8337-343637f3b492

Suboxone

4

2af7f79e-5717-4256-9fbe-4b65ea809832

Zoloft

70275

00001893-473d-4d35-b0d6-019d54c53460

477726

99499

00003aab-b2ea-43dc-b89d-ac18b3901e92

387170

4277

00007a6a-0c46-446e-b660-d7a5078d4125

91793

4276

00007a6a-0c46-446e-b660-d7a5078d4125

140871

33463

00036210-302a-4295-9ba4-cabad6029b49

107929

NCT00017381

0

NCT00091286

0

NCT00140556

0

NCT00176059

0

NCT00187941

0

0

NCT00000726

National Institute of Allergy and Infectious Diseases (NIAID)

nih

1

1

NCT00001302

National Cancer Institute (NCI)

nih

1

2

NCT00000179

National Institute on Aging (NIA)

nih

1

3

NCT00000333

Washington D.C. Veterans Affairs Medical Center

us_fed

0

4

NCT00000333

National Institute on Drug Abuse (NIDA)

nih

1

NCT00000102

Congenital Adrenal Hyperplasia: Calcium Channels as Therapeutic Targets

completed

treatment

This study will test the ability of extended release nifedipine (Procardia XL), a blood pressure medication, to permit a decrease in the dose of glucocorticoid medication children take to treat congenital adrenal hyperplasia (CAH).

This protocol is designed to assess both acute and chronic effects of the calcium channel antagonist, nifedipine, on the hypothalamic-pituitary-adrenal axis in patients with congenital adrenal hyperplasia. The multicenter trial is composed of two phases and will involve a double-blind, placebo-controlled parallel design. The goal of Phase I is to examine the ability of nifedipine vs. placebo to decrease adrenocorticotropic hormone (ACTH) levels, as well as to begin to assess the dose-dependency of nifedipine effects. The goal of Phase II is to evaluate the long-term effects of nifedipine; that is, can attenuation of ACTH release by nifedipine permit a decrease in the dosage of glucocorticoid needed to suppress the HPA axis? Such a decrease would, in turn, reduce the deleterious effects of glucocorticoid treatment in CAH.

1

NCT00000105

Vaccination With Tetanus and KLH to Assess Immune Responses.

Vaccination With Tetanus Toxoid and Keyhole Limpet Hemocyanin (KLH) to Assess Antigen-Specific Immune Responses

terminated

The purpose of this study is to learn how the immune system works in response to vaccines. We will give the vaccines to subjects who have cancer but have not had treatment, and to patients who have had chemotherapy or stem cell transplant. Some patients will get vaccines while they are on treatments which boost the immune system (like the immune stimulating drug interleukin-2 or IL-2). Although we have safely treated many patients with immune boosting drugs, we do not yet know if they improve the body's immune system to respond better to a vaccine. Some healthy volunteers will also be given the vaccines in order to serve as control subjects to get a good measure of the normal immune response. We will compare the patients and the healthy volunteers to study how their immune systems respond to the vaccines. There are several different types of white cells in the blood. We are interested in immune cells in the blood called T-cells. These T-cells detect foreign substances in the body (like viruses and cancer cells). We are trying to learn more about how the body fights these foreign substances. Our goal is to develop cancer vaccines which would teach T-cells to detect and kill cancer cells better. We know that in healthy people the immune system effectively protects against recurrent virus infection. For example, that is why people only get "mono" (mononucleosis) once under normal circumstances. When the body is infected with the "mono" virus, the immune system remembers and prevents further infection. We are trying to use the immune system to prevent cancer relapse. To test this, we will give two vaccines which have been used to measure these immune responses. Blood samples will be studied from cancer patients and will be compared to similar samples from normal subjects.

Patients will receive each vaccine once only consisting of: Arm A: Intracel KLH 1000 mcg (1 mg) without adjuvant, subcutaneous Tetanus Toxoid 0.5 ml intramuscularly (this arm closed 1/2/02). Arm B: Biosyn KLH 1000 mcg (1 mg) without adjuvant, subcutaneous tetanus toxoid 0.5 ml intramuscularly (this arm closed 3/18/03). Arm C: Biosyn KLH 1000 mcg (1 mg) with Montanide ISA51 (now replaced with vegetable (VG) source after 8/31/06 to increase product safety) subcutaneous Tetanus toxoid 0.5 ml intramuscularly (this arm open 3/18/03). Subjects ineligible for tetanus may still receive KLH on this protocol. This is especially true given the national shortage of tetanus vaccines. Subjects will be eligible for tetanus when it becomes available if there has been no significant change in treatment interventions or overall health status and it is within 3 months of the KLH vaccine.

1

Replaced by another study.

136

2002-07-01

2012-03-01

actual

NCT00000114

Randomized Trial of Vitamin A and Vitamin E Supplementation for Retinitis Pigmentosa

completed

treatment

To determine whether supplements of vitamin A or vitamin E alone or in combination affect the course of retinitis pigmentosa.

Retinitis pigmentosa (RP) is a group of inherited retinal degenerations with a worldwide prevalence of about 1 in 4,000. Patients typically report night blindness in adolescence and lose vision in the midperipheral followed by far-peripheral visual field in adulthood due to progressive loss of both rod and cone function. Most patients have reductions in central vision by age 50 to 80 years. Modern-day electroretinograms (ERGs) make it possible to record retinal responses from most patients with remaining vision and thereby monitor objectively the course of their disease. While the natural course of retinal degeneration in the common forms of RP was being studied, it was noted that a subgroup of patients aged 18 through 49 who were treating themselves with both vitamin A and vitamin E and other nutritional supplements exhibited less decline in ERG amplitude over a 2-year period. These preliminary findings, as well as the known roles of vitamins A and E in maintaining normal photoreceptor function and structure, prompted this randomized, controlled trial to determine whether these vitamins alone or in combination would halt or slow the progression of the common forms of RP. This study was a randomized, controlled double-masked trial with 2 x 2 factorial design and duration of 4 to 6 years. Patients were assigned to one of four treatment groups: 15,000 IU/day vitamin A 15,000 IU/day vitamin A + 400 IU/day vitamin E trace amounts of both vitamins A and E 400 IU/day of vitamin E The main outcome measure was the 30-Hz cone ERG amplitude. In addition, visual field and visual acuity were measured annually.

1

1984-05-01

1987-06-01

actual

NCT00000115

Randomized Trial of Acetazolamide for Uveitis-Associated Cystoid Macular Edema

completed

treatment

To test the efficacy of acetazolamide for the treatment of uveitis-associated cystoid macular edema.

Uveitis, an intraocular inflammatory disease, is the cause of about 10 percent of visual impairment in the United States. Uveitis may lead to many sight-threatening conditions, including cataract, vitreal opacities, glaucoma, and, most commonly, cystoid macular edema. Reduction of swelling or edema within the retina depends on the movement of fluid from the retina through the choroid. A number of studies indicate that this process requires active transport of fluid ions by the retinal pigment epithelium and may involve the carbonic anhydrase system. Current treatment of uveitis-associated cystoid macular edema requires the use of immunosuppressive or anti-inflammatory agents. However, many patients are either resistant or intolerant to this therapy. Recent reports suggested that acetazolamide, a carbonic anhydrase inhibitor that is used to lower intraocular pressure in some glaucoma patients, might be safe and effective in reducing uveitis-associated cystoid macular edema. Because the course of ocular inflammatory disease can be variable, a double-masked, randomized, crossover trial was designed to test the efficacy of acetazolamide compared with a placebo for the treatment of uveitis-associated cystoid macular edema. Randomized adult patients received either oral acetazolamide sodium 500 mg or a matched placebo every 12 hours for the first 4 weeks of the study. Children 8 years of age or older received a lesser dose based on body weight. Following a 4-week period, during which no medication was given, patients then received a 4-week course of the opposite medication. Primary end points included reduction in cystoid macular edema (graded on fluorescein angiography) and improvement in visual acuity (measured on standardized Early Treatment Diabetic Retinopathy Study [ETDRS] charts). Laser acuity was also assessed as a secondary outcome variable. Adverse effects of the acetazolamide therapy were monitored by clinical and laboratory examinations. A total of 40 patients were recruited for the study. Patients were seen at the beginning of the study for baseline measurements and at 4, 8, and 12 weeks after enrollment into the study.

1

1990-12-01

1994-06-01

actual

NCT00000116

Randomized Trial of DHA for Retinitis Pigmentosa Patients Receiving Vitamin A

Clinical Trial of Docosahexaenoic Acid (DHA) in Patients With Retinitis Pigmentosa Receiving Vitamin A Treatment

completed

treatment

The purpose of this trial is to determine whether a nutritional supplement in addition to vitamin A will slow the course of retinitis pigmentosa.

Retinitis pigmentosa (RP) is a group of inherited retinal degenerations with a worldwide prevalence of approximately 1 in 4,000. Patients typically report night blindness and difficulty with midperipheral visual field in adolescence. As the condition progresses, they lose far peripheral visual field. Most patients have reductions in central vision by age 50 to 80 years. Based on electroretinograms (ERGs), the course of the disease can be slowed on average among adults on 15,000 IU/day of vitamin A palmitate. While conducting the trial on the effects of vitamin A on RP, it became apparent that another substance in the diet could be affecting the course of the disease. This prompted the present randomized, controlled trial. This study is a randomized, controlled, double-masked trial with a planned duration of 5 years. Patients with the common forms of RP are assigned to either a test or a control group. All receive 15,000 IU/day of vitamin A palmitate in addition to either 1200 mg/d of docosahexaenoic acid or control capsules. Participants will not know the contents of the supplement or the group to which they have been assigned until the end of the trial. The main outcome measurement is the total point score on the Humphrey Field Analyzer (HFA). In addition, computer-averaged 30-Hz cone ERG amplitudes and visual acuity are measured annually.

1

1996-05-01

2002-09-01

actual

1

Business Decision

The trial has been terminated due to strategic decisions, administrative reasons, sponsor, or company decision.

0

6

Change in Medical/Clinical Practices

The drug(s) of interest might not be suitable to the disease that they were trying to treat due to changes in medical or clinical practices. 1. Surgeons stopped doing procedures 2. Additional published information on the topic since starting the study 3. Study no longer consistent with current clinical practice

0

11

Competing Studies

The study drug(s) are having worse/futile results in similar competing trials.

0

16

Completed

Trial was successfully completed (user input was incorrectly marked as terminated). [eg. accrual was reached]

0

21

Conflict of Interest

The parties involved had conflicts of interests.

0