0

NCT00000726

Cytomegalovirus Retinitis

283

1

NCT00000333

Cocaine-Related Disorders

37604

2

NCT00000218

Cocaine-Related Disorders

37604

3

NCT00000895

Mycobacterium avium-intracellulare Infection

13995

4

NCT00000170

Amblyopia

1060

0

NCT00000179

Trazodone

656

1

NCT00000333

Benztropine

245

2

NCT00000734

Trimethoprim, Sulfamethoxazole Drug Combination

3

NCT00000260

Nitrous Oxide

6691

4

NCT00000753

Zalcitabine

943

NCT06207370

21

NCT00415051

45

NCT00584194

45

NCT00869713

45

NCT03609398

45

NCT00000102

United States

NCT00000105

United States

NCT00000110

United States

NCT00000117

United States

NCT00000132

Sweden

000032d4-fe13-4112-beb1-f256ac218516

NCT02239380

All

0

3 Months

No

Inclusion Criteria: - Subjects with status epilepticus or repetitive status epilepticus / cluster seizure who have seizures that can be evaluated by investigator's visual observations based on motor symptoms or who have seizures that can be evaluated by EEG. - Subjects with status epilepticus accompanied by generalized seizure, partial seizure or secondarily generalized seizure lasting 5 minutes or longer - Subjects with repetitive status epilepticus / cluster seizure accompanied by not less than 3 consecutive episodes of generalized seizure, partial seizure or secondarily generalized seizure in 1 hour. - Subjects not younger than 3 months (either gender is eligible for the study) Exclusion Criteria: - Subjects with known or suspected recurrent seizures due to illegal drug or alcohol withdrawal - Subjects with known history of hypersensitivity to lorazepam or benzodiazepine - Subjects with a known history of benzodiazepine abuse. - Subjects currently receiving lorazepam - Subjects with angle-closure glaucoma - Subjects with myasthenia gravis - Subjects with either of aspartate transaminase, alanine transaminase, total bilirubin, blood urea nitrogen, or creatinine at screening visit exceeding 2x the upper limit of normal of the institutional reference value (if the data is available) - Subjects with white blood cell count less than 3000/mm3 or neutrophil count less than 1500/mm3 at screening visit (if the data is available)

0000ba16-b291-428d-b7a1-6cee104c7cfb

NCT07110246

All

0

12 Months

25 Years

No

Inclusion Criteria: Participants must have histologically confirmed LGG World Health Organization (WHO) Grade I or II with BRAF V600 mutation confirmed by immunohistochemistry or sequencing Participants must have measurable tumor. * For participants with measurable disease, this will be defined as lesions that can be accurately measured in two dimensions (longest diameter to be recorded) with a minimum size of no less than double the slice thickness. Previously irradiated lesions are considered non-measurable except in cases of documented progression of the lesion since the completion of radiation therapy. Participants without measurable disease may be considered for enrollment and followed for survival and progression purposes but will not be included as part of a measurable disease cohort. Cohort 1: Participants must have no prior therapy, except for surgical intervention (i.e. biopsy or resection) Participants may currently be taking dabrafenib and trametinib as frontline therapy, with a maximum duration of 21 months and participants must not yet have met criteria for confirmed best response as defined in this protocol. For participants entering the trial currently taking dabrafenib and trametinib, they must be taking a dose that is within 20% of the standard dosing for both drugs based on age and weight. Participants who are already on dabrafenib and trametinib when enrolling on trial and whose dosing deviates more than 20% from the protocol nomogram need to be discussed with the study chairs. Eligibility for these participants will be based on ability to wean within the parameters of the protocol Cohort 2: * Participants must have a history of recurrent or progressive disease following prior therapy (e.g., carboplatin and vincristine, vinblastine, bevacizumab, mitogen-activated extracellular signal-regulated kinase (MEK) inhibitor, radiation therapy etc). Participants who previously completed a course of therapy with dabrafenib and trametinib, who did not progress on this therapy, and who are beyond 6 months from completion of therapy are eligible for retreatment. ** Participants may currently be taking dabrafenib and trametinib as therapy for disease recurrence, for a maximum duration of 21 months and participants must not yet have met criteria for confirmed best response as defined in this protocol. For participants entering the trial currently taking dabrafenib and trametinib, they must be taking dose that is within 20% of the standard dosing for both drugs based on age and weight. Participants who are already on dabrafenib and trametinib when enrolling on trial and whose dosing deviates more than 20% from the protocol nomogram need to be discussed with the study chairs. Eligibility for these participants will be based on ability to wean within the parameters of the protocol Participants must have received their last dose of chemotherapy 3 weeks prior to enrollment (6 weeks for nitrosoureas) and recovered from acute adverse events due to agents administered Participants must be at least 7 days since the completion of therapy with a biologic or small molecule agent except dabrafenib and trametinib. For any agent with known adverse events that can occur beyond 7 days after administration, the period prior to enrollment must be beyond the time during which adverse events are known to occur. Such participants must be discussed with study chairs Radiation: No prior radiation is allowed for participants in Cohort 1 Participants in Cohort 2 must have: Had their last fraction of local irradiation to primary tumor ≥ 12 weeks prior to registration Had their last fraction of craniospinal irradiation ≥ 12 weeks prior to registration At least 14 days after local palliative radiation (small-port) Age: ≥ 12 months and < 25 years old Performance Score: Karnofsky ≥ 50 for participants > 16 years of age and Lansky ≥ 50 for participants ≤ 16 years of age. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score Peripheral absolute neutrophil count (ANC) ≥ 1000/mm^3 Platelet count ≥ 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment) A serum creatinine ≤ 1.5 upper limit of normal (ULN) based on age and gender Total bilirubin ≤ 1.5 x ULN for age; in presence of Gilbert's syndrome, total bilirubin ≤ 3 x ULN or direct bilirubin ≤ 1.5 x ULN Alanine aminotransferase (ALT) ≤ 3 x ULN Aspartate aminotransferase (AST) ≤ 3 x ULN Participants with seizure disorder may be enrolled if well controlled Left ventricular ejection fraction (LVEF) greater than or equal to institutional lower limit of normal (LLN) by echocardiogram (ECHO) (while not receiving medications for cardiac function) Correct QT (QTc) interval < 480 msecs Patient must agree to adequate contraception. (The effects of dabrafenib and trametinib on the developing human fetus are unknown. For this reason and because agents as well as other therapeutic agents used on this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method birth control, or abstinence) prior to study entry, for the duration of study participation, and 4 months after completion of the study medication administration. Should a women become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately) A legal parent/guardian or patient must be able to understand, and willing to sign, a written informed consent and assent document, as appropriate Participants must enroll on Pediatric Neuro-Oncology Consortium (PNOC) comprehensive follow up protocol (PNOC COMP) if PNOC COMP is open to accrual at the enrolling institution Pathology reports, next generation sequencing reports, or both, confirming BRAF V600E mutation status must be submitted at the time of enrollment Exclusion Criteria: Participant's tumor has any of the following additional previously known or expected activating molecular alterations: Isocitrate dehydrogenase 1 and 2 (IDH1 and IDH2) mutation Histone H3 mutation (p.K28M, p.G35R, p.G35V) Neurofibromatosis Type 1 (NF-1) loss of function alteration Participants who are receiving any other investigational agents History of allergic reactions attributed to compounds of similar chemical or biologic composition to dabrafenib and trametinib Medications that are affected by the induction of CYP3A4 and CYP2C9 should be avoided or used cautiously. Dabrafenib has been shown to induce CYP3A4 and CYP2C9. In addition, dabrafenib is an in vitro inducer of CYP2B6, CYP2C8, CYP2C19, Uridine 5'-diphospho (UDP)-glucuronosyltransferase. Co-administration of dabrafenib and medications which are affected by the induction of these enzymes (including warfarin) and transporters may result in loss of efficacy. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated list such as http://medicine.iupui.edu/clinpharm/ddis/table.aspx; medical reference texts such as the Physicians' Desk Reference may also provide this information. As part of the enrollment/informed consent procedures, the participant and/or legal parent or guardian will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection Women of childbearing potential must not be pregnant or breast-feeding Human immunodeficiency virus (HIV) positive participants will be ineligible if HIV therapy regimen has not been stable for at least 4 weeks or there is intent to change the regimen within 8 weeks following enrollment, or if they are severely immunocompromised

0000c2ab-2fd4-478b-bd36-5a743622e466

NCT00589485

Non-Probability Sample

All

0

18 Years

No

Inclusion Criteria: - Patients with painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved - Patients requiring correction of varus, valgus, or posttraumatic deformity - Patients requiring correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure Exclusion Criteria: - Infection, sepsis, and osteomyelitis

The study population will include patients who require total knee replacement.

0001264a-1354-4946-868a-7838224dd14b

NCT02060383

All

0

18 Years

No

Inclusion Criteria: - Patients greater than or equal to 18 years old - Confirmed diagnosis of Cushing's disease or acromegaly Exclusion Criteria: - Patients who require surgical intervention - Patients receiving DPP-4 inhibitors or GLP-1 receptor agonists within 4 weeks prior to study entry - HbA1c > 10 % at screening - Known hypersensitivity to somatostatin analogues Other protocol-defined inclusion/exclusion criteria may apply.

00013c19-631c-43f0-a80c-3e1876c4ce0f

NCT00505518

All

0

18 Years

No

Inclusion Criteria: - Clinical diagnosis of Major Depressive Disorder - Patient at South Cove Manor Nursing Home - Referred by nursing staff for psychiatric consultation Exclusion Criteria: - Not competent to participate in psychiatric interviews

0

NCT00000726

NCT00000726

primary

1

NCT00000726

ACTG 015

org_study_id

2

NCT00000726

FDA 20D

external

3

NCT00000726

10991

external

4

NCT00001302

NCT00001302

primary

00003369-7f9d-4f3d-a5f3-8791add7ae73

75f6ae02-19ef-40a8-a704-f21a0f22782d

00003369-7f9d-4f3d-a5f3-8791add7ae73

c87b54dd-5857-4b63-abcb-c020d2b3d70a

000087cb-d10e-429b-852b-a92a49bfc968

a0d6859d-79b5-4255-ac5f-b2d3b2631d35

000087cb-d10e-429b-852b-a92a49bfc968

a2e5d7c9-bddd-474b-a379-a5d1f7d9c21b

0000c179-971f-4b87-a009-fa35502ebc96

c73c651a-6f27-4da9-9a7f-4d7ada6662d6

00003369-7f9d-4f3d-a5f3-8791add7ae73

NCT02696954

drug

Amodiaquine

Amodiaquine on Day 0, 1 and 2 Washout period: more than 6 weeks

000087cb-d10e-429b-852b-a92a49bfc968

NCT05944952

drug

buprenorphine/naloxone

Participants will be dosed with buprenorphine/ naloxone strips

0000c179-971f-4b87-a009-fa35502ebc96

NCT02161965

drug

Warfarin

00010ba2-52e9-4928-966a-0b004d65e13e

NCT04605562

drug

Galunisertib

Administered orally

0001158e-8ef1-4fc1-b1cd-ad093d57ac17

NCT06836856

drug

Carvedilol

starting at 6.25mg carvedilol three times daily by mouth or per feeding tube. The dose was increased daily in 6.25 mg three times daily increments (18.75 mg/day total) until heart rate (HR) was less than 100 beats per minute (bpm) with maximum dose of 100 mg/day in addition to standard care until end of treatment.

206813

00003369-7f9d-4f3d-a5f3-8791add7ae73

613

347287

000087cb-d10e-429b-852b-a92a49bfc968

921

347286

000087cb-d10e-429b-852b-a92a49bfc968

1183

175209

0000c179-971f-4b87-a009-fa35502ebc96

682

296883

00010ba2-52e9-4928-966a-0b004d65e13e

11993

0

bf6f2649-31e2-4aee-b552-4bffe191f3b0

Elavil

1

f096be51-752d-4b08-829b-c90c16c00055

elavil plus prozac

2

95966692-f845-48e2-91ed-00b8e889ca85

Subutex

3

95966692-f845-48e2-91ed-00b8e889ca85

Suboxone

4

c07a15aa-8ddb-4fa3-9015-76bde5cff910

Zoloft

98160

000087cb-d10e-429b-852b-a92a49bfc968

157804

81580

00012692-6234-4c30-a7c1-cb1fde38bd99

489254

95327

0001d859-a82c-4a33-8072-0f4a7e4ba452

139536

72181

00046298-3c8b-432d-b463-62fb15cf588c

317307

72180

00046298-3c8b-432d-b463-62fb15cf588c

430009

NCT00017381

0

NCT00020670

0

NCT00091286

0

NCT00140556

0

NCT00176059

0

0

NCT00000726

National Institute of Allergy and Infectious Diseases (NIAID)

National Institute of Allergy & Infectious Diseases Niaid

nih

1

1

NCT00001302

National Cancer Institute (NCI)

National Cancer Institute Nci

nih

1

2

NCT00000179

National Institute on Aging (NIA)

National Institute on Aging Nia

nih

1

3

NCT00000333

Washington D.C. Veterans Affairs Medical Center

Washington Dc Veterans Affairs Medical Center

us_fed

0

4

NCT00000333

National Institute on Drug Abuse (NIDA)

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.

0

0

NCRR-M01RR01070-0506

0

0

0

0

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.

0

Replaced by another study.

136

2002-07-01

2012-03-01

actual

0

2002LS032

0

0

0

0

NCT00000110

Influence of Diet and Endurance Running on Intramuscular Lipids Measured at 4.1 TESLA

completed

treatment

The purpose of this pilot investigation is to use 1 H Magnetic Resonance Spectroscopy (MRS) to 1) document the change in intra-muscular lipid stores (IML) before and after a prolonged bout of endurance running and, 2) determine the pattern (time course) of IML replenishment following an extremely low-fat diet (10% of energy from fat) and a moderate-fat diet (35% of energy from fat). Specifically, the study will evaluate the change in IML following a 2-hour training run and the recovery of IML in response to the post-exercise low-fat or moderate-fat diet in 10 endurance trained athletes who will consume both diets in a randomly assigned cross-over fashion. We hypothesize that IML will be depleted with prolonged endurance exercise, and that replenishment of IML will be impaired by an extremely low-fat diet compared to a moderate-fat diet. Results of this pilot study will be used to apply for extramural grant support from NIH or the US Armed Forces to investigate the effect of dietary fat on the health and performance of individuals performing heavy physical training. It is anticipated that this methodology could also be employed in obesity research to delineate, longitudinally, the reported cross-sectional relationships among IML stores, insulin resistance and obesity.

0

1

NCRR-M01RR00032-0855

0

0

0

0

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.

0

1984-05-01

1987-06-01

actual

0

NEI-10

0

0

0

0

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.

0

1990-12-01

1994-06-01

actual

0

NEI-11

0

0

0

0

1

Business Decision

The trial was terminated due to a strategic or administrative decision by the sponsor company.

0

6

Change in Medical/Clinical Practices

The study drug was deemed no longer suitable for the target indication due to changes in medical or clinical practices.

0

11

Competing Studies

The study drug is being investigated in other competing trial(s), and continuing this trial was deemed futile.

0

16

Completed

The trial was successfully completed (user input was incorrectly marked as terminated).

0

21

Conflict of Interest

The parties involved had conflicts of interests.

0