ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00078806
Conditions: Juvenile Rheumatoid Arthritis
Keywords: Systemic Onset Juvenile Rheumatoid Arthritis SOJRA Fever Rash Joint Pain
Sponsor: Amgen
Start date: 2001-06-04; Completion date: 2004-05-06
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study was to determine the efficacy of etanercept in pediatric patients with systemically active system onset juvenile rheumatoid arthritis (SOJRA).

Detailed description:
Participants were to receive etanercept at a dose of 0.4 mg/kg twice weekly in Part 1A. Participants who had a partial response (not able to reduce prednisone dose by 50% of the baseline dose in 5 months) while on 0.4 mg/kg twice weekly etanercept in Part 1A were to enter Part 1B for up to 4 months and were to have the dose of etanercept increased to 0.8 mg/kg twice weekly. Participants who did not meet the response criteria in Part 1A or Part 1B of the study were to be withdrawn from the study as non-responders. Participants who responded in either Part 1A or Part 1B were randomized into Part 2, where they received etanercept or matching placebo in a double-blind manner twice weekly for up to 3 months. In Part 2, participants were stratified by the dosage of etanercept (0.4 mg/kg or 0.8 mg/kg) they were receiving in Part 1A or Part 1B. Participants could enter Part 3, the open-label re-treatment portion of the study, only if they had been entered into Part 2 of the study and had either flared in Part 2 or had completed 3 months of treatment in Part 2. The maximum time participants could receive etanercept in Part 2 and Part 3 combined was 12 months.

Arms: arm 1: Participants received 0.4 mg/kg etanercept administered subcutaneously twice a week for up to 6 months in Part 1A.

Participants who had a partial response entered Part 1B and received 0.8 mg/kg etanercept twice weekly for up to 4 months. arm 2: Participants who met response criteria in Part 1 were randomized to receive placebo twice a week for up to 3 months. arm 3: Participants who met response criteria in Part 1 were randomized to continue receiving etanercept twice a week at the same dose as in Part 1 (0.4 or 0.8 mg/kg) for up to 3 months. arm 4: Participants who experienced a flare or completed 3 months of treatment in Part 2 entered Part 3 and received open-label treatment with etanercept at the same dose as in Part 1 (0.4 or 0.8 mg/kg) for up to a maximum of 12 months, including treatment in Part 2.
Interventions: intervention 1: Etanercept intervention 2: Placebo
Intervention descriptions: intervention 1: Administered by subcutaneous injection twice a week intervention 2: Administered by subcutaneous injection twice a week

Protocol documents:
Clinical trial NCT00040443
Conditions: Mild Cognitive Impairment
Keywords: Mild Cognitive Impairment Memory Loss Alzheimer's Disease Brain Aging Ampalex® CX516
Sponsor: RespireRx
Start date: 2002-04-01; Completion date: 2004-06-01
Enrollment: 175 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Glutamate is fundamentally involved in learning and memory. Memory loss associated with mild cognitive impairment may be due to loss of glutamate receptors in the aging brain. There is evidence CX516 enhances brain activity by specifically targeting remaining glutamate receptors in the affected portions of the brain. This study will test the safety and efficacy of CX516 in the symptomatic treatment of participants with mild cognitive impairment.

Detailed description:

Arms: arm 1: CX516 - 900 mg arm 2: Placebo
Interventions: intervention 1: CX516 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00313846
Conditions: Osteoarthritis
Keywords: Chronic pain opioid transdermal osteoarthritis
Sponsor: Purdue Pharma LP
Start date: 2003-04-01; Completion date: 2004-06-01
Enrollment: 529 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) (5, 10 and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain of the hip and knee currently treated with oral opioids. The double-blind treatment intervention duration is 4 weeks during which time supplemental analgesic medication (acetaminophen) will be provided to all subjects in addition to study drug.

Detailed description:
Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.

Arms: arm 1: Buprenorphine transdermal patch 5, 10 or 20 micrograms/hour (mcg/h) arm 2: Placebo to match BTDS 5, 10 or 20 mcg/h
Interventions: intervention 1: Buprenorphine transdermal patch intervention 2: Placebo
Intervention descriptions: intervention 1: Buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear. intervention 2: Placebo to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.

Protocol documents:
Clinical trial NCT00486837
Conditions: Cystic Fibrosis
Sponsor: Grifols Therapeutics LLC
Start date: 2003-12-01; Completion date: 2004-06-01
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this trial is to determine the optimal region of the lung for depositing Prolastin (alpha-1 antitrypsin; AAT) by inhalation in order to treat cystic fibrosis (CF). The AKITA® nebulizer has settings which can be varied to target the inhaled drug to either the deep lung or to the upper airways in a one to one randomization. The study will measure how much of the activity of the enzyme elastase is inhibited by AAT.

Detailed description:
The optimum deposition site (bronchial or peripheral) in CF patients for AAT will be investigated by measuring several parameters in induced sputum. The study will start with a 2 week run-in period in which the planned 60 patients inhale isotonic saline once daily. This period is followed by a 4 week treatment period where 30 patients inhale AAT for peripheral deposition and 30 patients inhale AAT for bronchial deposition. Six patients in each group will be asked to collect spontaneous sputum at home.

Twenty-five milligrams of AAT will be deposited at one of the two target sites using the AKITA® device. The inhalation should take place in the evening between 18.00 and 23.00 h.

Patients will inhale saline once daily for 2 weeks (run-in period) followed by 4 weeks of once daily inhalation of AAT. Induced sputum will be collected at visits to the clinic at the start of the run-in, at the start of AAT treatment, and at 2 and 4 weeks after the start of AAT treatment.

Arms: arm 1: Bronchial Deposition Intervention: Alpha1-Proteinase Inhibitor (Human) Dosage: 25 mg in lungs, one inhalation per day over 4 weeks arm 2: Peripheral Deposition Intervention: Alpha1-Proteinase Inhibitor (Human) Dosage: 25 mg in lungs, one inhalation per day over 4 weeks
Interventions: intervention 1: Alpha1-Proteinase Inhibitor (Human)
Intervention descriptions: intervention 1: 25 mg of Alpha1-Proteinase Inhibitor (Human) in the lungs, one inhalation per day over 4 weeks.

Protocol documents:
Clinical trial NCT00685165
Conditions: Therapeutic Equivalency
Sponsor: Mutual Pharmaceutical Company, Inc.
Start date: 2004-05-01; Completion date: 2004-06-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to compare the bioequivalence of a test formulation of primidone tablets to an equivalent oral dose of the commercially available Mysoline®(primidone tablets) in adult subjects under fasting conditions.

Detailed description:
The purpose of this study is to compare the bioequivalence of a test formulation of primidone tablets to an equivalent oral dose of the commercially available Mysoline® (primidone tablets) in adult subjects under fasting conditions.

Twenty-two healthy, non-smoking, non-obese male and female volunteers at least 18 years of age will be randomly assigned in a crossover fashion to receive each of two primidone dosing regimens in sequence with a 14 day washout period between dosing periods. On the morning of Day 1, after an overnight fast of at least 10 hours, subjects will receive either a single oral dose of the test formulation, primidone (1 x 50 mg tablet) or a single oral dose of the reference formulation, Mysoline® (1 x 50 mg tablet). After a 14 day washout period, on the morning of Day 15 after an overnight fast, subjects will receive the alternate regimen. Blood samples will be drawn from all participants before dosing and for 72 hours post dose at times sufficient to adequately define the pharmacokinetics of primidone. A further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers. Subjects will be monitored throughout the confinement portion of the study for adverse reactions to the study drugs and/or procedures. Blood pressure and heart rate will be obtained prior to dosing and at 3, 4, 6, 24 and 72 hours post-dose. All adverse events whether elicited by query, spontaneously reported or observed by clinic staff will be evaluated by the investigator and reported in the subject's case report form.

Arms: arm 1: A single dose of primidone 50 mg administered after an overnight fast of at least 10 hours. arm 2: A single dose of Mysoline® 50 mg administered after an overnight fast of at least 10 hours.
Interventions: intervention 1: Primidone 50 mg Tablet intervention 2: Primidone (Mysoline®) 50 mg Tablet
Intervention descriptions: intervention 1: 50 mg tablet administered after an overnight fast of at least 10 hours. intervention 2: 50 mg tablet administered after an overnight fast of at least 10 hours.

Protocol documents:
Clinical trial NCT00726895
Conditions: Healthy
Keywords: Bioavailability
Sponsor: Mutual Pharmaceutical Company, Inc.
Start date: 2004-05-01; Completion date: 2004-06-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate and compare the dose proportionality of 324 mg Quinine Sulfate capsules following a single oral dose (1 x 324 mg capsules versus 2 x 324 mg capsules) in healthy adult volunteers when administered under fasting conditions.

Detailed description:
The purpose of this study is to evaluate and compare the dose proportionality of 324 mg Quinine Sulfate capsules following a single oral dose (1 x 324 mg capsules versus 2 x 324 mg capsules) in healthy adult volunteers when administered under fasting conditions.

Twenty-four healthy, non-smoking, non-obese, male and female volunteers at least 18 years of age will be randomly assigned in a crossover fashion to receive each of two Quinine Sulfate dosing regimens in sequence with a 7 day washout period between dosing periods. On the morning of Day 1, after an overnight fast of at least 10 hours, subjects will receive either a single oral dose of treatment A, Quinine Sulfate 1 x 324 mg capsule, or a single oral dose of treatment B, Quinine Sulfate 2 x 324 mg capsules. After a 7 day washout period,on the morning of Day 8 following an overnight fast of at least 10 hours, subjects will receive the alternate regimen. Blood samples will be drawn from all participants before dosing and for 24 hours post-dose on a confined basis at times sufficient to adequately define the pharmacokinetics of Quinine Sulfate. Blood sampling will then continue on a non-confined basis at 36 and 48 hours post-dose. A further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers. Subjects will be monitored throughout the confinement portion of the study for adverse reactions to the study drug and/or procedures. Blood pressure and heart rate will be obtained prior to dosing and as scheduled following each dose. All adverse events whether elicited by query, spontaneously reported, or observed by clinic staff will be evaluated by the investigator and reported in the subject's case report form.

Arms: arm 1: Quinine Sulfate 1 x 324 mg capsule dose. arm 2: Quinine Sulfate 2 x 324 mg capsules dose.
Interventions: intervention 1: Quinine Sulfate Capsules 324 mg intervention 2: Quinine Sulfate Capsules 324 mg
Intervention descriptions: intervention 1: 1 x 324 mg capsule intervention 2: 2 x 324 mg capsules

Protocol documents:
Clinical trial NCT01044056
Conditions: Contraception
Sponsor: Organon and Co
Start date: 2004-03-01; Completion date: 2004-06-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
An open-label, randomized, parallel group trial in healthy female subjects to compare the pharmacokinetics of ethinyl estradiol (EE) of NuvaRing®, a contraceptive patch (EVRA(TM)) and an oral contraceptive (Microgynon® 30).

Detailed description:

Arms: arm 1: Microgynon(R), 1 tablet every day for 21 days; each tablet contains 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE). arm 2: Evra(TM), One patch applied on lower abdomen for 7 days for 3 consecutive weeks, 3 patches in total. Each patch contains 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day. arm 3: Nuvaring(R), Place the ring in the vagina for 21 days, remove for one week. Repeat with new Ring. Dose: per ring 11.7 mg ENG and 2.7 mg EE releasing a daily average amount of 0.120 mg ENG and 0.015 mg EE.
Interventions: intervention 1: Levonorgestrel (LNG)/Ethinylestradiol (EE) oral contraceptive tablets intervention 2: norelgestrominum and ethinylestradiol patch oral contraceptive patch intervention 3: Nuvaring ™ (etonorgestrel/ethinylestradiol)
Intervention descriptions: intervention 1: LNG/EE oral contraceptive tablets (Microgynon® 30), 21 in total, containing 0.150 mg LNG and 0.030 mg EE per tablet administered once daily orally for 21 consecutive days. intervention 2: A contraceptive patch (EVRA ™), one patch for 7 days for three consecutive weeks, 3 patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day. intervention 3: NuvaRing ™ , one ring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonogestrel and 2.7 mg EE releasing a daily average amount of 0.120 mg etonogestrel and 0.015 mg EE.

Protocol documents:
Clinical trial NCT00111475
Conditions: Idiopathic Thrombocytopenic Purpura
Keywords: Immune Thrombocytopenic Purpura Idiopathic Thrombocytopenic Purpura Thrombocytopenic Thrombocytopenia ITP
Sponsor: Amgen
Start date: 2002-07-01; Completion date: 2004-06-17
Enrollment: 45 participants; Allocation: RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The primary objective of this study is to evaluate the safety and tolerability of romiplostim in thrombocytopenic patients with ITP.

Detailed description:

Arms: arm 1: Participants received 0.2 µg/kg romiplostim subcutaneously on day 1 and day 15 or 22, depending on platelet counts. arm 2: Participants received 0.5 µg/kg romiplostim subcutaneously on day 1 and day 15 or 22, depending on platelet counts. arm 3: Participants received 1.0 µg/kg romiplostim subcutaneously on day 1 and on day 15 or 22 depending on platelet counts. arm 4: Participants received 3.0 µg/kg romiplostim subcutaneously on day 1 and day 15 or 22, depending on platelet counts. arm 5: Participants received 6.0 µg/kg romiplostim subcutaneously on day 1 and day 15 or 22, depending on platelet counts. arm 6: Participants received 10.0 µg/kg romiplostim subcutaneously on day 1 and day 15 or 22, depending on platelet counts. arm 7: Participants received placebo subcutaneously once a week for 6 weeks. arm 8: Participants received 1.0 µg/kg subcutaneously once a week for 6 weeks. arm 9: Participants received 3.0 µg/kg subcutaneously once a week for 6 weeks. arm 10: Participants received 6.0 µg/kg subcutaneously once a week for 6 weeks.
Interventions: intervention 1: Romiplostim intervention 2: Placebo
Intervention descriptions: intervention 1: Administered by subcutaneous injection intervention 2: Administered by subcutaneous injection

Protocol documents:
Clinical trial NCT00003468
Conditions: Low Grade Astrocytomas
Keywords: childhood low-grade astrocytoma recurrent childhood astrocytoma persistent childhood astrocytoma
Sponsor: Burzynski Research Institute
Start date: 1996-07-01; Completion date: 2004-07-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Current therapies for children with low grade astrocytomas that have not responded to standard therapy provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of children with low grade astrocytomas that have not responded to standard therapy

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on children (\> 6 months of age) with low grade astrocytomas that has not responded to standard therapy.

Detailed description:
OBJECTIVES:

* To determine the efficacy of Antineoplaston therapy in children with low grade gliomas that has not responded to standard therapy, as measured by an objective response to therapy (complete response, partial response or stable disease).
* To determine the safety and tolerance of Antineoplaston therapy in children with a brain tumor.

OVERVIEW: This is a single arm, open-label study in which children with low grade astrocytomas that have not responded to standard therapy receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of disease progression or unacceptable toxicity. After 12 months, patients with a complete or partial response or with stable disease may continue treatment.

To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued to this study.

Arms: arm 1: Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Interventions: intervention 1: Antineoplaston therapy (Atengenal + Astugenal)
Intervention descriptions: intervention 1: Children with a low grade astrocytoma that have not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).

Protocol documents:
Clinical trial NCT00058552
Conditions: Ovarian Cancer
Keywords: Advanced, refractory, or recurrent ovarian cancer
Sponsor: Genentech, Inc.
Start date: 2003-05-01; Completion date: 2004-07-01
Enrollment: 129 participants; Allocation: ; Intervention model: 

Brief summary:
The purpose of this study is to determine if the study drug pertuzumab is effective in treating patients with advanced ovarian cancer that is refractory to, or has recurred following, prior chemotherapy.

Detailed description:

Interventions: intervention 1: Pertuzumab (rhuMAb 2C4)
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00071006
Conditions: Acute Myeloid Leukemia (AML) Myelodysplastic Syndrome
Sponsor: Pfizer
Start date: 2003-09-01; Completion date: 2004-07-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The study tests the safety and efficacy of axitinib in patients who have the hematologic disease of Acute Myeloid Leukemia or Myelodysplastic Syndrome. The study tests patients who have poor prognosis before entering the study.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: AG-013736 (Axitinib)
Intervention descriptions: intervention 1: patients were treated with axitinib at starting dose of 5 mg BID continuous dosing.

Protocol documents:
Clinical trial NCT00312572
Conditions: Osteoarthritis
Keywords: Osteoarthritis, opioid, transdermal
Sponsor: Purdue Pharma LP
Start date: 2003-06-01; Completion date: 2004-07-01
Enrollment: 204 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate the safety and efficacy of dose conversion from hydrocodone/ acetaminophen (Vicodin®) to the buprenorphine transdermal system (Butrans™) in subjects with osteoarthritis pain of the hip or knee. The double-blind treatment intervention duration is 2 weeks during which time supplemental analgesic medication will be allowed.

Detailed description:
Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.

Arms: arm 1: Initial doses (Level 1) of BTDS 10. Subjects were allowed to have their doses adjusted to BTDS 20 (Level 2) on or after day 4. arm 2: Initial doses (Level 1) of BTDS 20.
Interventions: intervention 1: Buprenorphine transdermal patch
Intervention descriptions: intervention 1: Buprenorphine transdermal patch applied for 7-day wear.

Protocol documents: