ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00003535
Conditions: High Grade Glioma
Keywords: childhood anaplastic astrocytoma childhood glioblastoma multiforme
Sponsor: Burzynski Research Institute
Start date: 1994-04-01; Completion date: 1998-01-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Current therapies for children with recurrent/progressive high grade gliomas provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of children with recurrent/progressive high grade gliomas.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on children (\> 6 months of age) with recurrent/progressive high grade gliomas.

Detailed description:
OBJECTIVES:

* To determine the efficacy of Antineoplaston therapy in children with recurrent/progressive high grade gliomas, 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 recurrent/progressive high grade gliomas.

OVERVIEW: This is a single arm, open-label study in which children with recurrent/progressive high grade gliomas 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 for 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 recurrent/progressive high grade glioma will receive Antineoplaston therapy (Atengenal + Astugenal).

Protocol documents:
Clinical trial NCT00315445
Conditions: Back Pain
Keywords: chronic back pain opioid transdermal
Sponsor: Purdue Pharma LP
Start date: 1997-12-01; Completion date: 1998-05-01
Enrollment: 134 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to assess the safety of the buprenorphine transdermal system (5, 10, and 20) in comparison to placebo transdermal system and immediate release oxycodone/ acetaminophen in subjects with chronic back pain. The double-blind treatment intervention duration is 84 days during which time supplemental analgesic medication (non-steroidal anti-inflammatory drugs) will be allowed for all subjects in addition to study drug.

Detailed description:
Buprenorphine is a synthetic opioid analgesic with over twenty-five 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: Placebo oxycodone (OXY)/acetaminophen (APAP) tablets and placebo transdermal patch (TDS) 5, 10, or 20 arm 2: 5 mg oxycodone/325 mg acetaminophen tablets arm 3: Buprenorphine transdermal patch 5, 10, or 20 mcg/hour
Interventions: intervention 1: Buprenorphine transdermal patch intervention 2: Placebo oxycodone/acetaminophen tablets intervention 3: OXY/APAP intervention 4: Placebo transdermal patch (TDS)
Intervention descriptions: intervention 1: Buprenorphine 5, 10, or 20 mcg/hour patch applied transdermally for 7-day wear. intervention 2: Placebo oxycodone/acetaminophen tablets; 1, 2, or 3 tablets taken four times/day. intervention 3: 5 mg oxycodone / 325 mg acetaminophen tablets; 1, 2, or 3 tablets taken four times/day. intervention 4: Placebo transdermal patch 5, 10, or 20 applied transdermally for 7-day wear

Protocol documents:
Clinical trial NCT03780959
Conditions: Juvenile Rheumatoid Arthritis
Sponsor: Amgen
Start date: 1997-05-01; Completion date: 1998-07-08
Enrollment: 69 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study was to determine the efficacy of etanercept in children with polyarticular course JRA.

Detailed description:
This was a two-part study. In the first part of the study, all participants received open-label etanercept twice a week for 90 days. At the end of the 90 days, participants with disease response as defined by the JRA Definition of Improvement (DOI) using the JRA Core Set Criteria were randomized in part 2 of the study to receive placebo or continued administration of etanercept until either disease flare occurred or 4 months elapsed, whichever was earlier.

Participants who did not meet the DOI at day 90, participants who had disease flare during part 2 and participants who completed the blinded part of the study were eligible to receive open-label treatment with etanercept under protocol 16.0018 (NCT00357903).

Arms: arm 1: Participants received 0.4 mg/kg etanercept twice weekly for 90 days during Part 1. In Part 2 participants were randomized to receive placebo subcutaneous injection twice weekly for up to 4 months. arm 2: Participants received 0.4 mg/kg etanercept twice weekly for 90 days during Part 1. In Part 2 participants were randomized to continue receiving etanercept twice weekly for up to 4 additional months.
Interventions: intervention 1: Etanercept intervention 2: Placebo
Intervention descriptions: intervention 1: Administered twice weekly by subcutaneous injection intervention 2: Administered twice weekly by subcutaneous injection

Protocol documents:
Clinical trial NCT00003511
Conditions: Multiple Myeloma
Keywords: Stage I multiple myeloma Stage II multiple myeloma Stage III multiple myeloma
Sponsor: Burzynski Research Institute
Start date: 1996-04-04; Completion date: 1999-10-21
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Current therapies for Multiple Myeloma provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Multiple Myeloma.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Multiple Myeloma.

Detailed description:
Multiple Myeloma patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity.

OBJECTIVES:

* To determine the efficacy of Antineoplaston therapy in patients with Multiple Myeloma, 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 patients with Multiple Myeloma.
* To determine objective response, tumor size is measured utilizing physical examination, radiologic studies, and bone marrow biopsies as necessary, 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.

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: Patients with Multiple Myeloma will receive Antineoplaston therapy (Atengenal + Astugenal).

The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.

Protocol documents:
Clinical trial NCT00963599
Conditions: Seasonal Allergic Rhinitis
Sponsor: Organon and Co
Start date: 1999-09-01; Completion date: 1999-11-01
Enrollment: 907 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the ability of oral montelukast/loratadine to improve the signs and symptoms of seasonal allergic rhinitis compared with loratadine alone, montelukast alone and placebo.

Detailed description:

Arms: arm 1: montelukast/loratadine arm 2: loratadine arm 3: montelukast arm 4: placebo
Interventions: intervention 1: Comparator: montelukast/loratadine intervention 2: Comparator: montelukast intervention 3: Comparator: loratadine intervention 4: Comparator: placebo
Intervention descriptions: intervention 1: montelukast 10 mg/loratadine 10 mg tablet taken once daily at bed time for 2 weeks intervention 2: montelukast 10 mg tablet taken once daily at bed time for 2 weeks intervention 3: loratadine 10 mg tablet taken once daily at bed time for 2 weeks intervention 4: placebo tablet taken once daily at bed time for 2 weeks

Protocol documents:
Clinical trial NCT00046475
Conditions: Hypotension, Orthostatic
Sponsor: Shire
Start date: 1997-12-01; Completion date: 1999-11-24
Enrollment: 140 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
We are seeking male and female patients to voluntarily take part in a clinical research study. Patients must be aged 18 or older and diagnosed with symptomatic orthostatic hypotension (low blood pressure while in the upright position) due to Parkinson's disease, multiple system atrophy, pure autonomic failure or autonomic neuropathies (i.e. neurogenic orthostatic hypotension). Symptoms of low blood pressure include dizziness, lightheadedness, changes in vision and generalized weakness upon standing. The main effect of the drug being studied is to increase blood pressure in the upright position so symptoms will decrease.

The purpose of this clinical study is to further assess the clinical benefit of midodrine hydrochloride (ProAmatine®), an approved treatment for orthostatic hypotension. During the course of the study, participants will receive either ProAmatine® or a placebo. Assessments will be made using questionnaires that measure symptom and activity levels. Blood pressure in the lying down and standing positions will be measured at each visit.

Detailed description:

Interventions: intervention 1: Midodrine Hydrochloride
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00979901
Conditions: Seasonal Allergic Rhinitis
Sponsor: Organon and Co
Start date: 2000-03-01; Completion date: 2000-05-01
Enrollment: 1577 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the ability of montelukast to improve the signs and symptoms of seasonal allergic rhinitis compared with loratadine and placebo.

Detailed description:

Arms: arm 1: montelukast arm 2: loratadine arm 3: placebo arm 4: montelukast/loratadine
Interventions: intervention 1: Comparator: montelukast intervention 2: Comparator: loratadine intervention 3: Comparator: placebo intervention 4: Comparator: montelukast/loratadine
Intervention descriptions: intervention 1: 10 mg montelukast tablet given once daily at bedtime for 2 weeks intervention 2: 10 mg loratadine tablet given once daily at bedtime for 2 weeks intervention 3: placebo tablet given once daily at bedtime for 2 weeks intervention 4: montelukast 10-mg/loratadine 10-mg combination tablet taken orally once daily at bedtime for 2 weeks

Protocol documents:
Clinical trial NCT01207934
Conditions: Type Two Diabetes Mellitus
Keywords: diabetes obesity
Sponsor: Washington University School of Medicine
Start date: 1998-08-01; Completion date: 2000-07-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Leptin therapy improves insulin sensitivity in people with leptin-deficiency but it is not known whether it improves insulin action in persons who are not leptin deficient. The purpose of the present study was to determine whether leptin therapy has effects on insulin action in obese subjects with type 2 diabetes mellitus (T2DM). A randomized, placebo controlled trial was conducted in obese subjects with newly-diagnosed T2DM. Subjects were randomized to treatment with placebo, low-dose, or high-dose leptin. Insulin sensitivity was measured.

Detailed description:
Leptin therapy improves insulin sensitivity in people with leptin-deficiency but it is not known whether it improves insulin action in persons who are not leptin deficient. The purpose of the present study was to determine whether leptin therapy has weight loss-independent effects on insulin action in obese subjects with type 2 diabetes mellitus (T2DM). A randomized, placebo controlled trial was conducted in obese subjects with newly-diagnosed T2DM. Subjects were randomized to treatment with placebo (saline), low-dose (30 mg/d), or high-dose (80 mg/d) recombinant methionyl human (r-met hu) leptin for 14 days. Multi-organ insulin sensitivity before and after treatment was evaluated by using the hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotopically labelled tracer infusions to measure glucose, glycerol and fatty acid kinetics.

Arms: arm 1: saline placebo for fourteen days arm 2: 30mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days arm 3: 80mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days
Interventions: intervention 1: placebo intervention 2: low-dose leptin intervention 3: high-dose leptin
Intervention descriptions: intervention 1: saline placebo intervention 2: 30mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days intervention 3: 80mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days

Protocol documents:
Clinical trial NCT00003479
Conditions: Ependymoma
Keywords: Ependymoma Anaplastic Ependymoma
Sponsor: Burzynski Research Institute
Start date: 1966-07-01; Completion date: 2000-10-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Current therapies for patients with ependymoma provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of patients with ependymoma .

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with ependymoma.

Detailed description:
OBJECTIVES:

* To determine the efficacy of Antineoplaston therapy in patients with ependymoma 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 patients with ependymoma

OVERVIEW: This is a single arm, open-label study in which patients with ependymoma 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: Patients with an ependymoma will receive Antineoplaston therapy (Atengenal + Astugenal).

Protocol documents:
Clinical trial NCT02171195
Conditions: Epilepsy
Keywords: Eslicarbazepine acetate BIA 2-093 Epilepsy
Sponsor: Bial - Portela C S.A.
Start date: 2000-07-01; Completion date: 2000-10-01
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the safety and tolerability of single rising oral doses of BIA 2-093 (proposed doses 20mg, 50mg, 100mg, 200mg, 400mg, 600mg, 900mg and 1200mg) in groups of 8 healthy male adult volunteers.

Detailed description:
Single centre, Phase I, double-blind, randomised, placebo-controlled study to investigate single rising oral doses of BIA 2-093 up to 1200 mg in sequential groups of eight healthy male adult subjects. Within each group of eight subjects two subjects were randomised to receive placebo and the remaining six subjects were randomised to receive BIA 2-093. No subject was a member of more than one treatment group. Doses of 20mg, 50mg, 100mg, 200mg, 400mg, 600mg, 900mg and 1200mg were investigated in ascending order. Progression to each dose occurred only after the previous dose level was deemed to be safe and well tolerated by the investigator and the sponsor.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None arm 8: None
Interventions: intervention 1: BIA 2-093 intervention 2: Placebo
Intervention descriptions: intervention 1: BIA 2-093 20mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg, 1200 mg intervention 2: Identical placebo administered as oral tablets with 200 ml potable water.

Protocol documents:
Clinical trial NCT00960141
Conditions: Seasonal Allergic Rhinitis
Sponsor: Organon and Co
Start date: 2000-08-01; Completion date: 2000-11-01
Enrollment: 829 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study of the ability of montelukast to improve signs and symptoms of seasonal allergic rhinitis compared with placebo. Loratadine is included in the study as an active control.

Detailed description:

Arms: arm 1: montelukast arm 2: loratadine arm 3: placebo
Interventions: intervention 1: montelukast sodium intervention 2: Comparator: loratadine intervention 3: Comparator: placebo
Intervention descriptions: intervention 1: montelukast 10 mg tablet, taken orally once daily at bed time for 2 weeks intervention 2: loratadine 10 mg tablet, taken orally once daily at bed time for 2 weeks intervention 3: placebo tablet, taken orally once daily at bed time for 2 weeks

Protocol documents:
Clinical trial NCT00003492
Conditions: Stage IV Lung Cancer
Keywords: Stage IV large cell lung cancer Stage IV non-small cell lung cancer
Sponsor: Burzynski Research Institute
Start date: 1996-04-10; Completion date: 2000-12-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Current therapies for Stage IV Lung Cancer provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Stage IV Pancreatic Cancer.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Stage IV Lung Cancer.

Detailed description:
Stage IV Lung Cancer patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity.

OBJECTIVES:

* To determine the efficacy of Antineoplaston therapy in patients with Stage IV Lung Cancer, 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 patients with Stage IV Lung Cancer.
* 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. Cancer patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity.

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: Patients with Stage IV Lung Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).

The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.

Protocol documents:
Clinical trial NCT00943683
Conditions: Asthma
Sponsor: Organon and Co
Start date: 2000-08-01; Completion date: 2001-02-01
Enrollment: 256 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study of Montelukast compared to placebo in asthmatic children aged 6-24 months.

Detailed description:

Arms: arm 1: Montelukast arm 2: Placebo
Interventions: intervention 1: montelukast sodium intervention 2: Comparator: Placebo
Intervention descriptions: intervention 1: Montelukast 4-mg oral granules mixed with applesauce once daily at bedtime for 6 weeks intervention 2: Placebo oral granules mixed with applesauce once daily at bedtime for 6 weeks

Protocol documents:
Clinical trial NCT01259102
Conditions: Healthy
Keywords: Healthy subjects Opioid Transdermal
Sponsor: Purdue Pharma LP
Start date: 2000-11-01; Completion date: 2001-03-01
Enrollment: 70 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the pharmacokinetics of BTDS following same-site patch reapplication after rest intervals.

Detailed description:
The purpose of this study is to determine the minimum application site rest period that ensures that reapplication of BTDS 10 to the same site in the deltoid region does not result in increased absorption of drug in normal healthy subjects.

Arms: arm 1: BTDS 10 with no application site rest period prior to application of second BTDS arm 2: BTDS 10 with 7-day rest period prior to application of second BTDS arm 3: BTDS 10 with 14-day rest period prior to application of second BTDS arm 4: BTDS 10 with 21-day rest period prior to application of second BTDS arm 5: BTDS 10 with 28-day rest period prior to application of second BTDS
Interventions: intervention 1: Buprenorphine transdermal patch
Intervention descriptions: intervention 1: Buprenorphine 10 mcg/hour patch applied transdermally for 7-day wear.

Protocol documents: