ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT03554005
Conditions: Neoplasms
Sponsor: Merck Sharp & Dohme LLC
Start date: 1997-12-29; Completion date: 2001-03-16
Enrollment: 29 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is an extension study to base study protocol C/I97-188 (MK-4031-006). Its primary purpose is to assess the safety and tolerability of extended administration of polyethylene glycol (PEG) interferon alfa-2b in participants with solid tumors.

Detailed description:

Arms: arm 1: Participants receive PEG interferon alfa-2b 0.75 mcg/kg by subcutaneous (SC) injection OW for up to 40 weeks. They also receive 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen should not exceed 3000 mg. arm 2: Participants receive PEG interferon alfa-2b 1.5 mcg/kg by SC injection OW for up to 40 weeks. They also receive 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen should not exceed 3000 mg. arm 3: Participants receive PEG interferon alfa-2b 3 mcg/kg by SC injection OW for up to 40 weeks. They also receive 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen should not exceed 3000 mg. arm 4: Participants receive PEG interferon alfa-2b 4.5 mcg/kg by SC injection OW for up to 40 weeks. They also receive 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen should not exceed 3000 mg. arm 5: Participants receive PEG interferon alfa-2b 6 mcg/kg by SC injection OW for up to 40 weeks. They also receive 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen should not exceed 3000 mg. arm 6: Participants receive PEG interferon alfa-2b 7.5 mcg/kg by SC injection OW for up to 40 weeks. They also receive 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen should not exceed 3000 mg.
Interventions: intervention 1: PEG Interferon Alfa-2b intervention 2: Acetaminophen
Intervention descriptions: intervention 1: Participants receive PEG interferon alfa-2b administered by SC injection, in doses ranging from 0.75 mcg/kg OW up to 7.5 mcg/kg OW, for up to 40 weeks of treatment. intervention 2: Participants receive 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and continue acetaminophen 500 to 1000 mg after administration every 4 to 6 hours as needed. The total daily dose of acetaminophen should not exceed 3000 mg.

Protocol documents:
Clinical trial NCT00003487
Conditions: Adenocarcinoma of the Esophagus
Keywords: esophageal cancer recurrent esophageal cancer stage IV esophageal cancer
Sponsor: Burzynski Research Institute
Start date: 1996-05-30; Completion date: 2001-04-27
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

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

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

Detailed description:
Esophageal 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 esophageal 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 Esophageal Cancer.
* To determine objective response, tumor size is measured utilizing physical examination, and radiologic studies 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 Adenocarcinoma of the Esophagus 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 NCT02171234
Conditions: Epilepsy
Keywords: Epilepsy BIA 2-093 Eslicarbazepine acetate
Sponsor: Bial - Portela C S.A.
Start date: 2001-02-01; Completion date: 2001-06-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the safety and tolerability of multiple dose regimens of BIA 2-093 in healthy young male volunteers

Detailed description:
Single centre, Phase I, double-blind, randomised, placebo-controlled study investigating 4 multiple rising oral doses of BIA 2-093 in 4 groups of 8 young healthy male subjects. Within each group, 2 subjects were randomised to receive placebo and the remaining 6 subjects to receive BIA 2-093. No subject was a member of more than one group. The dose regimens investigated were: 200 mg b.i.d.(twice daily), 400 mg o.d.(once daily; this was changed from 400 mg b.i.d. in protocol amendment 1, on the basis of interim pharmacokinetic analysis of Group 1 data), 800 mg o.d, and 1200 mg o.d. BIA 2-093/placebo was administered orally once daily on Days 1-8, or twice a day (at 12-hour intervals) on Days 1-7 with a final dose in the morning of Day 8. The multiple dose regimens were to be investigated in ascending order. Progression to each higher dose level was only to occur if the previous dose level was deemed by the investigator and the sponsor to be safe and well tolerated.

Arms: arm 1: BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets. arm 2: BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets. arm 3: BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets. arm 4: BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets.
Interventions: intervention 1: Placebo intervention 2: BIA 2-093
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00174967
Conditions: Gout
Keywords: Uric Acid xanthine oxidase tophi Drug Therapy
Sponsor: Takeda
Start date: 2001-01-01; Completion date: 2001-07-01
Enrollment: 153 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the efficacy of febuxostat, once daily (QD), in reducing serum urate levels in subjects with gout.

Detailed description:
Gout is a chronic urate crystal deposition disorder, which if left untreated may result in progressive disease characterized by joint and bone destruction from tophaceous deposits and renal impairment due to gouty nephropathy. Hyperuricemia, defined as a serum urate concentration of \>7.0 milligrams per deciliter (mg/dL), is the underlying metabolic aberration leading to urate crystal deposition in gout. Gout has several clinical presentations, including: recurrent acute attacks of inflammatory arthritis; deposition of monosodium urate monohydrate crystals in joints, bones and even parenchymal organs (tophaceous gout); renal impairment; and uric acid nephrolithiasis. As serum urate levels increase beyond \>7.0 mg/dL, the risks for gouty arthritis or for renal calculi increase.

Currently allopurinol is the only xanthine oxidase inhibitor available. Allopurinol is the agent of choice for reduction of serum urate levels in patients with: uric acid overproduction; unresponsive or intolerant to uricosuric agents; impaired renal function; uric acid urolithiasis; or tophi.

Febuxostat (TMX-67) is a non-purine selective xanthine oxidase inhibitor being developed as an orally administered agent for management of hyperuricemia in patients with gout.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Placebo intervention 2: Febuxostat intervention 3: Febuxostat intervention 4: Febuxostat
Intervention descriptions: intervention 1: Febuxostat placebo-matching tablets, orally, once daily for up to 4 weeks. intervention 2: Febuxostat 40 mg, tablets, orally, once daily for up to 4 weeks. intervention 3: Febuxostat 80 mg, tablets, orally, once daily for up to 4 weeks. intervention 4: Febuxostat 120 mg, tablets, orally, once daily for up to 4 weeks.

Protocol documents:
Clinical trial NCT00312195
Conditions: Chronic Non-malignant Pain
Keywords: Chronic pain opioid transdermal Butrans™ [BTDS]
Sponsor: Purdue Pharma LP
Start date: 2001-03-01; Completion date: 2001-07-01
Enrollment: 267 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 (5, 10 and 20) in comparison to matching placebo transdermal system in subjects with chronic nonmalignant pain syndromes currently controlled by oral opioids. The double-blind treatment intervention duration is 2 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 arm 2: Placebo to match buprenorphine transdermal patch
Interventions: intervention 1: Buprenorphine transdermal patch intervention 2: Placebo to match BTDS
Intervention descriptions: intervention 1: Buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear. intervention 2: Placebo to match buprenorphine transdermal patch applied for 7-day wear.

Protocol documents:
Clinical trial NCT00972738
Conditions: Seasonal Allergic Rhinitis
Sponsor: Organon and Co
Start date: 2001-04-01; Completion date: 2001-07-01
Enrollment: 1214 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the treatment effect of montelukast versus placebo over a 2 week period in patients with seasonal allergic rhinitis. Loratadine is included in the study as an active comparator.

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 orally once daily at bedtime for 2 weeks. intervention 2: Loratadine 10-mg tablet orally once daily at bedtime for 2 weeks. intervention 3: placebo tablet orally once daily at bedtime for 2 weeks

Protocol documents:
Clinical trial NCT01247272
Conditions: Healthy
Keywords: Bioequivalence Healthy Subjects
Sponsor: Teva Pharmaceuticals USA
Start date: 2001-05-01; Completion date: 2001-07-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study compared the relative bioavailability (rate and extent of absorption) of 90 mg Fluoxetine Hydrochloride Capsules by Teva Pharmaceuticals, USA with that of 90 mg PROZAC WEEKLY® Capsules by Eli Lilly and Company following a single oral dose (1 x 90 mg) in healthy adult volunteers under fasting conditions.

Detailed description:

Arms: arm 1: 90 mg PROZAC WEEKLY® Capsules (Eli Lilly) arm 2: 90 mg Fluoxetine Hydrochloride Capsules (Teva)
Interventions: intervention 1: Fluoxetine Hydrochloride intervention 2: PROZAC WEEKLY®
Intervention descriptions: intervention 1: 90 mg Capsules intervention 2: 90 mg Capsules

Protocol documents:
Clinical trial NCT01247285
Conditions: Healthy
Keywords: Bioequivalence Healthy Subjects
Sponsor: Teva Pharmaceuticals USA
Start date: 2001-05-01; Completion date: 2001-07-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study compared the relative bioavailability (rate and extent of absorption) of 90 mg Fluoxetine Hydrochloride Capsules by Teva Pharmaceuticals, USA with that of 90 mg PROZAC WEEKLY® Capsules by Eli Lilly and Company following a single oral dose (1 x 90 mg) in healthy adult volunteers under non-fasting conditions.

Detailed description:

Arms: arm 1: 90 mg Fluoxetine Hydrochloride Capsules (Teva) arm 2: 90 mg PROZAC WEEKLY® Capsules (Eli Lilly)
Interventions: intervention 1: Fluoxetine Hydrochloride intervention 2: PROZAC WEEKLY®
Intervention descriptions: intervention 1: 90 mg Capsules intervention 2: 90 mg Capsules

Protocol documents:
Clinical trial NCT01270555
Conditions: Attention Deficit Hyperactivity Disorder (ADHD) Substance Use Disorder (SUD)
Sponsor: Massachusetts General Hospital
Start date: 1999-05-01; Completion date: 2001-07-01
Enrollment: 32 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The investigators propose to conduct an open study to evaluate the efficacy and tolerability of Bupropion SR using clinically relevant doses in ADHD adults with a recent history of or current substance use disorders. We hypothesize that Bupropion SR will be effective in treating ADHD in this population.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Bupropion SR
Intervention descriptions: intervention 1: 100mg capsules Initial dosing 100mgSR every morning, to be titrated to 200mgSR twice daily maximum

Protocol documents:
Clinical trial NCT00943397
Conditions: Asthma
Sponsor: Organon and Co
Start date: 2001-04-01; Completion date: 2001-11-01
Enrollment: 190 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Patients were treated with either montelukast 4 mg oral granules or usual care. Patients who completed Protocol MK0476-176-01 (NCT00943683) had the option to enroll in this study. Additionally, patients with asthma who were 6 to 11 months of age and who had not participated in Protocol MK0476-176-01, could also enroll.

Detailed description:

Arms: arm 1: Montelukast arm 2: Usual Care
Interventions: intervention 1: montelukast sodium intervention 2: Comparator: Usual Care
Intervention descriptions: intervention 1: Montelukast 4 mg oral granules mixed with 1 tablespoon soft food once daily at bedtime for 52 weeks intervention 2: Usual care defined as inhaled/nebulized cromolyn or inhaled nedocromil or inhaled/nebulized corticosteroids, according to the investigator's usual clinical practice for 52 weeks

Protocol documents:
Clinical trial NCT00963469
Conditions: Seasonal Allergic Rhinitis
Sponsor: Organon and Co
Start date: 2001-08-01; Completion date: 2001-11-01
Enrollment: 1079 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study to evaluate the treatment effect of montelukast 10 mg taken in the morning, versus placebo, in patients with seasonal allergic rhinitis. 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 orally once daily in the morning for 4 weeks intervention 2: loratadine 10 mg tablet orally once daily in the morning for 4 weeks intervention 3: placebo tablet orally once daily in the morning for 4 weeks

Protocol documents:
Clinical trial NCT02170649
Conditions: Epilepsy
Keywords: BIA 2-093 Eslicarbazepine acetate
Sponsor: Bial - Portela C S.A.
Start date: 2001-09-01; Completion date: 2001-11-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to investigate the effect of food on the pharmacokinetics of a single 800 mg oral dose of BIA 2-093 in healthy volunteers.

Detailed description:
Single centre, open label, randomized, two-way crossover study in 12 healthy male volunteers. The study consisted of 2 periods separated by a washout period of 14 days or more. On each of the study periods the volunteers received a single 800 mg oral dose of BIA 2-093 following either a standard high fat content breakfast or 10 hours of fasting.

Arms: arm 1: the volunteers received a single 800 mg BIA 2-093 following either a standard high fat content breakfast or 10 hours of fasting. Fed and fasting periods were separated by a washout period
Interventions: intervention 1: BIA 2-093
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01020877
Conditions: Healthy
Keywords: Bioequivalence Healthy Subjects Healthy, Normal Subjects
Sponsor: Teva Pharmaceuticals USA
Start date: 2001-11-01; Completion date: 2002-01-01
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary object of this study was to evaluate the relative bioavailability of the test formulation of metronidazole vaginal gel with the already marketed reference formulation MetroGel-Vaginal Gel® in healthy adult female subjects.

Detailed description:
Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Arms: arm 1: Metronidazole Vaginal Gel arm 2: MetroGel-Vaginal®
Interventions: intervention 1: Metronidazole intervention 2: Metronidazole
Intervention descriptions: intervention 1: Vaginal Gel, 0.75% intervention 2: Vaginal Gel, 0.75%

Protocol documents:
Clinical trial NCT01151098
Conditions: Chronic Nonmalignant Pain
Keywords: Chronic nonmalignant pain Opioid Transdermal Butrans (BTDS)
Sponsor: Purdue Pharma LP
Start date: 2001-04-01; Completion date: 2002-02-01
Enrollment: 189 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this study was to evaluate the long-term safety and tolerability of 7-day BTDS in a 28-week open-label extension phase in subjects with chronic nonmalignant pain syndromes whose pain had been previously controlled by oral opioid combination therapy.

Detailed description:
Upon entering the extension phase (BUP3201S), subjects will receive BTDS 5, regardless of their dose level at discontinuation or completion of the BUP3201 core study. Subjects are allowed to titrate after 48 hours to BTDS 10 or 20 that provided stable pain control with minimal tolerability problems. Additional medical therapies are permitted if necessary, and there is no restriction on concomitant analgesic medications. The subjects have weekly visits for 4 consecutive weeks, and every 4 weeks thereafter, until the end of the scheduled extension phase.

Arms: arm 1: Buprenorphine transdermal patch
Interventions: intervention 1: Buprenorphine transdermal patch
Intervention descriptions: intervention 1: Buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear

Protocol documents:
Clinical trial NCT01678976
Conditions: Epilepsy
Keywords: Eslicarbazepine acetate Epilepsy Oxcarbazepine
Sponsor: Bial - Portela C S.A.
Start date: 2002-03-01; Completion date: 2002-04-01
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To investigate the pharmacokinetics of a single 900 mg oral dose of BIA 2-093 and a single 900 mg oral dose of Oxcarbazepine in healthy volunteers and to assess the tolerability of a single 900 mg dose of BIA 2-093 and Oxcarbazepine.

Detailed description:
Single centre, open label, balanced randomised, two-way crossover study in 12 healthy volunteers. The study consisted of 2 periods separated by a washout period of 7 days or more. On each of the study periods the volunteers received either a single 900 mg oral dose of BIA 2-093 or a single 900 mg oral dose of Oxcarbazepine.

Arms: arm 1: Period 1 - Subjects recieved 900 mg of BIA 2-093 Period 2 - Subjects recieved 900 mg of oxcarbazepine arm 2: Period 1 - Subjects recieved 900 mg of oxcarbazepine Period 2 - Subjects recieved 900 mg of BIA 2-093
Interventions: intervention 1: BIA 2-093 intervention 2: Oxcarbazepine
Intervention descriptions: intervention 1: Tablets containing BIA 2-093 in doses of 300 and 600 mg intervention 2: Tablets containing 300 mg and 600 mg of Trileptal®

Protocol documents:
Clinical trial NCT00974571
Conditions: Perennial Allergic Rhinitis
Sponsor: Organon and Co
Start date: 2001-11-01; Completion date: 2002-05-01
Enrollment: 1365 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the ability of montelukast to improve the signs and symptoms of perennial allergic rhinitis compared to placebo. Cetirizine is included in the study as an active control.

Detailed description:

Arms: arm 1: montelukast arm 2: cetirizine arm 3: placebo
Interventions: intervention 1: montelukast sodium intervention 2: Comparator: cetirizine intervention 3: Comparator: placebo
Intervention descriptions: intervention 1: montelukast 10 mg tablet orally once daily at bedtime for 6 weeks intervention 2: cetirizine 10 mg tablet orally once daily at bedtime for 6 weeks intervention 3: placebo tablet orally once daily at bedtime for 6 weeks

Protocol documents:
Clinical trial NCT02617784
Conditions: End Stage Renal Disease
Sponsor: Hoffmann-La Roche
Start date: 2001-10-01; Completion date: 2002-06-01
Enrollment: 24 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to assess the pharmacokinetics (PK) and safety of oseltamivir and its metabolite oseltamivir carboxylate in participants undergoing routine HD and CAPD for end-stage renal disease (ESRD). Participants will receive 6.5 and 6 weeks of the marketed oral oseltamivir suspension dosed according to the HD or CAPD schedule, respectively.

Detailed description:

Arms: arm 1: Participants will receive 30 milligrams (mg) of oseltamivir via oral suspension approximately 1 hour after alternating HD sessions. Sessions will occur three times per week within the 6.5-week study period, and participants will receive a total of 9 doses of oseltamivir. arm 2: Participants will receive 30 mg of oseltamivir via oral suspension once weekly after dialysis exchange. CAPD sessions will occur four times every 24 hours, and participants will receive a total of 6 doses of oseltamivir within the 6-week study period.
Interventions: intervention 1: Oseltamivir
Intervention descriptions: intervention 1: Oseltamivir will be given as marketed oral suspension, 30 mg after HD or CAPD treatment.

Protocol documents: