ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00102518
Conditions: Schizophrenia Bipolar Disorder
Keywords: Open Label Aripiprazole Bipolar I Disorder, Manic or Mixed Episode
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2004-09-01; Completion date: 2007-02-01
Enrollment: 325 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to test the long-term safety and tolerability of aripiprazole in adolescent patients with schizophrenia, and child and adolescent patients with bipolar I disorder, manic or mixed episode.

Detailed description:

Arms: arm 1: All subjects had either completed or had withdrawn from the double-blind extension phase of study NCT00110461 (OPDC 31-03-240) and study NCT00102063 (OPDC 31-03-239).
Interventions: intervention 1: Aripiprazole
Intervention descriptions: intervention 1: 2 to 30 mg/day orally (2, 5, 10, 15, 20, 25, or 30 mg/day); tablets in strengths of 2, 5, 10, and 15 mg were used to achieve desired doses

Protocol documents:
Clinical trial NCT00110461
Conditions: Bipolar Disorder
Keywords: Aripiprazole Bipolar I Disorder, Manic or Mixed Episode with or without Psychotic Features
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2005-03-01; Completion date: 2007-02-01
Enrollment: 296 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to test the safety and efficacy of two doses of aripiprazole in child and adolescent patients with bipolar I disorder, manic or mixed episode with or without psychotic features.

Detailed description:

Arms: arm 1: Aripiprazole 10 mg tablet arm 2: Aripiprazole 30 mg tablet arm 3: Placebo
Interventions: intervention 1: Aripiprazole intervention 2: Aripiprazole intervention 3: placebo
Intervention descriptions: intervention 1: Treatment Arm 1 (10 mg treatment arm): Aripiprazole 2 mg QD for 2 days, aripiprazole 5 mg QD for 2 days, and aripiprazole 10 mg QD as the target dose starting on Day 5. Subjects remained on the 10 mg dose for the remainder of the treatment period Subjects reached their target dose through a forced titration schedule and proceeded with treatment at their target dose until Week 4. If the subject reached Week 4, he or she continued into the Extension Phase, a 6-month double-blind treatment period, beginning at the same dose taken at the end of the Acute Phase. intervention 2: Treatment Arm 2 (30 mg treatment arm): Aripiprazole 2 mg QD for 2 days, aripiprazole 5 mg QD for 2 days, aripiprazole 10 mg QD for 2 days, aripiprazole 15 mg QD for 2 days, aripiprazole 20 mg QD for 2 days, aripiprazole 25 mg QD for 2 days, and aripiprazole 30 mg QD as the target dose starting on Day 13. Subjects remained on the 30 mg dose for the remainder of the treatment period. Subjects reached their target dose through a forced titration schedule and proceeded with treatment at their target dose until Week 4. If the subject reached Week 4, he or she continued into the Extension Phase, a 6-month double-blind treatment period, beginning at the same dose taken at the end of the Acute Phase. intervention 3: Placebo tablet

Protocol documents:
Clinical trial NCT00076011
Conditions: Kidney Neoplasms
Sponsor: Pfizer
Start date: 2003-10-01; Completion date: 2007-02-01
Enrollment: 52 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary purpose of this protocol is to determine the activity of AG 013736 in patients with metastatic renal cell cancer who have received 1 prior cytokine-based therapy.

Detailed description:

Interventions: intervention 1: Vascular Endothelial Growth Factor Receptor [VEGFR] and Platelet-Derived Growth Factor Receptor [PDGFR] inhibitor
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00175019
Conditions: Gout
Keywords: uric acid xanthine oxidase hyperuricemia tophi Drug Therapy
Sponsor: Takeda
Start date: 2003-07-01; Completion date: 2007-02-01
Enrollment: 1086 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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

Detailed description:
Uric acid is the end product of purine degradation in humans. Hyperuricemia, a urate concentration in serum exceeding the limit of urate solubility (approximately 7.0 mg/dL), is a common biochemical abnormality. Aberrations in any of the multiple mechanisms involved in the production and/or excretion of uric acid may increase serum urate concentrations, with persistent hyperuricemia as a marker for extracellular fluid monosodium urate supersaturation. As such, hyperuricemia is a necessary (but often insufficient) risk factor for monosodium urate crystal deposition in tissues and is the fundamental pathophysiological process underlying the clinical manifestations of gout, which is a chronic disease characterized by urate crystal formation and deposition in joints and bones. Gout may progress from episodic attacks of acute inflammatory arthritis to a disabling chronic disorder characterized by deforming arthropathy; destructive deposits of urate crystals (tophi) in bones, joints, and other organs; structural and functional renal impairment due to interstitial urate crystal deposition; and urinary tract stones composed entirely or partially of uric acid crystals. Management of gout requires chronic treatment aimed at lowering serum urate levels into a subsaturating range (usually \<6.0 mg/dL) in which crystal formation and deposition are prevented or reversed.

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

This study was originally designed and initiated having all subjects initially assigned to 80 mg febuxostat provided as an 80 mg tablet, to be administered orally. Subjects could be titrated to 120 mg, provided as one 40 and 80 mg tablet, between Months 2 and 6, if their serum uric acid rose \> 6.0 mg/dL; the dose could be down-titrated to 80 mg if the serum uric acid decreased to \< 3.0 mg/dL.

The protocol was amended to add a comparator arm, and to have subjects randomized to 80 or 120 mg febuxostat or allopurinol (100 or 300 mg, dependent on renal function). The information below reflects the treatments following the implementation of the revised protocol.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Febuxostat intervention 2: Febuxostat intervention 3: Allopurinol
Intervention descriptions: intervention 1: Febuxostat 80 mg, tablets, orally, once daily. intervention 2: Febuxostat 120 mg, tablets, orally, once daily. intervention 3: Allopurinol 100 mg or 300 mg, tablets, orally, once daily.

Protocol documents:
Clinical trial NCT00295061
Conditions: Alpha 1-Antitrypsin Deficiency
Keywords: alpha 1-Antitrypsin Deficiency alpha 1-Antitrypsin pulmonary emphysema
Sponsor: Grifols Therapeutics LLC
Start date: 2006-05-01; Completion date: 2007-02-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this clinical study (ChAMP - Comparability pharmacokinetics of Alpha-1 Modified Process) is to compare the pharmacokinetic, safety and tolerability of Alpha-1 Proteinase Inhibitor (Human), modified process (Alpha-1 MP) and Prolastin in adult Alpha1-antitrypsin deficient patients. Patients will be infused intravenously with study drug on a weekly schedule for 24 weeks.

Detailed description:
The objective of this study is to demonstrate the pharmacokinetic comparability of Alpha-1 MP to Prolastin® in subjects with Alpha1-antitrypsin deficiency.

This study is divided into three 8-week treatment sequences including an initial 8-week double-blind treatment period (with one of the 2 study drugs), a second 8-week double-blind treatment period (with the other study drug), and a third 8-week open-label treatment period (with Alpha-1 MP).

Arms: arm 1: Sequential, blinded treatment periods of Alpha-1 MP (experimental), then crossed-over to Prolastin (active comparator), followed by open-label Alpha-1 MP arm 2: Sequential, blinded treatment periods of Prolastin (active comparator), then crossed-over to Alpha-1 MP (experimental), followed by open-label Alpha-1 MP
Interventions: intervention 1: Alpha-1 MP intervention 2: alpha-1 proteinase inhibitor (human)
Intervention descriptions: intervention 1: alpha-1 proteinase inhibitor (human), 60 mg/kg body weight intervention 2: Prolastin

Protocol documents:
Clinical trial NCT00348673
Conditions: HIV-1
Sponsor: Pfizer
Start date: 2006-02-01; Completion date: 2007-02-01
Enrollment: 49 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
A phase 2a study to investigate the effects of 7-day monotherapy of UK-453,061 on viral load response in asymptomatic human immunodeficiency virus (HIV) infected subjects, to assess the dose-response relationship, and to assess the pharmacokinetics (PK), safety and tolerability of UK-453,061 in asymptomatic HIV infected subjects.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: UK-453,061 intervention 2: UK-453,061
Intervention descriptions: intervention 1: Placebo BID, Placebo QD, UK-453,061 10 mg BID, 30 mg BID, 100 mg BID or 500 mg QD for 7 days intervention 2: Placebo BID, Placebo QD, UK-453,061 100 mg QD, 500 mg BID or 750 mg QD for 7 days

Protocol documents:
Clinical trial NCT00364858
Conditions: Gaucher Disease, Type 1 Cerebroside Lipidosis Syndrome Glucocerebrosidase Deficiency Disease Glucosylceramide Beta-Glucosidase Deficiency Disease Gaucher Disease, Non-Neuronopathic Form
Keywords: Type 1 Gaucher Disease Glucocerebrosidase Deficiency Disease
Sponsor: Genzyme, a Sanofi Company
Start date: 2001-12-01; Completion date: 2007-02-01
Enrollment: 95 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter, randomized trial to compare the safety and efficacy of two dosing frequencies of Cerezyme® in patients with Gaucher disease who are currently being treated with Cerezyme®.

Approximately 90 patients will be randomized in a 2:1 (q4 : q2) ratio to one of two treatment arms at up to 26 study centers worldwide. Patients will continue to receive the same total 4-week dose that they were receiving prior to study enrollment, however, they will be randomized to receive either their total 4-week dose in two infusions, one infusion every 2 weeks or their total 4-week dose in one infusion every 4 weeks. The randomization scheme will ensure a 2:1 balance between the every 4-week versus every 2-week infusion groups, respectively.

Detailed description:

Arms: arm 1: Patients receiving Cerezyme one infusion every 2 weeks (Q2). arm 2: Patients receiving Cerezyme one infusion every 4 weeks (Q4).
Interventions: intervention 1: Cerezyme
Intervention descriptions: intervention 1: Cerezyme doses of 20-60U/kg every 2 weeks (Q2 Arm) or 40-120 U/kg every 4 weeks (Q4 Arm).

Protocol documents:
Clinical trial NCT00375609
Conditions: Thromboembolism
Keywords: Prevention of Venous Thromboembolism
Sponsor: Portola Pharmaceuticals
Start date: 2006-05-01; Completion date: 2007-02-01
Enrollment: 215 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Randomized study of PRT054021 40 mg and 15 mg bid vs. enoxaparin 30 mg q12h for the prophylaxis of venous thromboembolic events after unilateral knee replacement surgery.

Detailed description:
Approximately 200 patients undergoing unilateral knee replacement will be entered into the study and randomized to receive either enoxaparin 30 mg sq bid, PRT054021 15 mg po bid, or PRT054021 40 mg po bid for 10 to 14 days, at which time patients will undergo venography.

Arms: arm 1: Betrixaban 15 mg oral twice daily for 10 to 14 days arm 2: Betrixaban 40 mg oral twice daily for 10 to 14 days arm 3: Enoxaparin 30 mg administered subcutaneously every 12 hours for 10 to 14 days
Interventions: intervention 1: Betrixaban intervention 2: Enoxaparin
Intervention descriptions: intervention 1: Capsule intervention 2: Administered subcutaneously

Protocol documents:
Clinical trial NCT01181726
Conditions: Healthy
Keywords: Bioequivalence Healthy Subjects
Sponsor: Teva Pharmaceuticals USA
Start date: 2007-01-01; Completion date: 2007-02-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of this study was to determine and compare the rate and extent of absorption of norethindrone and unconjugated estradiol from a test formulation of Estradiol/Norethindrone Acetate Tablets, 1 mg/0.5 mg versus the reference Activella® (1 mg estradiol/0.5 mg norethindrone acetate) Tablets under fed conditions.

Detailed description:
Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Arms: arm 1: Estradiol/Norethindrone Acetate Tablets, 1 mg/0.5 mg arm 2: Activella® (1 mg estradiol/0.5 mg norethindrone acetate) Tablets
Interventions: intervention 1: Estradiol/Norethindrone acetate intervention 2: Activella®
Intervention descriptions: intervention 1: 1 mg/0.5 mg Tablets intervention 2: 1 mg/0.5 mg Tablets

Protocol documents:
Clinical trial NCT01536795
Conditions: Old World Cutaneous Leishmaniasis
Keywords: Ointment to treat leishmania skin lesions
Sponsor: U.S. Army Medical Research and Development Command
Start date: 2005-10-01; Completion date: 2007-02-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Phase 2 study is to determine whether WR279396 with occlusion (a polyurethane dressing) is more effective than WR279396 without occlusion for once daily treatment.

Extensive objective and subjective local tolerance data will also be captured during this trial, as well as surrogate markers (parasite loads and aminoglycosides concentration in the deep dermis) that may help to determine the optimal number and duration of treatments.

The results from this study will help determine the most practical treatment schedule and will answer questions that are crucial to improve the present treatment regimen with WR279396 which is twice a day for 20 days.

Detailed description:
Forty-eight patients (48) with Old World cutaneous leishmaniasis will be randomly allocated to WR279396 treatment once a day for 20 days with an optimized polyurethane dressing (occlusion) (24 patients), or without occlusion (24 patients). All patients will be rescued with the standard of care accepted in Tunisia, if the patient is not cured. The active ingredients of WR279396 are two aminoglycosides - paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC).

Each subject will be followed for clinical cure for 90 days after the initiation of treatment. Cure is defined as 100% reepithelialization without relapse by 3 months.

Tolerance will be evaluated by local adverse reactions and by laboratory signs of systemic events.

In addition to the clinical evaluation of the CL lesions, the following parameters/clinical healing surrogates will be investigated:

1. parasite load will be determined in superficial and deep lesional dermis samples at D0 and D10. The mean parasite reduction ratio (parasite load at D10/parasite load at D0) in each group will be compared;
2. aminoglycoside concentrations in superficial and deep infiltrated dermis in each group will be compared.

Arms: arm 1: 24 patients will be randomly allocated to WR279,396 treatment once-a-day for 20 days with using an occlusive polyurethane Tegaderm dressing arm 2: 24 subjects will be randomly allocated to WR279,396 treatment once a day for 20 days without an optimized polyurethane dressing (gauze and tape only).
Interventions: intervention 1: WR279,396 with Tegaderm Dressing intervention 2: WR 279,396 with Gauze and Tape Dressing
Intervention descriptions: intervention 1: Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days with polyurethane dressing intervention 2: Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days

Protocol documents:
Clinical trial NCT01879332
Conditions: Epilepsy
Keywords: Anticonvulsant
Sponsor: Bial - Portela C S.A.
Start date: 2006-12-01; Completion date: 2007-02-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Randomized, double-blind, placebo-controlled, sequential multiple ascending dose study to determine a maximum tolerated dose

Detailed description:
This study was designed as a randomized, double-blind, placebo-controlled, sequential multiple ascending dose study to assess the safety and pharmacokinetics of supratherapeutic doses of eslicarbazepine acetate in 32 healthy adult male and female subjects, with 8 subjects per treatment group. In each study group, subjects were to receive single doses of eslicarbazepine acetate or placebo once daily for 5 days.

A series of screening evaluations was performed within a 21-day period prior to the first dose of study medication in order to determine the eligibility of prospective study participants for the trial. Eligible subjects reported to the clinic on Day -1 prior to study medication administration and remained in the clinic until clinic discharge on Day 7. Plasma and urine samples were collected throughout the study to determine the pharmacokinetics of eslicarbazepine acetate and its metabolites.

Arms: arm 1: Matching placebo tablets for oral administration arm 2: Subjects in Cohort 2 received a dose of 3000 mg once daily (5 x 600 mg eslicarbazepine acetate tablets) arm 3: Subjects in Cohort 1 received a dose of 3600 mg once daily (6 x 600 mg eslicarbazepine acetate tablets)
Interventions: intervention 1: Placebo intervention 2: BIA 2-093 3000 mg once daily intervention 3: BIA 2-093 3600 mg once daily
Intervention descriptions: intervention 1: Matching placebo tablets for oral administration intervention 2: Eslicarbazepine acetate 600 mg tablets for oral administration intervention 3: Eslicarbazepine acetate 600 mg tablets for oral administration

Protocol documents:
Clinical trial NCT02283814
Conditions: Epilepsy
Sponsor: Bial - Portela C S.A.
Start date: 2007-01-01; Completion date: 2007-02-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Single centre, open-label, multiple doses, one-sequence design study in two parallel groups of healthy volunteers

Detailed description:
Single centre, open-label, multiple doses, one-sequence design study in two parallel groups of healthy volunteers: Group A: Pre-treatment with ESL, treatment with ESL and ascending doses of Topamax (TPM) in last phases; Group B: Pre-treatment with TPM, treatment with TPM and ascending doses of ESL in last phases

Arms: arm 1: Group A

* Pre-treatment: 600 mg once daily dose of eslicarbazepine acetate (ESL) administered for two consecutive days;
* Treatment 1: 1200 mg once daily dose of eslicarbazepine acetate (ESL) administered for six consecutive days
* Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 100 mg for two consecutive days
* Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 100 mg (morning) + 100mg (evening) for two consecutive days
* Treatment 4: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 200 mg for fifteen consecutive days arm 2: * Pre-treatment: 100 mg once daily dose of TPM administered for two consecutive days;
* Pre-treatment 2: 100 mg twice daily dose of TPM administered for two consecutive days;
* Treatment: 200 mg once daily dose of TPM administered for four consecutive days;
* Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 600 mg and TPM 200 mg for two consecutive days
* Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 200mg for seventeen consecutive days
Interventions: intervention 1: BIA 2-093 intervention 2: Topamax
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00003498
Conditions: Non Hodgkin Lymphoma
Keywords: Non Hodgkin Lymphoma Recurrent Non Hodgkin Lymphoma Refractory
Sponsor: Burzynski Research Institute
Start date: 1997-10-13; Completion date: 2007-02-02
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

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

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Non-Hodgkin's Lymphoma.

Detailed description:
OBJECTIVES:

* Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with non-Hodgkin's lymphoma who have failed high-dose chemotherapy and bone marrow transplantation.
* Describe the response to, tolerance to, and side effects of this regimen in these patients.

Non-Hodgkin's Lymphoma 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 Non-Hodgkin's Lymphoma, 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 Non-Hodgkin's Lymphoma.
* 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 Non-Hodgkin's Lymphoma 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: