ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00555880
Conditions: Hypotension, Orthostatic
Sponsor: Shire
Start date: 2004-09-08; Completion date: 2005-03-21
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this clinical study is to evaluate the clinical effect of midodrine hydrochloride (ProAmatine®) compared to placebo in patients with orthostatic hypotension by measuring the time to onset of near syncopal symptoms and assessing several cardiovascular measurements, such as heart rate, blood pressure, and ECG, using the tilt table test.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Midodrine hydrochloride intervention 2: Placebo
Intervention descriptions: intervention 1: one dose, 10-30mg, given orally intervention 2: Placebo

Protocol documents:
Clinical trial NCT00063154
Conditions: Non-small Cell Lung Cancer
Keywords: Lung cancer
Sponsor: Genentech, Inc.
Start date: 2003-07-01; Completion date: 2005-04-01
Enrollment: 51 participants; Allocation: NA; Intervention model: SINGLE_GROUP

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

Detailed description:

Arms: arm 1: Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.
Interventions: intervention 1: Pertuzumab
Intervention descriptions: intervention 1: Pertuzumab was supplied as a single-use liquid formulation.

Protocol documents:
Clinical trial NCT00069277
Conditions: Cancer
Keywords: Cancer, tumors
Sponsor: Eisai Inc.
Start date: 2003-08-01; Completion date: 2005-04-01
Enrollment: 21 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The malignancies (advanced solid tumors) that have been chosen for evaluation of E7389 are those where E7389 has demonstrated significant pre-clinical anti-tumor activity, both in vitro and in vivo. The ultimate goal is to demonstrate the clinical activity of E7389 in the treatment of these, and potentially other, tumor types.

Detailed description:

Interventions: intervention 1: E7389
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00804193
Conditions: Tinea Pedis
Keywords: Tinea Pedis Ciclopirox Olamine
Sponsor: Padagis LLC
Start date: 2004-06-01; Completion date: 2005-04-01
Enrollment: 553 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objectives of this study were to demonstrate comparable safety and efficacy of Ciclopirox Olamine Topical Suspension (Test Product) and Ciclopirox Topical Suspension 0.77% (Reference Product) in the treatment of subjects with tinea pedis, and to show the superiority of the active treatments over that of the vehicle.

Detailed description:

Arms: arm 1: Ciclopirox Olamine Topical Suspension arm 2: Loprox® Topical Suspension 0.77% arm 3: placebo of test product
Interventions: intervention 1: Ciclopirox Olamine Topical Suspension intervention 2: Ciclopirox Topical Suspension 0.77%-Reference Product intervention 3: Ciclopirox Olamine Topical Suspension-Placebo
Intervention descriptions: intervention 1: topical suspension intervention 2: topical suspension intervention 3: topical suspension

Protocol documents:
Clinical trial NCT01079988
Conditions: Psoriasis
Keywords: Psoriasis Discontinuation of efalizumab Managing inflammatory recurrence
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2004-02-01; Completion date: 2005-04-01
Enrollment: 41 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a pilot investigational study of the appropriate therapeutic regimens to treat subjects experiencing inflammatory recurrence (rebound) of psoriatic disease upon discontinuation of efalizumab therapy and of the biological mechanisms involved in inflammatory disease recurrence and control.

Detailed description:

Arms: arm 1: Starting dose 4.0 - 5.1 mg/kg/day until clinical improvement. Upon clinical improvement, cyclosporin dose to be tapered by 50% every two weeks. arm 2: Starting dose 25 - 50 mg/day until clinical improvement. Upon clinical improvement, retinoid dose to be reduced by 50%. Thereafter, treatment to be continued for 8 weeks and then stopped. arm 3: Starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, corticosteroids to be weaned by 50% every 2 weeks. arm 4: Starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, methotrexate dose to be reduced by 25% every two weeks. arm 5: Corticosteroid starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%.

Thereafter, to be weaned by 50% every 2 weeks. Methotrexate starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, to be reduced by 25% every two weeks.
Interventions: intervention 1: Cyclosporins intervention 2: Retinoids intervention 3: Systemic corticosteroids intervention 4: Methotrexate intervention 5: Systemic corticosteroids/methotrexate
Intervention descriptions: intervention 1: Starting dose 4.0 - 5.1 mg/kg/day until clinical improvement. Upon clinical improvement, cyclosporin dose to be tapered by 50% every two weeks. intervention 2: Starting dose 25 - 50 mg/day until clinical improvement. Upon clinical improvement, retinoid dose to be reduced by 50%. Thereafter, treatment to be continued for 8 weeks and then stopped. intervention 3: Starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, corticosteroids to be weaned by 50% every 2 weeks. intervention 4: Starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, methotrexate dose to be reduced by 25% every two weeks. intervention 5: Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, to be weaned by 50% every 2 weeks. Methotrexate starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, to be reduced by 25% every two weeks.

Protocol documents:
Clinical trial NCT01121913
Conditions: Healthy
Keywords: Healthy subjects
Sponsor: Labopharm Inc.
Start date: 2005-03-01; Completion date: 2005-04-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objectives of this study were:

* to compare the pharmacokinetic profiles of two prototype controlled-release (CR) trazodone hydrochloride (HCl) 300 mg tablets versus two reference products: Trittico® AC (2 x 150 mg CR tablets) and Desyrel® (3 x 100 mg IR (immediate-release) tablets) under fasting condition;
* to assess the controlled release properties of the two prototype formulations;
* to select a prototype formulation for further development;
* to validate the blood sampling schedule for future pivotal pharmacokinetic studies;
* to determine the appropriate sample size for pivotal studies based in the intra-subject variability.

Detailed description:

Arms: arm 1: Test product 1 and Test product 2 are two different prototype formulations of Trazodone Contramid® OAD (once a day) arm 2: Test product 1 and Test product 2 are two different prototype formulations of Trazodone Contramid® OAD (once a day) arm 3: None arm 4: None
Interventions: intervention 1: Trazodone HCl intervention 2: Trazodone HCl intervention 3: Trazodone HCl intervention 4: Trazodone HCl
Intervention descriptions: intervention 1: The dosage of trazodone.HCl during this treatment phase was a single oral dose of 300 mg (one CR tablet) at 07:30 (after an overnight fast of at least 10 hours) on clinic days. intervention 2: The dosage of trazodone.HCl during this treatment phase was a single oral dose of 300 mg (one CR tablet) at 07:30 (after an overnight fast of at least 10 hours) on clinic days. intervention 3: The dosage of trazodone.HCl during this treatment phase was 2 oral doses of 150 mg each: one controlled-release (CR) tablet at 07:30 (after an overnight fast of at least 10 hours) and 19:30 (after a fast of at least 2 hours) on clinic days. intervention 4: The dosage of trazodone.HCl during this treatment phase was three oral doses of 100 mg each: one immediate-release (IR) tablet at 07:30 (after an overnight fast of at least 10 hours), 15:30 and 23:30 (both dosages after a fast of at least 2 hours) on clinic days.

Protocol documents:
Clinical trial NCT01710033
Conditions: Kidney Transplant
Keywords: CP-690,550 kidney transplant
Sponsor: Pfizer
Start date: 2003-09-01; Completion date: 2005-04-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a Phase 1 dose escalation study to evaluate the safety, tolerability and pharmacokinetics of 28-day treatment of CP-690,550 in stable renal allograft recipients. In Stage 1, ascending doses of CP-690,550 were to be administered sequentially to 3-4 cohorts of subjects. After Stage 1, one dose level was to be selected for dosing in an expanded cohort in Stage 2.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Placebo intervention 2: CP-690,550 5 mg BID intervention 3: CP-690,550 15 mg BID intervention 4: CP-690,550 30 mg BID
Intervention descriptions: intervention 1: Placebo tables twice daily (BID) for 28 days intervention 2: CP-690,550 5 mg BID for 28 days intervention 3: CP-690,550 15 mg BID for 28 days intervention 4: CP-690,550 30 mg BID for 28 days

Protocol documents:
Clinical trial NCT02491892
Conditions: Breast Cancer
Sponsor: Hoffmann-La Roche
Start date: 2003-02-01; Completion date: 2005-04-01
Enrollment: 79 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy and safety of pertuzumab (rhuMAb 2C4) in participants with metastatic breast cancer which has progressed during or after standard chemotherapy and which is not amenable to curative therapy. Those who are maintaining a response to therapy or who have stable disease at the end of the formal study period will continue treatment until disease progression or unacceptable toxicity. Approximately 120 participants will be enrolled.

Detailed description:

Arms: arm 1: Participants will not receive a loading dose, but will receive pertuzumab 1050 milligrams (mg) via intravenous (IV) infusion every 3 weeks until unacceptable toxicity or disease progression. arm 2: Participants will receive a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
Interventions: intervention 1: Pertuzumab
Intervention descriptions: intervention 1: Participants will receive one of two IV treatment regimens with pertuzumab: either 420 mg every 3 weeks, with an initial 840-mg loading dose, or 1050 mg every 3 weeks with no loading dose administered.

Protocol documents:
Clinical trial NCT00003508
Conditions: Malignant Mesothelioma
Keywords: advanced malignant mesothelioma recurrent malignant mesothelioma
Sponsor: Burzynski Research Institute
Start date: 1996-03-08; Completion date: 2005-04-26
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

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

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

Detailed description:
Advanced Mesothelioma 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 advanced Mesothelioma, 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 advanced Mesothelioma.
* 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 advanced mesothelioma 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.hourly interEach infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.

Protocol documents:
Clinical trial NCT00048074
Conditions: Post Menopausal Osteoporosis
Sponsor: Hoffmann-La Roche
Start date: 2002-06-01; Completion date: 2005-05-01
Enrollment: 1395 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the efficacy and safety of intravenous administration of Bonviva regimens in women with post-menopausal osteoporosis, compared to oral daily administration. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.

Detailed description:

Arms: arm 1: oral placebo daily and IV ibandronate 2 mg q 2 mo arm 2: oral ibandronate 2.5 mg daily and IV placebo q 2 mo and q 3 mo arm 3: oral placebo daily and IV ibandronate 3 mg q 3 mo
Interventions: intervention 1: ibandronate [Bonviva/Boniva] intervention 2: ibandronate [Bonviva/Boniva] intervention 3: ibandronate [Bonviva/Boniva]
Intervention descriptions: intervention 1: 2mg iv every 2 months intervention 2: 2.5mg po daily intervention 3: 3mg iv every 3 months

Protocol documents:
Clinical trial NCT00090766
Conditions: Cytomegalovirus Infections
Sponsor: Hoffmann-La Roche
Start date: 2004-05-01; Completion date: 2005-05-01
Enrollment: 63 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will assess the safety and pharmacokinetics of Valcyte syrup in pediatric solid organ transplant recipients. The anticipated time on study treatment is 3-12 months and the target sample size is less than 100 individuals.

Detailed description:

Arms: arm 1: Eligible participants aged \<= 2 years received valganciclovir up to maximum of 900 milligrams (mg) once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose = 7 \* body surface area (BSA) \* creatinine clearance (CrCLS). arm 2: Eligible participants aged \>2 to \<12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose = 7 \* BSA \* CrCLS. arm 3: Eligible participants aged \>= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose = 7 \* BSA \* CrCLS.
Interventions: intervention 1: valganciclovir [Valcyte]
Intervention descriptions: intervention 1: po daily (dose based on body surface area and CrCL)

Protocol documents:
Clinical trial NCT00220805
Conditions: Macular Degeneration
Sponsor: Grifols Therapeutics LLC
Start date: 2004-01-01; Completion date: 2005-05-01
Enrollment: 96 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate visual improvement in patients treated with Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified (IGIV-C) or placebo who have Age-Related Macular Degeneration (AMD) with occult Choroidal Neovascularization (CNV).

Detailed description:
The purpose of this trial is to investigate the effect of IGIV-C in subjects suffering from AMD with occult CNV where fewer treatment options exist for patients with this disease form.

This study is designed as a randomized, double-blind, parallel group, placebo-controlled prospective trial. Sixty patients, 30 per treatment group, with newly diagnosed pure occult CNV defined by angiography diagnostic criteria will be enrolled. If a subject has more than one eye affected with occult CNV, the eye with the better vision as measured by visual acuity ( Logarithm of the Minimum Angle of Resolution \[LogMAR\] score) will be entered as the study eye.

Patients will be randomized to receive either IGIV-C at a dose of 2 g/kg body weight (bw) over 5 consecutive days or matching placebo. Additional 2 study drug treatment courses (IGIV-C or matching placebo) will be administered every 4 weeks at the same dose of 2 g/kg bw given over 5 days. Subjects' visual acuity will be measured and reported as LogMAR at screening, week 0 (baseline), day 5, week 4, week 8 and week 12. If at anytime during the study the subject's visual acuity worsens by ≥ 2 lines (0.2 on the LogMAR score), then a slit lamp examination will be performed and an angiogram will be conducted; the patient would be discontinued if the worsening is due to some other reason outside of the occult CNV or if the disease has changed from pure occult to the classic or mixed form.

Subjects will be evaluated for efficacy (LogMAR score) at endpoint (at week 12 or at last LogMAR assessment at or after week 8, if the subject prematurely discontinues the trial).

At the end of the treatment period (week 12), patients will be entered into a 3 month observation period with monthly visual acuity LogMAR score assessments.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified intervention 2: Albumin (Human) 25%, United States Pharmacopeia (USP)
Intervention descriptions: intervention 1: The dose per infusion cycle was 2 g/kg body weight over 5 consecutive days (= 4 mL/kg body weight/infusion). The infusion duration was approximately 1.5 - 2 h. intervention 2: Albumin (Human) 20% or 25% will be diluted with 5% glucose to a final concentration of 0.1%.

Protocol documents:
Clinical trial NCT00224042
Conditions: Anemia, Iron-Deficiency Kidney Failure, Chronic
Keywords: Iron deficiency Anemia Chronic kidney disease Erythropoietic agents Sodium Ferric Gluconate Anemia, Iron-Deficiency/drug therapy/etiology Kidney Failure, Chronic/blood/complications/therapy Erythropoietin, Recombinant/adverse effects/therapeutic use
Sponsor: Watson Pharmaceuticals
Start date: 2003-04-01; Completion date: 2005-05-01
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study compares the effect of Ferrlecit® (a form of intravenous iron) to ferrous sulfate (a form of oral iron) in treating anemia and iron deficiency in chronic kidney disease patients who are receiving erythropoietic agents, such as Procrit® and Aranesp®.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Sodium Ferric Gluconate complex in sucrose intervention 2: Ferrous sulfate tablets
Intervention descriptions: intervention 1: Sodium ferric gluconate complex in sucrose, 250 mg IV weekly for 4 doses intervention 2: ferrous sulfate 325 mg three times daily for 6 weeks

Protocol documents:
Clinical trial NCT00446043
Conditions: Acne Vulgaris
Keywords: Acne Vulgaris Adapalene Benzoyl Peroxide
Sponsor: Galderma R&D
Start date: 2004-02-17; Completion date: 2005-05-23
Enrollment: 452 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This was a multi-center, open-label, non-comparative study that evaluated the long-term safety and efficacy profile of Adapalene/Benzoyl Peroxide Gel.

Subjects were evaluated at Baseline, Weeks 1 and 2, and Months 1, 2, 4, 6, 8, 10, and 12.

Safety was evaluated by spontaneous reports of Adverse Events (AEs), the Local Tolerability Assessment (Erythema, Scaling, Dryness, and Stinging/Burning), routine laboratory testing (hematology, blood chemistry, and urinalysis), and monitoring of suspected sensitizations. Efficacy was evaluated by analysis of Percent Change from Baseline in Inflammatory, Noninflammatory, and Total Lesion Counts, and by the Subject's Assessment of Acne.

Detailed description:

Arms: arm 1: Participants were treated with adapalene 0.1 percent (%) \[weight by weight (W/W)\] and benzoyl peroxide 2.5 percent (%) (W/W) gel topically to the face and trunk area once daily in the evening.
Interventions: intervention 1: Adapalene/Benzoyl Peroxide
Intervention descriptions: intervention 1: Adapalene 0.1 percent (%) \[weight by weight (W/W)\] and benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening.

Protocol documents: