ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00048035
Conditions: Anemia
Sponsor: Hoffmann-La Roche
Start date: 2002-03-01; Completion date: 2005-06-01
Enrollment: 91 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will determine the appropriate dose and frequency of administration of iv Mircera maintenance therapy in hemodialysis patients with chronic renal anemia who were previously receiving iv epoetin. The anticipated time on study treatment is 3-12 months and the target sample size is \<100 individuals.

Detailed description:

Arms: arm 1: Eligible participant will be administered RO0503821 (methoxy polyethylene glycol-epoetin beta \[Mircera\]) intravenously (IV) using a dose conversion factor of 0.25/150 microgram (mcg)/kilogram (kg) of the previous weekly erythropoiesis stimulating agents (ESA) dose, (equal to 62.50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each). arm 2: Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to 62.50% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each). arm 3: Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each). arm 4: Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each). arm 5: Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each). arm 6: Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
Interventions: intervention 1: methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention descriptions: intervention 1: Differing doses and frequencies of iv administration

Protocol documents:
Clinical trial NCT00119158
Conditions: Atopic Dermatitis
Keywords: THerapy for acute moderate to severe flares
Sponsor: Children's Hospital of Philadelphia
Start date: 2004-10-01; Completion date: 2005-06-01
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Atopic dermatitis is a chronic relapsing disease with acute flares. The standard therapy is to treat acute flares using topical medications. The two most common classes of topical medications for atopic dermatitis (AD) are topical corticosteroids and topical calcineurin inhibitors.

Pimecrolimus and topical corticosteroids exert their activity by different mechanisms, there may be a synergistic effect of the combination therapy. Therefore, a combination therapy may provide a faster resolution of severe skin lesions and consequently reduce the duration of the topical corticosteroid treatment. Another benefit of the combination therapy maybe the use of a lower potency corticosteroid to achieve the same degree of clearance.

The hypothesis of this trial is that the combination of the two agents will lead to faster clearance than the single agent of topical corticosteroids.

Detailed description:
This trial is a double-blind controlled trial of fluticasone cream daily and pimecrolimus cream BID versus fluticasone cream daily and placebo cream BID for the treatment of acute flares of atopic dermatitis.

While pimecrolimus cream 1% has been proven to be effective in mild and moderate Atopic dermatitis (AD), there is a need for a fast control of severe skin lesions. On the other hand, reducing the duration of the topical corticosteroid treatment is a reasonable approach to minimize the occurrence of adverse effects.

Because pimecrolimus and topical corticosteroids exert their activity by different mechanisms, there may be a synergistic effect of the combination therapy. Therefore, a combination therapy may provide a faster resolution of severe skin lesions and consequently reduce the duration of the topical corticosteroid treatment. Another benefit of the combination therapy maybe the use of a lower potency corticosteroid to achieve the same degree of clearance.

In vitro data have demonstrated that a combination of steroids and tacrolimus has synergistic effects on in vitro human lymphocyte proliferation. In addition, it has previously been reported, in a pilot investigation in two subjects, that a combination regimen of pimecrolimus 1% twice a day and fluticasone propionate cream 0.05% once daily was superior to fluticasone propionate cream 0.05% once daily in the acute treatment of atopic dermatitis (AD).

This study is conducted to validate these findings in a larger number of patients.

Arms: arm 1: Placebo cream arm 2: None
Interventions: intervention 1: Combination of pimecrolimus and fluticasone intervention 2: pimecrolimus
Intervention descriptions: intervention 1: Pimecrolimus cream twice a day and fluticasone cream once a day intervention 2: apply daily with fluticasone cream for flares

Protocol documents:
Clinical trial NCT00622908
Conditions: Bacterial Conjunctivitis
Sponsor: Bausch & Lomb Incorporated
Start date: 2004-12-01; Completion date: 2005-06-01
Enrollment: 270 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the clinical and microbial efficacy of ISV-403 administered three times a day (TID) for 5 days compared to vehicle three times a day for 5 days in the treatment of bacterial conjunctivitis

Detailed description:

Arms: arm 1: ISV-403 0.6% arm 2: Vehicle of ISV-403
Interventions: intervention 1: ISV-403 intervention 2: Vehicle
Intervention descriptions: intervention 1: 0.6% TID, 5 days intervention 2: Vehicle of ISV-403 TID, 5 days

Protocol documents:
Clinical trial NCT00637572
Conditions: HIV Infections Cachexia Anorexia AIDS Wasting Syndrome HIV Wasting Syndrome
Keywords: Weight loss Cachexia Anorexia Megestrol acetate oral suspension Nanocrystal dispersion Nanocrystal technology Body weight changes AIDS wasting HIV wasting Emaciation Megace ES Megace Treatment Experienced
Sponsor: Endo Pharmaceuticals
Start date: 2004-12-01; Completion date: 2005-06-01
Enrollment: 63 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Explore weight gain in HIV-positive patients who have weight loss associated with AIDS-related wasting (anorexia/cachexia). Patients are treated for 12 weeks with either megestrol acetate oral suspension nanocrystal dispersion formulation, or megestrol acetate oral suspension original formulation

Detailed description:

Arms: arm 1: Megestrol acetate oral suspension nanocrystal dispersion formulation 115 mg/mL arm 2: Megestrol acetate oral suspension micronized formulation 60 mg/mL
Interventions: intervention 1: Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mL intervention 2: Megestrol acetate oral suspension 40 mg/mL
Intervention descriptions: intervention 1: Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mL administered as 575 mg once per day (5 mL dose) intervention 2: Megestrol acetate oral suspension 40 mg/mL administered as 800 mg once per day (20 mL dose)

Protocol documents:
Clinical trial NCT00069264
Conditions: Advanced Solid Tumors
Keywords: Metastatic Tumors Advanced Solid Tumors Stage IV Tumors Solid Tumors Recurrent Solid Tumors
Sponsor: Eisai Inc.
Start date: 2003-09-01; Completion date: 2005-07-01
Enrollment: 33 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To determine the maximum tolerated dose of E7389 in patients with advanced solid tumors that have progressed following standard therapy or for which no standard therapy exists.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: E7389
Intervention descriptions: intervention 1: E7389 Dose-escalation starting at 0.25 mg/m\^2 intravenous on Days 1, 8, and 15 of a 28 day cycle.

Protocol documents:
Clinical trial NCT00354341
Conditions: Anemia
Sponsor: Hoffmann-La Roche
Start date: 2002-09-01; Completion date: 2005-07-01
Enrollment: 170 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the effect of anemia correction with NeoRecormon on cardiac structure and function in patients with early diabetic nephropathy. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: Along with their standard treatment participants will receive epoetin beta at a starting dose of 2000 International Units (IU) subcutaneously (SC) once weekly to reach and maintain target hemoglobin (Hb) between 13 and 15 grams per deciliter (g/dL), for 15 months. Epoetin beta doses will be adjusted according to individual participant's Hb level. Standard treatment will be as per investigator discretion. arm 2: Participants will receive their standard treatment for 15 months but no treatment for anemia correction unless Hb level will be less than (\<) 10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level will be \<10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment will be as per investigator discretion.
Interventions: intervention 1: Epoetin beta
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00003531
Conditions: Stage IV Pancreatic Cancer
Keywords: Adenocarcinoma of the pancreas
Sponsor: Burzynski Research Institute
Start date: 1996-04-10; Completion date: 2005-07-18
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Current therapies for Stage IV Pancreatic 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 Pancreatic Cancer.

Detailed description:
Stage IV Pancreatic 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 Pancreatic 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 Pancreatic 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.

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 Pancreatic 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 NCT00077610
Conditions: Anemia
Sponsor: Hoffmann-La Roche
Start date: 2004-02-01; Completion date: 2005-08-01
Enrollment: 673 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the efficacy and safety of intravenous Mircera, given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv epoetin. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: Participants received RO0503821 (Mircera \[methoxy polyethylene glycol-epoetin beta\]) once every two weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (60, 100, or 180 microgram \[mcg\]) that was based on the Epoetin dose (\<8000, 8000-16000, \>16000 International units \[IU\]/Week) administered during the week preceding the switch to the study drug. arm 2: Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (120, 200, or 360 mcg) that was based on the Epoetin dose (\<8000, 8000-16000, \>16000 IU/Week) administered during the week preceding the switch to the study drug. arm 3: Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
Interventions: intervention 1: Epoetin alfa or beta intervention 2: RO0503821 (1x/2 Weeks) intervention 3: RO0503821 (1x/4 Weeks)
Intervention descriptions: intervention 1: intravenously 3 times weekly for 52 weeks, as prescribed intervention 2: 60, 100, or 180 microgram (mcg) (starting dose) once every two weeks intravenously for 52 weeks. intervention 3: 120, 200 or 360 mcg (starting dose) once every four weeks intravenously for 52 weeks.

Protocol documents:
Clinical trial NCT00077766
Conditions: Anemia
Sponsor: Hoffmann-La Roche
Start date: 2004-03-01; Completion date: 2005-08-01
Enrollment: 313 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the efficacy and safety of intravenous (iv) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv darbepoetin alfa. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: Eligible participants will be administered with RO0503821 (\[methoxy polyethylene glycol-epoetin beta\] {Mircera}) intravenously (IV), every 2 weeks during Weeks 1 through 52. The starting dose of RO0503821 (60, 100, or 180 micro gram \[µg\]) was based on the dose of darbepoetin alfa at the time of randomization (\< 40, 40 to 80, or \> 80 µg per week, respectively). arm 2: Eligible participants will be administered with darbepoetin alfa IV, every week or every 2 weeks during Weeks 1 through 52.
Interventions: intervention 1: Darbepoetin alfa intervention 2: methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention descriptions: intervention 1: Darbepoetin alfa was administered IV, every week or every 2 weeks during Weeks 1 through 52. intervention 2: RO0503821 was administered IV, every 2 weeks during Weeks 1 through 52. The starting dose of RO0503821 (60, 100, or 180 micro gram \[µg\]) was based on the dose of darbepoetin alfa at the time of randomization (\< 40, 40 to 80, or \> 80 µg per week, respectively).

Protocol documents:
Clinical trial NCT00170625
Conditions: Ovarian Cancer
Keywords: platin-resistant
Sponsor: North Eastern German Society of Gynaecological Oncology
Start date: 2004-06-01; Completion date: 2005-08-01
Enrollment: 28 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Compatibility of the topotecan therapy in combination with carboplatin.

Detailed description:
The aim of the study was to confirm the tolerability of 3-day topotecan therapy in combination with carboplatin in accordance with published data and to investigate the tolerability of continued therapy until disease progression or up to a maximum of 12 months.

Arms: arm 1: dose level 0: Topotecan 1mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application)

If dose limiting toxicity (DLT) is present then Topotecan dose will be reduced to dose level -1 (dose level -1: Topotecan 0.75 mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application))

A DLT is present if a patient has a postponement due to hematologic toxicity of more than 7 days within the first four courses at dose level 0. arm 2: dose level 0: Topotecan 1mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application)

If dose limiting toxicity (DLT) is present then Topotecan dose will be reduced to dose level -1 (dose level -1: Topotecan 0.75 mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application))

A DLT is present if a patient has a postponement due to hematologic toxicity of more than 7 days within the first four courses at dose level 0.
Interventions: intervention 1: Hycamtin
Intervention descriptions: intervention 1: Topotecan: 1,0 mg/m²/d, day 1-3; q21d Carboplatin: AUC 5 on day 3 after Topotecan, q21d

Protocol documents:
Clinical trial NCT00312221
Conditions: Osteoarthritis
Keywords: Osteoarthritis, opioid, transdermal
Sponsor: Purdue Pharma LP
Start date: 2004-04-01; Completion date: 2005-08-01
Enrollment: 418 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 (20 mg) in comparison to the buprenorphine transdermal system (5 mg) and oxycodone immediate release in subjects with moderate to severe osteoarthritis pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen, ibuprofen, immediate release oxycodone) will be provided to 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: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear arm 2: Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear arm 3: Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
Interventions: intervention 1: Buprenorphine intervention 2: Buprenorphine intervention 3: oxycodone immediate-release
Intervention descriptions: intervention 1: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear intervention 2: Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear intervention 3: Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).

Protocol documents:
Clinical trial NCT00340379
Conditions: Affective Disorders
Keywords: Psychotic
Sponsor: Duke University
Start date: 2003-04-01; Completion date: 2005-08-01
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare ziprasidone (Geodon) monotherapy for the treatment of psychotic major depression (PMD)with an antidepressant/antipsychotic combined therapy.

Detailed description:
Psychotic depression is a well-established DSM-IV diagnostic subtype indicating the presence of hallucinations and/or delusions as part of the clinical presentation. Currently the treatment of choice for psychotic depression is either electroconvulsive therapy or combination of antipsychotic and antidepressant medications. Ziprasidone will be compared to standard of care treatment comprising a combination of an antidepressant, sertraline and an antipsychotic, haloperidol, over a 12-week period. An additional 12-week extension phase is also included for responders to the initial study.

Arms: arm 1: Subjects in this arm received ziprasidone with a placebo to maintain the blind arm 2: Subjects in this arm received a combination of sertraline and haloperidol with a placebo to maintain the blind. Sertraline dosage was 150-200mg/day and haloperidol was 6-8mg/day based on tolerance.
Interventions: intervention 1: Ziprasidone intervention 2: Sertraline intervention 3: Haloperidol
Intervention descriptions: intervention 1: Target dosage 120-160mg/day based on tolerance intervention 2: Target dosage 150-200mg/day based on tolerance. intervention 3: Target dosage 6-8mg/day based on tolerance.

Protocol documents:
Clinical trial NCT01135524
Conditions: Osteoarthritis
Keywords: Osteoarthritis Opioid Transdermal
Sponsor: Purdue Pharma LP
Start date: 2004-04-01; Completion date: 2005-08-01
Enrollment: 196 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this phase is to evaluate the long-term safety and tolerability of BTDS. Qualified subjects are started on BTDS 5 and the dose may be titrated, if necessary, to a maximum of BTDS 20 to achieve stable pain control.

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
Interventions: intervention 1: Buprenorphine transdermal patch intervention 2: Buprenorphine transdermal patch intervention 3: Buprenorphine transdermal patch
Intervention descriptions: intervention 1: Buprenorphine transdermal patch 5 mcg/h applied transdermally for 7-day wear. intervention 2: Buprenorphine transdermal patch 10 mcg/h applied transdermally for 7-day wear. intervention 3: Buprenorphine transdermal patch 20 mcg/h applied transdermally for 7-day wear.

Protocol documents:
Clinical trial NCT01137032
Conditions: Psoriasis Atopic Dermatitis
Keywords: Psoriasis Atopic Dermatitis
Sponsor: Fougera Pharmaceuticals Inc.
Start date: 2004-06-01; Completion date: 2005-08-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the effect of Pandel® (hydrocortisone probutate cream) Cream 0.1% on the Hypothalamic Pituitary Adrenal (HPA) axis in pediatric and adult subjects with either psoriasis or atopic dermatitis involving greater than 20% body surface area.

Detailed description:

Arms: arm 1: Pandel Cream 0.1%
Interventions: intervention 1: Pandel Cream 0.1%
Intervention descriptions: intervention 1: A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days

Protocol documents: