ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00119678
Conditions: Systemic Lupus Erythematosus
Keywords: SLE
Sponsor: Bristol-Myers Squibb
Start date: 2005-09-01; Completion date: 2008-11-01
Enrollment: 183 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this clinical research study is to learn whether Abatacept can treat and prevent lupus flares; specifically, in patients with active lupus flares in at least one of three organ systems: skin (discoid lesions); inflammation of the lining of the heart (pericarditis), or inflammation of the lining of the lung (pleuritis/pleurisy); or inflammation of more than 4 joints (arthritis). All participants will receive prednisone or prednisone-equivalent treatment in combination with study medication. The safety of this treatment will also be studied.

Detailed description:

Arms: arm 1: Double Blind Period arm 2: Double Blind Period arm 3: Open Label
Interventions: intervention 1: Abatacept intervention 2: Placebo intervention 3: Prednisone intervention 4: Abatacept
Intervention descriptions: intervention 1: Injectable, intravenous, 10 mg/kg, abatacept every 28 days, 12 months intervention 2: Injectable, intravenous, 0 mg, every 28 days, 12 months intervention 3: Tablets, oral, 30 mg, daily for 28 days then taper off, 12 months intervention 4: Injectable, intravenous, 10 mg/kg, every 28 days

Protocol documents:
Clinical trial NCT00124709
Conditions: Atopic Dermatitis
Keywords: Atopic, dermatitis, asthma, children, modification Atopic dermatitis/atopy
Sponsor: Novartis Pharmaceuticals
Start date: 2003-10-01; Completion date: 2008-11-01
Enrollment: 1091 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study consists of a 3-year double-blind phase during which patients will receive atopic dermatitis (AD) treatment either with pimecrolimus cream 1% long-term management (LTM) or with a conventional corticosteroid-based treatment (1:1 ratio), followed by a 2 to 3-year open-label (OL) phase (all patients receiving pimecrolimus cream 1% LTM). At the end of the double-blind phase, the two treatment groups will be compared with respect to their efficacy in controlling AD; at the end of the OL phase, the incidence of asthma at the age of 6 years will be compared.

Detailed description:

Arms: arm 1: Pimecrolimus arm 2: Corticosteroid
Interventions: intervention 1: Pimecrolimus intervention 2: Corticosteroid
Intervention descriptions: intervention 1: Pimecrolimus cream 1 % intervention 2: conventional corticosteroid-based treatment

Protocol documents:
Clinical trial NCT00171925
Conditions: Multiple Myeloma Stage I
Keywords: Multiple Myeloma Stage I Zoledronic acid Progression
Sponsor: Novartis Pharmaceuticals
Start date: 2000-08-01; Completion date: 2008-11-01
Enrollment: 143 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Multiple myeloma is a disease of B-lymphocytes producing malignant plasma cells. Malignant plasma cells induce osteolytic lesions, which is characteristic for progression of multiple myeloma. It is the aim of this study to investigate whether zoledronic acid has an influence on the progression of multiple myeloma.

Detailed description:

Arms: arm 1: Participants received intravenous infusion of Zoledronic acid every 4 weeks for 48 weeks, and calcium and Vitamin D daily. arm 2: No treatment with study medication.
Interventions: intervention 1: Zoledronic acid intervention 2: Calcium / Vitamin D
Intervention descriptions: intervention 1: Zoledronic acid administered via normal saline intravenous infusion (over 15 minutes) every 4 weeks. Dosage was according to calculated creatinine clearance: patients with baseline creatinine clearance \> 60 ml/min received 4 mg; for patients with mild to moderate renal impairment, doses were calculated to achieve the same AUC as that achieved in patients with creatinine clearance of 75 ml/min, assuming target AUC of 0.66 (mg\*hr/l). intervention 2: Patients on zoledronic acid received 500 mg calcium and 400-500 IU vitamin D combination tablet daily.

Protocol documents:
Clinical trial NCT00191152
Conditions: Breast Cancer Breast Neoplasms Cancer of the Breast
Sponsor: Eli Lilly and Company
Start date: 2002-02-01; Completion date: 2008-11-01
Enrollment: 475 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a phase III randomized study between the docetaxel/gemcitabine and docetaxel/ capecitabine doublets, with crossover to the alternate agent. The experimental arm will receive gemcitabine 1000 mg/m2 intravenous (IV) over 30 minutes days 1 and 8 and docetaxel 75 mg/m2 IV day 1 over 1 hour repeated every three weeks. The comparator arm will receive docetaxel 75 mgm/m2 IV day 1 over 1 hour and oral capecitabine 1000 mg/m2 twice daily, days 1 through 14 repeated every three weeks. Patients who progress on the experimental arm, will be treated with capecitabine as dosed on the comparator arm. Patients who progress on the comparator arm will be treated with gemcitabine as dosed on the experimental arm.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: gemcitabine intervention 2: docetaxel intervention 3: capecitabine
Intervention descriptions: intervention 1: 1000 mg/m2, intravenous (IV) day 1 and day 8 every 21 days until disease progression intervention 2: 75 mg/m2, intravenous (IV), every 21 days until disease progression intervention 3: 1000 mg/m2, by mouth (PO) twice a day (BID), days 1-14, every 21 days until disease progression

Protocol documents:
Clinical trial NCT00207090
Conditions: Advanced Solid Tumors Neoplasms
Sponsor: R-Pharm
Start date: 2005-09-01; Completion date: 2008-11-01
Enrollment: 19 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to test how rifampin affects the removal of BMS-247550 (ixabepilone) from the body.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: ixabepilone intervention 2: Rifampin
Intervention descriptions: intervention 1: ixabepilone solution, intravenous, 40 mg/m2, once every 3 weeks until disease progression intervention 2: rifampin tablets, oral, 600 mg once daily, only on Days 15 to 21 of Cycle 1 and Days 1 to 7 of Cycle 2

Protocol documents:
Clinical trial NCT00239928
Conditions: Macular Degeneration
Keywords: Long-Term Study For Pegaptanib Sodium In Patients With Subfoveal Choroidal Neovascularization Secondary To Age-Related Macular Degeneration
Sponsor: Pfizer
Start date: 2005-09-01; Completion date: 2008-11-01
Enrollment: 61 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will examine the safety and efficacy of pegaptanib sodium in Japanese patients with wet-type age-related macular degeneration (AMD), who benefit further treatment and who want to continue the treatment after completion of the preceding study (A5751010).

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: pegaptanib sodium
Intervention descriptions: intervention 1: 1 drop per dosed eye per protocol.

Protocol documents:
Clinical trial NCT00264290
Conditions: HIV Infections Cytomegalovirus Infections
Keywords: HIV CMV T Cell activation Valganciclovir
Sponsor: University of California, San Francisco
Start date: 2006-08-01; Completion date: 2008-11-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether treatment with valganciclovir decreases T cell activation levels among HIV-infected patients with asymptomatic cytomegalovirus (CMV) co-infection, potentially improving immune responses to antiretroviral therapy.

Detailed description:

Arms: arm 1: 900mg PO qd arm 2: 900mg PO qd
Interventions: intervention 1: Valganciclovir intervention 2: Placebo
Intervention descriptions: intervention 1: 900mg PO qd x 8 weeks followed by 4 weeks of observation on background antiretroviral (ARV) regimen alone. intervention 2: Placebo designed to resemble Valganciclovir

Protocol documents:
Clinical trial NCT00276159
Conditions: Acute Lymphoblastic Leukemia Acute Myeloid Leukemia Non-Hodgkin's Lymphoma Hodgkin's Lymphoma Multiple Myeloma Chronic Lymphocytic Leukemia
Keywords: Leukemia Lymphoma Myeloma Hematology 852A IRM Oncology
Sponsor: Masonic Cancer Center, University of Minnesota
Start date: 2006-01-01; Completion date: 2008-11-01
Enrollment: 6 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the anti-tumor activity of 852A when used to treat certain hematologic malignancies not responding to standard treatment.

Detailed description:
852A will be administered as a subcutaneous injection (SC) 2 times per week for 12 weeks (24 doses) with provisions for dose escalation or reduction based on tolerability

Arms: arm 1: Patients receiving at least one dose of 852A.
Interventions: intervention 1: 852A
Intervention descriptions: intervention 1: Subcutaneous injection 0.6 mg/m2 2 times/week/12 weeks, may increase by 0.2 mg/m2 up to 1.2 mg/m2.

Protocol documents:
Clinical trial NCT00277355
Conditions: Huntington Disease
Keywords: Study of Minocycline in Huntington's Disease
Sponsor: Merit Cudkowicz
Start date: 2006-04-01; Completion date: 2008-11-01
Enrollment: 114 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being conducted to assess the impact of minocycline on the progression of symptoms of HD. The study will also assess whether it is reasonable to continue with further study of minocycline in HD. We will measure the effect of minocycline on HD by measuring the change in Huntington's disease symptoms.

Detailed description:
The DOMINO study is a randomized, double-blind, multi-center, futility study of minocycline in patients with HD. Subjects will be randomized (3:1) to one of the two study arms: (1) the group that receives active minocycline (100 mg po b.i.d.), and (2) the group that receives placebo. Subjects will be enrolled over an approximate six-month period and remain on blinded study drug for 18 months. The primary analysis will involve a comparison of the change over time in TFC between the minocycline group and a fixed value determined from historical control data. A placebo group will also be included to facilitate blinding and to permit a descriptive assessment of the validity of the assumed change over time in historical controls.

Arms: arm 1: Minocycline (3:1 randomization) 100 mg capsules taken by mouth twice daily, 200 mg per day total for 18 months treatment duration. arm 2: Sugar pill manufactured to mimic minocycline, 1 capsule taken by mouth twice daily for 18 months treatment duration.
Interventions: intervention 1: minocycline intervention 2: Matching placebo
Intervention descriptions: intervention 1: Minocycline: Oral; minocycline 100 mg capsules administered twice a day with the morning and evening meal (\~ 8 hours apart) intervention 2: Matching placebo 1 capsule twice daily, 18 months treatment duration.

Protocol documents:
Clinical trial NCT00280397
Conditions: Cancer: Solid Tumors
Keywords: Cancer, solid tumors
Sponsor: Eisai Inc.
Start date: 2006-01-01; Completion date: 2008-11-01
Enrollment: 27 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the maximum tolerable dose (MTD) and the related effects of E7080 administered to patients with solid tumors that are resistant to approved existing anti-tumor therapies, or for which no appropriate treatment is available.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: E7080
Intervention descriptions: intervention 1: E7080 is administered orally twice a day for 2 weeks to patients with solid tumors that are resistant to approved conventional therapies or for which no appropriate treatment is available.

Protocol documents:
Clinical trial NCT00287079
Conditions: Clinically Isolated Syndrome
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2005-10-01; Completion date: 2008-11-01
Enrollment: 35 participants; Allocation: ; Intervention model: PARALLEL

Brief summary:
The primary objective of this initiative is to assess the effectiveness of subcutaneous (sc) interferon (IFN) beta - 1a, (Rebif®), versus No Treatment in delaying the conversion to Clinically Definite Multiple Sclerosis (CDMS) - as defined by the occurrence of a second exacerbation - over 96 weeks in subjects that present with Clinically Isolated Syndrome (CIS) accompanied by an abnormal magnetic resonance imaging (MRI). The secondary objectives are to:

* Assess the effectiveness of sc IFN beta - 1a (Rebif®) therapy in reducing the proportion of patients with CIS converting to CDMS
* Assess the safety of sc IFN beta - 1a (Rebif®) in the patients with CIS

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Rebif® intervention 2: No Treatment
Intervention descriptions: intervention 1: 44 microgram (mcg) IFN beta-1a sc once a week (qw) for 96 weeks intervention 2: No treatment for 96 weeks

Protocol documents:
Clinical trial NCT00287729
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: Idiopathic Pulmonary Fibrosis Lung Pirfenidone InterMune
Sponsor: Genentech, Inc.
Start date: 2006-04-01; Completion date: 2008-11-01
Enrollment: 344 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purposes of this study are to assess the efficacy of treatment with pirfenidone 2403 milligrams per day compared with placebo in patients with idiopathic pulmonary fibrosis (IPF)and to assess the safety of treatment with pirfenidone 2403 milligrams per day compared with placebo in patients with idiopathic pulmonary fibrosis.

Detailed description:
This is a Phase 3, randomized, double-blind, placebo-controlled, safety and efficacy study of pirfenidone in patients with idiopathic pulmonary fibrosis (IPF). Approximately 320 patients at approximately 50 centers will be randomly assigned (1:1) to receive pirfenidone 2403 milligrams or placebo equivalent administered in divided doses three times per day (TID) with food. The primary outcome variable will be the absolute change in percent predicted Forced Vital Capacity from Baseline to Week 72. Patients will be randomized by geographic region.

Patients will receive blinded study treatment from the time of randomization until the last patient randomized has been treated for 72 weeks. A Data Monitoring Committee (DMC) will periodically review safety and efficacy data to ensure patient safety.

After week 72, patients who meet the Progression of Disease (POD) definition, which is a ≥ 10% absolute decrease in percent predicted Forced Vital Capacity or a ≥ 15% absolute decrease in percent predicted carbon monoxide diffusing capacity (DLco), will be eligible to receive permitted idiopathic pulmonary fibrosis therapies in addition to their blinded study drug. Permitted idiopathic pulmonary therapies include corticosteroids, azathioprine, cyclophosphamide and N-acetyl-cysteine (with restrictions).

Arms: arm 1: 2403 mg/day pirfenidone dose group. arm 2: Placebo equivalent.
Interventions: intervention 1: Pirfenidone intervention 2: Placebo
Intervention descriptions: intervention 1: 2403 mg/day given orally, and administered in divided doses three times daily with food, for the duration of the study. intervention 2: Placebo equivalent, given orally, and administered in divided doses three times daily with food, for the duration of the study.

Protocol documents:
Clinical trial NCT00293579
Conditions: Head and Neck Cancer
Keywords: head and neck cancer
Sponsor: Ohio State University Comprehensive Cancer Center
Start date: 2006-02-01; Completion date: 2008-11-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will estimate overall response rate of pemetrexed in poor risk patients with advanced, metastatic, or recurrent squamous cell carcinoma of the head and neck.

Detailed description:
Rationale: Patients with advanced stage head and neck cancer, especially those with disease in the hypopharynx, oropharynx, or oral cavity, and poor performance status defined through clinical testing, are often not eligible for clinical trials and treated with best supportive care. The possibility of developing a well-tolerated chemotherapy regimen in these patients may lead to an equivalent benefit and better palliation. The current study offers the chemotherapy drug pemetrexed to patients with advanced head and neck cancer. Researchers consider this agent to have some anti-tumor efficacy against a variety of site-specific cancers, including head and neck cancer with a response rate that is similar to other single chemotherapy drugs. In addition, previous research indicates that toxicities associated with pemetrexed have been reduced when patients are given folic acid and B12 vitamin supplementation. Along with pemetrexed, the current study provides study participants with both folic acid and B12.

Purpose: The primary objective of this study is to evaluate tumor response, including complete and partial remission, and toxicities from pemetrexed in patients with advanced head and neck cancer. Secondary objectives of this study include measurements of time to tumor progression, survival, and patient quality of life.

Treatment: Study participants will be given pemetrexed through intravenous infusions. Pemetrexed will be administered once every three weeks. This schedule of pemetrexed once every three weeks will be repeated up to six times. Study participants will also be provided with both folic acid and B12 vitamin supplementation before, during, and after study treatments with pemetrexed. Vitamin supplementation is considered critical and compliance must be followed closely. Several tests and exams will be given throughout the study to monitor patients. Treatments will be discontinued due to disease growth and unacceptable side effects.

Arms: arm 1: pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
Interventions: intervention 1: Pemetrexed
Intervention descriptions: intervention 1: 500 mg/m2 IV every 3 weeks for 6 cycles

Protocol documents:
Clinical trial NCT00294723
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2006-02-01; Completion date: 2008-11-01
Enrollment: 746 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in North America (the United States of America (USA) and Mexico).

The trial is designed to evaluate the effects of treatment with liraglutide versus glimepiride in subjects with type 2 diabetes. The trial is a 52-week randomised, double-blind trial period plus a 52-week open-label extension (week 104) followed by an additional 156-week continued open-label extension. The total duration of the treatment period is planned to be 260 weeks (5 years).

Detailed description:

Arms: arm 1: Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195). arm 2: Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195). arm 3: Glimepiride 8 mg once daily + liraglutide placebo 200 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195). arm 4: Glimepiride 8 mg once daily + liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195).
Interventions: intervention 1: liraglutide intervention 2: glimepiride intervention 3: liraglutide intervention 4: placebo intervention 5: placebo intervention 6: placebo
Intervention descriptions: intervention 1: 1.8 mg for s.c. (under the skin) injection intervention 2: 8 mg capsule intervention 3: 1.2 mg for s.c. (under the skin) injection intervention 4: Glimepiride placebo, 8mg capsule intervention 5: Liraglutide placebo, 200 mcl intervention 6: Liraglutide placebo, 300 mcl

Protocol documents:
Clinical trial NCT00318461
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2006-05-01; Completion date: 2008-11-01
Enrollment: 1091 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Europe, Oceania, Africa, Asia and South America. This trial is designed to show the effect of treatment with liraglutide when adding to existing metformin therapy and to compare it with the effects of metformin monotherapy and combination therapy of metformin and glimepiride. Two trial periods: A 6 month (26 weeks) randomised, double-blinded period followed by an 18 months open-label extension, in total 2 years (104 weeks).

Detailed description:

Arms: arm 1: Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day arm 2: Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day arm 3: Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day arm 4: Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo arm 5: Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo
Interventions: intervention 1: liraglutide intervention 2: metformin intervention 3: glimepiride intervention 4: placebo intervention 5: placebo intervention 6: liraglutide intervention 7: liraglutide
Intervention descriptions: intervention 1: 0.6 mg for s.c. (under the skin) injection. intervention 2: 1.5-2.0 g tablets intervention 3: 4 mg tablets intervention 4: Glimepiride placebo 1 mg and 2 mg tablets intervention 5: Liraglutide placebo 1-3 mL for s.c. (under the skin) injection intervention 6: 1.2 mg for s.c. (under the skin) injection intervention 7: 1.8 mg for s.c. (under the skin) injection

Protocol documents:
Clinical trial NCT00336817
Conditions: Immunosuppression
Keywords: Liver transplantation mycophenolate mofetil gastrointestinal adverse effects
Sponsor: University of Pittsburgh
Start date: 2006-11-01; Completion date: 2008-11-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to compare the safety and efficacy of Myfortic with CellCept in liver transplant patients. Myfortic and CellCept are both immunosuppressive (anti-rejection) drugs. CellCept is commonly used after liver transplantation but gastrointestinal (GI) side effects are very common, sometimes necessitating in its discontinuation. Myfortic is a new drug similar to CellCept, except it is enteric-coated. Our hypothesis is that Myfortic has less GI side effects than CellCept and also has comparable effectiveness to CellCept.

Detailed description:
This is a prospective, randomized, double-blinded, single center, safety and efficacy study comparing Myfortic with CellCept used after liver transplantation. Patients with biopsy-proven acute cellular rejection, renal insufficiency (i.e. acute or chronic renal failure requiring hemodialysis or patients with creatinine clearance \< 50 ml/min), or calcineurin inhibitor-induced neurotoxicity (defined as the presence of neurologic symptoms such as tremors, altered mental status, seizures, etc) will be randomized to start on either Myfortic (720 mg po bid) or CellCept (1 gm po bid). In those patients with calcineurin-induced neurotoxicity or nephrotoxicity, tacrolimus or cyclosporine doses will also be reduced to maintain serum trough levels of 4-8 mg/dl or 100-200 mg/dl, respectively.

Comparison: Thirty patients will be enrolled and randomized in this two-armed, double-blinded study- half of the patients will receive Myfortic and the other half, CellCept.

Arms: arm 1: Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days arm 2: Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days
Interventions: intervention 1: Myfortic intervention 2: CellCept
Intervention descriptions: intervention 1: Myfortic 360mg or 720 mg BID for 90 days intervention 2: CellCept 500mg or 1000mg BID for 90 days

Protocol documents: