ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00698685
Conditions: Leukemia Lymphoma Hodgkin's Disease Hematologic Neoplasms Multiple Myeloma Carcinoma, Renal Cell
Keywords: Allogeneic Hematopoietic Cell Transplantation Preparative Regimen Pentostatin Alemtuzumab Hodgkin Disease and Lymphoma, non-Hodgkin leukemia, myeloid, acute leukemia, lymphocytic, acute leukemia, myeloid, chronic leukemia, lymphocytic, chronic Multiple Myeloma Myelodysplastic Syndromes Carcinoma, Renal Cell
Sponsor: University of Arizona
Start date: 2006-01-23; Completion date: 2011-04-26
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study tests the hypothesis that a purely immunosuppressive preparative regimen allows engraftment of related or unrelated allogeneic hematopoietic stem cells in subjects with high-risk malignancies, without causing the post-transplant myelosuppression (e.g., neutropenia, thrombocytopenia) that occurs with currently used reduced-intensity (nonmyeloablative) preparative regimens. This study incorporates both safety and efficacy endpoints and evaluates a novel preparative regimen of alemtuzumab plus continuous-infusion pentostatin, two immunosuppressive agents with different mechanisms of action, in recipients of related or unrelated allogeneic hematopoietic stem cell transplantation.

Detailed description:
Primary Objectives of the study:

* To determine the efficacy of a preparative regimen of pentostatin and alemtuzumab plus related or unrelated allogeneic peripheral blood stem cell transplantation (PBSCT) in inducing durable donor lymphohematopoietic cell chimerism (defined as at least 50% donor cells in the peripheral blood) by 100 days after PBSCT (day +100) in subjects with high-risk malignancies who are at high risk for morbidity and mortality with conventional intensive pre-transplant conditioning regimens.
* To determine the safety of a preparative regimen of pentostatin and alemtuzumab plus related or unrelated allogeneic PBSCT, as measured by the non-relapse mortality at day +100 in the study subject population.

Arms: arm 1: Days - 8 through -6: pentostatin 4 mg/m2/24 hr as a continuous intravenous infusion (CIVI) (total cumulative dose, 12 mg/m2 over 3 days)

Days - 5 through - 1: alemtuzumab 20 mg per dose intravenously over 8 hours daily for 5 doses (total cumulative dose, 100 mg)

Followed by Allogeneic hematopoietic stem cell transplantation, related or unrelated donor, on day 0. Patients also receive cyclosporine intravenous (IV) continuously beginning on day -2, continuing (IV or orally) until day 100, followed by a taper.
Interventions: intervention 1: Pentostatin intervention 2: Alemtuzumab intervention 3: Allogeneic hematopoietic stem cell transplantation
Intervention descriptions: intervention 1: Days - 8 through -6: pentostatin 4 mg/m2/24 hr as a continuous intravenous infusion (CIVI) (total cumulative dose, 12 mg/m2 over 3 days) intervention 2: Days - 5 through - 1: alemtuzumab 20 mg per dose intravenously over 8 hours daily for 5 doses (total cumulative dose, 100 mg) intervention 3: Infusion of related or unrelated donor peripheral blood progenitor cells on day 0.

Protocol documents:
Clinical trial NCT01099774
Conditions: Glaucoma Ocular Hypertension
Sponsor: Allergan
Start date: 2010-05-01; Completion date: 2011-04-29
Enrollment: 597 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of bimatoprost 0.03% formulation B ophthalmic solution with LUMIGAN® (bimatoprost ophthalmic solution 0.03%) once daily for 12 weeks in patients with glaucoma or ocular hypertension

Detailed description:

Arms: arm 1: Bimatoprost 0.03% Formulation B Ophthalmic Solution arm 2: Bimatoprost 0.03% Ophthalmic Solution
Interventions: intervention 1: Bimatoprost 0.03% Formulation B Ophthalmic Solution intervention 2: Bimatoprost 0.03% Ophthalmic Solution
Intervention descriptions: intervention 1: One drop administered in each eye, every evening, for 12 weeks intervention 2: One drop administered in each eye, every evening, for 12 weeks

Protocol documents:
Clinical trial NCT00261950
Conditions: Secondary Hyperparathyroidism
Keywords: Cinacalcet HCl, Cinacalcet, Amgen (AMG) 073, Sensipar, Mimpara, Calcimimetic
Sponsor: Amgen
Start date: 2006-05-01; Completion date: 2011-05-01
Enrollment: 110 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the effects of cinacalcet on markers of bone turnover in patients with kidney disease who are receiving dialysis.

Detailed description:
Secondary hyperparathyroidism (HPT) is common in people with end stage renal disease (kidney disease). Patients with secondary HPT often have enlarged parathyroid glands in the neck and as a result often have elevated parathyroid hormone (PTH) levels . Patients with secondary HPT may have bone disease (osteodystrophy). Cinacalcet has been used to decrease PTH levels in patients with secondary HPT. Patients with secondary HPT may have bone disease (osteodystrophy). This bone disease may cause bone pain, fractures, and poor formation of red blood cells. The purpose of this study is to evaluate effects of cinacalcet on markers of bone turnover in patients with kidney disease who are receiving dialysis.

Arms: arm 1: All subjects were enrolled into the single arm to receive Cinacalcet. There was no comparator arm.
Interventions: intervention 1: Sensipar (Cinacalcet HCl)
Intervention descriptions: intervention 1: All enrolled subjects receive study medication at a starting dose of 30 mg cinacalcet once daily beginning on day 1. Possible sequential doses are 30 mg, 60mg, 90mg, 120mg, 180 mg taken once daily. During the study, dose adjustment (dose increase/decrease/withholding) is based upon iPTH, serum calcium, and subject safety information. Subjects swallowed tablets whole without biting or chewing. Subjects were dispensed investigational product every 4 weeks starting from Day 1 through to Week 48.

Protocol documents:
Clinical trial NCT00293254
Conditions: HIV Infections
Keywords: Treatment Experienced
Sponsor: Merck Sharp & Dohme LLC
Start date: 2006-02-01; Completion date: 2011-05-01
Enrollment: 351 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate the safety and efficacy of raltegravir as a therapy for Human Immunodeficiency Virus (HIV)-infected patients failing current therapy with 3-class antiviral resistance.

Detailed description:
The primary double-blind study of raltegravir versus placebo was extended to 156 weeks and was followed by an open-label raltegravir phase in which continuing participants from both the raltegravir and placebo groups received open-label raltegravir for an additional 84 weeks for a maximum duration of up to 240 weeks. Participants who had viral failure after Week 16 may have received open-label raltegravir until Week 240.

Arms: arm 1: raltegravir potassium arm 2: Placebo
Interventions: intervention 1: raltegravir potassium intervention 2: Comparator: placebo
Intervention descriptions: intervention 1: Raltegravir 400 mg twice daily (b.i.d.) by mouth (p.o.) with optimized background therapy. Treatment period of 48 weeks. intervention 2: Placebo p.o. b.i.d. with optimized background therapy. Treatment period of 48 weeks.

Protocol documents:
Clinical trial NCT00293267
Conditions: HIV Infections
Keywords: Treatment Experienced
Sponsor: Merck Sharp & Dohme LLC
Start date: 2006-02-01; Completion date: 2011-05-01
Enrollment: 352 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate the safety and efficacy of raltegravir as a therapy for HIV-infected patients failing current therapy with 3-class antiviral resistance.

Detailed description:
The primary double-blind study of raltegravir versus placebo was extended to 156 weeks and was followed by an open-label raltegravir phase in which continuing participants from both the raltegravir and placebo groups received open-label raltegravir for an additional 84 weeks for a maximum duration of up to 240 weeks. Participants who had viral failure after Week 16 may have received open-label raltegravir until Week 240.

Arms: arm 1: raltegravir potassium arm 2: Placebo
Interventions: intervention 1: raltegravir potassium intervention 2: Comparator: Placebo
Intervention descriptions: intervention 1: Raltegravir 400 mg twice daily (b.i.d.) by mouth (p.o.) with optimized background therapy. Treatment period of 48 weeks. intervention 2: Placebo b.i.d. p.o. with optimized background therapy. Treatment period of 48 weeks.

Protocol documents:
Clinical trial NCT00413036
Conditions: Lymphoma, Non-Hodgkin's
Keywords: Celgene Revlimid CC-5013 Non-hodgkin's lymphoma Lenalidomide CC5013 NHL
Sponsor: Celgene
Start date: 2006-06-01; Completion date: 2011-05-01
Enrollment: 217 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Subjects who qualify will receive oral lenalidomide daily on days 1-21 of every 28 day cycle. Treatment will continue until disease progression, or unacceptable adverse events develop

Detailed description:

Arms: arm 1: 25 mg oral lenalidomide once daily on Days 1-21 every 28 days
Interventions: intervention 1: lenalidomide
Intervention descriptions: intervention 1: once daily oral capsule

Protocol documents:
Clinical trial NCT00457002
Conditions: Venous Thrombosis Pulmonary Embolism
Keywords: Prevention of deep vein thrombosis and pulmonary embolism with acutely ill hospitalized patients
Sponsor: Bristol-Myers Squibb
Start date: 2007-06-01; Completion date: 2011-05-01
Enrollment: 6758 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep vein thrombosis \[DVT\]) and lung (pulmonary embolism \[PE\]) that sometimes occur within patients hospitalized for acute medical illness, and to learn how apixaban compares to enoxaparin (Lovenox®) for preventing these clots. The safety of apixaban will also be studied.

Detailed description:

Arms: arm 1: While hospitalized, Apixaban plus Placebo

Apixaban (Tablets, Oral, 2.5 mg), Placebo (Syringes, SC)

After hospital discharge, Apixaban

Apixaban (Tablets, Oral, 2.5 mg) arm 2: While hospitalized, Enoxaparin plus Placebo

Enoxaparin (Syringes, SC, 40 mg), Placebo (Tablets, Oral)

After hospital discharge: Placebo

Placebo (Tablets, Oral)
Interventions: intervention 1: Apixaban intervention 2: Enoxaparin
Intervention descriptions: intervention 1: Apixaban: Twice daily, 30 days

Placebo: Once daily, 6-14 days intervention 2: Enoxaparin: Once daily, 6-14 days

Placebo: Twice daily, 30 days

Protocol documents:
Clinical trial NCT00506415
Conditions: Alzheimer Disease
Keywords: Alzheimer's Patch Cognitive Decline
Sponsor: Novartis Pharmaceuticals
Start date: 2007-06-01; Completion date: 2011-05-01
Enrollment: 1584 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to support the optimal use of rivastigmine patch in long-term treatment of Alzheimer's Disease in patients demonstrating functional and cognitive decline at the target maintenance dose of rivastigmine patch 10 cm\^2.

Detailed description:

Arms: arm 1: Rivastigmine 5 cm\^2 transdermal patch once a day during the first 4 weeks of open label treatment followed by rivastigmine 10 cm\^2 transdermal patch once a day from week 4 to week 24, 36 or 48. arm 2: Rivastigmine transdermal patch 10 cm\^2 and placebo to rivastigmine 15 cm\^2 once daily for 48 weeks during the double blind period. arm 3: Rivastigmine transdermal patch 15 cm\^2 and placebo to rivastigmine 10 cm\^2 once daily for 48 weeks during double blind period. arm 4: Rivastigmine 10 cm\^2 transdermal patch once a day during 48 weeks open label treatment running in parallel to the double blind period.
Interventions: intervention 1: Rivastigmine 5 cm^2 intervention 2: Rivastigmine 10 cm^2 intervention 3: Rivastigmine 15 cm^2 intervention 4: Placebo to 15 cm^2 patch intervention 5: Placebo to 10 cm^2 patch
Intervention descriptions: intervention 1: 5 cm\^2 transdermal patch intervention 2: 10 cm\^2 transdermal patch. intervention 3: 15 cm\^2 transdermal patch. intervention 4: Placebo of rivastigmine transdermal patch 15 cm\^2. intervention 5: Placebo of rivastigmine transdermal patch 10 cm\^2.

Protocol documents:
Clinical trial NCT00534313
Conditions: Psoriatic Arthritis
Sponsor: Bristol-Myers Squibb
Start date: 2007-11-01; Completion date: 2011-05-01
Enrollment: 191 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine an optimal abatacept dosing regimen for the treatment of active arthritis due to psoriatic arthritis in patients who have had a prior inadequate response to disease-modifying antirheumatic drugs, including methotrexate and tumor necrosis factor alpha-blockade compounds.

Detailed description:

Arms: arm 1: Abatacept (30 mg/kg) was administered as intravenous (iv) infusion over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. The dose was calculated based on screening visit weight of participants for dosing on Days 1 and 15 followed by fixed dosing as per rheumatoid arthritis label (participants weighing \<60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \>100 kg received 1000 mg) thereafter. arm 2: Abatacept (10 mg/kg) was administered as iv infusion over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141 in the double-blind period and continued for next 18 months in the open-label period till Day 729. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing \<60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \>100 kg received 1000 mg). arm 3: Abatacept (3 mg/kg) was administered as iv infusion over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. The dose was calculated based on screening visit weight of participants. arm 4: Placebo solution (5% dextrose in water for injection, 0.9% sodium chloride injection) by iv infusion was administered on Days 1, 15, and 29 and every 28 days thereafter till Day 141.
Interventions: intervention 1: Abatacept intervention 2: Placebo
Intervention descriptions: intervention 1: Solution, intravenous, monthly, short-term = 24 weeks (6 months) intervention 2: Solution, intravenous, placebo (double dummy), monthly, short-term = 24 weeks (6 months)

Protocol documents:
Clinical trial NCT00565409
Conditions: Arthritis, Rheumatoid
Keywords: Active Rheumatoid Arthritis
Sponsor: Pfizer
Start date: 2008-03-01; Completion date: 2011-05-01
Enrollment: 834 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the efficacy of the combination of etanercept 50 mg once weekly plus methotrexate with that of methotrexate monotherapy in the treatment of rheumatoid arthritis over 88 weeks.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Etanercept intervention 2: Methotrexate intervention 3: Etanercept intervention 4: Methotrexate intervention 5: Placebo intervention 6: Methotrexate
Intervention descriptions: intervention 1: Subcutaneous (SC), 50 mg, once weekly for 88 weeks intervention 2: Oral, 15 to 25 mg (varying based on dosage the subject is receiving at the time of screening and may be increased at the discretion of the investigator through Week 28 to a maximum of 25 mg/week), once weekly for 88 weeks.

If a subject experiences an adverse event (AE) during the study, Methotrexate may be decreased by 2.5 or 5.0 mg weekly (the minimum dose to stay in the study is 10 mg/week). intervention 3: Subcutaneous (SC), 25 mg, once weekly from week 36 to week 88. intervention 4: Oral, 15 to 25 mg (varying based on dosage the subject is receiving at the time of screening and may be increased at the discretion of the investigator through Week 28 to a maximum of 25 mg/week), once weekly for 88 weeks.

If a subject experiences an adverse event (AE) during the study, Methotrexate may be decreased by 2.5 or 5.0 mg weekly (the minimum dose to stay in the study is 10 mg/week). intervention 5: Subcutaneous (SC), once weekly from week 36 to week 88. intervention 6: Oral, 15 to 25 mg (varying based on dosage the subject is receiving at the time of screening and may be increased at the discretion of the investigator through Week 28 to a maximum of 25 mg/week), once weekly for 88 weeks.

If a subject experiences an adverse event (AE) during the study, Methotrexate may be decreased by 2.5 or 5.0 mg weekly (the minimum dose to stay in the study is 10 mg/week).

Protocol documents:
Clinical trial NCT00633464
Conditions: Triple Negative Locally Advanced Non-resectable Breast Cancer Metastatic Breast Cancer
Sponsor: R-Pharm
Start date: 2008-06-01; Completion date: 2011-05-01
Enrollment: 79 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to estimate the response rate of ixabepilone monotherapy, and the combination of ixabepilone plus cetuximab as first-line treatment of female subjects with triple negative (estrogen receptor \[ER\], progesterone receptor \[PR\], Human Epidermal Growth Factor Receptor 2 \[HER2\] negative) locally advanced non-resectable and/or metastatic breast cancer

Detailed description:

Arms: arm 1: ixabepilone 40 mg/m\^2 every 3 weeks arm 2: cetuximab 400 mg/m\^2 loading dose then 250 mg/m\^2 weekly + ixabepilone 40 mg/m\^2 every 3 weeks
Interventions: intervention 1: ixabepilone intervention 2: ixabepilone + cetuximab
Intervention descriptions: intervention 1: injection, intravenous (IV), until unacceptable toxicity or progression or 15 months after the Last Subject First Visit (LSFV), whichever comes first.

Ixabepilone 40 mg/m\^2 was administered as a 3-hour IV continuous infusion on Day 1 in a 21-day cycle provided the participant met the re-treatment criteria. intervention 2: Ixabepilone: injection, IV, until unacceptable toxicity or progression or 15 months after the LSFV, whichever comes first.

Ixabepilone 40 mg/m\^2 was administered as a 3-hour IV continuous infusion on Day 1 in a 21-day cycle provided the participant meets the re-treatment criteria.

Cetuximab: injection, IV, until unacceptable toxicity or progression or 15 months after the LSFV, whichever comes first.

Cetuximab 400 mg/m\^2 was administered as a 2-hour IV loading dose via in-line filtration with an infusion pump, gravity drip, or a syringe pump on Day 1 of first cycle then 250 mg/m\^2 1-hour IV once a week, i.e. on Days 1, 8, and 15 of each cycle provided the participant meets the re-treatment criteria.

Protocol documents:
Clinical trial NCT00680186
Conditions: Thromboembolism
Sponsor: Boehringer Ingelheim
Start date: 2008-04-01; Completion date: 2011-05-01
Enrollment: 2589 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The general aim of this study is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin Pro re nata (As needed/PRN) to maintain an International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute symptomatic VTE.

The primary objective is to investigate the efficacy of dabigatran compared to warfarin during the 6 month treatment period. The investigation of other selected efficacy aspects and safety are regarded as secondary objective of this trial.

Detailed description:

Arms: arm 1: Patients will receive 1 capsule containing 150 mg dabigatran etexilate/matching placebo twice daily arm 2: Patients will receive tablets PRN warfarin/matching placebo to maintain a target INR of 2.0-3.0
Interventions: intervention 1: Warfarin intervention 2: Dabigatran etexilate
Intervention descriptions: intervention 1: PRN (to maintain a target INR of 2.0-3.0) intervention 2: 150mg bid

Protocol documents:
Clinical trial NCT00719472
Conditions: Non-Hodgkin's Lymphoma
Keywords: Follicular NHL NHL Large B-Cell NHL
Sponsor: Genentech, Inc.
Start date: 2008-07-01; Completion date: 2011-05-01
Enrollment: 451 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This was a prospective, open-label, Phase III, multicenter, single-arm trial designed to assess the safety, pharmacokinetics, and pharmacodynamics of an alternative dosing rate of rituximab in previously untreated patients with diffuse large B-cell lymphoma (DLBCL) and follicular non-Hodgkin lymphoma (NHL).

Detailed description:

Arms: arm 1: Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin \[doxorubicin\], Oncovin \[vincristine\], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m\^2 administered by intravenous (IV) infusion on Day 1 of each cycle.
Interventions: intervention 1: Rituximab intervention 2: CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) intervention 3: CVP (cyclophosphamide, vincristine, prednisone) intervention 4: Analgesic/antipyretic and antihistamine drugs
Intervention descriptions: intervention 1: During Cycle 1 rituximab was administered at an initial rate of 50 mg/hour. In the absence of infusion toxicity during Cycle 1, the infusion rate was escalated by 50 mg/h increments every 30 minutes to a maximum rate of 400 mg/hour. In case of infusion-related reactions, the infusion was interrupted or the infusion rate reduced. In case of Grade 3/4 infusion reactions, the rituximab infusion was discontinued and medical treatment provided. If the rituximab infusion in Cycle 1 was tolerated without a serious adverse event (AE) or Grade 3/4 infusion-related AE, as judged by the investigator, infusions in Cycle 2 onwards were administered as follows: 20% of the total dose was given over 30 minutes and the remaining 80% of the dose was given over the next 60 minutes, for a total infusion time of 90 minutes. Commercial preparations of rituximab were used. intervention 2: Commercial preparations of CHOP were used. Prednisone was administered prior to rituximab infusion. intervention 3: Commercial preparations of CVP were used. Prednisone was administered prior to rituximab infusion. intervention 4: An analgesic/antipyretic (eg, acetaminophen) and an antihistamine (eg, diphenhydramine) were administered 30 minutes before each infusion of rituximab.

Protocol documents:
Clinical trial NCT00745823
Conditions: HIV
Keywords: HIV Infections Treatment Naïve
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-09-01; Completion date: 2011-05-01
Enrollment: 775 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to evaluate the safety, tolerability and efficacy of once daily Raltegravir compared to twice daily raltegravir when each is given in combination with TRUVADA™ in treatment-naïve human immunodeficiency virus (HIV)-infected patients.

Detailed description:
Following the 96-week double-blind study period (MK0518-071)(NCT00745823), subjects may enroll in an extension study (MK0518-071-10)(NCT00745823). From weeks 96 to 120, subjects' treatment assignments will remain as in the base study.

From week 120 to 240, all subjects will receive open-label raltegravir (800 mg, once daily) in combination with TRUVADA™.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Comparator: Raltegravir 400 mg b.i.d. intervention 2: Experimental: Raltegravir 800 mg q.d. intervention 3: TRUVADA™
Intervention descriptions: intervention 1: Raltegravir 400 mg tablet by mouth (PO) twice daily (b.i.d.) + two raltegravir placebo tablets + one tablet of TRUVADA™ once daily (q.d.) intervention 2: Raltegravir 800 mg tablet PO q.d. + two raltegravir placebo tablets + one tablet TRUVADA™ q.d. intervention 3: One tablet TRUVADA™ q.d. (fixed combination 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate)

Protocol documents: