ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00590031
Conditions: Esophageal Carcinoma
Keywords: Esophageal Carcinoma Cisplatin Irinotecan Radiation Therapy 02-045
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2002-11-01; Completion date: 2009-12-01
Enrollment: 61 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Patients with surgically resectable T1N1M0 or T2-4N any M0 esophageal carcinoma will receive six weeks of induction chemotherapy with weekly irinotecan and cisplatin given weeks 1, 2, 4 and 5. Patients will then receive weekly irinotecan, cisplatin, and concurrent radiotherapy with chemotherapy given once weekly, weeks 8,9,11 and 12 during the six weeks of radiotherapy. Patients will be referred for surgery 4-8 weeks after completion of chemoradiotherapy.

Detailed description:

Arms: arm 1: External Beam Radiation Therapy, Cisplatin, Irinotecan
Interventions: intervention 1: Cisplatin intervention 2: Irinotecan intervention 3: External Beam Radiation Therapy
Intervention descriptions: intervention 1: pts will receive weekly cisplatin 30mg/m2 after hydration on weeks 8,9,11 and 12 intervention 2: Irinotecan will be given 65 mg/m2 intervention 3: will be delivered with multiple (\>2) field techniques using mega-voltage radiation therapy. pts will receive 50.4 Gy and will be treated over a 6 week period.

Protocol documents:
Clinical trial NCT00592358
Conditions: Pediatric Bipolar Disorder
Keywords: bipolar disorder children adolescents Invega
Sponsor: Massachusetts General Hospital
Start date: 2007-11-01; Completion date: 2009-12-01
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This will be an 8-week open-label trial, using daily doses of paliperidone (Invega) in the treatment of children and adolescents who meet DSM-IV criteria of Bipolar I, Bipolar II, or Bipolar Spectrum Disorder. Specific hypotheses are as follows:

Hypothesis 1: Bipolar Disorder symptomatology in children and adolescents with DSM-IV Bipolar I, Bipolar II, or Bipolar Spectrum Disorder will be responsive to Invega treatment.

Hypothesis 2: Invega -associated improvement in bipolar disorder symptomatology in children and adolescents will translate into improved functional capacities (neuropsychological, social, and occupational), as well as an increased quality of life throughout treatment.

Hypothesis 2: Invega treatment will be safe and well tolerated as reflected by a low drop out rate and absence of major side effects.

Detailed description:
Invega (paliperidone), a second generation antipsychotic (SGA), is a psychotropic agent belonging to the chemical class of benzisoxazole derivatives. Invega is approved by the FDA for the treatment of schizophrenia in adults. Initial data suggest a promising role for Invega in the treatment of bipolar disorder with minimal adverse events of weight gain. We propose to study the safety and efficacy of Invega therapy in children and adolescents with Bipolar I, Bipolar II, and Bipolar Spectrum Disorder. The study results will be used to generate hypotheses for a larger, randomized, controlled clinical trial with explicit hypotheses and sufficient statistical power.

The proposed study includes 1) use of a 8-week design to document the response rate, 2) assessment of the impact of Invega on functional capacities (quality of life, psychosocial function) and cognition, and 3) careful assessment of safety and tolerability.

Arms: arm 1: None
Interventions: intervention 1: paliperidone
Intervention descriptions: intervention 1: tablet, 3mgQAM - 6mgQAM, taken daily for 8 weeks

Protocol documents:
Clinical trial NCT00602446
Conditions: Breast Cancer Iron Overload Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Neuroblastoma Ovarian Cancer
Keywords: iron overload
Sponsor: Masonic Cancer Center, University of Minnesota
Start date: 2007-08-01; Completion date: 2009-12-01
Enrollment: 4 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Deferasirox may be effective in treating iron overload caused by blood transfusions in patients who have undergone donor stem cell transplant.

PURPOSE: This phase II trial is studying the side effects and how well deferasirox works in treating patients with iron overload after donor stem cell transplant.

Detailed description:
OBJECTIVES:

Primary

* To evaluate the safety of deferasirox given over 6 months in reducing liver iron concentration in patients with transfusional iron overload after undergoing allogeneic hematopoietic stem cell transplantation.

Secondary

* To evaluate the efficacy of deferasirox in reducing liver iron overload in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral deferasirox once daily for 6 months in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed at 4 weeks.

Arms: arm 1: Includes patients that were treated with deferasirox for 6 months.
Interventions: intervention 1: deferasirox
Intervention descriptions: intervention 1: 20 mg/kg once daily orally for 6 months

Protocol documents:
Clinical trial NCT00603408
Conditions: Breast Cancer
Keywords: Breast Cancer Locally Advanced Neoadjuvant
Sponsor: Washington University School of Medicine
Start date: 2007-12-01; Completion date: 2009-12-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether Cisplatin when given with radiation therapy prior to surgery is effective in improving response to treatment in breast cancer patients. Tumor, blood and bone marrow samples will be collected in this study and will also help researchers determine if cisplatin is able to change tumor DNA so it cannot multiply itself and create more tumor cells, and cause the tumor cells to die.

Detailed description:
After Diagnosis: Clinical Stage IIB, III Breast Cancer, Triple Negative

Week 0: Port-A-Cath placement Tumor biopsy (Core and FNA) Blood collection Bone marrow aspiration Sentinel Lymph node biopsy, if axillary US negative

Week 1: Chemo \& Radiation Day 1: Radiation Therapy, Cisplatin 75mg/m\^2 (cycle 1) Days 2-5: Radiation Therapy

Week 2: Radiation Day 1-5: Radiation Therapy

Week 3: Radiation Days 1-5: Radiation Therapy

Week 4: Chemo \& Radiation Day 1: Radiation Therapy, Cisplatin 75mg/m\^2 (cycle 2) Days 2-5: Radiation Therapy

Week 5: Radiation Days 1-5: Radiation Therapy

Week 6: Radiation Days 1-5: Radiation Therapy

Week 7: Chemo Day 1: Cisplatin 75mg/m\^2 (cycle 3)

Week 10: Chemo Day 1:Cisplatin 75mg/m\^2 (cycle 4)

Week 13: Surgery Mastectomy with/without axillary lymph node dissection Tumor biopsy (Core and FNA) Blood collection Bone marrow aspiration

Week 15 - 21: Recommended (physician discretion) Adjuvant Chemo Dose dense Doxorubicin: 60mg/m\^2 \& Cyclophosphamide: 600mg/m\^2, every 2 weeks for 4 cycles

Week 21 - 29: Recommended (physician discretion) Adjuvant Chemo Paclitaxel: 175mg/m\^2 every 2 weeks for 4 cycles

Week 52 IVAD Removal, Bone marrow aspiration

Follow-Up (up to 5 years) Q 3 months for year 1 Q 6 months for year 2-3 Q 1 year for years 4-5

Arms: arm 1: Cisplatin 75 mg/m\^2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10

Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.

Surgery (recommended) mastectomy with/without axillary lymph node dissection
Interventions: intervention 1: Cisplatin intervention 2: Radiation Therapy intervention 3: Mastectomy
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: (RECOMMENDED BUT NOT REQUIRED)

Protocol documents:
Clinical trial NCT00603473
Conditions: Epilepsies, Partial
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2008-01-01; Completion date: 2009-12-01
Enrollment: 92 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Examine the efficacy, safety and pharmacokinetics of gabapentin as adjunctive therapy in Japanese pediatric patients with partial seizures

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: gabapentin
Intervention descriptions: intervention 1: Orally administered gabapentin

Protocol documents:
Clinical trial NCT00606632
Conditions: Renal Cell Carcinoma Kidney Cancer
Keywords: Renal Mass Clear Cell Renal Cell Carcinoma Cancer of Kidney Kidney Cancer Neoplasms cG250 antibody, monoclonal Iodine 124 Positron-Emission Tomography Kidney Renal Cancer Renal Neoplasms
Sponsor: Heidelberg Pharma AG
Start date: 2008-03-01; Completion date: 2009-12-01
Enrollment: 226 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a multicenter Phase III study to demonstrate the diagnostic utility of 124I-cG250 PET/CT pre-surgical imaging in patients with operable renal masses.

Detailed description:
A preoperative 124I-cG250 PET scan may distinguish between clear cell and non-clear cell renal carcinoma in patients with renal masses. Studies of imaging characteristics of 124I by a variety of PET cameras, quantification of tumor uptake of 124I-labeled antibody and correlation with biopsy measurement of tumor and normal tissue have met with encouraging results. As clear cell renal cancers are associated with an aggressive phenotype their a priori determination may help guide appropriate surgical/therapeutic management.

Arms: arm 1: Single arm study, comparing 124I cG250 PET/CT and CT. Each patient underwent a PET/CT and CT scan days (+/-2days) after receipt of 124I cG250.
Interventions: intervention 1: 124-Iodine-cG250 (124I-cG250) intervention 2: CT
Intervention descriptions: intervention 1: i.v. and PET/CT scan 4+/-2 days after administration intervention 2: contrast enhanced CT scan

Protocol documents:
Clinical trial NCT00612105
Conditions: Postherpetic Neuralgia
Keywords: Postherpetic Neuralgia, PHN, Shingles,
Sponsor: Bausch Health Americas, Inc.
Start date: 2007-10-01; Completion date: 2009-12-01
Enrollment: 187 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the efficacy of retigabine vs. placebo in reducing pain associated with post-herpetic neuralgia.

Detailed description:
This is a Phase 2a proof of concept study evaluating the safety/efficacy of retigabine vs. placebo in patients with post-herpetic neuralgia. After screening, patients will enter a maximum 6 week titration period followed by a 4 week maintenance period and a 3 week taper phase.

Arms: arm 1: Retigabine arm 2: Placebo
Interventions: intervention 1: Retigabine intervention 2: Placebo
Intervention descriptions: intervention 1: 150mg/day up to 900mg/day intervention 2: daily

Protocol documents:
Clinical trial NCT00614445
Conditions: Nausea and Vomiting of Pregnancy
Keywords: Nausea Vomiting Pregnancy Hyperemesis gravidarum Pregnancy complications
Sponsor: Duchesnay Inc.
Start date: 2008-01-01; Completion date: 2009-12-01
Enrollment: 280 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether Diclectin® (doxylamine succinate USP 10 mg and pyridoxine HCl 10 mg) is more effective at controlling the nausea and vomiting of pregnancy than a placebo.

Detailed description:
Nausea and vomiting of pregnancy (NVP), also known as "morning sickness," is a common condition that affects a large percentage of pregnant women. The symptoms can range from mild nausea to severe nausea and vomiting for which a woman may need to be hospitalized. Nausea and vomiting of pregnancy can affect a woman's quality of life and ability to conduct daily activities.

Diclectin® is a combination of 10 mg doxylamine succinate (an antihistamine), and 10 mg pyridoxine hydrochloride (vitamin B6) in a delayed release tablet formulation. It has been commercially available in Canada for the management of NVP for over 25 years and has been prescribed to over 33 million pregnant women.

Presently, there is no Food Drug and Administration (FDA) approved drug on the market to treat the symptoms of NVP. This study will test the efficacy of Diclectin® (doxylamine 10 mg, pyridoxine 10 mg in a delayed-release formulation) for NVP.

Patients enrolled in the study will receive between 2 and 4 tablets of Diclectin® or placebo daily, depending on their symptoms for up to 14 days. Patients will assess their symptoms of nausea and vomiting daily using a standardized questionnaire.

Arms: arm 1: Diclectin® (doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg) delayed release tablet arm 2: Placebo tablets identical in size, shape, taste, and color to the experimental treatment (Diclectin®)
Interventions: intervention 1: doxylamine succinate 10 mg/pyridoxine hydrochloride 10 mg intervention 2: Placebo
Intervention descriptions: intervention 1: up to 4 tablets daily, titrated according to the protocol intervention 2: 2 to 4 tablets daily titrated according to the protocol

Protocol documents:
Clinical trial NCT00649389
Conditions: Hypertension
Sponsor: Daiichi Sankyo
Start date: 2008-05-01; Completion date: 2009-12-01
Enrollment: 2500 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine the effectiveness of four different strength combinations of three approved anti-hypertension therapies (olmesartan medoxomil, amlodipine, and hydrochlorothiazide) for lowering blood pressure.

Detailed description:

Arms: arm 1: olmesartan medoxomil 40mg and amlodipine 10mg arm 2: olmesartan medoxomil 40mg and hydrochlorothiazide 25mg arm 3: amlodipine 10mg and hydrochlorothiazide 25mg arm 4: olmesartan medoxomil 40mg, amlodipine 10mg, and hydrochlorothiazide 25mg
Interventions: intervention 1: Olmesartan medoxomil intervention 2: Amlodipine intervention 3: Hydrochlorothiazide
Intervention descriptions: intervention 1: 40mg olmesartan medoxomil intervention 2: Amlodipine 10mg intervention 3: Hydrochlorothiazide 25mg

Protocol documents:
Clinical trial NCT00655863
Conditions: Diabetes Mellitus
Keywords: Glucose Metabolism Disorder Dysmetabolic Syndrome Type II Diabetes Diabetes Mellitus Lipoatrophic; Dyslipidemia Drug Therapy
Sponsor: Takeda
Start date: 2007-07-01; Completion date: 2009-12-01
Enrollment: 71 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy of Alogliptin, once daily (QD), taken by itself and with pioglitazone on postprandial lipid measures in type 2 diabetes.

Detailed description:
SYR-322 (alogliptin) is a selective, orally available inhibitor of dipeptidyl peptidase IV being developed as a treatment for type 2 diabetes mellitus. Dipeptidyl peptidase IV is the primary enzyme involved in the in vivo degradation of at least 2 peptide hormones released in response to nutrient ingestion, namely glucagon-like peptide-1 and glucose-dependent insulinotropic peptide.

Pioglitazone HCl (ACTOS®) is a thiazolidinedione developed by Takeda Chemical Industries, Ltd. (Osaka, Japan). Pioglitazone HCl depends on the presence of insulin for its mechanism of action.

This study will assess the effects of alogliptin and alogliptin coadministered with pioglitazone HCl on postprandial lipid and lipoprotein metabolism in participants with type 2 diabetes. Individuals who participate in this study will be required to commit to a screening visit and up to 6 additional visits at the study center. Study participation is anticipated to be about 20 weeks (or approximately 5 months). Multiple procedures will occur at each visit which may include fasting, blood collection, urine collection, physical examinations and electrocardiograms. At 3 of the visits a meal will be served that must be eaten within 10 minutes.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Alogliptin and Pioglitazone intervention 2: Alogliptin intervention 3: Placebo
Intervention descriptions: intervention 1: Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks. intervention 2: Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks. intervention 3: Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.

Protocol documents:
Clinical trial NCT00658567
Conditions: Parkinson's Disease Psychosis
Sponsor: ACADIA Pharmaceuticals Inc.
Start date: 2008-03-01; Completion date: 2009-12-01
Enrollment: 123 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of two dose levels of pimavanserin (ACP-103) compared to placebo in patients with Parkinson's disease psychosis.

Detailed description:

Arms: arm 1: pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks arm 2: Placebo tablet, once daily by mouth, 6 weeks arm 3: pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
Interventions: intervention 1: Pimavanserin tartrate (ACP-103) intervention 2: Pimavanserin tartrate (ACP-103) intervention 3: Pimavanserin tartrate (ACP-103)
Intervention descriptions: intervention 1: 10 mg, tablet, once daily by mouth, for six weeks intervention 2: 20 mg, tablet, once daily by mouth, for six weeks intervention 3: Placebo, tablet, once daily by mouth, for six weeks

Protocol documents:
Clinical trial NCT00658606
Conditions: Plaque Psoriasis
Keywords: plaque psoriasis alefacept Amevive narrow band ultraviolet B phototherapy
Sponsor: Astellas Pharma Inc
Start date: 2007-10-01; Completion date: 2009-12-01
Enrollment: 98 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Assess the efficacy and safety of alefacept with nbUVB compared to alefacept alone in chronic plaque psoriasis subjects. Combination therapy may improve the clinical response to psoriatic subjects as both modalities have an effect on T cells

Detailed description:

Arms: arm 1: 15 mg alefacept intramuscularly (IM) once weekly for 12 weeks arm 2: 15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
Interventions: intervention 1: alefacept intervention 2: Narrow Band UVB Phototherapy
Intervention descriptions: intervention 1: IM intervention 2: UVB Phototherapy

Protocol documents:
Clinical trial NCT00660309
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 diabetes mellitus renal disease hypertension renal blood flow retinal blood flow aliskiren irbesartan captopril
Sponsor: Novartis
Start date: 2008-04-01; Completion date: 2009-12-01
Enrollment: 45 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study objective was to assess the effect of single and multiple doses of aliskiren on renal plasma flow, glomerular filtration rate and to compare the effects of single and multiple doses of aliskiren versus captopril or irbesartan on renal blood flow, glomerular filtration rate, and retinal blood flow in patients with type 2 diabetes mellitus.

Detailed description:

Arms: arm 1: On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days. arm 2: On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
Interventions: intervention 1: Aliskiren intervention 2: Irbesartan intervention 3: Captopril
Intervention descriptions: intervention 1: Aliskiren 300 mg tablets intervention 2: Irbesartan 300 mg tablets intervention 3: Captopril 25 mg tablet

Protocol documents:
Clinical trial NCT00661609
Conditions: Bladder Cancer Transitional Cell Bladder Cancer Urethra Cancer Ureter Cancer Renal Pelvis Cancer
Keywords: Anti-mitotic Eg5 Inhibitor Kinesin Spindle Protein Inhibitor Urothelial Cancer Bladder Cancer Renal Pelvis Cancer Urethra Cancer Ureter Cancer Recurrent Advanced Stage IV
Sponsor: AstraZeneca
Start date: 2008-05-01; Completion date: 2009-12-01
Enrollment: 54 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this Phase II study is to determine if AZD4877, an experimental drug that is a novel anti-mitotic agent (Eg5 or Kinesin Spindle Protein inhibitor that interferes with tumor cell division leading to tumor growth), can reduce tumor sizes in patients with bladder cancer

Detailed description:

Arms: arm 1: Single agent AZD4877
Interventions: intervention 1: AZD4877
Intervention descriptions: intervention 1: Intravenous (IV)25mg/weekly

Protocol documents:
Clinical trial NCT00672243
Conditions: Glioblastoma Gliosarcoma
Keywords: GBM Brain tumor Erlotinib Sirolimus Glioblastoma multiforme Glioblastoma Gliosarcoma3 Tarceva Rapamune
Sponsor: Duke University
Start date: 2007-04-01; Completion date: 2009-12-01
Enrollment: 32 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Primary objective:

To determine the 6-month progression free survival of patients with recurrent glioblastoma multiforme (GBM) treated with Erlotinib plus Sirolimus.

Secondary objectives:

To further define the safety and tolerability of Erlotinib plus Sirolimus when administered to patients with recurrent GBM; and to evaluate progression free survival, radiographic response and overall survival of patients with recurrent GBM treated with Erlotinib plus Sirolimus.

Detailed description:
The primary objective of this study will be to determine the 6-month progression free survival of patients with recurrent GBM treated with Erlotinib plus Sirolimus.

This is an exploratory, single-arm, phase II study designed to assess the anti-tumor activity of a combinatorial regimen consisting of Erlotinib plus Sirolimus among patients with recurrent GBM. The combinatorial regimen of Erlotinib plus Sirolimus is rationally designed to simultaneously inhibit upstream (EGFR) and downstream (mTOR) mediators of Phosphatidylinositide 3-kinase/Protein Kinase B (PI3/AKT) signaling. In a recently completed phase I study, we determined that an EGFR inhibitor (Gefitinib) can be safely combined with Sirolimus at dose levels that are routinely used in the monotherapy setting. Therefore, the primary endpoint of this study is the probability of progression-free survival at 6 months among recurrent GBM patients treated with standard doses of Erlotinib plus Sirolimus. An important secondary objective is to further assess the safety of Erlotinib and Sirolimus for patients with recurrent GBM.

Arms: arm 1: Erlotinib \& sirolimus on a daily dosing schedule on a 28-day cycle. Dosing was 150 mg of erlotinib and 5mg of sirolimus for patients not on concurrent Cytochrome P450, family 3 (CY3PA)-inducing anti-epileptics (EIAEDS) and 400 mg of erlotinib and 10 mg of sirolimus for patients on concurrent EIAEDS.
Interventions: intervention 1: Erlotinib + sirolimus
Intervention descriptions: intervention 1: Erlotinib \& sirolimus on a daily dosing schedule on a 28-day cycle. Dosing was 150 mg of oral erlotinib and 5mg of oral sirolimus for patients not on concurrent CY3PA-inducing anti-epileptics (EIAEDS) and 400 mg of oral erlotinib and 10 mg of oral sirolimus for patients on concurrent EIAEDS.

Protocol documents: