ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00199888
Conditions: Cancer of Kidney Kidney Cancer Renal Cancer Neoplasms, Kidney Renal Neoplasms Renal Cell Carcinoma (RCC) Clear Cell Renal Cell Carcinoma
Keywords: Kidney Cancer Renal Cancer Neoplasms, Kidney cG250 antibody Iodine 124
Sponsor: Ludwig Institute for Cancer Research
Start date: 2005-06-01; Completion date: 2009-05-29
Enrollment: 26 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to see if an antibody (cG250) attached to a radioactive substance (Iodine-124) safely detects clear cell renal cancer in patients with kidney tumors scheduled for surgery.

Detailed description:
Antibodies are proteins made by the immune system. They fight things that the body sees as foreign, such as bacteria and viruses. The body can also see cancer cells as foreign. When the body sees a foreign invader, it sends out antibodies that tag the invader. Once this happens, the immune system can work to destroy whatever the antibody has tagged.

Monoclonal antibodies are antibodies that can be made in the lab. They tag a portion of a cancer cell. Early monoclonal antibodies were made from antibodies grown in mice. They caused an antibody response in humans after one dose. Now they are more like human antibodies, and thus, do not produce the same reactions on repeated doses. These are called chimeric antibodies. The antibody we will use in this study is called chimeric G250 (cG250).

Recent research has shown that some antibodies can attach themselves to cancer cells, and that they bind to very few normal cells. This could help cancer treatment in two ways. One is that the body's own immune system might work to destroy tagged cancer cells. The other is that we can attach chemotherapy drugs or radioactive chemicals to the antibodies. These can then deliver treatment when the antibodies attach to the cancer cells.

This study is being done to test the tagging ability of cG250 to cancer cells. After you receive cG250, you will have a scan. The picture the scan produces will show where the antibody has collected inside the body. From this, it is possible to measure how well cG250 can detect kidney cancer. This is NOT a treatment for renal cancer. After your surgery, we will examine the tumor and other tissue to see how much of the antibody has attached to the tumor.

Arms: arm 1: Patients who were scheduled for surgical resection of renal masses received a single intravenous (IV) dose of 10 mg of 5 milliCurie (mCi) /10 mg 124I-cG250. Patients underwent Positron-Emission Tomography/Computed Tomography (PET/CT) imaging of the whole body on at least 2 occasions: once following injection and once immediately prior to surgical resection. Patients were scheduled for surgical resection of their renal masses on day 8.
Interventions: intervention 1: 124-Iodine-cG250 (124I-cG250)
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00644358
Conditions: Major Depressive Disorder
Sponsor: Forest Laboratories
Start date: 2007-12-31; Completion date: 2009-05-31
Enrollment: 616 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open label 52-week clinical trial is designed to assess the safety and tolerability of vilazodone and to analyze genetic markers of response to vilazodone in adult patients diagnosed with MDD. This study will enroll approximately 600 patients.

Detailed description:
Patients will be enrolled at approximately 40 US investigative sites and receive vilazodone for 52 weeks of open label treatment. Safety measurements will include adverse events, vital signs, laboratory, ophthalmologic exams, Changes in Sexual Function Questionnaire (CSFQ) scale and electrocardiogram (ECG) findings collected over the course of the treatment period. Effectiveness measurements will be done at baseline and each visit until week 52 or end-of-treatment. A deoxyribonucleic acid (DNA) sample will be collected for genetic analysis related to response to vilazodone.

Arms: arm 1: Vilazodone titrated up to 40 mg/day for 1 year.
Interventions: intervention 1: vilazodone
Intervention descriptions: intervention 1: titration to 40 milligrams (mg) every day (qd) for 1 year

Protocol documents:
Clinical trial NCT00617994
Conditions: Psoriasis
Keywords: psoriasis
Sponsor: Incyte Corporation
Start date: 2007-08-31; Completion date: 2009-05-31
Enrollment: 25 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This will be an open label study of ruxolitinib topical cream applied to 2 - 20% BSA in patients with active, stable plaque psoriasis.

Detailed description:

Arms: arm 1: Patients with active stable plaque psoriasis treated with topical cream application on lesions involving a small percent BSA. arm 2: Patients with active stable plaque psoriasis treated with topical cream application on lesions involving a larger percent BSA than Cohort 1. arm 3: Patients with active stable plaque psoriasis treated with topical cream application on lesions involving a larger percent BSA than Cohort 2.
Interventions: intervention 1: Ruxolitinib
Intervention descriptions: intervention 1: Ruxolitinib 1.5% cream BID for 28 days

Protocol documents:
Clinical trial NCT00113763
Conditions: Colorectal Cancer Metastases
Keywords: Metastatic Colorectal Cancer, Colon Colorectal, Rectal Cancer, Cancer Metastatic, EGFr, Clinical Trial Panitumumab, ABX-EGF Immunex, Abgenix, Amgen
Sponsor: Amgen
Start date: 2004-01-01; Completion date: 2009-06-01
Enrollment: 463 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine that panitumumab, using the proposed regimen, will safely increase progression free survival in patients with metastatic colorectal cancer who have failed available treatment options (i.e., patients who developed progressive disease or relapsed while on or after prior fluoropyrimidine, irinotecan and oxaliplatin chemotherapy).

Detailed description:

Arms: arm 1: Panitumumab will be administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants develop progressive disease or are unable to tolerate study drug. Participants will also receive best supportive care (BSC) as judged appropriate by the investigator and according to institutional guidelines. arm 2: Best supportive care will be defined in this study as the best care available as judged appropriate by the investigator and according to institutional guidelines and will include antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care will not include anti-neoplastic chemotherapy.
Interventions: intervention 1: Best supportive care intervention 2: Panitumumab
Intervention descriptions: intervention 1: Best supportive care as site routine excluding: antineoplastic chemotherapy, investigational agents, anti-EGFr(Epidermal growth factor receptor) targeting agents other than ABX-EGF(Panitumumab), experimental or approved anti-tumor therapies (e.g. Avastin), chemotherapy, radiotherapy (with the exception of radiotherapy for pain control limited to bone metastases). intervention 2: Intravenous infusion at a dose of 6 mg/kg once every 2 weeks.

Protocol documents:
Clinical trial NCT00139737
Conditions: Schizophrenia
Keywords: Open-label extension Ziprasidone study in Schizophrenia
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2002-03-01; Completion date: 2009-06-01
Enrollment: 344 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To provide treatment to eligible subjects who have successfully completed one of the following phase III ziprasidone studies, A1281028, A1281044, A1281045 (NCT00136994) or A1281088 (NCT00143351).

Detailed description:

Interventions: intervention 1: Ziprasidone
Intervention descriptions: intervention 1: 20mg capsules BID, 40mg capsules BID, 60mg BID or 80mg BID until drug commercialisation in Italy.

Protocol documents:
Clinical trial NCT00451906
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Sponsor: Hoffmann-La Roche
Start date: 2006-08-01; Completion date: 2009-06-01
Enrollment: 2252 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will assess the safety and efficacy of Avastin combined with platinum-containing chemotherapy regimens in patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC). Avastin will be given as first-line treatment in combination with platinum-based chemotherapy or in combination with any standard of care NSCLC first-line chemotherapy used in line with the licensed national prescribing information. Eligible patients will receive Avastin (15mg/kg iv on day 1 of each 3 week cycle) concomitantly with chemotherapy. Avastin treatment will continue after completion of chemotherapy cycles until disease progression, and the target sample size is 500+ individuals.

Detailed description:

Arms: arm 1: Participants with advanced or recurrent NSCLC will be administered bevacizumab infusions at a dose of 7.5 milligram per kilogram (mg/kg) or 15 mg/kg (investigator's choice) on Day 1 and then every 3 weeks, intravenously (IV) for a maximum of 6 cycles in combination with the standard of care NSCLC first-line chemotherapy in line with the licensed national prescribing information, during the treatment period. The initial dose of bevacizumab will be administered following chemotherapy; all subsequent doses could be given before or after chemotherapy.
Interventions: intervention 1: Platinum-based chemotherapy intervention 2: Bevacizumab [Avastin]
Intervention descriptions: intervention 1: As prescribed intervention 2: 15 mg/kg IV on Day 1 of each 3 week cycle

Protocol documents:
Clinical trial NCT00478205
Conditions: Alzheimer's Disease
Keywords: Moderate to Severe Alzheimer's Disease
Sponsor: Eisai Inc.
Start date: 2007-06-01; Completion date: 2009-06-01
Enrollment: 1467 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare 23 mg donepezil sustained release (SR) to the currently marketed formulation of 10 mg donepezil immediate release (IR) in patients with moderate to severe Alzheimer's disease.

Detailed description:
This study consists of a double-blind, double-dummy, parallel-group comparison of 23 mg donepezil SR with the currently marketed donepezil formulation (10 mg donepezil IR) in patients with moderate to severe Alzheimer's disease. Patients must have been taking 10 mg IR (or a bioequivalent generic) for at least 3 months prior to Screening. The study will consist of 24 weeks of daily administration of study medication, with clinic visits at Screening, Baseline, 3 weeks (safety only), 6 weeks, 12 weeks, 18 weeks and 24 weeks or early termination. Patients will receive either 10 mg donepezil IR in combination with the placebo corresponding to 23 mg donepezil SR, or 23 mg donepezil SR in combination with the placebo corresponding to 10 mg donepezil IR.

A total of approximately 1600 patients will be enrolled to obtain complete data from approximately 1200 completed patients (Revised per Amendment 02). During the Baseline visit, patients will be randomized in a 2:1 ratio (23 mg donepezil SR to 10 mg donepezil IR). The study will be performed at approximately 200 global sites (Asia, Oceania, Europe, India, Israel, North America, South Africa, and South America) (Revised per Amendments 01 and 02). An Independent Data Monitoring Committee (IDMC) will be established to review safety aspects of the study and to evaluate the results of a planned interim analysis.

Patients who complete the study may be eligible to undergo evaluation for enrollment into the open-label extension study, E2020-G000-328.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Aricept (donepezil SR 23 mg) intervention 2: Aricept (donepezil IR 10 mg)
Intervention descriptions: intervention 1: Patients will receive study medication orally, once daily, for 24 weeks according to a double-dummy design:

23 mg donepezil SR concurrently with placebo identical in appearance to the 10 mg donepezil IR formulation. intervention 2: Patients will receive study medication orally, once daily, for 24 weeks according to a double-dummy design:

10 mg donepezil IR concurrently with placebo identical in appearance to the 23 mg donepezil SR formulation.

Protocol documents:
Clinical trial NCT00607087
Conditions: Diabetes Mellitus, Type 1
Sponsor: Sanofi
Start date: 2008-01-01; Completion date: 2009-06-01
Enrollment: 289 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Primary objective: To demonstrate the superiority of insulin glulisine over insulin aspart and insulin lispro administered by external pump in term of unexplained hyperglycemia and/or infusion set occlusion.

Main Secondary objectives:

To compare insulin glulisine, insulin aspart and insulin lispro on:

* Unexplained hyperglycemia
* Infusion set occlusion
* Hypoglycemic episodes,7-point blood glucose profiles
* Episodes of significant ketosis and/or risk level for impending diabetic ketoacidosis
* Time to change the infusion set
* HbA1c (Glycosylated hemoglobin)
* Overall safety: incidence of adverse events

Detailed description:
The maximal duration of the study participation for patients was 41 weeks and one day, split in:

* a 2-week screening period,
* a 39-week treatment period: 3 treatment periods of 13 weeks with a crossover alternative regimen, including a dose adjustment period of 1 week at the beginning of each period (sequence1: insulin glulisine, then insulin aspart, then insulin lispro; sequence2: insulin aspart, then insulin lispro, then insulin glulisine; sequence 3: insulin lispro, then insulin glulisine, then insulin aspart)
* and a follow-up period of 24 hours.

Arms: arm 1: sequence 1: insulin glulisine / insulin aspart / insulin lispro. arm 2: Sequence 2: insulin aspart / insulin lispro / insulin glulisine arm 3: Sequence 3: insulin lispro / insulin glulisine / insulin aspart
Interventions: intervention 1: Insulin glulisine intervention 2: Insulin lispro intervention 3: Insulin aspart
Intervention descriptions: intervention 1: 100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump intervention 2: 100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump intervention 3: 100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump

Protocol documents:
Clinical trial NCT00619359
Conditions: Chemotherapy-Induced Nausea and Vomiting (CINV)
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-02-01; Completion date: 2009-06-01
Enrollment: 2322 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the safety, tolerability, and efficacy of MK0517 to prevent Chemotherapy-Induced Nausea and Vomiting (CINV) associated with Cisplatin chemotherapy.

Detailed description:

Arms: arm 1: Arm 1: study medication arm 2: Arm 2: Active comparator
Interventions: intervention 1: Comparator: fosaprepitant dimeglumine intervention 2: Comparator: Aprepitant intervention 3: Dexamethasone intervention 4: Dexamethasone intervention 5: Ondansetron
Intervention descriptions: intervention 1: single IV dose of 150 mg of fosaprepitant dimeglumine on Day 1. intervention 2: Aprepitant 3-day dosing oral regimen (125 mg on Day 1 followed by 80 mg on Days 2 and 3). intervention 3: Oral dose of 12 mg of dexamethasone on Day 1, 8 mg on Day 2, and 8 mg twice a day on Days 3-4. intervention 4: Oral dose of 12 mg of dexamethasone on Day 1, and 8 mg on Days 2-4. intervention 5: single IV dose of 32 mg of ondansetron on Day 1.

Protocol documents:
Clinical trial NCT00797108
Conditions: Pneumonia, Bacterial
Sponsor: Pfizer
Start date: 2009-01-01; Completion date: 2009-06-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test if intravenous sulopenem and an oral drug, PF-03709270 are safe and effective in patients that are hospitalized with community acquired pneumonia.

Detailed description:

Arms: arm 1: Loading dose of IV sulopenem with switch to oral PF-03709270 arm 2: IV sulopenem with switch to oral PF-03709270 arm 3: IV ceftriaxone with switch to oral amoxicillin/clavulanate potassium comparator
Interventions: intervention 1: sulopenem and PF-03709270 intervention 2: Sulopenem and PF-03709270 intervention 3: Ceftriaxone and amoxicillin/clavulanate
Intervention descriptions: intervention 1: Sulopenem - 600 mg infused over 1 hour, single loading dose and switch to oral PF-03709270 - 1000 mg twice a day intervention 2: Sulopenem - 600 mg infused over 1 hour twice daily for a minimum of 2 days and switch to oral PF-03709270 - 1000 mg twice a day intervention 3: IV ceftriaxone (2g) infused over 30 minutes QD (once daily) for minimum of 2 days Step down oral amoxicillin/clavulanate potassium suspension (400 mg/5 ml) BID (every 12 hours)

Protocol documents:
Clinical trial NCT01030718
Conditions: Chronic Myelogenous Leukemia Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
Sponsor: Bristol-Myers Squibb
Start date: 2006-01-01; Completion date: 2009-06-01
Enrollment: 54 participants; Allocation: ; Intervention model: PARALLEL

Brief summary:
To assess the safety of dasatinib (BMS-354825) in subjects with Imatinib resistant or intolerant chronic myelogenous leukemia (CML) and Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL) who are resistant or intolerant to treatment and will continue study drug after completing the previous Phase I/II study (CA180031/NCT00337454)

Detailed description:

Arms: arm 1: CML - Chronic Phase arm 2: CML - Accelerated Phase and Blast Phase arm 3: Ph+ Acute Lymphoblastic Leukemia
Interventions: intervention 1: dasatinib
Intervention descriptions: intervention 1: Tablet, Oral, (50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID

Protocol documents:
Clinical trial NCT00004143
Conditions: Sickle Cell Anemia Severe Aplastic Anemia Paroxysmal Nocturnal Hemoglobinuria (PNH) Pure Red Cell Aplasia
Keywords: sickle cell anemia severe aplastic anemia
Sponsor: David Rizzieri, MD
Start date: 1999-09-01; Completion date: 2009-06-01
Enrollment: 2 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Although used primarily to treat malignant disorders of the blood, allogeneic stem cell transplantation can also cure a variety of non-cancerous, inherited or acquired disorders of the blood. Unfortunately, the conventional approach to allogeneic stem cell transplantation is a risky procedure. For some non-cancerous conditions, the risks of this procedure outweigh the potential benefits. This protocol is designed to test a new approach to allogeneic stem cell transplantation. It is hoped that this approach will be better suited for patients with non-cancerous blood and bone marrow disorders.

Detailed description:
OBJECTIVES:

Primary Objective(s):

1. Evaluate the feasibility in terms of mortality, occurrence of acute graft versus host disease, and grades 3-4/4 toxicity of in vivo and in vitro Campath coupled with concomitantly administered nonmyeloablative fludarabine, cyclophosphamide and total body irradiation (TBI) followed by Human Leukocyte Antigen (HLA) 5-6/6 matched family member allo peripheral blood stem cell transplant (PBSCT).
2. Evaluate the engraftment rate of HLA 5-6/6 matched family member patients who receive in vivo Campath followed by concomitantly administered fludarabine, cyclophosphamide and total body irradiation (TBI) as a conditioning regimen with Campath-treated peripheral blood stem cells (in vitro and in vivo exposure).

Secondary Objective(s):

1. Evaluate the response rate and survival of patients who receive a non-myeloablative conditioning regimen of in vivo Campath followed by concomitantly administered fludarabine, cyclophosphamide and total body irradiation (TBI) with Campath-treated peripheral blood stem cells.
2. Evaluate the recovery of immune function post engraftment with this regimen.

Arms: arm 1: Campath, Chemo and/or TBI Allo SCT arm 2: Campath, Chemo and/or TBI Allo SCT
Interventions: intervention 1: Campath, Chemo and/or TBI Allo SCT
Intervention descriptions: intervention 1: Allogeneic PBSC/marrow will be collected/harvested from the donor after granulocyte colony-stimulating factor (G-CSF) priming. The allogeneic PBSCs will be infused as per current institutional practice.

Protocol documents:
Clinical trial NCT00043550
Conditions: Depression
Keywords: Major Depressive Disorder
Sponsor: University of Pennsylvania
Start date: 2001-11-01; Completion date: 2009-06-01
Enrollment: 156 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 4-8 month study, with a 2-year follow up period, will compare sertraline (Zoloft®), venlafaxine (Effexor®), supportive-expressive psychotherapy, and placebo to determine which is more effective in treating major depression.

Detailed description:
MDD is one of the most prevalent psychiatric disorders. Different forms of psychotherapy for depression have been found effective. This study compares a form of dynamic psychotherapy called supportive-expressive psychotherapy to medication and to placebo.

Participants are evaluated on 2 occasions, 1 week apart, before they are randomly assigned to receive either supportive-expressive psychotherapy, sertraline (Zoloft) (followed by venlafaxine \[Effexor\] if patients do not respond to sertraline), or placebo. The active phase of treatment lasts 4 months. The frequency of patients' visits depends on the assigned treatment.

Patients who are randomized to receive medication or placebo are initially seen on a weekly basis, then less often, depending on the rate of symptomatic improvement. Patients who are randomized to psychotherapy are seen twice a week for the first 4 weeks, then once a week for the remaining 12 weeks. Outcome is monitored at week 2,4,6,7,8, 12, 15 and 16. At the end of the first 16 weeks of treatment, patients are thoroughly evaluated. Those who have responded to treatment are assigned to a continuation phase and are seen once a month for another 16 weeks. At the end of the 16-week continuation phase, patients are again evaluated and all treatments are stopped. Follow-up continues every 3 months for up to 2 years to ensure that the patients' depression remains under control.

Arms: arm 1: Participants receive sertraline for the first 8 weeks. Participants will receive venlafaxine if they do not respond to sertraline by week 8 arm 2: Participants will receive supportive-expressive psychotherapy. arm 3: Participants receive placebo.
Interventions: intervention 1: Supportive Expressive Therapy intervention 2: Sertraline intervention 3: Pill Placebo intervention 4: Venlafaxine
Intervention descriptions: intervention 1: The aim of supportive-expressive psychotherapy is to help patients understand the causes of relationship conflicts in the context of a supportive relationship. intervention 2: Participants will receive sertraline. intervention 3: Participants will receive a pill placebo. intervention 4: Participants will receive venlafaxine.

Protocol documents: