ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00149890
Conditions: Liver Transplantation Infection
Keywords: pediatric liver transplantation Simulect Basiliximab ciclosporin microemulsion steroid reduction pediatric liver transplantation
Sponsor: Novartis
Start date: 2004-03-01; Completion date: 2009-03-01
Enrollment: 77 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Systemic infection is still a major concern in young children with liver transplantation. The approach of this study is to reduce the risk of systemic infections by avoiding intraoperative steroids (another class of immunosuppressive drugs) given in combination with basiliximab, cyclosporine and steroids in pediatric de novo liver transplant recipients. The treatment is compared to the same treatment regimen including intraoperative steroids with respect to rejection episodes.

Detailed description:

Arms: arm 1: Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was \<35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft. arm 2: No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was \<35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
Interventions: intervention 1: Basiliximab intervention 2: Cyclosporine/cyclosporine microemulsion intervention 3: Steroid
Intervention descriptions: intervention 1: Basiliximab (10 mg) was supplied as a lyophilisate in vials with ampoules of sterile water for injection (5 mL) and had to be given of 10 mg (body weight \<35 kg) or 20 mg (body weight ≥35 kg) strength. intervention 2: Cyclosporine/cyclosporine microemulsion had to be started with 100 mg/m²/day intravenous (i.v) (2x4h) for 7 days and was to be continued i.v. or orally from day 8 onwards as per center practice. During the 6 months treatment period Cyclosporine doses had to be adjusted according to Cyclosporine A (CsA)-trough levels. intervention 3: Intravenous prednisolone (loading dose: 300 mg/m2, maximum 500 mg) had to be administered intraoperatively only in treatment arm 1 (day 0). The first dose of steroids in treatment arm 2 (day 0) had to be administered within 8 hours after reperfusion of the graft. Beginning from day 1 to day 6 doses of 15 mg/m2/day had to be given intravenously (i.v.) in both treatment arms. Then, the steroid doses (oral prednisone or its equivalent) were to be decreased from 10 mg/m²/day orally (day 7-13), to 7.5 mg/m²/day orally (day 14-30), to 4 mg/m²/day orally (until end of month 2), to 2.5 mg/m²/day orally (until end of month 3) and to 1 mg/m²/day orally (until end of month 6).

Protocol documents:
Clinical trial NCT00153842
Conditions: Carcinoma, Non-small-cell Lung
Keywords: NSCLC Bexarotene Targretin
Sponsor: Dartmouth-Hitchcock Medical Center
Start date: 2001-08-01; Completion date: 2009-03-01
Enrollment: 33 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary aim is to evaluate the safety (Phase I components) of administering bexarotene (Targretin®, LGD1069) oral capsules in combination with two Taxol® and carboplatin (Paraplatin®) schedules to patients with stage IIIB and IV non-small cell lung cancer. This study will also evaluate the preliminary efficacy (Phase II component) of bexarotene oral capsules in combination with the weekly Taxol® schedule and carboplatin in these patients.

Detailed description:
The phase I portion of the study will evaluate the safety of administering bexarotene oral capsules daily at two dose levels (300 mg/m2 and 400 mg/m2) in combination with carboplatin and Taxol®. At least 6 patients will be entered onto each dose level. Doses will not be escalated over the course of treatment of an individual patient. The recommended Phase II dose is defined as the highest dose of bexarotene oral capsules (300 mg/m2 or 400 mg/m2) in combination with carboplatin and Taxol® that induces DLT in fewer than or equal to 33% of patients.

The sequential phase II portion of the study will evaluate the efficacy of bexarotene oral capsules in combination with carboplatin and weekly Taxol® in patients with advanced non-small cell lung cancer. The efficacy will be gauged according to the rate of major response where, by definition, a major response occurs if a patient achieves either complete remission (CR) or partial remission (PR). For these patients a true response rate of 20% or greater is sufficiently large to warrant further investigation. A true response rate of 10% or less indicates that the combination is less active.

Arms: arm 1: Bexarotene oral capsules will be administered daily beginning on the initial day of chemotherapy (day 1).
Interventions: intervention 1: Bexarotene (targretin) intervention 2: Bexarotene (targretin)
Intervention descriptions: intervention 1: Bexarotene oral capsules will be administered daily beginning on the initial day of chemotherapy (day 1).

Level 1: 300 mg intervention 2: Bexarotene oral capsules will be administered daily beginning on the intitial day of chemotherapy (Day 1).

Level 2: 400 mg

Protocol documents:
Clinical trial NCT00156247
Conditions: Psoriasis
Keywords: psoriasis etanercept acitretin
Sponsor: University of Medicine and Dentistry of New Jersey
Start date: 2005-09-01; Completion date: 2009-03-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To determine whether acitretin plus etanercept is more effective than etanercept alone in clearing psoriasis plaques in adults.

Detailed description:
This study will include patients with moderate to severe psoriasis who have been taking etanercept 50 mg/week for at least 3 months (12 weeks) and have not achieved PASI 75. They will be given acitretin 25 mg/day. The combined treatment will occur over 6 months. Subjects' progress will be assessed monthly, based on the improvement of their PASI and PGA scores.

Arms: arm 1: open-label
Interventions: intervention 1: acitretin
Intervention descriptions: intervention 1: Patients who have been taking etanercept 50 mg/week for at least 3 months (12 weeks) will take acitretin 25 mg pill once daily for 6 months.

Protocol documents:
Clinical trial NCT00176878
Conditions: Diamond-Blackfan Anemia Kostmann's Neutropenia Shwachman-Diamond Syndrome
Keywords: Stem cell transplant T-cell depletion TLI bone marrow failure disorders
Sponsor: Masonic Cancer Center, University of Minnesota
Start date: 2000-06-01; Completion date: 2009-03-01
Enrollment: 10 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The researchers hypothesize that it will be possible to perform unrelated bone marrow or cord blood transplants in a safer manner by using less intensive therapy yet still achieve an acceptable level of donor cell engraftment for non-malignant congenital bone marrow failure disorders.

Detailed description:
Prior to transplantation, subjects will receive the drugs busulfan (orally or through the catheter), as well as fludarabine and anti-thymocyte globulin (ATG) via the catheter. Busulfan, fludarabine and ATG will be given with Total Lymphoid Irradiation (TLI) to help the new donor bone marrow take and grow after transplantation.

Those patients receiving donor marrow will have the T cells (a type of white blood cell in the donor marrow) removed to lower the risk that the new marrow will react to their body, a condition called Graft-Versus-Host-Disease (GVHD). After bone marrow transplantation, subjects will receive drugs to help prevent GVHD, including cyclosporin and mycophenolate mofetil (MMF).

Blood samples are taken at day 28, day 60, day 100, 1 year and as required by medical status yearly for five years after transplant to evaluate how well the new marrow is growing. A bone marrow biopsy is required at day 21, at day 100 and 1 year.

Arms: arm 1: Patients with Diamond-Blackfan Anemia, Kostmann's Neutropenia, Shwachman-Diamond Syndrome
Interventions: intervention 1: Stem cell transplant intervention 2: Fludarabine monophosphate intervention 3: Total lymphoid irradiation intervention 4: Busulfan intervention 5: anti-thymocyte globulin
Intervention descriptions: intervention 1: Stem cell transplant on Day 0 - healthy marrow from an unrelated individual. A minimum of 1.0 x 10\^9/kg nucleated cells/kg ideal body weight will be collected with a goal of 2.0 x 10\^9/kg. intervention 2: fludarabine 175 mg/m\^2 (total) on Days -6 through -3. intervention 3: Dose 500 cGy radiation therapy to specific areas of the body intervention 4: Busulfan 8 mg/kg (total) on Days - 8 and -7 (orally or through the catheter), intervention 5: anti-thymocyte globulin (ATG) 15 mg/kg on days -2 and -1 via catheter

Protocol documents:
Clinical trial NCT00193050
Conditions: Breast Cancer
Sponsor: SCRI Development Innovations, LLC
Start date: 2001-11-01; Completion date: 2009-03-01
Enrollment: 110 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Treatment strategies that include induction chemotherapy have several potential advantages: early initiation of systemic chemotherapy, in vivo assessment of response, and down-staging of both the primary tumor and regional lymphatic metastases, making breast conservation an option for many. The aim of the present study is to determine the efficacy and toxicity of induction combination chemotherapy with the triplet, gemcitabine, epirubicin, and docetaxel, in patients with locally advanced or inflammatory breast cancer. Clearly, it is in the upfront treatment as well as in the adjuvant treatment of breast cancer, that effective new agents and combination of agents are likely to have the greatest potential impact.

Detailed description:
Upon determination of eligibility, all patients will be receive:

Gemcitabine + Epirubicin + Docetaxel

Arms: arm 1: In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles

Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed.

After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals.

After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines.
Interventions: intervention 1: Gemcitabine intervention 2: Epirubicin intervention 3: Docetaxel
Intervention descriptions: intervention 1: Gemcitabine intervention 2: Epirubicin intervention 3: Docetaxel

Protocol documents:
Clinical trial NCT00215137
Conditions: OCD
Keywords: OCD SSRI escitalopram relapse
Sponsor: Duke University
Start date: 2004-10-01; Completion date: 2009-03-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will determine the safety and effectiveness of escitalopram (Lexapro)in treating obsessive-compulsive disorder (OCD) symptoms.

Detailed description:
OCD is a chronic and disabling disorder for which Selective Serotonin Reuptake Inhibitor(SSRI) drugs can be effective. The purpose of this study is to evaluate the effects of an SSRI, escitalopram, in OCD patients.

This study will last 16 weeks and will comprise 2 phases. Phase 1 is an open label in which all participants will receive daily escitalopram for 8 weeks. Those who have responded to treatment at the end of the 8 weeks will be randomly assigned to either continue or discontinue their treatment for an additional 8 weeks. Those who do not respond to treatment at the end of Phase 1 will discontinue the study and be offered three free visits with a study clinician or referred elsewhere for treatment, based on the their preference. Study visits are made at baseline, and at Weeks 1, 2, 4, and 8 in Phase 1 and Weeks 12 and 16 in Phase 2.

Arms: arm 1: Fourteen patients who met criteria for the study were enrolled in the open-label phase. Thirteen of these patients completed the open-label phase, while one patient was terminated early due to side effects. arm 2: Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I \< 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7). arm 3: Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I \< 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7).
Interventions: intervention 1: escitalopram intervention 2: Placebo ( sugar pill)
Intervention descriptions: intervention 1: Open label Treatment: Escitalopram 10 mg/day for 1 week and then 20 mg /day for 7 weeks. Double Blind Treatment: Escitalopram 20 mg/day. intervention 2: Placebo Comparator in double.blind phase.

Protocol documents:
Clinical trial NCT00276380
Conditions: Stroke, Acute Neurological Impairment
Sponsor: Ipsen
Start date: 2003-02-01; Completion date: 2009-03-01
Enrollment: 204 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effectiveness of Tanakan® 240mg in association with Acetylsalicylic acid (325mg/day) in the recovery of neurological impairment following ischemic stroke.

Detailed description:

Arms: arm 1: EGb761® 240 milligrams (mg)/day for 6 months administered orally, in association with acetylsalicylic acid (325 mg/day).

The test treatment consists of 6 tablets/day. 2 tablets (each containing 40 mg EGb761®) taken orally with half a glass of water during 3 main meals. 1 tablet/day of acetylsalicylic acid during lunch. arm 2: 6 months, administered orally, in association with acetylsalicylic acid (325 mg/day).

The placebo consists of 6 tablets/day. 2 tablets taken orally with half a glass of water during 3 main meals. 1 tablet/day of acetylsalicylic acid during lunch.
Interventions: intervention 1: EGb761 intervention 2: Placebo intervention 3: Acetylsalicylic acid
Intervention descriptions: intervention 1: EGb761 (Tanakan) 40 mg tablets (2 tablets t.i.d. (3 times a day)) 240 mg/day for 6 months. intervention 2: Placebo 40 mg tablets (2 tablets t.i.d.) 240 mg/day for 6 months. intervention 3: Acetylsalicylic acid 325 mg/day (1 tablet once daily), for 6 months.

Protocol documents:
Clinical trial NCT00294762
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: NSCLC Erlotinib Tarceva Lung Cancer
Sponsor: OSI Pharmaceuticals
Start date: 2006-01-01; Completion date: 2009-03-01
Enrollment: 143 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This will be the first prospective study where patients will be selected on the basis of two measures of the epidermal growth factor receptor (EGFR) pathway. The study will assess prospectively the efficacy of erlotinib as a single agent or intercalated with chemotherapy in highly selected patients with EGFR overexpression and/or EGFR amplification.

Detailed description:

Arms: arm 1: 150 mg erlotinib daily arm 2: carboplatin AUC 6 on Day 1 to 21 days, paclitaxel 200 mg/m2 on Day 1 to 21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
Interventions: intervention 1: Tarceva intervention 2: carboplatin intervention 3: paclitaxel
Intervention descriptions: intervention 1: oral tablet intervention 2: IV intervention 3: IV

Protocol documents:
Clinical trial NCT00296374
Conditions: Diabetes Mellitus
Keywords: Hyperlipidemia Proteinuria Diabetes Mellitus
Sponsor: AstraZeneca
Start date: 2006-02-01; Completion date: 2009-03-01
Enrollment: 353 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effects of Crestor (rosuvastatin) and (Lipitor) atorvastatin on urinary protein excretion over 1 year in patients with Type 1 or 2 diabetes with moderate proteinuria and hypercholesterolaemia.

Detailed description:

Arms: arm 1: Rosuvastatin 10 mg arm 2: Rosuvastatin 40 mg arm 3: Atorvastatin 80 mg
Interventions: intervention 1: Rosuvastatin intervention 2: Rosuvastatin intervention 3: Atorvastatin
Intervention descriptions: intervention 1: 10 mg oral dose administered once daily for 52 weeks intervention 2: 20 mg oral dose administered once daily for 4 weeks followed by 40 mg oral dose administered once daily for 48 weeks intervention 3: 40 mg oral dose administered once daily for 4 weeks followed by 80 mg oral dose administered once daily for 48 weeks

Protocol documents:
Clinical trial NCT00308555
Conditions: Pain
Keywords: Cannabis Morphine Oxycodone Marijuana chronic pain
Sponsor: University of California, San Francisco
Start date: 2006-05-01; Completion date: 2009-03-01
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
We are conducting a study to assess whether smoking marijuana affects the safety of prescribed opioids in patients treated for chronic pain. This study will assess whether smoking cannabis affects the absorption, distribution, metabolism and excretion of widely used opioid analgesics. We propose to do this by investigating the effects of smoked cannabis in subjects prescribed morphine or oxycodone for chronic pain. We will also assess the clinical safety of cannabinoids and these opioids by monitoring the short-term side effects associated with combined therapy.

Detailed description:
Chronic pain conditions remain problematic, especially in patients with cancer. Although opioids are effective analgesics, dose-limiting side effects in the form of sedation, nausea and vomiting, and fear of dependence often limit their use at higher - and possibly more effective - doses. Of particular interest, however, is the potential for greater than additive analgesic effect of cannabinoids and opioids in combination that would allow for opioid analgesic effect to be achieved at lower dosages than are necessary alone, which could overcome problems with both tolerance and side effects for both drug classes. Unfortunately, safety data on the combination in humans does not exist at this time and needs to be obtained. As increasing numbers of patients with chronic pain may turn to cannabis to augment the effects of their opioid analgesics, data on potential pharmacokinetic interactions and clinical safety of the combinations should be evaluated in a controlled clinical research setting.

Arms: arm 1: None
Interventions: intervention 1: Cannabis
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00311402
Conditions: Cerebrovascular Accident
Sponsor: Boehringer Ingelheim
Start date: 2006-04-01; Completion date: 2009-03-01
Enrollment: 1295 participants; Allocation: ; Intervention model: PARALLEL

Brief summary:
Phase III study to compare the preventive effect of recurrent brain infarction and safety of Aggrenox (combination drug containing sustained-release dipyridamole 200 mg/acetylsalicylic acid 25 mg) twice daily vs. acetylsalicylic acid 81 mg once daily

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Aggrenox capsule intervention 2: Acetylsalicylic Acid (ASA)
Intervention descriptions: intervention 1: extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule, 2 capsules twice daily intervention 2: Acetylsalicylic Acid (ASA) 81 mg, 1 tablet once daily

Protocol documents:
Clinical trial NCT00316173
Conditions: Ovarian Cancer Neoplasms, Ovarian
Keywords: HYCAMTIN ovarian cancer recurrent relapsed carboplatin topotecan potentially platinum-sensitive
Sponsor: GlaxoSmithKline
Start date: 2005-03-01; Completion date: 2009-03-01
Enrollment: 77 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study was designed to find the most effective and safest doses of both HYCAMTIN and CARBOPLATIN that can be given for the treatment of ovarian cancer. This study may allow researchers to determine the effectiveness of combining HYCAMTIN and CARBOPLATIN.

Detailed description:

Arms: arm 1: HYCAMTIN at a dose of 2.0 - 2.5mg/m2 on Days 1 and 8 every 21 days followed by carboplatin at AUC 5 on Day 1, every 21 days
Interventions: intervention 1: topotecan intervention 2: CARBOPLATIN
Intervention descriptions: intervention 1: HYCAMTIN at a dose of 2.0 mg/m2 on Days 1 and 8 every 21 days followed by carboplatin at AUC 5 on Day 1 intervention 2: HYCAMTIN at a dose of 2.0 mg/m2 on Days 1 and 8 every 21 days followed by carboplatin at AUC 5 on Day 1

Protocol documents:
Clinical trial NCT00316225
Conditions: Non-small Cell Lung Cancer Mesothelioma Lung Neoplasms
Sponsor: Eli Lilly and Company
Start date: 2006-12-01; Completion date: 2009-03-01
Enrollment: 31 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will test the effects of pemetrexed on mesothelioma and non-small cell lung cancer patients with fluid around their lungs or abdomen.

Detailed description:

Arms: arm 1: Pemetrexed 500 mg/m\^2 intravenous (IV) every 21 days for 6 cycles
Interventions: intervention 1: pemetrexed
Intervention descriptions: intervention 1: 500 milligrams per meter squared (mg/m\^2) IV every 21 days for 6 cycles

Protocol documents:
Clinical trial NCT00360360
Conditions: Neoplasm, Unknown Primary
Keywords: Neoplasm, Unknown Primary
Sponsor: SCRI Development Innovations, LLC
Start date: 2006-07-01; Completion date: 2009-03-01
Enrollment: 60 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
We will evaluate the feasibility, toxicity, and effectiveness of combination chemotherapy (paclitaxel/carboplatin)plus combination targeted therapy (bevacizumab/erlotinib)in the first line treatment of patients with carcinoma of unknown primary site. There is limited experience with either bevacizumab or erlotinib in the treatment of cancers of unknown site but given the heterogeneous nature of the tumor, it is likely that inhibition of angiogenesis pathways and/or the EGFR pathway are effective strategies in at least a proportion.

Detailed description:
All eligible patients will receive:

* Bevacizumab 15mg/kg IV infusion,Day 1
* Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1
* Carboplatin AUC 6.0 IV Day 1
* Erlotinib 150 mg by mouth daily

The regimen will be repeated every 21 days for a total of 4 courses. Patients will be initially evaluated for response after completing 2 courses (6 weeks) of treatment. Patients with an objective tumor response or stable disease will continue treatment for another 2 courses. Patients will be re-evaluated after 4 courses and those with objective tumor response or stable disease will stop chemotherapy with paclitaxel/carboplatin and continue treatment with bevacizumab/erlotinib until tumor progression is documented for a maximum of 12 months. During treatment with bevacizumab/erlotinib response will be evaluated every 12 weeks.

Arms: arm 1: Bevacizumab 15mg/kg IV infusion,Day 1 Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1 Carboplatin AUC 6.0 IV Day 1 Erlotinib 150 mg by mouth daily
Interventions: intervention 1: paclitaxel intervention 2: carboplatin intervention 3: bevacizumab intervention 4: erlotinib
Intervention descriptions: intervention 1: Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1 intervention 2: Carboplatin AUC 6.0 IV Day 1 intervention 3: Bevacizumab 15mg/kg IV infusion,Day 1 intervention 4: Erlotinib 150 mg by mouth daily

Protocol documents: