ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00282347
Conditions: Lupus Nephritis
Keywords: Class IV LN Lupus LUNAR LN
Sponsor: Genentech, Inc.
Start date: 2006-01-01; Completion date: 2013-01-01
Enrollment: 144 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a Phase III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of rituximab in combination with mycophenolate mofetil (MMF) compared with placebo in combination with MMF in subjects diagnosed with International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 Class III or IV lupus nephritis.

Detailed description:
In addition to receiving study drug (rituximab or placebo), participants in each treatment group received mycophenolate mofetil at a starting dose of 1500 mg/day IV in 3 divided doses and were titrated up by 500 mg/week to 3000 mg/day by Week 4, as tolerated. Participants in each treatment group also received methylprednisolone 1000 mg IV prior to and 3 days following the first study drug infusion and methylprednisolone 100 mg IV prior to the other study drug infusions. Participants in each treatment group also received diphenhydramine 50 mg orally and acetaminophen 1000 mg orally 30-60 minutes prior to each study drug infusion. From Days 2 to 16, participants in each treatment group received prednisone 0.75 mg/kg/day orally (maximum dose of 60 mg) except on the day of the second methylprednisolone dose. On Day 16, a taper was initiated to achieve a dose of 10 mg/day by Week 16.

Arms: arm 1: Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details. arm 2: Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
Interventions: intervention 1: Rituximab intervention 2: Placebo intervention 3: Mycophenolate mofetil intervention 4: Methylprednisolone intervention 5: Diphenhydramine intervention 6: Acetaminophen intervention 7: Prednisone
Intervention descriptions: intervention 1: Rituximab was provided as a sterile solution for injection. intervention 2: Placebo was provided as a sterile solution for injection. intervention 3: None intervention 4: None intervention 5: None intervention 6: None intervention 7: None

Protocol documents:
Clinical trial NCT00368290
Conditions: Cocaine Dependence
Keywords: cocaine dependence hiv prevention
Sponsor: Kyle Kampman
Start date: 2006-09-01; Completion date: 2013-01-01
Enrollment: 94 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of study is to determine if modafinil promotes cocaine abstinence and reduces high risk behavior in cocaine dependent subjects.

Detailed description:
The purpose of study is to determine if modafinil promotes cocaine abstinence and reduces HRB in cocaine dependent subjects. Modafinil (300 mg/day) or placebo will be administered in an 8-week double-blind trial to patients meeting diagnostic criteria for cocaine dependence in conjunction with Cognitive Behavioral Therapy (CBT).

Arms: arm 1: modafinil plus CBT arm 2: placebo plus CBT
Interventions: intervention 1: Modafinil intervention 2: placebo intervention 3: Cognitive Behavioral Therapy (CBT)
Intervention descriptions: intervention 1: 300mg a day for 8 weeks intervention 2: placebo pills for 8 weeks intervention 3: Weekly cognitive behavioral therapy sessions for a period of 8 weeks.

Protocol documents:
Clinical trial NCT00369915
Conditions: Unipolar Depression Bipolar Depression
Keywords: Cholinergic Unipolar Bipolar Depression Muscarinic Scopolamine Major Depressive Disorder MDD Bipolar Disorder BP
Sponsor: National Institute of Mental Health (NIMH)
Start date: 2006-08-01; Completion date: 2013-01-01
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
A previous study showed that the intravenous administration of scopolamine produces antidepressant effects. This study is designed to determine if other routes of administration of scopolamine produce antidepressant effects.

Detailed description:
Despite the availability of a wide range of antidepressant drugs, clinical trials indicate that 30% to 40% of patients with major depression fail to respond to first-line antidepressant treatment, despite adequate dosage, duration, and compliance. Moreover, in those patients who do experience symptomatic relief following conventional anti-depressant treatment, clinical improvement is not evident for 3-4 weeks. Thus, there is a clear need to develop novel and improved therapeutics for unipolar and bipolar depression.

The cholinergic system is one of the neurotransmitter systems implicated in the pathophysiology of mood disorders. Evidence suggests that during major depressive episodes, the cholinergic system is hypersensitive to acetylcholine. Agents that enhance muscarinic cholinergic receptor function increase depressive symptoms in depressed subjects, and can produce symptoms of depression in healthy individuals. The preclinical literature more specifically implicates the muscarinic receptors and indicates that the use of muscarinic antagonists, in the context of animal models of depression, results in improvement in the behavioral analogs of depression.

Preliminary results obtained under protocol 3-M-0108 provide strong evidence for the potential effectiveness of the anticholinergic scopolamine in rapidly producing clinically significant antidepressant effects. We observed large reductions in Montgomery-Asberg Depression Rating Scale (MADRS) scores that occurred over hours/days following i.v. infusion of scopolamine, which stood in marked contrast to the 3-4 week period generally required for conventional therapies. Moreover, these improvements were observed in subjects who had been nonresponsive or incompletely responsive to conventional antidepressant therapies, highlighting the potential for this treatment to benefit a larger percentage of individuals with depression. The goal of this research project is to perform a clinical trial to evaluate the efficacy of the muscarinic cholinergic receptor antagonist scopolamine administered via transdermal patch on clinical symptoms of depression.

Arms: arm 1: Placebo then scopolamine arm 2: Scopolamine then placebo
Interventions: intervention 1: Scopolamine intervention 2: Scopolamine
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00378014
Conditions: Liver Transplantation
Keywords: Liver transplantation, everolimus, CNI
Sponsor: Novartis Pharmaceuticals
Start date: 2006-08-01; Completion date: 2013-01-01
Enrollment: 276 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is designed to show that everolimus initiation together with reduction and thereafter discontinuation of calcineurin inhibitor (CNI) will improve significantly renal function in de novo liver transplant recipients as compared to continuation of CNI-based treatment.

Detailed description:

Arms: arm 1: Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice arm 2: Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
Interventions: intervention 1: everolimus intervention 2: basiliximab intervention 3: CNI
Intervention descriptions: intervention 1: Start dose of everolimus was 1.5 mg in the morning followed by 1.5 mg in the evening. After one week, the dose was adjusted to achieve trough levels between 5-12 ng/mL. Once trough levels were above 5ng/mL, the CNI dose was reduced to 70%. At week 8 post-baseline (latest at week 16 post baseline), CNI was completely discontinued. For patients receiving Ciclosporin A (CiA) as CNI, the everolimus dosage was adjusted to achieve a trough level of 8-12 ng/mL, prior to discontinuation of CiA. After discontinuation of CNI, everolimus was maintained at a trough level of 5-12 ng/mL. intervention 2: All patients who met the eligibility criteria were treated with 2 doses of basiliximab on Day 0 (transplantation) and Day 4. intervention 3: Patients who met the screening eligibility received CNI-based immunosuppressive therapy for 1 month. Then at week 4 (or week 8 at maximum), patients randomized to the CNI arm continued on CNI-based immunosuppressive therapy.

Protocol documents:
Clinical trial NCT00429169
Conditions: Depression
Keywords: Major Depressive Disorder MDD
Sponsor: New York State Psychiatric Institute
Start date: 2004-06-01; Completion date: 2013-01-01
Enrollment: 101 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary study comparing effectiveness for suicidal ideation and/or behavior of two antidepressant medications in depressed patients who have attempted suicide or are currently experiencing suicidal thoughts has been completed.

A secondary study component using functional magnetic resonance imaging (fMRI) to investigate different medication effects on reward processing in the same sample is ongoing.

Detailed description:
Major depressive disorder (MDD) is a common and serious psychiatric illness. It is among the leading causes of disability and is the psychiatric disorder most often associated with suicide. The treatment of MDD with antidepressant medication remains largely trial and error. Little empirical evidence exists to guide the treatment of MDD when suicide risk is a major factor. Selective serotonin reuptake inhibitors (SSRIs) are a type of antidepressant medication that works by increasing the amount of serotonin, a natural substance in the brain that helps maintain mental balance. The study compared the effectiveness of paroxetine, an SSRI, versus bupropion, a non-SSRI, on suicidal ideation and/or behavior in depressed patients with a past suicide attempt and/or current suicidal thoughts. Results of the completed primary study have been published (Grunebaum MF et al. Neuropsychopharmacology. 2012 Feb;37(3):697-706).

In the ongoing secondary neuro-imaging component of the study, Participants are randomly assigned to either paroxetine or bupropion treatment for 8 weeks with fMRI scans involving a reward processing task at baseline and Week 8. Weekly study visits include interviews with a psychologist, self-report scales, and medication monitoring. All participants will then be offered 4 additional months of open clinical treatment. If original medication assignments prove to be ineffective, participants will have the option to switch to another medication. After completing the study, participants will be referred for ongoing treatment.

Arms: arm 1: Participants will receive paroxetine for 8 weeks arm 2: Participants will receive bupropion for 8 weeks
Interventions: intervention 1: Paroxetine intervention 2: Bupropion
Intervention descriptions: intervention 1: Dosage will be 25 mg every day for 2 weeks, then 37.5 mg every day for 2 weeks, and then optional increase to 50 mg every day for the remainder of treatment. intervention 2: Dosage will be 150 mg every day for 2 weeks, then 300 mg every day for 2 weeks, and then optional increase to 450 mg every day for the remainder of treatment.

Protocol documents:
Clinical trial NCT00439270
Conditions: Metastatic Prostate Cancer
Keywords: Metastatic hormone refractory prostate cancer
Sponsor: Bristol-Myers Squibb
Start date: 2007-07-01; Completion date: 2013-01-01
Enrollment: 49 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to find the recommended doses of dasatinib and docetaxel given in combination to men with metastatic hormone refractory prostate cancer and to assess the pharmacokinetic interactions between the 2 drugs.

Detailed description:

Arms: arm 1: Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m\^2. arm 2: Participants received dasatinib, 50 mg administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. arm 3: Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. arm 4: Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. arm 5: Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.
Interventions: intervention 1: Dasatinib intervention 2: Docetaxel
Intervention descriptions: intervention 1: Tablets, Oral, 50, 70, 100, or 120 mg once daily; treatment may continue until disease progression intervention 2: Infusion, 60 or 75 mg/m\^2, administered every 3 weeks.

Protocol documents:
Clinical trial NCT00456599
Conditions: Pancreatic Cancer
Sponsor: University of Michigan Rogel Cancer Center
Start date: 2007-04-01; Completion date: 2013-01-01
Enrollment: 71 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will examine a sequence of treatments including pre-operative chemotherapy and radiation, surgery and post-operative chemotherapy for resectable pancreatic cancer.

Detailed description:
This study will examine a sequence of treatments including pre-operative chemotherapy and radiation, surgery and post-operative chemotherapy for resectable pancreatic cancer. This research treatment will evaluate the combination of two chemotherapy agents, oxaliplatin and gemcitabine with radiation therapy. The researchers have already done studies using oxaliplatin, gemcitabine and radiation therapy together for pancreatic cancer. They want to build on the information they have from this previous research and do the research at multiple sites. They will use this study to determine how well people do who are treated with gemcitabine, oxaliplatin, and radiation therapy prior to having surgery for their pancreatic cancer. The researchers will also gather more information about what type of side effects occur with this treatment.

Arms: arm 1: This study will examine a sequence of treatments including pre-operative chemotherapy and radiation, surgery and post-operative chemotherapy for resectable pancreatic cancer.
Interventions: intervention 1: gemcitabine intervention 2: oxaliplatin intervention 3: Radiation
Intervention descriptions: intervention 1: Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1, 8, and 15 of a treatment cycle. intervention 2: Oxaliplatin 85mg/m2 will be infused following gemcitabine over approximately 90 minutes on days 1 and 15 of a treatment cycle. intervention 3: The total dose in a three week treatment block will be 30 Gy in 2.0 Gy fractions.

Protocol documents:
Clinical trial NCT00479557
Conditions: Alzheimer Disease
Keywords: Alzheimer's Disease active immunization
Sponsor: Pfizer
Start date: 2007-05-01; Completion date: 2013-01-01
Enrollment: 86 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization, in patients with mild to moderate Alzheimer's disease.

Detailed description:

Arms: arm 1: arm 1: ACC-001 (Vanutide Cridificar)+ QS-21 arm 2: arm 2: ACC-001 arm 3: arm 3: QS-21 arm 4: Drug: Phosphate Buffered Saline (PBS)
Interventions: intervention 1: ACC-001 + QS-21 intervention 2: ACC-001 intervention 3: QS-21 intervention 4: Placebo: Phosphate buffered saline
Intervention descriptions: intervention 1: Vanutide Cridificar (3, 10, 30µg) + QS-21 (50µg), IM on day 1, month 1, month 3, month 6 and month 12 intervention 2: Vanutide Cridificar (10, 30µg), IM on day 1, month 1, month 3, month 6 and month 12 intervention 3: QS-21 (50µg), IM on day 1, month 1, month 3, month 6 and month 12 intervention 4: Phosphate buffered Saline (pH : 7.4), IM on day 1, month 1, month 3, month 6 and month 12

Protocol documents:
Clinical trial NCT00492921
Conditions: Graft Versus Host Disease
Keywords: graft versus host disease
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Start date: 2007-05-01; Completion date: 2013-01-01
Enrollment: 12 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
RATIONALE: High-dose cyclophosphamide may be an effective treatment for acute graft-versus-host disease that did not respond to steroid therapy.

PURPOSE: This phase II trial is studying the side effects, best dose, and how well high-dose cyclophosphamide works in treating patients with acute graft-versus-host disease that did not respond to steroid therapy.

Detailed description:
OBJECTIVES:

* Determine the maximum tolerated dose of high-dose cyclophosphamide in patients with steroid refractory acute graft-versus-host disease (GVHD).
* Determine the efficacy of this regimen at 28 days post-treatment in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive high-dose cyclophosphamide once daily for 1-4 days beginning on day 1 and filgrastim (G-CSF) subcutaneously once daily beginning on day 10 and continuing until blood counts recover.

Cohorts of 3-6 patients receive escalating doses of high-dose cyclophosphamide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

After completion of study treatment, patients are followed weekly for 4 weeks.

Arms: arm 1: Treatment with cyclophosphamide 50 mg/kg/d x 1 days. arm 2: Treatment with cyclophosphamide 50 mg/kg/d x 2 days. arm 3: Treatment with cyclophosphamide 50 mg/kg/d x 3 days.
Interventions: intervention 1: Cyclophosphamide
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00537290
Conditions: Antiphospholipid Syndrome
Keywords: antiphospholipid syndrome
Sponsor: Hospital for Special Surgery, New York
Start date: 2007-09-01; Completion date: 2013-01-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RITuximab AntiphosPholipid Syndrome (RITAPS) Study is designed to evaluate whether a medication called rituximab would reduce the signs and symptoms of antiphospholipid antibody (aPL) -related certain clinical problems.

Detailed description:
Persistently antiphospholipid antibody (aPL)-positive patients, age 18 - 75 years of age, with anticoagulation-resistant manifestations of APS and fulfilling protocol defined study inclusion criteria will receive two doses of Rituximab, and will be followed for 6 and 12 months for clinical and safety outcomes, respectively.

Patients are eligible to take part in this study if their blood test is persistently positive for aPL and they have one or more of the aPL-related clinical problem(s) listed below: low platelet (blood cells involved in the prevention of bleeding) count; anemia (deficiency of red blood cells); heart valve disease; skin ulcers; kidney smal vessel blood clots; and/or memory problems.

Arms: arm 1: All patients will receive 1000 milligrams of rituximab by intravenous infusion on Days 1 and 15.
Interventions: intervention 1: Rituximab
Intervention descriptions: intervention 1: Rituximab 1000mg IV on Days 0 and 15

Protocol documents:
Clinical trial NCT00541099
Conditions: Lung Cancer
Keywords: stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer
Sponsor: Barbara Ann Karmanos Cancer Institute
Start date: 2008-01-01; Completion date: 2013-01-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as docetaxel, also work in different ways to kill tumor cells or stop them from growing. Giving bevacizumab together with docetaxel may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving bevacizumab together with docetaxel works in treating older patients with stage III or stage IV non-small cell lung cancer.

Detailed description:
OBJECTIVES:

Primary

* To determine the proportion of elderly (≥ 75 years of age) patients with stage III or IV non-small cell lung cancer surviving for at least 6 months when treated with a combination of bevacizumab and weekly docetaxel.

Secondary

* To assess the progression-free and overall survival of patients treated with this regimen.
* To determine the response rate in patients treated with this regimen.
* To assess the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and docetaxel IV on days 1, 8, and 15. Treatment may repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for 4 weeks.

Arms: arm 1: Avastin 10.0 mg/kg on days 1 and 15; Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel; Docetaxel 35 mg/m2 on day 1, 8, 15
Interventions: intervention 1: bevacizumab intervention 2: docetaxel
Intervention descriptions: intervention 1: Avastin 10.0 mg/kg on days 1 and 15 intervention 2: Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15

Protocol documents: