ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01056510
Conditions: Lymphocytic Leukemia, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2010-03-01; Completion date: 2014-03-01
Enrollment: 357 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized, open-label, parallel group study will assess the effect on response rate and the safety of MabThera added to either bendamustine or chlorambucil in patients with chronic lymphocytic leukemia. Patients will be randomized to receive six 4-week cycles of either A) MabThera (375mg/m2 iv day 1 of cycle 1, 500mg/m2 iv cycles 2-6) plus bendamustine (90mg/m2 as first-line or 70mg/m2 as second-line therapy, iv on days 1 and 2, cycles 1-6), or B)MabThera plus chlorambucil (10mg/m2 po daily, days 1-7, cycles 1-6). Patients in group B can receive up to 6 further cycles of chlorambucil as monotherapy. Anticipated time on study treatment is 6-12 months, and target sample size is 600-700 individuals.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: bendamustine intervention 2: chlorambucil intervention 3: rituximab [MabThera/Rituxan]
Intervention descriptions: intervention 1: 90mg/m2 (first-line) or 70mg/m2 (second-line) iv, days 1 and 2 every 4 weeks, cycles 1-6 intervention 2: 10mg/m2 po days 1-7 every 4 weeks, for up to 12 cycles intervention 3: 375mg/m2 iv day 1 of cycle 1, followed by 500mg/m2 iv every 4 weeks cycles 2-6

Protocol documents:
Clinical trial NCT01403064
Conditions: Oral Mucositis
Keywords: Oral mucositis; head and neck cancer; chemotherapy; radiotherapy
Sponsor: CSL Behring
Start date: 2011-07-01; Completion date: 2014-03-01
Enrollment: 76 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of ALD518 in modifying the course of oral mucositis in subjects with head and neck cancer receiving concomitant chemotherapy and radiotherapy

Detailed description:
This was a Phase 2, placebo-controlled, double-blind study in subjects newly diagnosed with head and neck cancer (who had not received previous treatment for oral mucositis) and who were receiving concomitant chemotherapy and radiotherapy. Subject eligibility, including tumor staging, was assessed during the screening period, which was to occur within 30 days prior to the initiation of radiation therapy. The radiation therapy treatment period was approximately 7 weeks, depending on the subject's prescribed radiation plan. Prior to the randomized portion of the trial, the first 7 subjects enrolled in the study entered a safety run-in evaluation and received a total of 2 doses of open-label clazakizumab 160 mg IV, 4 weeks apart (Day 0 and Week 4 of radiation); these subjects were not eligible for the randomized portion of the study. Subsequent to completion of the safety run-in, eligible subjects were randomized 1:1:1 to treatment with 2 doses of clazakizumab 160 mg, or clazakizumab 320 mg, or placebo, administered IV 3 weeks apart (Day 0 and Week 3 of radiation therapy). All subjects were to be followed for 4 weeks post last day of radiotherapy treatment for the primary efficacy and safety assessments and then for up to an additional 12 months of long-term follow-up.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: ALD518 intervention 2: 0.9% saline
Intervention descriptions: intervention 1: IV intervention 2: IV Infusion

Protocol documents:
Clinical trial NCT01492426
Conditions: Hepatitis C
Keywords: Hepatitis C Virus
Sponsor: Bristol-Myers Squibb
Start date: 2012-01-01; Completion date: 2014-03-01
Enrollment: 605 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the effectiveness of BMS-790052 (Daclatasvir) and Telaprevir when given in combination with Peginterferon alfa-2a and Ribavirin in genotype 1b patients

Detailed description:
Allocation: Randomized Stratified

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Daclatasvir intervention 2: Telaprevir intervention 3: Peginterferon alfa-2a intervention 4: Ribavirin
Intervention descriptions: intervention 1: Film-coated tablet, oral, 60 mg, once daily, 24 weeks intervention 2: Film-coated tablet, oral, 750 mg, 3 times daily intervention 3: Solution for injection, subcutaneous injection, 180 μg, weekly intervention 4: Film-coated tablet, oral, in a body weight stratified dose range of 1000-1200 mg per day

Protocol documents:
Clinical trial NCT01493960
Conditions: Colitis, Ulcerative
Keywords: Colitis, Ulcerative Gastrointestinal Diseases Inflammatory Bowel Diseases Immunomodulatory Therapy Glucocorticoids Anti-Inflammatory Agents Therapeutic uses
Sponsor: InDex Pharmaceuticals
Start date: 2011-12-01; Completion date: 2014-03-01
Enrollment: 131 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if cobitolimod (former called Kappaproct®) is effective in the treatment of chronic active ulcerative colitis patients not responding to available therapy.

Detailed description:
The study is a placebo-controlled, double-blind, randomised study to assess the efficacy and safety of cobitolimod as an add-on to current practice in treatment refractory ulcerative colitis patients. The study population will be chronic active ulcerative colitis patients who are no longer responding adequately to standard therapies and who are potential candidates for colectomy. Cobitolimod/placebo will be add-on treatment allowing all included patients to be on concomitant medication, as well as mandatory steroids at inclusion, throughout the study.

Cobitolimod (DIMS0150) is a modified single strand DNA-based synthetic oligodeoxyribonucleotide of 19 bases in length. The drug functions as an immunomodulatory agent by targeting the Toll-like receptor 9 (TLR9) present in immune cells (i.e., B-cells and pDCs) residing in high abundance on mucosal surfaces, such as colonic and nasal mucosa. The mucosa of the colon and rectum of patients with ulcerative colitis contains active immune cells, which produce damage to the tissue. The activation of these cells by cobitolimod results in the systemic release of specific cytokines (e.g., IL-10 and type I interferons) and chemokines which are believed to be important factors for the clinical effect cobitolimod of cobitolimod. 131 eligible patients was randomly assigned in a 2:1 allocation to receive two single rectal doses of cobitolimod at 30 mg each, or placebo, at week 0 and 4.

The primary endpoint is the induction of clinical remission at week 12 and patients will be continuously followed for efficacy and safety until 12 months after the first dose. Secondary endpoints include the induction of symptomatic remission (number of stools and blood in stools), induction of registration remission (clinical and endoscopic remission) and rate of colectomy.

Arms: arm 1: 2 doses 4 weeks apart arm 2: 2 doses 4 weeks apart
Interventions: intervention 1: Cobitolimod intervention 2: Placebo
Intervention descriptions: intervention 1: 30 mg rectal dose at week 0 and 4 intervention 2: Rectal dose at week 0 and 4

Protocol documents:
Clinical trial NCT01683266
Conditions: Type 1 Diabetes Mellitus
Sponsor: Sanofi
Start date: 2012-09-01; Completion date: 2014-03-01
Enrollment: 549 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Objective:

* To compare the efficacy of a new formulation of insulin glargine and Lantus (overall, regardless the injection time) in terms of change of HbA1c from baseline to endpoint (scheduled Month 6) in participants with type 1 diabetes mellitus

Secondary Objective:

* To compare HOE901-U300 and Lantus when given in the morning or in the evening in terms of:
* Change of HbA1c from baseline to endpoint (scheduled Month 6)
* Change from baseline to endpoint (Month 6) in fasting plasma glucose (FPG), plasma glucose prior to injection of study drug, plasma glucose at 03:00 hours, mean plasma glucose (8-point profiles), glucose variability, treatment satisfaction and health related quality of life in participants with Type 1 Diabetes Mellitus (T1DM)
* Reaching target HbA1c values and controlled plasma glucose (all and reaching target without hypoglycemia)
* Frequency of occurrence and diurnal distribution of hypoglycemia by category of hypoglycemia (symptomatic, asymptomatic, nocturnal, severe, probable and relative)
* Safety and tolerability of HOE901-U300 including development of anti-insulin antibody (AIAs) during the 12-month study period

Detailed description:
The maximum study duration was up to approximately 54 weeks per participants:

* Up to 2-week screening period
* 6-month open-label comparative efficacy and safety treatment period
* 6-month open-label comparative safety extension period
* 48-hour post-treatment safety follow-up period

Arms: arm 1: HOE901-U300 (new insulin glargine 300 units per milliliter \[U/mL\]) subcutaneous (SC) injection once daily in morning or evening for 12 months on top of mealtime insulin analogue. Dose titration seeking fasting plasma glucose 4.4-5.6 millimole per liter (mmol/L) (80 - 100 milligram per deciliter \[mg/dL\]). arm 2: Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily in morning or evening for 12 months on top of mealtime insulin analogue. Dose titration seeking fasting plasma glucose 4.4-5.6 mmol/L (80 - 100 mg/dL).
Interventions: intervention 1: HOE901-U300 (Insulin glargine new formulation) intervention 2: Lantus (Insulin glargine)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00057577
Conditions: Depression
Sponsor: Vanderbilt University
Start date: 2002-10-01; Completion date: 2014-03-01
Enrollment: 452 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will determine whether the addition of Cognitive Therapy (CT) to antidepressant medication (ADM) enhances treatment for depression. This study will also test whether the addition of CT to ADM will prevent recurrences of depression after therapy is over.

Detailed description:
It is commonly believed that the combination of ADM and psychotherapy is more effective in treating depression than either treatment alone. Data indicate that CT enhances the initial effects of ADM, but little research has been conducted to determine whether prior exposure to CT prevents the onset of new depressive episodes. This study will determine the effectiveness of adding CT to ADM for the treatment of depression.

Participants are randomly assigned to receive either ADM alone or ADM plus CT for up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue cognitive therapy; all recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms.

Arms: arm 1: Participants will receive antidepressant medication plus cognitive therapy arm 2: Participants will receive maintenance of antidepressant medication alone
Interventions: intervention 1: Cognitive Therapy intervention 2: Medications
Intervention descriptions: intervention 1: CT sessions occur weekly during acute treatment and monthly during continuation. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from initial randomization until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue CT. intervention 2: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms.

Protocol documents:
Clinical trial NCT00124514
Conditions: Systemic Lupus Erythematosus
Keywords: SLE Lupus Ovarian damage Menopause
Sponsor: Children's Hospital Medical Center, Cincinnati
Start date: 2003-06-01; Completion date: 2014-03-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to test the safety of triptorelin when used for the protection of the ovaries (pair of female reproductive organs) during cyclophosphamide therapy for systemic lupus erythematosus (SLE; lupus) and to see what effects (good or bad) it has on patients. The study will be done with female patients who have been diagnosed with systemic lupus erythematosus, are younger than 21 years of age, and require intravenous cyclophosphamide to control the disease. Each patient will be in the study for approximately 23 months, until 4 months after the intravenous cyclophosphamide treatment has been completed.

This study is currently being conducted at 3 sites across the United States and Brazil (Los Angeles, Cincinnati and San Paulo Brazil). A total of 50 patients will participate in this study.

Each patient will be randomized (assigned) to one of 5 groups. Randomization means that patients are put into a group completely by chance. It is like flipping a coin. Neither the patient nor the study staff knows what group the patient is in. The patient has a 20% chance of being placed in any group.

This is a dose escalation study, each patient will receive the first dose of the study drug (T1 - T4, placebo). If a patient has complete ovarian suppression on day 27 after the initial injection of study drug, then she will remain on this weight-adjusted dose of study drug throughout the study. The dose will be increased up for a weight gain of 5kg or greater. The dose will not be adjusted downward for a weight loss. If COS was not maintained with the 1st dose of study drug, then the subsequently injected 2nd dose will be increased by 25% or at least 20 microgram/kg/dose. The maximal dose of 150 microgram/kg/dose will not be exceeded. The absolute maximum dose is 20 mg.

Funding Source: FDA OOPD and Watson Pharmaceuticals

Detailed description:
Lupus is an autoimmune disease that may harm all organs in the body and especially affects the kidney, brain, skin and lungs. Cyclophosphamide is a very effective medication to treat lupus, but it can damage the ovaries (pair of reproductive organs).

Only female lupus patients may participate in this study.

Arms: arm 1: Triptorelin Pamoate 25 μg/kg body weight arm 2: Triptorelin Pamoate 50 μg/kg body weight arm 3: Triptorelin Pamoate 75 μg/kg body weight T3 arm 4: Triptorelin Pamoate 100 μg/kg body weight T4 arm 5: Normal Saline
Interventions: intervention 1: Triptorelin pamoate intervention 2: Triptorelin Pamoate intervention 3: Triptorelin Pamoate intervention 4: Triptorelin Pamoate intervention 5: placebo
Intervention descriptions: intervention 1: IM injection given monthly intervention 2: IM injection given monthly intervention 3: IM injection given monthly intervention 4: IM injection given monthly intervention 5: placebo 0.9% normal saline IM injection

Protocol documents:
Clinical trial NCT00125359
Conditions: Carcinoma, Non-small-cell Lung
Keywords: tarceva targretin non-small cell lung cancer Carcinoma, non-small cell lung cancer NSCLC
Sponsor: Konstantin Dragnev
Start date: 2005-08-01; Completion date: 2014-03-01
Enrollment: 42 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to learn about the effects of two new anticancer drugs, erlotinib (Tarceva) and bexarotene (Targretin), when treating patients with advanced lung cancer.

Erlotinib is approved by the Food and Drug Administration (FDA) for the treatment of non-small-cell lung cancer (NSCLC). Bexarotene is approved by the FDA for the treatment of cutaneous T-cell lymphoma. This combination of drugs is experimental.

Detailed description:
This is a single institution open label phase II trial. Consecutive, eligible patients presenting with the diagnosis of advanced NSCLC are to be enrolled in this study. All eligible patients will receive continuous daily oral erlotinib 150 mg (Tarceva™) with daily bexarotene oral capsules 400 mg/m2 (Targretin®). The two agents will be taken at the same time. We anticipate the maximum accrual of 40 patients to this trial.

Patients will be evaluated by history, physical examination, and laboratory assessment every 4 weeks. Radiographic disease assessments by chest radiograph will be obtained every 4 weeks and computer tomography every 8 weeks or longer if clinically indicated. Whole body PET scan will be obtained at 10 days and 8 weeks. All radiographic studies will be sent to Medical Metrix Solutions (MMS) for an independent radiographic review of tumor response.

Arms: arm 1: All eligible patients will receive continuous daily oral erlotinib 150mg with daily bexarotene oral capsules 400mg.
Interventions: intervention 1: erlotinib and bexarotene
Intervention descriptions: intervention 1: Daily Erlotinib 150mg and daily bexarotene oral capsules 400mg.

Protocol documents:
Clinical trial NCT00240110
Conditions: Bipolar Disorder Cocaine Dependence
Keywords: Bipolar Cocaine Comorbidity
Sponsor: University of Miami
Start date: 2006-03-01; Completion date: 2014-03-01
Enrollment: 152 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This proposal will test the efficacy of a promising pharmacological approach for the treatment of comorbid cocaine dependence and bipolar disorder. We propose a randomized, double blind, placebo controlled 12-week trial to test the efficacy of Divalproex sodium (Valproate) plus treatment as usual compared to placebo plus treatment as usual in decreasing cocaine use and stabilizing mood symptoms among patients with comorbid cocaine dependence and bipolar disorder. Treatment as usual includes the use of lithium carbonate for mood stabilization plus supportive psychosocial treatment.

Detailed description:
Bipolar disorder has the highest rate of association with cocaine and other substance use disorders than any other major severe psychiatric syndrome. This comorbidity represents a major treatment challenge and is associated with severe disability, morbidity, and heightened risk for suicide.

The aims of this study are:

1. Examine the efficacy of valproate plus treatment as usual compared to placebo plus treatment as usual in decreasing cocaine use in patients with cocaine dependence and comorbid bipolar disorder.
2. Determine whether primary vs. secondary cocaine dependence, bipolar subtype (depressed vs. manic/mixed) and the presence of additional substance use disorders moderate the association between treatment and cocaine use outcome.
3. Assess the effects of medication compliance and mood symptoms as mediators of cocaine use outcome.

Arms: arm 1: Lithium carbonate started and stabilized then participants randomized to placebo arm 2: Lithium carbonate started and stabilized then participants randomized to Valproate
Interventions: intervention 1: Valproate intervention 2: Placebo intervention 3: Lithium Carbonate
Intervention descriptions: intervention 1: Valproate with dose titration to achieve blood levels within the therapeutic range intervention 2: Control arm intervention 3: All participants were started and stabilized on lithium carbonate as a standard treatment for bipolar disorder

Protocol documents:
Clinical trial NCT00251225
Conditions: Prostate Cancer
Keywords: prostate
Sponsor: Leonard Appleman
Start date: 2005-08-01; Completion date: 2014-03-01
Enrollment: 49 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the effectiveness of two drugs, docetaxel and Gleevec®(also called imatinib), in prostate cancer that no longer responds to hormone therapy. The investigators are interested in finding out if the combination of these two drugs is more effective than docetaxel alone in the treatment of prostate cancer.

Detailed description:
This is a non-randomized multicenter Phase II trial of Gleevec and docetaxel in chemo naïve metastatic hormone refractory prostate cancer. The primary objective of this study is to assess the time to disease progression in patients with hormone refractory prostate cancer treated with daily oral imatinib and intravenous docetaxel, administered every three weeks. Secondary objectives include: 1) to assess the rate of response to imatinib and docetaxel, using Prostate Specific Antigen (PSA) and/or measurable disease; 2) to assess the overall survival of patients with hormone refractory prostate cancer treated with imatinib and docetaxel; and 3) to evaluate the qualitative and quantitative toxicities of this combination.

Arms: arm 1: Gleevec + Docetaxel: Daily Oral Gleevec in Combination with Every-Three-Week Intravenous Docetaxel
Interventions: intervention 1: Gleevec intervention 2: Docetaxel
Intervention descriptions: intervention 1: Imatinib-400mg po qd for 10 days to commence on day 3. On day 0, Docetaxel 60mg/m\^2 administered IV intervention 2: 60 mg/m\^2 administered IV on day 0

Protocol documents:
Clinical trial NCT00312377
Conditions: Non-small Cell Lung Cancer Lung Cancer
Keywords: Non-small cell lung cancer NSCLC
Sponsor: Genzyme, a Sanofi Company
Start date: 2006-05-01; Completion date: 2014-03-01
Enrollment: 1690 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This large phase III clinical study is studying the effect of vandetanib (ZACTIMA) in treating non-small cell lung cancer (NSCLC). Vandetanib is a new type of agent that targets the blood supply to a cancer tumour (through it's anti-vascular endothelial growth factor receptor (VEGFR) properties) and the tumour cells themselves (through it's anti-endothelial growth factor receptor (EGFR) actions). This study will look at the effects of vandetanib in lung cancer patients who have had their cancer re-appear after treatment with standard chemotherapy.

This clinical study will test if the vandetanib anti-VEGF and anti-EGFR characteristics can deliver longer improved progression free survival and improved overall survival than docetaxel (Taxotere) alone.

All patients participating this clinical study will receive treatment with docetaxel, a commonly used treatment for recurrent non-small cell lung cancer.

In addition, some patients will also receive vandetanib (ZACTIMA), an anti-EGFR / anti-VEGF agent.

Recent clinical research shows that vascular endothelial growth factor receptor (VEGFR) inhibition, when used with standard chemotherapy, can lead to increased survival in advanced non-small cell lung cancer (NSCLC) patients.

Other research shows that epidermal growth factor receptor (EGFR) inhibitors, like erlotinib (Tarceva) can also increase overall non-small cell lung cancer survival by killing tumour cells and stopping them from dividing.

Detailed description:

Arms: arm 1: Docetaxel monotherapy arm 2: Vandetanib + Docetaxel
Interventions: intervention 1: Docetaxel intervention 2: Vandetanib
Intervention descriptions: intervention 1: infusion intervention 2: oral

Protocol documents: