ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00813943
Conditions: Glioblastoma
Keywords: Newly diagnosed Glioblastoma (WHO Grade IV) Cilengitide Temozolomide Radiotherapy
Sponsor: EMD Serono
Start date: 2009-03-01; Completion date: 2013-08-01
Enrollment: 265 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
CORE is a Phase 2 clinical trial in newly diagnosed glioblastoma in subjects with an unmethylated O6-methylguanine-deoxyribonucleic acid methyltransferase (MGMT) gene promoter in the tumor tissue.

The MGMT gene promoter is a section of deoxyribonucleic acid (DNA) that acts as a controlling element in the expression of MGMT. Methylation of the MGMT gene promoter has been found to appear to be a predictive marker for benefit from temozolomide (TMZ) treatment.

In a safety run-in period in dedicated study centers, the safety and tolerability of Cilengitide given as an intense treatment in combination with the first part of standard therapy will be assessed. Thereafter the trial will investigate the overall survival and progression-free survival in subjects receiving two different regimens of Cilengitide in combination with standard treatment versus standard treatment alone.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Cilengitide (2-times weekly) intervention 2: cilengitide (5-times weekly) intervention 3: Temozolomide intervention 4: Radiotherapy
Intervention descriptions: intervention 1: Cilengitide 2000 milligram (mg) will be administered intravenously twice weekly over 1 hour infusion from Weeks -1 to 77 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. If considered beneficial in the opinion of the Investigator, continuation of cilengitide treatment will be optional in subjects without disease progression and after Week 77 since start of treatment. intervention 2: Cilengitide 2000 milligram (mg) will be administered intravenously 5-times weekly over 1 hour infusion from Weeks -1 to 77 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. If considered beneficial in the opinion of the Investigator, continuation of cilengitide treatment will be optional in subjects without disease progression and after Week 77 since start of treatment. intervention 3: Temozolomide (TMZ) 75 milligram per square meter \[mg/m\^2\] will be administered intravenously once daily from Week 1 to 6. From Week 11 onwards, TMZ will be given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 or until disease progression. intervention 4: Radiation therapy (RTX) at a dose of 2 gray (Gy) per fraction will be given once daily, 5 days per week from Week 1 to 6, total dose 60 Gy.

Protocol documents:
Clinical trial NCT00854087
Conditions: Chronic Hepatitis C Infection
Keywords: Hepatitis C Virus HCV Herbal treatment Herbs San Diego Non responder Relapser Treatment failure Antifibrotic Anti-fibrotic Fibrosis Failure of previous Interferon based therapy Refuse Interferon based therapy Intolerance to Interferon Male or female 18-70 years of age
Sponsor: Tarek Hassanein
Start date: 2010-08-01; Completion date: 2013-08-01
Enrollment: 118 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Current treatment of chronic liver disease relies upon removing the primary insult to the liver (e.g., alcohol) or treating the underlying viral infection (HBV, HCV, etc.). However, in the case of hepatitis C, a significant number of individuals will not clear the virus with current approved standard antiviral therapy, leaving them no options to manage their hepatic fibrosis, which can progress to cirrhosis and ultimately hepatocellular carcinoma (HCC).

Fuzheng Huayu has been used in numerous studies in China and has been found to have a satisfactory prophylaxis effect on the chronic liver injury and formed liver fibrosis in rats and humans. In addition, it enhances the degradation of liver fibrosis and protects hepatocytes from injury and death, manifesting as decreasing of ALT and AST, and enhancement of albumin level. In addition, preliminary studies indicate that the Fuzheng Huayu has a good safety and tolerability profile with promising efficacy.

The number of patients failing Interferon based therapy (i.e. not achieving SVR) is increasing. There are no approved standard of care treatment options for this population nor for patients who are intolerant or unwilling to receive Interferon; thus they are at higher risk for the progression of fibrosis. Moreover, there are no approved therapies to treat hepatic fibrosis, but basic research is exploring the pathophysiological mechanisms. Fuzheng Huayu is easy to administer, with a good safety and efficacy profile against fibrosis. Therefore, the investigators propose to further study the safety and efficacy profile of Fuzheng Huayu in a randomized, placebo-controlled, double blind study in Chronic Hepatitis C patients with hepatic fibrosis who have failed prior anti-HCV therapy or are intolerant or refuse Interferon based therapy.

The primary objective of this study is to establish the safety and efficacy of Fuzheng Huayu treatment in chronic hepatitis C subjects who have failed prior anti-HCV therapy or cannot receive or refused Interferon based therapy in improving liver fibrosis.

Detailed description:

Arms: arm 1: Pill with Fuzheng Huayu arm 2: Pill without Fuzheng Huayu (sugar pill)
Interventions: intervention 1: Fuzheng Huayu intervention 2: Placebo
Intervention descriptions: intervention 1: The subjects will be taking 2 tablets three times a day for 48 weeks. intervention 2: The subjects will be taking 2 tablets three times a day for 48 weeks.

Protocol documents:
Clinical trial NCT00891371
Conditions: Diarrhea
Keywords: symptomatic treatment of patients with refractory diarrhea
Sponsor: Ipsen
Start date: 2009-07-01; Completion date: 2013-08-01
Enrollment: 42 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study, is to assess the effect of lanreotide Autogel 120mg on stool frequency in subjects with refractory diarrhea at day 28 (mean of last 7 days) compared to baseline.

Detailed description:

Arms: arm 1: lanreotide (Autogel formulation) Autogel 120mg
Interventions: intervention 1: lanreotide (Autogel formulation)
Intervention descriptions: intervention 1: Autogel 120mg

Protocol documents:
Clinical trial NCT00895583
Conditions: Graft Rejection Kidney Transplant Renal Allograft Recipients Renal Transplant
Keywords: renal transplant immunosuppression sirolimus/rapamune planned transition
Sponsor: Pfizer
Start date: 2009-06-01; Completion date: 2013-08-01
Enrollment: 254 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will look at the effect on long-term kidney function using tacrolimus right after a transplant and then switching to sirolimus at 3 to 5 months after the transplant.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Tacrolimus intervention 2: Sirolimus intervention 3: Tacrolimus
Intervention descriptions: intervention 1: During the screening phase, tacrolimus is provided by the investigator (not the Sponsor) and is dosed to achieve a target trough level determined by the investigator. Therefore, the dosage form, dosage, and frequency are determined by the investigator. Duration of treatment is from transplantation until randomization (from 90 to 150 days). intervention 2: Following randomization, sirolimus is provided by the Sponsor in 1 and 2 mg oral tablets. Sirolimus is dosed once daily to achieve a target trough level of 7 to 15 ng/mL in the 1st year post-transplant and 5 - 15 ng/mL in the 2nd year post-transplant. Duration of treatment is from randomization through 2 years post-transplant (19 to 21 months). intervention 3: During the study, tacrolimus is provided by the investigator (not the Sponsor) and is dosed to achieve a target trough level determined by the investigator. Therefore, the dosage form, dosage, and frequency are determined by the investigator. Duration of treatment is 2 years post-transplant.

Protocol documents:
Clinical trial NCT00911326
Conditions: Head and Neck Squamous Cell Carcinoma (HNSCC)
Keywords: HNSCC
Sponsor: Navidea Biopharmaceuticals
Start date: 2009-05-01; Completion date: 2013-08-01
Enrollment: 101 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the false negative rate (FNR) associated with Lymphoseek-identified sentinel lymph nodes (SLNs) relative to the pathological status of non-sentinel lymph nodes in elective neck dissection (END) in head \& neck squamous cell carcinoma (HNSCC). NEO3-06 (this study) is a Phase 3 clinical trial designed to supplement NEO3-05, a completed Phase 3 clinical trial conducted in patients with breast cancer or melanoma. NEO3-05 was designed to establish Lymphoseek as an effective radio-diagnostic agent to be used in the intraoperative localization of lymph tissue (nodes) in the lymphatic pathway draining the primary site of a tumor.

Detailed description:

Interventions: intervention 1: Lymphoseek
Intervention descriptions: intervention 1: Single injection of 50 micrograms Lymphoseek radiolabeled with either 0.5 mCi (for same day surgery) or 2.0 mCi (for next day surgery) of Tc 99m

Protocol documents:
Clinical trial NCT00931463
Conditions: HIV Infections
Keywords: second line therapy combination antiretroviral therapy first-line failure AIDS treatment experienced
Sponsor: Kirby Institute
Start date: 2009-09-01; Completion date: 2013-08-01
Enrollment: 558 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators hypothesize that following virological failure of a standard NNRTI+2N(T)RTI regimen second-line antiretroviral therapy consisting of ritonavir-boosted lopinavir and 2N(T)RTIs will offer comparable efficacy to that provided by ritonavir-boosted lopinavir and raltegravir.

The study will be conducted for 96-weeks with the primary endpoint analyzed after 48-weeks.

The primary endpoint is virological: a comparison of virological suppression in plasma \< 200 copies/mL between the randomized arms after 48 weeks.

Secondary and exploratory endpoints include virological, immunological, safety, clinical, metabolic, drug adherence, drug resistance and quality of life.

Detailed description:
In HIV-infected subjects who have virologically failed first-line antiretroviral therapy comprising 2N(t)RTI + NNRTI a regimen of second-line therapy incorporating ritonavir-boosted lopinavir and raltegravir provides comparable (i.e., non-inferior) antiretroviral efficacy over 48 weeks to a regimen containing ritonavir-boosted lopinavir and 2-3N(t)RTIs.

Eligible patients will be randomised to one of two arms:

I. ritonavir boosted lopinavir (LPV/r) 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3N(t)RTIs

II. ritonavir boosted lopinavir (LPV/r) 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400 mg twice daily

The primary objective of this study is to compare the virological efficacy of the two strategies as measured by the proportion of participants with HIV RNA \< 200 copies/mL 48 weeks after randomisation.

Secondary objectives include virological, immunological, safety and antiretroviral therapy endpoints.

Exploratory endpoints include clinical, metabolic, drug resistance, medication adherence and quality of life endpoints.

Arms: arm 1: This is the current standard of care for second line therapy following failure of standard first-line NNRTI+2N(t)RTIs according to WHO guidelines. arm 2: This is an experimental arm which is likely to be fully active in the presence of N(t)RTI mutations and which preliminary evidence suggests should be potent and durable.
Interventions: intervention 1: raltegravir intervention 2: 2N(t)RTI intervention 3: Ritonavir-boosted lopinavir
Intervention descriptions: intervention 1: 400 mg raltegravir tablet taken every 12 hours intervention 2: 2N(t)RTIs as prescribed intervention 3: 2 heat-stable tablets of ritonavir-boosted lopinavir taken every 12 hours

Protocol documents:
Clinical trial NCT00936702
Conditions: Carcinoma of Unknown Primary Origin
Keywords: Newly Diagnosed Carcinoma of Unknown Primary Origin Squamous Cell Carcinoma of Unknown Primary Origin Undifferentiated Carcinoma of Unknown Primary newly diagnosed carcinoma of unknown primary
Sponsor: Alliance for Clinical Trials in Oncology
Start date: 2009-09-01; Completion date: 2013-08-01
Enrollment: 46 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well carboplatin given together with paclitaxel and everolimus works in treating patients with previously untreated cancer of unknown primary.

Detailed description:
OBJECTIVES:

Primary

* Evaluate the response rate in patients with previously untreated cancer of unknown primary treated with the combination of carboplatin, paclitaxel, and everolimus.

Secondary

* Assess time to progression, overall survival, duration of response, and time to treatment failure in patients treated with this regimen.
* Determine adverse events of this regimen in these patients.
* Perform descriptive correlative studies to determine response of specific tumor types, identified by the Origin-FFPE test, to this regimen.

OUTLINE: This is a multicenter study.

Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Patients also receive oral everolimus once daily on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients' tumor tissue samples from the most recent biopsy are analyzed for correlative studies, including gene expression profiling by Origin-FFPE test.

After completion of study therapy, patients are followed up every 3 months until disease progression, and then every 6 months for up to 3 years.

Arms: arm 1: Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Patients also receive everolimus PO QD on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: carboplatin intervention 2: everolimus intervention 3: paclitaxel
Intervention descriptions: intervention 1: Given IV intervention 2: Given PO intervention 3: Given IV

Protocol documents:
Clinical trial NCT00955357
Conditions: Partial Epilepsies
Keywords: Epilepsy Treatment Anti-epileptic drugs Seizures Vimpat
Sponsor: UCB Pharma
Start date: 2009-08-01; Completion date: 2013-08-01
Enrollment: 461 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy and safety of oral Lacosamide as first add on treatment in subjects with uncontrolled partial-onset seizures after prior treatment with a monotherapy Antiepileptic Drug (AED) regimen compared to subjects who have received treatment with at least 2 AEDs.

Detailed description:
The study consisted of 3 Periods: Period 1: a 1-week Screening Phase, Period 2: a 30-week Treatment Phase (consisting of a 6-week Titration Phase and a 24-week Maintenance Phase), and Period 3: a 3-week Taper/Safety Follow-Up Phase.

Arms: arm 1: Lacosamide added to first adequate monotherapy (no history of Antiepileptic Drug \[AED\] polytherapy) and epilepsy diagnosis \< or = 24 months at Screening. arm 2: Lacosamide added to 1 to 3 Antiepileptic Drugs (AEDs) (with tentatives of at least 2 prior AED treatment regimens) and epilepsy diagnosis \> or = 5 years at Screening.
Interventions: intervention 1: Lacosamide
Intervention descriptions: intervention 1: Oral Lacosamide:

Subjects Titration Phase (6 Weeks):

Week 1 - 50 mg tablet Twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid

Maintenance Phase (24 Weeks):

200 mg tablet bid OR 150 mg tablet bid

Taper Phase (1 - 3 Weeks):

50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week

Protocol documents:
Clinical trial NCT00963872
Conditions: Leukemia Lymphoma Multiple Myeloma Myelodysplastic Syndromes
Sponsor: Masonic Cancer Center, University of Minnesota
Start date: 2010-03-01; Completion date: 2013-08-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Giving low doses of chemotherapy and total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect).

PURPOSE: This phase I trial is studying the safety of donor umbilical cord blood transplant after fludarabine phosphate, cyclophosphamide, and total-body irradiation in treating patients with high-risk hematologic cancer (now closed).

The Phase II part of this trial is studying whether priming one of two UCB units with C3a facilitates engraftment of the treated unit.

Detailed description:
OUTLINE:

* Nonmyeloablative preparative regimen: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 2 hours on day -6. Patients then undergo total-body irradiation on day -1. Some patients also receive anti-thymocyte globulin IV every 12 hours on days -6, -5, and -4.
* Umbilical cord blood (UCB) transplantation: Patients undergo unmanipulated UCB transplantation followed by complement 3a fragment primed UCB transplantation on day 0.

Treatment for graft-vs-host disease prophylaxis is also given.

After completion of study therapy, patients are followed up periodically for up to 2 years.

Arms: arm 1: Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation. arm 2: Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
Interventions: intervention 1: cyclophosphamide intervention 2: fludarabine phosphate intervention 3: Total body irradiation intervention 4: Umbilical cord blood unit with C3a fragment intervention 5: Unmanipulated UCB Unit
Intervention descriptions: intervention 1: 50 mg/kg intravenously (IV) over 2 hours on Day -6. intervention 2: 40 mg/m\^2 over 1 hour on Days -6 through -2. intervention 3: 200 cGy on Day -1 intervention 4: On Day 0, the C3a primed UCB unit will be infused intravenously SECOND, within 30 minutes of the completion of the infusion of the unmanipulated UCB unit, through a central line without in-line filtration in a manner identical to the unmanipulated UCB unit. intervention 5: On Day 0, the unmanipulated UCB unit will be infused FIRST through a central line without in-line filtration per institutional guidelines.

Protocol documents:
Clinical trial NCT00964795
Conditions: Neovascular Age-related Macular Degeneration
Keywords: Eyes Neovascular Macular Degeneration Retina AMD VEGF Trap-Eye Best Corrected Visual Acuity
Sponsor: Regeneron Pharmaceuticals
Start date: 2009-12-01; Completion date: 2013-08-01
Enrollment: 323 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective is to assess long-term safety and tolerability of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in patients with neovascular AMD.

Detailed description:
The dose evaluated in this study, Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg, will be the higher of the 2 dose strengths evaluated in parent study VGFT-OD-0605 (NCT00509795) and is the dose level administered in study VGFT-OD-0702 (NCT00527423), a long-term open-label extension study. For these reasons, this dose has been selected for this extension study.

Participants will be seen in the clinic for quarterly visits starting with day 1 to assess safety. Study drug will be administered on an as-needed basis at the discretion of the investigator with a minimum allowed interval of every 4 weeks and a maximum allowed interval of every 12 weeks. This study will assess the frequency that re-treatment is needed and the effect of continued Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) treatment on BCVA.

Arms: arm 1: Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.
Interventions: intervention 1: Intravitreal Aflibercept Injection 2mg
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00979550
Conditions: Port Wine Stains
Keywords: laser pediatric skin pigmentation
Sponsor: Henry Vasconez
Start date: 2008-10-01; Completion date: 2013-08-01
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective is to determine the effects of Aldara on the cosmetic outcome of laser treatment of vascular malformations.

Detailed description:
This is a randomized, controlled, double-blinded study. Volunteers who are scheduled for laser treatment of Port Wine Stains will be screened and eligible subjects will be asked to participate. The patients will be randomized and placed in the experimental or the control group. They will be given unlabeled sachets and instructed to apply the product each night to the right half of their treated lesion beginning the night after surgery for 4 weeks. Digital photographs of the Port Wine Stain will be taken prior to surgery and repeated at follow up appointments at 1 week, 1 month, 2 months, and 3 months after surgery. The photographs will be analyzed by blinded board certified plastic surgeons as well as a computer program.

Arms: arm 1: Imiquimod (Aldara cream) will be applied nightly for four weeks after standard of care laser treatment for port wine stain. arm 2: Non-medicated petroleum cream will be applied nightly for four weeks after standard of care laser treatment for port wine stain.
Interventions: intervention 1: Imiquimod intervention 2: non-medicated petroleum cream
Intervention descriptions: intervention 1: commercially available topical antiviral drug intervention 2: Over the counter topical cream used to aid the healing process in skin lesions

Protocol documents: