ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00975611
Conditions: Schizophrenia Schizoaffective Disorder
Keywords: schizophrenia schizoaffective disorder paliperidone ER risperidone Consta prolactin hyperprolactinemia
Sponsor: David C. Henderson, MD
Start date: 2009-10-01; Completion date: 2012-01-01
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to show that amantadine might help to reduce the side effect of the medications which are prescribed to treat schizophrenia or schizoaffective disorder. High level of hormone prolactin, or hyperprolactinemia, is one of the side effects which might be developed in patients treated with the paliperidone ER or risperidone Consta.

High level of prolactin might stimulate breast development, might decrease sexual desire (libido). The goals of this study are to demonstrate that amantadine lowers prolactin levels, decreases side effects, and improves psychiatric symptoms.

Detailed description:
Trial Description: A double-blind, placebo-controlled, prospective, randomized trial to evaluate the effects of two doses of amantadine or placebo in the management of antipsychotic-induced hyperprolactinemia and psychiatric status in patients with schizophrenia or schizoaffective disorder who are clinically stable on paliperidone ER or risperidone Consta. Placebo or amantadine 100 mg or 200 mg BID will be administered to participants for 4 consecutive weeks as an adjunctive therapy in 72 schizophrenia subjects treated with paliperidone or risperidone Consta to examine amantadine effects on fasting AM serum prolactin levels. Participants will be followed after suspension of amantadine or placebo for an additional 4 weeks for safety purposes. The goals of this study are to prospectively demonstrate that amantadine lowers prolactin levels, and evaluate the impact of amantadine on psychiatric symptoms, and on prolactin-related side effects in patients treated with paliperidone ER or risperidone Consta.

Arms: arm 1: Subjects take amantadine 100mg tablets twice per day (BID) arm 2: Subjects take amantadine 200mg tablets twice per day (BID) arm 3: Subjects take placebo tablets twice per day (BID)
Interventions: intervention 1: Amantadine Hydrochloride, USP intervention 2: Amantadine Hydrochloride, USP intervention 3: Placebo
Intervention descriptions: intervention 1: amantadine tablets 100 mg. BID for 4 weeks intervention 2: amantadine 200 mg. tablets BID for 4 weeks intervention 3: tablets BID, for 4 weeks

Protocol documents:
Clinical trial NCT00987337
Conditions: Hepatitis Hepatitis C
Keywords: Hepatitis C Polymerase Inhibitor PF-00868554 Filibuvir
Sponsor: Pfizer
Start date: 2009-11-01; Completion date: 2012-01-01
Enrollment: 288 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective for this study is to determine if the addition of filibuvir to a standard regimen of peginterferon/ribavirin (pegIFN/RBV) significantly increases the proportion of subjects who achieve a sustained viral response (SVR) compared to peginterferon/ribavirin (pegIFN/RBV) therapy alone.

Detailed description:

Arms: arm 1: Filibuvir 300 mg BID + pegIFN/RBV x 24 weeks (subjects with undetectable HCV RNA at week 4)

\- or - Filibuvir 300 mg BID + pegIFN/RBV x 24 weeks followed by pegIFN/RBV x 24 weeks (subjects with detectable HCV RNA at week 4) arm 2: Filibuvir 600 mg BID + pegIFN/RBV x 24 weeks (subjects with undetectable HCV RNA at week 4)

\- or - Filibuvir 600 mg BID + pegIFN/RBV x 24 weeks followed by pegIFN/RBV x 24 weeks (subjects with detectable HCV RNA at week 4) arm 3: Placebo + pegIFN/RBV x 24 weeks followed by pegIFN/RBV x 24 weeks
Interventions: intervention 1: Filibuvir intervention 2: Filibuvir intervention 3: Placebo
Intervention descriptions: intervention 1: 300 mg BID intervention 2: 600 mg BID intervention 3: BID

Protocol documents:
Clinical trial NCT01040832
Conditions: Squamous Cell Carcinoma of the Head and Neck Cancer
Keywords: Head and Neck Cancer Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Cancer Cetuximab EMD 1201081
Sponsor: EMD Serono
Start date: 2009-12-01; Completion date: 2012-01-01
Enrollment: 107 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if EMD 1201081 in combination with cetuximab is more efficient than cetuximab alone to control the cancer.

EMD 1201081 is an immune modulatory oligonucleotide (IMO) containing phosphorothioate oligodeoxynucleotide and acts as an agonist of Toll-like receptor 9 (TLR9).

EMD 1201081 has been studied in six clinical trials in over 170 subjects either as a monotherapy or in combination with chemotherapeutic agents or targeted therapies. Two studies have been conducted in healthy volunteers. In the other five studies, subjects with advanced solid tumors, renal cell carcinoma, non-small cell lung cancer and colorectal cancer have been treated with EMD 1201081. Two studies are still ongoing. Future clinical development of EMD 1201081 will focus on colorectal cancer (CRC) and squamous cell cancer of the head and neck (SCCHN).

In this Phase 2 study, subjects with recurrent or metastatic squamous cell cancer of the head and neck (R/M SCCHN), will be treated with cetuximab plus EMD 1201081 or cetuximab alone. The study will be conducted as a multicenter study in several European Union (EU) member states and the Unites States.

EMD 1201081 in combination with cetuximab will be evaluated for antitumor activity in subjects by examining its effects on accepted clinical endpoints. Progression-free survival (PFS) will be evaluated in subjects treated with EMD 1201081 plus cetuximab compared to cetuximab alone in cetuximab-naïve subjects with R/M SCCHN who have progressed on a cytotoxic therapy.

Cetuximab, approved in colorectal cancer and SCCHN in combination with platinum-based chemotherapy and SCCHN in combination with radiotherapy in the EU, will be provided as investigational medicinal product (IMP) in this study. Commercially available Cetuximab will be provided in the United States.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Cetuximab intervention 2: EMD 1201081
Intervention descriptions: intervention 1: Cetuximab weekly (initial dose 400 milligram per square meter \[mg/m\^2\] over 120 minutes followed by 250 mg/m\^2 intravenous infusion over 60 minutes) will be administered in 3-week treatment cycle until disease progression. The total treatment period will be approximately 18 months. intervention 2: EMD 1201081 weekly (0.32 milligram per kilogram \[mg/kg\] by subcutaneous injection) will be administered in 3-week treatment cycle until disease progression. Subjects who will discontinue cetuximab due to toxicity in cetuximab monotherapy, could continue to receive EMD 1201081 monotherapy until disease progression. The total treatment period will be approximately 18 months.

Protocol documents:
Clinical trial NCT01041248
Conditions: Relapsing Polychondritis
Keywords: Relapsing Polychondritis Single Patient Study Tocilizumab
Sponsor: Children's Hospital of Eastern Ontario
Start date: 2010-01-01; Completion date: 2012-01-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Relapsing polychondritis (RP) is a rare, immune-mediated disease associated with inflammation in cartilaginous structures and other tissues throughout the body. Prognosis can be poor, especially in cases where there is acute involvement of the laryngotracheal cartilages leading to airway destruction, which are resistant to treatments such as corticosteroids, immunosuppressive or cytotoxic drugs. The pathogenesis remains unclear although it is thought that autoimmune reactions to antigens present in cartilages, such as type II collagen and matrilin may evoke symptoms. There are no known clinical or laboratory measures that predict the expression of specific disease manifestations or the overall disease course. Two recently published case reports have shown an association with elevated serum IL-6 levels and relapsing polychondritis. In these case reports, both patients with refractory relapsing polychondritis were treated with tocilizumab, a humanized monoclonal antibody to the Interleukin 6 receptor, and achieved sustained response to the drug. This single patient trial aims to evaluate the response to Tocilizumab in an eight year old boy with relapsing polychondritis who has been shown to have elevated serum IL-6 levels and who has responded poorly to conventional therapies. The study hypothesis is that Tocilizumab will be able to control the disease in this patient.

Detailed description:
In this N = 1 study a single known patient with relapsing polychondritis who has failed methotrexate, various anti TNF medications, anti IL1 medication and prolongued glucocorticosteroids will be recruited to receive Tocilizumab 8 mg /kg q 2 weeks iv.

The objective is to assess efficacy of tociliuzmab in combination with stable ongoing therapy. Our patient received tocilizumab 8 mg/kg over 1 hour by intravenous infusion every 2 weeks throughout the course of the study. To assess tocilizumab efficacy, the primary objective is the change in physician global assessment on a 100-mm horizontal visual analogue scale (VAS) of disease activity.

The secondary objectives were the change in parent global assessment of disease activity on a 100 mm VAS and the glucocorticoid dose in mg per day. Frequency of adverse events was also measured at baseline and after each biweekly tocilizumab infusion.

Arms: arm 1: Single arm open label study. In this arm patient will receive 8mg/kg of Tocilizumab q 2 weeks iv.
Interventions: intervention 1: Tocilizumab
Intervention descriptions: intervention 1: 8mg/kg every 2 weeks i.v.

Protocol documents:
Clinical trial NCT01042509
Conditions: Graft vs Host Disease
Keywords: Chronic Graft vs Host Disease Alemtuzumab Rituximab Low-dose Alemtuzumab and rituximab combination
Sponsor: Hospital Universitario Dr. Jose E. Gonzalez
Start date: 2009-10-01; Completion date: 2012-01-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether low-doses alemtuzumab and rituximab combination are effective in the treatment of chronic graft-versus-host disease (GVHD) after first-line therapy failure.

Detailed description:
Graft-versus-host disease (GVHD) is the most common long-term complication in patients who underwent allogeneic transplantation. First-line therapy for chronic GVHD is based on immunosuppressive agents (usually cyclosporine and corticosteroids) achieving satisfactory response in around 30% of patients. There is no ideal second-line treatment for chronic GVHD; however, numerous studies have been published with therapeutic options such as alemtuzumab (anti-CD52) and rituximab (anti-CD20).

This is a prospective, longitudinal, nonrandomized study in which alemtuzumab and rituximab will be administered at low-doses to patients with refractory chronic GVHD. Clinical response will be evaluated based on the Working Group Report 2006, published by the National Institute of Health Consensus. Follow-up sessions will be weekly for four weeks, every two weeks until achieve response, and finally every four weeks.

Arms: arm 1: Patients with chronic GVHD after first-line therapy failure will receive Alemtuzumab at 10mg subcutaneously daily for 3 doses (days 1, 2 and 3) Rituximab at 100mg intravenously weekly for 4 doses (days 4, 11, 18 and 25. THE STUDY HAVE ONLY ONE ARM.
Interventions: intervention 1: Alemtuzumab and rituximab
Intervention descriptions: intervention 1: Alemtuzumab at 10mg subcutaneously daily for 3 doses (days 1, 2 and 3) Rituximab at 100mg intravenously weekly for 4 doses (days 4, 11, 18 and 25

Protocol documents:
Clinical trial NCT01054222
Conditions: Urinary Bladder, Overactive
Keywords: overactive bladder idiopathic elderly fesoterodine SOFIA Portugal extension study
Sponsor: Pfizer
Start date: 2010-05-01; Completion date: 2012-01-01
Enrollment: 31 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an open-label extension study intended for subjects who have previously completed study A0221045 (fesoterodine in elderly OAB patients) and who have been recommended by the investigator as being suitable for the extended use of Fesoterodine. Data from this study will extend the evaluation of efficacy, tolerability and safety of Fesoterodine in older subjects from Portugal.

Detailed description:

Arms: arm 1: Dose determined as per previous drug regime in A0221045 and investigator's evaluation. arm 2: Dose determined as per previous drug regime in A0221045 and investigator's evaluation.
Interventions: intervention 1: Fesoterodine intervention 2: Fesoterodine
Intervention descriptions: intervention 1: Fesoterodine fumarate, sustained release (SR) tablet, 4 mg once daily, oral, duration - until fesoterodine is commercially available in Portugal or until 31 Dec 2011 (whichever is earlier) intervention 2: Fesoterodine fumarate, sustained release (SR) tablet, 8 mg once daily, oral, duration - until fesoterodine is commercially available in Portugal or until 31 Dec 2011 (whichever is earlier)

Protocol documents:
Clinical trial NCT01059565
Conditions: Cystic Fibrosis Burkholderia Infections
Keywords: Cystic Fibrosis Aztreonam Lysine lung infection Burkholderia CFQ-R inhaled antibiotic
Sponsor: Gilead Sciences
Start date: 2010-02-01; Completion date: 2012-01-01
Enrollment: 102 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this research study was to determine if an experimental drug called Aztreonam for Inhalation Solution (AZLI) was safe and effective to treat Burkholderia lung infections in patients with cystic fibrosis (CF).

Spirometry was used to assess pulmonary function, and the revised Cystic Fibrosis Questionnaire (CFQ-R) was used to assess quality of life. The CFQ-R is a validated, patient-reported outcome tool used to measure health-related quality of life for children and adults with CF.

The study consisted of a 24-week randomized phase, and a 24-week open-label phase. Primary and secondary efficacy analyses were conducted for the 24-week randomized phase only. Safety data were collected for both the randomized and open-label phases.

Detailed description:

Arms: arm 1: Participants were randomized to receive AZLI for up to 24 weeks and may have continued to receive AZLI during the open-label phase for up to an additional 24 weeks. arm 2: Participants were randomized to receive placebo to match AZLI for up to 24 weeks and may have switched to AZLI during the open-label phase for up to 24 weeks.
Interventions: intervention 1: AZLI intervention 2: Placebo
Intervention descriptions: intervention 1: Aztreonam for inhalation solution (AZLI; 75 mg aztreonam/52.5 mg lysine monohydrate) was administered three times a day, with at least 4 hours between doses, using the investigational nebulizer. intervention 2: Placebo to match AZLI (lactose and sodium chloride) was administered three times a day, with at least 4 hours between doses, using the investigational nebulizer.

Protocol documents:
Clinical trial NCT01064947
Conditions: Atopic Dermatitis Secondary Infection
Sponsor: Derm Research, PLLC
Start date: 2010-02-01; Completion date: 2012-01-01
Enrollment: 29 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Skin infections may complicate the treatment of atopic dermatitis.The use of topical ointments has become very important to avoid the use of oral antibiotics. There is little supporting literature regarding the use of topical antibiotics in secondarily infected atopic dermatitis.

This study will investigate the safety and effectiveness of Altabax ointment use in treating secondarily infected atopic dermatitis caused by Staphylococcus aureus and Streptococcus pyogenes.

Detailed description:
Atopic dermatitis patients are commonly secondarily infected with Staphylococcus aureus and/or Streptococcus pyogenes, more recently with Methicillin-resistant Staphylococcus aureus (MRSA), due to impaired barrier function. As cutaneous infections such as MRSA and others may complicate the treatment of atopic dermatitis, the use of topical antibiotics have become very important to avoid oral antibiotics and their side effects, especially in the pediatric population.

The current study will investigate the safety and efficacy of Altabax ointment use for treatment of secondarily infected lesions caused by Staphylococcus aureus and Streptococcus pyogenes in both the pediatric and adult populations.

Interventions: intervention 1: Retapamulin 1%
Intervention descriptions: intervention 1: Apply a thin layer of Retapamulin 1% to the affected area twice daily. The treated area may be covered with a sterile bandage or gauze dressing if desired.

Protocol documents:
Clinical trial NCT01067976
Conditions: Breast Cancer Diagnostic Imaging
Keywords: Breast Cancer Gadobutrol-enhanced MRI Mammography
Sponsor: Bayer
Start date: 2010-02-01; Completion date: 2012-01-01
Enrollment: 446 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to look at the efficacy (how does it work) and safety of gadobutrol when used for obtaining MR images of both breasts.Women with a recent diagnosis of breast cancer by mammogram (X-ray examination of the breasts) may benefit from MRI of the breasts as MRI may detect additional breast cancers.

Detailed description:

Arms: arm 1: Patients first received an unenhanced MRM, followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg bw \[0.1 ml/kg bw\] as an intravenous injection (i.v.) injection at a rate of 2 ml/sec. UMRM and CMRM image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective XRM was added and evaluated together with the UMRM images.
Interventions: intervention 1: Gadobutrol (Gadavist, Gadovist, BAY86-4875)
Intervention descriptions: intervention 1: A single bolus injection of gadobutrol 1.0 M 0.1mmol/kg body weight

Protocol documents:
Clinical trial NCT01071317
Conditions: Migraine
Sponsor: Montefiore Medical Center
Start date: 2010-02-01; Completion date: 2012-01-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Despite the fact that more than 10% of Americans suffer from migraine, this headache disorder is often not diagnosed and not appropriately treated. The goal of this proposal is to determine whether a migraine protocol designed for use in an emergency room can be used to deliver the headache care that many migraine patients never receive. This is a randomized trial. Consecutive inadequately treated migraine patients will be randomized to TYPICAL care or to COMPREHENSIVE care. Those patients in the comprehensive care arm will receive the following intervention: 1) reinforcement of diagnosis, 2) an adaptable online educational intervention, reading material, and headache diaries, 3) two migraine specific medications and 4) expedited referral to a headache specialist, if needed. Patients in the typical care arm will receive whatever intervention the emergency physician feels is most appropriate. Headache surveys will be used toll if the protocol improves migraine-related pain and functional disability one month after the ER visit.

Detailed description:

Arms: arm 1: Reinforcement of diagnosis, education, medications, and referral arm 2: Usual care
Interventions: intervention 1: Naproxen intervention 2: Sumatriptan intervention 3: Migraine education intervention 4: Reenforcement of diagnosis intervention 5: Typical care
Intervention descriptions: intervention 1: Naproxen 500mg PO bid prn headache intervention 2: 100mg po q day prn headache intervention 3: Educational program available through NIH/ national library of medicine/ X-plain intervention 4: Patient advised has migraine headache and how the headache meets migraine criteria intervention 5: Care to be determined by attending physician

Protocol documents:
Clinical trial NCT01077739
Conditions: Colorectal Cancer
Sponsor: Hoffmann-La Roche
Start date: 2009-07-01; Completion date: 2012-01-01
Enrollment: 75 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This open-label single arm study will evaluate the efficacy and safety of Avastin added to XELOX or FOLFOX in patients with metastatic colorectal cancer and disease progression on 1st line therapy with FOLFIRI plus Avastin. Patients will receive either Avastin (7.5mg/kg iv infusion every 3 weeks) and standard XELOX (Xeloda \[capecitabine\] plus oxaliplatin) chemotherapy or Avastin (5 mg/kg iv infusion every 2 weeks) and standard FOLFOX (5-FU and leucovorin plus oxaliplatin) chemotherapy. The anticipated time on study treatment is until disease progression, and the target sample size is 100 individuals.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: fluorouracil (5FU) intervention 2: leucovorin intervention 3: bevacizumab [Avastin] intervention 4: capecitabine [Xeloda] intervention 5: oxaliplatin
Intervention descriptions: intervention 1: standard FOLFOX regimen intervention 2: standard FOLFOX regimen intervention 3: 7.5 mg/kg iv infusion every 3 weeks OR 5 mg/kg iv infusion every 2 weeks intervention 4: standard XELOX regimen intervention 5: standard XELOX or FOLFOX regimen

Protocol documents:
Clinical trial NCT01102218
Conditions: End Stage Renal Disease
Keywords: Anemia, ESRD
Sponsor: Fresenius Medical Care North America
Start date: 2010-08-01; Completion date: 2012-01-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Chronic kidney disease (CKD) patients have increased levels of inflammation and oxidative stress, which in turn contribute to anemia and cardiovascular disease.

Pentoxifylline is known to have anti-inflammatory and anti-oxidant properties, and has shown promise in improving the treatment of patients with anemia. This study will examine the use of pentoxifylline for the treatment of anemia in chronic kidney disease.

Detailed description:
Treatment of the anemia of renal failure has been revolutionized by the use of erythropoietin and other ESAs (erythropoiesis-stimulating agent). Concerns with ESA use include a substantial number of End Stage Renal Disease (ESRD) patients with ESA-resistant anemia, and a growing body of evidence of potential negative effects of high doses of ESA use, including increased mortality and increased rate of tumor growth in cancer patients.

There are only a couple of small studies in the literature examining the effects of pentoxifylline on anemia in patients with renal failure. The results are limited by the very small number of patients. There is clearly a need for a larger, prospective, clinical trial of pentoxifylline in ESRD patients, not limited to those with ESA-resistant anemia. This would be the first prospective, randomized clinical trial of this size to study pentoxifylline for the treatment of anemia in chronic kidney disease.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Erythropoietin intervention 2: Erythropoietin intervention 3: Pentoxifylline
Intervention descriptions: intervention 1: Standard of Care intervention 2: Standard of Care intervention 3: 400 mg qd po for 6 months

Protocol documents: