ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00516321
Conditions: Hepatitis C, Chronic
Keywords: thrombopoietin hepatitis C ribavirin platelets Hepatitis C-related thrombocytopenia peginterferon alfa-2a
Sponsor: GlaxoSmithKline
Start date: 2007-10-01; Completion date: 2011-05-01
Enrollment: 687 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the ability of eltrombopag to maintain a platelet count sufficient to facilitate initiation of antiviral therapy, to minimise antiviral therapy dose reductions and to avoid permanent discontinuation of antiviral therapy. The clinical benefit of eltrombopag will be measured by the proportion of subjects who are able to achieve a Sustained Virological Response (SVR).

Detailed description:

Interventions: intervention 1: eltrombopag intervention 2: placebo
Intervention descriptions: intervention 1: 25, 50, 75, 100 mg tablets taken once daily orally intervention 2: matched placebo taken once daily orally

Protocol documents:
Clinical trial NCT00531479
Conditions: Aspergillosis
Sponsor: Pfizer
Start date: 2008-07-01; Completion date: 2011-05-01
Enrollment: 459 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study compares the effectiveness and safety of the combination of anidulafungin and voriconazole compared to that of voriconazole alone (which is generally considered the standard of care) for the treatment of Invasive Aspergillosis.

Detailed description:

Arms: arm 1: Voriconazole monotherapy arm 2: Combination therapy with voriconazole and anidulafungin
Interventions: intervention 1: voriconazole intervention 2: anidulafungin intervention 3: voriconazole
Intervention descriptions: intervention 1: First week: Voriconazole 6 mg/kg IV bid for the first 24 hours, followed by 4 mg/kg IV BID plus anidulafungin placebo IV qd.

Second week: Voriconazole 4 mg/kg IV bid or 300 mg PO bid plus anidulafungin placebo IV qd.

Third and fourth weeks: Voriconazole 4 mg/kg IV bid OR 300 mg PO bid plus anidulafungin placebo IV qd,

OR

Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy.

Fifth and sixth weeks: Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy. intervention 2: First week: Voriconazole 6 mg/kg IV bid for the first 24 hours, followed by 4 mg/kg IV bid plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV qd thereafter.

Second week: Voriconazole 4 mg/kg IV bid or 300 mg PO bid plus anidulafungin 100 mg IV qd.

Third and fourth weeks: Voriconazole 4 mg/kg IV bid OR 300 mg PO bid plus anidulafungin 100 mg IV qd,

OR

Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy.

Fifth and sixth weeks: Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy. intervention 3: First week: Voriconazole 6 mg/kg IV bid for the first 24 hours, followed by 4 mg/kg IV bid plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV qd thereafter.

Second week: Voriconazole 4 mg/kg IV bid or 300 mg PO bid plus anidulafungin 100 mg IV qd.

Third and fourth weeks: Voriconazole 4 mg/kg IV bid OR 300 mg PO bid plus anidulafungin 100 mg IV qd,

OR

Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy.

Fifth and sixth weeks: Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy.

Protocol documents:
Clinical trial NCT00533702
Conditions: Metastatic Malignant Melanoma
Keywords: Phase II Melanoma IMC-1121B ImClone
Sponsor: Eli Lilly and Company
Start date: 2007-11-01; Completion date: 2011-05-01
Enrollment: 106 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to determine the progression-free survival (PFS) of participants with previously untreated metastatic malignant melanoma when treated with IMC-1121B (ramucirumab) alone or in combination with dacarbazine.

Detailed description:
The purpose of this study is to determine the antitumor activity and safety profile of IMC-1121B (ramucirumab) when used alone or in combination with dacarbazine in participants with metastatic melanoma who have not received prior chemotherapy for this disease.

Arms: arm 1: IMC-1121B (ramucirumab) arm 2: IMC-1121B (ramucirumab) + dacarbazine
Interventions: intervention 1: IMC-1121B (ramucirumab) intervention 2: Dacarbazine
Intervention descriptions: intervention 1: 10 milligrams/kilogram (mg/kg) intravenously every 3 weeks in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria. intervention 2: 1000 milligrams/square meter (mg/m2) intravenously every 3 weeks in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.

Protocol documents:
Clinical trial NCT00545662
Conditions: Traumatic Brain Injury
Keywords: traumatic brain injury cognition behavioral outcome functional outcome treatment early intervention citicoline
Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Start date: 2007-07-01; Completion date: 2011-05-01
Enrollment: 1213 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The Citicoline Brain Injury Treatment (COBRIT) is a randomized, double-blind, placebo controlled, multi-center trial of the effects of 90 days of citicoline on functional outcome in patients with complicated mild, moderate and severe traumatic brain injury.

Detailed description:
Traumatic brain injury (TBI) is a major cause of death and disability. In the United States alone approximately 1.4 million sustain a TBI each year, of which 50,000 people die, and over 200,000 are hospitalized. Despite numerous prior clinical trials no standard pharmacotherapy for the treatment of TBI has been established in either the acute or post acute setting. Citicoline is a naturally occurring endogenous compound. This compound offers the potential of employing neuroprotection, neuro-recovery and neurofacilitation to enhance recovery after TBI.

The primary goal of this study is to assess the efficacy of citicoline compared to placebo on functional and cognitive outcome in participants with traumatic brain injury.

Arms: arm 1: Placebo tablets formulated to resemble the citicoline treatment. arm 2: Experimental treatment administered orally or enterally depending upon whether the participant can swallow at 1,000 mg twice a day for 90 days or until the 90-day outcome assessment.
Interventions: intervention 1: Placebo intervention 2: citicoline
Intervention descriptions: intervention 1: Drug Placebo Inactive twice a day given orally or enterally. The first dose is given within 24 hours of injury and treatment continues until 90 days or until the 90-day outcome assessment. intervention 2: 1000 mg twice a day orally or enterally. The first dose is within 24 hours of injury and treatment continues for 90-days or until the 90-day outcome assessment.

Protocol documents:
Clinical trial NCT00546104
Conditions: Advanced Breast Cancer
Keywords: Advanced Breast Cancer Breast cancer Dasatinib Inoperable Stage III Breast Cancer Metastatic Breast Cancer Stage IV Breast Cancer
Sponsor: Duke University
Start date: 2007-10-01; Completion date: 2011-05-01
Enrollment: 31 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to find out if dasatinib will safely reduce the size or spread of your tumor.

Detailed description:
The introduction of biologics with specific molecular targets has initiated a trend toward improved survival in women with metastatic breast cancer.

The tyrosine kinase SRC (pp60src) is a member of a family of proteins that contribute to cellular signal transduction activities such as cell growth, differentiation, survival, adhesion and migration. Abnormal signaling has been linked to cancer metastases; thus, identification of molecular regulators or inhibitors of SRC present therapeutic opportunity for cancer patients. Src kinases consist of eight non-receptor tyrosine kinases (Src, Fyn, Yes, Lck, Lyn, Hck, Fgr and Blk) that interact with the intracellular domains of growth factor/cytokine receptors, (G-protein-coupled receptor)GPCRs and integrins.

Inhibition of SRC has also been associated with reversal of chemoresistance and restored sensitivity to drug-resistant ovarian cancer cells, suggesting potential as second- line treatment for previously treated populations. Dasatinib is a potent, broad spectrum inhibitor of 5 critical oncogenic tyrosine kinases, including SRC.

Patients will receive dasatinib, a Src inhibitor, at an initial dose of 50 mg PO BID, with real-time PharmacoDynamic dose adjustment following 4 weeks of therapy based on inhibition of phosphorylation of SRC, focal adhesion kinase (FAK) and paxillin, until progression. The primary objective is to assess tolerability and estimate the proportion of patients who are progression-free at 16 weeks from the date of study enrollment.

A minimum of 2 (maximum of 3) tumor biopsies will be analyzed and compared for SRC signature: one at baseline (study enrollment, all patients); the second after 4 weeks of dasatinib therapy (all patients); and the third at progression (only patients who progress after a documented response).

Patients will receive continuous daily administration until documented disease progression, and will be followed until death.

The results of this study may be useful in designing future studies using dasatinib alone or in combination with chemotherapy, thus having the potential to alter the current standard of care in this incurable population.

Additional correlative studies will be conducted. Tumor biopsies will be analyzed and compared for SRC, pSRC, Ki67, and related genomic signatures.

Arms: arm 1: 50- 100 mg PO BID
Interventions: intervention 1: Dasatinib
Intervention descriptions: intervention 1: An initial dose of 50 mg PO BID; following 4 weeks of treatment, dose adjustment will be based on inhibition of phosphorylation of FAK and paxillin per biopsy assessment, as well as toxicity assessment.

Protocol documents:
Clinical trial NCT00556504
Conditions: Chronic Hepatitis C
Keywords: add-on treatment botanical drug HCV genotype 1 TCM-700C genotype I
Sponsor: TCM Biotech International Corp.
Start date: 2007-07-01; Completion date: 2011-05-01
Enrollment: 84 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the effectiveness of TCM-700C as an add-on treatment to the combination drug therapy (Peginterferon α-2b plus Ribavirin) for patients with genotype 1 chronic hepatitis C infections. This will be demonstrated by a higher sustained virologic response rate, defined as the absence of detectable HCV RNA 24 weeks after the termination of combinational drug treatment, compared with the placebo add-on.

Detailed description:
This was a randomized, double-blind, placebo controlled, parallel-group, Phase 2 study to evaluate the effects of adding a Chinese formulation (TCM-700C) on the standard combination treatment for patients with Genotype 1 hepatitis C infection. Patients were screened within 4 weeks before receive the first study drug dose. Eligible patients at baseline were stratified according to baseline HCV RNA (≤800,000 IU/ml vs \>800,000 IU/ml) and randomized with an equal chance to receive either TCM-700C or placebo as an add-on to the combination drug therapy. The combination drug therapy was peginterferon α-2b (PEG-INTRON®, Schering-Plough) 1.5 micrograms/kg once weekly injection for 48 weeks plus oral ribavirin (REBETOL®, Shering-Plough) 1000mg-1200mg daily for 48 weeks. The add-on treatment of TCM-700C or placebo was given 2 tablets thrice daily for 48 weeks.

During the 48 week treatment period and 24 week untreated follow-up, patients were assessed at regular intervals for safety and efficacy at weeks 2, 4, 8, 12, 16 and then every 8 weeks thereafter until study completion. Patients who prematurely discontinued test drug therapy had laboratory examination re-taken on the week patient was discontinued from study.

Arms: arm 1: an add-on drug (2 tablets/t.i.d) to conventional treatment(Peginterferon alfa-2a + ribavirin) of Hepatitis C arm 2: placebo add on(2 tablets/t.i.d) to conventional treatment(Peginterferon alfa-2a + ribavirin) of Hepatitis C
Interventions: intervention 1: TCM-700C intervention 2: Peginterferon alfa-2a intervention 3: Ribavirin intervention 4: Placebo
Intervention descriptions: intervention 1: An add-on drug to conventional treatment of Hepatitis C intervention 2: conventional treatment of Hepatitis C intervention 3: conventional treatment of Hepatitis C intervention 4: Placebo, without acting ingredient.

Protocol documents:
Clinical trial NCT00557310
Conditions: Osteoporosis, Postmenopausal
Keywords: osteoporosis, teriparatide, postmenopausal, MRI, finite element analysis
Sponsor: Eli Lilly and Company
Start date: 2007-11-01; Completion date: 2011-05-01
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to use imaging technologies to demonstrate the effects of teriparatide on bone structure following 18 to 24 months of therapy in postmenopausal women with osteoporosis.

Detailed description:
As teriparatide is approved for up to 24 months of treatment in the US, patients will be given the option to continue in a 6-month extension phase upon completion of 18 months of teriparatide treatment. This extension will allow for collection of additional bone quality data. In Canada, the use of teriparatide is currently approved for 18 months. Patients in Canada may be given the opportunity to participate in the 6-month extension phase, contingent upon Health Canada approval of the use of teriparatide treatment for 24 months.

Arms: arm 1: 20 micrograms (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
Interventions: intervention 1: teriparatide
Intervention descriptions: intervention 1: 20 mcg teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months

Protocol documents:
Clinical trial NCT00567879
Conditions: Breast Cancer
Keywords: Breast Cancer HER2 positive adult-female LBH589 HDAC inhibitor panobinostat
Sponsor: Novartis Pharmaceuticals
Start date: 2008-04-01; Completion date: 2011-05-01
Enrollment: 56 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary purpose of this study is to identify the maximum tolerated dose (MTD) of both intravenous and oral panobinostat plus trastuzumab. The study will evaluate safety and efficacy of the combination in adult female patients with HER2+ metastatic breast cancer

Detailed description:
This phase Ib/IIa study was prematurely terminated due to lack of efficacy noted in 55 patients with HER2-positive MBC who had progressed on or following a trastuzumab-based therapy.

Arms: arm 1: Panobinostat intravenously (i.v.) or orally was given in combination with trastuzumab.
Interventions: intervention 1: Panobinostat intervention 2: Trastuzumab
Intervention descriptions: intervention 1: Participants received escalating doses of panobinostat until the maximum tolerated dose (MTD) was reached. The starting dose of panobinostat i.v. was 10mg/m\^2 at days 1 and 8 during a 21-day treatment cycle. The oral panobinostat starting dose was 20 mg twice weekly. intervention 2: Fixed doses of trastuzumab were given in parallel with panobinostat. Trastuzumab i.v. was given weekly according to the instruction in the package insert.

Protocol documents:
Clinical trial NCT00576199
Conditions: Liver Cancer
Sponsor: Hoffmann-La Roche
Start date: 2008-02-01; Completion date: 2011-05-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single-arm, open-label study assessed the efficacy and safety of Avastin (bevacizumab) treatment combined with transarterial chemoembolisation (TACE) in patients with localized unresectable liver cancer. Patients were treated with TACE at 8 or 10 week intervals for 4 sessions (continuation depended on investigator's discretion). Avastin 5 mg/kg intravenously was administered 24-48 hours prior to each TACE session and every 2 weeks between the TACE sessions until disease progression.

Detailed description:

Arms: arm 1: Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals.
Interventions: intervention 1: Bevacizumab intervention 2: Transarterial chemoembolisation (TACE)
Intervention descriptions: intervention 1: Bevacizumab was supplied as a sterile liquid in single-use vials. intervention 2: TACE was conducted by the transfemoral artery approach with selective cannulation of the artery supplying the tumor. Cisplatin mixed with Lipiodol in a 1 mg:1 mL ratio was infused intra-arterially up to a maximum dose of 30 mg, depending on tumor size, followed by embolization of the artery using Gelfoam particle until the blood flow slowed. Bilobar lesions were treated by separate catheterization of right and left hepatic arteries followed by injection of the cisplatin-Lipiodol mixture and embolization.

Patients with stable disease or a partial response after 4 TACE sessions could be given further TACEs upon the investigator's discretion until there was evidence of progressive disease or contraindication due to severe complication or technical failure to perform the TACE.

Protocol documents:
Clinical trial NCT00579553
Conditions: Infant, Premature Premature Birth
Keywords: Pre Term Pre Term Birth Premature Birth Premature baby High risk pregnancy Progesterone IM Progesterone Vaginal Progesterone
Sponsor: University of Oklahoma
Start date: 2006-10-01; Completion date: 2011-05-01
Enrollment: 174 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized controlled trial comparing weekly intramuscular injection of 17 alpha hydroxylprogesterone caproate with daily vaginal progesterone in women with singleton pregnancies and history of prior spontaneous preterm birth in terms of maternal, fetal and neonatal outcomes.

Our aim is to assess the effects on maternal, fetal and neonatal outcomes of antenatal progesterone administered intramuscularly versus vaginally in women with singleton pregnancy and a history of prior preterm birth.

Detailed description:
This study is intended as a randomized controlled trial. Women with singleton pregnancies between 16 and 20 weeks 6 day will be randomized to one of two treatment groups.

Those randomized to weekly intramuscular progesterone will receive 250 mg of 17 alpha hydroxyprogesterone caproate every week in the clinic between randomization and delivery for those delivery preterm or 36 weeks 6 days.

While those randomized to vaginal progesterone will receive 100 mg vaginal progesterone daily at home. Vaginal progesterone to last between clinic visits will be provided to subject. Those women in the vaginal progesterone group will also be informed on how to obtain additional medication in case of missed clinic appointment. Treatment will be continued until 36 weeks 6 days or as dictated by date of preterm delivery.

Arms: arm 1: Intramuscular Progesterone arm 2: Vaginal Progesterone
Interventions: intervention 1: Intramuscular Progesterone intervention 2: Vaginal Progesterone
Intervention descriptions: intervention 1: Intramuscular Progestone: 17 alpha hydroxyprogesterone caproate: weekly 1 cc injections containing 250 mg of 17P intervention 2: Vaginal Progesterone: 100 mg vaginal suppository daily

Protocol documents:
Clinical trial NCT00583011
Conditions: Pregnancy
Keywords: Amniocentesis Genetic amniocentesis Fetal lung maturity Pain control Pregnancy High risk pregnancy
Sponsor: University of Oklahoma
Start date: 2007-10-01; Completion date: 2011-05-01
Enrollment: 76 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is been designed to answer the question of whether local anesthesia (1% lidocaine) decreases the perception of pain associated with amniocentesis in a randomized double blind placebo controlled manner. Our objective is to determine the effect of local anesthesia on the maternal pain perception from an amniocentesis.

Detailed description:
Women meeting criteria for project and agreeing to treatment will be randomized into either the 1% Lidocaine or placebo(normal saline) group. The initial injection of either 1% lidocaine or placebo (normal saline) will be administered 2 minutes prior to the amniocentesis procedure. 2cc of 1% lidocaine or placebo (normal saline) will be initially administered as an intradermal "wheal", followed by a deeper infiltration of the 1% lidocaine or placebo (normal saline) to the depth of the peritoneum. All procedures will be performed by either the Maternal-Fetal medicine (MFM) or the reproductive geneticist utilizing continuous ultrasound guidance under sterile conditions. Each woman will be asked to rate their pain perception immediately after the procedure on two pain scales.

Arms: arm 1: Local anesthesia group. 2cc of 1% lidocaine with epinephrine administered 2 minutes before amniocentesis, using a 21 gauge needle initially as an intradermal wheal followed by a deeper infiltration of 2cc of 1% lidocaine to the depth of the peritoneum. arm 2: Placebo normal saline group. 2cc of normal saline epinephrine administered 2 minutes before amniocentesis, using a 21 gauge needle initially as an intradermal wheal followed by a deeper infiltration of 2cc of normal saline to the depth of the peritoneum.
Interventions: intervention 1: Local Anesthesia intervention 2: Placebo Group
Intervention descriptions: intervention 1: Local anesthesia: 2 cc of 1% Lidocaine intervention 2: Placebo Group: 2cc Normal Saline

Protocol documents:
Clinical trial NCT00603733
Conditions: Active Ulcerative Colitis Remission of Ulcerative Colitis
Keywords: Ulcerative Colitis 5-Aminosalicylate
Sponsor: Ferring Pharmaceuticals
Start date: 2007-10-01; Completion date: 2011-05-01
Enrollment: 288 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to demonstrate that the new modified oral extended-release Pentasa® 500mg tablet is at least as efficacious as the currently marketed Pentasa® 500mg tablet in active mild to moderate Ulcerative Colitis (UC) and also in maintenance of quiescent disease.

Detailed description:
A multi-centre, randomized, double-blind, non-inferiority trial comparing the efficacy and safety of a new modified oral extended release Pentasa® (mesalamine) 500 mg tablet to the currently marketed Pentasa® (mesalamine) 500 mg tablet in subjects with active mild to moderate ulcerative colitis treated with 4 g/day for 8 weeks and in maintenance of remission of ulcerative colitis in subjects treated with 2 g/day for 24 weeks. The study involves male or non-pregnant female subjects aged 18 to 75 years.

Subjects were randomised on entry into the trial, and if they were in remission at the end of the 8-week Active Phase or the 4-week Run-in Phase, they were eligible for enrolment into the 24-week Maintenance Phase, remaining on the original randomised treatment.

Arms: arm 1: 5-ASA (5-Aminosalicylate) arm 2: 5-ASA (5-Aminosalicylate)
Interventions: intervention 1: 5-ASA (5-Aminosalicylate) intervention 2: 5-ASA (5-Aminosalicylate)
Intervention descriptions: intervention 1: 500 mg tablet (modified extended release) intervention 2: 500 mg tablet

Protocol documents: