ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01057810
Conditions: Prostate Cancer
Sponsor: Bristol-Myers Squibb
Start date: 2010-07-01; Completion date: 2015-07-01
Enrollment: 837 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if asymptomatic or minimally symptomatic patients with metastatic prostate cancer who have not received chemotherapy live longer when treated with ipilimumab than those treated with a placebo

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ipilimumab intervention 2: Placebo
Intervention descriptions: intervention 1: 5 mg/ml solution, Intravenous, 10 mg/kg, Every 3 weeks for up to 4 doses in the Induction Phase. Every 12 weeks in the Maintenance Phase. Up to 24 weeks in the Induction Phase. Treatment in the Maintenance Phase continues until total treatment period has reached three years,Treatment Stopping Criteria are met, withdrawal of consent, or study closure intervention 2: Solution, Intravenous, 0 mg, Every 3 weeks for up to 4 doses in the Induction Phase. Every 12 weeks in the Maintenance Phase. Up to 24 weeks in the Induction Phase. Treatment in the Maintenance Phase continues until total treatment period has reached three years,Treatment Stopping Criteria are met, withdrawal of consent, or study closure

Protocol documents:
Clinical trial NCT01575561
Conditions: Bipolar I Disorder
Keywords: Lurasidone Latuda Bipolar Disorder
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2012-06-01; Completion date: 2015-07-01
Enrollment: 377 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, multi-center,12 week extension study designed to evaluate the longer term safety, tolerability and effectiveness of lurasidone, flexibly dosed, adjunctive to lithium or divalproex for the treatment of subjects with bipolar I disorder, who have either completed the core study D1050296 or experienced a protocol defined recurrence of a mood event in the double-blind phase of the core study D1050296

Detailed description:
To evaluate the longer term safety of lurasidone (20, 40, 60 or 80 mg/day) in subjects with bipolar I disorder.

Subjects will be initially treated with open-label lurasidone 40 mg/day (Day 1).

Dose adjustment of study drug (20, 40, 60 or 80 mg /day) should occur at the regularly scheduled visits and in increments/decrements of 1 dose level.

Arms: arm 1: Lurasidone 20, 40, 60,80 mg flexible dose
Interventions: intervention 1: Lurasidone
Intervention descriptions: intervention 1: Lurasidone 20-80 mg taken orally once daily

Protocol documents:
Clinical trial NCT01592500
Conditions: Pediatric Growth Hormone Deficiency
Keywords: GHD r-hGH Long-acting
Sponsor: OPKO Health, Inc.
Start date: 2012-02-01; Completion date: 2015-07-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase II, open label, active-controlled, randomized safety and dose finding study of different MOD-4023 dose levels compared to daily r-hGH therapy in pre-pubertal growth hormone deficient children.

Detailed description:

Arms: arm 1: Once weekly subcutaneous injection of long acting r-hGH (MOD-4023) arm 2: Once weekly subcutaneous injection of long acting r-hGH (MOD-4023) arm 3: Once weekly subcutaneous injection of long acting r-hGH (MOD-4023) arm 4: Once daily subcutaneous injection of Somatropin (r-hGH; Genotropin)
Interventions: intervention 1: MOD-4023 intervention 2: Somatropin
Intervention descriptions: intervention 1: Once weekly subcutaneous injection intervention 2: Once daily subcutaneous injection of Genotropin

Protocol documents:
Clinical trial NCT01644188
Conditions: Hypercholesterolemia
Sponsor: Sanofi
Start date: 2012-08-01; Completion date: 2015-07-01
Enrollment: 720 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9).

Primary Objective of the study:

To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable maximally tolerated daily statin therapy in comparison with ezetimibe after 24 weeks of treatment in participants with hypercholesterolemia at high cardiovascular (CV) risk.

Secondary Objectives:

* To evaluate the effect of alirocumab in comparison with ezetimibe on LDL-C at other time points
* To evaluate the effect of alirocumab on other lipid parameters
* To evaluate the safety and tolerability of alirocumab

Detailed description:
The maximum study duration was 115 weeks per participant, including a 3-week screening period, 104-week randomized treatment period and 8-week follow-up period.

Arms: arm 1: Alirocumab 75 mg every 2 weeks (Q2W) and oral placebo capsule for ezetimibe daily added to stable Lipid Modifying Therapy (LMT) for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8. arm 2: Ezetimibe 10 mg capsule daily and subcutaneous placebo for alirocumab Q2W added to stable LMT for 104 weeks.
Interventions: intervention 1: Alirocumab intervention 2: Placebo (for alirocumab) intervention 3: Ezetimibe intervention 4: Placebo (for ezetimibe) intervention 5: Lipid Modifying Therapy (LMT)
Intervention descriptions: intervention 1: 1 mL subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using the autoinjector. intervention 2: 1 mL subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using the autoinjector. intervention 3: One over-encapsulated tablet orally once daily at approximately the same time of the day with or without food. intervention 4: One capsule once daily orally at approximately the same time of the day with or without food. intervention 5: Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose.

Protocol documents:
Clinical trial NCT01785875
Conditions: Hyperparathyroidism, Secondary
Keywords: Secondary Hyperparathyroidism (SHPT), chronic kidney disease (CKD), hemodialysis, parathyroid hormone (PTH), hypocalcemia, bone and mineral metabolism
Sponsor: Amgen
Start date: 2013-07-31; Completion date: 2015-07-01
Enrollment: 891 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is designed to describe the long-term safety and efficacy of etelcalcetide (AMG 416) for the treatment of SHPT in adults with CKD on hemodialysis.

Detailed description:

Arms: arm 1: Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Interventions: intervention 1: Etelcalcetide
Intervention descriptions: intervention 1: Administered by bolus injection into the venous line of the dialysis circuit at the end of hemodialysis treatment, and prior to or during rinse-back with each hemodialysis session (ie, 3 times per week).

Protocol documents:
Clinical trial NCT01854697
Conditions: Chronic Hepatitis C Infection
Keywords: Chronic Hepatitis C Interferon Free Hepatitis C Treatment Naive Hepatitis C Virus Hepatitis C Genotype 1
Sponsor: AbbVie
Start date: 2013-03-01; Completion date: 2015-07-01
Enrollment: 311 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study to evaluate the efficacy and safety of three experimental drugs compared with telaprevir (a licensed product) in people with hepatitis C virus infection who have not had treatment before.

Detailed description:
The primary purpose of this study is to demonstrate that treatment with ABT-450/ritonavir (r)/ABT-267 and ABT-333 administered with or without ribavirin (RBV) has non-inferior efficacy compared to treatment with telaprevir and pegylated interferon alpha-2a (pegIFN) and RBV and to compare the safety of these regimens in treatment-naive hepatitis C virus (HCV) genotype (GT) 1a- and 1b-infected adults.

Arms: arm 1: ABT-450/r/ABT-267 150 mg/100 mg/25 mg once daily (QD) and ABT-333 250 mg twice daily (BID) and weight-based RBV for 12 weeks (3 direct-acting antivirals \[DAAs\] with RBV in GT1a) arm 2: Telaprevir (TPV) 750 mg every 8 hours (q8h) and pegIFN 180 µg/week and weight-based RBV (PR) for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight-based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a) arm 3: ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b) arm 4: ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b) arm 5: Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight-based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
Interventions: intervention 1: ABT-450/r/ABT-267, ABT-333 intervention 2: Ribavirin intervention 3: Telaprevir intervention 4: Pegylated Interferon alpha 2-a (PegIFN)
Intervention descriptions: intervention 1: Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet intervention 2: Tablet intervention 3: Film-coated tablet intervention 4: Pre-filled syringe

Protocol documents:
Clinical trial NCT00351468
Conditions: Purpura, Thrombocytopaenic, Idiopathic
Keywords: eltrombopag olamine SB-497115-GR idiopathic thrombocytopenic purpura thrombocytopenia ITP platelets
Sponsor: Novartis Pharmaceuticals
Start date: 2006-06-01; Completion date: 2015-07-01
Enrollment: 302 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
An open-label, dose-adjustment, extension study to evaluate the safety and efficacy of eltrombopag for the treatment of subjects with idiopathic thrombocytopenic purpura (ITP) who have previously been enrolled in an eltrombopag trial. This study will allow adjustment of the eltrombopag dose to achieve an individualized dose and schedule for each subject. In addition, the ability to reduce the dose of concomitant ITP medications in the presence of eltrombopag, while maintaining platelet counts = 50,000/μL will be investigated.

Detailed description:

Arms: arm 1: Open-label eltrombopag
Interventions: intervention 1: eltrombopag olamine (SB-497115-GR)
Intervention descriptions: intervention 1: Eltrombopag with starting dose of 50mg daily, max dose of 75mg daily and min dose of 25mg daily or less frequently. Modifications were given to maintain platelet count in range of 50 to 200 Gi/L.

Protocol documents:
Clinical trial NCT00355030
Conditions: Idiopathic Short Stature (ISS)
Sponsor: Eli Lilly and Company
Start date: 2006-06-01; Completion date: 2015-07-01
Enrollment: 91 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The present randomized trial was initially intended to study the benefits of a combined treatment with growth hormone (GH) and a gonadotropin-releasing hormone (GnRH) agonist for pubertal children with idiopathic short stature. However, treatments were stopped in January 2012 at the request of the French drug agency. Therefore, a protocol amendment divided the study in two study periods.

Study Period 1 involved combined treatment with somatropin and leuprorelin or treatment with somatropin alone. Participants from France who participated in this Period 1 of the study were asked to participate in a long term safety follow up defined as a Period 2 of the study. Participants from the Netherlands were offered participation in Genetics and Neuroendocrinology of Short Stature International Study (GeNeSIS, clinicaltrials.gov Identifier: NCT01088412) for long term safety follow up independent of this study.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: somatropin intervention 2: leuprorelin
Intervention descriptions: intervention 1: 0.05 mg/kg/day intervention 2: 11.25 mg/3 months

Protocol documents:
Clinical trial NCT00463346
Conditions: Alcohol Dependence Schizophrenia
Keywords: Treatment Alcohol Dependence Schizophrenia
Sponsor: Yale University
Start date: 2006-09-01; Completion date: 2015-07-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this study is to evaluate the safety and efficacy of acamprosate for patients with alcohol dependence and comorbid schizophrenia spectrum disorders.

* 1: Relative to placebo, acamprosate will significantly increase cumulative days of abstinence in recently detoxified alcohol dependent schizophrenia patients measured by Timeline Follow-Back (TLFB) method.
* 2: Acamprosate will have no significant effect on the psychotic symptoms in schizophrenia patients with alcohol dependence as measured by the Positive and Negative Syndrome Scale (PANSS).

Detailed description:
Alcohol use disorders (AUD) are common comorbid conditions in patients with schizophrenia, and they cause a negative impact on the expression and course of schizophrenia. Improvements have been reported after attaining abstinence from alcohol, suggesting that effective treatments for AUD lead to clinically meaningful results. Acamprosate is a recently approved treatment for alcoholism, and it may be advantageous over other treatments since is not metabolized in the liver, and it has been used safely with other psychotropic medications. Therefore, acamprosate would be a promising treatment in schizophrenia patients. However, there are only few reports in the current literature evaluating the efficacy of medications available for the treatment of alcoholism in patients with schizophrenia, and the efficacy and safety of acamprosate have never been studied in this vulnerable group of patients.

Research Design:

This is a 12-week, randomized, double blind, placebo controlled trial of acamprosate (666 mg tid) in addition to neuroleptics in 30 recently abstinent (\>5 days) schizophrenia patients with comorbid alcohol dependence.

Methods:

The study will be conducted at the West Haven, CT VA with support from Forest Laboratories. Patients who are between 21 and 65, with a diagnosis of schizophrenia spectrum disorder, (on stable psychotropic treatment \> 2 weeks) and with current alcohol dependence (\>1 recent episode of heavy drinking) will be included. Patients will be willing to undergo detoxification or self discontinuation \>2weeks prior to the randomization. Main outcome variables include the TLFB method to document the degree of daily alcohol consumption, and PANSS, to assess the psychotic symptoms.

Arms: arm 1: Acamprosate arm 2: placebo
Interventions: intervention 1: Acamprosate intervention 2: Placebo
Intervention descriptions: intervention 1: Acamprosate 1998 mg tid intervention 2: Placebo

Protocol documents:
Clinical trial NCT00478699
Conditions: Non-small-cell Lung Cancer
Keywords: SCAT BRCA1 BRCA1 mRNA Levels ADJUVANT LUNG GECP-SCAT
Sponsor: Spanish Lung Cancer Group
Start date: 2007-06-01; Completion date: 2015-07-01
Enrollment: 500 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Randomized Study of Customized Adjuvant Chemotherapy based on BRCA1 mRNA Levels in Completely Resected stages II-IIIA Non-Small-Cell Lung Cancer Patients.

Detailed description:
Randomized, phase III, predictive pharmacogenomic, open, prospective, international, multicenter study in patients with non-small-cell lung carcinoma (NSCLC) after complete resection and with N1 or N2 involvement

Arms: arm 1: Control group:

\*Docetaxel 75 mg/m2, and cisplatin 75 mg/m2, both on day 1, every 21 days. Total cycles: Four. arm 2: Experimental group, according to the BRAC1 levels of the tumor tissue, will be assigned one of the following treatments:

* Low expression of BRCA1 → gemcitabine 1250 mg/m2, days 1 and 8, and cisplatin 75 mg/m2, day 1. Cycles every 21 days. Total cycles: 4
* Intermediate expression levels of BRCA1 → docetaxel 75 mg/m2, and cisplatin 75 mg/m2, both administered on day 1, every 21 days. Total cycles: 4.
* High expression levels of BRCA1 → docetaxel 75 mg/m2, day 1. Cycles every 21 days. Total cycles: 4.
Interventions: intervention 1: Docetaxel/Cisplatin control intervention 2: Docetaxel intervention 3: Gemcitabine/Cisplatin intervention 4: Docetaxel/Cisplatin
Intervention descriptions: intervention 1: Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 day 1, 4 cycles intervention 2: Docetaxel 75 mg/m2 day 1, 4 cycles intervention 3: Gemcitabine 1250 mg/m2, day 1 and 8 and cisplatin 75 mg/m2 day 1, 4 cycles intervention 4: Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 day 1, 4 cycles

Protocol documents:
Clinical trial NCT00559845
Conditions: Breast Cancer
Sponsor: Hoffmann-La Roche
Start date: 2008-02-01; Completion date: 2015-07-01
Enrollment: 56 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will assess the efficacy and safety of sequential neoadjuvant chemotherapy and bevacizumab (Avastin), before surgery and/or radiotherapy, in participants with inflammatory or locally advanced operable breast cancer. Participants will receive 5-fluorouracil, epidoxorubicin and cyclophosphamide (FEC), followed by paclitaxel, given concomitantly with bevacizumab. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Detailed description:

Arms: arm 1: Participants will receive FEC, followed by paclitaxel, given concomitantly with bevacizumab for approximately 3-12 months.
Interventions: intervention 1: 5-fluorouracil intervention 2: Epidoxorubicin intervention 3: Cyclophosphamide intervention 4: Paclitaxel intervention 5: Bevacizumab
Intervention descriptions: intervention 1: 600 milligrams per meter squared (mg/m\^2) as an intravenous (i.v.) bolus over ≤15 minutes every 3 weeks for 4 cycles. intervention 2: 90 mg/m\^2 as an i.v. infusion over 1 hour every 3 weeks for 4 cycles. intervention 3: 600 mg/m\^2 as an i.v. infusion over 1 hour every 3 weeks for 4 cycles. intervention 4: Paclitaxel was administered at 80 mg/m\^2 i.v. over 1 hour weekly for 12 weeks. intervention 5: Bevacizumab was administered at 10 milligrams per kilogram (mg/kg) i.v. every 2 weeks for 6 cycles.

Protocol documents:
Clinical trial NCT00562315
Conditions: Prostate Cancer
Sponsor: David M. Schuster, MD
Start date: 2007-10-01; Completion date: 2015-07-01
Enrollment: 128 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Hypothesis:Anti-\[18F\]FACBC PET-CT will adequately detect local and extraprostatic recurrence, and lead to better characterization of disease status in restaging patients.

This is a study that will test a compound (chemical substance) that has a small amount of radioactivity attached to it. This substance has a natural tendency to go to prostate tissue. The substance is called \[18\]FACBC and it is given in the form of an injection into a vein. After the substance reaches the prostate, scans called PET or Positron Emission Tomography, are done. This is similar to having CAT scans or x-rays. Usually a compound called \[18\]FDG is used for PET scans but this substance is eliminated by the kidneys and cannot reach the prostate. This substance called \[18\]FACBC is not eliminated by the kidneys and may allow tumors in the prostate to be seen better. It is sometimes difficult to tell if a growth on the prostate is cancer with scans or x-rays that are usually done.

Anti-\[18F\]FACBC PET-CT will be compared to ProstaScint (In-capromab pendetide) which is the conventional imaging for prostate cancer. Investigators will be blinded of the intervention.

This study will look at how the \[18\]FACBC goes into the prostate tissue and determine its ability to detect recurrent prostate cancer.

Detailed description:

Arms: arm 1: Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer will undergo an FACBC PET-CT scan and the ProstaScinct CT.
Interventions: intervention 1: FACBC intervention 2: ProstaScinct
Intervention descriptions: intervention 1: Anti-3-\[18F\]FACBC is an investigational positron emission tomography (PET) radiotracer being studies given intravenously prior to PET scan intervention 2: ProstaScint (In-Capromab Pendetide) is used to image the extent of prostate cancer in standard practice. Capromab is a mouse monoclonal antibody which recognizes prostate specific membrane antigen from prostate cancer cells and normal prostate tissue. It is given intravenously prior to undergoing CT imaging.

Protocol documents:
Clinical trial NCT00626639
Conditions: Mucositis Head and Neck Cancer
Keywords: palifermin Clinical Trial Oncology Head & Neck
Sponsor: Swedish Orphan Biovitrum
Start date: 2005-07-01; Completion date: 2015-07-01
Enrollment: 5 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Oral Mucositis associated with adjuvant radiation and concurrent chemotherapy in postoperative Head and Neck setting

Detailed description:
This study consisted of 2 phases. The acute oral mucositis (OM) evaluation phase includes the time from randomization to the time of severe OM (WHO Grade 3 or 4) resolution (up to Week 12 or up to Week 15 for participants whose severe OM is not resolved at Week 12). In the acute OM evaluation phase, participants were randomized to receive either a single IV bolus dose of palifermin or placebo at 120 μg/kg, 3 days before the start of radiotherapy, plus 7 once-weekly palifermin or placebo doses at the same dose level during a 7-week radio/chemotherapy course. In the long-term follow up phase, participants are followed until death, withdrawal of consent, or loss to follow-up. The long-term follow up phase is still ongoing.

Arms: arm 1: Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m\^2 on days 1, 22 and 43. arm 2: Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m\^2 on days 1, 22 and 43.
Interventions: intervention 1: Placebo intervention 2: palifermin intervention 3: Radiotherapy intervention 4: Cisplatin
Intervention descriptions: intervention 1: Administered by intravenous (IV) bolus injection intervention 2: Administered by intravenous (IV) bolus injection intervention 3: Once daily irradiation of 20 centigray (cGy)/day x 33 fractions for a total target dose of 6600 cGy (conventional radiation therapy using standard fractionation \[one fraction per day\]) intervention 4: 100 mg/m\^2 intravenously (IV) on days 1, 22 and 43.

Protocol documents: