ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02074982
Conditions: Chronic Plaque Type Psoriasis
Keywords: chronic plaque type psoriasis, secukinumab, ustekinumab, inflammatory skin disease, scaling
Sponsor: Novartis Pharmaceuticals
Start date: 2014-02-26; Completion date: 2016-06-29
Enrollment: 676 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study assessed efficacy of secukinumab, compared to ustekinumab, in patients that have plaque-type psoriasis

Detailed description:

Arms: arm 1: patients received AIN457 (secukinumab) 300 mg (two secukinumab 150 mg injections) s.c. (subcutaneously) once every week at weeks 0, 1,2,3, followed by monthly dosing starting at week 4 to week 48 inclusive arm 2: patients received ustekinumab 45/90 mg (weight depended, according to label) s.c. (subcutaneously) and/or placebo secukinumab injections once every week at weeks 0,1,2, and 3 followed by monthly dosing starting at week 4 to week 48 inclusive
Interventions: intervention 1: AIN457 300 mg intervention 2: ustekinumab 45/90 mg intervention 3: placebo secukinumab
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: Placebo

Protocol documents:
Clinical trial NCT01745848
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Roflumilast COPD
Sponsor: University of Pittsburgh
Start date: 2013-02-01; Completion date: 2016-06-30
Enrollment: 26 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Our primary hypothesis is that Roflumilast (500 μcg, once daily) will significantly decrease surrogate markers of bone metabolism and early cardiovascular disease in individuals with moderate to severe airflow obstruction and a chronic bronchitis phenotype.

Detailed description:
Study participants will be given Roflumilast 500 micrograms daily for 30 days. At baseline, prior to drug administration, blood samples will be collected for analysis of markers of bone metabolism (C-terminal telopeptide of Type I Collagen (CTx), Amino-terminal Propeptide of Type-1 Procollagen (P1NP) and participants will undergo measurement of endothelial function with measurement of brachial flow mediated dilation. After completion of one month of Roflumilast therapy, participants will have a repeat blood collection for measurement of CTx and P1NP and repeat measurement of brachial flow mediated dilation testing.

Arms: arm 1: Roflumilast 500 μcg, once daily, for 30 days
Interventions: intervention 1: Roflumilast
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01955837
Conditions: Colorectal Cancer
Sponsor: Taiho Pharmaceutical Co., Ltd.
Start date: 2013-09-01; Completion date: 2016-06-30
Enrollment: 406 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the effects of TAS-102 with placebo in patients with metastatic colorectal cancer refractory or intolerable to standard chemotherapies.

Detailed description:
This is a multinational, double-blind, two-arm, parallel, randomized Phase 3 comparison study evaluating the efficacy and safety of TAS-102 versus placebo in patients with refractory metastatic colorectal cancer. Patients will be randomly assigned (2:1) to TAS-102 (experimental arm) or placebo (control arm).

Arms: arm 1: None arm 2: None
Interventions: intervention 1: TAS-102 intervention 2: Placebo
Intervention descriptions: intervention 1: TAS-102 (35 mg/m2/dose) orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met. intervention 2: Placebo orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met.

Protocol documents:
Clinical trial NCT02402166
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Sponsor: Shire
Start date: 2015-04-15; Completion date: 2016-06-30
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to gain initial safety, tolerability, pharmacokinetic, and efficacy information on SPD489 in preschool children 4-5 years old who are diagnosed with ADHD. Generating such data will provide data on the use of SPD489 in the preschool ADHD population.

Detailed description:

Arms: arm 1: There are 4 periods in this study: 1)screening and washout; 2) Dose Optimization; 3) Dose Maintenance; 4) Safety Follow-up. SPD489 will be used to treat all subjects.
Interventions: intervention 1: SPD489
Intervention descriptions: intervention 1: All subjects will begin with 5mg of SPD489 daily and will be titrated until optimal dose is reached (5, 10, 15, 20, and 30mg)

Protocol documents:
Clinical trial NCT02472886
Conditions: Hepatitis C Virus Infection
Keywords: HCV genotype 1 HCV Sustained Virologic Response Direct Acting Antiviral Combination Therapy GS-7977 GS-5885 Ribavirin Sofosbuvir ledipasvir Hepatitis C Hepatitis C, Chronic Liver Diseases Virus Diseases Antiviral Agents HCV/HIV co-infection
Sponsor: Gilead Sciences
Start date: 2015-06-17; Completion date: 2016-06-30
Enrollment: 153 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) with or without ribavirin (RBV) in adults with chronic hepatitis C virus (HCV) infection.

Detailed description:

Arms: arm 1: Treatment-naive participants with genotype 1 HCV infection without cirrhosis will receive LDV/SOF FDC for 8 weeks. arm 2: Treatment-naive participants with genotype 1 HCV infection without cirrhosis and who are coinfected with HIV-1 will receive LDV/SOF FDC for 8 weeks. arm 3: Participants with genotype 1 or 3 HCV infection who failed to achieve SVR12 in Gilead Study GS-US-334-0119 will receive LDV/SOF FDC + RBV for 12 weeks.
Interventions: intervention 1: LDV/SOF intervention 2: RBV
Intervention descriptions: intervention 1: 90/400 mg FDC tablet administered orally once daily intervention 2: Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Protocol documents:
Clinical trial NCT02597543
Conditions: Heart Transplant Acute Graft Rejection Chronic Graft Rejection
Keywords: heart transplantation cardiac MRI graft rejection nonspecific allograft dysfunction allograft vasculopathy
Sponsor: Paul Kim
Start date: 2015-11-01; Completion date: 2016-06-30
Enrollment: 14 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators will use cardiac MRI to measure the myocardial perfusion reserve and amount of myocardial edema and fibrosis in heart-transplant patients with nonspecific allograft dysfunction in contrast to those with normal graft function. The investigators hypothesize that patients with nonspecific allograft dysfunction will demonstrate decreased myocardial perfusion reserve, related to microvascular allograft vasculopathy, compared to those with normal graft function.

Detailed description:
Adult heart-transplant patients, excluding those with a GFR less than 30 mL/min/1.73m2, contraindications to MRI and allergies to either regadenoson or gadolinium contrast, will be enrolled over 10 months. Patients will be recruited from UC San Diego and San Diego Veterans Affairs. The investigators will specifically enroll patients with nonspecific allograft dysfunction and patients with normal graft function.

Brief protocol:

Cardiac MRI is performed. Cine images in standard views are obtained. T2 mapping sequences are performed on short axis images. For stress imaging, intravenous regadenoson is given as a 0.4 mg bolus followed by a 5 mL saline flush. After 30 seconds, short-axis images are acquired for 30 consecutive heartbeats with administration of gadolinium. Rest imaging is performed 30 minutes after stress imaging. Lastly, late gadolinium enhancement images are obtained in standard views. Images are analyzed offline by a blinded independent reader. Patients will be followed for one month after enrollment for MACE.

Arms: arm 1: Patients with nonspecific allograft dysfunction will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart. arm 2: Patients with normal graft function will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.
Interventions: intervention 1: Regadenoson intervention 2: Gadolinium intervention 3: Cardiac MRI
Intervention descriptions: intervention 1: For use in stress myocardial perfusion imaging. intervention 2: For use in both perfusion imaging and late gadolinium enhancement. intervention 3: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart.

Protocol documents:
Clinical trial NCT01709110
Conditions: Postmenopausal Osteoporosis
Keywords: Bone Loss Vertebral fractures
Sponsor: Eli Lilly and Company
Start date: 2012-10-01; Completion date: 2016-07-01
Enrollment: 1366 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of participation in this study is to answer whether teriparatide is superior to risedronate in reducing the occurrence of new vertebral fractures during 24 months of therapy.

Detailed description:

Arms: arm 1: Teriparatide 20 microgram (µg) administered by subcutaneous (SC) injection once daily for 24 months.

Placebo given orally once weekly for 24 months.

Elemental Calcium 500 to 1000 milligram per day and Vitamin D 400 to 800 International Units per day, both administered orally once daily while receiving treatment. arm 2: Risedronate 35 milligram (mg) administered orally once weekly for 24 months.

Placebo given by SC injection once daily for 24 months.

Elemental Calcium 500 to 1000 milligram per day and Vitamin D 400 to 800 International Units per day, both administered orally once daily while receiving treatment.
Interventions: intervention 1: Teriparatide intervention 2: Risedronate intervention 3: Placebo intervention 4: Calcium intervention 5: Vitamin D
Intervention descriptions: intervention 1: Administered SC intervention 2: Administered orally intervention 3: Teriparatide arm placebo administered orally.

Risedronate arm placebo administered SC. intervention 4: Administered orally intervention 5: Administered orally

Protocol documents:
Clinical trial NCT02273180
Conditions: Type 1 Diabetes Mellitus
Sponsor: Sanofi
Start date: 2014-10-01; Completion date: 2016-07-01
Enrollment: 507 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Objective:

To demonstrate non-inferiority of SAR342434 versus Humalog in glycated haemoglobin A1c (HbA1c) change from baseline to Week 26 in participants with type 1 diabetes mellitus (T1DM) also using insulin glargine.

Secondary Objectives:

To assess the immunogenicity of SAR342434 and Humalog in terms of positive/negative status and antibody titers at baseline and during the course of the study.

To assess the relationship of anti-insulin antibodies with efficacy and safety including during the safety extension.

To assess the efficacy of SAR342434 and Humalog in terms of proportion of participants reaching target HbA1c (\<7%), Fasting plasma glucose (FPG), self-measured plasma glucose (SMPG) profiles, and insulin dose.

To assess safety of SAR342434 and Humalog.

Detailed description:
The study consisted of a:

* Up to 2 weeks screening period
* 26-week treatment period
* 26-week comparative safety extension period
* 1-day follow-up period
* The maximum study duration would be 54 weeks per participant and a 1-day safety follow-up

Arms: arm 1: SAR342434 before meals intake on top of once daily (QD) Insulin Glargine, up to Week 52. arm 2: Humalog before meals intake on top of QD Insulin Glargine, up to Week 52.
Interventions: intervention 1: SAR342434 intervention 2: Humalog intervention 3: Insulin glargine HOE901
Intervention descriptions: intervention 1: SAR342434 100 U/mL (dose range of 1 Unit to 80 Units) self-administered by deep subcutaneous (SC) injection, immediately (within 5-10 minutes) before meal intake. Dose adjusted to achieve a 2-hour post prandial plasma glucose (PPG) in range of 6.7 to 8.9 mmol/L (120 to 160 mg/dL) while avoiding hypoglycemia. intervention 2: Humalog 100 U/mL (dose range of 1 unit to 60 units) self-administered by deep SC injection, immediately (within 5-10 minutes) before meal intake. Dose adjusted to achieve a 2 hour PPG in range of 6.7 to 8.9 mmol/L (120 to 160 mg/dL) while avoiding hypoglycaemia. intervention 3: Insulin glargine 100 U/mL injected QD subcutaneously consistent with the local label. Doses adjusted to achieve glycemic target for fasting, preprandial plasma glucose (SMPG) between 4.4 to 7.2 mmol/L (80 to 130 mg/dL) without hypoglycemia.

Protocol documents:
Clinical trial NCT00543127
Conditions: Breast Cancer
Keywords: luminal anastrozole fulvestrant early breast cancer HR+/HER2-
Sponsor: Spanish Breast Cancer Research Group
Start date: 2007-11-01; Completion date: 2016-07-01
Enrollment: 870 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Postmenopausal women with hormone receptor positive and negative Her2 tumours.

Before randomization, the patients will be stratified according to the center, positive nodes (0 vs. 1-3 vs. ≥4), previous chemotherapy (yes vs no) and hormonal receptors status.

Detailed description:
It is expected that disease-free survival for patients receiving Anastrozole alone for 5 years will be up to 90%. An increase of 3% in disease-free survival (DFS) is expected in the arm of Fulvestrant plus Anastrozole, i.e a DFS of up to 93%. They will be required 1358 patients per treatment group (i.e, 2716 patients in total) to give 80% power, alfa bilateral 0.05, and OR 0.6888. Assuming 5% screening failures 2852 patients are required to enter the study. In Jun-2010 the recruitment was stopped due to lack of support of the financier based on the result of Faslodex® and Arimidex® in Combination Trial (FACT-trial), comparing Fulvestrant + Anastrozole vs Anastrozole alone in 1st relapse showed no difference in time to progression at more than 40 months follow-up.

Arms: arm 1: Fulvestrant loading dose regimen will consist of two 5 ml intramuscular injections on day 0 (500 mg), 250 mg single injection on days 14 and 28, and 250 mg single injection every 28 days thereafter for 3 years plus Anastrozole 1 mg PO once daily for 5 years arm 2: Anastrozole 1 mg will be administered orally as one tablet daily for 5 years.
Interventions: intervention 1: Fulvestrant intervention 2: Anastrozole
Intervention descriptions: intervention 1: 500 mg Im Fulvestrant day 0, 250 mg days 14 and 28(charge dose); later 250 mg each 28 days during 3 years plus 1 mg oral Anastrozole per day during 5 years. intervention 2: 1 mg oral Anastrozole per day during 5 years.

Protocol documents:
Clinical trial NCT00624923
Conditions: Coronary Artery Disease Overweight
Keywords: Coronary Artery Disease Inflammation Overweight Metabolic Syndrome Salsalate
Sponsor: Joslin Diabetes Center
Start date: 2008-09-01; Completion date: 2016-07-01
Enrollment: 340 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The hypothesis is that western lifestyle, with sedentary behaviors and caloric excess promote a chronic, subacute inflammatory state that participates in the development and progression of atherosclerosis. We will evaluate the effects of targeting inflammation using the anti-inflammatory drug salsalate, compared to placebo, on coronary artery plaque volume assessed by multi-detector computed tomographic angiography (MDCTA). The TINSAL-CVD study is a randomized, double-masked, placebo-controlled, 2 arm, clinical trial.

The purpose of the study is to compare the effect of salsalate or placebo on sub-acute inflammation and coronary plaque, in people with cardiovascular disease. Participants are randomized to active intervention (salsalate) or placebo interventions for a period of 30 months. The primary endpoint is change in plaque volume in the coronary arteries assessed by MDCTA from baseline to 30 months.

Detailed description:
OBJECTIVE:

To determine whether targeting inflammation using salsalate compared with placebo reduces progression of noncalcified coronary artery plaque.

DESIGN, SETTING, AND PARTICIPANTS:

In the Targeting Inflammation Using Salsalate in Cardiovascular Disease (TINSAL-CVD) trial participants were randomly assigned to 30 months of salsalate or placebo in addition to standard, guideline-based therapies. Randomization was computerized and centrally allocated, with patients, health care professionals, and researchers masked to treatment assignment. Participants were overweight and obese statin-using patients with established, stable coronary heart disease.

INTERVENTIONS:

Salsalate (3.5 g/d) or placebo orally over 30 months.

MAIN OUTCOMES AND MEASURES:

The primary outcome was progression of noncalcified coronary artery plaque assessed by multidetector computed tomographic angiography. Secondary outcomes were other measures of safety and efficacy.

Arms: arm 1: Salsalate arm 2: Placebo
Interventions: intervention 1: Salsalate intervention 2: Placebo
Intervention descriptions: intervention 1: Salsalate, 500 mg, seven tablets daily by mouth, divided into two doses, for 30 months intervention 2: Placebo matched to Salsalate, seven tablets daily by mouth, divided into two doses, for 30 months

Protocol documents:
Clinical trial NCT00721630
Conditions: Breast Cancer
Keywords: CAPECITABINE LAPATINIB
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2008-07-01; Completion date: 2016-07-01
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
HER2 is a protein that sits on the surface of breast cancer cells in some people. Because you are one of these people, your breast cancer is called "HER2-positive." The HER2 protein is involved in the growth of your breast cancer. Certain drugs can interfere with the ability of the HER2 protein to cause breast cancer growth. Trastuzumab is one of these drugs. You must have already received trastuzumab as treatment for your breast cancer to be considered for this study.

Other drugs are being studied in women with HER2-positive breast cancer. Lapatinib (Tykerb™) blocks signals that stimulate HER2-positive breast cancers to grow. The FDA approved lapatinib for use with capecitabine (Xeloda™) in patients who have metastatic breast cancer that has grown or spread after treatment with trastuzumab.

Capecitabine was approved by the FDA in 1998 for treating metastatic breast cancer. Capecitabine is a pill that blocks the way cancer cells multiply and grow. Usually, this medicine is taken twice a day for fourteen days. Then, patients do not take the pill for seven days. With this schedule and dose, some patients have had side effects that interfered with their comfort. We have used mathematical models to recommend a new schedule of capecitabine. In animals, 7 days of treatment with capecitabine followed by a 7-day break was safer and more active against breast cancer. The purpose of this study is to find out what effect (both good and bad) capecitabine has on you and your breast cancer when given in this new schedule and combined with lapatinib.

Detailed description:

Arms: arm 1: The regimen consists of capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily.
Interventions: intervention 1: capecitabine, lapatinib
Intervention descriptions: intervention 1: Capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily. Cycle length is 28 days (+/- 2 days).Toxicity assessment will occur q2 weeks for the first 4 weeks, then q4 weeks(+/- 2 days). Radiographic response assessment will take place q12 weeks (+/- 1 week). LVEF assessment will be repeated q12 weeks (+/- 1 week).

Protocol documents:
Clinical trial NCT00988559
Conditions: HPV16 Positive Cervical Intraepithelial Neoplasia (CIN 2/3)
Keywords: high grade cervical dysplasia treatment vaccine therapeutic HPV DNA vaccine gene therapy gene gun pre-cancerous
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Start date: 2009-09-01; Completion date: 2016-07-01
Enrollment: 132 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will test the efficacy and safety of different routes of administration of a DNA vaccine in patients with HPV16+ CIN2/3. Subjects will be enrolled in one of six treatment groups. Subjects enrolled in the first two groups will receive vaccination intradermally with a needle-free delivery device. Subjects enrolled in groups 3 and 4 will receive vaccination intramuscularly. Subjects enrolled in groups 5 and 6 will receive vaccine intralesionally.

Detailed description:
Primary Objectives

* To evaluate the feasibility and toxicity of vaccination in women with CIN2/3 caused by HPV16
* To evaluate the effect of vaccination on histology
* To compare immunogenicity of three different routes of administration: intradermal (ID), intramuscular (IM), intralesional (IL).

Secondary Objectives:

* To evaluate changes in HPV viral load
* To evaluate the cellular immune response to vaccination
* To evaluate the humoral immune response to vaccination
* To evaluate local tissue immune response
* To correlate measures of immune response with clinical response
* To correlate measures of immune response with those observed in the preclinical model

Arms: arm 1: Subjects will receive pNGVL4a-CRT/E7(detox) via gene gun at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15. arm 2: Subjects will receive pNGVL4a-CRT/E7(detox) intramuscularly at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15. arm 3: Subjects will receive pNGVL4a-CRT/E7(detox) intra-mucosally at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15. arm 4: Subjects will receive pNGVL4a-CRT/E7(detox) intra-mucosally and imiquimod applied to the cervix at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.
Interventions: intervention 1: DNA vaccination intervention 2: Gene gun vaccine intervention 3: intramuscular vaccination intervention 4: intra-lesional vaccine administration intervention 5: therapeutic resection of the lesion intervention 6: imiquimod
Intervention descriptions: intervention 1: vaccination with pNGVL4a-CRT/E7(detox) intervention 2: 8 micrograms (group 1) or 16 micrograms (group 2) intervention 3: 1mg (group 3) or 3mg (group 4) of pNGVLra-CRT/E7(detox) administered intramuscularly intervention 4: 1mg (group 5) or 3mg (group 6) of pNGVL4a-CRT/E7(detox)administered intra-lesionally intervention 5: at week 15, all residual lesions will be resected intervention 6: imiquimod applied to the cervix by the physician

Protocol documents: