ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00712673
Conditions: Diabetes Mellitus, Type 2
Keywords: hyperglycemia, GLP-1, metformin
Sponsor: Sanofi
Start date: 2008-06-01; Completion date: 2011-03-01
Enrollment: 680 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to metformin, over a period of 24 weeks of treatment, followed by an extension.

The primary objective is to assess the effects of lixisenatide as an add-on treatment to metformin in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24.

The secondary objectives are to assess the effect of lixisenatide, in comparison to placebo, when administered in the evening within 1 hour prior to the meal in terms of HbA1c reduction, percentage of patients reaching HbA1c less than (\<) 7 percent (%), percentage of patients reaching HbA1c less than or equal to 6.5%, fasting plasma glucose (FPG), plasma glucose, plasma insulin, C-peptide, glucagon, and proinsulin during a 2-hour standardized meal test (only in morning injection arms), body weight, beta-cell function assessed by homeostasis model assessment (HOMA)-beta, fasting plasma insulin (FPI) and adiponectin; to evaluate safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development, beta-cell function 4 weeks after study drug discontinuation (only in patients from the morning injection arms in some selected centers).

Detailed description:
Patients who complete the 24-week main double-blind treatment would undergo a variable double-blind extension treatment, which ends for all patients at approximately the scheduled date of Week 76 visit (Visit 25) for the last randomized patient.

Arms: arm 1: 2-step initiation morning regimen of lixisenatide: 10 microgram (mcg) once daily (QD) for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to end of treatment. arm 2: 2-step initiation evening regimen of lixisenatide: 10 mcg QD for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to end of treatment. arm 3: 2-step initiation morning regimen of volume matching placebo: 10 mcg QD for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to end of treatment. arm 4: 2-step initiation evening regimen of volume matching placebo: 10 mcg QD for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to end of treatment.
Interventions: intervention 1: Lixisenatide (AVE0010) intervention 2: Placebo intervention 3: Pen auto-injector intervention 4: Metformin
Intervention descriptions: intervention 1: Self administered by subcutaneous injections once daily within the hour preceding meal (either breakfast or dinner). intervention 2: Self administered by subcutaneous injections once daily within the hour preceding meal (either breakfast or dinner). intervention 3: None intervention 4: Metformin to be continued at stable dose (at least 1.5 gram per day) up to the end of treatment.

Protocol documents:
Clinical trial NCT00715208
Conditions: Relapsed Follicular Lymphoma
Sponsor: Millennium Pharmaceuticals, Inc.
Start date: 2008-09-01; Completion date: 2011-03-01
Enrollment: 55 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase 2, two-arm, non-randomized, open-label, multicenter study evaluating the safety and efficacy of 2 VELCADE-containing regimens. Patients will be treated with either a combination of VELCADE, rituximab, cyclophosphamide, doxorubicin, and prednisone (VELCADE-R-CAP) or a combination of VELCADE, rituximab, cyclophosphamide, and prednisone (VELCADE-R-CP) based on investigator preference. Following completion of the treatment period, patients will receive maintenance therapy with rituximab up to a maximum of 2 years.

Detailed description:

Arms: arm 1: VELCADE will be administered as a 3- to 5-second intravenous bolus injection, rituximab 375 mg/m2 Intravenous on Day 1, cyclophosphamide 750 mg/m2 intravenous on Day 1, doxorubicin 50 mg/m2 intravenous on Day 1, VELCADE 1.6 mg/m2 intravenous on Days 1 and 8, prednisone 100 mg orally on Days 1 to 5 of a 21-day (3-week) cycle for 6 cycles. arm 2: VELCADE will be administered as a 3- to 5-second intravenous bolus injection, rituximab 375 mg/m2 intravenous on Day 1, cyclophosphamide 1000 mg/m2 intravenous on Day 1, VELCADE 1.6 mg/m2 intravenous on Days 1 and 8, prednisone 100 mg orally on Days 1 to 5 of a 21-day (3-week) cycle for 6 cycles.
Interventions: intervention 1: rituximab intervention 2: cyclophosphamide intervention 3: doxorubicin intervention 4: VELCADE intervention 5: prednisone
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None

Protocol documents:
Clinical trial NCT00717236
Conditions: Rheumatoid Arthritis
Keywords: Certolizumab pegol Cimzia Rheumatoid Arthritis Joint Disease Chronic Arthritis
Sponsor: UCB Pharma
Start date: 2008-07-01; Completion date: 2011-03-01
Enrollment: 1648 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase IIIb multicenter study to evaluate the safety and efficacy of certolizumab pegol (CZP) administered to patients with moderate-to-severe rheumatoid arthritis.

Detailed description:
The treatment period starts with a 12-week, double-blind, placebo-controlled, randomized period followed by an open-label extension phase. In the double-blind phase, eligible patients are randomized (4:1 ratio) to receive either certolizumab pegol (CZP) or Placebo up to and including Week 10. The randomization will be stratified according to the three factors: concomitant use of methotrexate (MTX, Yes or No), prior anti-tumor necrosis factor (anti-TNF) use (Yes or No), and disease duration categories (\< 2 years or ≥ 2 years). From Week 12 all patients remaining in the study receive open-label CZP for a minimum 16 additional weeks until CZP is commercially available.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Certolizumab pegol (CZP) intervention 2: Placebo
Intervention descriptions: intervention 1: 400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. intervention 2: Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.

Protocol documents:
Clinical trial NCT00719537
Conditions: Preeclampsia
Keywords: preeclampsia progesterone aspirin prevent soluble fms-like tyrosine kinase (sFlt-1) Placental Growth Factor (PlGF) risk
Sponsor: John Uckele
Start date: 2008-07-01; Completion date: 2011-03-01
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study investigates whether low dose aspirin combined with progesterone will decrease the risk of preeclampsia in pregnant women with a history of preeclampsia in a previous pregnancy.

Detailed description:
Recent advances have shown that certain proteins may be present in a pregnant woman's blood very early in pregnancy which can predict who is at the highest risk for developing preeclampsia. These proteins can be measured and may be used to predict a woman's risk of developing preeclampsia.

Special placental cells called endovascular cytotrophoblasts are needed in the early formation of the placenta. These placental cells invade the maternal blood vessels in the formation of the maternal-placental blood interface. Human Leukocytes Antigen-G (HLA-G) is a protein produced by the placental cells and prevents these special cells from being rejected by the mother's immune system. Recent studies have indicated that the level of HLA-G is decreased in placentas from mothers with preeclampsia. Progesterone, a naturally occurring hormone produced in pregnancy, has been shown to increase the production of HLA-G in the placental cytotrophoblast cells.

In regards to the treatment of preeclampsia, studies have shown that low dose aspirin if given to mothers who have had severe early preeclampsia, lowers the risk for having preeclampsia again. This study aims to show that low dose aspirin combined with progesterone will decrease the risk of preeclampsia in pregnant women with a history of preeclampsia in a previous pregnancy. Data generated will determine levels and ratios of blood proteins that are predictive of preeclampsia at specific gestational ages.

Arms: arm 1: Drug: Aspirin 81 mg, given orally once per day Drug: Placebo tablet given orally, once a day arm 2: Drug: Aspirin 81mg, given orally once per day Drug: Progesterone 200mg given orally, once a day
Interventions: intervention 1: Aspirin intervention 2: Placebo Oral Tablet intervention 3: Progesterone
Intervention descriptions: intervention 1: Aspirin 81 mg once a day intervention 2: Placebo 1 tab Daily intervention 3: Oral Progesterone 200 mg Twice Daily

Protocol documents:
Clinical trial NCT00753012
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Keywords: cardiovascular testing home blood pressure monitoring office home blood pressure monitoring cardiopulmonary exercise testing transthoracic echocardiography Lisdexamfetamine Vyvanse normotensive and hypertensive adults with ADHD ADHD medication.
Sponsor: Massachusetts General Hospital
Start date: 2008-04-01; Completion date: 2011-03-01
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to learn about the effects of a medication called Vyvanse on the heart (cardiovascular system). The U.S. Food and Drug Administration (FDA) has approved Vyvanse for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). People who have ADHD have trouble paying attention, organizing, and planning; these symptoms can cause problems at work, socially and at home.

Vyvanse (also known as Lisdexamfetamine) is a stimulant class medication. There have been reports of serious cardiovascular effects in children and adults treated with stimulants. While there is no definite evidence that these events were related to the use of stimulants, the deaths have raised questions about the cardiovascular safety of stimulants.

The study will involve in-depth cardiovascular tests, namely echocardiograph (ultrasound of the heart) and cardiopulmonary exercise test (also called stress test; subjects exercise on a bicycle while measuring their heart activity and breathing is monitored by cardiologists).

The investigators predict to see changes in blood pressure and heart rate as shown in previous clinical studies, and that the in-depth cardiovascular tests will provide new insights into the cardiovascular impact of stimulants.

Detailed description:

Arms: arm 1: Adults who meet DSM-IV-TR criteria for ADHD.

Group 1 is normotensive adults; Group 1 does not have high blood pressure. Group 2 is primary hypertensive adults; Group 2 does have high blood pressure and is being treated with stable doses of hypertensive medications achieving a blood pressure of \<135/85.
Interventions: intervention 1: Lisdexamfetamine
Intervention descriptions: intervention 1: Lisdexamfetamine daily until the completion of participation in the clinical trial (up to Week 11 or final study visit). Subjects will start on 30 mg of LDX per day for the first week of treatment. The dose will be increased weekly in 20 mg increments, up to a 70 mg daily (maximum). If significant adverse effects (AE) occur, the daily dose may be reduced by 20 mg. At subsequent visits, a higher dose may be resumed if tolerated. Both cohorts of the study will follow the same treatment plan.

Protocol documents:
Clinical trial NCT00754832
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis fatigue ginseng
Sponsor: Oregon Health and Science University
Start date: 2005-09-01; Completion date: 2011-03-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This research project will determine the safety and tolerability of ginseng in subjects with MS and will gather preliminary data on the efficacy of ginseng vs placebo for the treatment of MS fatigue.

Detailed description:
Fatigue is a major cause of disability in MS and is associated with a reduced quality of life. Treatment options for MS fatigue include central nervous system stimulants and amantadine. These medications are of limited efficacy, are often poorly tolerated, and can be expensive. Ginseng may represent a novel approach to treating MS fatigue. Ginseng has been tested in clinical trials for its ability to improve mental alertness and fatigue. However, there have been no published clinical trials addressing the effects of ginseng in subjects with MS, even though many people with MS use ginseng and report deriving benefit from it.

This double-blinded, placebo controlled crossover pilot study will determine the safety and tolerability of ginseng in subjects with MS and will gather preliminary data on the efficacy of ginseng vs. placebo for the treatment of MS fatigue. Additionally, the project will collect information on the impact of ginseng on cognition, stress, actigraphy, salivary cortisol, differential cytokine response, and quality of life.

Arms: arm 1: Period 1 with Ginseng therapy intervention; Washout Period with no drug; Period 2 with placebo arm 2: Period 1 with placebo; Washout period with no drug; Period 2 with ginseng therapy intervention
Interventions: intervention 1: American ginseng extract HT-1001 intervention 2: placebo
Intervention descriptions: intervention 1: Ginseng HT-1001 was dosed at 100 mg orally per day initially, increased after one week to 200 mg per day, then further increased the next week to 400 mg per day as tolerated. Subjects were then maintained on 400 mg per day or the maximum tolerated dose for the remainder of the 6 week treatment period. intervention 2: Placebo capsules were identical to the study drug and were dose escalated to match the study drug. Subjects were maintained on placebo capsules for the remainder of the 6 week treatment period.

Protocol documents:
Clinical trial NCT00760474
Conditions: Fibromyalgia
Keywords: Fibromyalgia; fMRI; pain; pregabalin; Lyrica; imaging
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2009-01-01; Completion date: 2011-03-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to explore how pregabalin works in patients with fibromyalgia by evaluating brain imaging signals. To find out whether fMRI (functional magnetic resonance imaging) is an efficient way to show whether new pain medications are effective in treating fibromyalgia.

Detailed description:
Methodology study

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Pregabalin, then placebo intervention 2: Placebo, then pregabalin
Intervention descriptions: intervention 1: Placebo and pregabalin will be given orally twice daily in capsules at different times during the course of the study. The highest dose of pregabalin to be used in the study is 450 mg/day. intervention 2: Placebo and pregabalin will be given orally twice daily in capsules at different times during the course of the study. The highest dose of pregabalin to be used in the study is 450 mg/day.

Protocol documents:
Clinical trial NCT00763035
Conditions: Coronary Artery Disease Asthma Chronic Obstructive Pulmonary Disease (COPD) Angina
Keywords: Coronary Artery Disease Coronary Vessels Myocardial Ischemia Coronary Disease Ischemic heart disease asthma copd
Sponsor: Wake Forest University Health Sciences
Start date: 2009-01-01; Completion date: 2011-03-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The goal of this research is to determine the utility of Regadenoson (Lexiscan)for use as an imaging agent with cardiac MR. If found useful, it will help us establish a protocol for regadenoson stress MR perfusion (Regadenoson stress test with cardiac MR).The investigators will compare regadenoson with dobutamine so each participant will undergo two studies. A cardiac MR stress test with regadenoson and with dobutamine. The investigators participants will include patients with history of COPD and Asthma, so it will also help us determine feasibility of Regadenoson in these patient's subgroups.

Detailed description:

Arms: arm 1: Arm A will get Dobutamine Stress test with cardiac MR (CMR). Both arms will then cross over to the other arm to get the second test. So each participant will undergo two types of testing. arm 2: Arm B will get Regadenoson stress test with CMR. Both arms will then cross over to the other arm to get the second test. So each participant will undergo two types of testing.
Interventions: intervention 1: Regadenoson intervention 2: Dobutamine
Intervention descriptions: intervention 1: Each participant will receive regadenoson 0.4mg (5ml) one time bolus dose at one visit. intervention 2: Each participant will receive dobutamine infusion (as per protocol to achieve a target heart rate of 85% of predicted for age) at another visit.

Protocol documents:
Clinical trial NCT00774046
Conditions: Myelodysplastic Syndrome Acute Myeloid Leukemia
Keywords: Therapy-related myelodysplastic syndrome/ Therapy -related Acute myeloid leukemia Myelodysplastic syndrome Acute myeloid leukemia
Sponsor: University of Chicago
Start date: 2002-12-01; Completion date: 2011-03-01
Enrollment: 32 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the effectiveness of a particular combination of drugs used to treat cancer.

Detailed description:

Arms: arm 1: Ara-C Mitoxantrone Etoposide Stem cell mobilization Autologous transplant
Interventions: intervention 1: Ara-C intervention 2: Mitoxantrone intervention 3: Etoposide
Intervention descriptions: intervention 1: Induction: 3000mg/m2 IV infusion for day 1 and day 5

Mobilization: within 2 weeks of end of induction therapy - 2000mg/m2 as 2 hour IV infusion once every 12 hours for 3 days (6 doses total) intervention 2: Induction: 30mg/m2 after the end of HiDAC day 1 and day 5 intervention 3: Mobilization: 30mg/kg over 6 doses given once every 12 hours for 3 days

Protocol documents:
Clinical trial NCT00778622
Conditions: Type 2 Diabetes Mellitus
Sponsor: Bristol-Myers Squibb
Start date: 2009-11-01; Completion date: 2011-03-01
Enrollment: 371 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the effect of the baseline body mass index (BMI) on the response to Glucophage XR monotherapy in glycemic control in Chinese patients with newly diagnosed type 2 diabetes

Detailed description:

Arms: arm 1: Normal Weight by Body Weight Index arm 2: Overweight by Body Weight Index arm 3: Obese by Body Weight Index
Interventions: intervention 1: Metformin XR
Intervention descriptions: intervention 1: Tablets, Oral, 500mg tid, 1500 mg/day, 16 weeks

Protocol documents:
Clinical trial NCT00791336
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: NSCLC chemotherapy radiation therapy nelfinavir NFV
Sponsor: University of Iowa
Start date: 2008-08-01; Completion date: 2011-03-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study combines nelfinavir (NFV) with radiation therapy and chemotherapy as a treatment for non-small cell lung cancer (NSCLC) who are considered candidates for pre-operative treatment.

Detailed description:
This is a phase 2 trial of the HIV protease inhibitor (HPI) Nelfinavir (NFV) in combination with radiotherapy and chemotherapy in patients with locally advanced non-small cell lung cancer (NSCLC) who are considered candidates for pre-operative treatment. This study is to be conducted according to US and international standards of Good Clinical Practice (FDA Title 21 part 312 and International Conference on Harmonization guidelines), applicable government regulations and Institutional research policies and procedures. The endpoints are to determine safety of NFV with chemoradiation, gather preliminary data for response, and tissue specimens for correlative molecular studies. Unacceptable toxicity is unlikely as prior studies have determined dosing 1250 mg twice a day is relatively safe for HIV patients receiving radiation therapy. NFV will start one week prior to chemo-radiotherapy and continue for the duration of chemoradiation (approximately 6 1/2 weeks). Standard radiotherapy (minimum total dose 5040 cGy) and combined (cisplatin/etoposide) chemotherapy based on SWOG 8805 will be delivered in combination with NFV. The thoracic surgery attending physician will determine the feasibility of resection. If the patient has resectable disease, the attending thoracic surgeon will perform the thoracotomy and anatomical resection. If the patient has unresectable disease, subject will be followed for 30 days post NFV administration. After the initial 30 days post-NFV, subjects will be followed for long-term outcomes (disease response and overall survival). Adjuvant therapy may be continued off-study at the discretion of managing oncology personnel. Tumors obtained at the time of surgical resection will be assessed for pathological response. Tumor tissue taken pre-treatment will be assessed for markers that may predict response such as Akt, VEGF, and EGFR.

Arms: arm 1: None
Interventions: intervention 1: Nelfinavir
Intervention descriptions: intervention 1: 1250 mg twice daily starting for approximately 6.5 weeks.

Protocol documents:
Clinical trial NCT00795639
Conditions: Pulmonary Arterial Hypertension Pulmonary Hypertension
Keywords: Sitaxsentan endothelin receptor antagonist
Sponsor: Pfizer
Start date: 2008-12-01; Completion date: 2011-03-01
Enrollment: 183 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This protocol is for subjects with pulmonary arterial hypertension and is the first of 3 studies forming the Sitaxsentan efficacy and safety trial with Randomized Prospective Assessment of Adding Sildenafil (SR-PAAS) program.

Detailed description:

Arms: arm 1: Monotherapy arm 2: Monotherapy
Interventions: intervention 1: Sitaxsentan intervention 2: Placebo
Intervention descriptions: intervention 1: Sitaxsentan = 100 mg tablet administered orally, once daily intervention 2: Sitaxsentan Placebo = 1 tablet administered orally, once daily

Protocol documents:
Clinical trial NCT00796666
Conditions: Pulmonary Arterial Hypertension Pulmonary Hypertension
Keywords: endothelin receptor antagonist (ETRA) Sitaxsentan
Sponsor: Pfizer
Start date: 2009-05-01; Completion date: 2011-03-01
Enrollment: 131 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
As monotherapy for pulmonary arterial hypertension (PAH) begins to fail additional therapies are introduced. Although co-administration of sitaxsentan and sildenafil is well tolerated the controlled safety/efficacy database of the combination is limited.

Detailed description:

Arms: arm 1: Monotherapy arm arm 2: Combination treatment
Interventions: intervention 1: Sitaxsentan intervention 2: Sitaxsentan and Sildenafil
Intervention descriptions: intervention 1: Sitaxsentan = 100 mg tablet administered orally, once daily Sildenafil placebo = 1 tablet administered orally, three times a day intervention 2: Sitaxsentan = 100 mg tablet administered orally, once daily plus Sildenafil = 20 mg tablet administered orally, three times a day

Protocol documents: