ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01006603
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus elderly patients saxagliptin randomised double-blind
Sponsor: AstraZeneca
Start date: 2009-10-01; Completion date: 2012-06-01
Enrollment: 957 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy and tolerability of saxagliptin compared to glimepiride in elderly patients with type 2 diabetes mellitus who have inadequate glycaemic control on metformin monotherapy.

Detailed description:

Arms: arm 1: Saxagliptin 5 mg arm 2: Glimepiride 1 - 6 mg
Interventions: intervention 1: Saxagliptin intervention 2: Glimepiride
Intervention descriptions: intervention 1: 5 mg, oral tablet, once daily intervention 2: 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily

Protocol documents:
Clinical trial NCT01009047
Conditions: Schizophrenia
Keywords: Schizophrenia Paliperidone Aripiprazole
Sponsor: Janssen Research & Development, LLC
Start date: 2009-12-01; Completion date: 2012-06-01
Enrollment: 228 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of extended-release (ER) paliperidone compared to aripiprazole (atypical antipsychotic) in symptomatic (having symptoms) adolescent participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations \[imagining things\], and withdrawal into the self) .

Detailed description:
This is a multi-center (conducted in more than 1 center), double-blind (neither physician nor participant knows the name of the assigned drug), randomized (study drug is assigned by chance), active-controlled (paliperidone ER is compared to aripiprazole), parallel-group (a medical research study comparing the response in 2 or more groups of participants receiving different treatments), flexible-dose (the physician has the freedom to give different doses to the participant depending on how they respond to treatment) study designed to determine the efficacy and safety of paliperidone ER in symptomatic adolescents (12 to 17 years of age) with schizophrenia. The total duration of the study will be approximately 29 weeks. The study consists of 3 phases: a Screening phase up to 3 weeks (with a possible overlapping washout period), a Double-blind acute phase of 8 weeks, and a Double-blind maintenance phase of 18 weeks. Participants will be randomly assigned to 1 of the 2 treatment groups (paliperidone ER or aripiprazole flexible oral doses). Dosage will be adjusted at the scheduled visits. Efficacy of the participants will primarily be evaluated through Positive and Negative Syndromes Scale (PANSS). Participants' safety will be monitored throughout the study.

Arms: arm 1: Paliperidone ER will be administered as oral capsule at a dose of 6 milligram (mg) for 1 week and then will be administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning. arm 2: Aripiprazole will be administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4, 10 mg Days 5, 6 and 7; and then will be administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
Interventions: intervention 1: Paliperidone extended release (ER) intervention 2: Aripiprazole
Intervention descriptions: intervention 1: Paliperidone ER will be administered as oral capsule at a dose of 6 mg for 1 week and then will be administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning. intervention 2: Aripiprazole will be administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4, 10 mg Days 5, 6 and 7; and then will be administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.

Protocol documents:
Clinical trial NCT01011907
Conditions: Substance Dependence
Sponsor: University of California, San Francisco
Start date: 2010-01-01; Completion date: 2012-06-01
Enrollment: 99 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Purpose: This is an outpatient, randomized, double-blinded, placebo-controlled study in which either varenicline (twice daily) or placebo will be administered over a 12 week study period to examine genetic influences on treatment response to varenicline for reduction of hazardous drinking.

Detailed description:
Hazardous alcohol use and alcohol use disorders (AUDs) are an area of large unmet medical needs. Although there has been some progress with pharmacotherapy for alcohol-dependent individuals, a critical need for the development of novel and additional therapeutic approaches remains. Pharmacotherapy development for AUDs as a therapeutic area has had several recent advancements, where clinically as well as commercially successful additions to available treatment options are available and several more are expected in the near future. Based on recent preclinical work, we believe that varenicline has potential to become one of the first among those newly evolving treatments.

In this study, participants with nicotine dependence will receive standard varenicline or placebo treatment over the recommended course of 12 weeks. Since our research question addresses whether alcohol drinking also diminishes with varenicline treatment, we will not ask participants to alter alcohol use; we will simply follow their use over time. Study visits will take place at the Ernest Gallo Clinic and Research Center. The procedures to be completed include vital signs, blood samples at screening and end of study, urine toxicology screening and the completion of standard questionnaires. No special facilities are required for these procedures. Group therapy (which is not a research procedure, but part of standard nicotine dependence treatment) will take place at the Gallo Center.

Arms: arm 1: Drug: varenicline (Chantix) 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84). arm 2: Drug: placebo for varenicline 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).
Interventions: intervention 1: varenicline intervention 2: placebo
Intervention descriptions: intervention 1: 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84). intervention 2: 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).

Protocol documents:
Clinical trial NCT01014442
Conditions: Lung Transplantation
Sponsor: Hoffmann-La Roche
Start date: 2010-01-01; Completion date: 2012-06-01
Enrollment: 68 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This open-label, single center study will assess the pharmacokinetics, efficacy and safety of mycophenolate mofetil in lung allograft recipients. Participants will be split into 2 groups according to the original disease: Group A (cystic fibrosis) and Group B (chronic obstructive pulmonary disease \[COPD\], emphysema, idiopathic pulmonary fibrosis, alpha-1 antitrypsin deficiency \[A1AD\]). All participants will receive mycophenolate mofetil orally, 1.5 grams (g) twice daily (BID) from Day 2 to 30 post transplantation, and 1 g BID from Day 31 to 90 post transplantation. Anticipated time on study treatment is 90 days, and target sample size is 50-100 individuals.

Detailed description:

Arms: arm 1: Participants with cystic fibrosis will receive mycophenolate mofetil 1.5 g, orally (PO), BID from Days 2 through 30 post-transplantation, and 1 g, PO, BID from Days 31 through 90 post-transplantation. arm 2: Participants with COPD, emphysema, idiopathic pulmonary fibrosis, or A1AD will receive mycophenolate mofetil 1.5 g, PO, BID, from Days 2 through 30 post-transplantation, and 1 g, PO, BID from Days 31 through 90 post-transplantation.
Interventions: intervention 1: mycophenolate mofetil
Intervention descriptions: intervention 1: 1.5 g PO BID from Days 2 to 30 post-transplantation, 1 g PO BID Days 31 to 90 post-transplantation

Protocol documents:
Clinical trial NCT01014728
Conditions: Blood Loss
Sponsor: University of Chicago
Start date: 2009-11-01; Completion date: 2012-06-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the blood loss during sinus surgery looking at two different types of anesthesia: either intravenous anesthesia with propofol or inhalational anesthesia with sevoflurane.

Detailed description:

Arms: arm 1: Intravenous anesthesia with propofol for endoscopic sinus surgery arm 2: Inhalation anesthesia with sevoflurane for endoscopic sinus surgery
Interventions: intervention 1: propofol intervention 2: sevoflurane
Intervention descriptions: intervention 1: 100-200mcg/kg/min by infusion intervention 2: 1-3% of sevoflurane (expired)

Protocol documents:
Clinical trial NCT01020786
Conditions: Non Small Cell Lung Cancer
Keywords: Non-squamous
Sponsor: Eli Lilly and Company
Start date: 2009-11-01; Completion date: 2012-06-01
Enrollment: 109 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To investigate efficacy and safety of the combination with pemetrexed plus carboplatin, followed by pemetrexed in patients with advanced nonsquamous Non Small Cell Lung Cancer (NSCLC) who receive at least one dose of the induction therapy.

Detailed description:

Arms: arm 1: After four 21-day cycles of Pemetrexed plus Carboplatin treatment, Pemetrexed monotherapy is continued until study discontinuation.
Interventions: intervention 1: Pemetrexed intervention 2: Carboplatin
Intervention descriptions: intervention 1: Induction Therapy: 500 milligrams per square meter (mg/m\^2) given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.

Maintenance Therapy: 500 mg/m\^2 given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity. intervention 2: Dosage equal to area under the curve (AUC)6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.

Protocol documents:
Clinical trial NCT01023256
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis GM-CSF MOR103
Sponsor: MorphoSys AG
Start date: 2009-12-01; Completion date: 2012-06-01
Enrollment: 96 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
GM-CSF is considered to have a key role in the initiation and progression of arthritic inflammation. The purpose of this study is to evaluate the safety, preliminary efficacy, pharmacokinetics, and immunogenicity of multiple doses of MOR103, a human antibody to GM-CSF, in patients with active rheumatoid arthritis.

Detailed description:
Rheumatoid arthritis (RA) is a chronic systemic inflammatory disease that affects 0.5% to 1% of the adult population world wide. RA primarily affects the joints and is characterized by chronic inflammation of the synovial tissue, which eventually leads to the destruction of cartilage, bone and ligaments and can cause joint deformity.

Pro-inflammatory cytokines, such as tumor necrosis factor-alpha (TNFα), interleukin (IL)-1, IL-6 and granulocyte macrophage colony stimulating factor (GM-CSF), which lead to the activation and proliferation of immune cells, are found to be increased in the inflamed joint. Several preclinical findings support an anti-GM-CSF therapy for RA.

Arms: arm 1: Biological: MOR103 0.3 mg/kg or placebo arm 2: Biological: MOR103 1.0 mg/kg or placebo arm 3: Biological: MOR103 1.5 mg/kg or placebo
Interventions: intervention 1: MOR103 intervention 2: MOR103 intervention 3: MOR103
Intervention descriptions: intervention 1: MOR103 0.3 mg/kg or placebo iv x 4 doses intervention 2: MOR103 1.0 mg/kg or placebo iv x 4 doses intervention 3: MOR103 1.5 mg/kg or placebo iv x 4 doses

Protocol documents:
Clinical trial NCT01029392
Conditions: Type 1 Diabetes Mellitus
Keywords: Diabetes Type I Newly Diagnosis Type I Diabetes Mellitus
Sponsor: William Beaumont Hospitals
Start date: 2009-11-01; Completion date: 2012-06-01
Enrollment: 75 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Our objective is to demonstrate that providing supplemental vitamin D to children with new onset DM will significantly decrease the levels of HbA1c and insulin requirement by the following methods.

1. Identify how often vitamin D levels are low in patients with new onset Type 1 diabetes mellitus (DM).
2. Record the hemoglobin A1c (HbA1c) level (which reflects the average blood sugar level over the past few months) and document insulin requirements before and after vitamin supplementation is given.

Hypothesis: Maintaining vitamin D levels \>30 ng/ml will decrease HbA1c and insulin requirements.

Detailed description:
New onset type 1 DM patients who present at William Beaumont Hospital, Royal Oak or to the Pediatric Endocrine Clinic will be approached about the study at their presentation and time will be given for the patient and family to discuss and ask questions regarding the study. Patients will then be enrolled following informed consent. Glucose levels and insulin requirements will be monitored continuously from the faxed weekly logbooks from the point of diagnosis for 3 months (as standard practice for all newly diagnosed diabetic patients in our clinic). At the baseline visit a Vitamin D level will be drawn and frozen for 3 months prior to processing. .After 3 months vitamin D, calcium, alkaline phosphatase, phosphorus and other standard of care lab draws will be done. Approximately an additional 3 tsp of blood will be taken. All female subjects of child bearing potential will have a pregnancy test done. EMLA cream to anesthetize the area will be used prior to blood draw. A vitamin D level of \<30 ng/ml is considered insufficient and the patient will then be given vitamin D supplement. The vitamin D level, calcium, alkaline phosphatase and phosphorus will be rechecked at 6 months (additional 3 tsp of blood) . Glucose levels and insulin requirements will be monitored continuously from the faxed weekly logbooks again for another 3 months.

Arms: arm 1: Those children whose Vitamin D level was low (\<30 ng/mL) are given Vitamin D supplementation arm 2: Those children whose Vitamin D level was normal (50-80 ng/mL) did not receive Vitamin D supplementation
Interventions: intervention 1: Vitamin D
Intervention descriptions: intervention 1: 2000iu once a day

Protocol documents:
Clinical trial NCT01033227
Conditions: Sickle Cell Disease
Keywords: sickle cell disease sickle cell anemia pain crisis nitric oxide nitrite vaso occlusive crisis pain medication sickled cells blood flow microcirculation
Sponsor: Children's Hospital Los Angeles
Start date: 2009-12-01; Completion date: 2012-06-01
Enrollment: 5 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will determine if administration of sodium nitrite is safe and can improve small vessel blood flow and tissue oxygenation when given as an additional treatment in patients with acute vaso-occlusive crisis (pain crisis) associated with sickle cell disease.

Detailed description:
Nitric oxide (NO) is a naturally occuring chemical that relaxes blood vessels and helps improve blood flow.

The pain associated with vaso-occlusive crisis (pain crisis) in sickle cell disease is caused in part by lack of oxygen and increased tissue acid because blood flow is blocked by stiff sickle red cells. Administration of sodium nitrite should generate nitric oxide in this area of hypoxia and acidosis and improve blood flow.

Arms: arm 1: No study drug administered arm 2: Administration if sodium nitrite injection, USP
Interventions: intervention 1: sodium nitrite injection, usp
Intervention descriptions: intervention 1: Sodium nitrite injection, USP will be administered in blocks of six subjects (3 sodium nitrite and 3 no drug). A total of five dose levels are planned, pending safety starting. Drug will be given by continuous infusion infusion for 48 hours starting at 6 nmol/min/kg (10% of the maximal tolerated dose).

Protocol documents:
Clinical trial NCT01044030
Conditions: Acute Otitis Media
Keywords: otitis media ear infection
Sponsor: Boston Children's Hospital
Start date: 2010-02-01; Completion date: 2012-06-01
Enrollment: 326 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the proposed study is to determine the effectiveness and safety of orally administered viscous-adherent xylitol syrup given in a dose of five grams three times daily for 12 weeks in reducing the incidence of clinically-diagnosed acute otitis media (ear infection) in children with a history of recurrent acute otitis media.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Xylitol syrup intervention 2: Placebo
Intervention descriptions: intervention 1: 7.5 mL (5 grams) by mouth three times daily intervention 2: 7.5 mL by mouth three times daily

Protocol documents:
Clinical trial NCT01050569
Conditions: Tobacco Use Disorder
Keywords: Smoking Cessation Nicotine Free Cigarettes
Sponsor: University of Minnesota
Start date: 2008-10-01; Completion date: 2012-06-01
Enrollment: 235 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The purpose of this study is to evaluate the effect of a combination of the 21 mg nicotine patch and very low nicotine content (VLNC) cigarettes compared to 21 mg nicotine patch only and very low nicotine content cigarette only on abstinence, time to relapse and toxicant levels. The study will determine if adding nicotine replacement medication to the very low content cigarettes (VLNC) will augment treatment compared to nicotine patch only or to very low nicotine content cigarettes only.

Detailed description:
The purpose of this study is to evaluate the effect of a combination of the 21 mg nicotine patch and very low nicotine content cigarette (VLNC) compared to the VLNC cigarette alone or 21 mg nicotine patch alone on abstinence, time to relapse and toxicant levels.

The following primary hypothesis will be tested:

Abstinence rates will be highest and the time to relapse will be the longest in the VLNC cigarettes plus nicotine patch condition compared to nicotine patch or VLNC cigarettes alone.

Other hypotheses include:

1. Greater positive subjective responses to cigarettes will be observed with VLNC cigarettes plus patch vs. VLNC cigarette;
2. Less drop-outs will be observed in the VLNC plus patch vs the other two conditions; and
3. Less compensatory smoking will be observed in the VLNC plus patch condition compared to VLNC cigarette alone condition.

Cigarette smokers will be randomized to:

1. VLNC cigarettes (which provide sensory behavioral aspects of smoking but with limited nicotine) plus nicotine patch for 6 weeks;
2. Nicotine patch for 6 weeks; or
3. VLNC cigarettes alone.

Outcome measures will include cessation assessed at the end of treatment as the primary endpoint and at 36 weeks post-treatment, time to lapse and relapse to usual brand cigarettes, and biomarkers of toxicant exposure. Predictors of abstinence and treatment response for each of the treatment conditions will be explored.

Arms: arm 1: Very Low Nicotine Content Cigarette. Dosage: 0.05 mg to 0.09 mg nicotine yield cigarette; Frequency: Daily; Duration: 6 weeks. arm 2: 21 mg nicotine patch. Dosage: 21 mg; Frequency: Daily; Duration: 6 weeks. arm 3: Very Low Nicotine Content Cigarette plus 21 mg Nicotine Patch. Patch Dosage: 21 mg; Cigarette Dosasge: 0.05 to 0.09 mg nicotine yield; Frequency: Daily; Duration: 6 weeks
Interventions: intervention 1: Nicotine Patch intervention 2: VLNC Cigarette intervention 3: VLNC Cigarette Plus Nicotine Patch
Intervention descriptions: intervention 1: 21 mg intervention 2: Cigarette where the tobacco contains \<0.1 mg of nicotine yield. intervention 3: 21 mg nicotine patch plus use of cigarette with tobacco containing \<0.1 mg nicotine yield.

Protocol documents:
Clinical trial NCT01059318
Conditions: Lymphangioleiomyomatosis
Keywords: Lymphangioleiomyomatosis, High Resolution CT scan, chest x-ray, 6 minute walk test, pulse oximetry, renal MRI, Pikometer
Sponsor: Novartis Pharmaceuticals
Start date: 2010-01-01; Completion date: 2012-06-01
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This was an exploratory study to determine whether escalating doses of RAD001 (everolimus) were safe and effective in patients with Lymphangioleiomyomatosis

Detailed description:
In addition to the data collected in this study, historical data from 43 patients treated with placebo from the multicenter trial of sirolimus in LAM (MILES) study (NCT00414648) were down weighted to an effective sample size of 18 for comparison of FEV1 and FVC endpoints. Reference to the publication of the MILES study has been provided under "Result Publication".

Arms: arm 1: All patients received a starting dose of everolimus 2.5mg/day for 4 weeks, followed by a dose of 5 mg/day for 4 weeks and finally a dose of 10mg/day for 18 weeks.

The 26 week treatment period was followed by an optional extension period wherein patients continued therapy until the last patient had completed 26-weeks of treatment. The longest period a patient participated in the study was 62 weeks.
Interventions: intervention 1: Everolimus
Intervention descriptions: intervention 1: Everolimus was formulated as tablets in strengths of 2.5mg, 5mg and 10mg.

Protocol documents:
Clinical trial NCT01072773
Conditions: Primary Systemic Amyloidosis
Sponsor: Mayo Clinic
Start date: 2010-03-01; Completion date: 2012-06-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with combination chemotherapy may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving bortezomib, cyclophosphamide, and dexamethasone together works in treating patients with primary systemic light chain amyloidosis.

Detailed description:
PRIMARY OBJECTIVE:

I. To assess the confirmed hematologic response rate of the combination of bortezomib, cyclophosphamide and dexamethasone in patients with primary systemic amyloidosis.

SECONDARY OBJECTIVES:

I. Organ response rate of the bortezomib, cyclophosphamide and dexamethasone combination.

II. Severity and frequency of adverse events associated with bortezomib, cyclophosphamide and dexamethasone treatment in patients with primary systemic amyloidosis.

III. Time to progression.

IV. Survival.

OUTLINE: Patients receive bortezomib IV on days 1, 8, and 15 and oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 6 months for 2 years.

Arms: arm 1: Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
Interventions: intervention 1: bortezomib intervention 2: cyclophosphamide intervention 3: dexamethasone
Intervention descriptions: intervention 1: 1.3 mg/m\^2, by IV on days 1, 8 and 15 every 28 days intervention 2: 300 mg/m\^2, orally, on days 1, 8, 15 \& 22 every 28 days. intervention 3: 40 mg, orally, on days 1, 8, 15 \& 22 every 28 days

Protocol documents: