ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT03914417
Conditions: Actinic Keratosis
Keywords: Actinic Keratosis
Sponsor: Icahn School of Medicine at Mount Sinai
Start date: 2013-01-01; Completion date: 2015-04-30
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The study team had plans to treat approximately 30 subjects. Each subject that had qualified had at least 4-8 visible AKs on the face and/or scalp. At Day 0, one Actinic Keratosis (AK) in the treatment area had been biopsied via a 3 mm punch. The tissue collected was sent to pathology for confirmatory diagnosis as well as genomic analysis. The remaining AKs had been identified, photographed, and documented on a transparency. One of the remaining AKs was designated as the target lesion. The patient returned to the clinic in 7 days (+/- 3) for suture removal. Approximately two weeks after Day 0, the entire treatment area was treated with imiquimod 3.75% cream. Subjects utilized the 2 weeks on, 2 weeks off, 2 weeks on regimen. Subjects were followed every 2 weeks during treatment (week 2, 4 and 6) and then at 4 and 8 weeks post last-imiquimod application (week 10 and 14). At week 14, a biopsy via a 3 mm punch was done of the target lesion. Yet, if the target lesion was no longer present, a biopsy was done at the site where the lesion was previously located.

Detailed description:

Arms: arm 1: applied topically
Interventions: intervention 1: Imiquimod 3.75% Cream
Intervention descriptions: intervention 1: Approximately two weeks after Day 0, the entire treatment area was treated with imiquimod 3.75% cream. Subjects utilized the 2 weeks on, 2 weeks off, 2 weeks on regimen. Subjects were followed every 2 weeks during treatment (week 2, 4 and 6) and then at 4 and 8 weeks post last-imiquimod application (week 10 and 14).

Protocol documents:
Clinical trial NCT00608881
Conditions: Huntington's Disease
Keywords: Huntington's disease Huntington disease HD coenzyme Q10 CoQ
Sponsor: Massachusetts General Hospital
Start date: 2008-03-01; Completion date: 2015-05-01
Enrollment: 609 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goals of this trial are to determine if coenzyme Q10 is effective in slowing the worsening symptoms of Huntington's disease and to learn about the safety and acceptability of long-term coenzyme Q10 use by determining its effects on people with Huntington's disease.

Detailed description:
Huntington's disease (HD) is a slowly progressive disorder that devastates the lives of those affected and their families. There are no treatments that slow the progression of HD, only mildly effective symptomatic therapies are available.

The purpose of this trial is to find out if coenzyme Q10 (CoQ) is effective in slowing the worsening symptoms of HD. In this study, researchers also will learn about the safety and acceptability of long-term CoQ use by determining its effects on people with HD.

Participants in this trial will be randomly chosen to one of two groups. Group 1 will receive CoQ (2400 mg/day), and group 2 will receive a placebo (an inactive substance). Researchers will compare the change in total functional capacity (TFC)-a measure of functional disability-in the two groups. The TFC is a valid and reliable measure of disease progression and is particularly responsive to change in the early and mid-stages of HD. Researchers will also compare the changes in other components of the Unified Huntington's Disease Rating Scale '99 (UHDRS) including: the total motor score, total behavioral frequency score, total behavior frequency X severity score, verbal fluency test, symbol digit modalities test, Stroop, interference test, functional checklist, and independence scale scores. The groups will also be compared with respect to tolerability, adverse events, vital signs, and laboratory test results as measures of safety.

Arms: arm 1: Randomized to active treatment (coenzyme Q10 2400 mg/day) arm 2: Randomized to placebo
Interventions: intervention 1: coenzyme Q10 intervention 2: placebo
Intervention descriptions: intervention 1: 4 - 300 mg CoQ chewable wafers taken orally twice a day intervention 2: an inactive substance

Protocol documents:
Clinical trial NCT01285401
Conditions: Relapsing-Remitting Multiple Sclerosis
Keywords: Multiple Sclerosis Rebif VigantOL® oil Vitamin D Add-on treatment
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2011-02-01; Completion date: 2015-05-01
Enrollment: 260 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The drug being tested is called VigantOL® oil - a very effective form of Vitamin D hormone supplement (cholecalciferol). Low levels of Vitamin D have been described to be associated with a higher risk of developing Multiple Sclerosis (MS), and it is known that up to 90% of patients with Multiple Sclerosis have Vitamin D deficiency.

Rebif® is known to be an effective treatment for slowing down the progression of MS. The purpose of this research trial is to evaluate if VigantOL® oil on top of Rebif® has any benefit on the progression of MS compared to Rebif® and placebo.

Disease activity will be assessed by clinical examination and Magnetic Resonance Imaging (MRI). The planned study treatment duration for each study participant is 48 weeks, and the study consists of a total of 8 visits. Study participants who are already passed Week 48 at the time of approval of Protocol Amendment 5 will have a study duration of 96 weeks and a total of 12 visits.

During the study, the participant will undergo physical examination, neurological assessments, safety assessments, blood tests and urinalysis (including pregnancy tests).

Detailed description:

Arms: arm 1: VigantOL oil plus Rebif in subjects with 25-hydroxy-vitamin D plasma levels below 150 nmol/L arm 2: Placebo daily plus Rebif in subjects with 25-hydroxy-vitamin D plasma levels below 150 nmol/L arm 3: Rebif alone in subjects with 25-hydroxy-vitamin D plasma levels equal or higher than 150 nmol/L
Interventions: intervention 1: VigantOL oil plus interferon beta-1a (Rebif) intervention 2: Placebo plus interferon beta-1a (Rebif) intervention 3: Interferon beta-1a (Rebif®) alone
Intervention descriptions: intervention 1: VigantOL oil 6,670 International Units per day (IU/d) (167 microgram per day \[mcg/day\]), was administered orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) administered orally for 44 weeks on top of Rebif 44mcg three times per week (tiw) administered subcutaneously. intervention 2: Matching placebo daily, orally administered matched placebo for 48 weeks on top of Rebif 44 mcg tiw. intervention 3: Rebif® 44 mcg tiw, sub-cutaneously alone.

Protocol documents:
Clinical trial NCT01722487
Conditions: Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma
Keywords: CLL, SLL
Sponsor: Pharmacyclics LLC.
Start date: 2013-03-01; Completion date: 2015-05-01
Enrollment: 269 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor PCI-32765 versus Chlorambucil in Patients 65 Years or Older with Treatment-naive Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma.

Detailed description:
Study design: This is a randomized, multicenter, open-label, Phase 3 study designed to compare the safety and efficacy of Ibrutinib versus Chlorambucil in treatment-naive patients 65 years or older who have CLL or SLL.

Eligible patients will be randomized in a 1:1 ratio to Treatment Arm A or B:

* Treatment Arm A: Oral Chlorambucil 0.5 mg/kg on Days 1 and 15 of each 28-day cycle; the dose can be increased, if well tolerated, in increments of 0.1 mg/kg on Day 1 of each cycle to a maximum of 0.8 mg/kg; patients receive a minimum of 3 and a maximum of 12 cycles, in the absence of progressive disease or unacceptable toxicity.
* Treatment Arm B: Oral Ibrutinib 420 mg/day Randomization will be stratified on Eastern Cooperative Oncology Group (ECOG) performance status (0,1 versus 2); presence of advanced Rai stage (yes/no), advanced being defined as Stages 3-4; and geographic region: US versus non-US.

Arms: arm 1: Ibrutinib will be supplied as hard gelatin 140-mg capsules for oral (PO) administration. Ibrutinib 420 mg (3 x 140-mg capsules) is administered orally once daily. The first dose will be delivered in the clinic on Day 1, after which subsequent dosing is typically on an outpatient basis. Ibrutinib will be dispensed to patients in bottles at each visit. arm 2: Chlorambucil will be supplied as 2-mg tablets for PO administration. Chlorambucil is administered orally on Days 1 and 15 of each 28-day cycle.The starting dosage (Cycle 1) is 0.5 mg/kg. If well tolerated, the Chlorambucil dose can be increased starting at Cycle 2, with increments of 0.1 mg/kg on Day 1 of each cycle to a maximum of 0.8 mg/kg.
Interventions: intervention 1: Ibrutinib intervention 2: Chlorambucil
Intervention descriptions: intervention 1: Ibrutinib will be supplied as hard gelatin 140-mg capsules for oral (PO) administration. Ibrutinib 420 mg (3 x 140-mg capsules) is administered orally once daily. The first dose will be delivered in the clinic on Day 1, after which subsequent dosing is typically on an outpatient basis. Ibrutinib will be dispensed to patients in bottles at each visit. intervention 2: Chlorambucil will be supplied as 2-mg tablets for PO administration. Chlorambucil is administered orally on Days 1 and 15 of each 28-day cycle. The starting dosage (Cycle 1) is 0.5 mg/kg. If well tolerated, the Chlorambucil dose can be increased starting at Cycle 2, with increments of 0.1 mg/kg on Day 1 of each cycle to a maximum of 0.8 mg/kg.

Protocol documents:
Clinical trial NCT01799941
Conditions: Pseudobulbar Affect (PBA) Stroke Dementia Traumatic Brain Injury (TBI)
Sponsor: Avanir Pharmaceuticals
Start date: 2013-02-01; Completion date: 2015-05-01
Enrollment: 367 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objectives of the study are to evaluate the safety, tolerability, and effectiveness of NUEDEXTA capsules containing 20 mg DM (Dextromethorphan)/10 mg Q (Quinidine) for treatment of Pseudobulbar Affect (PBA) in patients with prevalent conditions such as dementia, stroke, and traumatic brain injury (TBI)over a 12 week period.

Detailed description:
This will be an Open-label, Multicenter, study in patients with PBA and dementia, stroke or TBI. Patients with a clinical diagnosis of PBA and who meet all other inclusion and exclusion criteria will be eligible to participate and receive NUEDEXTA for 12 weeks.

Males and females patients with a minimum age of 18 years, a clinical diagnosis of Pseudobulbar Affect and a documented diagnosis of neurologic disease or brain injury, will be enrolled in this study.

The primary effectiveness endpoint is the mean change in the Center for Neurologic Study-Lability scale (CNS-LS). Secondary objectives include measures to evaluate treatment outcomes.

Arms: arm 1: Single Arm, Open Label Dosing with Nuedexta (DM 20 mg/Q 10 mg)
Interventions: intervention 1: Nuedexta (DM 20 mg/Q 10 mg)
Intervention descriptions: intervention 1: Single Arm, Open-Label Dosing with Nuedexta (DM 20 mg/Q 10 mg)

Protocol documents:
Clinical trial NCT02195700
Conditions: Tardive Dyskinesia
Keywords: Dyskinesias Movement Disorders Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms
Sponsor: Auspex Pharmaceuticals, Inc.
Start date: 2014-06-01; Completion date: 2015-05-01
Enrollment: 117 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether an investigational drug, SD-809 (deutetrabenazine), will reduce the severity of abnormal involuntary movements of tardive dyskinesia.

Detailed description:

Arms: arm 1: SD-809 tablets taken twice daily for 12 weeks. arm 2: Placebo tablets taken twice daily for 12 weeks.
Interventions: intervention 1: SD-809 intervention 2: Placebo
Intervention descriptions: intervention 1: SD-809 tablets taken twice daily for 12 weeks, includes a dose titration period and maintenance period. intervention 2: Placebo tablets taken twice daily for 12 weeks.

Protocol documents:
Clinical trial NCT00357734
Conditions: Lung Cancer Breast Cancer
Keywords: lung cancer breast cancer
Sponsor: AstraZeneca
Start date: 2005-01-01; Completion date: 2015-05-01
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the long-term safety profile and the secondary objective to estimate clinical benefit of ZD1839 (gefitinib).

Detailed description:

Arms: arm 1: ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
Interventions: intervention 1: Gefitinib
Intervention descriptions: intervention 1: ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial

Protocol documents:
Clinical trial NCT00580957
Conditions: Obesity
Keywords: Obesity Hypertension Autonomic Nervous System
Sponsor: Vanderbilt University
Start date: 2008-08-01; Completion date: 2015-05-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The overall goal of this proposal is to determine the role of the autonomic nervous system in the insulin resistant state associated with obesity and the metabolic syndrome. Obesity results from an accumulation of excessive fat deposit due to increase caloric intake or decrease energy expenditure, this condition is usually associated with diseases such as hypertension or diabetes, a cluster known as the metabolic syndrome. The first step in the development of the metabolic syndrome is a resistance to the action of insulin. The mechanism underlying insulin resistance in obesity is still unknown, however some investigators have proposed that the autonomic nervous system, particularly the increase sympathetic activation in obesity may play an important role. We have extensive experience studying the role of the autonomic nervous system in the cardiovascular alterations associated with obesity by producing complete autonomic withdrawal with a drug named trimethaphan. We propose to use the same approach to study the role of the autonomic nervous system in the development of insulin resistance in obesity.

Detailed description:
The purpose of this study is to look at the role of the autonomic nervous system, an involuntary nervous system that controls your blood pressure, in insulin resistance and the metabolic syndrome. Insulin is a substance that helps your body use the sugar in the food that you eat. Some people's tissues stop reacting in a normal way to insulin, a condition known as insulin resistance. A person with insulin resistance can have other health problems, such as obesity, high cholesterol, and high blood pressure. These problems together are called the metabolic syndrome. We think that the autonomic or involuntary nervous system controls the way your body responds to insulin. This system is changed in obese people, and we think that it may cause the insulin resistance. We plan to study this with two drugs -trimethaphan and L-NMMA. Neither of these drugs are approved by the Food and Drug Administration (FDA), and they will be used for research purposes only.

Fifty people will take part in this study.

Arms: arm 1: Active treatment arm. Transient autonomic blockade with Trimethaphan and blood pressure restoration with L-NMMA will be used during insulin clamp arm 2: Saline will be used instead of trimethaphan during insulin clamp
Interventions: intervention 1: Blocked intervention 2: Intact
Intervention descriptions: intervention 1: Trimethaphan 4 mg/min IV will be infused for the duration of the study. L-NMMA 125-500 mcg/k/min IV will be titrated to restore blood pressure to pre-trimethaphan levels Insulin clamp will be used to determine insulin resistance intervention 2: Saline IV infusion to simulate trimethaphan infusion in active arm Insulin clamp will be done to determine insulin resistance

Protocol documents:
Clinical trial NCT00679367
Conditions: Multiple Myeloma
Keywords: primary systemic amyloidosis
Sponsor: Boston Medical Center
Start date: 2008-05-01; Completion date: 2015-05-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as melphalan and dexamethasone, work in different ways to stop the growth of abnormal plasma cells, either by killing the cells or by stopping them from dividing. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop the abnormal plasma cells from growing. Giving melphalan together with lenalidomide and dexamethasone may be an effective treatment for primary systemic amyloidosis.

PURPOSE: This phase II trial is studying the side effects and how well giving melphalan together with lenalidomide and dexamethasone works in treating patients with primary systemic amyloidosis.

Detailed description:
OBJECTIVES:

Primary

* To determine the tolerability and safety of melphalan, lenalidomide, and dexamethasone, in terms of toxicity, in patients with primary systemic amyloidosis.
* To determine the hematologic response rate in patients treated with this regimen.

Secondary

* To assess organ response in patients treated with this regimen.

OUTLINE: Patients receive oral lenalidomide once daily on days 1-21, oral melphalan once daily on days 1-4, and oral dexamethasone once on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 months in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 3 months until disease progression and then annually thereafter.

Arms: arm 1: Melphalan Lenalidomide Dexamethasone
Interventions: intervention 1: dexamethasone intervention 2: lenalidomide intervention 3: melphalan
Intervention descriptions: intervention 1: 40 mg once weekly intervention 2: 10 mg/day D1-21 intervention 3: 5 mg/m2 D1-4

Protocol documents:
Clinical trial NCT00724503
Conditions: Colorectal Cancer Colorectal Carcinoma Liver Metastases
Keywords: colon cancer Colorectal carcinoma liver metastases SIR-Spheres microspheres yttrium-90 FOLFOX bevacizumab metastatic colorectal cancer
Sponsor: Sirtex Medical
Start date: 2006-08-01; Completion date: 2015-05-01
Enrollment: 530 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a randomized multi-center trial that will assess the effect of adding Selective Internal Radiation Therapy (SIRT), using SIR-Spheres microspheres®, to a standard chemotherapy regimen of FOLFOX as first line therapy in patients with non-resectable liver metastases from primary colorectal adenocarcinoma.

Treatment with the biologic agent bevacizumab, if part of the standard of care at participating institutions, is allowed within this study at the discretion of the treating Investigator.

Detailed description:

Arms: arm 1: A single injection of SIR-Spheres microspheres into the liver plus systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5-Fluorouracil (FOLFOX) arm 2: Systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5- Fluorouracil (FOLFOX).
Interventions: intervention 1: SIR-Spheres yttrium-90 microspheres intervention 2: Systemic chemotherapy (FOLFOX)
Intervention descriptions: intervention 1: SIR-Spheres microspheres (yttrium-90 \[Y-90\] labelled resin microspheres), hepatic artery injection administered on Day 3 or 4 of cycle 1.

mFOLFOX6 administered on Day 1 and at the start of each cycle every 14 days: 85 or 60 mg/m2 oxaliplatin by 2-hour intravenous (IV) infusion + 200 mg/m2 leucovorin by 2-hour IV infusion + 400 mg/m2 5-fluorouracil (5-FU) by IV bolus + 2.4 g/m2 5-FU by 46-hour continuous IV infusion.

Treatment with the biologic agent bevacizumab, if part of standard practice at the participating institution, was permitted at the discretion of the treating Investigator.

In the event that leucovorin was not available, use of levofolinic acid (the active S enantiomer) was acceptable at half the dose of the racemic leucovorin i.e. 100 mg/m2. intervention 2: mFOLFOX6 administered on Day 1 and at the start of each cycle every 14 days: 85 or 60 mg/m2 oxaliplatin by 2-hour intravenous (IV) infusion + 200 mg/m2 leucovorin by 2-hour IV infusion + 400 mg/m2 5-fluorouracil (5-FU) by IV bolus + 2.4 g/m2 5-FU by 46-hour continuous IV infusion.

Treatment with the biologic agent bevacizumab, if part of standard practice at the participating institution, was permitted at the discretion of the treating Investigator.

In the event that leucovorin was not available, use of levofolinic acid (the active S enantiomer) was acceptable at half the dose of the racemic leucovorin i.e. 100 mg/m2.

Protocol documents:
Clinical trial NCT00754936
Conditions: Depression
Keywords: Depression
Sponsor: Weill Medical College of Cornell University
Start date: 2007-05-01; Completion date: 2015-05-01
Enrollment: 106 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to examine the relationship between brain electrical activity in elderly depressed patients and response to antidepressant medication treatment. Elderly patients with depression will be treated for 12 weeks with an antidepressant medication commonly used in clinical practice called escitalopram (Lexapro). Brain electrical activity will be assessed using electrophysiological tests. Researchers are interested in whether the brain electrical activity of elderly people with depression before they start the medication can tell us who amongst them will improve with antidepressant treatment and to what extent. They will also determine whether patients' brain electrical activity during the 12 weeks of medication treatment will change in any way and whether this change will be linked with a change in the severity of their depression. Researchers hope that information gained from this study will help to better understand the brain processes associated with depression and its successful treatment.

Detailed description:
This research study will examine how the brain electrical activity of elderly depressed patients is related to how quickly and how well they respond to antidepressant medication treatment. Brain electrical activity will be assessed using electrophysiological tests. Elderly patients with depression will be treated for 12 weeks with an antidepressant medication commonly used in clinical practice called escitalopram (Lexapro). Before they start treatment, patients will be asked questions about their depression to measure how severe it is. They will also be asked to have their brain electrical activity recorded while they perform tests on a computer screen. The questions about their depression and the brain electrical recordings will be repeated regularly during the 12 weeks they will be treated with antidepressant medication. The researchers are interested to see whether the brain electrical activity of elderly people with depression before they start the medication can tell us who amongst them and to what extent will finally improve with treatment with escitalopram (Lexapro). They will also determine whether patients' brain electrical activity, during the 12 weeks they will be receiving the medication treatment, will change in any way and whether this change will be linked with the change in the severity of their depression. It is hoped that information gained from this study will help the investigators to better understand the brain processes associated with depression and its successful treatment.

Arms: arm 1: 12 week open label with 2 week placebo period (14 weeks total)
Interventions: intervention 1: Escitalopram
Intervention descriptions: intervention 1: 20 mg by mouth daily

Protocol documents: