ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00980044
Conditions: Substance Withdrawal Syndrome
Sponsor: Michelle Lofwall
Start date: 2009-10-01; Completion date: 2012-03-01
Enrollment: 53 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Prescription opioid addiction is a growing public health problem and more pharmacologic treatments are needed because current approved medications have had limited patient acceptance (naltrexone), limited availability (methadone), and concerns about misuse and diversion (methadone and buprenorphine). Tramadol is a currently approved medication used to treat moderate-severe pain, and initial studies demonstrate that it may be useful for treatment of the uncomfortable syndrome of opioid withdrawal without producing euphoric effects. This study will determine whether two different doses of extended release tramadol can treat opioid withdrawal and whether tramadol itself produces withdrawal after it is no longer taken.

Detailed description:

Arms: arm 1: Tramadol 200 mg daily for 1 week then placebo given for 1 week arm 2: Medication arm 3: Tramadol 600 mg daily given for 1 week given then placebo given for 1 week
Interventions: intervention 1: Tramadol intervention 2: Placebo
Intervention descriptions: intervention 1: Oral Medication intervention 2: Oral Medication

Protocol documents:
Clinical trial NCT00982345
Conditions: Major Depression
Keywords: Depression Anxiety Seroquel Quetiapine fMRI pictures
Sponsor: Indiana University School of Medicine
Start date: 2009-03-01; Completion date: 2012-03-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to find out what parts of the brain have increased or decreased connectivity when people are depressed and how Seroquel extended release (XR) changes this connectivity in depressed patients. The genetic samples collected are to look at variation in a gene (serotonin transporter gene), which affects the functioning of the chemical serotonin in the brain.

Detailed description:
This study will measure the activity and connectivity in different parts of the brain, while the patients are seeing some pictures, using Magnetic Resonance Imaging (MRI) scan. For this study three MRI scans will be conducted. One before the patient begins on any medication, one during the study after 3 weeks of treatment and one after six more weeks of treatment with seroquel.

Arms: arm 1: Open-label Quetiapine XL 50 - 400 mg daily treatment 8 weeks
Interventions: intervention 1: quetiapine (Seroquel XR)
Intervention descriptions: intervention 1: Seroquel XR (starting dose 100mg and increased up to 400 mg as tolerated) treatment.

Protocol documents:
Clinical trial NCT00983853
Conditions: Hepatitis C HIV Infections
Keywords: VX-950 INCIVEK INCIVO
Sponsor: Vertex Pharmaceuticals Incorporated
Start date: 2009-10-01; Completion date: 2012-03-01
Enrollment: 62 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether the combination of telaprevir, peginterferon alfa-2a, and ribavirin is safe and effective in treating hepatitis C virus (HCV) infection in subjects who are infected with both HCV and human immunodeficiency virus (HIV).

Detailed description:

Arms: arm 1: The dose of ribavirin used (fixed versus weight-based) is region dependent arm 2: The dose of ribavirin used (fixed versus weight-based) is region dependent
Interventions: intervention 1: telaprevir or matching placebo intervention 2: telaprevir or matching placebo intervention 3: peginterferon alfa-2a intervention 4: ribavirin (fixed dose) intervention 5: ribavirin (weight-based dose)
Intervention descriptions: intervention 1: Tablet, Oral, 750 mg, q8h, 12 weeks intervention 2: Tablet, Oral, 750 mg or 1125 mg, q8h, 12 weeks intervention 3: Subcutaneous injection, 180 μg, once weekly, 48 weeks intervention 4: Tablet, Oral, 800 mg, b.i.d., 48 weeks intervention 5: Tablet, Oral, 1000 mg for subjects weighing \<75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks

Protocol documents:
Clinical trial NCT00996658
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2009-10-01; Completion date: 2012-03-01
Enrollment: 278 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the current study is to investigate the efficacy, safety and tolerability of Linagliptin (5 mg once daily) compared to placebo given for 24 weeks as add on therapy to metformin in combination with pioglitazone in patients with type 2 diabetes mellitus with insufficient glycaemic control.

Detailed description:

Arms: arm 1: Linagliptin tablets once daily arm 2: Placebo tablets once daily
Interventions: intervention 1: Placebo intervention 2: Linagliptin
Intervention descriptions: intervention 1: Placebo matching linagliptin tablets once daily intervention 2: Linagliptin tablets once daily

Protocol documents:
Clinical trial NCT01009840
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma Bone marrow transplant Stem cell transplant Busulfan Bortezomib
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2010-05-01; Completion date: 2012-03-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Study for the outcome and safety of individualized busulfan dosing with bortezomib for patients preparing for a second stem cell transplant to treat multiple myeloma.

Detailed description:
Evaluation of six-month response in relapsed multiple myeloma subjects, who have had a prior autologous HSCT (greater than one year previously) receiving an IV busulfan-based conditioning regimen with the combination of pharmacokinetic (PK)-guided IV busulfan dosing and bortezomib, followed by a second autologous HSCT.

Assessment of the safety profile of this conditioning regimen will also be completed.

Arms: arm 1: Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m\^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
Interventions: intervention 1: IV busulfan intervention 2: bortezomib intervention 3: Autologous Hematopoietic Stem Cell Transplant (HSCT)
Intervention descriptions: intervention 1: PK-directed dosing of IV busulfan for 4 days intervention 2: Single IV bortezomib at a dose of 1.3 mg/m\^2. intervention 3: None

Protocol documents:
Clinical trial NCT01023672
Conditions: Dementia With Lewy Bodies
Keywords: Dementia with Lewy Bodies hypersomnolence cognition neuropsychiatric morbidity quality of life
Sponsor: Mayo Clinic
Start date: 2009-11-01; Completion date: 2012-03-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This research study is to examine the effects of the study medication Armodafinil in patients with dementia with Lewy bodies (DLB).

DLB is associated with memory and other thinking problems, excessive daytime sleepiness, hallucinations, delusions, apathy, and reduced quality of life.

One type of medication that could potentially improve daytime sleepiness, memory and thinking skills, hallucinations, delusions, apathy, and quality of life is known as a wake-promoting medication. Armodafinil is a wake-promoting medication that has been developed for treatment of patients with narcolepsy, sleep apnea, and other disorders which cause excessive daytime sleepiness.

The drug used in this study is considered investigational, which means it has either not been approved by the Food and Drug Administration (FDA) for routine clinical use or for the use described in this study. However the FDA has allowed the use of this drug/device in this research study.

In this study, patients with DLB will receive daily oral Armodafinil tablets, and their response to treatment will be assessed over 12 weeks. This study does not involve any placebo medication, so all patients will receive Armodafinil treatment.

Detailed description:
In patients with DLB, the following aims/objectives will be addressed by comparing data on key measures at baseline and at 4 and 12 weeks of therapy:

Primary Aims - to test the hypotheses that armodafinil therapy at 150-250 mg every morning:

* will result in improvement in excessive daytime sleepiness as measured by the Epworth Sleepiness Scale (ESS) and Maintenance of Wakefulness Test (MWT) (Aim 1A)
* will result in improvement in the cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-Cog) (Aim 1B)
* will result in improvement in the Alzheimer's Disease Cooperative Study-Clinician's Global Impression of Change (ADCS-CGIC) (Aim 1C)
* will be well-tolerated with no significant side-effects present (Aim 1D)

Secondary Aims - to test the hypotheses that armodafinil therapy at 150-250 mg every morning will result in improvement in:

* cognition as measured by the Mini-Mental State Examination (MMSE) and other focused neuropsychological tests (Aim 2A)
* neuropsychiatric morbidity, particularly apathy, depression, visual hallucinations, and delusions, as measured by the Neuropsychiatric Inventory (NPI) (Aim 2B)
* functional status as measured by the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) (Aim 2C)
* patient and caregiver quality of life (QOL) as measured by the linear analog scale (LASA) (Aim 2D)

Arms: arm 1: 150-250 mg armodafinil by mouth daily
Interventions: intervention 1: Armodafinil
Intervention descriptions: intervention 1: 150-250 mg armodafinil by mouth daily

Protocol documents:
Clinical trial NCT01030458
Conditions: Blood Pressure
Keywords: Blood pressure Hypertension Blacks Africa Blood pressure control Side-effects
Sponsor: KU Leuven
Start date: 2010-09-01; Completion date: 2012-03-01
Enrollment: 183 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the blood pressure lowering efficacy of a treatment regimen based on a dihydropyridine calcium-channel blocker combined with an angiotensin II type-1 receptor blocker with the recommended treatment regimen based on a low-dose thiazide diuretic combined with a beta-blocker.

Detailed description:
Primary objective:

Sitting systolic blood pressure (average of three readings) will be the primary outcome variable.

Secondary

1. To compare the time interval between the two treatment groups, which after randomisation will be required, to reach and maintain the target defined as a blood pressure below 140 mm Hg systolic and 90 mm Hg diastolic;
2. To compare the duration of follow-up, during which a steady blood pressure control will be achieved;
3. To evaluate the incidence of adverse events, symptoms, biochemical abnormalities and ECG changes in the two treatment groups;
4. To assess the adherence to antihypertensive treatment as well as the rate of drop-outs in both treatment arms during a six-month period.

Arms: arm 1: In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and amlodipine 10 mg plus 160 mg valsartan. arm 2: In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg or 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol
Interventions: intervention 1: amlodipine 5/10 mg per day plus valsartan 160 mg/day intervention 2: hydrochlorothiazide 6.25 mg/day plus bisoprolol 5/10 mg/day
Intervention descriptions: intervention 1: Amlodipine 5/10 mg/day plus valsartan 160 mg/day, once daily, in the morning intervention 2: hydrochlorothiazide 6.25 mg/day plus bisoprolol 5/10 mg/day, once daily, in the morning

Protocol documents:
Clinical trial NCT01054404
Conditions: Brain Swelling Brain Edema Dehydration
Keywords: Brain Swelling Brain Edema Dehydration
Sponsor: Northwestern University
Start date: 2010-02-01; Completion date: 2012-03-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Increased brain bulk may be problematic during brain surgery for tumors because it may limit surgical exposure and access to the surgical site. Mannitol, an osmotic diuretic, is commonly given to alleviate brain bulk, and sometimes furosemide in a small dose is added if mannitol alone is insufficient. It is unclear if adding this furosemide truly helps to diminish brain bulk, and it is possible that furosemide may cause too much diuresis, leading to dehydration and its side effects (e.g., low blood pressure). Our purpose is to investigate what the effects of furosemide are in the setting of brain surgery for tumors, specifically with regards to decreasing brain bulk and/or causing dehydration.

Study Hypothesis: The addition of furosemide to mannitol will result in improved brain relaxation in human subjects undergoing craniotomy for brain tumor resection than that seen with mannitol alone. However, the combination of mannitol and furosemide will also lead to more significant intravascular volume depletion than that seen with mannitol alone.

Detailed description:
Rating of brain relaxation will be on a 4-point scale:

0 = brain very relaxed under dura, acceptable

1. = brain adequately relaxed under dura, acceptable
2. = brain slightly tense under dura, acceptable
3. = brain very tense under bulging dura, unacceptable

Arms: arm 1: Furosemide 0.3 mg/kg arm 2: Up to 5 mL saline
Interventions: intervention 1: Furosemide intervention 2: Placebo
Intervention descriptions: intervention 1: Furosemide 0.3 mg/kg intervention 2: Placebo (up to 5mL)

Protocol documents:
Clinical trial NCT01066520
Conditions: Sprain of Ankle
Keywords: ankle sprain traumeel diclofenac antiinflammatory time to normal function
Sponsor: Biologische Heilmittel Heel GmbH
Start date: 2009-08-01; Completion date: 2012-03-01
Enrollment: 449 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to determine the efficacy of Traumeel S (both ointment and gel) compared to another antiinflammatory drug called Diclofenac in patients with a sprained ankle.

Detailed description:
Study objective is the confirmatory proof of efficacy for Traumeel® S topical treatment, both ointment and gel, as compared to diclofenac topical treatment for patients with ankle sprain. In addition tolerability/safety of both drug preparations is to be compared, so that the benefit-risk relation can be determined.

Arms: arm 1: Traumeel S ointment 2 g, 3 times daily topical during 14 days arm 2: Traumeel S gel 2 g, 3 times daily topical during 14 days arm 3: Diclofenac gel 2 g, 3 times daily topical during 14 days
Interventions: intervention 1: Traumeel S ointment intervention 2: Traumeel S gel intervention 3: Diclofenac gel
Intervention descriptions: intervention 1: 2 g, 3 times daily topical during 14 days intervention 2: 2 g, 3 times daily topical during 14 days intervention 3: 2 g, 3 times daily topical during 14 days

Protocol documents:
Clinical trial NCT01085214
Conditions: Recurrent Plasma Cell Myeloma Refractory Plasma Cell Myeloma
Sponsor: National Cancer Institute (NCI)
Start date: 2010-03-01; Completion date: 2012-03-01
Enrollment: 37 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well selumetinib works in treating patients with multiple myeloma, a type of cancer in which a specific protein is over active. Selumetinib may stop the growth of cancer cells by blocking this protein.

Detailed description:
PRIMARY OBJECTIVES:

I. To assess the response rate of AZD6244 (selumetinib) hydrogen sulfate capsules in patients with relapsed or refractory multiple myeloma (MM).

SECONDARY OBJECTIVES:

I. To evaluate the toxicity of AZD6244 in patients with MM. II. To estimate progression-free survival and duration of response to AZD6244. III. To test whether AZD6244 hydrogen sulfate capsules downregulate tumor cell phosphorylated mitogen-activated protein kinase (pERK)1/2.

OUTLINE:

Patients receive selumetinib orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 weeks.

Arms: arm 1: Participants receive AZD6244 (Selumetinib) orally (PO) twice a day (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Laboratory Biomarker Analysis intervention 2: Selumetinib
Intervention descriptions: intervention 1: Correlative studies intervention 2: AZD6244 (Selumetinib), 75 mg was administered orally, twice a day, continuously for 28-day cycles

Protocol documents:
Clinical trial NCT01089595
Conditions: GIST Metastatic Disease
Keywords: Imatinib Resistance GIST Advanced Disease Nilotinib
Sponsor: Fox Chase Cancer Center
Start date: 2009-02-01; Completion date: 2012-03-01
Enrollment: 5 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Patients with advanced GIST are treated with imatinib. This study seeks to look at a new therapeutic agent at the time of tumor progression following treatment with 600-800 mg daily of imatinib. The study is looking to see if Nilotinib (tasigna) alone or in combination with imatinib (gleevec) is more effective at controlling disease.

Detailed description:
Resistance to imatinib does develop and represents a major clinical challenge. Mechanisms implicated in imatinib resistance include: target resistance due to new KIT or PDGFRA mutations or over expression of the KIT protein; target modulation due to activation of an alternate receptor tyrosine kinase protein with loss of KIT oncoprotein expression; functional resistance due to KIT or PDGFRA activation without a secondary mutation; and alterations in imatinib uptake by P-glycoprotein.

This study seeks to test nilotinib alone and nilotinib in combination with imatinib in patients that have progressed on imatinib.

Nilotinib is a new synthetic second-generation inhibitor of the BCR-ABL tyrosine kinase that competes for the ATP-bindings sites of BCR-ABL. A completed phase I trial assessed the activity of nilotinib alone and in combination with imatinib in patients that have progressed on imatinib in a population of patients with imatinib refractory and intolerant patients. There were rare responses, but stable disease was observed in grater than 50% of patients.

This study is aiming to treat patients with advanced or metastatic GIST who have disease progression on imatinib dose escalated up to 600 mg or greater. The rationale for exploring Nilotinib in this setting is to determine if it has therapeutic efficacy, with potentially less toxicity than the current standard of care for second line therapy. In addition, since it is not uncommon to see progression of some metastatic GIST lesions on imatinib, while others remain controlled, adding nilotinib may treat the progressing lesions while imatinib continues to control the areas without disease progression.

Arms: arm 1: Nilotinib 400 mg po bid arm 2: Nilotinib 400 mg BID with Imatinib 400 mg daily
Interventions: intervention 1: Nilotinib intervention 2: Nilotinib with Imatinib
Intervention descriptions: intervention 1: Nilotinib 400 mg po bid intervention 2: Nilotinib 400 mg po BID Imatinib 400 mg po daily

Protocol documents:
Clinical trial NCT01094548
Conditions: Multiple Myeloma
Keywords: L-BLP25 liposome Multiple myeloma
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2008-01-01; Completion date: 2012-03-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Tecemotide (L-BLP25) is believed to induce a Mucinous glycoprotein 1 (MUC1)-specific T-cell response after vaccination. The primary purpose of this study is to ascertain whether vaccination with tecemotide (L-BLP25) induces a MUC1-specific T-cell response in slowly progressive or chemotherapy naive multiple myeloma subjects.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Tecemotide (L-BLP25) intervention 2: Tecemotide (L-BLP25) intervention 3: Single low dose cyclophosphamide intervention 4: Multiple low dose cyclophosphamide
Intervention descriptions: intervention 1: After receiving single low dose of cyclophosphamide, subjects will receive 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide (L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy is documented. intervention 2: After receiving multiple low dose of cyclophosphamide, subjects will receive 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide (L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy is documented. intervention 3: An intravenous (IV) infusion of 300 milligram per square meter (mg/m\^2) (to a maximum 600 mg) of cyclophosphamide will be given 3 days before the first vaccine treatment. intervention 4: An IV infusion of 300 mg/m\^2 (to a maximum 600 mg) of cyclophosphamide will be given 3 days before the first vaccine treatment plus an intravenous dose of cyclophosphamide (300 mg/m\^2, to a maximum of 600 mg) 3 days prior to the tecemotide (LBLP25) administration at week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week 14 up to a maximum treatment period of 2 years.

Protocol documents:
Clinical trial NCT01095653
Conditions: Type 2 Diabetes
Sponsor: AstraZeneca
Start date: 2010-06-01; Completion date: 2012-03-01
Enrollment: 1179 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can improve (decrease) blood glucose values in Asian patients with Type 2 Diabetes who have never been treated with medication or have been on medication for less than 24 weeks since their original diagnosis of Diabetes. The safety of this treatment will also be studied.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Dapagliflozin intervention 2: Dapagliflozin intervention 3: Metformin intervention 4: Dapagliflozin Placebo
Intervention descriptions: intervention 1: Tablets, Oral, 5 mg, Once daily, 24 weeks intervention 2: Tablets, Oral, 10 mg, Once daily, 24 weeks intervention 3: Tablets, Oral, 500-2000 mg (as needed for rescue based on protocol specific criteria), Up to 20 weeks intervention 4: Tablets, Oral, 0 mg, Once daily, 24 weeks

Protocol documents: