ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00919854
Conditions: Human Immunodeficiency Virus 1
Keywords: Human immunodeficiency virus 1 HIV-1 Darunavir Ritonavir Norvir
Sponsor: Tibotec Pharmaceuticals, Ireland
Start date: 2009-09-01; Completion date: 2011-02-01
Enrollment: 27 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the pharmacokinetics (what the body does to the medication), safety and antiviral activity to support dose recommendations by body weight of darunavir with low-dose ritonavir (DRV/rtv), in combination with other antiretroviral drugs (ARVs), in treatment-experienced Human immunodeficiency virus 1 (HIV 1) infected children.

Detailed description:
This is an open-label (all people know the identity of the intervention), study to evaluate the pharmacokinetics, safety and antiviral activity. Approximately 24 HIV-1 infected children will be enrolled in this study. The study consists of a 4-week screening period, a 48-week treatment period, and a 4-week follow-up period. Participants will receive DRV/rtv according to their body weight. Safety evaluations will include assessment of adverse events, laboratory tests, physical Examination, neurologic examination, vital signs, and electrocardiogram. The total duration of the study will be 56 weeks.

Arms: arm 1: Before dose adjustment, oral darunavir suspension (100 mg/mL): 20 mg per kg body weight twice daily for children weighing between 10 and \<20 kg. After dose adjustment, 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg twice daily if weight more than or equal to 15 kg. Before dose adjustment, oral ritonavir solution (80 mg/mL): 3 mg per kg body weight twice daily and after dose adjustment fixed dose of 50 mg twice daily if weight more than or equal to 15 kg.
Interventions: intervention 1: Darunavir intervention 2: Ritonavir
Intervention descriptions: intervention 1: Darunavir oral suspension (100 mg/mL) will be administered as 20 mg per kg body weight twice daily for children weighing between 10 and \<20 kg before dose adjustment. Darunavir oral suspension will be administered 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg darunavir tablets twice daily if weight more than or equal to 15 kg after dose adjustment. intervention 2: Ritonavir oral solution (80 mg/mL) will be administered as 3 mg per kg body weight twice daily before dose adjustment and after dose adjustment fixed dose of 50 mg twice daily if weight more than or equal to 15 kg.

Protocol documents:
Clinical trial NCT00923156
Conditions: Heart Failure
Keywords: Heart failure Systolic Aliskiren Ramipril Angiotensin II Ang II Plasma Renin Activity PRA Plasma Renin Concentration PR, brain natriuretic peptide BNP urinary aldosterone Escape Pharmacokinetic PK
Sponsor: Novartis Pharmaceuticals
Start date: 2009-05-01; Completion date: 2011-02-01
Enrollment: 123 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In addition to the blood pressure lowering effects of aliskiren, it may have beneficial effects on blocking the so called RAAS (renin-angiotensin-aldosterone system) at the tissue level. An increase of angiotensin II is associated with progression of heart failure. Although the use of ACE-inhibitors in heart failure shows clinical benefit, an increase in angiotensin II due to an angiotensin II "escape" phenomenon is not desirable. It is not yet known if a direct renin inhibitor can reduce or even prevent the angiotensin II escape phenomenon associated with the use of an ACE-inhibitor. Therefore the study tested the effects of ramipril, aliskiren and the combination of both on levels of angiotensin II in the blood in patients with systolic heart failure

Detailed description:

Arms: arm 1: In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules. arm 2: In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.

In double blind phase (Period 2), patients received ramipril 10 mg capsule o.d and matching placebo of aliskiren tablet. arm 3: In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.

In double blind phase (period 2), patients received ramipril (10 mg once daily capsule) and aliskiren (150 mg once daily tablet) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site
Interventions: intervention 1: aliskiren intervention 2: ramipril intervention 3: Placebo to aliskiren intervention 4: Placebo to ramipril
Intervention descriptions: intervention 1: Aliskiren 150 mg once daily up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site intervention 2: 2.5 mg , 5.0 mg or 10 mg once daily intervention 3: matching placebo to aliskiren in double blind phase intervention 4: Matching placebo to ramipril capsule in double blind phase

Protocol documents:
Clinical trial NCT00953667
Conditions: Healthy Volunteers
Sponsor: University of Pennsylvania
Start date: 2007-06-01; Completion date: 2011-02-01
Enrollment: 400 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine genetic factors that affect responses to niacin therapy and endotoxemia in healthy volunteers.

Detailed description:
Niacin is a vitamin that has beneficial effects on cholesterol (a type of fat in the blood) when used in high doses. Different people respond differently to cholesterol lowering doses of niacin, some people have a side effect termed flushing (similar to a hot flash) while others do not and some people have more pronounced effects on cholesterol. Endotoxin or lipopolysaccharide (LPS) is a small part of bacteria (that is no longer living) that can cause many of the effects similar to bacterial infections in humans. However, it can be administered in very small amounts to produce a mild inflammatory response much the same as a 'flu-like" illness. Within 1 ½ -3 hours after giving LPS by vein, a response consisting of fever, chills, headache, nausea and vomiting and generalized aches and pains will occur which lasts up to 6-8 hours. In addition to the flu like symptoms, the inflammation causes changes in cholesterol, triglycerides and glucose clearance. Different people respond differently to endotoxin and inflammation. We are performing this study to see if there are genetic factors that predict how people will respond to niacin and to endotoxin and its inflammatory response.

Arms: arm 1: All subjects are expected to have the same interventions- Niacin and Endotoxin.
Interventions: intervention 1: Immediate Release Niacin, Extended Release Niacin, Endotoxin
Intervention descriptions: intervention 1: Subjects receive a one-time 1000mg dose of immediate release Niacin (Niacor pills), a one-time 1000mg dose of extended release Niacin (Niaspan pill) and one-time 1ng/kg injection of endotoxin (LPS).

Protocol documents:
Clinical trial NCT00962104
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD
Sponsor: Eli Lilly and Company
Start date: 2009-08-01; Completion date: 2011-02-01
Enrollment: 391 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the efficacy, the quality of life, and the safety of multiple dosing atomoxetine in Asian adult subjects with attention deficit/hyperactivity disorder (ADHD).

Detailed description:
The treatment will be initiated at the lowest dosage 40 milligrams per day (mg/day), and it will be titrated up to 80 mg/day. Patients who are unable to tolerate a dose of at least 80 mg/day through the end of this study will be discontinued. The dosage will be titrated up to a maximum of 120 mg/day.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Atomoxetine intervention 2: Placebo
Intervention descriptions: intervention 1: 40-120 milligrams (mg) taken by mouth, once daily for 10 weeks. intervention 2: Taken by mouth, once daily for 10 weeks.

Protocol documents:
Clinical trial NCT00964743
Conditions: Neoplastic Meningitis
Keywords: Neurologic Oncology Neoplastic Meningitis from solid tumors Brain and Nervous System Breast Cancer
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Start date: 2009-08-01; Completion date: 2011-02-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the tolerability and side effects of oral sorafenib in combination with intrathecal DepoCyt.

Detailed description:
After an Ommaya reservoir has been placed in the patient's head, the patient will receive DepoCyt through that reservoir every 2 weeks for 5 doses, then every 4 weeks for an additional 5 doses (a total of 10 DepoCyt treatments). Patients will also receive oral sorafenib at 400 mg twice a day throughout the treatment course until disease progression or death. Patients will receive brain magnetic resonance imaging (MRIs) with contrast (and whole spine, if necessary) and spinal fluid studies will be obtained every 8 weeks through the Ommaya reservoir until disease progression, death, or unacceptable toxicity. In addition, patients will have spinal fluid obtained to test for sorafenib levels at each study visit after the start of sorafenib as well as prior to sorafenib treatment for controls.

Arms: arm 1: This is a single arm pilot study. Investigators planned to enroll approximately 10 patients to receive concurrent intrathecal DepoCyt and oral Sorafenib. DepoCyt: through a reservoir every 2 weeks for 5 doses, then every 4 weeks for an additional 5 doses (a total of 10 DepoCyt treatments). Oral Sorafenib: at 400 mg twice a day throughout the treatment course until disease progression or death.
Interventions: intervention 1: DepoCyt intervention 2: Sorafenib
Intervention descriptions: intervention 1: Patients were to receive DepoCyt through a reservoir every 2 weeks for 5 doses, then every 4 weeks for an additional 5 doses. intervention 2: Patients received oral sorafenib at 400 mg twice a day

Protocol documents:
Clinical trial NCT00972777
Conditions: Bacterial Conjunctivitis
Sponsor: Bausch & Lomb Incorporated
Start date: 2009-10-01; Completion date: 2011-02-01
Enrollment: 474 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being conducted to evaluate the clinical and microbial efficacy of besifloxacin ophthalmic suspension compared with vehicle in the treatment of bacterial conjunctivitis. This study was conducted as a phase IIb study and continued with further enrollment as a phase III study.

Detailed description:

Arms: arm 1: 0.6% ophthalmic suspension arm 2: None
Interventions: intervention 1: Besifloxacin intervention 2: Vehicle (Placebo)
Intervention descriptions: intervention 1: Besifloxacin 0.6% administered into the study eye two times a day for three days. intervention 2: Vehicle administered to the study eye two times a day for three days.

Protocol documents:
Clinical trial NCT00977379
Conditions: Breast Cancer
Sponsor: Hoffmann-La Roche
Start date: 2009-08-01; Completion date: 2011-02-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This open-label, randomized, parallel arm study will evaluate the effect of capecitabine administered concurrently with WBRT and as maintenance therapy in participants with breast cancer and newly diagnosed brain metastases. Participants will be randomized to receive either capecitabine with 10 days standard WBRT, or WBRT alone. Maintenance therapy will follow with capecitabine or another systemic therapy in the WBRT only group.

Detailed description:

Arms: arm 1: Participants will receive 3000 centi-Gray (cGy) WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants will be followed during the treatment until the halting of standard of care for any reason (central nervous system \[CNS\] or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death). arm 2: Participants will receive 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 milligrams per square meter (mg/m\^2) orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m\^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
Interventions: intervention 1: WBRT intervention 2: Capecitabine intervention 3: Standard of Care
Intervention descriptions: intervention 1: 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction). intervention 2: 825 mg/m\^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by 1000 mg/m\^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2. intervention 3: The choice of standard of care will be at the discretion of the treating oncologist. The protocol does not specify any particular standard of care treatment.

Protocol documents:
Clinical trial NCT00982878
Conditions: HIV Infections
Keywords: treatment experienced
Sponsor: Imperial College London
Start date: 2009-09-01; Completion date: 2011-02-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to describe the Central Nervous System exposure of maraviroc in HIV-1 infected subjects receiving a stable antiretroviral regimen, including maraviroc, at steady state.

Detailed description:
15 HIV-1 infected subjects currently receiving stable antiretroviral therapy will be recruited. At study entry, within 14 days of screening procedures, subjects will commence maraviroc dosed at 150 mg twice daily. For the rest of study period antiretroviral therapy will comprise:

* Truvada™ one tablet once daily at 0900
* Kaletra™ two tablets twice daily 0900 and 2100
* maraviroc 150 mg twice daily at 0900 and 2100

Subjects will attend for regular clinic visits during study treatment phase.

On day 15, subjects will attend the unit in the morning prior to usual dosing time. Blood with be drawn to assess plasma maraviroc concentration pre dose and pre lumbar puncture. A lumbar puncture will be performed under standard aseptic techniques to asses CSF maraviroc concentration and routine CSF parameters.

On completion of this study visit, subjects will cease maraviroc, continue on their usual antiretroviral regimen and attend for a follow up visit 10 days later.

Arms: arm 1: None
Interventions: intervention 1: Maraviroc
Intervention descriptions: intervention 1: 150mg twice daily

Protocol documents:
Clinical trial NCT00989950
Conditions: Attention Deficit Hyperactivity Disorder INSOMNIA
Keywords: daytrana sleep latency adhd rating scales ADHD
Sponsor: Cox Health Systems
Start date: 2009-12-01; Completion date: 2011-02-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Methylphenidate may improve sleep in children with ADHD. By leaving Daytrana (methylphenidate) patch for a longer time then 9 hours, many children report short sleep latencies and better quality of sleep.

Detailed description:
Once the optimal dose of Daytrana that controlled the ADHD symptoms is established. The patch will be removed 1, 2, and 3 hours before bed time in a random fashion, at weekly intervals, and parents will keep a sleep diary.

25 patients will be enrolled in order to obtain statistical significance.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Daytrana intervention 2: Daytrana intervention 3: Daytrana intervention 4: Daytrana
Intervention descriptions: intervention 1: Daytrana patch 10-30 mg administered once daily for 9hr intervention 2: Daytrana 10-30 mg worn once daily for 10 hr wear intervention 3: Daytrana 10-30 mg worn once daily for 11 hr intervention 4: Daytrana 10-30 mg worn once daily for 12 hrs

Protocol documents:
Clinical trial NCT00994214
Conditions: Acromegaly
Sponsor: Ipsen
Start date: 2009-10-01; Completion date: 2011-02-01
Enrollment: 109 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the efficacy of repeated subcutaneous (under the skin) injections at different doses of BIM 23A760 on growth hormone and insulin-like growth factor-1 levels in patients with acromegaly after 6 months of treatment.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: BIM 23A760
Intervention descriptions: intervention 1: Subcutaneous injections of BIM23A760 once a week. Until progression or unacceptable toxicity develops.

Protocol documents:
Clinical trial NCT00996034
Conditions: Nicotine Dependence
Keywords: Nicotine, SPECT, vaccine, receptor
Sponsor: Yale University
Start date: 2009-09-01; Completion date: 2011-02-01
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a molecular imaging research study designed to examine how much nicotine gets into the brain before and after vaccination with NicVAX, a nicotine vaccine developed by Nabi Biopharmaceuticals. NicVAX (Nicotine Conjugate Vaccine) is an investigational vaccine designed as an aid to smoking cessation and long-term abstinence, as well as an aid to prevent relapses of a treated smoker.

In this project we want to understand the degree to which NicVAX administration changes how much nicotine enters the brain in smokers.

Detailed description:
The purpose of the present study is to examine the occupancy of brain β2-containing nicotinic acetylcholine receptors (β2-nAChR) by nicotine both at baseline and following administration of a nicotine vaccine. The number of brain β2-nAChR and the amount of nicotine occupancy both before and after vaccination will be measured using the nicotinic agonist \[123I\]5-IA-85380 (\[123I\]5-IA) and single photon emission computed tomography (SPECT). \[123I\]5-IA will be administered using the bolus plus constant infusion paradigm to smokers abstinent for 4-9 days (time period necessary for nicotine and pharmacological active metabolites to clear from brain). Three baseline SPECT images will be obtained after equilibrium has been reached (\~6 hours into the \[123I\]5-IA infusion). Then, IV nicotine will be administered (0.5-1.5 mg/70 kg will be infused over 10 minutes). Following a series of 4 nicotine vaccine shots, the same procedure will be repeated for a second \[123I\]5-IA scan day. We hypothesize that occupancy of β2-nAChR will be significantly lower, and take longer to plateau, following nicotine vaccine administration.

Arms: arm 1: There is only one arm to the study. All subjects will receive NicVax, \[123I\]5-I-A-85380,and Nicotine bitartrate.
Interventions: intervention 1: NicVAX intervention 2: [123I]5-IA-85380 intervention 3: Nicotine bitartrate
Intervention descriptions: intervention 1: 1.0 mL of Nicotine Conjugate Vaccine(x4), I.M. at 3 week intervals between SPECT studies intervention 2: up to 10 mCi of \[123I\]5-IA-85380, I.V. on each of two SPECT Scan days intervention 3: 0.5-1.5 mg of Nicotine bitartrate, I.V. on each of two SPECT Scan days

Protocol documents:
Clinical trial NCT00996164
Conditions: Sexual Dysfunctions, Psychological
Sponsor: Sprout Pharmaceuticals, Inc
Start date: 2009-10-01; Completion date: 2011-02-01
Enrollment: 1090 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The object of this trial is to assess the safety and efficacy of a 24 week course of flibanserin for the treatment of hypoactive sexual desire disorder in premenopausal women.

Detailed description:

Arms: arm 1: flibanserin 100mg po qd arm 2: placebo 1 tab po qd
Interventions: intervention 1: Flibanserin intervention 2: Placebo
Intervention descriptions: intervention 1: patients will be randomized to flibanserin or placebo in a double-blind manner intervention 2: patients will be randomized to flibanserin or placebo in a double-blind manner

Protocol documents:
Clinical trial NCT01001208
Conditions: Psoriasis
Keywords: Etanercept Methotrexate Psoriasis
Sponsor: Amgen
Start date: 2009-11-01; Completion date: 2011-02-01
Enrollment: 478 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy of adding methotrexate to etanercept compared with etanercept monotherapy as measured by the percentage of participants achieving a 75% improvement from baseline in the Psoriasis Area and Severity Index (PASI 75) at Week 24.

Detailed description:

Arms: arm 1: Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period. arm 2: Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
Interventions: intervention 1: Methotrexate intervention 2: Etanercept intervention 3: Placebo
Intervention descriptions: intervention 1: Methotrexate tablets over-encapsulated for blinding intervention 2: 1 mL for subcutaneous injection intervention 3: Matching placebo to methotrexate capsules

Protocol documents:
Clinical trial NCT01007149
Conditions: Asthma
Keywords: Severe asthma, non-atopic, omalizumab
Sponsor: Novartis Pharmaceuticals
Start date: 2009-09-01; Completion date: 2011-02-01
Enrollment: 79 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the change in the expression of FcεRI receptors of blood basophils and dendritic cells after 16 weeks of treatment with omalizumab as compared with placebo, in adult patients with non-atopic severe persistent asthma, uncontrolled despite optimal therapy.

Detailed description:

Arms: arm 1: Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight. arm 2: Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
Interventions: intervention 1: omalizumab intervention 2: Placebo
Intervention descriptions: intervention 1: Omalizumab was supplied in 5mL vials with solution for subcutaneous injection. intervention 2: Placebo was supplied in vials with solution for subcutaneous injection.

Protocol documents: