ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00806585
Conditions: Type 2 Diabetes Mellitus Hypertension
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-12-01; Completion date: 2010-06-01
Enrollment: 620 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will assess the efficacy and tolerability of MK0736 in patients with Type 2 Diabetes Mellitus and Hypertension who are on ongoing therapy with Angiotensin-Converting Enzyme or Angiotensin Receptor Blocker. After a 3 to 5 week pre-randomization phase, patients will be randomized to either MK0736 (3 doses), placebo, or hydrochlorothiazide (HCTZ). The study will also include a 3 week, posttreatment follow-up period.

Detailed description:

Arms: arm 1: One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B). arm 2: One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B). arm 3: One MK-0736 8.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for 52 weeks (Phase B). arm 4: one 12.5 mg hydrochlorothiazide (HCTZ) tablet daily, orally, for 12 weeks. Participant then switched to MK-0736 8.0 mg for 12 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B). arm 5: One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)
Interventions: intervention 1: MK-0736 intervention 2: Comparator: Placebo intervention 3: Comparator: HCTZ
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00810017
Conditions: HER-2 Positive Metastatic Breast Cancer
Keywords: Her2 Positive Breast Cancer Metastatic
Sponsor: Medstar Health Research Institute
Start date: 2009-02-01; Completion date: 2010-06-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is for women and men who have previously treated metastatic (has spread to other parts in the body), Her2- positive breast cancer. The purpose of this study is to find out what effects (good and bad) the FDA-approved drugs etoposide and trastuzumab have on this type of breast cancer and to determine if these drugs are safe to use together. This research is being done to find more effective treatment for this type of condition.

In this study, trastuzumab and etoposide will be given by intravenous infusion (IV; through a vein) on the first 3 days of every 3-week cycle. This is repeated for 6 cycles. After 6 cycles, only trastuzumab will be given until worsening of disease. In this study, a small amount of your tissue that was collected when you had surgery will be evaluated in the lab to look at genetic differences among people and how those differences may affect a response to a specific drug or medicine. This testing will look for a gene called Top2A. Previous studies suggest that people who have both the Top2A and Her2 genes respond to certain chemotherapies (anti-cancer drugs) differently from those who only have the Her2 gene.

Detailed description:

Arms: arm 1: Etoposide 100mg/m2 daily x 3 days Q3W and Trastuzumab 8mg/kg loading dose then 6mg/kg, then single agent until disease progression
Interventions: intervention 1: Etoposide intervention 2: Trastuzumab
Intervention descriptions: intervention 1: etoposide 100 mg/m2 daily for 3 days every three weeks for 6 cycles intervention 2: intravenous trastuzumab 8 mg/kg loading dose and then 6 mg/kg every three weeks and then single agent trastuzumab until progression of disease

Protocol documents:
Clinical trial NCT00814307
Conditions: Arthritis, Rheumatoid
Keywords: Antirheumatic Agents Clinical Trial
Sponsor: Pfizer
Start date: 2009-02-01; Completion date: 2010-06-01
Enrollment: 611 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Phase 3 study is intended to provide evidence of the efficacy and safety of CP 690,550 when dosed 5 mg and 10 mg twice a day as monotherapy in adult patients with moderate to severe Rheumatoid Arthritis. It is intended to confirm the benefits of CP-690,550 in improving signs and symptoms and physical function that were observed in the Phase 2 Rheumatoid Arthritis studies.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: CP-690,550 intervention 2: CP-690,550 intervention 3: Placebo intervention 4: Placebo
Intervention descriptions: intervention 1: 5mg CP-690,550 BID PO for 6 months intervention 2: 10 mg CP-690,550 BID PO for 6 months intervention 3: Placebo patients advance to 5mg CP-690,550 BID at Month 3 visit intervention 4: Placebo patients advance to 10mg CP-690,550 BID at Month 3 visit

Protocol documents:
Clinical trial NCT00817089
Conditions: Alcoholism
Sponsor: University of Pennsylvania
Start date: 2007-12-01; Completion date: 2010-06-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study involving treatment for alcohol dependence among males of European or Asian decent. The ultimate aim of this line of investigation is to further establish a genetic link between alcohol dependence and treatment by defining an endophenotype associated with treatment response. The study consists of two inpatient alcohol challenge sessions with treatment using random assignment to either naltrexone or placebo.

Detailed description:
Despite the well-established efficacy of naltrexone, there are significant variations in individual responses to naltrexone. A critical question remains: under what circumstances and for which patients will naltrexone be most beneficial? Recent work at our center provides evidence that the mu-opioid receptor (OPRM1) gene polymorphism A118G (Asn40Asp) imparts a significant change in treatment response. We have shown that patients with Asn40 variant (absence of heavy drinking -73.9% v/s 49% response). To further consolidate our knowledge, we wish to test the relationship between A118G polymorphism and the subjective/objective measures to alcohol among alcoholics treated with naltrexone. This work is focused on subjects of European or Asian decent as the A118G polymorphism occurs in less than 1% of those of African decent.

Up to 40 subjects will be recruited. The subjects were admitted to the UPenn Translational Research Center and receive two alcohol challenge sessions after pretreatment with naltrexone or placebo.

Arms: arm 1: Each alcohol session preceded by pretreatment with placebo oral tablet arm 2: The first alcohol session preceded by pretreatment with placebo oral tablet. The second alcohol session preceded by pretreatment with naltrexone 50 mg as a single dose. arm 3: Each alcohol session preceded by pretreatment with placebo oral tablet arm 4: The first alcohol session preceded by pretreatment with placebo oral tablet. The second alcohol session preceded by pretreatment with naltrexone 50 mg as a single dose.
Interventions: intervention 1: Placebo Oral Tablet intervention 2: Naltrexone
Intervention descriptions: intervention 1: Placebo pill intervention 2: 50 mg of naltrexone prior to challenge session

Protocol documents:
Clinical trial NCT00824564
Conditions: Femoral Fractures
Keywords: Tranexamic Acid Blood Loss Long Bone Fracture Surgery
Sponsor: Pfizer
Start date: 2009-04-01; Completion date: 2010-06-01
Enrollment: 82 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Tranexamic acid has been shown to reduce postoperative blood losses and transfusion requirements in a number of types of surgery. Most trials in orthopedic surgery have been conducted in arthroplasty, hip fracture and spine surgeries. This study would aim to see the effect of tranexamic acid in reduction of blood loss and transfusions for long bone fracture surgery, primarily fracture shaft of femur.

Detailed description:

Arms: arm 1: Tranexamic Acid plus standard of care arm 2: Standard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss.
Interventions: intervention 1: Tranexamic Acid plus standard of care intervention 2: Standard of care
Intervention descriptions: intervention 1: Tranexamic acid given slowly intravenously (15 mg/kg body weight) 15 minutes before surgery followed by a second dose at three hour interval from first dose and third dose at three hour interval from the second + Standard of care (Standard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss) intervention 2: Standard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss

Protocol documents:
Clinical trial NCT00829439
Conditions: Angelman Syndrome
Keywords: Angelman syndrome Levodopa Carbidopa L-dopa
Sponsor: Boston Children's Hospital
Start date: 2009-01-01; Completion date: 2010-06-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is designed to determine the highest dose of levodopa/carbidopa that can be tolerated without any serious side effects by children with Angelman syndrome.

It has been hypothesized that levodopa may lead to an improvement in the neurodevelopment and abnormal movements (e.g. tremors) in children with Angelman syndrome.

Data from this study will be used to design a phase II trial to determine the efficacy of levodopa in treating children with Angelman syndrome.

Detailed description:
Levodopa is a prodrug that "delivers" dopamine to the brain. It is usually given with carbidopa, a peripheral decarboxylase inhibitor, to increase the bioavailability of levodopa. Animal studies have suggested that levodopa can reverse the excess phosphorylation of some enzymes involved in synaptic and neuronal function, including calcium/calmodulin-dependent kinase type 2 (CaMKII).

Recently, it was shown that excess phosphorylation of CaMKII may be responsible for some of the neurological deficits seen in Angelman syndrome. Therefore, it is hypothesized that levodopa may lead to an improvement in the neurodevelopment and abnormal movements (e.g. tremors) in children with Angelman syndrome.

Although many children have used levodopa for a variety of medical conditions over the last 30 years, it has not been approved by the Food and Drug Administration (FDA) for use in children, and it has not been formally studied in children with Angelman syndrome, so we do not know what dose of levodopa is most appropriate for children with Angelman syndrome.

Therefore, the purpose of this study is to find out the highest dose of levodopa that children with Angelman syndrome can tolerate without any serious side effects.

Once we know the dose of levodopa that can be tolerated by children with Angelman syndrome, we will conduct a larger follow-up study to find out whether levodopa will lead to an improvement in their development and tremor.

Arms: arm 1: Other Names:

Sinemet L-dopa

Dosages are based on levodopa.

Each cohort of 3 subjects will be placed on an increasing dose of levodopa (2, 5, 10, and 15 mg/kg/day) for 1 week, provided subjects in the preceding cohort tolerated the lower dose.

Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day.
Interventions: intervention 1: Levodopa/Carbidopa (4:1)
Intervention descriptions: intervention 1: Dosages are based on levodopa.

Each cohort of 3 subjects will be placed on an increasing dose of levodopa (2, 5, 10, and 15 mg/kg/day) for 1 week, provided subjects in the preceding cohort tolerated the lower dose.

Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day.

Protocol documents:
Clinical trial NCT00843024
Conditions: Migraine Disorders
Keywords: Migraine with or without aura Migraine efficacy Migraine Migraine headache Adolescent migraine TREXIMET Sumatriptan succinate Naproxen sodium Migraine, acute
Sponsor: GlaxoSmithKline
Start date: 2008-12-01; Completion date: 2010-06-01
Enrollment: 589 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was designed to determine how well the combination medication, sumatriptan and naproxen sodium, treats migraine headache in adolescents 12-17 years old

Detailed description:
The purpose of this study is to determine whether the combination product, sumatriptan and naproxen sodium, is effective compared to placebo in the treatment of acute migraine in adolescent subjects 12-17 years old. Subjects will treat two migraine attacks over a \~25 week period.

Arms: arm 1: Sumatriptan succinate and naproxen sodium combination 10mg/60mg arm 2: Sumatriptan succinate and naproxen sodium combination 30mg/180mg arm 3: Sumatriptan succinate and naproxen sodium combination 85mg/500mg arm 4: Placebo to match
Interventions: intervention 1: Sumatriptan and Naproxen Sodium intervention 2: Placebo
Intervention descriptions: intervention 1: Sumatriptan succinate and naproxen sodium intervention 2: Placebo to match

Protocol documents:
Clinical trial NCT00861757
Conditions: Benign Prostatic Hyperplasia
Sponsor: Eli Lilly and Company
Start date: 2009-03-01; Completion date: 2010-06-01
Enrollment: 612 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a randomized, double-blind, placebo and tamsulosin-controlled, parallel design, multinational study to evaluate the efficacy and safety of Tadalafil once-a-day dosing for 12 weeks in Asian men with signs and symptoms of benign prostatic hyperplasia (BPH).

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Tadalafil intervention 2: Placebo intervention 3: Tamsulosin
Intervention descriptions: intervention 1: by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks intervention 2: PO, QD (30 min after meal) for 12 weeks intervention 3: PO, QD (30 min after meal) for 12 weeks

Protocol documents:
Clinical trial NCT00865020
Conditions: Hypertension
Keywords: Hypertension ABPM systolic blood pressure diastolic blood pressure cardiovascular disease aliskiren telmisartan
Sponsor: Novartis
Start date: 2009-03-01; Completion date: 2010-06-01
Enrollment: 822 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was specifically designed to provide additional information on the mechanism of action of direct renin inhibition postulating the higher-level RAS cascade inhibition. The purpose of this study was to compare the prolonged efficacy and safety of aliskiren to that of telmisartan in mild to moderate hypertensive patients in the 24 hrs Ambulatory Blood Pressure Monitoring setting after a one week treatment withdrawal.

Detailed description:

Arms: arm 1: Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period. arm 2: Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.
Interventions: intervention 1: Aliskiren intervention 2: Telmisartan intervention 3: Placebo to Aliskiren intervention 4: Placebo to Telmisartan
Intervention descriptions: intervention 1: Aliskiren 150 mg tablets taken orally daily. 1 tablet for the first two weeks followed by 2 tablets for 10 weeks. intervention 2: Telmisartan 40 mg capsules taken orally daily. 1 capsule the first 2 weeks followed by 2 capsules for 10 weeks. intervention 3: Placebo to Aliskiren tablets taken orally daily. 1 Tablet for the first 2 weeks and 2 tablets during the no treatment (withdrawal) week. intervention 4: Placebo to Telmisartan capsule taken orally daily. 1 capsule for the first 2 weeks and 2 capsules during the no treatment (withdrawal) week.

Protocol documents:
Clinical trial NCT00865098
Conditions: Carcinoma of the Head and Neck
Keywords: Newly diagnosed locally advanced squamous cell carcinoma of the head and neck (SCCHN)
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2009-03-01; Completion date: 2010-06-01
Enrollment: 27 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is conducted in Japanese newly diagnosed locally advanced SCCHN patients in order to assess tolerability and feasibility of Cetuximab plus concomitant boost radiotherapy (RT) regimen (the study treatment) and its safety profile (i.e. AEs: adverse events). In addition, efficacy (i.e. anti-tumor effect) of the study treatment is also evaluated.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Cetuximab
Intervention descriptions: intervention 1: Patients receive Cetuximab at an initial dose of 400 mg/m\^2 of Cetuximab to be infused 6 or 7 days before starting radiotherapy, followed by subsequent weekly infusions at a dose of 250 mg/m\^2 of Cetuximab and RT (72.0 Gy total in 42 fractions) for the next 6 weeks of the treatment course. Subjects will receive Cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of Cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with Cetuximab monotherapy every 7 days is continued.

Protocol documents:
Clinical trial NCT00866658
Conditions: Diabetes Mellitus, Type 2
Keywords: hyperglycemia GLP-1 sulfonylurea insulin
Sponsor: Sanofi
Start date: 2009-03-01; Completion date: 2010-06-01
Enrollment: 311 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to basal insulin with or without sulfonylurea, over a period of 24 weeks of treatment.

The primary objective is to assess the effects of lixisenatide, when added to basal insulin, on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction at Week 24.

The secondary objectives are to assess the effects of lixisenatide on body weight, 2-hour postprandial plasma glucose (PPG) after standardized meal challenge test, percentage of patients reaching HbA1c less than 7 percent (%), percentage of patients reaching HbA1c less than or equal to 6.5%, fasting plasma glucose (FPG), change in 7-point self-monitored plasma glucose (SMPG) profiles, change in daily basal insulin and total insulin doses; to evaluate safety, tolerability, pharmacokinetics (PK), and anti-lixisenatide antibody development.

Detailed description:

Arms: arm 1: 2-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24. arm 2: 2-step initiation regimen of volume matching placebo: 10 mcg QD for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
Interventions: intervention 1: Lixisenatide (AVE0010) intervention 2: Placebo intervention 3: Pen auto-injector intervention 4: Sulfonylurea intervention 5: Basal Insulin
Intervention descriptions: intervention 1: Self-administered by subcutaneous injections once daily within the hour preceding breakfast. intervention 2: Self-administered by subcutaneous injections once daily within the hour preceding breakfast. intervention 3: None intervention 4: Sulfonylurea if given, to be continued at a stable dose. intervention 5: To be continued at a stable dose.

Protocol documents:
Clinical trial NCT00883740
Conditions: Fibromyalgia Sleep Disorders
Keywords: Fibromyalgia sleep maintenance disturbance pregabalin
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2009-06-01; Completion date: 2010-06-01
Enrollment: 119 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of the study is to demonstrate the effect of Lyrica on Wake after sleep onset in subjects with fibromyalgia with sleep maintenance disturbance (on polysomnogram)

Detailed description:

Arms: arm 1: flexible dosing Lyrica 300-450mg/day arm 2: Placebo
Interventions: intervention 1: Pregabalin intervention 2: Placebo
Intervention descriptions: intervention 1: Capsule, flexible dosing double-blind. Treatment duration is approximately 4 weeks titrated to 300-450 mg/day intervention 2: Capsule, flexible dosing double-blind. Treatment duration is approximately 4 weeks

Protocol documents:
Clinical trial NCT00884286
Conditions: Leukemia Lymphoma
Keywords: Aplidin Aggressive Non Hodgkin Lymphoma Leukemia-Lymphoma, Adult T-Cell and B-cell
Sponsor: PharmaMar
Start date: 2004-12-01; Completion date: 2010-06-01
Enrollment: 67 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a multicenter study to assess the anti-tumour activity,to investigate the safety profile and to obtain additional pharmacokinetic information for Aplidin® given as 1-hour weekly IV infusion in patients with aggressive non-Hodgkin's Lymphoma.

Detailed description:
A Phase II Multicenter,Open-Label, Clinical And Pharmacokinetic Study Of Aplidin® As A 1-Hour Weekly IV Infusion, In Patients With Relapsed Or Refractory aggressive non-Hodgkin's Lymphoma.

Primary

• To assess the anti-tumour activity of Aplidin® given as a 1-hour weekly IV infusion, in patients with aggressive non-Hodgkin's Lymphoma, relapsing or refractory to a prior therapy.

Secondary

* To further investigate the safety profile of Aplidin® given as 1-hour weekly IV infusion in this patient population.
* To obtain additional pharmacokinetic information for Aplidin® given as 1-hour weekly IV infusion in patients with aggressive non-Hodgkin's Lymphoma.

Arms: arm 1: Aplidin® given as a 1-hour weekly IV infusion
Interventions: intervention 1: Aplidin®
Intervention descriptions: intervention 1: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle.

Protocol documents: