ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00732940
Conditions: Systemic Lupus Erythematosus
Keywords: SLE Lupus Systemic Lupus Erythematosus Antibodies Autoimmune Diseases Belimumab
Sponsor: Human Genome Sciences Inc.
Start date: 2008-10-01; Completion date: 2012-03-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test the safety and tolerability of repeated subcutaneous (SC) doses of belimumab in subjects with SLE.

Detailed description:
This clinical trial will evaluate the safety, pharmacokinetics (PK), and effect on biomarkers of repeated subcutaneous (SC) administration of belimumab in subjects with SLE. As data permit, an exploratory pharmacodynamic analysis will be performed to evaluate the correlation between belimumab serum exposure, PGA, SELENA SELDAI, and biomarker effects.

Arms: arm 1: Every other week: 100 mg of belimumab (1 injection) subcutaneous (under the skin) on days 0, 7, and 14, then every other week until final evaluation at Week 24 with option to continue receiving belimumab at the same dose through 144 week continuation period. arm 2: Three times weekly: 200 mg of belimumab (2 injections of 100 mg each) subcutaneous (under the skin) on days 0, 2, and 4 then 100 mg three times a week until final evaluation at Week 24 with option to continue receiving belimumab at the same dose through 144 week continuation period.
Interventions: intervention 1: Belimumab 100 mg SC intervention 2: Belimumab 100 mg SC
Intervention descriptions: intervention 1: Belimumab 100 mg SC for 1 injection on Days 0, 7, 14, and then every two weeks. intervention 2: Belimumab 100mg SC for 2 injections (of 100mg each) on Days 0, 2, and 4, then 100 mg (1 injection) three times per week.

Protocol documents:
Clinical trial NCT00768755
Conditions: Carcinoma, Non-Small Cell Lung
Keywords: non-squamous NSCLC axitinib pemetrexed/cisplatin
Sponsor: Pfizer
Start date: 2009-01-01; Completion date: 2012-03-01
Enrollment: 180 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
AG-013736 (axitinib) in combination with cisplatin and pemetrexed will be evaluated as first-line treatment of patients with locally advanced, recurrent, or metastatic non-squamous, non small cell lung cancer (NSCLC).

Detailed description:

Arms: arm 1: Axitinib (continuous) + Pemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles followed by axitinib maintenance arm 2: Axitinib (modified) + Pemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles followed by axitinib maintenance arm 3: pemetrexed and cisplatin arm 4: Axitinib interrupted before each chemo cycle (Pemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles followed by axitinib maintenance arm 5: pemetrexed and cisplatin
Interventions: intervention 1: axitinib intervention 2: axitinib intervention 3: chemotherapy intervention 4: axitinib intervention 5: chemotherapy
Intervention descriptions: intervention 1: 5mg BID po up to max 10mg BID po intervention 2: 5mg BID po up to max 10mg BID po paused for 3 days before each cycle of concomitant chemotherapy intervention 3: Pemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles intervention 4: 5mg BID po up to max 10mg BID po paused before each concomitant chemotherapy intervention 5: Pemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles

Protocol documents:
Clinical trial NCT00798135
Conditions: Breast Neoplasms Neoplasm Metastasis
Sponsor: Indiana University
Start date: 2008-11-01; Completion date: 2012-03-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Cancer cells need to be able to make new blood vessels in order to keep growing. This is called angiogenesis. In a laboratory setting, the drug itraconazole was shown to help stop the growth of new blood vessels (anti-angiogenesis). It is hoped that itraconazole will prevent new blood vessels from forming in humans too.

The purpose of this study is to look at how the body processes and breaks down itraconazole (called pharmacokinetics). This study will also measure markers in your blood to see if itraconazole stops new blood vessels from forming. The safety of itraconazole will also be tested to see what effects (good and bad) it has on you and your breast cancer.

Detailed description:

Arms: arm 1: Patients will receive oral itraconazole 200mg a day until disease progression.
Interventions: intervention 1: itraconazole
Intervention descriptions: intervention 1: oral itraconazole 200mg a day until disease progression or unacceptable toxicities.

Protocol documents:
Clinical trial NCT00800735
Conditions: Hepatitis C, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2009-04-01; Completion date: 2012-03-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will provide treatment or re-treatment with PEGASYS as monotherapy or in combination with ribavirin (Copegus), to patients with chronic hepatitis C (CHC) who have participated in a previous Roche or Roche partner protocol where access to treatment or re-treatment was promised or deemed appropriate following completion of the original protocol ('donor' protocol). Patients who qualify for treatment or re-treatment will begin PEGASYS monotherapy, at a maximum dose of 180 µg weekly, or combination therapy with Copegus, 800-1200 mg daily, as continuation of treatment after the wash-out period defined in their donor protocol. PEGASYS treatment is not to exceed the approved treatment duration of 48 weeks in genotype G1 with a treatment-free follow up period of 24 weeks.

Detailed description:

Arms: arm 1: Participants received pegylated-interferon alfa-2a 180 µg/week subcutaneously plus ribavirin 1000 mg/day orally for patients weighing \< 75 kg or 1200 mg/day for patients weighing ≥ 75 kg for 48 weeks.
Interventions: intervention 1: Pegylated-interferon alfa-2a intervention 2: Ribavirin
Intervention descriptions: intervention 1: Pegylated-interferon alfa-2a was administered subcutaneously once weekly. intervention 2: Participants received ribavirin with food, as the bioavailability of ribavirin is increased when taken with food. Ribavirin was administered as split doses, that is, 2 doses were given 12 hours apart, 1 in the morning and 1 in the evening. Participants received either 1000 or 1200 mg ribavirin per day according to body weight: 400 mg (2 tablets) in the morning and 600 mg (3 tablets) in the evening for participants weighing \< 75 kg or 600 mg (3 tablets) in the morning and 600 mg (3 tablets) in the evening for participants weighing ≥ 75 kg.

Protocol documents:
Clinical trial NCT00803179
Conditions: Cystic Fibrosis
Keywords: CF
Sponsor: University of Massachusetts, Worcester
Start date: 2008-11-01; Completion date: 2012-03-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Our hypothesis is that Growth Hormone (GH) will not only target the peripheral tissue to stimulate weight and muscle growth which will maximize nutritional potential and improve overall quality of life. We theorize that this will occur through a multitude of factors: increased appetite, more constructive utilization of caloric intake and decreased catabolic signaling. The first aim will address changes in weight and lean body mass following the institution of GH therapy in adults with Cystic Fibrosis (CF) related wasting. The second aim will measure impact on quality of life of these individuals. Additionally, the third aim will monitor effects of GH therapy on diabetes and insulin sensitivity. Finally, the fourth aim will observe changes in the subjects underlying diagnosis of CF, specifically lung function, muscle strength and inflammatory state.

Detailed description:
The following is a more detailed description of the aims listed above:

Specific Aim 1: Measure change in weight in adults with CF related wasting following GH therapy.

1.1) Monitor weight gained or loss from baseline. 1.2) Assess changes in fat free mass from baseline by bioelectrical impedence analysis.

Specific Aim 2: Evaluate overall quality of life (QOL) in adults with CF related wasting treated with GH therapy.

2.1) Perform CF disease-specific and general QOL analysis via CF QOL questionnaires.

2.2) Monitor compliance with therapy via subject report.

Specific Aim 3: Monitor impact of GH therapy in relation to CF related diabetes onset or control.

3.1) Measure impact on insulin sensitivity in non-diabetes subjects 3.2) Observe change in exogenous insulin requirements and glycemic control in subjects with diabetes.

Specific Aim 4: Quantify impact of anabolic therapy on manifestations of underlying diagnosis associated with CF.

4.1) Observe changes in lung function from baseline during GH therapy. 4.2) Determine changes in overall muscle strength via hand grip and six minute walk.

4.3) Evaluate changes in serum markers.

Arms: arm 1: Nutropin Aqueous (AQ):

Initiation treatment for adult males is 0.2mg/d and for women 0.4mg/d
Interventions: intervention 1: Nutropin AQ
Intervention descriptions: intervention 1: Based on recommendations from the 2007 GH Deficiency Consensus Workshop on adult GH deficiency, the recommended initiation of treatment for adult males is 0.2mg/d and for women 0.4mg/d, with a titration upwards based on insulin-like growth factor (IGF-1) (product of GH stimulation at target tissues) levels and patient response. IGF-1 will be monitored at the 3,4,5 and 11 month intervals. For subjects under the age of 25 with an open epiphysis of the hand and/or wrist we will treat with the dose of 0.3mg/kg/week. Subjects will be on growth hormone for 8 months with a baseline visit prior to initiation of therapy and a 3 month follow-up visit after stopping therapy.

Protocol documents:
Clinical trial NCT00810394
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Keywords: unspecified adult solid tumor, protocol specific
Sponsor: University of California, Davis
Start date: 2008-12-01; Completion date: 2012-03-01
Enrollment: 50 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying the side effects and best dose of sorafenib and to see how well it works in treating patients with advanced malignant solid tumors.

Detailed description:
OBJECTIVES:

Primary

* To evaluate the feasibility of re-escalating the dose of sorafenib tosylate in patients with advanced malignant solid tumors who initially required a dose reduction for toxicity, and dose escalation in those patients who are able to tolerate the initial dose.

Secondary

* To evaluate the efficacy of this drug in these patients who are able to tolerate a dose escalation initially or after a dose reduction compared to those who are unable to tolerate a dose escalation.

Tertiary

* To evaluate the percentage and demographic characteristics of patients who are able to tolerate 2 dose escalations without a dose reduction.

OUTLINE: This is a dose-finding study.

* Course 1: Patients receive oral sorafenib tosylate twice daily at dose level 0 on weeks 1-4.
* Course 2: Patients experiencing no dose-limiting or intolerable toxicities receive oral sorafenib tosylate at dose level +1 twice daily on weeks 5-8; while patients experiencing dose-limiting or intolerable toxicities receive oral sorafenib tosylate at dose level -1 once daily on weeks 5-8.
* Course 3: Depending on whether or not patients are experiencing dose-limiting or intolerable toxicities, they are escalated to dose level 0 or dose level +2 (patients in both dose levels receive oral sorafenib tosylate twice daily) in weeks 9-12, or de-escalated to dose level 0 or dose level -2 (patients in dose level -2 receives oral sorafenib tosylate once every other day) in weeks 9-12.
* Maintenance therapy: Patients receive oral sorafenib tosylate at the dose level\* attained at the end of course 3. Treatment continues in the absence of unacceptable toxicity.
* Dose level de-escalation for toxicity or dose re-escalation after a toxicity-related dose reduction allowed to a maximum level of the initial dose level of the maintenance therapy.

After completion of study therapy, patients are followed for up to 1 year.

Arms: arm 1: Dose Re-Escalation Following a Dose Reduction
Interventions: intervention 1: Sorafenib
Intervention descriptions: intervention 1: Patients will be registered and started on the standard recommended dose-schedule for sorafenib (400 mg tablet by mouth twice a day continuously). Dose reductions will be instituted in the event of grade 3 or higher hematologic or non-hematologic toxicity or for any toxicity that is considered by the patient or physician as intolerable.

Protocol documents:
Clinical trial NCT00855894
Conditions: Non-Small Cell Lung Cancer
Keywords: Tarceva NSCLC
Sponsor: Genentech, Inc.
Start date: 2009-03-01; Completion date: 2012-03-01
Enrollment: 41 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This was a Phase II, open-label, single-arm, single-stage, multicenter trial in patients with relapsed non-small cell lung cancer (NSCLC), with the objective of assessing the activity of the combination of erlotinib and pertuzumab on the basis of the endpoint of FDG-PET response rate.

Detailed description:

Arms: arm 1: Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
Interventions: intervention 1: Pertuzumab intervention 2: Erlotinib
Intervention descriptions: intervention 1: After a single administration of a loading dose of 840 mg IV, patients received a maintenance dose of 420 mg IV every 3 weeks (q3w). intervention 2: Patients received 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.

Protocol documents:
Clinical trial NCT00879879
Conditions: Precancerous Condition
Keywords: precancerous condition
Sponsor: University of South Florida
Start date: 2009-03-01; Completion date: 2012-03-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Losartan may be effective in treating patients with idiopathic pulmonary fibrosis.

PURPOSE: This clinical trial is studying the side effects of losartan and to see how well it works in treating patients with idiopathic pulmonary fibrosis.

Detailed description:
OBJECTIVES:

* Evaluate the effects of losartan potassium on disease progression in patients with idiopathic pulmonary fibrosis.
* Determine the safety of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral losartan potassium daily for 1 year in the absence of disease progression or unacceptable toxicity.

Patients undergo pulmonary function tests with gas diffusion lung volumes, Carbon monoxide diffusing capacity (DLCO) tests, and 6-minute walk tests at baseline and then at 3, 6, 9, and 12 months. Patients also complete baseline/transition dyspnea index questionnaires at baseline and then at 1, 3, 6, 9, and 12 months.

Arms: arm 1: 50 mg tablets of losartan taken daily by mouth for 1 year
Interventions: intervention 1: losartan
Intervention descriptions: intervention 1: 50 mg losartan taken daily by mouth in capsule form for 1 year

Protocol documents:
Clinical trial NCT00894413
Conditions: Head and Neck Squamous Cell Carcinoma
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Start date: 2007-05-08; Completion date: 2012-03-01
Enrollment: 45 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to determine whether or not Cialis (tadalafil) administered to head and neck squamous cell cancer patients augments immune response.

Detailed description:

Arms: arm 1: None arm 2: Tadalafil 20 mg once per day
Interventions: intervention 1: Tadalafil intervention 2: Placebo Pill
Intervention descriptions: intervention 1: 20 mg once daily for 10 - 14 days intervention 2: Placebo

Protocol documents:
Clinical trial NCT00911898
Conditions: Her2 Amplified Solid Tumors Metastatic Breast Cancer
Keywords: Her2 amplified solid tumors Breast Cancer Her3/ErbB3 Bispecific Antibody
Sponsor: Merrimack Pharmaceuticals
Start date: 2009-06-01; Completion date: 2012-03-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is an open-label Phase 1 trial of MM-111.

Detailed description:
Phase 1: Patients with any solid tumor type may be enrolled to evaluate the safety and tolerability of MM-111.

Arms: arm 1: None
Interventions: intervention 1: MM-111
Intervention descriptions: intervention 1: For Phase 1: Dose-escalation cohorts, drug is administered weekly via IV

Protocol documents:
Clinical trial NCT00912743
Conditions: Colorectal Cancer
Keywords: Colorectal cancer Olaparib MSI status Stage IV Measurable Colorectal Cancer Stratified by MSI Status
Sponsor: AstraZeneca
Start date: 2009-05-01; Completion date: 2012-03-01
Enrollment: 33 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is being carried out to see if the new drug, olaparib (AZD2281), can effectively and safely treat advanced large bowel cancer. The primary goal of this clinical trial is to determine whether olaparib will have a beneficial effect on the patient's cancer by causing a response and increasing the time it takes for the cancer to progress.

Detailed description:

Arms: arm 1: MSI - H arm
Interventions: intervention 1: olaparib
Intervention descriptions: intervention 1: 400 mg po bid continuously

Protocol documents:
Clinical trial NCT00920699
Conditions: Huntington's Disease
Sponsor: Johns Hopkins University
Start date: 2010-02-01; Completion date: 2012-03-01
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To establish the tolerability of treatment with 600, 1200 or 2400 mg per day of coenzyme Q10 in pre-manifest participants carrying the CAGn expansion for Huntington's Disease (HD).

Detailed description:
secondary objectives:

1. To assess the change from baseline to 20 weeks on biomarkers of oxidative stress (8OHdG and 8OHrG) and DNA repair mechanisms (OGG1) in pre-manifest participants treated with 600, 1200 or 2400 mg per day of CoQ10.
2. To assess the dose-response relationship between CoQ10 at dosages of 600, 1200 or 2400 mg per day and 8OHdG/8OHrG and OGG1.
3. To assess the serum levels of CoQ10 at 600, 1200 or 2400 mg in pre-manifest participants and their relationship to 8OHdG/8OHrG and OGG1.
4. To assess the feasibility of implementing a preventive therapeutic trial in a pre-manifest population.
5. To assess the utility and stability of clinical measures of HD, social relations, behavior and employment in a pre-manifest sample enrolled in a treatment trial.

Arms: arm 1: All participants will start on a dosage of 600 mg/day of CoQ10 in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20. arm 2: All participants will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20. arm 3: All participants will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.
Interventions: intervention 1: CoQ10
Intervention descriptions: intervention 1: Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.

Protocol documents:
Clinical trial NCT00931801
Conditions: HIV
Keywords: AIDS HIV Atazanavir Raltegravir Tenofovir protease inhibitors
Sponsor: Community Research Initiative of New England
Start date: 2009-12-01; Completion date: 2012-03-01
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this Phase IV pilot study is to evaluate the safety, tolerability, and satisfaction of a nucleoside analog reverse-transcriptase inhibitors (NRTI)sparing regimen for participants fully suppressed on an atazanavir/ritonavir based highly active antiretroviral therapy (HAART)regimen plus emtricitabine/tenofovir (Truvada). Several pharmacologic factors support this concept including the favorable drug interaction between atazanavir and raltegravir. Participants will be randomized to either continue on their current regimen or one of two study arms (atazanavir 300mg plus ritonavir 100mg daily plus raltegravir 400mg twice daily or atazanavir 300mg twice daily plus raltegravir 400mg twice daily). Participants will be followed for 48 weeks for safety, tolerability, and satisfaction. After baseline, the participants will have six clinic visits for evaluation and labs.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: Continue baseline regimen
Interventions: intervention 1: atazanavir/raltegravir intervention 2: atazanavir/raltegravir intervention 3: atazanavir/tenofovir/emtricitabine
Intervention descriptions: intervention 1: Atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily intervention 2: Atazanavir 300mg twice daily plus raltegravir 400mg twice daily intervention 3: Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine

Protocol documents:
Clinical trial NCT00943579
Conditions: Autistic Disorder
Keywords: autism autistic disorder tetrahydrobiopterin sapropterin treatment
Sponsor: The Children's Health Council
Start date: 2009-08-01; Completion date: 2012-03-01
Enrollment: 41 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label extension study available only to subjects who completed an earlier double-blind, placebo-controlled study of sapropterin in children with autism.

Detailed description:
This is an open-label extension study available only to subjects who completed an earlier double-blind, placebo-controlled study of sapropterin in children with autism. During this protocol, all subjects will be receiving brand-name Kuvan 20 mg/kg/day for 16 weeks; subject who complete the first 16 weeks will have the option of continuing on Kuvan at the same dose for up to 90 days after the last subject has completed the first 16 weeks of this protocol. The purpose of the study primarily is to gather additional information on safety and efficacy in this population.

Arms: arm 1: Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks.
Interventions: intervention 1: Kuvan®
Intervention descriptions: intervention 1: Brand-name Kuvan® (sapropterin) will be administered to all subjects at a dose of 20 mg/kg/day for 16 weeks.

Protocol documents: