ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00999037
Conditions: Secondary Hyperparathyroidism
Sponsor: University of California, Los Angeles
Start date: 2009-10-01; Completion date: 2015-06-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
FGF-23 is a newly described protein that is an important regulator of phosphorus in the body. This protein increases in people with kidney disease and people who need dialysis have very high levels of FGF-23 in the blood. However, although some studies have indicated that FGF-23 levels go up with increased intake of phosphorus, no one knows if FGF-23 levels can be lowered in patients with kidney disease by preventing them from absorbing phosphorus from food. This study is designed to see what happens to levels of FGF-23 in the blood when patients with chronic kidney disease take medications to prevent phosphorus absorption. Since high levels of FGF-23 have been linked with increased rates of death in patients with advanced kidney disease, controlling the levels may, in the future, be a way to decrease heart disease in patients with kidney disease.

Detailed description:

Arms: arm 1: Daily renvela with meals for 12 weeks arm 2: None
Interventions: intervention 1: Sevelamer Carbonate intervention 2: Placebo
Intervention descriptions: intervention 1: Daily renvela (800 mg tid with meals) x 12 weeks intervention 2: 1 inert tablet tid x 12 weeks

Protocol documents:
Clinical trial NCT01007942
Conditions: HER2/Neu Over-expressing Locally Advanced Breast Cancer Metastatic Breast Cancer
Keywords: Metastatic breast cancer locally advanced breast cancer HER2/neu positive breast cancer HER2/neu over-expressing progressive-free survival (PFS) over survival (OS) bolero bolero 3 Breast cancer everolimus HER+ vinorelbine herceptin trastuzumab RAD001
Sponsor: Novartis Pharmaceuticals
Start date: 2009-10-01; Completion date: 2015-06-01
Enrollment: 569 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This phase III, double-blind, placebo-controlled multinational study will assess the combination everolimus, vinorelbine, and trastuzumab compared to the combination vinorelbine and trastuzumab with respect to progressive-free survival and over survival in HER2/neu positive women with locally advanced or metastatic breast cancer who are resistant to trastuzumab and have been pre-treated with a taxane.

Detailed description:

Arms: arm 1: Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only) arm 2: Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only
Interventions: intervention 1: everolimus intervention 2: Placebo intervention 3: vinorelbine intervention 4: trastuzumab
Intervention descriptions: intervention 1: Oral everolimus was taken once 5 mg/day (2 × 2.5 mg tablets) and were packaged into blister packs. intervention 2: Oral everolimus placebo was taken once 5 mg/day (2 × 2.5 mg tablets) and were packaged into blister packs. intervention 3: intravenous vinorelbine (25 mg/m2 weekly) intervention 4: intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)

Protocol documents:
Clinical trial NCT01009515
Conditions: Melanoma
Keywords: metastatic melanoma skin cancer paclitaxel carboplatin temozolomide
Sponsor: New Mexico Cancer Research Alliance
Start date: 2009-08-01; Completion date: 2015-06-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The number of melanoma cases has been steadily increasing over the past few decades. For many patients with metastatic melanoma, there are no effective therapies. The goal of this study is to determine whether a combination drug treatment of carboplatin, paclitaxel and temozolomide is effective in the treatment of metastatic or recurrent melanoma.

Detailed description:
Over the past several decades, significant research has been conducted to try to identify active chemotherapeutic agents for the treatment of melanoma. The rationale for combining taxanes and platinum agents is that both have activity in melanoma; in vitro and clinical data suggest synergy between these drugs when used in combination in a wide variety of tumors, including melanoma; and the toxicity profiles of these agents do not overlap. Temozolomide (a drug approved for the treatment of melanoma) has been combined with other drugs, including taxanes and platinums, in previous clinical trials for melanoma. Specifically, a previous phase I study of the combination of temozolomide, paclitaxel, and carboplatin in melanoma showed objective responses. The efficacy of this combination is now being studied in this phase II trial.

Arms: arm 1: Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle.
Interventions: intervention 1: Paclitaxel, carboplatin, temozolomide
Intervention descriptions: intervention 1: Combination chemotherapy was administered for up to 6 cycles

Protocol documents:
Clinical trial NCT01015443
Conditions: Non-Small Cell Lung Cancer
Keywords: Non-Small Cell Lung Carcinoma Tecemotide L-BLP25 Cyclophosphamide placebo controlled Non-Small Cell Lung Cancer
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2009-12-01; Completion date: 2015-06-01
Enrollment: 285 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether the cancer vaccine tecemotide (L-BLP25) in addition to best supportive care is effective in prolonging the lives of Asian subjects with unresectable stage III non-small cell lung cancer in comparison to a placebo plus best supportive care (a so-called placebo controlled study).

Detailed description:

Arms: arm 1: Tecemotide (L-BLP25) + Single low dose cyclophosphamide + Best supportive care (BSC) arm 2: Saline + Placebo + Best supportive care (BSC)
Interventions: intervention 1: Tecemotide intervention 2: Single low dose cyclophosphamide intervention 3: Placebo intervention 4: Saline intervention 5: Best Supportive Care (BSC)
Intervention descriptions: intervention 1: Subjects will receive 8 consecutive weekly subcutaneous vaccinations with 918 microgram (mcg) of tecemotide (L-BLP25) at Week 1, 2, 3, 4, 5, 6, 7, and 8 (primary treatment phase) and then at 6-Week intervals, beginning at Week 14 (maintenance phase) until disease progression (PD) is documented or the subject discontinues for any other reason. intervention 2: A single 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 administration of tecemotide. intervention 3: Subjects will receive 8 consecutive weekly subcutaneous vaccinations of tecemotide (L-BLP25) matching placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinues for any other reason. intervention 4: A single IV infusion of 0.9 percent (%) sodium chloride (saline) will be given 3 days before first placebo vaccination. intervention 5: The BSC will be provided as per the investigator's discretion, and is not limited to palliative radiation, psychosocial support, analgesics and nutritional support.

Protocol documents:
Clinical trial NCT01082367
Conditions: Treatment of Early Pulmonary Infections With P. Aeruginosa in Cystic Fibrosis Patients
Keywords: Tobramycin Inhalation solution Cystic fibrosis Lung disease anti-bacterial agents
Sponsor: Novartis Pharmaceuticals
Start date: 2010-04-01; Completion date: 2015-06-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study investigated the efficacy of inhaled TOBI treatment for early infections of P. aeruginosa in paediatric patients with cystic fibrosis.

Detailed description:

Arms: arm 1: Participants randomized to TOBI received the investigational treatment for 28 days twice daily (bi)d in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the open label (OL) phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received placebo for 28 days bid (second treatment cycle). arm 2: Participants randomized to placebo group received 0.9 % saline (NaCl) for 28 days bid in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the OL phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received TOBI for 28 days bid (second treatment cycle).
Interventions: intervention 1: TOBI intervention 2: Placebo
Intervention descriptions: intervention 1: TOBI (tobramycin inhaled solution) intervention 2: Placebo

Protocol documents:
Clinical trial NCT01106352
Conditions: Bone Metastases Castration-Resistant Prostate Cancer
Keywords: The target population is patients with bone metastasis from castration-resistant prostate cancer intended for treatment with docetaxel
Sponsor: Bayer
Start date: 2010-07-01; Completion date: 2015-06-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to establish a recommended dose of Alpharadin to be used in combination with docetaxel in patients with bone metastases from castration-resistant prostate cancer and to investigate safety and explore efficacy of the recommended dose.

Detailed description:
The trial was initially conducted and submitted by Algeta ASA. After acquiring Algeta, Bayer is now the sponsor.

Arms: arm 1: Alpharadin (Radium-223 dichloride) is administered intravenously as a bolus injection. In the randomized phase IIa part of the protocol, the dose established in the dose-escalation part of the protocol (Phase I) will be used, i.e. 5 doses of 50 kBq/kg b.w. every 6 weeks in combination with the approved step-down dose of docetaxel (60 mg/m\^2) administered intravenously every 3 weeks with 5 mg prednisone twice a day continuously and pre-medication with dexamethasone. arm 2: Docetaxel (75 mg/m2) will be administered intravenously every 3 weeks with 5 mg prednisone twice a day continuously and pre-medication with dexamethasone. Step-down to 60 mg/m\^2 is allowed as per the approved docetaxel label.
Interventions: intervention 1: Radium-223 dichloride (Xofigo, BAY88-8223) intervention 2: Docetaxel
Intervention descriptions: intervention 1: Alpharadin (Radium-223 dichloride) is administered intravenously as a bolus injection. intervention 2: Docetaxel (75 mg/m\^2) will be administered intravenously every 3 weeks with 5 mg prednisone twice a day continuously and pre-medication with dexamethasone. Step-down to 60 mg/m\^2 is allowed as per the approved docetaxel label.

Protocol documents:
Clinical trial NCT01142310
Conditions: Memory Impairment
Sponsor: University of Texas Southwestern Medical Center
Start date: 2010-06-01; Completion date: 2015-06-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Medically stable outpatients receiving chronic oral corticosteroid therapy were enrolled in a 48-week randomized, double-blind, placebo-controlled, parallel-group, trial of lamotrigine.

Detailed description:
Stress and corticosteroid exposure are associated with changes in both the human and animal hippocampus. An extensive literature suggests that corticosteroid-induced changes in the hippocampus are, in part, mediated through increases in extracellular glutamate. In animals, agents that decrease glutamate release prevent dendritic changes in the hippocampus secondary to stress or corticosterone. We have developed a research program using patients receiving prescription corticosteroids (e.g., prednisone) to explore the effects of corticosteroids on the human hippocampus. Our research program is translational in focus, with a goal of exploring whether the reported effects of corticosteroids on the animal hippocampus are also found in humans. A current focus of our research is examining glutamate release inhibitors in patients taking corticosteroids. We have both open-label and placebo-controlled pilot data suggesting that the glutamate release inhibitor lamotrigine is associated with significant improvement in declarative memory (a measure of hippocampal performance) in this population. A definitive study examining declarative memory in corticosteroid-dependent patients receiving lamotrigine vs. placebo is proposed. Neuroimaging and mood will also be assessed.

Arms: arm 1: Dose titration: begin at Baseline at 25mg PO QD for two weeks. Increase to 50mg PO QD at Week 2 for two weeks. Increase to 100mg PO QD at Week 4. Increase to 150mg PO QD at Week 5. Increase to 200mg PO QD at Week 6. Increase to 250mg PO QD at Week 7. Increase to 300mg PO QD at Week 8. Increase to 350mg PO QD at Week 9. Increase to 400mg PO QD at Week 10. Stay at 400mg PO QD from Week 10 to Week 48. arm 2: Placebo administered the same as the Lamotrigine just described.
Interventions: intervention 1: Lamotrigine intervention 2: Placebo
Intervention descriptions: intervention 1: Lamotrigine will be initiated at 25 mg/day and upwardly titrated to a dose of 400 mg/day over 10 weeks. intervention 2: None

Protocol documents:
Clinical trial NCT01165112
Conditions: Recurrent Adult Diffuse Large Cell Lymphoma Recurrent Adult Hodgkin Lymphoma
Sponsor: University of Washington
Start date: 2010-09-01; Completion date: 2015-06-01
Enrollment: 48 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase I/II trial is studying the side effects and best dose of bendamustine hydrochloride when given together with carboplatin, etoposide, and rituximab in treating patients with diffuse large B cell lymphoma or Hodgkin lymphoma that has come back after a period of improvement or has not responded to previous treatment. Drugs used in chemotherapy, such as bendamustine hydrochloride, etoposide, and carboplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, may block cancer growth by targeting certain cells. Giving bendamustine hydrochloride together with carboplatin, etoposide, and rituximab may kill more cancer cells.

Detailed description:
PRIMARY OBJECTIVES:

I. To estimate the maximally tolerated dose of bendamustine (bendamustine hydrochloride) that can be combined with rituximab, carboplatin, and etoposide chemotherapy in patients with relapsed or refractory lymphoid malignancies.

II. To determine the safety and toxicity of the above regimen.

SECONDARY OBJECTIVES:

I. To gain a preliminary assessment of the efficacy of the above regimen.

II. To determine the ability to proceed to peripheral blood stem cell collection following the above regimen (the impact of above regimen on stem cell reserve).

III. To investigate whether findings from laboratory, radiographic or pathologic studies have any prognostic impact on the response to treatment.

OUTLINE: This is a phase I, dose-escalation study of bendamustine hydrochloride followed by a phase II study.

Patients receive bendamustine hydrochloride intravenously (IV) over 30-60 minutes on days 1 and 2, etoposide IV over 60 minutes on days 1-3, and carboplatin IV over 60 minutes on day 1. Patients with cluster of differentiation (CD)20+ T-cell lymphoma disease also receive rituximab IV on day 2 or 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months for 4 years.

Arms: arm 1: Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60 minutes on days 1-3, and carboplatin IV over 60 minutes on day 1. Patients with CD20+ T-cell lymphoma disease also receive rituximab IV on day 2 or 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Bendamustine Hydrochloride intervention 2: Carboplatin intervention 3: Rituximab intervention 4: Etoposide intervention 5: Laboratory Biomarker Analysis
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV intervention 3: Given IV intervention 4: Given IV intervention 5: Correlative studies

Protocol documents:
Clinical trial NCT01172639
Conditions: Rheumatoid Arthritis
Keywords: CoBRA
Sponsor: P. Verschueren
Start date: 2009-02-01; Completion date: 2015-06-01
Enrollment: 400 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The Combinatietherapie Bij Reumatoide Artritis (CoBRA) trial was a milestone in the development of the present treatment paradigm for Rheumatoid Arthritis (RA). This study introduced the principle of fast remission induction by means of a combination of standard Disease Modifying AntiRheumatic Drugs (DMARDs) and a step down bridge therapy with high dose glucocorticoids in early Rheumatoid Arthritis.

The purpose of the present study is to compare different combinations of traditional DMARDs and glucocorticoids, based on the original CoBRA protocol, for treatment of early Rheumatoid Arthritis.

Besides the efficacy and effectiveness of these strategies, patient centered outcomes and potential implementation problems of such treatment strategies are evaluated.

Detailed description:

Arms: arm 1: * Methotrexate 15mg tablet by mouth, weekly for entire trial
* Sulfasalazine 2g tablet by mouth, daily for 40 weeks
* Prednisone tablet by mouth, weekly step down scheme 60 - 40 - 25 - 20 - 15 - 10 mg daily for 6 weeks, followed by 7.5mg daily till week 28, then further tapered down to stop at week 32 arm 2: * Methotrexate 15mg tablet by mouth, weekly for entire trial
* Prednisone tablet by mouth, weekly step down scheme 30 - 20 - 12.5 - 10 - 7.5 mg daily for 5 weeks, followed by 5mg daily till week 28, then further tapered down to stop at week 32 arm 3: * Methotrexate 15mg tablet by mouth, weekly for 40 weeks (continued for entire trial if randomized to Methotrexate monotherapy at week 40)
* Leflunomide 10mg tablet by mouth, daily for 40 weeks (continued for entire trial if randomized to Leflunomide monotherapy at week 40)
* Prednisone tablet by mouth, weekly step down scheme 30 - 20 - 12.5 - 10 - 7.5 mg daily for 5 weeks, followed by 5mg daily till week 28, then further tapered down to stop at week 32 arm 4: * Methotrexate 15mg tablet by mouth, weekly for entire trial
* Prednisone tablet by mouth, weekly step down scheme 30 - 20 - 12.5 - 10 - 7.5 mg daily for 5 weeks, followed by 5mg daily till week 28, then further tapered down to stop at week 32 arm 5: * Methotrexate 15mg tablet by mouth, weekly for entire trial
* No oral steroids allowed during the first year of the trial
Interventions: intervention 1: Methotrexate intervention 2: Sulfasalazine intervention 3: Leflunomide intervention 4: Prednisone
Intervention descriptions: intervention 1: Methotrexate tablet intervention 2: Sulfasalazine tablet intervention 3: Leflunomide tablet intervention 4: Prednisone tablet

Protocol documents:
Clinical trial NCT01188421
Conditions: Opioid Related Disorders Opioid Dependence Opioid Addiction
Sponsor: Johns Hopkins University
Start date: 2010-10-01; Completion date: 2015-06-01
Enrollment: 106 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study of tramadol as an agent for short-term opioid withdrawal treatment. A randomized, double blind clinical trial comparing the efficacy and safety of tramadol to clonidine and buprenorphine in the short-term treatment of opioid withdrawal will be conducted. Opioid dependent participants will be treated on a residential unit. The primary outcome measure is opioid withdrawal symptoms.

Detailed description:

Arms: arm 1: Sublingual buprenorphine/naloxone tablets (or placebo) arm 2: Oral clonidine tablets (or placebo) arm 3: Oral tramadol tablets (or placebo)
Interventions: intervention 1: Buprenorphine/naloxone intervention 2: Clonidine intervention 3: Tramadol ER
Intervention descriptions: intervention 1: up to 8/2 mg Sublingual (SL) per day intervention 2: up to 0.8 mg per day (oral) intervention 3: up to 600 mg per day

Protocol documents:
Clinical trial NCT01194869
Conditions: Breast Cancer
Keywords: Breast Cancer
Sponsor: Emory University
Start date: 2010-06-01; Completion date: 2015-06-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to identify new treatment regimens with better response rates and to find out if the combination of cisplatin and sorafenib followed by paclitaxel and sorafenib can shrink the size of your breast tumor and allow you to preserve your breast. Sorafenib is a newer drug that targets blood vessel formation and may help the chemotherapy work better. Additionally, by receiving chemotherapy before surgery, we will be able to determine if your cancer is responsive to chemotherapy.

Detailed description:

Arms: arm 1: Sorafenib 400 mg twice daily throughout the study. Patients will receive this as a single-agent for the first four weeks, then in combination with cisplatin followed by paclitaxel.
Interventions: intervention 1: Sorafenib intervention 2: Cisplatin intervention 3: Paclitaxel
Intervention descriptions: intervention 1: Sorafenib 400 mg twice daily throughout the study. Patients will receive this as a single-agent for the first four weeks, then in combination with cisplatin followed by paclitaxel. intervention 2: 75 mg/m² given IV intervention 3: 175 mg/m² given IV

Protocol documents: