ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01151449
Conditions: Estrogen Receptor-negative Breast Cancer HER2-negative Breast Cancer Male Breast Cancer Progesterone Receptor-negative Breast Cancer Recurrent Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Stage IV Breast Cancer Triple-negative Breast Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2010-06-01; Completion date: 2015-08-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II clinical trial studies how well gamma-secretase/Notch signalling pathway inhibitor RO4929097 works in treating patients with advanced, metastatic, or recurrent triple negative invasive breast cancer. Gamma-secretase/Notch signalling pathway inhibitor RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. To assess the antitumour activity of RO4929097 in recurrent and/or metastatic triple negative breast cancer through co-primary endpoints of overall response rate (ORR) using RECIST and 6-month progression-free survival rate (PFS).

SECONDARY OBJECTIVES:

I. To assess the antitumour activity of RO4929097 through secondary endpoints including: duration of radiologic response, progression-free and overall survival rates within the protocol defined follow-up period.

II. To assess the safety and tolerability of single agent RO4929097 in breast cancer.

III. To explore expression of Notch biomarkers in triple negative breast cancer and potential interaction with RO4929097 response and toxicity.

IV. To evaluate the downstream effects of RO4929097 in advanced triple negative breast cancer.

OUTLINE:

Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 orally (PO) once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 30 days.

Arms: arm 1: Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: gamma-secretase/Notch signalling pathway inhibitor RO4929097 intervention 2: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given orally intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT01160640
Conditions: Pelvic Inflammatory Disease
Keywords: PID Pelvic Inflammatory Disease
Sponsor: Harold Wiesenfeld
Start date: 2010-11-01; Completion date: 2015-08-01
Enrollment: 233 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a randomized placebo-controlled trial comparing two antibiotic treatment regimens for acute PID. Women with acute PID will be randomized to one of two treatment regimens: 1) a single intramuscular dose of ceftriaxone 250 mg, doxycycline 100 mg orally twice a day for 14 days, along with placebo tablets orally twice a day for 14 days or 2) same doses of ceftriaxone and doxycycline, and metronidazole 500 mg orally twice a day for 14 days. The primary objective is to compare the eradication of anaerobic organisms from the upper genital tract between women who receive standard outpatient antibiotic treatment to those who receive standard outpatient treatment along with a two-week course of metronidazole.

Detailed description:
This study is a randomized placebo-controlled trial comparing two antibiotic treatment regimens for acute PID. Women with acute PID will be randomized to one of two treatment regimens. One group of women will receive a single intramuscular dose of ceftriaxone 250 mg, doxycycline 100 mg orally twice a day for 14 days, along with placebo tablets orally twice a day for 14 days. The second group of women will receive the same doses of ceftriaxone and doxycycline, and metronidazole 500 mg orally twice a day for 14 days. The primary objective is to compare the eradication of anaerobic organisms from the upper genital tract in women with acute PID who receive standard outpatient antibiotic treatment to the eradication of these organisms from the upper genital tract in women who receive standard outpatient treatment along with a two-week course of metronidazole. Women will be followed for one month for clinical outcomes, and will undergo assessment for clearance of microorganisms from the upper genital tract. Our hypothesis is that an antibiotic treatment regimen that includes anaerobic coverage will more effectively clear anaerobic organisms from the endometrium in women with acute PID compared to a standard antibiotic treatment regimen lacking effective antibiotic coverage against anaerobes.

Arms: arm 1: ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo oral capsule PO bid x 14 days arm 2: ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days
Interventions: intervention 1: Ceftriaxone intervention 2: Doxycycline intervention 3: Metronidazole intervention 4: Placebo Oral Capsule
Intervention descriptions: intervention 1: ceftrixone 250mg IM single dose intervention 2: Doxycycline 100 mg PO bid x 14 days intervention 3: metronidazole 500 mg PO bid x 14 days intervention 4: placebo oral capsule PO bid x 14 days

Protocol documents:
Clinical trial NCT01175343
Conditions: Recurrent Fallopian Tube Carcinoma Recurrent Ovarian Carcinoma Recurrent Primary Peritoneal Carcinoma Stage IV Fallopian Tube Cancer Stage IV Ovarian Cancer Stage IV Primary Peritoneal Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2010-07-01; Completion date: 2015-08-01
Enrollment: 45 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying the side effects and how well RO4929097 works in treating patients with recurrent and/or metastatic epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. To assess the antitumor activity of RO4929097 in recurrent and / or metastatic epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer by progression free survival rate at the end of 4 cycles.

SECONDARY OBJECTIVES:

I. To assess the antitumor activity of RO4929097 through secondary endpoints including: overall response rate and CA125 response rate (GCIC criteria).

II. To assess the safety of single agent RO4929097 in advanced platinum resistant ovarian, fallopian tube and primary peritoneal cancers.

III. To explore expression of Notch biomarkers in advanced platinum resistant ovarian, fallopian, and primary peritoneal cancers.

IV. To explore the impact of RO49097 on ascitic fluid circulating tumor cells.

OUTLINE: This is a multicenter study.

Patients receive oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Blood and tumor tissue samples are collected for correlative studies. Ascitic fluid may also be collected.

After completion of study therapy, patients are followed up every month for at least 1 year.

Arms: arm 1: Patients receive oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Blood and tumor tissue samples are collected for correlative studies. Ascitic fluid may also be collected.
Interventions: intervention 1: Gamma-Secretase Inhibitor RO4929097 intervention 2: Laboratory Biomarker Analysis
Intervention descriptions: intervention 1: Given PO intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT01188811
Conditions: Multiple Sclerosis, Chronic Progressive
Keywords: Multiple Sclerosis Multiple sclerosis, chronic progressive Neuroprotective agents Magnetic resonance imaging Optical coherence tomography Gait Thioctic acid Alpha-lipoic acid
Sponsor: VA Office of Research and Development
Start date: 2010-10-01; Completion date: 2015-08-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine if lipoic acid can protect the brain and slow disability in secondary progressive multiple sclerosis.

Detailed description:
There are no approved medications that are neuroprotective or able to slow disability accumulation in secondary progressive multiple sclerosis (SPMS). This two-year study will determine if daily oral intake of lipoic acid, a natural supplement, will prove superior to placebo in reducing injury to the brain and reducing disability progression in SPMS. Neuroprotection will be measured by the extent of brain volume loss seen on MRI, and disability will be measured by neurological status and quality of life.

Arms: arm 1: 28 subjects receive oral lipoic acid 1200mg daily arm 2: 28 subjects receive placebo daily
Interventions: intervention 1: lipoic acid intervention 2: Placebo
Intervention descriptions: intervention 1: 1200 mg taken by mouth daily starting on day one of the study and ending on the last day of study participation. intervention 2: The placebo comparator will be taken by mouth daily starting on day one of the study and ending on the last day of study participation

Protocol documents:
Clinical trial NCT01204918
Conditions: Depression
Keywords: MDD Depression Treatment refractory Glutamate Riluzole Major depressive disorder psychopharmacology rilutek
Sponsor: Yale University
Start date: 2011-06-01; Completion date: 2015-08-01
Enrollment: 104 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study aims to examine the antidepressant efficacy of riluzole, employing a randomized, double-blind, placebo-controlled, adjunctive trial in treatment-resistant major depressive disorder (TRD).

Detailed description:
This study aims to examine the antidepressant efficacy of riluzole, employing a randomized, double-blind, placebo-controlled, 8 week trial of adjunctive trial in treatment-resistant major depressive disorder (TRD). Preclinical studies have shown riluzole to modulate Glu release and clearance, and to have potent neuroprotective properties, promoting neuro-resiliency. Other preclinical data now also show the drug to have antidepressant-like effects in rodent models used to screen for antidepressant activity. In addition, several small open-label clinical studies further suggest riluzole has antidepressant and anxiolytic properties, even in patients who do not respond to standard monoaminergic antidepressant and anxiolytic medications.

Arms: arm 1: Riluzole 100mg added to ongoing SSRI or SNRI antidepressant for 8 weeks arm 2: Placebo will be added to ongoing SSRI or SNRI antidepressant treatment for 8 weeks arm 3: Riluzole 100mg added to ongoing SSRI or SNRI antidepressant for 4 weeks and placebo will added to ongoing SSRI or SNRI antidepressant treatment for 4 weeks
Interventions: intervention 1: Riluzole intervention 2: placebo
Intervention descriptions: intervention 1: Riluzole 100mg PO intervention 2: placebo

Protocol documents:
Clinical trial NCT01205646
Conditions: Prostate Cancer
Keywords: prostate cancer metastatic zoledronate zometa
Sponsor: Barbara Ann Karmanos Cancer Institute
Start date: 2010-09-01; Completion date: 2015-08-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary goal for this trial is to assess the change in PET scans with the administration of zoledronate (bisphosphonate) therapy in patients with metastatic prostate cancer. It has been established that zoledronate therapy may play a role in delaying and reducing the incidence of skeletal events. Researchers propose to evaluate the change in the uptake value of FMAU PET scan after the zoledronate therapy. It has been demonstrated that FMAU PET scans can successfully demonstrate and detect bony metastatic sites in prostate cancer.

In addition, investigators would like to evaluate the change in the level of the prostate-specific antigen (PSA) in the patient as well as outcome of bone scans.

Detailed description:

Arms: arm 1: Zoledronate therapy \& PET scan ;2 scans \[about 1-2 weeks apart\] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility, Bone scan (within 4 weeks prior to registration), bone turnover markers, and PSA will be obtained pretherapy. After that, Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration.
Interventions: intervention 1: zoledronate therapy intervention 2: PET Scan
Intervention descriptions: intervention 1: Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. Intravenous (through a vein in the arm) infusion every four weeks. Dose will be determined by kidney function. intervention 2: 2 scans \[about 1-2 weeks apart\] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility.A third PET scan will be obtained within 1-2 weeks after Zometa administration.

Protocol documents:
Clinical trial NCT01214759
Conditions: HIV
Keywords: HIV prevention prophylaxis Raltegravir Truvada
Sponsor: The University of Texas Health Science Center, Houston
Start date: 2011-05-01; Completion date: 2015-08-01
Enrollment: 103 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the safety and tolerability of the combination of truvada and raltegravir given for 28 days for the prevention of HIV infection.

Detailed description:
Non-Occupational Post-Exposure Prophylaxis (nPEP) after sexual exposure to HIV is recommended by the Centers for Disease Control (CDC). Although no efficacy data exist for Post-Exposure Prophylaxis (PEP) after sexual exposure, PEP has been shown to reduce HIV transmission in other exposure situations such as occupational exposures and mother-to-child transmission. The role in nPEP of the newer agents approved for the treatment of HIV infection remains unknown. The anti-HIV drug raltegravir works early in the life cycle of the virus, before it integrates with human DNA. It has few side effects and drug interactions what makes it an ideal drug for an nPEP regimen.

We aim to asses the safety and tolerability of the combination of truvada and raltegravir for nPEP.

Arms: arm 1: Single arm
Interventions: intervention 1: Truvada intervention 2: Raltegravir
Intervention descriptions: intervention 1: Tenofovir 200mg/emtricitabine 300mg once a day intervention 2: Raltegravir 400mg twice a day

Protocol documents:
Clinical trial NCT01239316
Conditions: Recurrent Childhood Medulloblastoma
Sponsor: National Cancer Institute (NCI)
Start date: 2010-11-01; Completion date: 2015-08-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well vismodegib works in treating younger patients with recurrent or refractory medulloblastoma. Vismodegib may slow the growth of tumor cells.

Detailed description:
PRIMARY OBJECTIVES:

I. Estimate the efficacy of GDC-0449 (vismodegib) treatment for pediatric patients with recurrent or refractory medulloblastoma, as measured by the sustained objective response rates for patients without (stratum A) and with (stratum B) evidence of activation of Hedgehog (Hh) signaling pathway in their tumors.

II. Characterize the pharmacokinetics (plasma) of GDC-0449 in children/adolescents with refractory medulloblastoma.

III. To document pathologic and genomic methods to identify medulloblastomas with activation of the Hh signaling pathway.

SECONDARY OBJECTIVES:

I. Document and describe toxicities associated with GDC-0449 administered on a daily schedule.

II. Estimate the duration of objective response and progression-free survival (PFS).

III. Characterize the pharmacokinetics (cerebrospinal fluid) of GDC-0449 in children/adolescents with refractory medulloblastoma.

OUTLINE: This is a multicenter study. Patients are stratified according to evidence of activation of Hedgehog signaling pathway in their tumors (without vs with vs unknown).

Patients receive vismodegib orally (PO) once daily (QD) on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.

Plasma and cerebrospinal fluid samples are collected periodically for pharmacokinetic and other correlative studies.

After completion of study treatment, patients are followed up every other month for up to 12 months.

Arms: arm 1: Patients receive vismodegib PO QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Laboratory Biomarker Analysis intervention 2: Pharmacological Study intervention 3: Vismodegib
Intervention descriptions: intervention 1: Correlative studies intervention 2: Correlative studies intervention 3: Given PO

Protocol documents:
Clinical trial NCT01243177
Conditions: Epilepsy Monotherapy
Keywords: Lacosamide Vimpat® Epilepsy Monotherapy Velocity
Sponsor: UCB BIOSCIENCES GmbH
Start date: 2011-04-01; Completion date: 2015-08-01
Enrollment: 888 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Compare efficacy and safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR) as monotherapy in newly or recently newly diagnosed subjects with a primary efficacy endpoint of 6-month seizure freedom. Noninferiority design to show a similar risk/benefit balance between Lacosamide (LCM) and Carbamazepine-CR (CBZ-CR).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Lacosamide intervention 2: Carbamazepine-Controlled Release
Intervention descriptions: intervention 1: Lacosamide:

* Strengths: 50 mg / 100 mg
* Form: tablets
* Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose
* Duration: up to 118 weeks intervention 2: Carbamazepine-CR:

* Strengths: 200 mg
* Form: tablets
* Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose
* Duration: up to 118 weeks

Protocol documents:
Clinical trial NCT01246076
Conditions: Myelodysplastic Syndromes
Sponsor: Washington University School of Medicine
Start date: 2011-06-01; Completion date: 2015-08-01
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the proportion of confirmed responses (complete response, partial response, and hematologic improvement as defined by revised IWG criteria during the 12 months of treatment.

Detailed description:

Arms: arm 1: Lenalidomide 50 mg/day for two 28 day cycles.

Patients who have bone marrow aplasia as defined by a cellularity of \<10% will be observed till counts recover. If patients do not progress following 2 cycles of HD lenalidomide, they will receive low dose lenalidomide 10 mg daily for 12 cycles.
Interventions: intervention 1: Lenalidomide
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01294306
Conditions: Adenosquamous Lung Carcinoma Bronchioloalveolar Carcinoma Large Cell Lung Carcinoma Lung Adenocarcinoma Recurrent Non-Small Cell Lung Carcinoma Squamous Cell Lung Carcinoma
Sponsor: National Cancer Institute (NCI)
Start date: 2011-02-01; Completion date: 2015-08-01
Enrollment: 80 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies the side effects and how well Akt inhibitor MK2206 (MK2206) and erlotinib hydrochloride works in treating patients with advanced non-small cell lung cancer who have progressed after previous response to erlotinib hydrochloride therapy. MK2206 and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate the efficacy (with the primary endpoint of disease control at 12 weeks) and tolerability of the combination of MK2206 plus erlotinib (erlotinib hydrochloride) in previously erlotinib-treated patients with recurrent or progressive advanced non-small cell lung cancer (NSCLC) whose tumors are either epidermal growth factor receptor (EGFR) mutated or EGFR wild-type.

SECONDARY OBJECTIVES:

I. To determine progression-free survival of previously erlotinib-treated patients with NSCLC who are treated with MK2206 plus erlotinib. II. To determine the overall survival of previously erlotinib-treated patients with NSCLC who are treated with MK2206 plus erlotinib.

III. To assess the toxicity experienced by previously erlotinib-treated patients with NSCLC treated with MK2206 plus erlotinib. IV. To perform correlative analysis of tumor biomarkers to assess, in a preliminary manner, the association between tumor mutations and/or abnormalities and clinical outcome of previously erlotinib-treated patients with NSCLC treated with MK2206 plus erlotinib.

OUTLINE:

Patients receive Akt inhibitor MK2206 orally (PO) every other day (QOD) of a 28-day course, and erlotinib hydrochloride PO once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed up every 12 weeks for one year and then annually thereafter.

Arms: arm 1: Patients receive Akt inhibitor MK2206 PO QOD of a 28-day course, and erlotinib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Akt Inhibitor MK2206 intervention 2: Erlotinib Hydrochloride intervention 3: Laboratory Biomarker Analysis intervention 4: Pharmacological Study
Intervention descriptions: intervention 1: Given PO intervention 2: Given PO intervention 3: Correlative studies intervention 4: Correlative studies

Protocol documents:
Clinical trial NCT01306643
Conditions: Indolent Non-Hodgkin's Lymphoma Follicular Lymphoma Small Lymphocytic Lymphoma Marginal Zone Lymphoma
Keywords: Indolent Non-Hodgkin's Lymphoma Non-Hodgkin Lymphoma iNHL NHL CAL-101 PI3K Phosphatidylinositol 3-kinase Follicular Lymphoma (FL) Small Lymphocytic Lymphoma (SLL) Marginal Zone Lymphoma (MZL)
Sponsor: Gilead Sciences
Start date: 2011-02-01; Completion date: 2015-08-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objectives of this study is to evaluate the safety and efficacy of idelalisib (GS-1101, CAL-101) in participants with previously treated indolent non-Hodgkin lymphoma (iNHL).

Eligible patients will initiate oral therapy with idelalisib at a starting dose of 150 mg twice per day. Treatment with idelalisib can continue in compliant participants for up to twelve 28-day cycles of idelalisib. Participants who appear to be benefiting from treatment at the completion of 12 cycles of treatment with idelalisib may be eligible for participation in a long-term safety extension study of idelalisib.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Idelalisib
Intervention descriptions: intervention 1: Tablet(s) administered orally twice daily

Protocol documents: