ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01327053
Conditions: Basal Cell Carcinoma
Keywords: locally advanced basal cell carcinoma metastatic basal cell carcinoma LDE225 sonidegib Basel Cell Carcinoma (BCC) skin cancer Basel Cell Carcinoma BCC
Sponsor: Novartis Pharmaceuticals
Start date: 2011-06-29; Completion date: 2018-06-29
Enrollment: 230 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study assessed the efficacy and safety of oral treatment with two dose levels of LDE225 in patients with locally advanced or metastatic BCC.

Detailed description:

Arms: arm 1: The study was double blinded and enrolled at least 50 evaluable patients in the 200 mg LDE225 arm. The efficacy and safety of LDE225 was analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent. arm 2: The study was double blinded and enrolled at least 100 evaluable patients in the 800 mg LDE225 arm. The efficacy and safety of LDE225 was analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
Interventions: intervention 1: LDE225
Intervention descriptions: intervention 1: LDE225 was administered orally, on a continuous once daily dosing schedule and was supplied as 200 mg hard gelatin capsules in bottles. Every 4 weeks on the day of study visit, patients received a prescription of an adequate drug supply for self-administration at home. The 800 mg dose patients received 4 capsules of LDE225 and 200 mg dose arm patients received 1 LDE225 capsule + 3 placebo capsules.

Protocol documents:
Clinical trial NCT00467051
Conditions: Childhood Extracranial Germ Cell Tumor Childhood Extragonadal Malignant Germ Cell Tumor Childhood Malignant Ovarian Germ Cell Tumor Childhood Malignant Testicular Germ Cell Tumor Ovarian Choriocarcinoma Ovarian Embryonal Carcinoma Ovarian Yolk Sac Tumor Recurrent Childhood Malignant Germ Cell Tumor Recurrent Malignant Testicular Germ Cell Tumor Recurrent Ovarian Germ Cell Tumor Testicular Choriocarcinoma Testicular Embryonal Carcinoma Testicular Mixed Choriocarcinoma and Embryonal Carcinoma Testicular Mixed Choriocarcinoma and Yolk Sac Tumor Testicular Mixed Embryonal Carcinoma and Yolk Sac Tumor Testicular Yolk Sac Tumor
Sponsor: Children's Oncology Group
Start date: 2007-11-05; Completion date: 2018-06-30
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well giving combination chemotherapy works in treating young patients with recurrent or resistant malignant germ cell tumors. Drugs used in chemotherapy, such as paclitaxel, ifosfamide, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

Detailed description:
PRIMARY OBJECTIVES:

I. Determine the response rate in pediatric patients with recurrent or resistant malignant germ cell tumors (GCT) treated with paclitaxel, ifosfamide, and carboplatin.

SECONDARY OBJECTIVES:

I. Determine the toxicity of this regimen in these patients. II. To Collect tissue for the tumor bank that will aid in the identification of the biological characteristics of recurrent GCT.

OUTLINE: This is a multicenter study.

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood count returns to normal. 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 periodically for up to 5 years.

Arms: arm 1: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood count returns to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Carboplatin intervention 2: Filgrastim intervention 3: Ifosfamide intervention 4: Laboratory Biomarker Analysis intervention 5: Paclitaxel
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV or subcutaneously intervention 3: Given IV intervention 4: Optional correlative studies intervention 5: Given IV

Protocol documents:
Clinical trial NCT02414204
Conditions: Improve Endothelial Function and Decrease Vascular Stenosis
Keywords: Arteriovenous Fistulas (AVFS) Hemodialysis Fistula Maturation (HFM) Flow-Mediated Dilation (FMD) Nitroglycerin-Mediated (NMD) Venous Plethysmography (VP)
Sponsor: University of Alabama at Birmingham
Start date: 2015-04-01; Completion date: 2018-06-30
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Patients with stage IV and V chronic kidney disease and end stage renal disease requiring hemodialysis at University of Alabama at Birmingham (UAB) Dialysis Clinics will be recruited from the UAB Vascular Access Clinic, which has been the site for recruitment of patients requiring new vascular access for the last 10 years.

Detailed description:
The main purpose of this research study is to conduct a research study to determine if Sildenafil compared to placebo will improve the vascular health of arteries and veins before arteriovenous fistula creation (shunt) and how quickly your veins and arteries dilate and increase in blood flow after fistula creation. An arteriovenous fistula (shunt) is a connection between the artery and vein in the arm for dialysis use. Another purpose of this study is to determine if Sildenafil reduces the blood and tissue levels of oxidants prior to fistula creation. Oxidants are harmful substances in the body that damage the cells tissues, and organs.

Arms: arm 1: 20 mg twice a day orally arm 2: Placebo twice a day orally
Interventions: intervention 1: Sildenafil intervention 2: Placebo
Intervention descriptions: intervention 1: Sildenafil, a phosphodiesterase 5 inhibitor that enhances the effects of nitric oxide (NO), has been shown in experimental and clinical studies in cardiovascular disease to improve endothelial function and decrease vascular stenosis. intervention 2: Placebo will be over encapsulated to identical to drug comparison

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT00976248
Conditions: Waldenstrom's Macroglobulinemia
Keywords: everolimus RAD001 WM
Sponsor: Dana-Farber Cancer Institute
Start date: 2009-11-01; Completion date: 2018-07-01
Enrollment: 33 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to determine the safety of RAD001(Everolimus) and the highest dose of this drug that can be given to people safely. RAD001(Everolimus) is a drug that works by preventing cells in the body from growing and dividing. Information from basic and Phase I clinical research studies suggests that RAD001 also may help to prevent tumor growth in people with relapsed or refractory lymphoma.

Detailed description:
* Participants will take RAD001 orally once a day in the morning. Each treatment cycle lasts for four weeks. Participants will receive up to 72 cycles of treatment.
* During each cycle, participants will be asked to visit the clinic for scheduled tests and exams. They will visit the clinic on the first day of each of the first three cycles, and then once every 3 cycles. During the visits, participants will have a physical exam and blood tests.. Participants may also have CT scans of the chest, abdomen and pelvis as well as a bone marrow aspirate and biopsy.

Arms: arm 1: RAD001, oral, 10 mg, daily
Interventions: intervention 1: RAD001
Intervention descriptions: intervention 1: Taken orally once a day

Protocol documents:
Clinical trial NCT01822886
Conditions: Peripheral T-cell Lymphoma
Keywords: T-cell lymphoma Romidepsin
Sponsor: Fondazione Italiana Linfomi - ETS
Start date: 2013-01-01; Completion date: 2018-07-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Pilot clinical trial - Phase 2a, multicenter, single arm, open label trial - to evaluate efficacy and safety of concomitant combination treatment with Gemcitabine and Romidepsin (GEMRO) regimen as salvage treatment in relapsed/refractory PTCL (peripheral T-cell lymphoma) in a selected population of patients.

Detailed description:
Objectives will be focused on preliminary dose-response, type of patients, frequency of dosing, and safety and tolerability profile.

Arms: arm 1: Romidepsin 12 mg/m2 day 1,8, 15 + Gemcitabine 800 mg/m2 day 1, 15 for 6 cycles by 28 days followed by Romidepsin 14 mg/m2 day 1, 15 to PD (progression disease)
Interventions: intervention 1: Romidepsin + Gemcitabine
Intervention descriptions: intervention 1: Romidepsin 12 mg/m2 day 1,8, 15 + Gemcitabine 800 mg/m2 day 1, 15 for 6 cycles by 28 days followed by Romidepsin 14 mg/m2 day 1, 15 to PD

Protocol documents:
Clinical trial NCT03098615
Conditions: Onychomycosis Dermatophytosis
Sponsor: University of Alabama at Birmingham
Start date: 2015-09-01; Completion date: 2018-07-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will examine how Jublia affects dermatophytomas, which are difficult to treat with other therapeutic options.

Detailed description:
Dermatophytomas are known to be resistant to even long courses of systemic antifungals, and have therefore been excluded from both topical and systemic clinical trials for onychomycosis, including those for Efinaconazole solution. Efinaconazole (Jublia) 10% solution is an FDA approved topical medication indicated for treatment of distal lateral subungual onychomycosis (DLSO), and the utility of this medication likely exceeds published results. Efinaconazole solution's novel ability to penetrate into the subungual space likely accounts for improved treatment results seen in DLSO treated with Jublia. We will investigate the utility of topical efinaconazole solution in the treatment of dermatophytomas.

Arms: arm 1: Subjects with distal lateral subungual onychomycosis (DLSO) with dermatophytoma.
Interventions: intervention 1: Jublia (Efinaconazole 10% Topical Solution)
Intervention descriptions: intervention 1: Efinaconazole 10% Topical Solution will be applied to the great toenail with the DLSO and dermatophytoma.

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT03110029
Conditions: Onychomycosis of Toenail
Sponsor: University of Alabama at Birmingham
Start date: 2015-09-01; Completion date: 2018-07-01
Enrollment: 13 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will test how well efinaconazole solution (Jublia) works to treat toenail fungal infections in patients who wear polish compared to those who do not.

Detailed description:
Topical efinaconazole 10% solution is known to be an efficacious and safe treatment modality for toenail onychomycosis. This study will examine the compatibility of topical efinaconazole and nail polish in patients with distal and lateral subungual onychomycosis (DLSO). It is hypothesized that the treatment of DLSO with efinaconazole 10% solution will not be adversely affected by the application of nail polish.

Arms: arm 1: Subject will have Efinaconazole 10% solution application and nail polish arm 2: Subject will have only Efinaconazole 10% application and no nail polish
Interventions: intervention 1: Efinaconazole 10% Topical Application Solution [JUBLIA] intervention 2: Application of Nail Polish
Intervention descriptions: intervention 1: Topical efinaconazole 10% solution (Jublia) intervention 2: Application of Nail Polish

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT00720356
Conditions: Brain and Central Nervous System Tumors
Keywords: adult glioblastoma adult gliosarcoma
Sponsor: Northwestern University
Start date: 2009-07-07; Completion date: 2018-07-05
Enrollment: 115 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving bevacizumab together with erlotinib may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving bevacizumab together with erlotinib works after radiation therapy and temozolomide in treating patients with newly diagnosed glioblastoma multiforme or gliosarcoma.

Detailed description:
OBJECTIVES:

Primary

* To determine the overall survival of patients with newly diagnosed glioblastoma multiforme (GBM) with unmethylated MGMT promoter treated with bevacizumab and erlotinib hydrochloride after radiotherapy and temozolomide.

Secondary

* To determine the 12- and 24-month progression-free survival (PFS) of patients with newly diagnosed GBM with unmethylated MGMT promoter treated with this regimen.
* To assess radiographic response rates.
* To perform correlative tissue assays.
* To collect safety data on the combination of bevacizumab and erlotinib hydrochloride in patients with newly diagnosed GBM with unmethylated MGMT promoter treated with bevacizumab and erlotinib hydrochloride after radiotherapy and temozolomide.

OUTLINE: This is a multicenter study.

Patients undergo radiotherapy (either intensity-modulated radiation therapy or 3-D conformal radiotherapy) once daily 5 days a week and receive oral temozolomide concurrently with radiotherapy once daily for 6 weeks (as planned). Patients whose tumor has a methylated MGMT promoter are removed from study.

Approximately 4 weeks after completion of radiotherapy and temozolomide, patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28. Treatment with bevacizumab and erlotinib hydrochloride repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at approximately 30 days and then every 3 months thereafter.

Arms: arm 1: erlotinib and bevacizumab
Interventions: intervention 1: bevacizumab intervention 2: erlotinib hydrochloride
Intervention descriptions: intervention 1: 10mg/kg administered intravenously every 2 weeks intervention 2: 150 mg/daily orally

Protocol documents:
Clinical trial NCT01125566
Conditions: Breast Neoplasms
Sponsor: Boehringer Ingelheim
Start date: 2010-06-22; Completion date: 2018-07-06
Enrollment: 508 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To investigate the efficacy and safety of BIBW 2992 in combination with vinorelbine i.v. chemotherapy as treatment in patients with HER2-overexpressing, metastatic breast cancer, who failed one prior trastuzumab (Herceptin®) treatment

Detailed description:

Arms: arm 1: patients receive weekly intravenous infusion of trastuzumab and vinorelbine arm 2: patients receive BIBW 2992 tablets once daily combined with weekly intravenous infusion of vinorelbine
Interventions: intervention 1: BIBW 2992 intervention 2: trastuzumab intervention 3: vinorelbine intervention 4: vinorelbine
Intervention descriptions: intervention 1: patients receive BIBW 2992 tablets once daily and can reduce dose for adverse event management intervention 2: patients receive trastuzumab 2mg/kg intravenously every week intervention 3: patients receive vinorelbine 25mg/m² intravenously every week intervention 4: patients receive vinorelbine 25mg/m² intravenously every week

Protocol documents:
Clinical trial NCT01328535
Conditions: Recurrent Melanoma Stage IV Melanoma
Sponsor: Mayo Clinic
Start date: 2011-01-01; Completion date: 2018-07-11
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This clinical trial studies individualized temozolomide (TMZ) in treating patients with stage IV melanoma that cannot be removed by surgery. Drugs used in chemotherapy, such as TMZ, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving TMZ at different times, which are determined individually for each patient based on the phase (biorhythm) of the immune system response against the tumor may allow for a better drug response and may kill more tumor cells

Detailed description:
PRIMARY OBJECTIVES: I. To assess the clinical activity of timed administration of TMZ therapy in patients with stage IV melanoma who have or have not received prior chemotherapy for metastatic melanoma. SECONDARY OBJECTIVES: I. To assess the toxicity profile of timed administration of TMZ therapy in patients with stage IV melanoma who have or have not received prior chemotherapy for their metastatic disease. II. To evaluate the parameters of immune homeostasis that are associated with the anti-tumor immune biorhythm in order to gain insight into the mechanism of the observed clinical and immunological effect of timed TMZ chemotherapy. III. To evaluate the impact of timed TMZ chemotherapy on immune biomarkers and the anti-tumor immune biorhythms. OUTLINE: Prior to initiation of therapy patients will undergo a period of immunologic monitoring to analyze the bioperiodicity of their anti-tumor immune response. Patients with an established biorhythm will receive TMZ orally (PO) starting on the recommended day for 5 days. Treatment repeats every 21-42 days (based on the established biorhythm) until of disease progression or unacceptable toxicity. Patients without an established biorhythm are given the option to go off study or receive TMZ PO on days 1-5. Courses repeat every 28 days until disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for up to 2 years.

Arms: arm 1: Patients with an established biorhythm receive TMZ PO on recommended day for 5 days. Treatment repeats every 21-42 days until disease progression or unacceptable toxicity. Patients without an established biorhythm receive TMZ PO on days 1-5. Courses repeat every 28 days until disease progression or unacceptable toxicity.
Interventions: intervention 1: temozolomide intervention 2: flow cytometry intervention 3: staining method intervention 4: biopsy intervention 5: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given PO intervention 2: Correlative studies intervention 3: Correlative studies intervention 4: Optional correlative studies intervention 5: Correlative studies

Protocol documents:
Clinical trial NCT02159365
Conditions: Multiple Myeloma
Sponsor: Bristol-Myers Squibb
Start date: 2014-03-08; Completion date: 2018-07-11
Enrollment: 84 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To explore whether Elotuzumab dose administration over approximately 60 minutes is feasible and safe.

Detailed description:

Arms: arm 1: Elotuzumab 10 mg/kg solution intravenously weekly in cycle 1 and 2, then every other week, Lenalidomide 25 mg tablet by mouth Days 1-21 of each cycle / Dexamethasone 40 mg tablet by mouth / solution intravenously weekly until progression or discontinuation of Elotuzumab
Interventions: intervention 1: Elotuzumab intervention 2: Lenalidomide intervention 3: Dexamethasone
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01393821
Conditions: Dermatologic Complications Malignant Neoplasm Pain
Sponsor: Mayo Clinic
Start date: 2012-01-23; Completion date: 2018-07-14
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This clinical trial studies menadione topical lotion in treating skin discomfort and psychological distress in patients with cancer receiving panitumumab, erlotinib hydrochloride, or cetuximab. Menadione topical lotion may prevent rash or other skin discomfort and help alleviate psychological distress and pain in patients receiving treatment with panitumumab, erlotinib hydrochloride, or cetuximab

Detailed description:
PRIMARY OBJECTIVES:

I. Explore the effectiveness of a menadione topical lotion to the face to prevent cutaneous and psychological discomfort from epidermal growth factor receptor (EGFR) inhibitors.

SECONDARY OBJECTIVES:

I. Explore the adverse event profile of a menadione topical lotion to the face to prevent rash from EGFR inhibitors.

II. Explore whether rash or adverse events worsen over a 4 week period after this 4-week intervention.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients apply menadione topical lotion twice daily (BID) for 28 days.

ARM II: Patients apply topical placebo lotion BID for 28 days.

After completion of study treatment, patients are followed up for 4 weeks.

Arms: arm 1: Patients apply menadione topical lotion BID for 28 days. arm 2: Patients apply topical placebo lotion BID for 28 days.
Interventions: intervention 1: menadione topical lotion intervention 2: placebo intervention 3: questionnaire administration intervention 4: management of therapy complications
Intervention descriptions: intervention 1: Given topically intervention 2: Given topically intervention 3: Ancillary studies intervention 4: Given menadione topical lotion

Protocol documents:
Clinical trial NCT01818596
Conditions: HIV HIV Infections
Keywords: HIV HIV-1 Infected Treatment Experienced Treatment Naive
Sponsor: Gilead Sciences
Start date: 2013-03-27; Completion date: 2018-07-18
Enrollment: 252 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to evaluate the effect of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) tablet on renal parameters at Week 24 in treatment-naive and treatment-experienced HIV-positive, adults with mild to moderate renal impairment.

Detailed description:

Arms: arm 1: Participants will receive E/C/F/TAF for 144 weeks. Following Week 144, in countries where E/C/F/TAF is not available (except for the United Kingdom), participants will be given the option to continue in the study and receive E/C/F/TAF for another 48 weeks, or until the product becomes available through an access program, or until Gilead Sciences elects to discontinue the study in that country, whichever comes first.
Interventions: intervention 1: E/C/F/TAF
Intervention descriptions: intervention 1: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food

Protocol documents: