ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00096226
Conditions: Lung Cancer
Keywords: stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer
Sponsor: Radiation Therapy Oncology Group
Start date: 2004-09-01; Completion date: 2016-05-16
Enrollment: 60 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving paclitaxel and carboplatin together with radiation therapy before surgery may shrink the tumor so that it can be removed. Giving chemotherapy after surgery may kill any tumor cells remaining after surgery.

PURPOSE: This phase II trial is studying how well giving paclitaxel and carboplatin together with radiation therapy works in treating patients who are undergoing surgery for stage III non-small cell lung cancer.

Detailed description:
OBJECTIVES:

* Determine the mediastinal node clearance rate in patients with stage IIIA or IIIB non-small cell lung cancer treated with neoadjuvant induction chemoradiotherapy comprising paclitaxel, carboplatin, and high-dose radiotherapy followed by surgical resection for patients found to be resectable and consolidative chemotherapy comprising paclitaxel and carboplatin.
* Determine the rate of complete pathological response in patients treated with this regimen.
* Determine the feasibility of surgical resection after neoadjuvant induction chemoradiotherapy in these patients.
* Determine disease-free and overall survival of patients treated with this regimen.
* Determine the toxicity of this regimen in these patients.

Arms: arm 1: Induction paclitaxel(50 mg/m2 I.V. in a one-hour infusion) and induction carboplatin (AUC 2.0 I.V. in a thirty-minute infusion): 1x/week for 6 weeks. Concurrent radiation therapy (RT): 1.8 Gy/day, 5 fx/week, for a total of 50.4 Gy in 28 fractions plus a boost of 1.8 Gy/day, 5 fx/week, for a total of 10.8 Gy in 6 fractions. Followed by an assessment to determine whether patient will undergo a resection or not. Followed by consolidation paclitaxel (200 mg/m2 I.V. over three hours) and consolidation carboplatin (AUC 6.0 over one hour) q 21 days x 2.
Interventions: intervention 1: Induction Carboplatin intervention 2: Induction Paclitaxel intervention 3: Resection intervention 4: Consolidation Carboplatin intervention 5: Radiation Therapy intervention 6: Consolidation Paclitaxel
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None

Protocol documents:
Clinical trial NCT01830621
Conditions: Colorectal Carcinoma
Sponsor: NCIC Clinical Trials Group
Start date: 2013-05-10; Completion date: 2016-05-16
Enrollment: 282 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to find out whether it is better to receive a new drug, BBI608, or better to receive no further treatment for colon or rectal cancer. To do this, half of the patients in this study will get BBI608 and the other half will receive a placebo (a substance that is designed not to do anything).

Detailed description:
This research is being done because currently there are no approved remaining effective treatments for colon or rectal cancer.

The purpose of this study is to compare the effects on colon cancer of a new drug, BBI608, and best supportive care (BSC) compared to BSC alone.

BBI608 has been shown to shrink tumours in animals and has been studied in a few people and seems promising, but it is not clear if it can offer better results than the usual care which is best supportive care alone.

The standard or usual treatment for this disease is treatment with drugs and other treatments that may help to make a patient feel better or may improve their quality of life. This treatment is known as "best supportive care" (BSC). Although patients with best supportive care can feel better for some months, the cancer usually continues to grow.

Arms: arm 1: BBI608 480 mg two times daily (960 mg total daily dose)+ Best Supportive Care arm 2: Placebo two times daily + Best Supportive Care
Interventions: intervention 1: BBI608 intervention 2: Placebo intervention 3: Best Supportive Care
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02397460
Conditions: Refractory Chronic Cough
Sponsor: Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Start date: 2015-04-29; Completion date: 2016-05-16
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective of this double-blind crossover study is to assess the effect of single doses of 50 mg and 300 mg gefapixant (AF-219/MK-7264) on cough reflex sensitivity to capsaicin in both healthy participants and participants with chronic cough. This study will also assess the effect of single doses of gefapixant on cough reflex sensitivity to adenosine triphosphate (ATP) in healthy participants and participants with chronic cough.

Detailed description:
Up to 30 participants (male and female) who meet all entry criteria will be randomly assigned to treatment with gefapixant or matching placebo.

There will be a Screening Period, a Baseline Visit (cough participants only), and four Treatment Periods, with a washout period between treatments. Participants will return after their last Treatment Visit for a Follow-up Visit.

At the Screening Visit and during the Treatment Periods, cough sensitivity will be measured by standard clinical methodology incorporating two cough challenges: 1) capsaicin; 2) ATP. The ATP challenge will only be performed during the study treatment period. The Baseline Visit (cough participants only) will occur prior to Treatment Period 1. Daytime cough monitoring will be performed at the Baseline Visit and during each of the four Treatment Periods (cough participants only).

Arms: arm 1: Gefapixant 50 mg (1 tablet) administered as a single dose arm 2: Gefapixant 300 mg (6 tablets) administered as a single dose arm 3: Placebo-matching tablets administered as a single dose
Interventions: intervention 1: Gefapixant intervention 2: Placebo
Intervention descriptions: intervention 1: Gefapixant tablets administered orally as a single dose of 50 mg (1 tablet) or 300 mg (6 tablets) intervention 2: None

Protocol documents:
Clinical trial NCT01706666
Conditions: Stage I Multiple Myeloma Stage II Multiple Myeloma Stage III Multiple Myeloma
Keywords: Maintenance Consolidation
Sponsor: Mayo Clinic
Start date: 2012-12-07; Completion date: 2016-05-17
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase II trial studies how well giving bortezomib with or without combination chemotherapy works as consolidation therapy in patients with newly diagnosed multiple myeloma who have completed stem cell transplant. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide, dexamethasone, and lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving bortezomib is more effective with or without combination chemotherapy in the post transplant setting.

Detailed description:
PRIMARY OBJECTIVES:

I. To compare the stringent complete response (sCR) rate after 12 cycles among arms.

SECONDARY OBJECTIVES:

I. To compare progression-free and overall survival among arms. II. To describe the adverse event profile of each arm.

TERTIARY OBJECTIVES:

I. To compare sCR after 6 cycles and 24 cycles and quality of life among arms.

OUTLINE: Patients are randomized to 1 of 3 treatment arms.

ARM A: Patients receive bortezomib subcutaneously (SC) on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.

ARM B: Patients receive bortezomib SC as in Arm A, cyclophosphamide orally (PO) on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.

ARM C: Patients receive bortezomib SC as in Arm A and lenalidomide PO once daily (QD) on days 1-28.

In all arms, treatment continues every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for 3 years.

Arms: arm 1: Patients receive bortezomib SC on days 1 and 15 of courses 1-12 and day 1 of courses 13-24. arm 2: Patients receive bortezomib SC as in Arm A, cyclophosphamide PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24. arm 3: Patients receive bortezomib SC as in Arm A and lenalidomide PO QD on days 1-28.
Interventions: intervention 1: bortezomib intervention 2: cyclophosphamide intervention 3: lenalidomide intervention 4: laboratory biomarker analysis intervention 5: dexamethasone intervention 6: quality-of-life assessment
Intervention descriptions: intervention 1: Given SC intervention 2: Given PO intervention 3: Given PO intervention 4: Correlative studies intervention 5: Given PO intervention 6: Ancillary studies

Protocol documents:
Clinical trial NCT01732926
Conditions: Indolent Non-Hodgkin's Lymphomas
Keywords: iNHL indolent NHL follicular lymphoma CAL-101 rituximab bendamustine small lymphocytic lymphoma lymphoplasmacytoid lymphoma Waldenstrom macroglobulinemia LPL WM Marginal zone lymphoma MZL SLL FL GS-1101 PI3K inhibitor idelalisib
Sponsor: Gilead Sciences
Start date: 2013-01-02; Completion date: 2016-05-17
Enrollment: 475 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the addition of idelalisib to bendamustine/rituximab on progression-free survival (PFS) in adults with previously treated indolent non-Hodgkin lymphoma (iNHL).

An increased rate of deaths and serious adverse events (SAEs) among participants with front-line chronic lymphocytic leukemia (CLL) and early-line iNHL treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated this study in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA).

Detailed description:

Arms: arm 1: Participants will receive rituximab + bendamustine + idelalisib. arm 2: Participants will receive rituximab + bendamustine + placebo.
Interventions: intervention 1: Idelalisib intervention 2: Rituximab intervention 3: Bendamustine intervention 4: Placebo
Intervention descriptions: intervention 1: 150 mg tablet administered orally twice daily intervention 2: 375 mg/m\^2 single-use vials administered intravenously every 4 weeks (up to a total of 6 infusions) intervention 3: 90 mg/m\^2 single-use vials administered intravenously for two consecutive days every 4 weeks (up to a total of 4-6 cycles as tolerated) intervention 4: Tablet administered orally twice daily

Protocol documents:
Clinical trial NCT02044822
Conditions: B-cell Chronic Lymphocytic Leukemia (CLL) With 17p Deletion
Keywords: Chronic Lymphocytic Leukemia CLL
Sponsor: Gilead Sciences
Start date: 2014-08-06; Completion date: 2016-05-17
Enrollment: 102 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to evaluate overall response rate (ORR) following treatment with idelalisib plus rituximab in participants with previously untreated chronic lymphocytic leukemia (CLL) with 17p deletion.

An increased rate of deaths and serious adverse events (SAEs) among participants with front-line CLL and early-line indolent non-Hodgkin lymphoma (iNHL) treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated those studies in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA). All front-line studies of idelalisib, including this study, were also terminated.

Detailed description:

Arms: arm 1: Participants will receive rituximab for 8 weeks and Idelalisib continuously throughout the study (up to 10 years).
Interventions: intervention 1: Idelalisib intervention 2: Rituximab
Intervention descriptions: intervention 1: 150 mg tablets administered orally twice daily intervention 2: 375 mg/m\^2 administered intravenously once weekly x 8 weeks

Protocol documents:
Clinical trial NCT02512900
Conditions: Asthma
Keywords: Asthma
Sponsor: MedImmune LLC
Start date: 2015-09-10; Completion date: 2016-05-17
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate the PK profile of a single-dose of 140 mg subcutaneous (SC) administration of MEDI9929 (AMG 157) in adolescent subjects with mild to moderate asthma.

Detailed description:
The primary objective is to evaluate the PK profile of a single-dose of 140 mg subcutaneous (SC) administration of MEDI9929 (AMG 157) in adolescent subjects with mild to moderate asthma. The secondary objective is to evaluate the safety and tolerability of MEDI9929 and to evaluate the immunogenicity of MEDI9929 (AMG 157). The exploratory objective is to evaluate the effect of MEDI9929 (AMG 157) on pulmonary function

Arms: arm 1: On Day 1, one MEDI9929 subcutaneous injection of 70 mg was given into the anterior aspect of one thigh immediately followed by the second injection of 70 mg into the anterior aspect of the contralateral thigh to make the required dose of 140 mg in participants with 12 to 14 years of age. arm 2: On Day 1, one MEDI9929 subcutaneous injection of 70 mg was given into the anterior aspect of one thigh immediately followed by the second injection of 70 mg into the anterior aspect of the contralateral thigh to make the required dose of 140 mg in participants with 15 to 17 years of age.
Interventions: intervention 1: MEDI9929, 140 mg
Intervention descriptions: intervention 1: On Day 1, two MEDI9929 subcutaneous injection of 70 mg each were given into the anterior aspect of one thigh immediately followed by the second injection into the anterior aspect of the contralateral thigh to make the required dose of 140 mg in participants of 12 to 17 years of age.

Protocol documents:
Clinical trial NCT01383707
Conditions: Colorectal Cancer
Sponsor: Hoffmann-La Roche
Start date: 2011-08-12; Completion date: 2016-05-18
Enrollment: 77 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The multicenter, open-label, single-arm, non-randomized, two-stage Simon's design, phase II study (The CLMO-001 Trial) will evaluate the efficacy and safety of bevacizumab in combination with mFOLFOX-6 (Levofolinic acid, 5-Fluorouracil \[5-FU\] and oxaliplatin) in participants with colorectal cancer and liver metastases. Participants will receive combination therapy of bevacizumab 5 milligrams per kilogram (mg/kg) intravenous (IV) dose and mFOLFOX-6 every 2 weeks during Cycles 1-5 and Cycles 7-12. Participants will receive mFOLFOX-6 alone (without bevacizumab) on Cycle 6. In between Cycle 6 and 7, participants will undergo liver surgery if operable. Thereafter participants will receive bevacizumab (5 mg/kg IV every 2 weeks) alone for 52 weeks (26 cycles) after the end of the post-operative phase (maintenance therapy). At the end of the preoperative treatment phase (Cycles 1-6), participants showing different alternative conditions admitted by the protocol will undergo different management (alternative study designs 1 to 3).

Detailed description:

Arms: arm 1: Participants will receive combination therapy of bevacizumab 5 mg/kg IV dose and mFOLFOX-6 (Levofolinic acid, 5-FU and oxaliplatin) on Day 1 of every 2 weeks' cycle for 5 cycles (Cycle 1-5), followed by 1 cycle (Cycle 6) of mFOLFOX6 alone (preoperative treatment phase). After 3 weeks of preoperative treatment phase, participants satisfying the surgical criteria for hepatic resectability will undergo a liver metastasectomy. Thereafter participants will receive combination therapy of mFOLFOX-6 + bevacizumab for another 6 cycles (Cycle 7-12); (post-operative treatment phase) followed by bevacizumab alone for 52 weeks (26 cycles) (maintenance therapy).
Interventions: intervention 1: 5-Fluorouracil (5-FU) intervention 2: Bevacizumab intervention 3: Levofolinic acid intervention 4: Oxaliplatin
Intervention descriptions: intervention 1: Participants will receive 5-FU 400 mg per meter-squared (mg/m\^2) IV dose on Day 1 of each 2 weeks' cycle followed by 2400 mg/m\^2, continuous infusion over 46 hours up to 12 cycles. intervention 2: Participants will receive 5 mg/kg bevacizumab IV dose on Day 1 of each 2 weeks' cycle up to Cycle 5 and thereafter cycles 7 to 12; followed by maintenance therapy of 5 mg/kg IV every 2 weeks up to 52 weeks (26 cycles). intervention 3: Participants will receive levofolinic acid 200 mg/m\^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle up to 12 cycles. intervention 4: Participants will receive oxaliplatin 85 mg/m\^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle up to 12 cycles.

Protocol documents:
Clinical trial NCT01732913
Conditions: Indolent Non-Hodgkin's Lymphomas
Keywords: iNHL indolent NHL follicular lymphoma CAL-101 Rituximab Small lymphocytic lymphoma lymphoplasmacytoid lymphoma Waldenstrom macroglobulinemia LPL WM Marginal zone lymphoma MZL SLL FL GS-1101 idelalisib
Sponsor: Gilead Sciences
Start date: 2013-01-16; Completion date: 2016-05-18
Enrollment: 295 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the effect of the addition of idelalisib to rituximab on progression-free survival (PFS) in adults with previously treated indolent non-Hodgkin lymphoma (iNHL).

An increased rate of deaths and serious adverse events (SAEs) among participants with front-line chronic lymphocytic leukemia (CLL) and early-line iNHL treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated this study in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA).

Detailed description:

Arms: arm 1: Participants will receive rituximab + idelalisib. arm 2: Participants will receive rituximab + placebo. Following confirmation of iNHL disease progression by the independent review committee and unblinding, participants may be eligible to receive open-label idelalisib 150 mg twice daily.
Interventions: intervention 1: Placebo intervention 2: Rituximab intervention 3: Idelalisib
Intervention descriptions: intervention 1: Tablets administered orally twice daily intervention 2: 375 mg/m\^2 administered intravenously weekly for 4 weeks, then every 8 weeks (up to a total of 8 infusions) intervention 3: 150 mg tablets administered orally twice daily

Protocol documents:
Clinical trial NCT02342704
Conditions: Relapsing-Remitting Multiple Sclerosis
Sponsor: Biogen
Start date: 2014-11-30; Completion date: 2016-05-18
Enrollment: 111 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to assess the effect of natalizumab compared to fingolimod on the evolution of new on-treatment T1-gadolinium-enhancing (Gd+) lesions to persistent black holes (PBH) over 52 weeks. The secondary objectives of this study in this study population are to assess the effect of natalizumab compared to fingolimod on: magnetic resonance imaging (MRI) measures of central nervous system (CNS) tissue destruction as measured by the number of new T1-Gd+ lesions; various other MRI measures of disease activity; No Evidence of Disease Activity (NEDA); Relapse on treatment over 52 weeks; The change in information processing speed as measured by the Symbol Digit Modalities Test (SDMT).

Detailed description:
This study also includes a Diffusion Tensor Imaging (DTI) sub-study that includes healthy volunteers. Healthy volunteers will not receive any study medication.

Arms: arm 1: Open-label natalizumab 300 mg IV every 4 weeks (Q4W) arm 2: Open-label fingolimod 0.5 mg once daily orally
Interventions: intervention 1: natalizumab intervention 2: fingolimod
Intervention descriptions: intervention 1: Administered as specified in the treatment arm intervention 2: Administered as specified in the treatment arm

Protocol documents:
Clinical trial NCT02612623
Conditions: Refractory Chronic Cough
Sponsor: Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Start date: 2015-12-17; Completion date: 2016-05-18
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was an 8-week randomized, parallel, double-blind, placebo-controlled study of gefapixant (AF-219) in participants with refractory chronic cough.

Detailed description:

Arms: arm 1: Two 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks arm 2: Four 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks arm 3: One 50 mg gefapixant tablet administered by mouth twice daily for 8 weeks arm 4: Matching placebo tablets administered by mouth twice daily for 8 weeks
Interventions: intervention 1: Gefapixant intervention 2: Placebo (for gefapixant)
Intervention descriptions: intervention 1: Gefapixant tablets administered by mouth twice daily for 8 weeks intervention 2: Matching placebo to gefapixant tablets administered by mouth twice daily for 8 weeks

Protocol documents: