ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00253630
Conditions: Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue Nodal Marginal Zone Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Mantle Cell Lymphoma Recurrent Marginal Zone Lymphoma
Sponsor: National Cancer Institute (NCI)
Start date: 2005-09-01; Completion date: 2016-05-01
Enrollment: 37 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well vorinostat works in treating patients with relapsed or refractory indolent non-Hodgkin's lymphoma. Drugs used in chemotherapy, such as vorinostat, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate the anti-tumor activity of SAHA (vorinostat) as assessed by the objective response rate, time to progression and survival in subjects with advanced lymphoma.

II. To assess the toxicity profile of SAHA in this patient population. III. To perform correlative laboratory investigations to confirm modulation of chromatin acetylation as the biologic target and attempt to gain insight into the downstream molecular mechanisms involved in the induction of apoptosis mediated by SAHA.

OUTLINE:

Patients receive vorinostat orally (PO) twice daily (BID) on days 1-14. Treatment repeats every 21 days for up to 12 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 2 years.

Arms: arm 1: Patients receive vorinostat PO BID on days 1-14. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Laboratory Biomarker Analysis intervention 2: Vorinostat
Intervention descriptions: intervention 1: Correlative studies intervention 2: Given PO

Protocol documents:
Clinical trial NCT00433550
Conditions: Small Intestine Adenocarcinoma Recurrent Small Intestine Cancer
Sponsor: Alliance for Clinical Trials in Oncology
Start date: 2007-05-01; Completion date: 2016-05-01
Enrollment: 33 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This phase II trial studies how well giving irinotecan hydrochloride together with oxaliplatin and capecitabine works as first-line therapy in treating patients with metastatic or unresectable locally advanced small bowel cancer. Drugs used in chemotherapy, such as irinotecan hydrochloride, oxaliplatin, and capecitabine, 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 OBJECTIVE:

To assess the confirmed tumor response of the combination of oxaliplatin, irinotecan (irinotecan hydrochloride), and capecitabine in patients with advanced adenocarcinoma of the small bowel when dosed according to UGT1A1 genotype.

SECONDARY OBJECTIVES:

1. To assess the toxicity of this regimen in these groups of patients.
2. To gain preliminary data on whether microsatellite instability influences outcome within this arm.
3. To gain preliminary data on whether evidence of celiac disease may affect toxicity and outcome.
4. To gain preliminary data on whether site of tumor origin (duodenal, jejunal, or ileal) affects response or survival.

OUTLINE: Patients are assigned to 1 of 3 treatment groups based on UGT1A1 genotype.

GROUP 1 (6/6 UGT1A1 genotype): Patients receive irinotecan hydrochloride intravenously (IV) over 90 minutes and oxaliplatin IV over 2 hours on day 1 and capecitabine orally (PO) twice daily (BID) on days 2-15.

GROUP 2 (6/7 UGT1A1 genotype): Patients receive irinotecan hydrochloride as in group 1. They also receive oxaliplatin and capecitabine as in group 1 but at lower doses.

GROUP 3 (7/7 UGT1A1 genotype): Patients receive irinotecan hydrochloride, oxaliplatin, and capecitabine as in group 1 but at lower doses.

In all groups, treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

After the completion of study treatment, patients are followed every 6 weeks for 2 years and then periodically thereafter.

Arms: arm 1: Patients receive irinotecan hydrochloride IV over 90 minutes and oxaliplatin IV over 2 hours on day 1 and capecitabine PO BID on days 2-15 arm 2: Patients receive irinotecan hydrochloride as in group 1. They also receive oxaliplatin and capecitabine as in group 1 but at lower doses. arm 3: Patients receive irinotecan hydrochloride, oxaliplatin, and capecitabine as in group 1 but at lower doses.
Interventions: intervention 1: capecitabine intervention 2: irinotecan hydrochloride intervention 3: oxaliplatin
Intervention descriptions: intervention 1: given orally intervention 2: given IV intervention 3: given IV

Protocol documents:
Clinical trial NCT00450385
Conditions: Lymphoma
Keywords: recurrent adult diffuse large cell lymphoma stage III adult diffuse large cell lymphoma stage IV adult diffuse large cell lymphoma contiguous stage II adult diffuse large cell lymphoma noncontiguous stage II adult diffuse large cell lymphoma stage I adult diffuse large cell lymphoma
Sponsor: University of Miami
Start date: 2007-04-24; Completion date: 2016-05-01
Enrollment: 57 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The investigators hypothesize that survival of newly diagnosed DLBCL (diffuse large B-cell lymphoma) patients treated with R-CHOP can be predicted by RNA or protein gene expression or by presence of biomarkers associated with the anti-tumor effects of Rituximab.

Detailed description:
In this phase II multi-institutional trial, the investigators will identify genes associated with either good or bad outcome in DLBCL patients treated with R-CHOP, will construct a robust predictive models based on RNA extracted from or paraffin specimens as well on immunohistochemistry and will examine the predictive power of new biomarkers associated with the anti-tumor effects of rituximab. The acquisition of fixed tissue as a component of this uniformly treated prospective study will also afford future studies with this informative dataset.

Arms: arm 1: Patients will receive R-CHOP for 6 to 8 cycles:

* Rituximab 375 mg/m2 on day 1
* Cyclophosphamide 750 mg/m2 IV on day 1
* Doxorubicin 50 mg/m2 on day 1
* Vincristine 1.4 mg/m2 (maximum = 2 mg) IV on day 1
* Prednisone 100 mg orally days 1-5, repeated every 21 days.
Interventions: intervention 1: Rituximab intervention 2: Cyclophosphamide intervention 3: Doxorubicin intervention 4: Prednisone intervention 5: Vincristine
Intervention descriptions: intervention 1: Rituximab 375 mg/m2 on day 1 for 6 to 8 cycles intervention 2: Cyclophosphamide 750 mg/m2 IV on day 1 for 6 to 8 cycles intervention 3: Doxorubicin 50 mg/m2 on day 1 for 6 to 8 cycles intervention 4: Prednisone 40 mg/m2 orally days 1-5, repeated every 21 days for 6 to 8 cycles. intervention 5: Vincristine 1.4 mg/m2 (maximum = 2 mg) IV on day 1 for 6 to 8 cycles

Protocol documents:
Clinical trial NCT00533442
Conditions: Type 1 Diabetes
Keywords: Rapamycin Mycophenolate Mofetil (MMF) Kidney-Pancreas Transplant
Sponsor: University of Miami
Start date: 2000-09-01; Completion date: 2016-05-01
Enrollment: 170 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study was designed to determine which maintenance immunosuppressive agent, rapamycin or mycophenalate mofetil, resulted in better outcome in patients with type 1 diabetes and renal failure, who presented for a kidney-pancreas transplant.

Detailed description:
This is a randomized, prospective single center study evaluating the two maintenance drugs above.

Arms: arm 1: Patients randomized to this arm were scheduled to receive maintenance therapy consisting of Tacrolimus, Mycophenolate Mofetil (MMF), and Steroids. Patients in both treatment arms received dual induction therapy consisting of Rabbit Anti-thymocyte Globulin (Thymoglobulin) plus Daclizumab. arm 2: Patients randomized to this arm were scheduled to receive maintenance therapy consisting of Tacrolimus, Rapamycin (Sirolimus), and Steroids. Patients in both treatment arms received dual induction therapy consisting of Rabbit Anti-thymocyte Globulin (Thymoglobulin) plus Daclizumab.
Interventions: intervention 1: Rapamycin intervention 2: Mycophenolate Mofetil intervention 3: Tacrolimus intervention 4: Steroids
Intervention descriptions: intervention 1: Rapamycin was initiated on day 1 postoperatively, 4mg/day;levels were maintained 5-8ng/ml. Those patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day. intervention 2: MMF 1 gm BID beginning 1st day postoperative day intervention 3: Part of standard maintenance. intervention 4: Part of standard maintenance

Protocol documents:
Clinical trial NCT00583453
Conditions: Tonsillitis
Keywords: Tonsillectomy Analgesia Pain measurement Celecoxib
Sponsor: University of Iowa
Start date: 2007-10-01; Completion date: 2016-05-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The hypothesis is that celecoxib effectively reduces pain after a tonsillectomy and reduces post-operative narcotic use.

To test this hypothesis, the study is placebo controlled (sugar pill). Half of the participants will receive a sugar pill, half will not.

All participants will receive the standard post-operative pain medications.

We ask participants to log the amount of medications they use daily, and the amount of pain they have each day. It is hoped that celecoxib will reduce the amount of post-operative pain medication needed.

Detailed description:
Post-tonsillectomy pain is typically controlled through narcotic medications, such as Lortab elixir. Despite its standard use, this pain control is typically not as effective as a non-steroidal anti-inflammatory medication (NSAID). The problem with using NSAIDs for post-tonsillectomy operative pain is the significant increased risk of rebleeding.

Celecoxib is an NSAID that is a COX-2 inhibitor; the drug is designed to act as an NSAID without the increased risk of rebleeding or hemorrhage.

This study is a double blind, randomized study; neither the study participant or the study investigator knows if the participant is receiving celecoxib or a placebo (sugar pill). The blinded list is maintained by the research pharmacists and can be unblinded when needed (such as in an emergency).

Participants begin taking the study medication the night before surgery and continue through 10 days post-operative. Participants are asked to complete a journal that catalogs the amount of standard post-operative medications taken, the amount of pain experienced, and any other comments.

Participants are contacted by phone at 5 and 10 days post-op.

Study participation ends at the standard 3-week post-operative check-up.

Arms: arm 1: Celecoxib 200 mg tablets arm 2: Placebo with same dosing schedule as the active comparator arm
Interventions: intervention 1: Celecoxib intervention 2: Placebo
Intervention descriptions: intervention 1: Celecoxib 200 mg capsule

1. capsule the night before surgery
2. capsules the morning of surgery

1 capsule the night of surgery

1 capsule twice daily for 10 days immediately after the surgery intervention 2: Placebo capsule

1. capsule the night before surgery
2. capsules the morning of surgery

1 capsule the night of surgery

1 capsule twice daily for 10 days immediately after the surgery

Protocol documents:
Clinical trial NCT00833261
Conditions: Head and Neck Cancer
Keywords: recurrent hypopharynx Cancer recurrent larynx Cancer recurrent verrucous carcinoma squamous cell carcinoma recurrent oral cavity cancer recurrent metastatic occult primary cancer recurrent oropharynx cacner recurrent paranasal sinus and nasal cavity cancer tongue cancer
Sponsor: University of Texas Southwestern Medical Center
Start date: 2008-12-01; Completion date: 2016-05-01
Enrollment: 37 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Monoclonal antibodies, such as cetuximab, 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. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cetuximab and cisplatin together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cetuximab and cisplatin together with radiation therapy works in treating patients with recurrent head and neck cancer.

Detailed description:
OBJECTIVES:

Primary

* To evaluate whether treatment with cetuximab, cisplatin, and intensity-modulated radiotherapy improves the overall survival of patients with recurrent squamous cell carcinoma of the head and neck.

Secondary

* To determine the progression-free survival and local-regional progression in these patients.
* To identify and estimate the incidence rate of acute and late toxicities associated with this treatment regimen.
* To determine the pattern of disease progression in these patients.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV over 60-120 minutes once weekly in weeks 1-7. Patients also receive cisplatin IV over 60 minutes once weekly and undergo intensity-modulated radiotherapy once daily 5 days a week in weeks 2-7.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 4 years.

Arms: arm 1: Nab-Paclitaxel, Cetuximab, Cisplatin, and Radiation Therapy intensity-modulated radiation therapy
Interventions: intervention 1: cetuximab intervention 2: cisplatin intervention 3: intensity-modulated radiation therapy intervention 4: Nab-Paclitaxel
Intervention descriptions: intervention 1: cetuximab intervention 2: cisplatin intervention 3: IMRT intervention 4: Nab-Paclitaxel

Protocol documents:
Clinical trial NCT00856830
Conditions: Small Cell Lung Cancer Extensive Stage Lung Cancer Chemonaive
Keywords: Small cell lung cancer Chemonaive Bendamustine Irinotecan Etoposide Carboplatin
Sponsor: University of Alabama at Birmingham
Start date: 2009-04-01; Completion date: 2016-05-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Small cell lung cancer, or SCLC, constitutes approximately 15% of the 170,000 new cases of lung cancer diagnosed annually in the United States. Extensive-stage SCLC comprises two thirds of new cases and is generally considered sensitive to chemotherapy, despite a median time to progression of 4 months. SCLC is one of the most aggressive and lethal types of cancer, with a median survival of 9 months (range 7-11 months) in patients diagnosed with extensive disease. Overall, the majority of patients with SCLC die in less than 2 years (2-year survival rates generally less than 10%), and the 5-year survival rate is 2.3% for patients with extensive disease. The regimen of etoposide in combination with a platinum (cisplatin or carboplatin) is generally considered the "standard of care" although a recent Phase III trial suggests improved survival with the combination of cisplatin/irinotecan. Further evaluation of new agents in combination regimens attempting to overcome the intrinsic drug resistance seen in extensive-stage SCLC is warranted attempting to improve survival and achieve palliation of disease-related symptoms.

Detailed description:
We are proposing a novel combination of bendamustine plus irinotecan followed by the standard regimen of etoposide with carboplatin. This will allow the investigation of response to the novel combination as well as any improvement in outcomes compared to historical controls.

Arms: arm 1: This novel drug combination includes: Bendamustine, Irinotecan, and Etoposide/Carboplatin.

This study has only one arm but it incorporates two phases. Phase I utilizes a combination of bendamustine and irinotecan for Regimen A followed by etoposide and carboplatin for Regimen B.
Interventions: intervention 1: Novel Drug Combination
Intervention descriptions: intervention 1: This novel drug combination includes: Bendamustine, Irinotecan, and Etoposide/Carboplatin. Subjects will be treated with irinotecan (150 mg/m2) infusion on Day 1 followed by infusion of bendamustine on Days 1 and 2 at increasing dose levels using a 3+3 design (starting dose of 80-mg/m2/d with 20 mg/mg/d incremental increase to max 120 mg/m2/d) (Regimen A). This will be repeated every 3 weeks for a total of 3 cycles. Restaging for response will be performed prior to the next regimen.

* All subjects will then be given carboplatin (AUC 6) on day 1 and etoposide (100 mg/m2) on days 1, 2 and 3 (Regimen B). They will receive 3 cycles of this regimen every 3 weeks prior to restaging.
* At the end (3 weeks after) of the sixth total round of chemotherapy, subjects will be re-evaluated for response, and will be followed-up for recurrent disease every 8 weeks.

Protocol documents:
Clinical trial NCT00888511
Conditions: Non-small Cell Lung Cancer
Keywords: Lung cancer Non-small cell lung cancer Tarceva Radiotherapy Local-regionally advanced non-small cell lung cancer
Sponsor: Olfred Hansen
Start date: 2009-05-01; Completion date: 2016-05-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The trial is a phase II study of daily Tarceva combined with definitive radiotherapy in inoperable locally advanced non small cell lung cancer (stage IIB-IIIB). The objective of the phase II trial is to examine Tarceva concomitant with curatively intended irradiation 66 Gy (2 Gy x 33 F, 5 F per week).

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Tarceva intervention 2: Radiotherapy
Intervention descriptions: intervention 1: Tarceva 150 mg/day intervention 2: 66 Gy/33 F/5 F per week for 5 weeks

Protocol documents:
Clinical trial NCT01083667
Conditions: Familial Amyotrophic Lateral Sclerosis
Keywords: ALS Familial ALS SOD1 Gene Mutation
Sponsor: Weill Medical College of Cornell University
Start date: 2009-11-01; Completion date: 2016-05-01
Enrollment: 32 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this study will be to evaluate the safety, tolerability and effect on SOD1 levels by pyrimethamine in patients with familial amyotrophic lateral sclerosis.

Detailed description:
Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease causing relentlessly progressive weakness of the arms, legs and respiratory muscles that is uniformly fatal. There are approximately 30,000 patients living with ALS in the United States. There is no treatment. The cause is uncertain in most patients. However, 3% of patients (\< 1000 in number) have a familial form of ALS (FALS), phenotypically identical to the sporadic illness, that is caused by a mutation in the gene coding for the free radical scavenging enzyme copper/zinc superoxide dismutase (SOD1). Inserting the SOD1 mutant gene into mice causes them to develop a disease closely resembling ALS.

Inhibiting expression of the SOD1 gene prevents animals from developing the disease. Increasing or decreasing the number of mutated genes proportionately speeds or slows the progression of the disease. Therefore, reducing SOD1 levels in patients with SOD1 associated FALS may be a promising therapeutic approach. Through an extensive in vitro screening program for medications having the ability to reduce SOD1 levels, several molecules that reduce SOD1 protein levels are known. One of the most potent molecules is pyrimethamine, an FDA approved medication used for the treatment of malaria and toxoplasmosis. Pyrimethamine dramatically reduces SOD1 levels in mice and our preliminary studies show similar findings in humans. Our study's primary objective is to determine if familial ALS patients taking pyrimethamine will show a decline in SOD1 levels in the CSF by 15% or more. We will also determine if SOD1 and pyrimethamine are present in the blood and if the SOD-1 levels decline over the course of the study. We will also evaluate the safety and tolerability of pyrimethamine in patients with FALS. Secondary objectives will be to determine dose optimization for maximal SOD1 level reduction and tolerability of medication. We will also assess the feasibility of proceeding to phase II/III studies using pyrimethamine. Change in ALS-FRS, Appel ALS score and quality of life will also be measured. A clinical effect realized in patients with FALS associated with an SOD1 mutation may serve as an important foundation toward finding a treatment for sporadic ALS.

Arms: arm 1: Open label. Only one arm will receive the intervention.
Interventions: intervention 1: Pyrimethamine
Intervention descriptions: intervention 1: Open Label, dose escalating,

Protocol documents:
Clinical trial NCT01208922
Conditions: Traveler's Diarrhea
Sponsor: Dr. Falk Pharma GmbH
Start date: 2010-11-01; Completion date: 2016-05-01
Enrollment: 835 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to prove the non-inferiority of Rifamycin SV-MMX® versus Ciprofloxacin for the treatment of adults with traveller's diarrhoea.

Detailed description:

Arms: arm 1: Rifamycin SV-MMX® 200 mg tablets arm 2: Ciprofloxacin 500 mg capsules
Interventions: intervention 1: Rifamycin SV-MMX® intervention 2: Ciprofloxacin
Intervention descriptions: intervention 1: 2 Rifamycin SV-MMX® 200 mg tablets and 1 placebo to ciprofloxacin capsule, b.i.d. intervention 2: 1 ciprofloxacin 500 mg capsule and 2 placebos to Rifamycin SV-MMX® 200 mg tablets, b.i.d.

Protocol documents: