ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01186458
Conditions: Lymphoma, Non-Hodgkin
Sponsor: Hoosier Cancer Research Network
Start date: 2010-10-01; Completion date: 2013-10-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the effectiveness of fludarabine, Velcade, and rituximab treatment regimen in patients with relapsed or refractory follicular non-Hodgkin lymphoma.

Detailed description:
OUTLINE: This is a multi-center study.

* Fludarabine 25 mg/m2 IV over 30 minutes , Days 1, 2, 4
* Velcade(given after fludarabine) 1.3 mg/m2 IV push over 3 to 5 seconds, Days 1, 4, 8, 11
* Rituximab (given after Velcade) 375 mg/m2 IV piggyback, Day 1
* Cycle = 28 days; max 6 cycles

ECOG Performance Status: 0-2

Life Expectancy: Not specified

Hematopoietic:

* Absolute neutrophil count (ANC) ≥ 1.5 K/mm3 (ANC \> 0.5 K/mm3 if known lymphomatous involvement of the bone marrow).
* Platelets ≥ 100 K/mm3 (Platelets \>50 K/mm3 if known lymphomatous involvement of the bone marrow).

Hepatic:

* Total bilirubin ≤1.5 ULN
* Aspartate aminotransferase (AST, SGOT) ≤ 2.5 x ULN
* Alanine aminotransferase (ALT, SGPT) ≤ 2.5 x ULN

Renal:

* Creatinine \< 1.5 x institutional upper limit (ULN) or creatinine clearance ≥ 50 cc/min

Cardiovascular:

* No myocardial infarction within 6 months prior to enrollment
* No heart failure per New York Heart Association Classification III or IV
* No severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia

Arms: arm 1: Fludarabine, Velcade and Rituximab
Interventions: intervention 1: Fludarabine intervention 2: Velcade intervention 3: Rituximab
Intervention descriptions: intervention 1: Fludarabine 25 mg/m2 IV over 30 minutes on days 1, 2, 4. Cycle = 28 days; maximum of 6 cycles of therapy. intervention 2: Velcade (given after fludarabine)1.3 mg/m2 IV push over 3 to 5 seconds on days 1, 4, 8, 11. Cycle = 28 days; maximum of 6 cycles of therapy. intervention 3: Rituximab given after Velcade) 375 mg/m2 IV piggyback on day 1. Cycle = 28 days; maximum of 6 cycles of therapy.

Protocol documents:
Clinical trial NCT01202903
Conditions: Persistent Allergic Asthma
Keywords: omalizumab asthma immunoglobulin E IgE
Sponsor: Novartis Pharmaceuticals
Start date: 2010-09-01; Completion date: 2013-10-01
Enrollment: 616 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the efficacy, safety and tolerability of omalizumab, compared to placebo in 18 to 75 year old Chinese patients with moderate to severe persistent allergic asthma who have inadequate asthma control despite treatment according to GINA (2009) Step 4 therapy.

Detailed description:

Arms: arm 1: Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection. arm 2: The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
Interventions: intervention 1: Omalizumab intervention 2: Placebo
Intervention descriptions: intervention 1: The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection. intervention 2: The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.

Protocol documents:
Clinical trial NCT01211145
Conditions: Migraine Headache
Keywords: Migraine Headache Pain Efficacy Adolescents
Sponsor: AstraZeneca
Start date: 2010-09-01; Completion date: 2013-10-01
Enrollment: 1653 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate if Zomig® Nasal Spray will help children (age 12-17 years) with migraine headaches feel better. This will be done by comparing 3 different doses of Zomig Nasal Spray with placebo nasal spray (inactive treatment).

Detailed description:

Arms: arm 1: Placebo arm 2: ZOMIG 0.5 mg arm 3: ZOMIG 2.5 mg arm 4: ZOMIG 5.0 mg
Interventions: intervention 1: Placebo intervention 2: Zolmitriptan intervention 3: Zolmitriptan intervention 4: Zolmitriptan
Intervention descriptions: intervention 1: Placebo nasal spray intervention 2: 0.5 mg nasal spray intervention 3: 2.5 mg nasal spray intervention 4: 5.0 mg nasal spray

Protocol documents:
Clinical trial NCT01246206
Conditions: Hematological Malignancies
Keywords: ● Non-Hodgkin lymphoma, ● Hodgkin disease, ● Acute Myelogenous or Acute Lymphocytic Leukemia ● Myelodysplastic Syndromes, ● Chronic Myelogenous Leukemia ● Multiple Myeloma ● Chronic Lymphocytic Leukemia ● Myelofibrosis and other myeloproliferative disorders;
Sponsor: Barbara Ann Karmanos Cancer Institute
Start date: 2010-11-01; Completion date: 2013-10-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary goal of the study is to determine the incidence and severity of acute Graft versus Host Disease (GVHD) following human leukocyte antigen (HLA) matched related donor Hematopoetic Stem Cell(HSC) transplant in patients with blood related cancers who receive the combination of tacrolimus and Thymoglobulin as GVHD prophylaxis. The investigators also will determine the safety of this combination in the first six months post transplant.

Secondary goals include determining the time to recovery of white blood cells and platelets (engraftment), determining the occurrence of opportunistic infections, defined as infection that occurs in people with weakened immune systems and caused by organisms that do not normally cause disease (fungal infections, pneumocystis carinii pneumonia (PCP), and viral infections), estimating the incidence of chronic GVHD at two years and the overall and disease free survival at two years.

Immune response will be assessed by means of immuno-correlative studies both prior to and at various points after transplant.

Detailed description:

Arms: arm 1: Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis
Interventions: intervention 1: Tacrolimus and Thymoglobulin
Intervention descriptions: intervention 1: Intravenous Tacrolimus 0.03 mg/kg/d, beginning day -3, where day 0 is the day of stem cell infusion or "transplant." Intravenous tacrolimus will be discontinued once the participant starts eating, and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. Tacrolimus will be discontinued starting 100 days after transplant unless signs of acute and chronic GVHD develop or if severe toxicity occurs. Thymoglobulin will be given 0.5 mg/kg day-3, Thymoglobulin 1.5 mg/kg day -2, Thymoglobulin 2.5 mg/kg day -1. Thymoglobulin will be given intravenously over 6 hours.

Protocol documents:
Clinical trial NCT01277523
Conditions: Asthma
Sponsor: Boehringer Ingelheim
Start date: 2011-01-01; Completion date: 2013-10-01
Enrollment: 392 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat® inhaler (2.5 mcg and 5 mcg once daily) over 12 weeks, compared to placebo, as add-on controller therapy on top of usual care in adolescents (12 to 17 years old) with severe persistent asthma.

The primary objective of the trial is to demonstrate superiority of tiotropium (5 mcg and possibly 2.5 mcg once daily in the evening) over placebo with regard to the primary pulmonary function endpoint after 12 weeks of treatment.

Secondary objectives are to evaluate efficacy of tiotropium with regard to other endpoints, and to evaluate the safety of tiotropium, compared to placebo, as add-on controller therapy on top of usual care in this patient population.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: tiotropium high dose intervention 2: placebo intervention 3: tiotropium low dose
Intervention descriptions: intervention 1: 2 actuations once daily intervention 2: 2 actuations once daily intervention 3: 2 actuations once daily

Protocol documents:
Clinical trial NCT01281865
Conditions: Adult Synovial Sarcoma Recurrent Adult Soft Tissue Sarcoma Stage III Adult Soft Tissue Sarcoma Stage IV Adult Soft Tissue Sarcoma
Sponsor: National Cancer Institute (NCI)
Start date: 2011-01-01; Completion date: 2013-10-01
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase I/II clinical trial is studying the side effects and best dose of everolimus when given with imatinib mesylate and to see how well they work in treating patients with locally advanced, locally recurrent or metastatic soft tissue sarcoma. Everolimus and imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the maximum-tolerated dose (MTD) of everolimus in combination with imatinib mesylate in patients with synovial sarcoma. (Phase I) II. To determine the overall response rate (RR = CR + PR). (Phase II)

SECONDARY OBJECTIVES:

I. To determine RR, progression-free survival (PFS), and overall survival (OS). (Phase I) II. To determine predictors of response. (Phase II) III. To obtain tissue biopsy and plasma samples for correlative studies pre- and post-treatment. (Phase II)

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

Patients receive everolimus orally (PO) once daily and imatinib mesylate PO once daily on days 1-28. Course repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood and tumor tissue sample collection at baseline and periodically during study for correlative biomarker and protein expression studies.

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

Arms: arm 1: Patients receive everolimus PO once daily and imatinib mesylate PO once daily on days 1-28. Course repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood and tumor tissue sample collection at baseline and periodically during study for correlative biomarker and protein expression studies.
Interventions: intervention 1: diagnostic laboratory biomarker analysis intervention 2: everolimus intervention 3: imatinib mesylate
Intervention descriptions: intervention 1: Correlative studies intervention 2: Given PO intervention 3: Given PO

Protocol documents:
Clinical trial NCT01324999
Conditions: Pulmonary Hypertension
Keywords: Sarcoidosis Associated Pulmonary Hypertension
Sponsor: University of North Carolina, Chapel Hill
Start date: 2011-03-01; Completion date: 2013-10-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is designed to assess safety and efficacy of tadalafil in patients with Sarcoidosis Associated Pulmonary Hypertension.

Hypothesis: Tadalafil is safe and effective in treating pulmonary hypertension in patients with Sarcoidosis

Detailed description:

Arms: arm 1: Single-arm open-label proof of concept study of tadalafil in patients with sarcoidosis associated pulmonary hypertension.
Interventions: intervention 1: Tadalafil
Intervention descriptions: intervention 1: 20mg/day for one month then 40mg/day for additional 4 months

Protocol documents:
Clinical trial NCT01330355
Conditions: Bacterial Conjunctivitis
Keywords: Ocular infections, bacterial
Sponsor: Bausch & Lomb Incorporated
Start date: 2011-05-01; Completion date: 2013-10-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate the safety and efficacy of Besivance (besifloxacin 0.6%) ophthalmic suspension compared to gatifloxacin 0.3% ophthalmic solution when administered three times daily (TID) for seven days to neonatal subjects who are 31 days or younger on the day of randomization (Visit 1).

Detailed description:

Arms: arm 1: Besifloxacin 0.6% ophthalmic suspension arm 2: Gatifloxacin 0.3% ophthalmic solution
Interventions: intervention 1: Besivance intervention 2: Gatifloxacin
Intervention descriptions: intervention 1: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days intervention 2: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days

Protocol documents:
Clinical trial NCT01335464
Conditions: Pulmonary Fibrosis
Sponsor: Boehringer Ingelheim
Start date: 2011-04-01; Completion date: 2013-10-01
Enrollment: 515 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Idiopathic Pulmonary Fibrosis (IPF) is a chronic disease of unknown cause that results in scarring of the lung and there is a high unmet medical need for effective treatment to halt lung function decline, delay or avoid exacerbation (flare-ups), and ultimately to reduce the death rate.

In a large Phase 2 trial (1199.30) (NCT00514683), investigating the effects of 52 weeks of treatment with BIBF 1120 in patients with IPF, a positive effect was seen on lung function of patients treated with high dose of BIBF 1120 compared to placebo.

Hence it is the purpose of this trial to investigate and confirm the efficacy and safety of BIBF 1120 at a high dose in treating patients with IPF, compared with placebo. The trial will be conducted as a prospective, randomised design with the aim to collect safety and efficacy data.

Respiratory function is globally accepted for assessment of treatment effects in IPF patients. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is part of the usual examinations done in IPF patients.

Detailed description:

Arms: arm 1: patient receives capsules containing BIBF 1120 twice a day arm 2: patient receives capsules identical to those containing active drug
Interventions: intervention 1: placebo intervention 2: BIBF 1120
Intervention descriptions: intervention 1: placebo matching BIBF1120, BID intervention 2: BIBF1120 BID (twice daily)

Protocol documents:
Clinical trial NCT01335477
Conditions: Pulmonary Fibrosis
Sponsor: Boehringer Ingelheim
Start date: 2011-05-01; Completion date: 2013-10-01
Enrollment: 551 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Idiopathic Pulmonary Fibrosis (IPF) is a chronic disease of unknown cause that results in scarring of the lung and there is a high unmet medical need for effective treatment to halt lung function decline, delay or avoid exacerbation (flare-ups), and ultimately to reduce the death rate.

In a large Phase 2 trial (1199.30) (NCT00514683), investigating the effects of 52 weeks of treatment with BIBF 1120 in patients with IPF, a positive effect was seen on lung function of patients treated with high dose of BIBF 1120 compared to placebo.

Hence it is the purpose of this trial to investigate and confirm the efficacy and safety of BIBF 1120 at a high dose in treating patients with IPF, compared with placebo. The trial will be conducted as a prospective, randomised design with the aim to collect safety and efficacy data.

Respiratory function is globally accepted for assessment of treatment effects in IPF patients. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is part of the usual examinations done in IPF patients.

Detailed description:

Arms: arm 1: patient receives capsules identical to those containing active drug arm 2: patient receives capsules containing BIBF 1120 twice a day
Interventions: intervention 1: placebo intervention 2: BIBF 1120
Intervention descriptions: intervention 1: placebo matching BIBF 1120 BID intervention 2: BIBF 1120 BID (twice daily)

Protocol documents:
Clinical trial NCT01340482
Conditions: X-linked Hypophosphatemia
Keywords: XLH
Sponsor: Kyowa Kirin Co., Ltd.
Start date: 2011-04-01; Completion date: 2013-10-01
Enrollment: 29 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary purpose of this study is to assess the safety and efficacy of repeated subcutaneous (SC) injections of KRN23 in adult subjects with X-Linked Hypophosphatemia (XLH). A Bone Substudy will evaluate the effects of single-blind KRN23 versus Placebo on bone mineral density and bone quality.

Detailed description:

Arms: arm 1: Escalating doses of KRN23 (0.05, 0.10, 0.30 and 0.60 mg/kg) will be administered SC every 28 days (up to 4 doses)
Interventions: intervention 1: KRN23
Intervention descriptions: intervention 1: Subjects will receive escalating doses of KRN23 administered by SC injections every 28-days (up to 4 doses) based on a dosing algorithm and discretion of the investigator and sponsor.

Protocol documents:
Clinical trial NCT01346774
Conditions: Urinary Tract Infection
Keywords: cystitis pyelonephritis bladder infection kidney infection
Sponsor: Betsy Foxman
Start date: 2011-06-01; Completion date: 2013-10-01
Enrollment: 200 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Approximately 10-27% of patients undergoing gynecologic surgeries develop a catheter associated urinary tract infection (CAUTI) in the post operatory period, as bladder catheterization is a common practice in gynecologic surgery. Cranberry products provide alternative means for preventing CAUTI and could result in decreased use of antimicrobials. In this pilot study we will enroll 200 women post gynecologic surgery and randomize them to take either cranberry powder capsules or placebo powder capsules. The low risk of harm associated with using cranberry to reduce UTI coupled with its potential benefit makes it a desirable intervention for the prevention of CAUTI. The conduct/ results of this pilot /feasibility study will prepare us for the conduct of a large scale clinical trial.

Detailed description:
Cranberry products prevent bacteria that cause UTI, especially Escherichia coli, from adhering to bladder cell wall thus preventing infection. Adherence of type 1 pili is inhibited by the fructose and of p pili by the proanthocyanidins present in cranberry.

Arms: arm 1: TheraCran® cranberry: based upon proanthocyanidin content, the four cranberry capsules are equivalent to two 8-ounce servings of cranberry juice.

Participants were directed to take two capsules by mouth twice each day (once in the morning and once in the evening) starting at time of discharge for 4-6 weeks, or until their return for their post-operative doctor's visit. Participants were instructed to drink an 8 oz glass of water while taking the capsule with or without food. arm 2: Placebo: participants were directed to take two capsules by mouth twice each day (once in the morning and once in the evening) starting at time of discharge for 4-6 weeks, or until their return for their post-operative doctor's visit. Participants were instructed to drink an 8 oz glass of water while taking the capsule with or without food.
Interventions: intervention 1: Cranberry powder capsules intervention 2: Placebo powder capsules
Intervention descriptions: intervention 1: 2 cranberry powder capsules twice a day intervention 2: 2 placebo capsules twice a day

Protocol documents:
Clinical trial NCT01349933
Conditions: Recurrent Squamous Cell Carcinoma of the Nasopharynx Stage IV Squamous Cell Carcinoma of the Nasopharynx
Sponsor: National Cancer Institute (NCI)
Start date: 2011-04-01; Completion date: 2013-10-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well Akt inhibitor MK2206 works in treating patients with recurrent or metastatic head and neck cancer. Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the proportion of patients alive and progression-free at 6 months along with the confirmed response rate as a dual primary endpoint..

SECONDARY OBJECTIVES:

I. To evaluate best response and duration of response for patients treated with MK2206 (Akt inhibitor MK2206).

II. To evaluate the overall survival and progression-free survival (PFS) of patients treated with MK2206.

III. To evaluate safety and tolerability of MK2206.

TERTIARY OBJECTIVES:

I. To evaluate the pharmacokinetics of MK2206 in Asian patients. II. To study the pharmacodynamic effect of MK2206 using biomarkers and correlation with cancer-related outcomes.

OUTLINE: This is a multicenter study.

Patients receive Akt inhibitor MK2206 orally (PO) on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients undergo blood sample collection at baseline and periodically during study for pharmacogenomic and pharmacokinetic studies.

After completion of study therapy, patients are followed up for up to 3 years.

Arms: arm 1: Patients receive 200 mg Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Akt inhibitor MK2206
Intervention descriptions: intervention 1: Given PO

Protocol documents:
Clinical trial NCT01359007
Conditions: Adenocarcinoma of Pancreas
Keywords: Locally advanced unresectable adenocarcinoma of pancreas Borderline resectable adenocarcinoma of pancreas
Sponsor: University of Oklahoma
Start date: 2011-05-01; Completion date: 2013-10-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The prognosis of patients with locally advanced unresectable pancreatic cancer is poor, and the median survival is less than 1 year. FOLFIRINOX therapy, which induces tumor downstaging sufficient to allow surgical resection, could improve the overall survival of patients with locally advanced pancreatic cancer. Based on the FOLFIRINOX regimen for advanced pancreatic cancer, a phase II study of this regimen in patients with locally advanced unresectable and borderline pancreatic cancer is planned to determine the rate of conversion to operability.

Detailed description:

Arms: arm 1: Combination of drugs (Irinotecan, Oxaliplatin, Leucovorin, and 5-Fluorouracil (5-FU)) known as FOLFIRINOX every 2 weeks for 4 treatments. At the end of 4 cycles, patients will be re-evaluated for resectability by CT scan within 28 days of the last dose of chemo. If found amendable to surgery, patient will proceed with resection, and type of resection (R0 or R1) will be recorded.
Interventions: intervention 1: Irinotecan, Oxaliplatin, Leucovorin, 5-FU
Intervention descriptions: intervention 1: 5-FU 2400 mg/m2 IV continuous infusion for 46-48 hours Days 1-3 for 2 weeks 5-FU 400 mg/m2 IV Bolus Day 1 Oxaliplatin 85 mg/m2 IV over 120min +/-30 min. Day 1 Irinotecan 180 mg/m2 IV to run over 90 min +/- 30 min Day 1 Leucovorin (Before bolus 5-FU) 400 mg/m2 IV over 120 min. +/- 30 Day 1 May give oxaliplatin and leucovorin concurrently

Protocol documents: