ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01274533
Conditions: Adult T Cell Leukemia/Lymphoma
Keywords: ATLL
Sponsor: Columbia University
Start date: 2010-12-01; Completion date: 2013-05-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a research study for subjects who have been diagnosed with Adult T cell Leukemia/Lymphoma, a rare and aggressive peripheral T cell neoplasm caused by the virus HTLV1. Currently, there is no accepted standard therapy for this disease. The purpose of this research study is to evaluate the use of the investigational drug lenalidomide in the treatment of Adult T cell Leukemia/Lymphoma.

Lenalidomide is a drug that alters the immune system and it may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells.

Lenalidomide is approved by the Food and Drug Administration (FDA) for the treatment of specific types of myelodysplastic syndrome (MDS) and in combination with dexamethasone for patients with multiple myeloma (MM) who have received at least 1 prior therapy. MDS and MM are cancers of the blood. It is currently being tested in a variety of cancer conditions. In this case it is considered experimental.

Detailed description:
The Primary Objective is to determine the efficacy of lenalidomide monotherapy in relapsed or refractory HTLV 1 associated Adult T Cell Leukemia/Lymphoma. Efficacy will be assessed by measuring the response rate, tumor control rate, duration of response, time to progression and progression free survival.

The Secondary Objective is to evaluate the safety of lenalidomide monotherapy as treatment for subjects with relapsed or refractory HTLV 1 associated Adult T Cell Leukemia/Lymphoma.

Arms: arm 1: Oral lenalidomide is initiated on Day 1 of Cycle 1 and continues once daily days 1-21 of a 28 day cycle. Subjects may continue participation in the Treatment Phase of the study for 24 months unless disease progression or drug is discontinued for safety reasons.
Interventions: intervention 1: Lenalidomide
Intervention descriptions: intervention 1: 25mg or 10mg (based on creatinine clearance) once daily for days 1-21 of a 28 day cycle

Protocol documents:
Clinical trial NCT01286402
Conditions: Smoking Cessation
Keywords: Smoking cessation during pregnancy bupropion
Sponsor: The University of Texas Health Science Center, Houston
Start date: 2011-04-01; Completion date: 2013-05-01
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to gather preliminary effectiveness and safety data on the use of bupropion for smoking cessation in pregnant women attending a community prenatal clinic. This study will provide critical preliminary data in preparation for a larger, Phase III clinical trial.

Detailed description:
A randomized, double-blind, parallel group design will be used to allow a rigorous preliminary assessment of the feasibility, effectiveness, and safety of bupropion SR (sustained release; packaged as Zyban by GlaxoSmithKline) in promoting smoking cessation among women in their second and third trimester of pregnancy. Fifty pregnant smokers will be randomized to receive an 8-week course of either bupropion SR or matching placebo tablets. Both groups will receive evidence-based smoking cessation counseling. The primary smoking outcome will be 7-day point prevalence abstinence with cotinine validation at the end of the treatment. Secondary outcomes include enrollment, retention, and compliance rates; continuous abstinence from end of treatment through the 2 week followup; continuous abstinence from birth to 2nd week postpartum followup; self-reported reduction in number of cigarettes smoked per day; and maternal side effects and perinatal/neonatal outcomes. Preliminary smoking cessation and safety outcomes will be assessed for the generation of evidence-based hypotheses regarding clinical benefit of bupropion for pregnant smokers in preparation fo a larger trial.

Arms: arm 1: Group receiving bupropion SR medication arm 2: None
Interventions: intervention 1: Bupropion SR intervention 2: Placebo
Intervention descriptions: intervention 1: * 150mg, taken orally, taken daily for the 1st 3 days
* 300mg, taken orally, taken daily for the rest of the 8 weeks of drug treatment intervention 2: -Avicel PH 302, Emcocel 50M, Cab-O-Sil M5P, Magnesium Stearate (appearance, taste, and dosing instructions were identical to the bupropion group), i.e., 1 pill orally, taken daily for the 1st 3 days; 2 pills, taken orally, taken daily for the rest of the 8 weeks of drug treatment

Protocol documents:
Clinical trial NCT01292135
Conditions: B-cell Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma
Keywords: Lymphoma, B-Cell Leukemia, Lymphoid Leukemia, B-Cell Bruton's Tyrosine Kinase
Sponsor: Pharmacyclics LLC.
Start date: 2011-02-01; Completion date: 2013-05-01
Enrollment: 33 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to establish the safety of orally administered PCI-32765 in combination with fludarabine/cyclophosphamide/rituximab (FCR) and bendamustine/rituximab (BR) in patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma(SLL).

Detailed description:
This is a Phase 1b, open-label, parallel-group, nonrandomized, multicenter study of PCI 32765 420 mg once daily oral (PO) administration in combination with 2 different chemotherapy regimens in subjects with relapsed/refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).

Arms: arm 1: None arm 2: None
Interventions: intervention 1: PCI-32765
Intervention descriptions: intervention 1: 420 mg daily

Protocol documents:
Clinical trial NCT01313208
Conditions: Rheumatoid Arthritis
Keywords: RA Enbrel DMARD Joint Count Rheumatoid Arthritis Etanercept disease modifying anti-rheumatic drug
Sponsor: Amgen
Start date: 2011-03-01; Completion date: 2013-05-01
Enrollment: 210 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to evaluate the effectiveness of adding etanercept to disease modifying anti-rheumatic drug (DMARD) therapy in patients with moderately active Rheumatoid Arthritis (RA).

Detailed description:

Arms: arm 1: Participants received placebo subcutaneous injections once a week for 12 weeks and then open-label etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.

All participants continued their disease modifying anti-rheumatic drug (DMARD) treatment throughout the 24-week study period. arm 2: Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then open-label etanercept 50 mg subcutaneous injection for the next 12 weeks.

All participants continued their DMARD treatment throughout the 24-week study period.
Interventions: intervention 1: etanercept intervention 2: Placebo intervention 3: DMARD Therapy
Intervention descriptions: intervention 1: Administered by subcutaneous injection once weekly. intervention 2: Placebo subcutaneous injection intervention 3: Standard-of-care DMARD therapy, including methotrexate, sulfasalazine, leflunomide, minocycline, and/or hydroxychloroquine

Protocol documents:
Clinical trial NCT01313221
Conditions: Psoriasis
Keywords: plaque psoriasis moderate severe etanercept Enbrel topical
Sponsor: Amgen
Start date: 2011-04-01; Completion date: 2013-05-01
Enrollment: 310 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To estimate the difference in effectiveness between treatment with etanercept 50 mg twice weekly (BIW) and treatment with etanercept 50 mg once weekly (QW) plus an as needed (PRN) topical agent for 12 weeks in adults with moderate to severe plaque psoriasis.

Detailed description:
The recommended starting dose of etanercept for adult plaque psoriasis patients is a 50 mg dose given twice a week (BIW) for 3 months followed by a reduction to a maintenance dose of 50 mg once weekly (QW). While most patients with moderate to severe plaque psoriasis are managed satisfactorily on etanercept monotherapy, a proportion may require a modified or alternative treatment regimen (eg, to handle flares or loss of effect) at some point during their chronic management. Despite the clinical need, no published data from randomized controlled studies are currently available that demonstrate efficacy and safety of combined etanercept-based regimens in patients with plaque psoriasis.

The addition of an as-needed topical medication to the step-down dose of etanercept 50 mg once weekly administered after the initial 12 week period of 50 mg twice weekly may be a potential option for patients who may require adjunctive therapy. This study aimed to provide data on this treatment option by estimating the difference in mean percent change in Psoriasis Area and Severity Index (PASI) scores between step-down etanercept 50 mg once weekly supplemented with as-needed topical medication and continuous treatment with etanercept 50 mg twice weekly.

Eligible patients will be enrolled in the study and will receive etanercept 50 mg twice weekly for 12 weeks. After 12 weeks of etanercept treatment, participants will be randomized in a 1:1 ratio to 1 of 2 treatment groups.

Arms: arm 1: Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg etanercept twice weekly for 12 weeks. arm 2: Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg etanercept once weekly plus as needed topical agents.
Interventions: intervention 1: etanercept intervention 2: Topical agents
Intervention descriptions: intervention 1: Administered by subcutaneous injection intervention 2: Topical agents prescribed at the discretion of the Principal Investigator and were are limited to the following:

* hydrocortisone 2.5%
* betamethasone valerate 0.1%
* betamethasone dipropionate 0.05%
* clobetasol 0.05%
* calcitriol
* calcipotriol plus betamethsone dipropionate 0.05%

Protocol documents:
Clinical trial NCT01319045
Conditions: Pulmonary Arterial Hypertension Congenital Heart Disease Eisenmenger's Syndrome
Keywords: Pulmonary Arterial Hypertension Congenital Heart Disease Eisenmenger's Syndrome Prostacyclin Iloprost
Sponsor: University of California, Los Angeles
Start date: 2011-06-01; Completion date: 2013-05-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Pulmonary arterial hypertension (PAH), or high blood pressure in the lungs, is common in patients with congenital heart disease. Historically these patients suffered significant morbidity and mortality due to a lack of effective therapies. More recently, advanced therapies which target the mechanisms underlying the development and progression of PAH have been introduced into clinical care. Oral, intravenous, subcutaneous, and inhaled therapies are all available for the treatment of PAH. Patients with PAH are first treated with oral agents (including sildenafil and bosentan). However, if these agents fail to achieve the desired effect for the patient, intravenous or inhaled therapies may be initiated. Combination therapy with multiple agents is common in routine clinical care. However, the most efficacious therapeutic regimen has yet to be delineated. The present study seeks to evaluate the efficacy of one specific regimen: iloprost, an inhaled prostacyclin derivative, used in combination with oral therapy (sildenafil and/or bosentan). Iloprost has been approved by the FDA for use in this patient population. Adults with PAH already receiving oral therapy will be invited to participate in this study. Iloprost will be added to their current therapeutic regimen for a period of three months, with pre- and post-treatment assessments. These will include a cardiopulmonary exercise test, BNP (a blood test), six minute walking distance, and a quality of life questionnaire.

Detailed description:

Arms: arm 1: Participants will be administered iloprost at 5 mcg/dose x 6 doses daily for 3 months.
Interventions: intervention 1: Iloprost
Intervention descriptions: intervention 1: Aerosolized iloprost, 5 mcg/dose x 6 doses daily for 3 months

Protocol documents:
Clinical trial NCT01332097
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease Exacerbation Pulmonary Inflammation
Sponsor: Mereo BioPharma
Start date: 2011-03-01; Completion date: 2013-05-01
Enrollment: 183 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess preliminary parameters of safety and efficacy of a single dose of BCT197 in patients with a Chronic Obstructive Pulmonary Disease (COPD) exacerbation.

Detailed description:
This was an exploratory, double-blind, randomized, placebo-controlled, multicenter, adaptive parallel-group design study in four parts in patients with acute COPD exacerbation. In Part I, patients were randomized to receive either a single dose of 75mg BCT197, placebo or 40 mg oral prednisone in the ratio of 1:1:1. In Part II patients were randomized to receive either a single dose of 20 mg BCT197 or placebo in the ratio of 5:1. Patients in Parts I and II received their single dose on Day 1 of the study. In Parts III and IV patients were randomized to receive either BCT197 or placebo in a ratio of 5:1 at a dose of 20mg (Part III) or 75 mg (Part IV) with patients receiving a single dose on both Day 1 and Day 6 of the study.

Arms: arm 1: Single 75mg oral dose of BCT197 capsules + single oral dose of prednisone placebo capsules arm 2: Matching placebo comparator arm arm 3: Single oral dose of BCT 197 placebo capsules + single oral dose of 40mg prednisone capsules arm 4: Single oral dose of 20mg dose of BCT197 capsules arm 5: Single oral dose of 20 mg dose of BCT197 capsules on Day 1 and Day 6 arm 6: Single oral dose of 75mg dose of BCT197 capsules on Day 1 and Day 6
Interventions: intervention 1: BCT197 intervention 2: Prednisone placebo intervention 3: BCT197 placebo intervention 4: Prednisone
Intervention descriptions: intervention 1: None intervention 2: capsules intervention 3: capsules intervention 4: capsules

Protocol documents:
Clinical trial NCT01347788
Conditions: Prostate Adenocarcinoma
Keywords: Prostate cancer Castration Resistant Bone Metastases
Sponsor: Massachusetts General Hospital
Start date: 2011-04-01; Completion date: 2013-05-01
Enrollment: 34 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Cabozantinib (XL184) is a new drug that is being developed to treat cancer. Cabozantinib works by blocking the "angiogenesis," or the growth of new blood vessels, to the tumor. This is similar to how several other cancer drugs work but in addition Cabozantinib also blocks other pathways that may be responsible for allowing cancer cells to become resistant to these other "anti-angiogenic" treatments. So far cabozantinib has been investigated in treating brain cancer and a rare form of thyroid cancer. This study will explore lower doses of cabozantinib with the goal to find the most effective, safe, and tolerable dose without undesirable side effects.

Detailed description:
Cabozantinib will be taken by mouth daily. The first five treatment cycles will be 21 days. All cycles after that will be 42 days long. Patients will keep a diary to record study drug dosing.

During the screening phase patients will receive a physical exam, blood and urine tests, a bone scan, a CT of the abdomen and pelvis, and an MRI scan of total body. On Day 1 of each cycle patients will receive a physical exam and blood and urine tests. Bone scan, CT and MRI scans will be performed at the start of cycles 3 and 5, and then repeated once every 12 weeks.

Patients will continue to receive study treatment as long as they are receiving benefit from the treatment, do not experience any severe or unmanageable side effects, and disease does not get any worse.

Arms: arm 1: Dose level 0: cabozantinib 40 mg daily arm 2: Dose level -1: cabozantinib 20 mg daily arm 3: Dose level 0: cabozantinib 40 mg daily
Interventions: intervention 1: cabozantinib
Intervention descriptions: intervention 1: Cabozantinib PO QD

Protocol documents:
Clinical trial NCT01351766
Conditions: Smoking
Keywords: Behavioral Activation
Sponsor: University of Maryland, College Park
Start date: 2010-04-01; Completion date: 2013-05-01
Enrollment: 39 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary purpose of this study is to develop a specialized behavioral activation treatment for smoking in youths ages 18-21 with elevated depressive symptoms. In the first phase we utilize focus groups and pilot testing with 15 youths to develop the behavioral activation smoking treatment for youth. In Phase II, we will conduct an open-label trial of the new treatment that will include 8 weeks of transdermal nicotine patch, which will begin at the time of quitting smoking. Participants will be followed over 26 weeks post-quit date. A subset of participants will also undergo an fMRI session to examine reward sensitivity.

Detailed description:
1. 18-21 years of age,
2. a regular smoker for at least 6 months
3. currently smoking an average of at least 5 cigarettes per day
4. want to quit smoking
5. report current elevated depressive symptoms

Arms: arm 1: Eight 60-minute group sessions over an eight-week period. Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue after treatment sessions have ended.

Transdermal Nicotine: Participants will use 8 weeks of the nicotine patch at 24 hour doses of 21, 14, and 7 mg respectively depending on participant's initial level of nicotine use. Nicotine patch dose will decrease at 2 or 4 week increments also specific to participant's initial nicotine level.
Interventions: intervention 1: Transdermal Nicotine Patch
Intervention descriptions: intervention 1: Transdermal Nicotine: Participants will use 8 weeks of the nicotine patch at 24 hour doses of 21, 14, and 7 mg respectively depending on participant's initial level of nicotine use. Nicotine patch dose will decrease at 2 or 4 week increments also specific to participant's initial nicotine level.

Protocol documents:
Clinical trial NCT01368263
Conditions: Estrogen Receptor-positive Breast Cancer HER2-negative Breast Cancer Stage II Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer
Sponsor: Washington University School of Medicine
Start date: 2011-09-01; Completion date: 2013-05-01
Enrollment: 8 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This phase II trial studies the impact of a presurgical endocrine therapy, consisting of goserelin with letrozole or anastrozole on the treatment of premenopausal patients with stage II-III estrogen receptor-positive (ER+) and human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Endocrine therapy reduces the amount of estrogen in the body. E+ breast cancer require estrogen, so lower levels of estrogen may slow or stop cell growth. Giving goserelin together with letrozole or anastrozole before surgery may enhance the effectiveness of, or eliminate the need for, chemotherapy

Detailed description:

Arms: arm 1: Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Neoadjuvant treatment repeats every 28 days for a total of 16-18 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Recommendations for postsurgical treatment will be based on PEPI score and physician discretion. arm 2: Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant chemotherapy in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion. arm 3: Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant therapy at the discretion of the physician. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
Interventions: intervention 1: goserelin acetate intervention 2: letrozole intervention 3: anastrozole intervention 4: chemotherapy intervention 5: Surgery
Intervention descriptions: intervention 1: Given SC intervention 2: Given PO intervention 3: Given PO intervention 4: Standard chemotherapy intervention 5: None

Protocol documents:
Clinical trial NCT01371838
Conditions: Community-Acquired Bacterial Pneumonia Lung Infection of Individual Not Recently Hospitalized
Keywords: Community-Acquired Bacterial Pneumonia
Sponsor: Pfizer
Start date: 2011-12-01; Completion date: 2013-05-01
Enrollment: 848 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This purpose of this study is to Evaluate the Efficacy and Safety of Intravenous Ceftaroline Versus Intravenous Ceftriaxone in the Treatment of Adult Hospitalised Patients With Community-Acquired Bacterial Pneumonia in Asia.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ceftaroline intervention 2: Ceftriaxone
Intervention descriptions: intervention 1: Two consecutive infusions q12h for 5 to 7 days intervention 2: One dose infusion followed by IV saline placebo infused q24h for 5 to 7 days plus two consecutive saline placebo infusion q24h.

Protocol documents: