ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00471315
Conditions: Sphincter of Oddi Dysfunction
Keywords: SOD Common Bile Duct Diseases Sphincterotomy Cholangiopancreatography, Endoscopic Retrograde
Sponsor: Medical University of South Carolina
Start date: 2006-07-01; Completion date: 2012-03-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Open-label single center study of duloxetine in patients with SOD who have failed to respond to the standard treatments.

This protocol is designed to explore the tolerability and efficacy of Duloxetine in the management of patients with known or suspected Sphincter of Oddi dysfunction (SOD).

Detailed description:
SOD is a disorder involving the bile duct or pancreas causing a burning pain or cramping in the epigastric (upper stomach) area that can radiate (spread) to the back or under the right shoulder blade. This discomfort is thought to be caused by tightening of the Sphincter of Oddi, which is the muscle opening that controls the flow of bile and juices from the pancreas (enzymes) into the small intestine. It can also be caused by contractions of the common bile duct (the duct that allows bile from the liver into the small intestine).

The purpose of this research is to study how well a medication called Duloxetine works when used to treat pain associated with SOD. Duloxetine (also called Cymbalta) is a medication approved by the FDA for the treatment of depression and for the treatment of pain caused by nerve damage associated with diabetes. However, for the purposes of this research, Duloxetine is considered investigational (experimental) since it will test how well this medication works for the treatment of pain associated with SOD. (Cymbalta replaced with Duloxetine in remainder of consent as requested).

PRIMARY OBJECTIVE

● Treatment effect as measured by the global assessment of change (PGIC) after 3 months of treatment with duloxetine.

SECONDARY OBJECTIVES

* Toleration of the medication as measured by the duloxetine compliance rate;
* Safety as recorded by adverse events (AEs)
* Effect of treatment on pain reduction as measured by a pain burden assessment tool (RAPID 3 \& RAPID 1-Month);
* Effect of treatment on quality of life (QOL) as measured by the SF-36.

Arms: arm 1: A preliminary, open-label single center study of duloxetine in patients with SOD
Interventions: intervention 1: Duloxetine
Intervention descriptions: intervention 1: A preliminary, open-label single center study of duloxetine in patients with SOD

Protocol documents:
Clinical trial NCT00475150
Conditions: Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) de Novo Myelodysplastic Syndromes Previously Treated Myelodysplastic Syndromes Recurrent Adult Acute Myeloid Leukemia Secondary Acute Myeloid Leukemia Secondary Myelodysplastic Syndromes Untreated Adult Acute Myeloid Leukemia
Sponsor: National Cancer Institute (NCI)
Start date: 2008-05-01; Completion date: 2012-03-01
Enrollment: 39 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well cediranib maleate works in treating patients with relapsed, refractory, or untreated acute myeloid leukemia or high-risk myelodysplastic syndrome. Cediranib maleate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer.

Detailed description:
PRIMARY OBJECTIVES:

I. Evaluate the objective response rate in patients with relapsed, refractory, or untreated acute myeloid leukemia or high-risk myelodysplastic syndromes treated with AZD2171 (cediranib maleate).

SECONDARY OBJECTIVES:

I. Determine the toxicity of this drug in these patients. II. Determine the response duration, event-free survival, and overall survival of patients treated with this drug.

III. Determine the hematological response rate in patients treated with this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to disease (acute myeloid leukemia vs myelodysplastic syndromes).

Patients receive oral cediranib maleate once daily (QD) on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy at baseline and on day 28 for correlative studies. Samples are analyzed for circulating endothelial cells, VEGF receptor expression, and leukemic blasts via flow cytometry and microvessel density via histopathological techniques.

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

Arms: arm 1: Patients receive oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: cediranib maleate intervention 2: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given orally intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT00479232
Conditions: Leukemia, Myelocytic, Acute Myelodysplastic Syndromes Myelodysplastic Syndromes
Keywords: Leukemia Myelocytic Acute Myelodysplastic Syndromes
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-06-01; Completion date: 2012-03-01
Enrollment: 71 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is to evaluate the safety and tolerability of vorinostat in combination with decitabine as well as the in vivo molecular and biological effects of vorinostat in patients with refractory or relapsed Acute Myelogenous Leukemia (AML) and intermediate or high risk as defined by International Prognostic Scoring System (IPSS) Myelodysplastic Syndrome (MDS). Participants with Acute Myelogenous Leukemia or Myelodysplastic Syndrome are eligible.

Detailed description:

Arms: arm 1: Vorinostat 400 mg capsules once daily given 7, 10 or 14 days in 28 day cycles. Up to 24 months of treatment.

Decitabine IV 20 mg/m\^2 daily for 5 days in each 28 day cycle. Up to 24 months of treatment. arm 2: Vorinostat 400 mg capsules once daily given 7 days, 14 days with 8 day break after first 7 days or 14 days without break, out of 28 day cycles.

Decitabine IV 20 mg/m\^2 daily for 5 days in each 28 day cycle. Up to 24 months of treatment.
Interventions: intervention 1: vorinostat intervention 2: decitabine
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00489255
Conditions: Parkinson's Disease
Keywords: Parkinson's disease Anti-emetic Nausea Vomiting
Sponsor: Ipsen
Start date: 2007-05-01; Completion date: 2012-03-01
Enrollment: 117 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purposes of the study are to determine:

i. To assess the efficacy of Tigan® (trimethobenzamide) in preventing nausea and vomiting when initiating therapy with Apokyn® (apomorphine)

ii. To determine the optimal duration for continuation of Tigan® following initiation of Apokyn® therapy

iii. To assess the safety of Tigan® in combination with Apokyn®

iv. To characterize the pharmacokinetic (PK) profile of apomorphine in subjects treated concomitantly with and without Tigan®

Detailed description:
Initial randomization is Tigan or Placebo (3:1) with phased withdrawal of Tigan to Placebo after 4 and 8 weeks. Subjects completing 4 weeks Tigan re-randomized to Tigan or Placebo (2:1) with patients completing 8 weeks Tigan re-randomized to receive Tigan or Placebo (1:1). Subjects randomized to Placebo over the previous 4 weeks assigned to continue on Placebo for the remainder of the study.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Tigan® intervention 2: Placebo
Intervention descriptions: intervention 1: Oral capsule, 300mg three times daily intervention 2: Oral capsule, three times daily

Protocol documents:
Clinical trial NCT00494091
Conditions: Advanced Renal Cell Carcinoma
Sponsor: Pfizer
Start date: 2007-02-01; Completion date: 2012-03-01
Enrollment: 82 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a study to evaluate the safety, efficacy and pharmacokinetics of temsirolimus in Asian patients with advanced renal cell carcinoma. The trial is only being conducted in Japan, Korea, and China.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Temsirolimus (CCI-779) intervention 2: Temsirolimus (CCI-779)
Intervention descriptions: intervention 1: 20 mg/m2 IV TEMSR weekly (Japan, n=6) intervention 2: 25 mg IV TEMSR weekly (all other pts)

Protocol documents:
Clinical trial NCT00497146
Conditions: Chronic Kidney Disease Left Ventricular Hypertrophy
Keywords: paricalcitol Zemplar PRIMO Chronic Kidney Disease Stage 3B/4
Sponsor: AbbVie (prior sponsor, Abbott)
Start date: 2008-02-01; Completion date: 2012-03-01
Enrollment: 227 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the effects of paricalcitol capsules on cardiac structure and function over 48 weeks in patients with Stage 3/4 chronic kidney disease (CKD) who had left ventricular hypertrophy (LVH).

Detailed description:
Patients who met the inclusion criteria and did not meet any of the exclusion criteria were randomized in a 1:1 ratio to each treatment group to receive paricalcitol capsules or placebo. A stratified randomization scheme was used to ensure balance among treatment groups with respect to country, gender, and baseline renin angiotensin-aldosterone system (RAAS) inhibitor use (yes/no).

Participants who completed the 48-Week Treatment Period could continue on in the ongoing Long-term Follow-up Period that was to last 18 months, with study visits at 6 months, 12 months and 18 months post Treatment Week 48 Visit. Participants did not receive study drug, nor were they to have undergone echocardiogram/MRI procedures during the Long-term Follow-up Period.

Arms: arm 1: Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period. arm 2: Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Interventions: intervention 1: paricalcitol intervention 2: placebo
Intervention descriptions: intervention 1: 2 µg capsule intervention 2: placebo capsule

Protocol documents:
Clinical trial NCT00498433
Conditions: Hypertension Abdominal Obesity
Keywords: Aliskiren Renin-Angiotensin System (RAS) Hypertension Abdominal obesity
Sponsor: Novartis
Start date: 2007-06-01; Completion date: 2012-03-01
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Part 1 determined: aliskiren, amlodipine and angiotensin II concentrations in interstitial fluid of fat and skeletal muscle; aliskiren and angiotensin II concentrations, and renin activity and concentration in fat and skeletal muscle tissues (biopsies); aliskiren, amlodipine and angiotensin II concentrations, and renin activity and concentration in plasma.

Part 2 investigated the potential for aliskiren to modulate renin-angiotensin-aldosterone system (RAAS) activity, and lipid/carbohydrate metabolism in adipose and skeletal muscle tissue in obese patients with hypertension in comparison to amlodipine.

Detailed description:

Arms: arm 1: Part 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase (period 1) consisting of treatment with one tablet of placebo to aliskiren once daily (o.d.). This was followed by a 4 week treatment phase (period 2) consisting of treatment with 300 mg aliskiren o.d..

Part 2: Eligible randomized patients in this arm received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks. arm 2: Part 1: After aliskiren treatment (period 2), each patient was entered into a second washout period (4 weeks) during which blood pressure was required to be ≤ 140/90 mmHg. If blood pressure exceeded 140/90 mmHg on two consecutive days (home monitoring) and was confirmed at the study center, the patient was entered into the amlodipine treatment period (period 3). In period 3, all patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks.

Part 2: Eligible patients randomized to part 2 received amlodipine 5 mg o.d. and aliskiren placebo for 12 weeks
Interventions: intervention 1: Aliskiren intervention 2: Amlodipine intervention 3: Placebo of Aliskiren intervention 4: Placebo of amlodipine
Intervention descriptions: intervention 1: 300 mg tablet once daily intervention 2: 5 mg capsule once daily intervention 3: Matching placebo of aliskiren 300 mg tablet intervention 4: Matching placebo of amlodipine 5 mg capsule

Protocol documents:
Clinical trial NCT00502671
Conditions: Colorectal Cancer
Sponsor: Hoffmann-La Roche
Start date: 2007-07-01; Completion date: 2012-03-01
Enrollment: 228 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will evaluate the safety profile of Xeloda as monotherapy for adjuvant treatment of colon cancer. All patients will receive Xeloda 1250mg/m2 p.o. twice daily as intermittent treatment (3 week cycles consisting of 2 weeks of treatment followed by 1 week without treatment). The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: capecitabine [Xeloda]
Intervention descriptions: intervention 1: 1250mg/m2 po bid on days 1-14 of each 3 week cycle

Protocol documents:
Clinical trial NCT00504504
Conditions: Lymphoma
Keywords: Hodgkin's Disease Lymphoma Rituximab Rituxan Adriamycin Doxorubicin Rubex Bleomycin Bleomycin sulfate Blenoxane BLM Dacarbazine DTIC DTIC-Dome Vincristine Vinblastine Vinblastine Sulfate ABVD ABVD Chemotherapy Treatment
Sponsor: M.D. Anderson Cancer Center
Start date: 2001-03-01; Completion date: 2012-03-01
Enrollment: 85 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Primary Objective:

\- To determine the feasibility, toxicity, and efficacy of Rituximab with standard dose ABVD combination chemotherapy.

ABVD combination chemotherapy consists of Adriamycin, Bleomycin, Vinblastine and DTIC.

Detailed description:
Before treatment starts, patients will have a physical exam. Bone marrow samples will be taken. Blood samples (4 to 8 tablespoons) will be taken before and during the study. A chest x-ray, CT scans of the abdomen and pelvis, and a gallium scan will be done if necessary.

Patients in this study will receive rituximab by vein over 3 to 8 hours weekly for 6 weeks in a row. ABVD will be injected over 3 hours every other week for a total of 12 treatments. On the cycles where both rituximab and ABVD are given, rituximab will be given on day 1, and ABVD will be given on day 2. Response to therapy will be determined after 3 months and at the end of therapy (6 months). At the end, patients may receive radiation therapy to areas of large masses. All treatments can be given in an outpatient setting.

Scans and x-rays will be repeated if needed after completion of therapy and every 3 months from then on. If tumors do not shrink after 3 months of therapy, patients will be offered a different treatment.

This is an investigational study. Although ABVD is considered the standard treatment for patients with Hodgkin's disease, the combination of ABVD with rituximab is considered investigational. All drugs involved in this study are commercially available and are approved by the FDA. Up to 85 patients will take part in this study. All will be enrolled at M. D. Anderson. This protocol is partially funded by a research grant from Genentech.

Arms: arm 1: Rituximab 375 mg/m\^2 by vein (IV) over 3 to 8 hours weekly for 6 weeks in a row. ABVD Chemo: Adriamycin 25 mg/m\^2 IV, Bleomycin 10 U/m\^2 IV, Vinblastine 6 mg/m\^2 IV, DTIC 375 mg/m\^2 IV. Each but Rituximab over 3 hours every other week for a total of 12 treatments.
Interventions: intervention 1: Rituximab intervention 2: Adriamycin intervention 3: Bleomycin intervention 4: Vinblastine intervention 5: Dacarbazine (DTIC)
Intervention descriptions: intervention 1: 375 mg/m\^2 by vein over 3 to 8 hours weekly for 6 weeks in a row. intervention 2: 25 mg/m\^2 injected by vein over 3 hours every other week for a total of 12 treatments. intervention 3: 10 U/m\^2 injected by vein over 3 hours every other week for a total of 12 treatments. intervention 4: 6 mg/m\^2 injected by vein over 3 hours every other week for a total of 12 treatments. intervention 5: 375 mg/m\^2 injected by vein over 3 hours every other week for a total of 12 treatments.

Protocol documents:
Clinical trial NCT00519428
Conditions: Major Depressive Disorder
Keywords: depression Major Depressive Disorder
Sponsor: New York State Psychiatric Institute
Start date: 2007-08-01; Completion date: 2012-03-01
Enrollment: 245 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will utilize a randomized double-blind design to evaluate whether initial treatment with two anti-depressant medications (escitalopram and bupropion) results in more rapid remission and greater over-all remission rates than either monotherapy in 240 depressed subjects.

Detailed description:
Depression is a major public health problem due to its prevalence and accompanying dysfunction and costs. Depression is undertreated, but even when treatment is adequate and effective, sources of delay in current pharmacologic strategies include: mechanistic delays, those related to the physiologic and behavioral effects of antidepressants; dosing delays in identifying the effective dose; and programmatic delays in identifying an effective agent using sequential monotherapy. This study will randomize 240 patients with Diagnostic and Statistical Manual, 4th Edition (DSM-IV) Major Depressive Disorder (MDD) to 12 week double blind treatment with combined escitalopram and bupropion or each antidepressant administered alone to evaluate whether combined escitalopram and bupropion result in more rapid remission and greater over-all remission than monotherapy. Preclinical and clinical studies suggest that bupropion might prevent one mechanistic delay inherent in escitalopram monotherapy. Rapid dose escalation may counter dosing delays. The simultaneous use of two known antidepressant medications may alleviate programmatic delays inherent in usual sequential monotherapy. Six months follow up and careful assessment of adverse events will address tolerability, acceptability, sustainability, and pharmacoeconomic concerns. If successful, this study might have a significant impact on clinical practice, public health, and depression's cost consequences.

Arms: arm 1: escitalopram plus bupropion extra long (XL) as dual treatment (i.e., this is not a SINGLE treatment arm; all patients assigned this arm received both medications) arm 2: escitalopram monotherapy arm 3: bupropion extra long (XL) monotherapy
Interventions: intervention 1: escitalopram intervention 2: bupropion extra long (XL) intervention 3: escitalopram + bupropion
Intervention descriptions: intervention 1: 10mg/d increasing by 10 mg/week to a maximum of 40 mg/d if tolerated and not remitted intervention 2: 150mg/d increasing to 300 mg/d after 1 week and 450 mg/d after 3 weeks, all increases if tolerated and not remitted intervention 3: same dosing schedule as for monotherapy

Protocol documents:
Clinical trial NCT00547157
Conditions: Cancer Head and Neck Cancer Oncology Squamous Cell Carcinoma
Keywords: head and neck squamous cell carcinoma radiotherapy chemoradiotherapy panitumumab locally advanced head & neck cancer EGFr epidermal growth factor receptor SCCHN locally advanced SCCHN HNC epidermal growth factor
Sponsor: Amgen
Start date: 2007-11-01; Completion date: 2012-03-01
Enrollment: 152 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to estimate, with pre-specified precision, the difference in local-regional control (LRC) rate at 2 years in subjects receiving chemoradiotherapy (CRT) or panitumumab plus radiotherapy (PRT) as first line treatment for locally advanced squamous cell carcinoma for the head and neck (SCCHN). A formal hypothesis will not be tested in this trial; however, the treatment arm difference in LRC rates at 2 years will be estimated.

Detailed description:
Primary Objective: To estimate, with pre-specified precision, the difference in local-regional control (LRC) rate at 2 years in subjects receiving chemoradiotherapy (CRT) or panitumumab plus radiotherapy (PRT) as first line treatment for locally advanced squamous cell carcinoma for the head and neck (SCCHN).

Secondary Objectives: To estimate the difference between 2 treatment regimens (CRT vs PRT) on other measures of clinical benefit, including LRC, overall response rate (ORR), progression-free survival (PFS), overall survival (OS); and safety.

Tertiary Objectives: To estimate the difference in health-related quality of life (HRQoL) and performance status in subjects receiving PRT or CRT.

Exploratory Objectives: To investigate potential biomarker development based on assessment of blood and tumor and the proposed mechanism of actions of study drugs. In addition, to investigate the effect of genetic variation in cancer genes and drug target genes on SCCHN and subject response to study drugs (separate informed consent required).

Hypothesis: A formal hypothesis will not be tested in this trial; however, the treatment arm difference in LRC rates at 2 years will be estimated.

Study Design: This is a phase 2, open-label, randomized, multicenter study. Eligible subjects will be randomized in a 2:3 ratio to either of the following regimens:

Arm 1 CRT:

* Accelerated fractionation RT: 70 to 72 Gy - delivered over 6 to 6.5 weeks
* Cisplatin: 100 mg/m2 (given on days 1 and 22 of RT) or

Arm 2 PRT:

* Accelerated fractionation RT: 70 to 72 Gy - delivered over 6 to 6.5 weeks
* Panitumumab: 9.0 mg/kg Q3W (given on days 1, 22, and 43 of RT)

Arms: arm 1: Cisplatin plus RT arm 2: Panitumumab plus RT
Interventions: intervention 1: Panitumumab intervention 2: Cisplatin
Intervention descriptions: intervention 1: Arm 2 consists of panitmumab plus RT intervention 2: Cisplatin

Protocol documents: