ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00514917
Conditions: Prostatic Neoplasms
Sponsor: Sanofi
Start date: 2007-07-01; Completion date: 2012-09-01
Enrollment: 413 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective was to evaluate and compare the efficacy of androgen deprivation with or without docetaxel as determined by the median progression free survival (PFS) over the period of 18-month therapy and at least 18-month follow-up.

The secondary objectives were:

* To assess cancer specific survival;
* To compare overall survival between the 2 treatment groups;
* To evaluate patient-reported outcomes including quality of life, fatigue, and sexual functioning as measured by 3 different assessments.

Detailed description:
The duration of the study per participant was to be at least 36 months, of which the treatment period was 18 months for all participants, followed by at least 18 months follow-up period.

Participants received study treatment for up to 18 months from the time of study therapy initiation or less if one of the following occurred: disease progression, unacceptable toxicity, death, participant refusal or treatment delay beyond the time frame that is permitted for each treatment.

Arms: arm 1: Participants received docetaxel 75 milligram per square meter (mg/m\^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment. arm 2: Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
Interventions: intervention 1: Docetaxel intervention 2: Leuprolide intervention 3: Bicalutamide
Intervention descriptions: intervention 1: 75 mg/m\^2 intravenous infusion over 1 hour every 3 weeks up to 10 cycles. intervention 2: 22.5 mg injection subcutaneously every 12 weeks up to 18 months. intervention 3: 50 mg tablet orally once daily for first 4 weeks of treatment.

Protocol documents:
Clinical trial NCT00529100
Conditions: Non-Small Cell Lung Cancer
Sponsor: Eli Lilly and Company
Start date: 2005-12-01; Completion date: 2012-09-01
Enrollment: 49 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Measure the 1 year survival of non small cell lung cancer (NSCLC) patients who are being treated with pemetrexed in combination with cisplatin and radiation.

Detailed description:

Arms: arm 1: Treatment included: radiation as 61-65 Gray (Gy) in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed intravenous (IV) bolus with doses escalating from 300 milligrams per square meter (mg/m\^2) IV through 500 mg/m\^2 IV on Days 1 and 22; concurrent cisplatin 25 mg/m\^2 IV on Days 1-3 and 22-24 for Cohorts 1-3 and cisplatin 20 mg/m\^2 IV on Days 1-5 and 22-26 for Cohort 4. Participants then received 2 additional consolidation cycles repeated every 3 weeks (q3 weeks) of pemetrexed 500 mg/m\^2 IV and cisplatin 75 mg/m\^2 IV. arm 2: Treatment included: radiation, 61-65 Gy in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent phase pemetrexed IV bolus as determined by Phase 1 trial to be 500 mg/m\^2 IV on Days 1 and 22 ; concurrent cisplatin 20 mg/m\^2 IV as determined by Phase 1 trial with cycles commencing on Days 1 and 22; 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m\^2 IV and cisplatin 75 mg/m\^2 IV.
Interventions: intervention 1: Pemetrexed Phase 1 intervention 2: Cisplatin Phase 1 intervention 3: Radiation Therapy intervention 4: Pemetrexed Phase 2 intervention 5: Cisplatin Phase 2
Intervention descriptions: intervention 1: 300 mg/m\^2 IV, Days 1 and 22; intermediate dose escalation level of 400 mg/m\^2 IV; then 500 mg/m\^2 IV, repeated every 21 days (q 21 days) x 2 cycles intervention 2: Cohorts 1-3: 25 mg/m\^2 IV, Days 1-3 and 22-24 then 75 mg/m\^2 IV, q21 days x 2 cycles

Cohort 4 carried into Phase 2: 20 mg/m\^2 IV, Days 1-5 and 22-26 then 75 mg/m\^2 IV, q21 days x 2 cycles. intervention 3: Phases 1 and 2: 61-65 Gy in 33-35 fractions intervention 4: Concurrent phase pemetrexed IV bolus as determined by Phase 1 trial to be 500 mg/m\^2 IV on Days 1 and 22. intervention 5: Phase 2 (Cohort 4 carried over from Phase 1): 20 mg/m\^2 IV, Days 1-5 and 22-26 then 75 mg/m\^2 IV, q21 days x 2 cycles.

Protocol documents:
Clinical trial NCT00565721
Conditions: High-grade Glioma Lung Cancer Head & Neck Cancer Sarcoma Melanoma
Keywords: Static PET imaging Dynamic PET imaging Angiogenesis αvβ3 integrins oncology imaging
Sponsor: GE Healthcare
Start date: 2007-11-01; Completion date: 2012-09-01
Enrollment: 33 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This proof-of-concept study is designed to assess the ability of \[18F\]AH-111585 PET imaging to detect tumors and angiogenesis. Up to 30 evaluable subjects are planned to be included at up to 2 study centers in the US. Subjects are considered evaluable if they undergo administration of AH-111585 (18F) Injection, dynamic and static PET imaging, and tumor tissue acquisition. The targeted population is adult subjects at initial diagnosis or recurrence with tumors ≥2.5 cm in diameter who are scheduled to undergo resection or biopsy of the tumor as a result of routine clinical treatment. The tumors must belong to one of the following 5 types:

* High-grade glioma, including glioblastoma multiforme, anaplastic astrocytoma, and anaplastic oligodendroglioma
* Lung cancer, including small cell lung cancer and non-small cell lung cancer
* Head and neck (H\&N) tumors, including laryngeal squamous cell carcinoma, well-differentiated thyroid and oral cavity carcinoma
* Sarcoma
* Melanoma

Safety will be assessed from the rates of adverse events, changes in vital signs, changes in electrocardiogram (ECG) parameters, changes in physical examination findings, and changes in clinical laboratory findings.

Efficacy will be assessed as the correlations between parameters derived from the PET images and the reference standards. The reference standards will be immunohistology for αvβ3 integrins and other biomarkers specific for oncology and angiogenesis and from the standard of care imaging.

Measures obtained from optional DCE-CT imaging may also be used to compare the uptake and retention of \[18F\]AH-111585 in tumors obtained from the dynamic PET to assess functional status of the vascular system of the tumor.

Detailed description:

Arms: arm 1: Using of the drug product named, AH111585 (F18) Injection. It's generic chemical name is Fluciclatide.
Interventions: intervention 1: Fluciclatide Injection - (AH111585 (F18))
Intervention descriptions: intervention 1: 18F labelled Cyclic RGD peptide PET agent for injection.

Protocol documents:
Clinical trial NCT00578448
Conditions: Renal Transplantation
Sponsor: Bristol-Myers Squibb
Start date: 2008-03-01; Completion date: 2012-09-01
Enrollment: 14 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the pharmacokinetics and safety of belatacept in de novo renal transplant subjects treated with belatacept-based immunosuppressant medication

Detailed description:

Arms: arm 1: 10mg/kg

6 doses (Day 1, 5, week 2, 4, 8 and 12) for 12 weeks arm 2: 5mg/kg

33 doses (every 4 weeks) for 144 weeks
Interventions: intervention 1: Belatacept
Intervention descriptions: intervention 1: IV infusion

Protocol documents:
Clinical trial NCT00584948
Conditions: Fragile X-Associated Tremor/Ataxia Syndrome Fragile X Premutation Carriers
Keywords: FXTAS, Fragile X Premutation
Sponsor: University of California, Davis
Start date: 2007-09-01; Completion date: 2012-09-01
Enrollment: 94 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if memantine is effective in treating symptoms of Fragile X-associated Tremor Ataxia Syndrome.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Memantine intervention 2: Placebo
Intervention descriptions: intervention 1: Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study. intervention 2: Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study.

Protocol documents:
Clinical trial NCT00616772
Conditions: Coronary Artery Disease Coronary Heart Disease Dyslipidemia
Sponsor: AbbVie (prior sponsor, Abbott)
Start date: 2008-02-01; Completion date: 2012-09-01
Enrollment: 682 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to test the effect and safety of once daily ABT-335 on the thickness of the lining of the carotid artery (a blood vessel to the brain) in patients with abnormal blood lipids who have optimal levels of low density lipoprotein cholesterol ("bad cholesterol") after taking atorvastatin.

Detailed description:

Arms: arm 1: ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years. arm 2: Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
Interventions: intervention 1: ABT-335 intervention 2: Placebo intervention 3: Atorvastatin
Intervention descriptions: intervention 1: Capsule intervention 2: Capsule intervention 3: Capsule

Protocol documents:
Clinical trial NCT00619112
Conditions: Recurrent Central Nervous System Neoplasm
Keywords: adult glioblastoma adult gliosarcoma adult anaplastic astrocytoma adult anaplastic oligodendroglioma adult mixed glioma recurrent adult brain tumor
Sponsor: University of California, San Francisco
Start date: 2007-10-01; Completion date: 2012-09-01
Enrollment: 60 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with recurrent high-grade glioma.

Detailed description:
OBJECTIVES:

Primary

* Determine the efficacy, as measured by 6-month progression-free survival, of a dose-intense temozolomide treatment schedule in patients with recurrent high-grade glioma.

Secondary

* Assess the toxicities of this dose-intense temozolomide.
* Determine the overall survival of patients treated with this dose-intense schedule.
* Determine whether methylation status of the MGMT gene within patients' tumors predicts greater efficacy (progression-free survival), in patients treated on this protocol.
* Determine whether patients' tumors have functional alterations of the mismatch repair (MMR) system by PCR analysis for microsatellite instability (MSI) and whether such alterations may influence outcome in patients treated on this protocol.
* Determine how initial success with temozolomide may influence outcome in recurrent patients treated on this protocol by evaluating patients progressing after two first-line adjuvant courses of temozolomide, patients progressing within 6 months after the 6th adjuvant course of temozolomide, and patients progressing 6 months after temozolomide is voluntarily discontinued.

OUTLINE: Patients receive oral temozolomide once daily on days 1-7 and days 15-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Formalin-fixed paraffin-embedded tissue blocks or unstained paraffin slides from available surgical samples are evaluated for molecular abnormalities in the tumor, including (but not limited to) MGMT status and microsatellite instability.

After completion of study therapy, patients are followed every 3 months for survival.

PROJECTED ACCRUAL: A total of 40 patients with WHO II grade 4 tumors (glioblastoma multiforme \[GBM\]) and 20 patients with WHO II grade 3 tumors (non-GBM) will be accrued for this study.

Arms: arm 1: single arm trial; Patients treated with temozolomide at a dose of 150mg/m2 daily for seven consecutive days of every other week. One 28-day cycle will include treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14
Interventions: intervention 1: temozolomide
Intervention descriptions: intervention 1: single arm study

Protocol documents:
Clinical trial NCT00623623
Conditions: Myocardial Infarction
Sponsor: Boehringer Ingelheim
Start date: 2008-03-01; Completion date: 2012-09-01
Enrollment: 1899 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study aims at evaluating, in a proof of concept approach, the outcome of patients presenting with acute ST-elevation myocardial infarction within 3 hours of symptom onset in either a pre-hospital setting or community hospital emergency room without a PCI facility. Following randomisation a strategy of early tenecteplase and additional antiplatelet and antithrombin therapy followed by catheterisation within 6-24 hours with timely coronary intervention as appropriate (or by rescue coronary intervention if required) in Group A will be compared to primary PCI performed according to local standards in Group B.

The study is exploratory in nature and will examine this medical question. The efficacy and safety endpoints as well as mixed (efficacy and safety) composite endpoints up to or before 30 days following randomisation will be evaluated.

All clinical endpoints of main interest will be assessed as single or composite endpoints for evaluation of the trial objective. All statistical tests are of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.

Detailed description:

Arms: arm 1: Early tenecteplase, clopidogrel and enoxaparin followed by routine or rescue coronary intervention arm 2: Standard primary PCI
Interventions: intervention 1: primary PCI intervention 2: enoxaparin intervention 3: catheterisation intervention 4: tenecteplase intervention 5: clopidogrel
Intervention descriptions: intervention 1: Standard primary PCI intervention 2: Adjunctive treatment intervention 3: Routine or rescue coronary intervention intervention 4: Single, weight-adjusted i.v. bolus of tenecteplase intervention 5: Adjunctive treatment

Protocol documents:
Clinical trial NCT00632099
Conditions: Cocaine Dependence
Keywords: cocaine treatment progesterone
Sponsor: New York State Psychiatric Institute
Start date: 2008-02-01; Completion date: 2012-09-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this pilot treatment trial is to evaluate the efficacy of oral micronized PROG in cocaine-dependent women. Since we have shown (Evans \& Foltin, 2006) that oral micronized PROG attenuates the positive subjective effects of smoked cocaine in females, but not in males, and we have preliminary data indicating that oral micronized PROG also reduces smoked cocaine self-administration in the laboratory, PROG appears to be an ideal potential candidate medication to evaluate in cocaine-dependent women. Prior to randomization to treatment, women will reside inpatient for one week to ensure cocaine abstinence since one of the primary outcome measures will be time to cocaine relapse.

Detailed description:
Primary Aims: The primary aims will be directed at treatment efficacy. Relatively unique to cocaine treatment trials, one of the principal outcome measures will be time to cocaine relapse. We hypothesize that maintenance on PROG will increase the time to cocaine relapse compared to maintenance on placebo (PBO). Another cocaine-related efficacy endpoint will be the proportion of patients who achieve at least 2 consecutive weeks of cocaine abstinence (based on urine toxicology results) during the double-blind treatment phase. Lastly, the proportion of cocaine-negative urines collected throughout the treatment trial will be measured. We hypothesize that women in the PROG group will show a greater reduction in cocaine use compared to those in the PBO group.

Secondary Aims: 1) Determine if response to laboratory stressors will predict treatment outcome. We hypothesize that those women with the greatest stress response will do worse in treatment and that maintenance on PROG will reduce stress/anxiety and thereby improve treatment outcome. 2) Determine if treatment retention is better in the PROG group compared to the PBO group and determine if maintenance on PROG improves overall functioning compared to maintenance on PBO based on the Clinical Global Inventory (CGI). We hypothesize that women in the PROG group will have better treatment retention and improvement in CGI scores compared to women in the PBO group.

Tertiary Aims: To conduct exploratory analyses to determine whether 1) trauma history is related to treatment outcomes and 2) improvements in treatment outcome measures are related to decreases in HIV high-risk behaviors.

Arms: arm 1: matched placebo arm 2: Oral micronized progesterone (up to 400 mg/day)
Interventions: intervention 1: Oral micronized progesterone intervention 2: Placebo
Intervention descriptions: intervention 1: Oral micronized progesterone (up to 400 mg/day), suspended in olive oil intervention 2: matched placebo

Protocol documents:
Clinical trial NCT00660699
Conditions: Cholangiocarcinoma Cancer Gallbladder Cancer Pancreatic Cancer Ampullary Cancer
Keywords: Cholangiocarcinoma Gallbladder Pancreatic Ampullary Cancer
Sponsor: Washington University School of Medicine
Start date: 2002-09-01; Completion date: 2012-09-01
Enrollment: 50 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To assess the feasibility of administering induction chemotherapy with gemcitabine and docetaxel followed by concurrent radiation and continuous infusion 5FU and consolidation gemcitabine/docetaxel chemotherapy.

Detailed description:

Arms: arm 1: Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles

Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles

5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)

Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.

Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)

Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
Interventions: intervention 1: Gemcitabine intervention 2: Docetaxel intervention 3: Radiation
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00691678
Conditions: Breast Cancer Joint Pain
Keywords: breast cancer aromatase inhibitor supportive care
Sponsor: Dawn L. Hershman
Start date: 2008-10-01; Completion date: 2012-09-01
Enrollment: 53 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Investigators are hoping to learn if glucosamine with chondroitin can help relieve joint pain/stiffness associated with aromatase inhibitors.

Detailed description:
Due to early detection and improved treatments, women with breast cancer are living longer. The increase in breast cancer survival is largely due to the benefits of hormonal therapy, such as tamoxifen and aromatase inhibitors (AIs), for the treatment of hormone-sensitive breast cancer. Recent clinical trials have demonstrated that AIs are more effective than tamoxifen at reducing breast cancer recurrences. However, breast cancer patients receiving AIs have a higher incidence of osteoporosis, bone fractures and musculoskeletal symptoms, particularly joint pain and stiffness. Musculoskeletal pain, which occurs in up to 50% of patients treated with AIs, often does not respond to conventional pain medications, may lead to noncompliance, may cause major disability, and may interfere with quality of life. Many women are unable to tolerate these life-saving drugs because of severe joint pain, therefore, safe and effective treatments that alleviate these symptoms are needed.

Arms: arm 1: Postmenopausal breast cancer patients that have joint symptoms induced by aromatase inhibitors and are receiving chondroitin and glucosamine.
Interventions: intervention 1: Chondroitin intervention 2: Glucosamine
Intervention descriptions: intervention 1: 400mg chondroitin three times a day (TID) for twenty-four weeks intervention 2: 500mg glucosamine TID for twenty-four weeks

Protocol documents:
Clinical trial NCT00695292
Conditions: Small Cell Lung Cancer
Keywords: Small Cell Lung Cancer Extensive Stage irinotecan carboplatin sunitinib
Sponsor: SCRI Development Innovations, LLC
Start date: 2008-06-01; Completion date: 2012-09-01
Enrollment: 37 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This proposed Phase II trial will investigate the combination of irinotecan and carboplatin followed by sunitinib in the first-line treatment of patients with extensive-stage SCLC.

Detailed description:
Irinotecan/platinum regimens are emerging as standard treatments for patients with extensive-stage disease. The irinotecan/carboplatin doses that will be used in this study have been used in two previous Phase II SCLC trials, and were found to be extremely well tolerated (Thompson et al. 2005; Spigel et al. 2007). Adding a novel, minimally toxic agent to this regimen may further enhance efficacy in this patient population without contributing to toxicity. This trial will evaluate the use of sunitinib following 6 cycles of treatment with chemotherapy in the treatment of SCLC.

The trial will be performed under the leadership of SCRI, a community-based, multi-center, clinical trial organization.

Arms: arm 1: Patients in the study will receive the following for the duration of the study: irinotecan 60 mg/m2 intravenously on Days 1, 8, and 15 and carboplatin AUC=4 on Day 1. The study will consist of 28-day cycles, to a maximum of 6 cycles of therapy with irinotecan and carboplatin. After treatment with irinotecan and carboplatin, sunitinib will be given alone as maintenance therapy in all patients who have achieved study entry hematologic criteria and who do not have progressive disease or severe toxicity. During sunitinib maintenance therapy, patients will receive sunitinib at 25 mg orally daily. Sunitinib maintenance therapy will continue until progressive disease or irreversible toxicity occurs.

Re-staging will be performed every 2 cycles (every 8 weeks) during the study.
Interventions: intervention 1: irinotecan intervention 2: Carboplatin intervention 3: sunitinib
Intervention descriptions: intervention 1: irinotecan 60 mg/m2 intravenously (IV) on Days 1, 8, and 15 intervention 2: carboplatin AUC=4 on Day 1 intervention 3: sunitinib 25 mg orally (PO) daily after initial chemotherapy

Protocol documents: