ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00552396
Conditions: Multiple Myeloma
Keywords: multiple myeloma Anti-KIR (1-7F9)
Sponsor: Innate Pharma
Start date: 2007-05-01; Completion date: 2011-01-01
Enrollment: 32 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Development of new treatments for diseases such as multiple myeloma is a focus for research. The research being conducted is on treatment called Anti-KIR (1-7F9), which activates the body's own cells to kill tumor cells. This is different from many other treatments where chemicals are given to kill tumor cells. The purpose of the study is to determine a safe dose of Anti-KIR (1-7F9) to administer in humans and to gain information about its effectiveness in the treatment of multiple myeloma.

Detailed description:
Trial Design:

The trial is an open-label, dose-escalation trial to determine the safety and tolerability of Anti-KIR (1-7F9) in subjects with relapsed or refractory multiple myeloma (RRMM). A 3+3 design will be employed for the first dosing cycle at each dose level. The 7 planned dose levels are 0.0003 mg/kg, 0.003 mg/kg, 0.015 mg/kg, 0.075 mg/kg, 0.3 mg/kg, 1.0 mg/kg and 3.0 mg/kg. The subjects will receive up to a total of 4 administrations of Anti-KIR (1-7F9) with a dosing interval between each administration of 4 weeks. Safety, toxicity, PK (pharmacokinetic) and PD (pharmacodynamic) obtained in the first 4 weeks after dosing per group will be the basis for dose-escalation decisions. There will be follow-up visits every week the one month after the first administration and every two weeks following the second, third and fourth administrations. After the last administration there will be follow-up visits every month until KIR occupancy is no longer detected.

Interventions: intervention 1: Anti-KIR (1-7F9)
Intervention descriptions: intervention 1: human monoclonal antibody

Protocol documents:
Clinical trial NCT00554619
Conditions: Pulmonary Arterial Hypertension Hypertension, Pulmonary
Keywords: Pulmonary Arterial Hypertension Ambrisentan
Sponsor: GlaxoSmithKline
Start date: 2008-02-01; Completion date: 2011-01-01
Enrollment: 21 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to evaluate the safety of long-term administration of GSK1325760A in patients with PAH.

The secondary objectives of this study are to evaluate long-term administration of GSK1325760A on:

* Improvement in exercise capacity (six-minutes walk distance: 6MWD), change in WHO Functional Classification and time to clinical worsening of PAH
* Change in the Borg Dyspnea Index (assessed immediately following the six-minute walk test \[6MWT\])
* Change in plasma brain natriuretic peptide (BNP) levels
* Cardiopulmonary hemodynamics parameters (as measured by echocardiography)

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: GSK1325760A
Intervention descriptions: intervention 1: 2.5mg, 5mg or 10mg/day, po, GSK1325760A treatment will be continued until its approval by the MHLW.

Protocol documents:
Clinical trial NCT00585585
Conditions: Recurrent Major Depressive Disorder With Atypical Features
Keywords: Depression Betahistine Dihydrochloride
Sponsor: University of Cincinnati
Start date: 2007-07-01; Completion date: 2011-01-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine a dose of the investigational drug betahistine dihydrochloride that is both well tolerated and potentially effective in treating the symptoms of atypical depression. Atypical depression is characterized by the ability of the person's mood to improve temporarily in response to positive events, as well as features such as increased appetite, increased sleep and severe fatigue.

Detailed description:
All patients will start taking 50 mg of betahistine dihydrochloride on treatment day 1 (after baseline visit). Starting on day 4, the daily dose will be increased by adding a 50 mg dose. If tolerated, the daily dose will be titrated to 200 mg. At the end of week 3, the dose will be titrated to 300 mg.

Arms: arm 1: Oral betahistine dihydrochloride; daily dose 50-300 mg
Interventions: intervention 1: betahistine dihydrochloride
Intervention descriptions: intervention 1: oral, 50-300 mg, daily

Protocol documents:
Clinical trial NCT00604461
Conditions: Mesothelioma
Keywords: Carboplatin Bevacizumab Avastin Pemetrexed Alimta
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Start date: 2007-10-01; Completion date: 2011-01-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study was to evaluate how effective the combination of Carboplatin, Bevacizumab (Avastin™) and, Pemetrexed (Alimta™) is in the treatment of patients with Malignant Pleural Mesothelioma (MPM). A combination of cisplatin and pemetrexed is considered standard for this disease and typically off protocol patients would receive cisplatin or carboplatin and pemetrexed as standard of care.

The planned length of the study (first patient screened to last patient enrolled) was 24 months. The planned length of the entire study (enrollment period + the treatment period + a follow-up period of at least 12 months) was 36 months.

Detailed description:
This was a planned Phase I/II dose escalation study. Patients were enrolled in a cohort of 3.

Eligible patients with unresectable pleural mesothelioma received frontline treatment consisting of carboplatin AUC 5, bevacizumab 15 mg/kg, and pemetrexed 500 mg/m\^2 every 21 days (Tier-1). Dose escalation continued to achieve a target dosage using carboplatin AUC 6 (Tier-2). After a maximum of 6 treatment cycles, non-progressing patients received maintenance therapy with bevacizumab and pemetrexed every 21 days to complete 1-year total treatment duration.

Arms: arm 1: A: Tiered Dose Escalation/Phase II Dose -

* Tier -1: Carboplatin AUC 4 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m\^2.
* Tier 1: Carboplatin AUC 5 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m\^2.
* Tier 2: Carboplatin AUC 6 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m\^2.

B: Maintenance Therapy -

* Patient was maintained on pemetrexed plus bevacizumab for a total of one year after initiation of maintenance or until progression which ever occured first.
Interventions: intervention 1: Carboplatin, Bevacizumab and Pemetrexed
Intervention descriptions: intervention 1: Chemotherapy was given for 2 cycles after maximal response. Patients were taken off study at the time of progression. If the patient had stable disease or better, as a response, then the patient was maintained on pemetrexed plus bevacizumab for a total of one year after initiation of maintenance or until progression which ever occured first. Computed tomography (CT) scans were be done every 12 weeks during the maintenance phase.

Protocol documents:
Clinical trial NCT00613028
Conditions: Glioblastoma Gliosarcoma
Keywords: Glioblastoma Gliosarcoma GBM Bevacizumab Avastin Etoposide Brain tumor Irinotecan Glioblastoma multiforme Temodar Temozolomide Etopophos Toposar VePesid VP-16 Camptosar
Sponsor: Duke University
Start date: 2008-04-01; Completion date: 2011-01-01
Enrollment: 23 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary objective To estimate 6-month progression free survival probability of pts w recurrent GBM treated w bev + either daily temozolomide/etoposide following progression on bev + irinotecan Secondary Objectives To evaluate safety \& tolerability of bev + either daily temozolomide/etoposide among pts w recurrent GBM who have progressed on bev + irinotecan To evaluate radiographic response, progression free survival \& overall survival of pts w recurrent GBM treated w bev + either daily temozolomide/etoposide following progression on bev + irinotecan

Detailed description:
This is exploratory, two-arm, phase II study designed to assess anti-tumor activity of bev + either daily temozolomide/etoposide among GBM pts w progressive disease following bev + irinotecan. About 48 participants w recurrent GBM will take part in this study. Approximately 24 participants will receive bev plus temozolomide \& approximately 24 will receive bev + etoposide. Pts must have confirmed diagnosis of GBM \& radiographic evidence of recurrence following prior therapy bev + irinotecan. 24 pts will be enrolled onto each arm of this single-stage study. If 4 or more of these 24 pts live 6/more months without disease progression, treatment regimen will be considered worthy of further investigation. Otherwise, treatment regimen will be determined not worthy of further investigation within pt population. Type I \& II error rates associated w testing are 0.030 \& 0.115 respectively. Management guidelines dose reduction/interruption for temo, etoposide, \& bev.

Arms: arm 1: Patients treated with bevacizumab + temozolomide arm 2: Patients treated with bevacizumab and VP-16 (etoposide)
Interventions: intervention 1: Temo + Avastin intervention 2: VP-16 + Avastin
Intervention descriptions: intervention 1: Patients have progressed/had gr3/\> toxicity related to etoposide, with no had progression/gr 3/\> toxicity related to temozolomide, will only be considered for bevacizumab and temozolomide. Bevacizumab intravenously at dose 10mg/kg every other wk. For patients on bevacizumab and temozolomide, temozolomide administered on continuous dosing schedule at 50mg/m2/day. intervention 2: Patients have progressed/had gr3/\> toxicity related to temozolomide, but have not progressed/gr3/\> toxicity related to etoposide,considered only for bevacizumab and etoposide. Bevacizumab intravenously at dose 10mg/kg every other wk. Patients on bevacizumab and etoposide, etoposide once daily at 50mg/m2/day first 21 days of each 28-day cycle.

Protocol documents:
Clinical trial NCT00616109
Conditions: Extensive-Stage Small Cell Lung Cancer
Sponsor: University of Michigan Rogel Cancer Center
Start date: 2007-09-01; Completion date: 2011-01-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this study is to determine the progression-free survival rate in patients with extensive-stage small cell lung cancer who had achieved complete response, partial response, or stable disease with their previous platinum chemotherapy regimen, such as cisplatin or carboplatin in combination with etoposide or irinotecan. In addition, the safety and effectiveness of sunitinib will also be evaluated.

Detailed description:
Despite a high initial response rate, all patients with extensive-stage small cell lung cancer treated with standard chemotherapy will develop disease progression, usually within one year of initial treatment. Therefore, prolonging progression-free survival in this disease is meaningful for clinical trials exploring agents such as sunitinib. Sunitinib is a drug that inhibits the biological pathway responsible for the growth and spread of cancer cells. For this reason, we believe that sunitinib maintenance therapy will delay or prevent recurrence and prolong survival.

The goal of this study is to determine the progression-free survival rate in patients with extensive-stage small cell lung cancer who had achieved complete response, partial response, or stable disease with their previous platinum chemotherapy regimen, such as cisplatin or carboplatin in combination with etoposide or irinotecan. In addition, the safety and effectiveness of sunitinib will also be evaluated.

Arms: arm 1: Main interventional arm of study. Subjects who received maintenance sunitinib experimentally on this study were from a population of (consenting) patients with histologically or cytologically documented Extensive-State Small Cell Lung Cancer (ES-SCLC) who did not progress (were classified as Complete Response or "CR", Partial Response or "PR", or Stable Disease or "SD") after an induction chemotherapy (Cisplatin and etoposide)
Interventions: intervention 1: sunitinib
Intervention descriptions: intervention 1: Sunitinib will be given at 50 mg/day as a single agent for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.

Protocol documents:
Clinical trial NCT00618982
Conditions: Carcinoma, Renal Cell
Keywords: Kidney cancer, Sorafenib, Dose escalation, No previous treatment
Sponsor: Bayer
Start date: 2008-02-01; Completion date: 2011-01-01
Enrollment: 83 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Sorafenib is a new drug, which is approved under the brand name Nexavar for the treatment of advanced kidney cancer. It is also currently being tested in various other cancers. Sorafenib works by stopping the development of new cancer cells and new blood vessels. By stopping the growth of new blood vessels around a tumor, it is believed that sorafenib prevents the growth of kidney cancer tumors.

This is an "open-label" study which means that the patient, the doctor and Bayer Healthcare will know what tablets the patient is taking. All patients in this study will receive sorafenib tablets. Sorafenib is taken orally as a tablet (two tablets are taken twice a day). Treatment with sorafenib will continue until the patient's tumor grows larger or spreads further or if the patient has intolerable side effects. The dose of sorafenib that the patient will receive in the study will increase at certain points during the patient's treatment, as long as the patient is not experiencing side effects and the patient's tumor has not grown.

Detailed description:
Issues on Outcome Measure "Safety and tolerability" will be addressed in the Adverse Events section.

Arms: arm 1: Intrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle, 600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed.
Interventions: intervention 1: Sorafenib (Nexavar, BAY43-9006)
Intervention descriptions: intervention 1: The initial dose of sorafenib will be 400 mg bid administered orally, on a continuous basis. A treatment cycle is considered to be 28 days. Intrapatient dose escalation will occur according to the following schedule, providing no grade 3 or 4 toxicities are observed (except for alopecia, nausea and vomiting); Day 1-28 400 mg bid, Day 29-56 600 mg bid, Day 57 onwards 800 mg bid. Subjects will continue on treatment until progression, unacceptable toxicity, subject withdraws consent or the decision is taken to stop the study following the analysis of response rates.

Protocol documents:
Clinical trial NCT00623636
Conditions: Migraine Disorders
Keywords: Migraine
Sponsor: Allergan
Start date: 2008-07-01; Completion date: 2011-01-01
Enrollment: 902 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double blind, placebo controlled, parallel group study of MAP0004 in adult migraineurs. Subjects will self administer study drug in the outpatient setting.

Detailed description:

Arms: arm 1: MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks. arm 2: Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to 52 weeks.
Interventions: intervention 1: MAP0004 intervention 2: Placebo
Intervention descriptions: intervention 1: MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks. Placebo treated patients will receive MAP0004 1.0mg inhaled to treat qualifying migraines for up to 52 weeks only. intervention 2: Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks.

Protocol documents:
Clinical trial NCT00624468
Conditions: Optic Neuritis
Keywords: atacicept neuritis
Sponsor: EMD Serono
Start date: 2008-06-01; Completion date: 2011-01-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was intended to evaluate the efficacy, safety and tolerability of atacicept compared to placebo and to explore the neuroprotective effect of atacicept as assessed by OCT in subjects with ON as CIS. The study was randomized. Study medication was administered via subcutaneous (under the skin) injections.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Atacicept intervention 2: Placebo matched to atacicept
Intervention descriptions: intervention 1: Atacicept will be administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks. intervention 2: Placebo matched to atacicept will be administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.

Protocol documents:
Clinical trial NCT00627978
Conditions: Metastatic Breast Cancer
Keywords: breast
Sponsor: Weill Medical College of Cornell University
Start date: 2007-11-01; Completion date: 2011-01-01
Enrollment: 15 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Primary Objectives

* Assess ultrastructure changes in dermal myelinated nerves of patients who receive ixabepilone chemotherapy
* Detailed characterization of peripheral neuropathy in patients who receive ixabepilone

Secondary Objectives

* Clinical benefit rate
* Time to progression ( TTP)
* Toxicity
* Exploratory studies:

  * Relation of MDR 1 and TRKA polymorphisms to evolution of ultrastructural neurologic changes observed in neurons.
  * Relation of NGF, IL8, and IL10 to the development of clinical symptoms and ultrastructural changes in neurons.

Detailed description:
Eligible patient population:

* Stage 4 breast cancer
* Resolution from toxicity of prior therapy to ≤ CTC grade 1 ( except alopecia)
* No limit on prior number of therapies to treat cancer
* Adequate organ function
* Life expectancy greater than 3 months

Treatment: ixabepilone 40 mg/m2 Q3w over 3 hours

Evaluation on Study:

I. Efficacy evaluation:

* Baseline CT chest, abdomen and pelvis and bone scan within 4 weeks of starting therapy
* Evaluation of disease every 2 cycles of chemotherapy
* Ongoing toxicity evaluation using NCI CTC 3.

II. Neurological evaluation:

* Detailed neurologic exam using Neuropathy Assessment Instrument (represents a standard neurological exam)
* Serum NGF, IL 8,10, prior to starting therapy and prior to each cycle of ixabepilone
* DNA for assessment of TRK A and MDR1 polymorphisms
* Punch biopsy of skin prior to starting therapy and after every 2 cycles. Laboratory evaluation of peripheral nerve biopsies will be conducted at Rockefeller University under the direction of Dr. Carlson in Dr. Strickland's Lab.

Arms: arm 1: Participants are treated with Ixabepilone. arm 2: None
Interventions: intervention 1: ixabepilone
Intervention descriptions: intervention 1: ixabepilone 40 mg/m2 Q3w over 3 hours

Protocol documents:
Clinical trial NCT00644280
Conditions: Glaucoma
Keywords: Glaucoma,Ahmed Valve
Sponsor: University of California, San Francisco
Start date: 2008-04-01; Completion date: 2011-01-01
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine whether ranibizumab therapy before and after tube insertion for glaucoma surgeries can maintain the patency of the tube and prevent scar formation, and increase the chances for a successful procedure compared to observation.

Detailed description:
This is a randomized, open-label, Phase I/II study of intravitreally administered ranibizumab for the treatment of tube patency in glaucoma patients.

Thirty (30) patients with severe glaucoma requiring tubes will be randomized (2:1) to either ranibizumab or observation.

Consented, enrolled subjects assigned to the treatment group will receive open-label intravitreal injection of 0.5 mg ranibizumab 1 week prior to tube insertion and then monthly x 2 more injections Sham intravitreal injections for the observation group will NOT be performed.

Study periods:

Study start date: May 1st, 2007 (estimated) Enrollment period: 6-8 months (estimated) Follow-up period: 6 months Study end Date: December 1st, 2010 (estimated)

Arms: arm 1: Ranibizumab (0.5 mg in 0.05 mL) administered intravitreally at 3 time points: 9 days before Ahmed tube insertion for open-angle glaucoma, 1 month post-surgery, and 2 months post-surgery arm 2: Standard of care Ahmed tube insertion for open-angle glaucoma without injections of Ranibizumab
Interventions: intervention 1: Ranibizumab
Intervention descriptions: intervention 1: intravitreal injection of 0.5 mg ranibizumab 1 week prior to tube insertion and then monthly x 2 more injections

Protocol documents:
Clinical trial NCT00644332
Conditions: Chronic Angina
Sponsor: Gilead Sciences
Start date: 2007-11-01; Completion date: 2011-01-01
Enrollment: 172 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
According to the American Heart Association (AHA) 2011 update of heart disease and stroke statistics, more than 9 million adult patients in the United States (US) have angina. This update also notes that a study of 4 national cross-sectional health examination studies found that, among Americans 40 to 74 years of age, the age-adjusted prevalence of angina was higher among women than men. Per ACC/AHA guidelines, the goal of antianginal therapy is the complete or near complete elimination of anginal chest pain and a return to normal activities and functional capacity. However, evaluating angina and responses to antianginal therapy is often not straightforward. This is particularly true of female patients with angina. Because angina and response to antianginal therapy may differ in men and women, an instrument designed specifically to address symptomatology in women with angina could enhance our understanding and characterization of angina and responses to therapy in this population. The current study will evaluate the validity, reliability, and responsiveness of the newly developed Women's Ischemia Symptom Questionnaire (WISQ) based on changes in angina symptomatology in a female angina population treated with ranolazine, compared with the widely used Seattle Angina Questionnaire (SAQ).

Detailed description:

Interventions: intervention 1: Ranolazine
Intervention descriptions: intervention 1: Oral dosage form.

Protocol documents: