ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01591460
Conditions: Hepatitis C, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2012-08-01; Completion date: 2014-06-01
Enrollment: 165 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This open-label, multicenter, treatment response guided study will evaluate the sustained virological response and safety of the triple combination therapy boceprevir, Pegasys (peginterferon alfa-2a) and Copegus (Ribavirin) in previously untreated patients with genotype 1 chronic hepatitis C. In the lead-in phase, patients will receive a dual combination therapy of Pegasys and Copegus for 4 weeks. In the following triple combination therapy phase, 800 mg boceprevir, 180 mcg Pegasys and 1000-1200 mg Copegus will be administered for 24, 32 or 44 weeks; the duration depending on the patient's treatment response. The anticipated time on study treatment is up to 48 weeks.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: boceprevir intervention 2: peginterferon alfa-2a [Pegasys] intervention 3: peginterferon alfa-2a [Pegasys] intervention 4: ribavirin (Copegus] intervention 5: ribavirin (Copegus]
Intervention descriptions: intervention 1: 800 mg three times daily for 24, 32 or 44 weeks intervention 2: 180 mcg subcutaneously once a week for 24, 32 or 44 weeks intervention 3: 180 mcg subcutaneously once a week for 4 weeks intervention 4: 1000 mg or 1200 mg orally once a day for 24, 32 or 44 weeks intervention 5: 1000 mg or 1200 mg orally once a day for 4 weeks

Protocol documents:
Clinical trial NCT00072475
Conditions: Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms
Keywords: refractory anemia with excess blasts refractory anemia with ringed sideroblasts refractory cytopenia with multilineage dysplasia chronic myelomonocytic leukemia de novo myelodysplastic syndromes secondary myelodysplastic syndromes myelodysplastic/myeloproliferative neoplasm, unclassifiable refractory anemia previously treated myelodysplastic syndromes
Sponsor: Alliance for Clinical Trials in Oncology
Start date: 2003-12-01; Completion date: 2014-06-01
Enrollment: 155 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Vatalanib may be effective in preventing the development of leukemia in patients who have myelodysplastic syndromes.

PURPOSE: This phase II trial is studying vatalanib to see how well it works in treating patients with primary or secondary myelodysplastic syndromes.

Detailed description:
OBJECTIVES:

Primary

* Determine the response rate, in terms of hematologic improvement and complete and partial remission, in patients with primary or secondary (therapy-related) myelodysplastic syndromes treated with vatalanib.
* Determine the time to transformation to acute myeloid leukemia (at least 20% blasts) or death in patients treated with this drug.

Secondary

* Determine the safety of this drug in these patients.
* Determine the duration of response in patients treated with this drug.
* Determine the cytogenetic response rate in patients treated with this drug.
* Determine the overall and progression-free survival of patients treated with this drug.
* Determine the incidence of infections requiring antibiotics or hospitalization or bleeding requiring red blood cell transfusions in patients treated with this drug.

OUTLINE: This is a multicenter study. Patients are stratified\* according to risk group (low grade \[refractory anemia with or without ringed sideroblasts, refractory anemia with excess blasts-1, refractory cytopenia with multilineage dysplasia with or without ringed sideroblasts, myelodysplastic syndromes-unclassified, or chronic myelomonocytic leukemia-1\] vs high grade \[refractory anemia with excess blasts-2 or chronic myelomonocytic leukemia-2\]).

NOTE: \*Stratification according to risk (low vs high) does not occur after 11/30/06.

Patients receive oral vatalanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 6 additional courses after documentation of a CR.

Patients are followed periodically for up to 5 years from study entry.

PROJECTED ACCRUAL: Approximately 144 patients will be accrued for this study within 2.5 years.

Arms: arm 1: Adult patients with MDS receive treatment with vatalanib.
Interventions: intervention 1: vatalanib
Intervention descriptions: intervention 1: Pts registered before 1/15/05 1250 mg/day PO After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or \> tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)

Protocol documents:
Clinical trial NCT00372996
Conditions: Breast Neoplasms
Sponsor: Pfizer
Start date: 2007-02-01; Completion date: 2014-06-01
Enrollment: 219 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To test the efficacy of CP-751,871 combined with exemestane in the treatment of postmenopausal patients with hormone positive advanced breast cancer

Detailed description:

Arms: arm 1: CP-751,871 + exemestane Treatment until progression or toxicity arm 2: None
Interventions: intervention 1: CP-751,871 intervention 2: exemestane intervention 3: exemestane intervention 4: Fulvestrant
Intervention descriptions: intervention 1: CP-751,871 given at 20 mg/kg IV on day 1 of each 21 day cycle. intervention 2: Exemestane given at 25 mg orally once a day. intervention 3: Exemestane given at 25 mg orally once a day. Treatment until progression or toxicity intervention 4: Used for salvage therapy and administered according to the local label and standard clinical practice.

Protocol documents:
Clinical trial NCT00373425
Conditions: Non-small Cell Lung Cancer
Keywords: Adjuvant Non-small Cell Lung Cancer Tarceva Early-stage Lung Cancer Adjuvant RADIANT NSCLC EGFR-positive tumor Stage IB Non-small Cell Lung Cancer Stage II Non-small Cell Lung Cancer Stage IIIA Non-small Cell Lung Cancer
Sponsor: OSI Pharmaceuticals
Start date: 2006-09-01; Completion date: 2014-06-01
Enrollment: 1252 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study to evaluate the effectiveness of erlotinib compared with a placebo sugar pill following complete surgical removal of the tumor with or without chemotherapy after surgery in Stage IB-IIIA NSCLC patients.

Detailed description:
After the initiation of the study, the sponsor became aware of an error in the drug dispensing module of the interactive voice response such that most patients who were randomized prior to 07 November 2007 were dispensed the incorrect study drug at least once. Since the integrity of the data from these patients was seriously compromised, these patients were considered unevaluable for the protocol-specified analyses. These participants are referred to as the breached protocol cohort (BPC) and those still on study treatment at the time of the breach were offered the option of receiving open-label erlotinib for up to 2 years (including posttreatment and long-term follow-up assessments), not receiving open-label erlotinib but remaining in the study for posttreatment and long-term follow-up assessment, or withdrawing consent from treatment and further assessments. Participants who had discontinued study treatment prior to the breach were not offered open-label erlotinib and remained in long-term follow-up. Data from the BPC participants were analyzed separately and were not included in the assessments of primary or secondary endpoints in the randomized cohort and were not considered part of the primary analyses.The sample size for the randomized cohort was not changed due to the BPC and the data from RC and BPC were analyzed separately.

Arms: arm 1: Participants received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity. arm 2: Participants received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
Interventions: intervention 1: Erlotinib intervention 2: Placebo
Intervention descriptions: intervention 1: 150 mg tablet intervention 2: Placebo tablet

Protocol documents:
Clinical trial NCT00528567
Conditions: Breast Cancer
Sponsor: Hoffmann-La Roche
Start date: 2007-12-01; Completion date: 2014-06-01
Enrollment: 2591 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main objective of the trial is to compare Invasive Disease-Free Survival (IDFS) of patients randomised to treatment with adjuvant chemotherapy alone or to adjuvant chemotherapy with 1 year of bevacizumab.

The secondary objectives of this trial are to:

* compare Overall Survival (OS), Breast Cancer-Free Interval (BCFI), Disease- Free Survival (DFS) and Distant Disease-Free Survival (DDFS) of patients randomised to treatment with adjuvant chemotherapy alone or to adjuvant chemotherapy in combination with 1 year of bevacizumab
* evaluate the safety and tolerability of bevacizumab

An exploratory sub-study (not reported here) was to identify biomarkers (from tumour or serum) predictive of toxicity and for the level of benefit from the addition of bevacizumab to standard adjuvant systemic treatment.

Detailed description:

Arms: arm 1: Participants randomized to receive bevacizumab in combination with chemotherapy as prescribed. arm 2: Participants randomized to receive standard adjuvant chemotherapy as prescribed.
Interventions: intervention 1: Bevacizumab intervention 2: Standard adjuvant chemotherapy
Intervention descriptions: intervention 1: Bevacizumab was administered at a dose equivalent of 5 mg/kg/week using 1 of 3 different scheduling options depending on the schedule of the adjuvant chemotherapy regimen selected for an individual patient. intervention 2: All chemotherapy schedules and doses for each patient were prescribed according to the labeled indication of the country in which the patient was receiving therapy.

Protocol documents:
Clinical trial NCT00580151
Conditions: Pain Anxiety
Keywords: Pain not controled by morphine Anxiety not controled by lorazepam
Sponsor: The University of Texas Medical Branch, Galveston
Start date: 2004-06-01; Completion date: 2014-06-01
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Some of the children who suffer acute burn injury do not have adequate pain and anxiety management with the current regimen of scheduled opiates (morphine) and benzodiazepines (lorazepam). Other children have significant side effects or contraindications, such as constipation or over sedation, when taking these medications. Clonidine is known to reduce the need for morphine in the management of postoperative pain. The addition of clonidine to the pharmacological treatment of burn wound pain offers a possible adjunct to the standard opiate and benzodiazepines regimen. Clonidine has been used in children in both on a short-term basis (such as postoperative pain management) and on a long-term basis (such as the treatment of attention deficit hyperactivity disorder (ADHD)). This study tests the hypothesis that clonidine in a dose of 5 ug/kilo every 8 hours will be a useful adjunct to the management of pain and anxiety in the acutely burned child. All children will be treated by protocol with morphine (0.03mg/kilo) q4hr prn pain and lorazepam (0.03 mg/kilo) q 4 hours prn anxiety. In addition, after informed consent is obtained the children will be randomized to the addition clonidine or placebo. Pain and anxiety will be assessed using standard instruments blind to the medication being used on a daily basis Also the total dose of morphine and lorazepam during the 10 days of added clonidine or placebo will be recorded.. The pain rating, anxiety ratings, total morphine dose, and total lorazepam dose will be compared between the placebo and clonidine groups with a Student's t test. Once the blind is broken the child will be allowed to remain on the clonidine if it is beneficial. The second year of the grant will expand the age groups down to younger children and also begin to gain information about the effect of clonidine on the hypermetabolic state secondary to burn injury.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: clonidine intervention 2: placebo
Intervention descriptions: intervention 1: 3-5 microgram per kilogram every 6 hours for 10 days intervention 2: 1 dose every 6 hours

Protocol documents:
Clinical trial NCT00637494
Conditions: Psychotic Depression Severe Major Depression With Psychotic Features Psychosis
Keywords: psychotic depression major depression with psychotic features psychosis
Sponsor: Corcept Therapeutics
Start date: 2008-03-01; Completion date: 2014-06-01
Enrollment: 292 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Approximately 450 patients will be randomized to receive mifepristone or placebo for 7 days followed by antidepressant. The purpose is to compare the efficacy of mifepristone followed by antidepressant versus placebo followed by antidepressant in reducing psychotic symptoms in patients with a diagnosis of psychotic depression.

Detailed description:
Up to 450 patients with psychotic depression will be randomly assigned to receive either mifepristone or matching placebo. Patients will be assessed by the investigator or site staff during screening and on study days. A single antidepressant selected from a list of approved drugs will be administered after the administration of investigational drug. Adverse events, laboratory assessments, electrocardiograms, and physical examinations will be used to assess safety.

Arms: arm 1: Mifepristone followed by an antidepressant arm 2: Placebo followed by an antidepressant
Interventions: intervention 1: mifepristone intervention 2: placebo
Intervention descriptions: intervention 1: 1200 mg (administered as four 300 mg tablets) once a day by mouth for the initial 7 days intervention 2: Tablets of identical appearance to active drug, once a day by mouth for the initial 7 days

Protocol documents:
Clinical trial NCT00667420
Conditions: Esophageal Adenocarcinoma Gastric Adenocarcinoma
Keywords: gastric esophageal panitumumab
Sponsor: Massachusetts General Hospital
Start date: 2008-04-01; Completion date: 2014-06-01
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A pilot study to determine the safety of using perioperative panitumumab with EOX (epirubicin, oxaliplatin, and capecitabine) in patients with adenocarcinoma of the esophagus and stomach.

Detailed description:

Arms: arm 1: open-label, single-arm EOXP Epirubicin 50mg/m2 by IV on day 1 of each 21 day cycle, Oxaliplatin 100 mg/m2 by IV on day 1 of each 21 day cycle, Capecitabine 400 mg/m2 twice daily by mouth on days 1-21 of the 21 day cycle Panitumumab - 9mg/kg by IV on day 1 of each 21 day cycle
Interventions: intervention 1: panitumumab, epirubicin, oxaliplatin, xeloda
Intervention descriptions: intervention 1: pilot study

Protocol documents:
Clinical trial NCT00687739
Conditions: Obesity
Keywords: hormone therapy obesity postmenopause disease /disorder proneness /risk insulin sensitivity /resistance metabolic syndrome women's health
Sponsor: University of Colorado, Denver
Start date: 2008-05-01; Completion date: 2014-06-01
Enrollment: 79 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate potential mechanisms by which estradiol deficiency accelerates fat gain and abdominal fat accumulation in women.

Detailed description:
Many factors contribute to the current epidemic of obesity. Although estrogen status is not commonly recognized as a determinant of obesity risk in women, there is strong evidence from large randomized controlled trials that estradiol (E2)-based hormone therapy (HT) reduces weight gain by about 40% in postmenopausal women. Importantly, there is also strong evidence that E2 reduces abdominal fat accumulation, a fundamental component of the Metabolic Syndrome. Some studies suggest risks of HT outweigh the benefits for some women. However, this does not negate the importance of learning the mechanisms by which E2 influences energy balance and fat patterning.

This study uses gonadotropin releasing hormone (GnRH) analog therapy to determine the effects of chronic (5-month) sex hormone suppression on resting energy expenditure (REE), altered hypothalamic-pituitary-adrenal (HPA) axis activity, and fat gain.

It is hypothesized that REE will be reduced in response to chronic sex hormone suppression, promoting fat gain. It is also hypothesized that stress-induced hypothalamic-pituitary-adrenal (HPA)axis activity will be amplified during sex hormone suppression; altered HPA axis activity leading to cortisol excess causes abdominal fat accumulation. Finally, it is hypothesized that E2 add-back therapy will lessen these responses.

Participants will be randomized so that half of the women in each treatment arm will participate in an exercise training program, consisting of progressive resistance exercise to prevent the decline in fat-free mass (FFM) and the increase in fat mass that has been observed in young women in response to GnRH analog therapy.

Arms: arm 1: GnRH agonist + placebo arm 2: GnRH agonist + placebo + exercise arm 3: GnRH agonist + Estradiol arm 4: GnRH agonist + Estradiol + exercise
Interventions: intervention 1: leuprolide acetate intervention 2: Estradiol Transdermal intervention 3: progressive resistance exercise training
Intervention descriptions: intervention 1: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months intervention 2: 0.075 mg patch per day for 5 months intervention 3: 45 minute exercise sessions 4 times per week for 5 months

Protocol documents:
Clinical trial NCT00696072
Conditions: Metastatic Breast Cancer
Sponsor: Bristol-Myers Squibb
Start date: 2008-08-01; Completion date: 2014-06-01
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to find out what effect the combination of letrozole (brand name: Femara) and dasatinib (brand name: Sprycel) has on metastatic breast cancer compared to letrozole alone

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Dasatinib intervention 2: Letrozole
Intervention descriptions: intervention 1: Tablets, Oral, 100 mg once daily, up to 2 years intervention 2: Tablets, Oral, 2.5 mg, once daily, up to 2 years

Protocol documents:
Clinical trial NCT00721214
Conditions: Myelodysplastic Syndrome
Keywords: Myelodysplastic Syndrome 5-azacytidine allogeneic stem cell transplantation
Sponsor: Virginia Commonwealth University
Start date: 2008-07-01; Completion date: 2014-06-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to examine the feasibility and efficacy of using the demethylating agent 5-Azacytidine prior to allogeneic stem cell transplantation in patients with high risk myelodysplastic syndrome (MDS).

Detailed description:
The study drug, 5-azacytidine, is given daily intravenously for 7 days. After every 2 cycles study participants will have a bone marrow test to evaluate the effect of the 5-azacytidine on the Myelodysplastic Syndrome (MDS). Participants continue to get cycles of 5-Azacytidine until 2 bone marrow tests show the MDS has stopped responding to the treatment. At that time they will undergo a transplant if a donor is available.

Arms: arm 1: 5-azacytidine as pre-transplant cytoreduction prior to allogeneic stem cell transplantation for High Risk Myelodysplatic Syndromes.
Interventions: intervention 1: 5-azacytidine
Intervention descriptions: intervention 1: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days.

Protocol documents:
Clinical trial NCT00730483
Conditions: Gastrointestinal Carcinoid Tumor Islet Cell Tumor Metastatic Cancer
Keywords: liver metastases metastatic gastrointestinal carcinoid tumor regional gastrointestinal carcinoid tumor islet cell carcinoma gastrinoma insulinoma glucagonoma pancreatic polypeptide tumor somatostatinoma
Sponsor: Yale University
Start date: 2009-02-01; Completion date: 2014-06-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Infusing doxorubicin beads into the liver, and blocking blood flow to the tumor, may keep doxorubicin near the tumor and kill more tumor cells.

PURPOSE: This clinical trial is studying the side effects of doxorubicin beads and to see how well they work in treating patients with unresectable liver metastases from neuroendocrine tumors.

Detailed description:
OBJECTIVES:

Primary

* To gather preliminary data and determine the feasibility of a randomized study of patients with unresectable hepatic neuroendocrine metastases using PVA microporous hydrospheres/doxorubicin hydrochloride.

OUTLINE: A catheter is placed into the right or left hepatic artery. Patients with unifocal tumors will have the catheter or microcatheter placed more selectively into the 2nd or 3rd order branch off the right or left hepatic artery in closer proximity to the tumor. Polyvinyl alcohol (PVA) microporous hydrospheres/doxorubicin hydrochloride mixture is injected into the delivery area.

Patients with less than 75% necrosis at 1 month undergo a second (and possibly a third a month later) chemoembolization.

After completion of study therapy, patients are followed at 1 month, every 2 months for 1 year, and then every 3 months for 1 year.

Arms: arm 1: PVA microporous hydrospheres loaded with doxorubicin hydrochloride used for the treatment of unresectable liver metastases from neuroendocrine tumors.
Interventions: intervention 1: PVA microporous hydrospheres/doxorubicin hydrochloride
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00844519
Conditions: HIV Infection Cardiovascular Disease Inflammation HIV Infections
Keywords: Treatment Experienced CCR5 receptor maraviroc
Sponsor: University of California, San Francisco
Start date: 2010-01-01; Completion date: 2014-06-01
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the potentially beneficial aspects of CCR5 inhibition on inflammation and endothelial function as measured by brachial artery reactivity in antiretroviral treated HIV patients with an undetectable viral load.

Detailed description:

Arms: arm 1: For subjects assigned to the maraviroc group, subjects will receive maraviroc at 300mg by mouth twice daily for 24 weeks in addition to taking their current anti-HIV medication. For subjects on ritonavir, the dose of maraviroc will be 150mg by mouth twice daily. arm 2: None
Interventions: intervention 1: Maraviroc intervention 2: placebo
Intervention descriptions: intervention 1: For subjects assigned to the maraviroc group, they will receive maraviroc at 300mg by mouth twice daily for 24 weeks in addition to taking their current anti-HIV medications. For subjects on ritonavir, the dose will be reduced to 150mg by mouth twice daily for 24 weeks. intervention 2: For subjects assigned to the placebo group, they will receive a matching placebo pill 300mg to be taken by mouth twice daily for 24 weeks in addition to taking their current anti-HIV medications.

Protocol documents: