ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00842348
Conditions: Non Functioning Entero-pancreatic Endocrine Tumour
Keywords: Lanreotide Somatuline Neuroendocrine tumour NET
Sponsor: Ipsen
Start date: 2009-02-01; Completion date: 2015-12-01
Enrollment: 89 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary purpose of this extension study was to assess the long term safety of patients with nonfunctioning enteropancreatic neuroendocrine tumour (NET), who were treated with open label lanreotide Autogel (120 mg every 28 days) and who participated in a previous study, 2-55-52030-726 (NCT00353496).

Detailed description:
While somatostatin analogue treatment is the primary medical therapy for patients with hormone related symptoms and is indicated for the treatment of hormone related symptoms in many international countries, there is no reference standard medical therapy for asymptomatic patients. A 96-week study (Study 2-55-52030-726 (726), NCT00353496) was conducted to investigate the effect of lanreotide Autogel on progression free survival (PFS) in patients with well or moderately differentiated nonfunctioning enteropancreatic NET. While Study 726 was ongoing, the sponsor considered that therapy with lanreotide Autogel should continue to be an option to patients with stable disease at the end of the 96-week treatment period. This extension study was therefore initiated (Study 2-55-52030-729 (729)) which investigated the long term safety of treatment with lanreotide Autogel and enabled investigators to continue to treat their patients who had stable disease, as well as to treat placebo patients who experienced disease progression during the initial 96-week study (Study 726).

Arms: arm 1: Patients from the preceding DB study (Study 726) were treated with open label lanreotide Autogel 120 mg by deep subcutaneous injections every 28 days. Patients were included if they had been treated with lanreotide (Autogel formulation) or placebo in DB Study 726 and had stable disease at the end of the 96-week treatment period, or if they had received placebo and had disease progression at any time during Study 726. Safety data were based on the safety population patients who received lanreotide in Study 729). The main efficacy analysis was based on the ITT population (patients randomised in Study 726 regardless of whether they continued into Study 729).
Interventions: intervention 1: lanreotide (Autogel formulation)
Intervention descriptions: intervention 1: Autogel 120 mg

Protocol documents:
Clinical trial NCT00886743
Conditions: Severe Thrombocytopenia
Sponsor: Pfizer
Start date: 2009-09-01; Completion date: 2015-12-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label study in which oprelvekin will be administered for the prevention of severe low blood platelet cell counts (cells in your blood that keep bleeding and clotting stable) in adults with cancer who are taking chemotherapy (anti-cancer drug) that has a side effect of blocking your bone marrow from making platelet cells. The purpose of this study is to learn more about the effects of the recommended dose of oprelvekin on the heart's electrical cycle.

Detailed description:

Arms: arm 1: Open label treatment with oprelvekin
Interventions: intervention 1: oprelvekin
Intervention descriptions: intervention 1: injection, 50 mg/kg, once daily

Protocol documents:
Clinical trial NCT00903929
Conditions: Thrombocytopenia Acute Radiation Syndrome
Sponsor: Jane Liesveld
Start date: 2009-12-01; Completion date: 2015-12-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Patients who undergo total body irradiation (TBI) for stem cell transplantation have prolonged periods of low counts of specific blood cells called platelets. These low platelets counts can cause bleeding and infection. Thus far, no drug is available for use to speed the recovery of platelets, and therefore transfusions are often necessary.

The purpose of this study is to test the safety of a drug called eltrombopag in patients who have received TBI. The investigators want to find out what effects, good or bad, it has on people with low platelet counts due to treatment with TBI. The investigators will also be testing how well eltrombopag may work at different doses and determine if this drug speeds up the recovery of the platelets.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Eltrombopag
Intervention descriptions: intervention 1: dose escalation

Protocol documents:
Clinical trial NCT00920829
Conditions: Alcohol Dependence
Keywords: Alcohol Dependence Alcoholism Naltrexone Substance Abuse Genetics
Sponsor: Medical University of South Carolina
Start date: 2009-06-01; Completion date: 2015-12-01
Enrollment: 358 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The overarching aim of this trial is to evaluate naltrexone's efficacy in light of genetic variation and brain response to alcohol cues utilizing a neuroimaging paradigm. This trial has four specific aims. First, this trial will evaluate whether the presence of the OPRM1 Asp40 allele substitution is associated with improved treatment response to naltrexone in treatment-seeking alcoholics. Second, it will evaluate whether there is a difference in the naltrexone dampening of the alcohol cue-induced brain activation dependent on OPRM1 genotype. Third, it will explore whether alcohol cue-induced brain activation dampening by naltrexone might be a mediating factor in the treatment effects of naltrexone, the OPRM1 gene, or their interaction that might be observed in the first aim. Finally, this trial will evaluate the effect of medication compliance, or adverse effects, on the observed medication by genotype treatment response. A secondary aim will measure medication compliance and side effects based on OPRM1 genotype.

Detailed description:

Arms: arm 1: Individuals with the OPRM1 genotype Asn40 are given naltrexone 50 mg after 2 days at 25 mg for 16 weeks with Medication Management 9 visits in 16 weeks arm 2: Individuals with the OPRM1 genotype Asn40 are given Placebo for 16 weeks with Medication Management in 16 weeks arm 3: Individuals with the OPRM1 genotype Any G (Asp) are given naltrexone 50 mg after 2 days of naltrexone 25 mg for 16 weeks with Medication Management 9 visits in 16 weeks arm 4: Individuals with the OPRM1 genotype Any G (Asp) are given 50 mg naltrexone after 2 days at 25 mg for 16 weeks with Medication Management 9 visits in 16 weeks
Interventions: intervention 1: Naltrexone 50 Mg intervention 2: Placebo
Intervention descriptions: intervention 1: Naltrexone 25 or 50 mg per titration schedule intervention 2: placebo

Protocol documents:
Clinical trial NCT00928187
Conditions: HIV HIV Infections
Keywords: HIV Second line treatment WHO recommendations Africa Treatment strategies treatment experienced
Sponsor: ANRS, Emerging Infectious Diseases
Start date: 2009-11-01; Completion date: 2015-12-01
Enrollment: 454 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Since the first line antiretroviral (ARV) treatment is now largely accessible in the Sub-Saharian Africa countries, documentation of virological failure, drug resistance patterns and second line treatment evaluation are still to be consolidated in settings where viral load monitoring is not available and non-B HIV subtype is predominant.

This trial aims at evaluating the efficacy and tolerance of 3 different second line treatment strategies: two recommended by WHO combine two non-nucleoside reverse transcriptase inhibitor associated with a ritonavir boosted protease inhibitor (emtricitabine-tenofovir-lopinavir/ritonavir and abacavir-didanosine-lopinavir/ritonavir); the third strategy combines emtricitabine-tenofovir-darunavir/ritonavir and is not yet evaluated in Sub-Saharian Africa. Darunavir has a potentially superior antiviral efficacy, a better tolerance and its single daily administration may facilitate treatment adherence.

Detailed description:

Arms: arm 1: emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line) arm 2: abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line) arm 3: emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)
Interventions: intervention 1: emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line) intervention 2: abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line) intervention 3: emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)
Intervention descriptions: intervention 1: Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening intervention 2: Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight \< 60 kg, 400 mg if weight \> 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening intervention 3: Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food

Protocol documents:
Clinical trial NCT00935792
Conditions: Lymphocytic Leukemia
Keywords: hematopoietic cancer lymphoid cancer
Sponsor: Mayo Clinic
Start date: 2009-07-01; Completion date: 2015-12-01
Enrollment: 28 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the signaling molecules needed for cell growth. Monoclonal antibodies, such as alemtuzumab, can bind to and kill malignant lymphocytes.

PURPOSE: This phase I/II trial is studying the side effects and best dose of everolimus when given together with alemtuzumab and will see how well they work in treating patients with recurrent chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL).

Detailed description:
PRIMARY OBJECTIVES: I. Test the safety and tolerability of the combination of everolimus and alemtuzumab. (Phase I) II. Determine the maximum tolerated dose of everolimus in this combination. (Phase I) III. Assess the rate of overall responses in patients with relapsed/refractory CLL to treatment with the maximum tolerated dose of everolimus together with a standard dose of alemtuzumab using conventional NCI-WG 1996 response criteria. (Phase II) IV. To assess the complete responses to this combination regimen using conventional NCI-WG 1996 criteria and an expanded definition of response, including CT scans of chest-abdomen-pelvis, immunohistochemical analysis for residual disease in the bone marrow, and sensitive flow cytometry for minimal residual disease in patients in complete clinical remission. V. To monitor and assess toxicity of this regimen. SECONDARY OBJECTIVES: I. To determine the overall and progression-free survival, duration of response, and time to next treatment. II. To assess the correlation between the individual prognostic markers (17p-, p53 gene mutations, 11q-, unmutated VH gene, use of VH3-21, ZAP70+, CD38+, CD49d, B2 microglobulin) and clinical outcome. III. Serial measurement of clinical status and lymphocyte counts to test the rate of reduction in CLL tumor burden. TERTIARY OBJECTIVES: I. Determine the effect of everolimus on the sensitivity of CLL cells to alemtuzumab CDC and ADCC. II. Determine the effect of everolimus on the CLL cell-stroma interaction. III. Detail the in vivo effect of the everolimus-alemtuzumab regimen on critical aspects of the immune system in CLL. OUTLINE: This is a phase I, dose escalation study of everolimus followed by a phase II study. Patients receive oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 7 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for up to 5 years. PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.

Arms: arm 1: Patients receive oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
Interventions: intervention 1: alemtuzumab intervention 2: everolimus
Intervention descriptions: intervention 1: Given subcutaneously intervention 2: Given orally

Protocol documents:
Clinical trial NCT00937235
Conditions: Cigarette Smoking Nicotine Dependence Post-traumatic Stress Disorder Tobacco Use Disorder
Keywords: Smoking Cessation Anxiety Behavior Therapy Varenicline
Sponsor: University of Pennsylvania
Start date: 2009-01-01; Completion date: 2015-12-01
Enrollment: 142 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will examine the effect of combining prolonged exposure, a cognitive-behavioral treatment program for post-traumatic stress disorder (PTSD) with medication (varenicline) and counseling treatments for smoking cessation. Subjects will be randomly assigned to a 3-month treatment of either: 1) varenicline and smoking cessation counseling alone, or 2) prolonged exposure, varenicline, and smoking cessation counseling. Assessments will be completed at the end of treatment and 6-month follow-up.

We hypothesize that, at the end of treatment and at follow-up, abstinence rates and decrease in cigarettes smoked will be greater among participants who receive the combined treatment for both PTSD and smoking.

Detailed description:

Arms: arm 1: Prolonged Exposure + Varenicline + Medication Management Counseling arm 2: Varenicline + Medication Management Counseling
Interventions: intervention 1: Varenicline intervention 2: Medication Management Counseling intervention 3: Prolonged Exposure
Intervention descriptions: intervention 1: 1 mg tablets, orally, twice daily x 12 weeks intervention 2: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation intervention 3: 75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders

Protocol documents:
Clinical trial NCT00948194
Conditions: Liver Transplantation Ischemia/Reperfusion Injury Oxidative Injury
Keywords: Extended Donor Criteria
Sponsor: University of Colorado, Denver
Start date: 2009-10-01; Completion date: 2015-12-01
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In this study, the researchers propose to investigate the efficacy of inhaled nitric oxide to prevent ischemia-reperfusion (I/R) hepatocyte injury in patients who receive extended donor criteria(EDC)liver grafts based on changes in proteomic and metabolomic markers following revascularization of the donor graft.

In reviewing the literature, no uniform extended criteria donor classification exists. The characteristics most associated with liver graft failure appear to be cold ischemia time greater than 10 hours, warm ischemia time greater than 40 minutes, donor age \> 55 years of age, donor hospitalization \> 5 days, a donation after cardiac death (DCD) graft, and a split graft. The researchers will exclude warm ischemia time as this is impossible to predict prior to the transplantation. Any donor meeting at least one of the other criteria will be classified as an EDC donor.

Hypothesis 1: Inhaled nitric oxide will improve overall outcome of liver recipients after EDC liver transplantation

* Suppression of oxidative injury will improve graft function postoperatively as measured by International Normalized Ratio (INR) bilirubin, transaminases, and duration of hospital stay.

Hypothesis 2: The mechanisms of therapeutic efficacy of inhaled nitric oxide is based on reduction in post-reperfusion oxidative injury as readily measured by the detectable changes in the protein and metabolic profiles in plasma of patients treated with inhaled-NO

* Nuclear Magnetic Resonance (NMR)-based metabolic markers (xanthine end-products, lactate, and hepatic osmolytes) that are consistent with acute liver injury will be decreased in NO-treated recipients.
* Protein markers of reperfusion injury (argininosuccinate synthase (ASS) and estrogen sulfotransferase (EST-1) will be greater in the plasma of patients who are not treated with inhaled-NO
* Reduced oxidative injury will be reflected by a decrease in the number of mitochondrial peroxiredoxins isoforms and the number that are oxidized in NO-treated liver recipients.

Detailed description:

Arms: arm 1: This arm will not receive nitric oxide, but will receive other standard inhaled anesthetics arm 2: Will receive Nitric oxide and other standard inhaled anesthetics
Interventions: intervention 1: Nitric Oxide
Intervention descriptions: intervention 1: Inhalation - 40 ppm, at the initiation of anesthesia to the end of surgery

Protocol documents:
Clinical trial NCT00953849
Conditions: Mouth Neoplasms
Keywords: Calcitriol Celecoxib Immunotherapy
Sponsor: VA Office of Research and Development
Start date: 2009-11-01; Completion date: 2015-12-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The poor survival of Veterans with oral cancer underscores the significance of identifying new treatment approaches. The proposed studies will test a new 2 pronged immunotherapeutic approach for oral cancer patients which lessen the immune inhibitory environment while maturing cells that can stimulate T cell reactivity against oral cancer cells.

Detailed description:
The hypothesis of this study is beneficial T cell reactivity in oral squamous cell carcinoma (OSCC) tumors can be synergistically stimulated by blocking suppressor endothelial cells and their induction of other inhibitory cell populations while also maturing immune inhibitory CD34+ cells into antigen-presenting dendritic cells.

To test this hypothesis, newly diagnosed OSCC patients will be administered the cyclooxigenase 2 inhibitor celecoxib and/or Calcitriol for the 3 week duration between cancer diagnosis and surgical treatment. The following aims will test the immunological and clinical effectiveness of the combination treatment:

* 1\. To block the suppressive activity of endothelial cells and increase the levels of dendritic that are stimulatory to T cell reactivity, thereby synergistically increasing intratumoral T cell reactivity. These functional immune analyses will use OSCC tissues removed from untreated patients or patients treated with celecoxib and/or Calcitriol.
* 2\. To reduce development of OSCC recurrences by synergistically stimulating intratumoral T cell reactivity with celecoxib to block suppressor endothelial cell activity and Calcitriol to mature CD34+ suppressor cells into T cell stimulatory dendritic cells.

Arms: arm 1: Celecoxib treatment prior to surgery arm 2: Treatment with Calcitriol prior to surgery arm 3: Treatment with Celecoxib plus Calcitriol prior to surgery. arm 4: no treatment prior to surgery
Interventions: intervention 1: Celecoxib intervention 2: Calcitriol intervention 3: Celecoxib plus Calcitriol
Intervention descriptions: intervention 1: Celecoxib (400 mg twice daily) intervention 2: 3 week pre-surgical enteral treatment of Calcitriol (1,25-dihydroxyvitamin D3) (3 cycles of 4 microg Calcitriol 3 for each of 3 sequential days followed by 4 days of no treatment) intervention 3: 3 week pre-surgical enteral treatment of Calcitriol (1,25-dihydroxyvitamin D3) (3 cycles of 4 microg Calcitriol for each of 3 sequential days followed by 4 days of no treatment) plus Celecoxib (400 mg twice daily)

Protocol documents:
Clinical trial NCT00956085
Conditions: Obsessive-Compulsive Disorder
Keywords: OCD
Sponsor: New York State Psychiatric Institute
Start date: 2009-08-01; Completion date: 2015-12-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Obsessive-compulsive disorder (OCD) is a common psychiatric illness that affects up to 2-3% of the population. People with OCD experience anxiety-provoking, intrusive thoughts, known as obsessions, and feel compelled to perform repetitive behaviors, or compulsions. The only medications proven effective for OCD are serotonin reuptake inhibitors (SRIs), but even with SRI treatment, most patients continue to experience significant OCD symptoms, impaired functioning, and diminished quality of life. Recent evidence suggest that a different neurotransmitter, glutamate, may contribute to the symptoms in OCD. Medications that target glutamate hold promise for ameliorating symptoms for those patients continuing to suffer from OCD. In this study the investigators are recruiting patients to receive the drug memantine, which is thought to modulate the neurotransmitter glutamate, added to whatever other OCD medications they are taking.

Open label memantine will be titrated in 5mg increments weekly to target dose of 10mg po bid for up to 6 weeks. Memantine will be continued to 12 weeks in those with treatment response,13 either previous response to ketamine (≥ 35% Y-BOCS reduction 1 week after IV ketamine) or current response to memantine (≥ 35% Y-BOCS reduction from pre- to post-6 weeks of memantine).

Detailed description:
see above

Arms: arm 1: Open label memantine titrated in 5mg increments weekly to target dose of 10mg po bid for up to 6 weeks. Memantine was continued to 12 weeks in those with treatment response,13 either previous response to ketamine (≥ 35% Y-BOCS reduction 1 week after IV ketamine) or current response to memantine (≥ 35% Y-BOCS reduction from pre- to post-6 weeks of memantine).
Interventions: intervention 1: Memantine
Intervention descriptions: intervention 1: Open label memantine titrated in 5mg increments weekly to target dose of 10mg po bid for up to 6 weeks. Memantine was continued to 12 weeks in those with treatment response,13 either previous response to ketamine (≥ 35% Y-BOCS reduction 1 week after IV ketamine) or current response to memantine (≥ 35% Y-BOCS reduction from pre- to post-6 weeks of memantine).

Protocol documents: