ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02157506
Conditions: Heart Failure Decompensated Heart Failure Acute Heart Failure
Keywords: Acute Heart failure Hemodynamics Pharmacokinetics Renal Function
Sponsor: Bristol-Myers Squibb
Start date: 2014-06-30; Completion date: 2015-07-31
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A randomized, double-blinded, placebo-controlled study of continuous 6-hour IV infusions of CXL-1427 in hospitalized patients with systolic heart failure.

Detailed description:
This is a dose finding, randomized, double-blinded, placebo-controlled study of continuous 6-hour IV infusions of CXL-1427 in hospitalized patients with systolic heart failure which will first evaluate up to four ascending dose levels of CXL-1427 in up to four cohorts of 8 patients each (the "Dose Escalation" cohorts). Subsequently, up to three of the initial dose levels of CXL-1427 may be assessed in the additional "Expansion" cohorts of up to approximately 16 patients to gain further confidence in the results at these dose levels. The CXL-1427 dose that will be evaluated in the first cohort will be 3µg/kg/min. The dose levels for the next three sequential Dose Escalation cohorts will be dependent on clinical safety and tolerability, as well as the results of the invasive hemodynamic measurements.

Arms: arm 1: The Starting dose of CXL-1427 in the dose escalation arms will be 3mcg/kg/min arm 2: The Second Dose level of CXL-1427 will be evaluated in the Dose Escalation Arm of the study as determined by the independent dose escalation committee arm 3: The Third Dose level of CXL-1427 will be evaluated in the Dose Escalation Arm of the study as determined by the independent dose escalation committee arm 4: The Third Dose level of CXL-1427 will be evaluated in the Dose Escalation Arm of the study as determined by the independent dose escalation committee arm 5: The forth level of CXL-1427 will be evaluated in the Dose Escalation Arm of the study as determined by the independent dose escalation committee arm 6: Up to 16 Patients will be enrolled across 1 or more of the previously evaluated Dose escalation Levels as determined by the independent dose escalation committee arm 7: Each Dose escalation Arm of the study will have a placebo group in a 2:1 ratio to active treatment for the first 3 patients enrolled and 4:1 to active treatment in the remaining 5 patients so that the overall randomization ratio in each Dose escalation arm will be 3:1 active to placebo. In the expansion Cohort of the study, the ratio of patients randomized to receive a 6-hour infusion of active CXL-1427 or placebo will be 3:1
Interventions: intervention 1: CXL-1427 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00751881
Conditions: Multiple Sclerosis
Keywords: relapsing multiple sclerosis
Sponsor: Sanofi
Start date: 2008-08-01; Completion date: 2015-08-01
Enrollment: 1169 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study was to assess the effect of two doses of teriflunomide, in comparison to placebo, on the frequency of multiple sclerosis (MS) relapses in participants with relapsing MS.

Key secondary objective was to assess the effect of the two doses of teriflunomide, in comparison to placebo, on disability progression.

Other secondary objectives were:

* To assess the effect of the two doses of teriflunomide in comparison to placebo on:

  * Fatigue;
  * Health-related quality of life, a measure of the impact of the participant's health on his or her overall well being.
* To evaluate the safety and tolerability of teriflunomide.

Detailed description:
The study consists of:

* A core treatment period: Teriflunomide 7 mg or Teriflunomide 14 mg or placebo was administered in double-blind fashion until a fixed common end date which was approximately 48 weeks after randomization of the last participant.
* An extension treatment period: the highest dose of teriflunomide was administered in open-label fashion to participants who successfully complete the core treatment period and wish to continue.

The overall treatment period was followed by a 4-week elimination follow-up period.

Arms: arm 1: Core treatment period: Teriflunomide 7 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily. arm 2: Core treatment period: Teriflunomide 14 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily. arm 3: Core treatment period: Placebo (for teriflunomide) once daily. Extension treatment period: Teriflunomide 14 mg once daily.
Interventions: intervention 1: Placebo intervention 2: Teriflunomide
Intervention descriptions: intervention 1: Film-coated tablet

Oral administration intervention 2: Film-coated tablet

Oral administration

Protocol documents:
Clinical trial NCT01167881
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2010-08-01; Completion date: 2015-08-01
Enrollment: 1549 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a pivotal phase III study, mandatory to seek approval by regulatory authorities for BI 10773 as an anti-diabetic agent compared to an active comparator in patients with type 2 diabetes mellitus and insufficient glycaemic control.

Detailed description:

Arms: arm 1: Patients receive one BI10773 tablet and one placebo Glimepiride capsule once daily arm 2: Patients receive one glimepiride capsule and one placebo tablet Bi 10773 once daily.
Interventions: intervention 1: BI 10773 intervention 2: Glimepiride intervention 3: Placebo intervention 4: Placebo
Intervention descriptions: intervention 1: Medium dose once daily intervention 2: 1-4 mg once daily intervention 3: Placebo matching BI 10773 intervention 4: Placebo matching Glimepiride

Protocol documents:
Clinical trial NCT01308580
Conditions: Prostate Cancer
Sponsor: Sanofi
Start date: 2011-04-01; Completion date: 2015-08-01
Enrollment: 1200 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Objective:

\- To demonstrate the non inferiority in term of overall survival (OS) of Cabazitaxel 20 mg/m² (Arm A) versus Cabazitaxel 25 mg/m² (Arm B) in combination with prednisone in participants with metastatic castration resistant prostate cancer (mCRPC) previously treated with a docetaxel-containing regimen.

Secondary Objectives:

* To evaluate safety in the 2 treatment arms and to assess if Cabazitaxel 20 mg/m² was better tolerated than Cabazitaxel 25 mg/m².
* To compare efficacy of Cabazitaxel at 20 mg/m² and 25 mg/m² for:

  * Progression Free Survival (PFS) defined as the first occurrence of any of the following events: tumor progression per Response Evaluation Criteria In Solid Tumors (RECIST), prostate-specific antigen (PSA) progression, pain progression or death due to any cause;
  * PSA Progression;
  * Pain progression;
  * Tumor response in participants with measurable disease (RECIST 1.1);
  * PSA response;
  * Pain response in participants with stable pain at baseline.
* To compare Health-related Quality of Life (HRQoL).
* To assess the pharmacokinetics and pharmacogenomics of Cabazitaxel.

Detailed description:
Participants were treated until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles. All participants were followed when on study treatment and after completion of study treatment during follow up period until death or the study cutoff date, whichever came first.

Arms: arm 1: Cabazitaxel 20 mg/m\^2 intravenous (IV) infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until disease progression (DP), unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles. arm 2: Cabazitaxel 25 mg/m\^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
Interventions: intervention 1: Cabazitaxel (XRP6258) intervention 2: Prednisone (or Prednisolone)
Intervention descriptions: intervention 1: Pharmaceutical form: Concentrate and solvent for solution for infusion

Route of administration: Intravenous intervention 2: Pharmaceutical form: Tablet

Route of administration: Oral

Protocol documents:
Clinical trial NCT01701362
Conditions: Neuropathic Pain
Keywords: post-traumatic peripheral neuropathic pain
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2012-10-01; Completion date: 2015-08-01
Enrollment: 542 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to investigate if pregabalin is effective in treating neuropathic (nerve) pain resulting from peripheral nerve trauma due to a traumatic or surgical event such as, for example, motor vehicle accident, fall, sports injury, knee or hip replacement, hernia repair, thoracotomy, mastectomy, focal/localized burns or crush injury.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: pregabalin intervention 2: placebo
Intervention descriptions: intervention 1: capsules, 150-600 mg/day administered in divided doses twice a day for 15 weeks after randomization intervention 2: capsules, placebo for pregabalin administered in divided doses twice a day for 15 weeks after randomization

Protocol documents:
Clinical trial NCT00176826
Conditions: Hemophagocytic Lymphohistiocytosis X-Linked Lymphoproliferative Disorders Chediak-Higashi Syndrome Griscelli Syndrome Immunologic Diseases Langerhans-Cell Histiocytosis Hematologic Diseases
Keywords: Stem Cell Transplant T-cell depletion immune deficiencies Busulfan pharmacokinetics Non-Malignant Hematological Disorders
Sponsor: Masonic Cancer Center, University of Minnesota
Start date: 2000-09-01; Completion date: 2015-08-01
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The hypothesis is to determine if a preparative regimen of busulfan, cyclophosphamide, and antithymocyte globulin (ATG) plus allogeneic stem cell transplantation will be effective in the treatment of immune deficiencies and histiocytic disorders.

Detailed description:
Subjects will begin chemotherapy as a preparative regimen, which is intended to completely eliminate their defective immune system and bone marrow. The preparative regimen consists of the chemotherapy drugs (busulfan, cyclophosphamide, and antithymocyte globulin (ATG)).

Transplantation: subjects will then have a source of blood stem cells (bone marrow) from their donor administered into their catheter. Medication will be given to help prevent Graft-Versus Host Disease (GVHD). The ATG will help to deplete the donor stem cells of the type of cells that can cause GVHD and will also help to promote engraftment of the new stem cells.

Recovery Phase: The second phase of treatment consists of a period after transplantation during which we wait for the return of bone marrow function. This usually takes two to four weeks. Subjects will be given a blood cell growth factor, G-CSF, to help speed recovery of the white blood cells and potentially decrease the risk of infection and decrease the time until the bone marrow recovers.

Arms: arm 1: Patients who were treated with chemotherapies (myeloablative conditioning regimen) and stem cell transplant. Busulfan intravenously for 4 days followed by cyclophosphamide intravenously for 4 days. Rabbit ATG is given intravenously for 4 doses pre-transplant.
Interventions: intervention 1: Stem Cell Transplant intervention 2: Myeloablative conditioning regimen
Intervention descriptions: intervention 1: Infusion of hematopoietic stem cells (bone marrow, cord blood, peripheral blood stem cells) following myeloablative conditioning regimen. intervention 2: Busulfan intravenously for 4 days followed by cyclophosphamide intravenously for 4 days. Rabbit ATG is given intravenously for 4 doses pre-transplant.

Protocol documents:
Clinical trial NCT00238238
Conditions: Lymphoma
Keywords: recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma
Sponsor: Alliance for Clinical Trials in Oncology
Start date: 2006-03-01; Completion date: 2015-08-01
Enrollment: 97 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Lenalidomide may also stop the growth of non-Hodgkin's lymphoma by blocking blood flow to the cancer. Giving rituximab together with lenalidomide may kill more cancer cells. This randomized phase II trial is studying how well rituximab and/or lenalidomide work in treating patients with follicular non-Hodgkin's lymphoma that is not refractory to rituximab.

Detailed description:
Outline:

This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms. Please see the "Arms" section for a description of each treatment arm. The primary and secondary objectives of the study are provided below.

Primary Objectives:

* To determine the response rate (overall and complete) after lenalidomide therapy and rituximab + lenalidomide in follicular NHL patients who have relapsed.
* To determine time to progression after lenalidomide therapy and rituximab and lenalidomide in follicular NHL patients who have relapsed.

Secondary Objectives:

* To compare the time to progression of the previous rituximab regimen to that obtained subsequently to lenalidomide therapy and rituximab + lenalidomide.
* To determine the toxicity profile of lenalidomide therapy and of rituximab and lenalidomide in follicular NHL patients who have received a previous rituximab regimen.
* To correlate Fc receptor polymorphism profiling with response to lenalidomide or rituximab + lenalidomide in previously treated patients with follicular NHL who have relapsed.
* To evaluate changes in Natural Killer (NK) cells, activated NK cells, activated T-cells and several plasma cytokines followed by rituximab therapy and correlation of observed changes to objective response rates.

After completion of study treatment, patients are followed for up to 10 years from study entry.

Arms: arm 1: Patients receive rituximab IV on days 1, 8, 15, and 22. arm 2: Patients receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. arm 3: Patients receive lenalidomide as in arm II. Patients also receive rituximab IV on days 8, 15, 22 and 29.
Interventions: intervention 1: rituximab intervention 2: lenalidomide
Intervention descriptions: intervention 1: Given IV intervention 2: Given orally

Protocol documents:
Clinical trial NCT00427999
Conditions: Prostate Cancer
Keywords: Hormone-refractory prostate cancer multitargeted tyrosinkinase
Sponsor: Novartis Pharmaceuticals
Start date: 2007-02-01; Completion date: 2015-08-01
Enrollment: 67 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the efficacy, tolerability and safety of a multi-targeted therapy in patients with hormone-refractory prostate cancer.

Detailed description:

Arms: arm 1: STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks
Interventions: intervention 1: imatinib mesylate intervention 2: Treosulfane intervention 3: etoricoxib intervention 4: pioglitazone intervention 5: dexamethasone
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None

Protocol documents:
Clinical trial NCT00510744
Conditions: Obesity
Keywords: obesity, bariatric surgery, pancreatic secretion
Sponsor: University of Pittsburgh
Start date: 2007-08-01; Completion date: 2015-08-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Hypothesis: Bypass of the upper GI tract with bariatric surgery results in suppression of pancreatic function resulting in maldigestion and further malabsorption. In this study we will measure pancreatic secretion in previously obese gastric bypass patients with excessive weight loss. If malabsorption is associated with diminished pancreatic secretion, we will test over a 3 month period whether supplementation with enzyme supplements prevent further weight loss.

Detailed description:
Obesity has reached epidemic proportions in the USA and Europe, and is increasing world-wide. Morbid obesity (BMI\>40kg/m2) is usually resistant to medical and dietary therapy while surgical treatment results in a permanent loss of most of the excess weight. The most popular technique today is the Roux-en-Y gastric bypass procedure which results in a weight loss of approximately 95 lbs per year or a 2/3 loss of the excess weight in 2 years (7-9). Weight loss occurs for 2 reasons: first the volume of the stomach is reduced, and second, the duodenum and first part of the jejunum is bypassed resulting in malabsorption. Although most patients tolerate the procedure well with a leveling off of weight loss close to the ideal body weight, a subpopulation of patients continue to lose weight, becoming progressively more malnourished, necessitating reversal of the surgery. To date, no studies have investigated what happens to pancreatic function in obese patients following bypass surgery, but from an understanding of the physiology of pancreatic stimulation, it is likely that the pancreas atrophies because the intestinal phase of pancreatic stimulation is bypassed and the inhibitory ileal brake is perpetually stimulated. In the following study we plan to investigate whether patients with excessive weight loss after bypass surgery develop malabsorption not only due to bypass of the upper GI tract but also because of impaired pancreatic enzyme secretion resulting from chronic activation of the ileal brake mechanism. Up to 20 post-bariatric surgery (Roux-en-Y) patients with excessive and continued weight loss will be screened for fat absorption and loss of pancreatic secretion. Those with loss of \>20% fat absorption will then be treated at home with pancreatic enzyme supplements for a 3 month period to assess weight stabilization or gain. After 3 months, fat absorption and the pancreatic stimulation test will be repeated while patients are on enzyme supplementation to determine whether fat digestion and absorption has improved from baseline.

Arms: arm 1: 3 month supplementation in those gastric bypass patients shown to have a fat absorption less than 80%
Interventions: intervention 1: pancreatic enzyme supplement
Intervention descriptions: intervention 1: 4 caps with meals, 2 with snacks

Protocol documents:
Clinical trial NCT00524303
Conditions: Neoplasms, Breast
Keywords: ErbB2 Overexpressing ErbB2 Positive Lapatinib Invasive Breast Cancer
Sponsor: GlaxoSmithKline
Start date: 2007-08-01; Completion date: 2015-08-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will examine safety and efficacy of Lapatinib in combination with a standard neoadjuvant chemotherapy including 5FU, Epirubicin, Cyclophosphamide and Paclitaxel. Tumor tissue will be obtained at 3 timepoints (optional 4th) to evaluate tumor response to treatment.

Detailed description:

Arms: arm 1: Trastuzumab alone for 2 weeks then in combination with FEC75 for 4 (21 Day) cycles and Paclitaxel for 4 (21 day) cycles then continued trastuzumab until time of definitive surgery arm 2: Lapatinib alone for 2 weeks then in combination with FEC75 for 4 (21 Day) cycles followed by Paclitaxel for 4 (21 day) cycles then continued lapatinib until time of definitive surgery arm 3: Trastuzumab + Lapatinib for 2 weeks then added FEC75 for 4 (21 Day) cycles followed by Paclitaxel for 4 (21 day) cycles then continued trastuzumab + lapatinib until time of definitive surgery
Interventions: intervention 1: Trastuzumab intervention 2: Paclitaxel intervention 3: FEC75 intervention 4: Lapatinib
Intervention descriptions: intervention 1: 4mg/kg IV loading dose followed by 2mg/kg IV weekly intervention 2: 80mg/m2 IV weekly for 4 (21 day) cycles intervention 3: 5FU 500mg/m2 + Epirubicin 75 mg/m2 + cyclophosphamide 500 mg/m2 IV on day 1 of 4 (21 day) cycles intervention 4: 1250 mg oral daily dose in arm 2, 750 mg oral daily dose for FEC cycles and then 1000 mg oral daily dose during the Paclitaxel cycles in arm 3

Protocol documents:
Clinical trial NCT00525148
Conditions: Carcinoma, Non-Small-Cell Lung
Sponsor: Boehringer Ingelheim
Start date: 2007-08-01; Completion date: 2015-08-01
Enrollment: 129 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this open-label, single arm Phase II trial is to explore the efficacy of BIBW 2992 defined by the objective response rate (CR, PR) as determined by RECIST criteria in patients with advanced NSCLC Stage IIIB or IV whose tumors harbor activating mutations within exon 18 to exon 21 of the EGFR receptor. Patients progressing or relapsing after one prior cytotoxic chemotherapy regimen as well as chemotherapy naïve patients (only in stage 2) will be allowed to enter into the trial.

Detailed description:

Arms: arm 1: Patients start continuous once daily oral treatment of BIBW 2992 at high dose, until progression or undue Adverse Events (AEs) develop. Patients can be dose-reduced up to two times if needed after temporary discontinuation of treatment due to drug-related AEs. After protocol amendment 2 (17 Dec 2008), the starting dose of BIBW 2992 was reduced to a medium dose, with 2 possible dose reductions if needed after discontinuation due to drug-related AEs.
Interventions: intervention 1: BIBW 2992
Intervention descriptions: intervention 1: This is an open label study. Patients are treated with BIBW 2992 until disease progression or undue AEs

Protocol documents: