ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01696084
Conditions: High Risk Acute Myeloid Leukemia
Keywords: AML Acute Myeloid Leukemia high risk AML secondary AML AML in elderly
Sponsor: Jazz Pharmaceuticals
Start date: 2012-12-13; Completion date: 2015-12-31
Enrollment: 309 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To confirm the efficacy of CPX-351 compared to 7+3 as first line therapy in elderly patients (60-75 yrs) with high risk (secondary) Acute Myeloid Leukemia. The primary efficacy endpoint will be overall survival.

Detailed description:

Arms: arm 1: Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response. arm 2: Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.
Interventions: intervention 1: CPX-351 intervention 2: 7+3 (cytarabine and daunorubicin)
Intervention descriptions: intervention 1: First induction: 100 units/m2 by 90-minute IV infusion on Days 1, 3, 5. Second induction: 100 units/m2 by 90-minute IV infusion on Days 1 and 3. Consolidation therapy: 65 units/m2 by 90-minute IV infusion on Days 1 and 3. intervention 2: First induction: 7+3 was administered as: cytarabine at a dose of 100 mg/m2/day on Days 1 through 7 by continuous infusion, and daunorubicin at a dose of 60 mg/m2/day on Days 1, 2, and 3.

Second induction: 5+2 was administered as: cytarabine at a dose of 100 mg/m2/day on Days 1 through 5 by continuous infusion and daunorubicin at a dose of 60 mg/m2/day on Days 1 and 2.

Consolidation therapy: 5+2 was administered as: cytarabine at a dose of 100 mg/m2/day on Days 1 through 5 by continuous infusion, and daunorubicin at a dose of 60 mg/m2/day on Days 1 and 2.

Protocol documents:
Clinical trial NCT02410343
Conditions: Growth Hormone Deficiency
Keywords: long acting growth hormone
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2015-04-30; Completion date: 2015-12-31
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to determine the efficacy of 6 months of treatment with TV-1106 compared with placebo on body fat composition.

Detailed description:

Arms: arm 1: Placebo was injected subcutaneously once weekly on the same day and time for 24 weeks. To maintain the blind, placebo could be titrated by an unblinded central reader on weeks 4, 8, 12 and 16 to match the effect of dose titration. arm 2: TV-1106 was injected subcutaneously once weekly on the same day and time for 24 weeks. A common starting dose was 5.0 mg. Doses could be titrated by an unblinded central reader on weeks 4, 8, 12 and 16 until the participant's insulin-like growth factor 1 (IGF-1) standard deviation score (SDS) was within the range of -0.5 to +1.5.
Interventions: intervention 1: TV-1106 intervention 2: Placebo
Intervention descriptions: intervention 1: A starting dose of 5.0 mg was expected to be appropriate for most patients because the daily recommended starting dose of recombinant human growth hormone (rhGH) treatments (e.g. somatropin) is 0.2 mg/day, and the conversion factor was 28. Dosage could be titrated by an unblinded central reader on weeks 4, 8, 12 and 16 until the participant's insulin-like growth factor 1 (IGF-1) standard deviation score (SDS) was within the range of -0.5 to +1.5. intervention 2: Placebo treatment was administered in a blinded fashion and titrated on weeks 4, 8, 12 and 16 to mimic the active treatment.

Protocol documents:
Clinical trial NCT03101150
Conditions: Vitamin D Deficiency Pre-Eclampsia
Keywords: Maternal vitamin D Deficiency Insufficiency Pregnancy Pre-eclampsia IUGR
Sponsor: King Fahad Medical City
Start date: 2012-10-01; Completion date: 2015-12-31
Enrollment: 179 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Vitamin D deficient pregnant ladies were selected and randomized into 2 groups for routine daily dose of multivitamin (400IU vitamin D3) versus maximum safest treatment daily dose (4000IU vitamin D3). Participants were assessed and compared for number of pre-eclampsia cases.

Detailed description:
Vitamin D3 has key role in decidualization and implantation of placenta.Vitamin D deficiency is thought to have positive association with pre-eclampsia.Vitamin D deficiency is highly prevalent in some parts of the world and it is not universally screened antenatally. Pre-eclampsia is a known multifactorial pregnancy disorder with significant maternal and perinatal morbidity and mortality. Vitamin D3 has a down-regulating effect on inflammatory pathways and reducing endothelial cell damage.

Investigators want to assess in vitamin D deficient group whether treatment reduces the risk of pre-eclampsia.

Arms: arm 1: 400IU vitamin D3 contained in antenatal multivitamin once daily by mouth starting from 14 weeks of pregnancy till delivery. arm 2: 4000 IU Vitamin D3 drops once daily by mouth starting from 14 weeks of pregnancy till delivery.
Interventions: intervention 1: 400 IU Vitamin D3 intervention 2: 4000 IU Vitamin D3
Intervention descriptions: intervention 1: Antenatal multivitamin intervention 2: 4000 IU Vitamin D3 (cholecalciferol) daily = 40 drops daily

Protocol documents:
Clinical trial NCT00117676
Conditions: Chronic Hepatitis B
Keywords: tenofovir adefovir hepatitis B virus HBeAg Negative
Sponsor: Gilead Sciences
Start date: 2005-02-01; Completion date: 2016-01-01
Enrollment: 382 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This primary objectives of this study are to compare the efficacy, safety, and tolerability of tenofovir disoproxil fumarate (TDF) versus adefovir dipivoxil (ADV) for the treatment of pre-core mutant chronic hepatitis B. Participants will receive TDF or ADV for 48 weeks (double-blind). After 48 weeks, eligible participants switched to open-label TDF for up to 480 weeks.

Detailed description:

Arms: arm 1: TDF plus ADV placebo (double-blind period), followed by TDF (open-label period). Participants may add FTC (as part of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) FDC tablet) to their treatment regimen in the open-label period. arm 2: ADV plus TDF placebo (double-blind period), followed by TDF (open-label period). Participants may add FTC (as part of FTC/TDF FDC tablet) to their treatment regimen in the open-label period.
Interventions: intervention 1: TDF intervention 2: ADV intervention 3: TDF placebo intervention 4: ADV placebo intervention 5: FTC/TDF
Intervention descriptions: intervention 1: 300 mg tablet administered orally once daily intervention 2: 10 mg tablet administered orally once daily intervention 3: Tablet administered orally once daily intervention 4: Tablet administered orally once daily intervention 5: 200/300 mg fixed-dose combination (FDC) tablet administered orally once daily

Protocol documents:
Clinical trial NCT01085136
Conditions: Carcinoma, Non-Small-Cell Lung
Sponsor: Boehringer Ingelheim
Start date: 2010-02-01; Completion date: 2016-01-01
Enrollment: 1154 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this randomized, open-label, active-controlled, multi-center trial is to determine the efficacy of BIBW 2992 given as an add-on to chemotherapy in patients with NSCLC Stage IIIb or IV progressing after BIBW 2992 monotherapy compared to chemotherapy alone in this patient population. Patients on both treatment arms will receive best supportive care in addition to study treatment. Patients enrolled into the trial will be treated and followed until death or lost to follow-up. Additional information on the health-related quality of life (HRQOL) will be collected.

Detailed description:

Arms: arm 1: Patients will be treated with investigator's choice of chemotherapy arm 2: Patients will be treated with BIBW 2992daily with a medium dose and weekly administration of Paclitaxel at a dose of 80 mg/m2
Interventions: intervention 1: Investigator´s choice of chemotherapy intervention 2: BIBW 2992
Intervention descriptions: intervention 1: BIBW 2992 in a medium dose in combination with Paclitaxel to explore safety and efficacy versus investigator´s choice of chemotherapy intervention 2: BIBW 2992 will be given in a medium dose in combination with Paclitaxel to explore safety and efficacy versus investigator´s choice of chemotherapy

Protocol documents:
Clinical trial NCT01583218
Conditions: Venous Thromboembolism (VTE)
Keywords: Phase III
Sponsor: Portola Pharmaceuticals
Start date: 2012-03-01; Completion date: 2016-01-01
Enrollment: 7513 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate whether extended prophylaxis with oral betrixaban can prevent blood clots in the leg and lung that sometime occur in patients hospitalized for an acute medical illness and to compare these results with standard of care enoxaparin. The safety of betrixaban will also be studied.

Detailed description:

Arms: arm 1: Daily oral (PO) betrixaban capsules for 35 to 42 days and subcutaneous (SQ) injections of enoxaparin placebo for 10 ± 4 days arm 2: Daily subcutaneous (SQ) injections of enoxaparin for 10 ± 4 days and oral (PO) betrixaban placebo capsules for 35 to 42 days
Interventions: intervention 1: Betrixaban intervention 2: Enoxaparin
Intervention descriptions: intervention 1: Betrixaban 80 mg PO once daily (QD) for 35 day + 7 days.

Enoxaparin Placebo: Once daily, 6-14 days intervention 2: Enoxaparin 40 mg subcutaneous (SC) QD for 10 ± 4 days.

Betrixaban Placebo: once daily, 35 days

Protocol documents:
Clinical trial NCT01808092
Conditions: Nosocomial Pneumonia (NP) Ventilator-associated Pneumonia (VAP)
Keywords: Ceftazidime, Meropenem, Anti-Bacterial Agents, Anti-Infective Agents, Therapeutic Uses, Pharmacologic Actions, Physiological Effects of Drugs
Sponsor: Pfizer
Start date: 2013-04-01; Completion date: 2016-01-01
Enrollment: 969 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the effects of Ceftazidime-Avibactam compared to Meropenem for treating hospitalized adults with nosocomial pneumonia including ventilator-associated pneumonia

Detailed description:
A Phase III, Randomized, Multicentre, Double-blind, Double-dummy, Parallel-group Comparative Study to Determine the Efficacy, Safety And Tolerability of Ceftazidime-Avibactam Versus Meropenem in the Treatment of Nosocomial Pneumonia Including Ventilator-Associated Pneumonia in Hospitalized Adults

Arms: arm 1: Intra-Venous treatment arm 2: Intra-Venous treatment
Interventions: intervention 1: ceftazidim-avibactam (CAZ-AVI, experimental product) intervention 2: meropenem (active comparator)
Intervention descriptions: intervention 1: 2000mg ceftazidime plus 500mg avibactam intervention 2: 1000mg of Meropenem

Protocol documents:
Clinical trial NCT02230670
Conditions: Liver Cirrhosis Hepatic Cirrhosis
Keywords: Liver Cirrhosis Hepatic Cirrhosis
Sponsor: Conatus Pharmaceuticals Inc.
Start date: 2014-08-01; Completion date: 2016-01-01
Enrollment: 87 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter study to see if treatment with IDN-6556 can help improve the liver function of patients with liver cirrhosis with Model for End-Stage Liver Disease scores between 11-18.

Detailed description:
Numerous studies have shown that caspase cleaved cytokeratin 18 (cCK18) is elevated in the serum of liver disease patients and has been associated with disease severity, thus associating both excessive apoptosis and caspase activity with disease. Studies have also shown that caspase cleaved cytokeratin 18 is generally elevated to an even greater degree in cirrhosis than in other liver diseases. In addition, increasing stages of cirrhosis from Child-Pugh A, Child-Pugh B to Child-Pugh C are associated with progressively higher levels of caspase cleaved cytokeratin 18. Therefore, it appears that apoptosis and caspase activity tend to correlate with the stage of cirrhosis. A caspase inhibitor like IDN-6556 could have clinical utility by reducing the rate of apoptosis in cirrhotic patients and potentially reduce the progression of disease as determined by clinical markers of progression.

Arms: arm 1: 25 mg BID of IDN-6556 arm 2: Placebo BID
Interventions: intervention 1: IDN-6556 intervention 2: Placebo
Intervention descriptions: intervention 1: 25 mg BID intervention 2: None

Protocol documents:
Clinical trial NCT00116805
Conditions: Chronic Hepatitis B
Keywords: tenofovir adefovir hepatitis B HBeAg Positive
Sponsor: Gilead Sciences
Start date: 2005-06-01; Completion date: 2016-01-01
Enrollment: 266 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objectives of this study are to compare the efficacy, safety, and tolerability of tenofovir disoproxil fumarate (TDF) versus adefovir dipivoxil (ADV) for the treatment of HBeAg-positive chronic hepatitis B. Participants will receive TDF or ADV for 48 weeks (double-blind). After 48 weeks, eligible participants switched to open-label TDF for up to 480 weeks.

Detailed description:

Arms: arm 1: TDF plus ADV placebo (double-blind period), followed by TDF (open-label period). Participants may add FTC (as part of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) FDC tablet) to their treatment regimen in the open-label period. arm 2: ADV plus TDF placebo (double-blind period), followed by TDF (open-label period). Participants may add FTC (as part of FTC/TDF FDC tablet) to their treatment regimen in the open-label period.
Interventions: intervention 1: TDF intervention 2: ADV intervention 3: TDF placebo intervention 4: ADV placebo intervention 5: FTC/TDF
Intervention descriptions: intervention 1: 300 mg tablet administered orally once daily intervention 2: 10 mg tablet administered orally once daily intervention 3: Tablet administered orally once daily intervention 4: Tablet administered orally once daily intervention 5: 200/300 mg fixed-dose combination (FDC) tablet administered orally once daily

Protocol documents:
Clinical trial NCT00185640
Conditions: Blood Cancer Leukemia
Sponsor: Stanford University
Start date: 2003-03-01; Completion date: 2016-01-01
Enrollment: 303 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To measure how frequently and to what degree a complication of transplant cell acute graft versus host disease (GvHD) occurs.

Detailed description:
This study evaluated whether TLI-ATG conditioning followed by allogeneic hematpoietic cell transplant (HCT), which has provided excellent overall survival for patients with relapsed lymphoma after failed autologous HCT, provides a similar benefit in the setting of elderly patients with hematologic malignancies.

Arms: arm 1: Pre-transplant total lymphoid irradiation (TLI) and anti-thymocyte globulin (ATG) infusion with Day 0 allogeneic hematopoietic cell transplant (HCT), followed by post-transplant immunosuppression by cyclosporine and mycophenolate mofetil.
Interventions: intervention 1: Cyclosporine intervention 2: Anti-thymocyte globulin (ATG) intervention 3: Mycophenolate mofetil (MMF) intervention 4: Filgrastim intervention 5: Total Lymphoid Irradiation (TLI)
Intervention descriptions: intervention 1: Starting day -3 at a dose of 5 mg/kg orally twice daily with a target trough level of 350 to 450 ng/mL intervention 2: 1.5 mg/kg for total dose of 7.5mg/kg, IV starting on day -11 to day -7 before HCT intervention 3: Begins on day 0 after HCT at a dose of 15 mg/kg. Transplant recipients who received related donor grafts received MMF twice daily and those who received unrelated donor grafts received MMF 3 times daily. intervention 4: * Donors mobilized with 16 µg/kg/day filgrastim.
* As needed, myelosuppression in transplant recipients will be managed with subcutaneous filgrastim 5 µg/kg/day intervention 5: 0.8 Gy/day from day -11 to day -7 (inclusive) from day -4 to day -2 (inclusive) with 2 additional fractions of 0.8 Gy delivered on day -1 for total dose of 8 Gy.

Protocol documents:
Clinical trial NCT00308165
Conditions: Brain Neoplasms, Primary Malignant
Keywords: Recurrent Primary Malignant Brain Tumors Brain Tumors Neoplasms, Brain Brain Cancer Brain cancer treatment Topotecan
Sponsor: Jeffrey N. Bruce
Start date: 2004-03-01; Completion date: 2016-01-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the safety and efficacy of a chemotherapeutic drug (topotecan) as it is given directly into brain tumors by a delivery technique called convection-enhanced delivery. This drug has been used for different types of cancer, but in this study it will be given by an experimental delivery technique designed to maximize the amount of drug delivered to the brain tumor and minimize the side effects in other parts of the body.

This study will also evaluate advanced magnetic resonance (MR) imaging techniques.

The study will assess quality of life parameters throughout the follow-up period.

Detailed description:
Clinical efficacy with chemotherapy has been discouraging for malignant brain tumors, mostly because of side effects and delivery limitations. Because they are locally invasive and rarely metastasize, malignant gliomas have features that make them uniquely amenable to new strategies of regional drug delivery. Intracerebral clysis (convection-enhanced delivery) is a novel drug delivery strategy that uses a microinfusion pump to establish a pressure gradient in the brain via implanted catheters. The pressure gradient produces convective forces that distribute a therapeutic agent throughout the tumor and surrounding brain tissue.

Non-invasive magnetic resonance imaging (MRI) methods of monitoring drug distribution and treatment response have been developed to maximize the clinical applications and minimize complications associated with treatment risks.

Study participants will be taken to the operating room to have 2 catheters surgically placed into their tumor and surrounding tumor bed. These catheters will then be connected to small infusion pumps which will slowly infuse topotecan continuously over 4-5 days. Patients will have daily MRI scans while in the hospital. Upon completion of the experimental treatment, patients will be discharged and will be followed up in the outpatient clinic.

Arms: arm 1: Once a plastic catheter is placed, within 24 hours of placement, the catheter will be connected to a small pump at the bedside, and the convection-enhanced delivery of the Topotecan will begin. The Topotecan will be infused for 4 to 5 days after which time the catheters will simply be pulled out. Patients will be monitored with blood tests and MRI scans during the treatment and at different time periods during the following months.
Interventions: intervention 1: Convection-Enhanced Delivery intervention 2: Topotecan
Intervention descriptions: intervention 1: microinfusion pumps to deliver chemotherapy directly into brain tumors intervention 2: chemotherapeutic drug for the treatment of brain tumors

Protocol documents:
Clinical trial NCT00541034
Conditions: Leukemia Lymphoma
Keywords: B-cell chronic lymphocytic leukemia stage I small lymphocytic lymphoma stage II small lymphocytic lymphoma stage III small lymphocytic lymphoma stage IV small lymphocytic lymphoma stage I chronic lymphocytic leukemia stage II chronic lymphocytic leukemia stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2005-05-01; Completion date: 2016-01-01
Enrollment: 49 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Pentostatin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. 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. Giving pentostatin together with cyclophosphamide and rituximab may kill more cancer cells.

PURPOSE: This phase II trial is studying the side effects and how well giving pentostatin together with cyclophosphamide and rituximab works in treating patients with previously untreated chronic lymphocytic leukemia.

Detailed description:
OBJECTIVES:

* To determine the frequency of response in patients with previously untreated, intermediate- or high-risk B-cell chronic lymphocytic leukemia (CLL) treated with pentostatin, cyclophosphamide, and rituximab.
* To characterize the toxicity of this regimen in these patients.

OUTLINE: Patients receive cyclophosphamide IV followed by pentostatin IV on day 1 in course 1. Beginning in course 2 and in all subsequent courses, patients receive cyclophosphamide IV on day 1, pentostatin IV on day 1, and rituximab IV on day 1 or on days 1 and 2. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at least every 3 months for 1 year.

Arms: arm 1: Patients receive cyclophosphamide IV followed by pentostatin IV on day 1 in course 1. Beginning in course 2 and in all subsequent courses, patients receive cyclophosphamide IV on day 1, pentostatin IV on day 1, and rituximab IV on day 1 or on days 1 and 2. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: rituximab intervention 2: cyclophosphamide intervention 3: pentostatin
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00603447
Conditions: Relapsed Multiple Myeloma
Sponsor: Amgen
Start date: 2008-05-01; Completion date: 2016-01-01
Enrollment: 84 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate the safety and maximum tolerated dose (MTD) of carfilzomib in combination with lenalidomide and dexamethasone in patients with relapsed multiple myeloma

Detailed description:

Arms: arm 1: Treatment during Cycles 1 through 12 consisted of carfilzomib (15, 20, or 20/27 mg/m²) on Days 1, 2, 8, 9, 15, and 16; lenalidomide (10, 15, 20, or 25 mg) on Days 1 to 21; and low-dose dexamethasone (40 mg) given 30 minutes to 4 hours before the carfilzomib dose on Days 1, 8, and 15, as well as on Day 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
Interventions: intervention 1: Carfilzomib intervention 2: Lenalidomide intervention 3: Dexamethasone
Intervention descriptions: intervention 1: Carfilzomib for Injection was administered intravenously over 10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for the first 12 cycles. Each dose of Carfilzomib for Injection was normalized to body surface area. intervention 2: Lenalidomide was administered orally on Days 1 to 21 of each 28-day cycle. intervention 3: Dexamethasone 40 mg orally or intravenous equivalent was administered 30 minutes to 4 hours before carfilzomib on Days 1, 8, and 15, as well as on Day 22 of each 28-day cycle.

Protocol documents: