ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00590187
Conditions: Acute Myeloid Leukemia
Sponsor: Cyclacel Pharmaceuticals, Inc.
Start date: 2007-12-01; Completion date: 2018-12-01
Enrollment: 105 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective is to treat elderly AML and MDS patients with sapacitabine.

Detailed description:
The main objective of this study is to learn which sapacitabine treatment is more likely to keep the cancer in check for at least one year in AML patients who are at least 70 years of age or older and in MDS patients who are at least 60 years of age.

Arms: arm 1: 200 mg b.i.d. x 7 days every 3-4 weeks arm 2: 300 mg b.i.d. x 7 days every 3 - 4 weeks arm 3: 400 mg b.i.d. x 3 days/week x 2 weeks every 3 - 4 weeks arm 4: 200 mg b.i.d. x 7 consecutive days every 4 weeks arm 5: 300 mg q.d. x 7 consecutive days every 4 weeks arm 6: 300 mg b.i.d. x 3 consecutive days per week for 2 weeks every 4 weeks arm 7: 200 mg b.i.d. x 7 consecutive days every 4 weeks arm 8: 300 mg q.d. x 7 consecutive days every 4 weeks arm 9: 100 mg q.d. x 5 consecutive days per week for 2 weeks every 4 weeks
Interventions: intervention 1: Sapacitabine, Arm A intervention 2: Sapacitabine, Arm B intervention 3: Sapacitabine, Arm C intervention 4: Sapacitabine, Arm D intervention 5: sapacitabine, Arm E intervention 6: sapacitabine, Arm F intervention 7: Sapacitabine, Arm G intervention 8: Sapacitabine, Arm H intervention 9: Sapacitabine, Arm I
Intervention descriptions: intervention 1: 200 mg b.i.d. x 7 days every 3-4 weeks intervention 2: 300 mg b.i.d. x 7 days every 3 - 4 weeks intervention 3: 400 mg b.i.d. x 3 days/week x 2 weeks every 3 - 4 weeks intervention 4: 200 mg b.i.d. x 7 consecutive days every 4 weeks intervention 5: 300 mg q.d. x 7 consecutive days every 4 weeks intervention 6: 300 mg b.i.d. x 3 consecutive days per week for 2 weeks every 4 weeks intervention 7: 200 mg b.i.d. x 7 consecutive days every 4 weeks intervention 8: 300 mg q.d. x 7 consecutive days every 4 weeks intervention 9: 100 mg q.d. x 5 consecutive days per week for 2 weeks every 4 weeks

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT00978562
Conditions: Childhood Brain Neoplasm Recurrent Childhood Brain Neoplasm
Sponsor: OHSU Knight Cancer Institute
Start date: 2009-08-01; Completion date: 2018-12-01
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This clinical trial studies dynamic susceptibility-weighted contrast enhanced magnetic resonance imaging (DSC-MRI) after administration of ferumoxytol and dynamic contrast-enhanced MRI (DCE-MRI) after administration of a gadolinium-based contrast agent (GBCA) in viewing the vessels of the brain in younger patients with brain tumors. Ferumoxytol is an experimental form of very small iron particles that are taken by the blood stream to cells adjacent and inside the tumor. These iron particles may make it easier to see the areas of the brain that are affected by tumor. Ferumoxytol may work better than standard GBCA in viewing the vessels of the brain and brain tumor on MRI. Using ferumoxytol and GBCA in the same MRI session may provide more information about tumor blood supply and the extent of the tumor.

Detailed description:
PRIMARY OBJECTIVES:

I. To describe the vascular properties of pediatric brain tumors using ferumoxytol for DSC-MRI and GBCA for DCE-MRI in pediatric brain tumor (proven or presumptive) patients in a single MRI session.

II. To describe evolving imaging characteristics of tumor vasculature using DSC-MRI with ferumoxytol and DCE-MRI with GBCA in pediatric brain tumor patients.

SECONDARY OBJECTIVES:

I. Compare and evaluate magnetic resonance angiogram (MRA) with ferumoxytol between different time points.

II. To describe number and size of tumors imaged. III. To assess histology and electron microscopy (EM) on tissue samples. IV. To demonstrate differences in patients with prior therapy versus (vs.) no prior therapy (radiation and/or chemotherapy).

OUTLINE:

Patients receive ferumoxytol and gadolinium intravenously (IV) and then undergo DSC-MRI and DCE-MRI. An optional MRI without injection of a contrast agent may be obtained after 20-24 hours at the discretion of the clinician. Patients may receive up to 3 more scans at least 3 weeks apart over up to 2 years.

After completion of study treatment, patients are followed up at approximately 4-6 weeks.

Arms: arm 1: Patients receive ferumoxytol and gadolinium IV and then undergo DSC-MRI and DCE-MRI. An optional MRI without injection of a contrast agent may be obtained after 20-24 hours at the discretion of the clinician. Patients may receive up to 3 more scans at least 3 weeks apart over up to 2 years.
Interventions: intervention 1: Dynamic Contrast-Enhanced Magnetic Resonance Imaging intervention 2: Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging intervention 3: Ferumoxytol Non-Stoichiometric Magnetite intervention 4: Gadolinium
Intervention descriptions: intervention 1: Undergo DCE-MRI intervention 2: Undergo DSC-MRI intervention 3: Given IV intervention 4: Given IV

Protocol documents:
Clinical trial NCT01280682
Conditions: Type 1 Diabetes
Keywords: type 1 diabetes age course of disease autoantibodies C-peptide levels
Sponsor: Yang Tao
Start date: 2010-07-01; Completion date: 2018-12-01
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Transient elimination of B lymphocytes with anti-CD20 monoclonal antibody would decrease immune-mediated destruction of beta cells and result in preserved beta-cell function in patients with type 1 diabetes of recent onset.

Detailed description:
Although the presence of autoantibodies is a diagnostic criterion, the immunopathogenesis of beta-cell destruction in type 1 diabetes is typically associated with T-lymphocyte autoimmunity.

Many T-lymphocyte-mediated diseases include a B-lymphocyte component. B lymphocytes can play a crucial role as antigen-presenting cells, expressing high levels of class II major-histocompatibility-complex antigens and generating cryptic peptides to which T lymphocytes are not tolerant.

B lymphocytes can be selectively depleted with the anti-CD20 monoclonal antibody. We will test the hypothesis that transient elimination of B lymphocytes with anti-CD20 monoclonal antibody would decrease immune-mediated destruction of beta cells and result in preserved beta-cell function in patients with type 1 diabetes of recent onset.

Arms: arm 1: patients who had newly diagnosed type 1 diabetes are assigned to receive infusions of rituximab of 125mg/m\^2 day1 day8 day15 day22 repeat after six months (only day1 and day8) besides insulin arm 2: patients who had newly diagnosed type 1 diabetes only use insulin
Interventions: intervention 1: rituximab
Intervention descriptions: intervention 1: anti-CD20 monoclonal antibody 125mg/m\^2 day1 day8 day15 day22 repeat after six months (only day1 and day8)

Protocol documents:
Clinical trial NCT01520207
Conditions: Intra-dialytic Hypotension
Sponsor: Brigham and Women's Hospital
Start date: 2012-05-01; Completion date: 2018-12-01
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Kidney failure can result from a variety of conditions and can be temporary or permanent. Hemodialysis is available as a replacement treatment to perform the work that the kidneys normally do. However, the dialysis procedure can be associated with rapid changes in the composition of the blood - this may lead to changes in blood pressure and in turn reduced blood supply to important parts of the body. We aim to investigate if giving a medicine (called mannitol) during dialysis may be able to reduce the frequency of these low blood pressure events.

Detailed description:

Arms: arm 1: 0.9% saline will be administered (IV) during the hemodialysis session at 1.25mL/kg/hour (max 375mLs per session). Administration will be discontinued 30 minutes before the end of the hemodialysis session. arm 2: Mannitol will be administered (IV) during the hemodialysis session at a maximum rate of 0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session). Administration will be discontinued 30 minutes before the end of the hemodialysis session.
Interventions: intervention 1: Mannitol (20%) intervention 2: 0.9% saline
Intervention descriptions: intervention 1: 0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session) intervention 2: 1.25mL/kg/hour; maximum 125mLs/hour; maximum total volume 375mLs per treatment

Protocol documents:
Clinical trial NCT01791985
Conditions: Breast Cancer
Keywords: Breast Cancer AZD4547 Safety Run-In FGFR1 ER positive breast cancer Single arm phase IIa study
Sponsor: Imperial College London
Start date: 2012-07-01; Completion date: 2018-12-01
Enrollment: 52 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is looking at a new drug called AZD4547 which is being tested for the treatment of oestrogen receptor positive breast cancer. AZD4547 is a drug which specifically "blocks" proteins called fibroblast growth factor receptors (FGFR1) that are involved in the processes that help cancer cells to grow. These proteins may also be responsible for the development of resistance to hormonal therapies used to treat some breast cancers. AZD4547 is not yet approved for use in breast cancer and is therefore being used in this study as a research drug.

The investigators will also test the theory that it is not necessary for high levels of FGFR1 to be present in the body to see benefit from AZD4547. (Stage 1 only)

Detailed description:
The study will be carried out in two stages. Stage 1 is to find a suitable dose of AZD4547 which can be used together with a class of drugs called nonsteroidal aromatase inhibitors (e.g. anastrozole or letrozole) i.e. a dose which does not cause too many unacceptable side effects.

Patients with hormone sensitive (oestrogen receptor positive) breast cancer, whose current treatment with anastrozole or letrozole has recently stopped working properly will be eligible for this stage.

Stage 2 will then assess the efficacy of AZD4547, based on the change in tumour size at 12 weeks (or progression if prior to week 12), when used in combination with either anastrozole or letrozole in patients with hormone sensitive (oestrogen receptor positive) breast cancer, who have progressed on treatment with either anastrozole or letrozole in any setting.

In both stages, the study will look at how well the new treatment is tolerated.

Each patient is only allowed to take part in either stage 1 or 2.

The study will be run in 9 Hospitals across England and Scotland.

Arms: arm 1: NSAI (anastrozole (1mg) or letrozole (2.5mg)), orally, once daily but together with twice daily AZD4547 (80mg).

AZD4547 will be given on an intermittent schedule of one week on / one week off.
Interventions: intervention 1: AZD4547 / anastrozole or letrozole
Intervention descriptions: intervention 1: Patients will continue or restart the NSAI which they have progressed\* on: either anastrozole (1mg) or letrozole (2.5mg), orally, once daily but together with twice daily AZD4547 (80mg).

AZD4547 will be given on an intermittent schedule of one week on / one week off.

\*Prior to study entry, patients must have taken anastrozole or letrozole at some stage in their treatment to date for breast cancer; and shown evidence of resistance to this therapy. The NSAI does not have to be the most recent line of treatment.

Protocol documents:
Clinical trial NCT02110901
Conditions: Chronic Kidney Disease
Keywords: radiocephalic arteriovenous fistula AVF hemodialysis PRT-201 vascular access kidney renal vonapanitase PATENCY-1
Sponsor: Proteon Therapeutics
Start date: 2014-07-01; Completion date: 2018-12-01
Enrollment: 349 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This research study is designed to assess the safety and effectiveness of an experimental drug called PRT-201 in patients both receiving or expecting to receive dialysis who have chronic kidney disease and who are undergoing surgery to create a new access point to their bloodstream for hemodialysis. PRT-201 is a protein that has been shown in previous research studies to help keep vessels patent when applied to the outside surface of the blood vessels (arteries and veins) in patients who undergo surgery to create an arteriovenous fistula (AVF). The purpose of this study is to determine whether PRT-201 when applied to a limited segment of your blood vessel (about 2 inches) immediately after surgery is safe and improves the patency of your AVF.

Detailed description:

Arms: arm 1: PRT-201 administered at the time of radiocephalic fistula creation arm 2: Placebo administered at the time of radiocephalic fistula creation. The placebo is identical in appearance and composition to PRT-201 but lacks the active ingredient.
Interventions: intervention 1: PRT-201 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02962427
Conditions: Headache
Sponsor: University of Colorado, Denver
Start date: 2016-11-01; Completion date: 2018-12-01
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The purpose of this research study is to compare the effectiveness of a sphenopalatine ganglion block to an epidural blood patch for post-dural puncture headache relief in randomized postpartum parturients over a 48 hour period.

Detailed description:
The purpose of this research study is to compare the effectiveness of a sphenopalatine ganglion block to an epidural blood patch for post-dural puncture headache relief in randomized postpartum parturients over a 48 hour period. A known dural puncture is defined as free flow of cerebral spinal fluid (CSF) during neuraxial placement. An unknown dural puncture is defined as neuraxial placement where free flow of CSF is not appreciated, however the patient is diagnosed with a post-dural puncture headache as defined by the International Classification of Headache Disorders.

Arms: arm 1: Sphenopalatine Ganglion Block: The patient is placed in the supine position. Four cc of 2% viscous lidocaine is placed to the level of the sphenopalatine ganglion with a 20 gauge angiocatheter along sterile swabs which were placed carefully into the patients nostrils bilaterally and lateral to the middle turbinate. It will be documented that the patient has no pain or paresthesia during or after the procedure. The swabs are withdrawn after 30 minutes. arm 2: Epidural Blood Patch: The patient is positioned in the sitting or lateral positon. Using aseptic technique, 20mL of autologous blood is drawn by a trained practitioner. The epidural placement is performed by a trained practitioner using aseptic technique and the vertebral space accessed is at or immediately below the original neuraxial placement. After entrance into the epidural space is confirmed with loss of resistance technique to either air or saline, 15-20 milliliters of sterile autologous venous blood is injected. After the procedure the patient rests supine for at least 1 hour. Patients are instructed to avoid heavy lifting, abdominal straining, or coughing for at least 48 hours.
Interventions: intervention 1: Sphenopalatine ganglion Block intervention 2: Epidural blood patch
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT02105688
Conditions: Chronic Hepatitis C
Sponsor: Merck Sharp & Dohme LLC
Start date: 2014-09-02; Completion date: 2018-12-04
Enrollment: 301 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 2-part study. The purpose of Part A is to assess the efficacy and safety of grazoprevir (MK-5172) 100 mg in combination with elbasvir (MK-8742) 50 mg for 12 weeks in the treatment of chronic HCV GT1, GT4, or GT6 infection in treatment-naïve participants who are on opiate substitution therapy (OST). The primary hypothesis is that the percentage of participants who receive grazoprevir/elbasvir fixed-dose combination (FDC) in the Immediate Treatment Arm and achieve a Sustained Virologic Response 12 weeks after the end of all study therapy (SVR12) will be superior to 67%. In addition, participants who received at least 1 dose of grazoprevir/elbasvir in Part A will be eligible to participate in Part B, which is a 3-year observational follow-up.

Detailed description:

Arms: arm 1: In Part A, participants receive grazoprevir 100 mg plus elbasvir 50 mg FDC (MK-5172A) once daily for 12 weeks (blinded) and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B). arm 2: In Part A, participants receive placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up. Afterwards, participants received 12 weeks of open-label treatment with the MK-5172A FDC and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B).
Interventions: intervention 1: Grazoprevir 100 mg/Elbasvir 50 mg FDC tablet (MK-5172A) intervention 2: Placebo to Grazoprevir 100 mg/Elbasvir 50 mg FDC tablet
Intervention descriptions: intervention 1: Grazoprevir 100 mg/Elbasvir 50 mg FDC tablet, taken once daily by mouth for 12 weeks. intervention 2: Placebo Grazoprevir 100 mg/Elbasvir 50 mg FDC tablet, taken once daily by mouth for 12 weeks.

Protocol documents:
Clinical trial NCT02466958
Conditions: Major Depressive Disorder
Keywords: depressed older adults antidepressants depression MDD
Sponsor: University of California, Los Angeles
Start date: 2016-06-01; Completion date: 2018-12-09
Enrollment: 29 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the effects of levomilnacipran (FETZIMA) compared to placebo for the treatment of depression in older adults.

Detailed description:
A 12-week pilot double-blind comparison of levomilnacipran (FETZIMA) to placebo for the treatment of geriatric depression. The investigators are interested in assessing the efficacy of levomilnacipran (LMIL) to placebo (PBO), and exploring the effects of antidepressant response on brain connectivity and neuroplasticity. This pilot study is designed to determine any differences in the efficacy, safety and tolerability of levomilnacipran compared to placebo, and to perform dose finding (20-120 mg per day) in 40 older depressed adults. The investigators anticipate that the LMIL will be superior to PBO in improving levels of depressive symptoms and rates of remission, as well as improving cognition, apathy, and quality of life. This proposal expands the investigator's focus on the biomarkers of neuroplasticity that have been used in several prior studies and demonstrated responsivity to antidepressant treatment. The purpose is to examine this directly in 40 older adults with major depression. This proposed trial will also serve as a pilot study to estimate the efficacy and tolerability of the drug in older depressed adults, and the dose-finding in this population.

Arms: arm 1: All eligible subjects will be randomized to levomilnacipran or placebo group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups. arm 2: All eligible subjects will be randomized to levomilnacipran or placebo group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups.
Interventions: intervention 1: levomilnacipran intervention 2: Placebo
Intervention descriptions: intervention 1: antidepressant intervention 2: an inactive drug

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT01373294
Conditions: Bladder Cancer
Keywords: non-muscle-invasive transitional cell oral lenalidomide intravesical
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Start date: 2011-11-30; Completion date: 2018-12-10
Enrollment: 17 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purposes of this study are to:

* find out whether participants' cancer returns or gets worse while they are taking lenalidomide and Bacille Calmette-Guerrin (BCG);
* evaluate the safety and tolerability of the combination of lenalidomide and BCG;
* compare the cancer progression of participants taking lenalidomide and BCG versus participants taking only BCG

Detailed description:
Investigators planned to screen approximately 100 people with bladder cancer who are 18 years of age or older throughout the United States for this study.

This is a multi-center study combining two marketed drugs, one of which has not been used previously in people with transitional cell cancer. Lenalidomide (Revlimid®) is a drug that alters the immune system and it may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells. Lenalidomide is approved by the U.S. Food and Drug Administration (FDA) for the treatment of specific types of myelodysplastic syndrome (MDS) and in combination with dexamethasone for patients with multiple myeloma (MM) who have received at least 1 prior therapy. MDS and MM are cancers of the blood. Lenalidomide is currently being tested in a variety of cancer conditions. It is not approved by the FDA for use in people with bladder cancer, so in this case it is considered experimental.

The other drug used in this study is Bacille Calmette-Guerrin (BCG). BCG is approved by the FDA for use in people with bladder cancer.

Arms: arm 1: Bacille Calmette-Guerrin (BCG) and lenalidomide.

Participants were assigned to receive BCG or BCG and lenalidomide based on their cancer. This group received BCG + lenalidomide) arm 2: Bacille Calmette-Guerrin (BCG) only.

Participants were assigned to receive BCG or BCG and lenalidomide based on their cancer.

This group was not eligible to receive the combination of BCG + lenalidomide.
Interventions: intervention 1: Bacille Calmette-Guerrin (BCG) intervention 2: Lenalidomide
Intervention descriptions: intervention 1: Participants will receive BCG instillations once per week for the first 6 weeks. At 3 months and 6 months, participants will receive BCG instillations once per week for three weeks. intervention 2: Participants may also receive capsules of lenalidomide 10 mg to swallow once per day for 7 months. The study doctor will tell participants if they will be taking lenalidomide.

Protocol documents: