ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT03658876
Conditions: Renal Failure Chronic Anemia
Keywords: Hemodialysis
Sponsor: Imperial College London
Start date: 2015-06-03; Completion date: 2017-12-31
Enrollment: 197 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to identify predictors of treatment response. This involves collected baseline clinical parameters and bloods for biochemical parameters prior to administering the study treatment. A positive outcome following treatment was defined as an uptitration of haemoglobin by greater than 5g/l within 2 months. The study evaluated the participants response to treatment against the clinical and biochemical information collected prior to treatment being received.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Iron Sucrose Solution for Injection intervention 2: Epoetin Beta
Intervention descriptions: intervention 1: 200mg iron sucrose given on 5 successive haemodialysis sessions intervention 2: Uptitration of epoetin beta dose. Scale as follows (in units /session): 0-1000-2000-3000-4000-6000-8000-12000

Protocol documents:
Clinical trial NCT01664923
Conditions: Prostate Cancer
Keywords: prostate cancer enzalutamide MDV3100
Sponsor: Pfizer
Start date: 2012-08-01; Completion date: 2018-01-01
Enrollment: 396 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the safety and efficacy of enzalutamide vs bicalutamide in asymptomatic or mildly symptomatic patients with prostate cancer who have disease progression despite primary androgen deprivation therapy.

Detailed description:
This study is a multicenter phase 2, randomized, double-blind, efficacy and safety study of enzalutamide (160 mg/day) vs. bicalutamide (50 mg/day) in patients with recurrent prostate cancer who have serologic and/or radiographic disease progression despite primary androgen deprivation therapy.

Throughout the study, safety and tolerability will be assessed by the recording of adverse events, monitoring of vital signs, physical examinations, and safety laboratory evaluations.

Following study unblinding, study patients receiving enzalutamide or bicalutamide at the time of unblinding and qualifying patients randomized to bicalutamide who discontinued prior to unblinding will be offered the opportunity to receive open label enzalutamide treatment.

Arms: arm 1: Enzalutamide 160 mg/day orally arm 2: 50 mg/day orally
Interventions: intervention 1: Enzalutamide intervention 2: Bicalutamide
Intervention descriptions: intervention 1: 160 mg, daily, by mouth. intervention 2: 50 mg, daily, by mouth

Protocol documents:
Clinical trial NCT00706121
Conditions: Colorectal Cancer Precancerous Condition
Keywords: colon cancer rectal cancer adenomatous polyp
Sponsor: SWOG Cancer Research Network
Start date: 2008-06-01; Completion date: 2018-01-01
Enrollment: 8094 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Studying tissue samples in the laboratory from participants receiving treatment on the Selenium and Vitamin E Cancer Prevention Trial (SELECT) SWOG-S0000 may help doctors predict a participant's response to treatment and help plan the best treatment.

PURPOSE: This phase III trial is studying the effect of vitamin E and/or selenium on colorectal polyps in men enrolled on SELECT Trial SWOG-S0000.

Detailed description:
OBJECTIVES:

Primary

* To assess the effect of selenium on colorectal adenoma (CRA) occurrence.
* To assess the effect of selenium on number, location, size, histologic type, and degree of dysplasia of CRA.
* To assess the effect of selenium on colorectal cancer (CRC) incidence.

Secondary

* To assess the effect of vitamin E on CRA occurrence.
* To assess the effect of vitamin E on CRC incidence.

Tertiary

* To explore the effect modification of selenium and vitamin E by aspirin on CRA occurrence.
* To explore the effect modification of selenium and vitamin E by body mass index.

OUTLINE: This is a multicenter study.

Endoscopically obtained tissue samples are reviewed by study pathologists to confirm the presence (or absence) of a colorectal adenoma (CRA). If a CRA is present, the number, location, size, histology, and degree of dysplasia are documented. The CRA is also reviewed to exclude a diagnosis of colorectal cancer.

Additional data, including aspirin use, height and weight, date of birth, and other demographic and baseline characteristics, is also obtained. Participants' medical records are reviewed periodically.

Participants are followed annually.

Arms: arm 1: Vitamin E and selenium placebo daily for 7 - 12 years arm 2: Selenium and vitamin E placebo daily for 7 - 12 years arm 3: Vitamin E and selenium daily for 7 - 12 years arm 4: Vitamin E placebo and selenium placebo daily for 7 - 12 years
Interventions: intervention 1: Vitamin E intervention 2: Selenium intervention 3: Vitamin E placebo intervention 4: selenium placebo
Intervention descriptions: intervention 1: 400 IU daily by mouth for 7 - 12 years intervention 2: 200 mcg daily for 7 - 12 years intervention 3: 1 pill by mouth daily for 7 - 12 years intervention 4: 1 pill by mouth daily for 7 - 12 years

Protocol documents:
Clinical trial NCT00726596
Conditions: Prostate Cancer
Keywords: recurrent prostate cancer stage IV prostate cancer Prostate-Specific Antigen
Sponsor: Rutgers, The State University of New Jersey
Start date: 2008-08-01; Completion date: 2018-01-01
Enrollment: 64 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well hydroxychloroquine works in treating patients with previously treated prostate cancer. Autophagy destroys proteins and other substances in cells and may be used by prostate cancer cells to survive. Hydroxychloroquine, which blocks autophagy, may slow the growth of and possibly kill prostate cancer cells.

Detailed description:

Arms: arm 1: Hydroxychloroquine - 400 mg (cohort A) Hydroxychloroquine - 600 mg (cohort B)
Interventions: intervention 1: hydroxychloroquine
Intervention descriptions: intervention 1: Hydroxychloroquine will be taken at a dose of 200 mg twice per day in the first 27 patients (cohort A). Once cohort A completed, the dose of hydroxychloroquine will then be increased to 600mg per day (200mg three times per day)(cohort B).

Protocol documents:
Clinical trial NCT01060384
Conditions: Non-Hodgkin's Lymphoma
Sponsor: University of Nebraska
Start date: 2010-03-29; Completion date: 2018-01-01
Enrollment: 46 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this trial is to investigate the efficacy (how well the drug works) of ofatumumab and lenalidomide in patients with lymphoma and to investigate if any possible unwanted side effects may occur. The purpose of the Phase I portion of this trial will be to determine the maximum dose of these medications that can be given with minimal side effects.

Detailed description:
This trial will investigate the efficacy of ofatumumab and lenalidomide in patients with lymphoma and investigate if any possible unwanted side effects may occur. Ofatumumab is a human antibody (a type of protein) that binds specifically to a protein (CD20) on the surface of some of the white blood cells (B-cells). Research, so far, has shown that ofatumumab can destroy cancer cells which originate from B cells. Ofatumumab is approved for sale by the US Food and Drug Administration (FDA). The medicine has an approved indication for Chronic Lymphocytic Leukemia (CLL) but is not approved for Non-Hodgkin's Lymphoma (NHL).

Lenalidomide is a drug that affects the immune system. Lenalidomide can change the body's immune system and it may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, it may reduce or prevent the growth of cancer cells. Lenalidomide is approved by the FDA for treatment of multiple myeloma (MM) and myelodysplastic syndrome (MDS) and has been shown to be effective in lymphoma that does not respond to treatment or has come back after treatment. Lenalidomide has not been approved by the United States (US) Food and Drug Administration (FDA) and is experimental (investigational) in this study.

Arms: arm 1: All participants will receive the same dose of Ofatumumab. There will be three planned dose cohorts for the Lenalidomide in the Phase 1 portion of this trial. A maximum of 18 patients will be enrolled in to Phase 1. Three evaluable patients will be enrolled in to each of the dose cohorts with an additional 3 patients to be enrolled in the maximum tolerated dose (MTD). An additional 29 evaluable patients will be enrolled in to Phase II using the MTD for Lenalidomide that was determined in Phase 1.
Interventions: intervention 1: Lenalidomide intervention 2: ofatumumab
Intervention descriptions: intervention 1: Dose Cohort -1\^ 10mg daily on Days 1-21 every 28 days

Dose Cohort +1\^\^ 15mg daily on Days 1-21, every 28 days

Dose Cohort +2 20 mg daily on Days 1-21, every 28 days

Dose Cohort #3 25 mg daily on Days 1-21, every 28 days

\^Used only if Dose Cohort +1 requires further reduction

\^\^Starting Dose Cohort in Phase I intervention 2: 8 weekly infusions of ofatumumab 1000mg.

Protocol documents:
Clinical trial NCT01441882
Conditions: Refractory Chronic Lymphocytic Leukemia Stage I Chronic Lymphocytic Leukemia Stage II Chronic Lymphocytic Leukemia Stage III Chronic Lymphocytic Leukemia Stage IV Chronic Lymphocytic Leukemia
Sponsor: OHSU Knight Cancer Institute
Start date: 2011-10-01; Completion date: 2018-01-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well dasatinib works in treating patients with chronic lymphocytic leukemia (CLL). Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. To estimate the biologic target activity of dasatinib in CLL patients found to have pre-treatment in vitro dasatinib cytotoxicity (as defined by a \>= 50% decrease in absolute lymphocyte count and/or bone marrow CLL count and/or lymph node or spleen size).

SECONDARY OBJECTIVES:

I. To evaluate overall objective response rates per CLL National Cancer Institute (NCI) working group.

II. To determine drug safety and tolerability of dasatinib in patients with CLL.

III. To determine overall (OS) and progression-free survival (PFS).

TERTIARY OBJECTIVES:

I. To determine if v-src avian sarcoma (Schmidt-Ruppin A-2) viral oncogene homolog (SRC), Bruton agammaglobulinemia tyrosine kinase (BTK), or tec protein tyrosine kinase (TEC) family kinase inhibition correlates with clinical response.

II. To determine which prognostic subgroups (presence of \>= 1 of the following: 11q or 17p deletion; cluster of differentiation \[CD\]38 or zeta-chain-associated protein kinase 70 \[Zap 70\] expression; unmutated immunoglobulin heavy chain \[IgVH\]) respond to dasatinib therapy.

III. To evaluate differences in baseline CLL gene expression between CLL samples that are sensitive or in-sensitive to dasatinib.

IV. To analyze changes in CLL gene expression after dasatinib treatment. V. To evaluate dasatinib pharmacokinetics. VI. To evaluate changes in type I receptor tyrosine kinase-like orphan receptor (ROR-1) expression with dasatinib treatment.

VII. To correlate response to pre-clinical IC50 in the presence/absence of HS-5 conditioned media.

VIII. To explore role of possible kinase mutations related to dasatinib response.

IX. To measure chemokines before and during treatment.

OUTLINE:

Patients receive dasatinib orally (PO) once daily (QD) during course 1 and if tolerated, twice daily (BID) in subsequent courses. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 2 years.

Arms: arm 1: Patients receive dasatinib PO QD during course 1 and if tolerated, BID in subsequent courses. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Dasatinib intervention 2: Laboratory Biomarker Analysis intervention 3: Pharmacological Study
Intervention descriptions: intervention 1: Given PO intervention 2: Correlative studies intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT01534078
Conditions: Hodgkin Lymphoma
Keywords: non-bulky limited stage
Sponsor: Massachusetts General Hospital
Start date: 2012-03-01; Completion date: 2018-01-01
Enrollment: 34 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Brentuximab is an antibody-drug conjugate (ADC), which is the combination of an antibody (a protein that binds to cells) and a chemotherapy molecule. Brentuximab works by using the antibody portion to enter into the Hodgkin lymphoma cells and then releasing the chemotherapy portion, which attempts to destroy the cell.

The intravenous chemotherapy drugs Adriamycin, Vinblastine and Dacarbazine (AVD) which you will receive in this research study are approved for use in people with Hodgkin Lymphoma. A drug called bleomycin is usually included with AVD, but since it appears to be a less effective drug with significant potential risks, it is being replaced in this study with the drug brentuximab.

In this research study, the investigators are looking to see whether brentuximab in combination with AVD is effective in treating limited-stage Hodgkin Lymphoma.

Detailed description:
Each treatment cycle is 28 days. You will receive brentuximab alone on Day 1 and 15 of the first cycle (lead-in cycle). After cycle 1, you will receive brentuximab combined with AVD on Day 1 and 15 for 4-6 cycles, depending on your response to therapy. Brentuximab and AVD will be given to you by intravenous infusion (IV).

The following test and procedures will be performed on Days 1 and 15 of each cycle:

* Review of any side effects you have experienced and all medications you are taking
* Performance Status
* Physical exam and vital signs
* Routine blood tests
* Questionnaire to evaluate symptoms of neuropathy
* Research blood sample to look at markers to see how your body is responding to study medication
* PET-CT scan prior to completing cycle 2 of combination brentuximab/AVD

After the final dose of the study drug: The following assessments will be performed within one month of your last dose of study medication:

* Review of any side effects you have experienced and all medications you are taking
* Performance Status
* Physical exam and vital signs
* Routine blood tests
* Questionnaire to evaluate symptoms of neuropathy
* Research blood sample to look at markers to see how your body is responding to study medication
* PET-CT scan Follow up will include the following
* Review of any side effects you have experienced and all medications you are taking
* Performance Status
* Review and Physical exam
* Routine blood tests
* Questionnaire to evaluate symptoms of neuropathy
* CT scans

Arms: arm 1: Brentuximab Vedotin in combination with Adriamycin, Vinblastine and Dacarbazine
Interventions: intervention 1: Brentuximab Vedotin intervention 2: Adriamycin, vinblastine, and dacarbazine
Intervention descriptions: intervention 1: 2 doses administered 14 days apart; followed by combination therapy with AVD for 4-6 cycles; 1.2 mg/kg intervention 2: Combination therapy with brentuximab for 4-6 cycles; 25 mg/m2 Adriamycin; 6 mg/m2 Vinblastine; 375 mg/m2 Dacarbazine

Protocol documents:
Clinical trial NCT02368457
Conditions: Osteoradionecrosis
Keywords: Mandibular osteoradionecrosis Tocopherol pentoxifylline vitamine E wounds and injuries antioxidants free radical scavengers radiation-protective agents vasodilatadors agents osteonecrosis mandible extraoral fistula exposed bone necrotic bone head and neck radiotherapy
Sponsor: Hospital Vall d'Hebron
Start date: 2016-02-01; Completion date: 2018-01-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Mandibular osteoradionecrosis, despite its low incidence, remains being the most problematic and irreversible complication after head and neck radiotherapy with no medical treatment to limit or reduce symptoms.

Different clinical trials have shown a significant scientific evidence that the treatment with pentoxifylline + tocopherol achieves a certain effectiveness in the treatment of the tissue fibrosis. This study proposes to use this drugs to determine if there is healing of mandibular osteoradionecrosis and/or a symptomatic improvement as well.

Detailed description:
Mandibular osteoradionecrosis which occurs after the use of radiation therapy for the treatment of head and neck cancer remains being the most problematic and irreversible complication despite its low incidence with no medical treatment to limit or reduce symptoms.

Clinical trials conducted to date have shown a significant scientific evidence that the treatment with pentoxifylline + tocopherol achieves a certain effectiveness in the treatment of the tissue fibrosis that have been irradiated based on the properties of this drugs in increased tissue oxygenation and their antioxidant effect.

The aim of this study is to determine if there is a clinical improvement of mandibular osteoradionecrosis using Pentoxifylline in combination with Tocopherol as treatment because, currently, there is no effective treatment to achieve bone healing and/or a symptomatic improvement.

Arms: arm 1: Drug: pentoxifylline with tocopherol Combination of pentoxifylline and tocopherol during a minimum of 6 months and a maximum of 24 months. arm 2: No drug treatment
Interventions: intervention 1: Pentoxifylline and Tocopherol
Intervention descriptions: intervention 1: pentoxifylline with tocopherol Pentoxifylline 800 mg/day, oral (1cp 400 mg twice a day) + Vitamin E (alfa-tocopherol) 1000 UI/day, oral (1cp 400UI twice a day + 1cp200UI once a day) during 24 months (maximum).

Protocol documents:
Clinical trial NCT02617485
Conditions: Diffuse Large B-Cell Lymphoma
Sponsor: Mabion SA
Start date: 2015-12-01; Completion date: 2018-01-01
Enrollment: 143 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the study is to demonstrate the high level of biosimilarity between MabionCD20 (MABION SA) and the reference product: MabThera (rituximab by Hoffman-La Roche) in patients with CD20-positive diffuse large B-cell lymphoma.

Detailed description:
Patients who meet criteria for participation in this study receive 8 intravenous infusions of MabionCD20® or MabThera® 21 days interval in combination with standard dosage regimen of CHOP. The duration of the study is 12 months. The treatment and observation period will last 26 weeks starting from Day 1, until Week 26 - one month after last IMP infusion.

Arms: arm 1: A course of MabionCD20 consists of intravenous infusions in dose 375 mg/m2 body surface area, administered on day 1 of each chemotherapy cycle for 8 cycles.

Intervention: Drug: Rituximab arm 2: A course of MabThera consists of intravenous infusions in dose 375 mg/m2 body surface area, administered on day 1 of each chemotherapy cycle for 8 cycles.

Intervention: Drug: Rituximab
Interventions: intervention 1: Rituximab intervention 2: Doxorubicin intervention 3: Vincristine intervention 4: Cyclophosphamide intervention 5: prednisone
Intervention descriptions: intervention 1: 375 mg/m2 IV on day 1 of each 21 days chemotherapy cycle. Number of Cycles: 8. intervention 2: 50 mg of doxorubicin per square meter administrated IV on day 1 of each chemotherapy cycle intervention 3: 1.4 mg of vincristine per square meter, up to a maximal dose of 2 mg, administrated IV on day 1 of each chemotherapy cycle intervention 4: 750 mg of cyclophosphamide per square meter of body-surface area administrated IV on day 1 of each chemotherapy cycle intervention 5: 100 mg of prednisone administrated PO per day for five days, day 1-5 of each chemotherapy cycle

Protocol documents:
Prot_000.pdf: 


















































































℃



















































































SAP_001.pdf:
Clinical trial NCT02883400
Conditions: Transplant, Liver
Sponsor: Wake Forest University Health Sciences
Start date: 2014-12-01; Completion date: 2018-01-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To study spironolactone to prevent calcineurin inhibitor (CNI) kidney injury.

Detailed description:
The aim of this study is to determine if spironolactone decreases nephrotoxicity from calcineurin inhibitors in liver transplant recipients and to determine the best study of renal function in liver transplant recipients.

Arms: arm 1: standard of care, nontreatment arm 2: spironolactone
Interventions: intervention 1: Spironolactone
Intervention descriptions: intervention 1: spironolactone 25 mg up to 50 mg

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT00709761
Conditions: Neoplasms, Breast
Keywords: Erbb2 ABRAXANE MBC first or second line therapy Metastatic Breast Cancer TYKERB
Sponsor: Novartis Pharmaceuticals
Start date: 2008-07-02; Completion date: 2018-01-03
Enrollment: 60 participants; Allocation: ; Intervention model: 

Brief summary:
This was an open-label, single-arm, multi-center, Phase II study to determine the activity of nab-paclitaxel plus lapatinib in the first and second-line setting in women with ErbB2 overexpressing metastatic breast cancer (MBC). Sixty subjects were to be enrolled in the study. Subjects were to receive nab-paclitaxel (100 mg/m2 intravenously once weekly for 3 weeks, followed by a rest week in a 4-week cycle) plus lapatinib (1000 mg once daily). Subjects were to receive treatment until disease progression or withdrawal from the study. The primary objective of this study was to evaluate overall tumor response rate of lapatinib in combination with nab-paclitaxel administered in women with ErbB2 overexpressing MBC who received no chemotherapeutic regimen in the metastatic setting. Secondary objectives included progression-free survival, overall survival, duration of response, time to response and time to progression and safety. Safety and efficacy assessments were to be performed at 8 and 12 week intervals, and at the end of treatment.

Subject: Metastatic Breast Cancer, ErbB2, First-line therapy, Lapatinib, Nab-paclitaxel

Detailed description:

Arms: arm 1: Single arm combination therapy of Lap and NabPaclitaxel combination
Interventions: intervention 1: Lapatinib/nab-Paclitaxel
Intervention descriptions: intervention 1: This was an open-label, single-arm, multi-center, Phase II study to determine the activity of nab-paclitaxel plus lapatinib (TYKERB) in the first and second-line setting in women with ErbB2 overexpressing metastatic breast cancer (MBC). Subjects were to receive nab-paclitaxel (100 mg/m2 intravenously on Day 1, 8, 15, every 28 days (q28) days plus lapatinib (1000 mg once daily on a continuous basis).

Protocol documents: