ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00824265
Conditions: Leukaemia, Lymphocytic, Chronic
Keywords: Relapsed Oncology Safety Chronic Lymphocytic Leukemia Ofatumumab Efficacy
Sponsor: Novartis Pharmaceuticals
Start date: 2009-03-12; Completion date: 2017-10-25
Enrollment: 365 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to evaluate the safety and efficacy of ofatumumab added to fludarabine-cyclophosphamide in patients with relapsed Chronic Lymphocytic Leukemia (CLL).

Detailed description:
Fludarabine is currently approved for treatment of relapsed Chronic Lymphocytic Leukemia. Studies have shown that drugs in combination with fludarabine have shown more effectiveness than fludarabine alone. The addition of ofatumumab to fludarabine-cyclophosphamide combination offers potentially a more effective therapy, without additional toxicity.

The objective of this study was to determine the effect of ofatumumab added to fludarabine and cyclophosphamide in patients with Chronic Lymphocytic Leukemia who have responded previously to therapy but later develop progressive disease and require additional therapy.

Arms: arm 1: Ofatumumab Cycle 1-Day 1 300mg, Cycle 1-Day 8 1000mg, then Cycles 2-6 Day 1 1000mg every 28 days, Fludarabine 25mg/m2 Days 1-3 every 28 days for 6 cycles, Cyclophosphamide 250 mg/m2 Days 1-3 every 28 days for 6 cycles arm 2: Fludarabine 25mg/m2 Days 1-3 every 28 days for 6 cycles, Cyclophosphamide 250 mg/m2 Days 1-3 every 28 days for 6 cycles
Interventions: intervention 1: OFC Infusion intervention 2: FC infusion
Intervention descriptions: intervention 1: Ofatumumab Cycle 1-Day 1 300mg, Cycle 1-Day 8 1000mg, then Cycles 2-6 Day 1 1000mg every 28 days, Fludarabine 25mg/m2 Days 1-3 every 28 days for 6 cycles, Cyclophosphamide 250 mg/m2 Days 1-3 every 28 days for 6 cycles intervention 2: Fludarabine 25mg/m2 Days 1-3 every 28 days for 6 cycles, Cyclophosphamide 250mg/m2 Days 1-3 every 28 days for 6 cycles

Protocol documents:
Clinical trial NCT00413699
Conditions: Arthritis, Rheumatoid
Keywords: long-term open-label safety
Sponsor: Pfizer
Start date: 2007-02-05; Completion date: 2017-10-26
Enrollment: 4488 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the long-term effectiveness and safety of CP-690,550 for the treatment of rheumatoid arthritis. Subjects are eligible for this study only after participating in another "qualifying" study of CP-690,550

A sub-study will be conducted within the A3921024 study, this study will evaluate the immune response to pneumococcal and influenza vaccines in patients receiving CP-690,550

Detailed description:

Arms: arm 1: Patients enrolling from Phase 2 studies arm 2: Patients enrolling from Phase 3 studies
Interventions: intervention 1: CP-690,550 intervention 2: CP-690,550
Intervention descriptions: intervention 1: 5 mg PO BID open label; may increase to 10 mg PO BID to provide greater control of RA if no related AEs are present. May be off study drug temporarily for up to 28 days for mild to moderate AEs. intervention 2: 10 mg PO BID open label; may decrease to 5 mg PO BID for mild to moderate AEs. May be off study drug temporarily for up to 28 days for mild to moderate AEs.

Protocol documents:
Clinical trial NCT01730729
Conditions: Recurrent Breast Cancer Stage IV Breast Cancer
Sponsor: Northwestern University
Start date: 2013-02-11; Completion date: 2017-10-27
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Prolactin is a hormone produced in the pituitary gland. Previous studies have revealed that elevated levels of the hormone prolactin might be associated with an increased risk of breast cancer. Cabergoline has been shown to lower prolactin levels in the blood.

The purpose of this study is to evaluate the effectiveness of cabergoline in treating metastatic breast cancer disease in those who test positive for the prolactin receptor.

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate overall response rate (ORR) of cabergoline in women with metastatic breast cancer.

SECONDARY OBJECTIVES:

I. Evaluate the progression-free survival (PFS) and overall survival (OS). II. Evaluate toxicity. III. Correlate serum prolactin levels during therapy with response. IV. Evaluate within-patient changes in computed tomography (CT) and bone scan measurements taken at baseline and after 2 cycles of treatment.

V. Evaluate within-patient changes in prolactin receptor (PRLr) expression from baseline to after 1 cycle of treatment in those patients who consent to optional repeat biopsy.

OUTLINE:

Patients receive cabergoline orally (PO) twice weekly for weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days and then every 6 months thereafter.

Arms: arm 1: Patients receive cabergoline oral (PO) twice weekly for weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: cabergoline
Intervention descriptions: intervention 1: Given orally

Protocol documents:
Clinical trial NCT01801111
Conditions: Non-Small-Cell Lung Carcinoma
Sponsor: Hoffmann-La Roche
Start date: 2013-06-20; Completion date: 2017-10-27
Enrollment: 138 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open-label, non-randomized, multicenter, Phase 1/2 study will evaluate the safety and efficacy of alectinib in participants with non-small cell lung cancer who have ALK mutation and failed crizotinib treatment. In Part 1, cohorts of participants will receive escalating doses of alectinib orally twice daily. In Part 2, participants will receive the recommended phase 2 dose (RP2D) of alectinib as determined in Part 1. Treatment will continue in Part 1 and Part 2 on the same dose until disease progression. In Part 3, following disease progression, participants without epidermal growth factor receptor (EGFR) mutation will be offered continued treatment with alectinib, participants with EGFR mutations will be offered a combination of alectinib and erlotinib.

Detailed description:

Arms: arm 1: Participants will receive alectinib treatment continuously starting from Day 1 Cycle 1 (in 28-day cycles) until disease progression, death, or withdrawal for any other reasons, whichever occurs first. After PD, participants without EGFR mutation will continue treatment with alectinib alone and participants with EGFR mutation will receive alectinib in combination with erlotinib as per discretion of the treating physician.
Interventions: intervention 1: Erlotinib intervention 2: Alectinib
Intervention descriptions: intervention 1: Erlotinib will be administered at a dose of 100 mg via tablet, orally, once daily in combination with alectinib to participants who progressed on alectinib alone treatment as per treating physician discretion. intervention 2: Alectinib will be administered at a dose of 600 milligrams (mg) via capsule, orally, twice daily.

Protocol documents:
Clinical trial NCT02300298
Conditions: Carcinoma, Non-Small-Cell Lung
Sponsor: Boehringer Ingelheim
Start date: 2014-12-24; Completion date: 2017-10-27
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To determine the appropriateness of the dose of nintedanib 200 mg b.i.d. plus docetaxel 75 mg/m2 as starting dose by evaluating the safety in Japanese patients with body surface area (BSA) \<1.5 m2 and locally advanced or metastatic adenocarcinoma subtype non-small cell lung cancer (NSCLC) after failure of first line platinum- based chemotherapy

Detailed description:

Arms: arm 1: patients to receive backbone chemotherapy and nintedanib
Interventions: intervention 1: Nintedanib intervention 2: Docetaxel
Intervention descriptions: intervention 1: Nintedanib intervention 2: Docetaxel

Protocol documents:
Clinical trial NCT01461057
Conditions: Gastric Cancer
Sponsor: Hoffmann-La Roche
Start date: 2011-12-06; Completion date: 2017-10-31
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized, multicenter, open-label study will evaluate two different doses of pertuzumab in combination with Herceptin (trastuzumab) and chemotherapy in the first-line treatment of participants with metastatic HER2-positive adenocarcinoma of the stomach or gastroesophageal junction. Participants will be randomized in a 1:1 ratio to two treatment arms. Participants in the Pertuzumab 840/420 mg Arm will receive a pertuzumab loading dose of 840 mg for Cycle 1 and a dose of 420 mg for Cycles 2-6, and participants in the Pertuzumab 840/840 mg Arm will receive pertuzumab 840 mg for all six cycles. Participants in both treatment arms will receive trastuzumab, cisplatin, and capecitabine.

Detailed description:

Arms: arm 1: Participants received pertuzumab as an intravenous (IV) infusion at a loading dose of 840 milligrams (mg) for cycle 1 and a dose of 420 mg every three weeks (Q3W) for cycles 2-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 milligram per meter squared (mg/m\^2) was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m\^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 milligram per kilogram (mg/kg) Q3W for subsequent cycles. arm 2: Participants received 840 mg as an IV infusion Q3W for cycles 1-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 mg/m\^2 was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m\^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg Q3W for subsequent cycles.
Interventions: intervention 1: Capecitabine intervention 2: Cisplatin intervention 3: Pertuzumab intervention 4: Pertuzumab intervention 5: Trastuzumab
Intervention descriptions: intervention 1: 1000 mg/m2 twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle intervention 2: 80 mg/m2 on Day 1 of each cycle intervention 3: loading dose of 840 mg, then 420 mg once every three weeks intervention 4: 840 mg once every three weeks intervention 5: loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg for subsequent cycles

Protocol documents:
Clinical trial NCT00186069
Conditions: Abruptio Placentae
Sponsor: Stanford University
Start date: 2004-03-01; Completion date: 2017-11-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate the safety and efficacy of magnesium sulfate for preterm suspected abruption.

Detailed description:
We hope to learn if there is a difference in the efficacy of intravenous magnesium sulfate versus intravenous saline infusion in the resolution of vaginal bleeding and contractions in patients with a suspected placental abruption.

Arms: arm 1: Magnesium Sulfate 4 gram bolus, followed by 2 grams per hour arm 2: Normal Saline 4 gram bolus, followed by 2 grams per hour
Interventions: intervention 1: Magnesium Sulfate intervention 2: Normal Saline
Intervention descriptions: intervention 1: Magnesium Sulfate 4 gram bolus, followed by a maintenance dose at 2 grams per hour. Rate increases up to 4 grams per hour may be administered per physician discretion. intervention 2: Normal Saline infusion of 4 gram bolus, followed by 2 grams per hour with rate increases up to 4 grams per hour per physician discretion.

Protocol documents:
Clinical trial NCT00946998
Conditions: Chronic Kidney Disease Depression
Keywords: Chronic Kidney Disease Depression Antidepressants randomized controlled trial treatment Sertraline
Sponsor: VA Office of Research and Development
Start date: 2010-02-08; Completion date: 2017-11-01
Enrollment: 201 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized double-blinded placebo-controlled trial to see if treatment with sertraline as compared with placebo tablets will improve depression symptoms in patients with chronic kidney disease who have not yet started dialysis or received a kidney transplant. The investigators will also investigate whether sertraline treatment will improve quality of life and whether it is safe to use in patients with kidney disease. The study subject will be randomly assigned to take either sertraline or a placebo tablet for 12 weeks.

Detailed description:
This is a randomized double-blinded placebo-controlled trial of adults with predialysis stages 3-5 Chronic Kidney Disease and Major Depressive Episode. Subjects will be randomized in a double-blind fashion to placebo or sertraline (beginning at 50 mg/d and escalated by 50 mg increments every 2 weeks to a maximum of 200 mg/d) and followed for 12 weeks. The primary outcome is to investigate if treatment with sertraline, as compared with placebo, results in an improvement in depression symptom severity as measured by the Quick Inventory of Depressive Symptomatology Clinician Rated (QIDS-C-16) score. Secondary outcomes include whether sertraline, as compared with placebo, improves overall function and quality of life and whether it will result in more serious adverse events.

Arms: arm 1: Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode arm 2: Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode
Interventions: intervention 1: Sertraline intervention 2: placebo
Intervention descriptions: intervention 1: Sertraline is a serotonin-selective reuptake inhibitor (SSRI) used to treat major depression. Dosage will begin at 50 mg/d and will be escalated by 50 mg increments every 2 weeks to a maximum of 200 mg/d intervention 2: Placebo tablet will be identical and matched to sertraline tablet.

Protocol documents:
Clinical trial NCT01058239
Conditions: Post-transplant Lymphoproliferative Disease Solid Organ Transplant Stem Cell Transplant (Bone Marrow Transplant) Epstein Barr Virus Infections
Keywords: bortezomib rituximab PTLD EBV transplantation
Sponsor: Massachusetts General Hospital
Start date: 2011-11-01; Completion date: 2017-11-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Post transplant lymphoproliferative disease (PTLD) is a type of B-cell non-Hodgkin lymphoma that occurs in patients with weakened immune systems due to immunosuppressive medications taken after organ or stem cell transplantation. This is usually related to a virus called Epstein-Barr (EPV). Rituximab is a type of drug called an "antibody" that specifically destroys both normal and cancerous B-cells, and is commonly used for PTLD. Bortezomib is a drug that has been approved by the Food and Drug Administration (FDA) to treat multiple myeloma and a B-cell non-Hodgkin lymphoma called Mantle Cell Lymphoma, and shows significant activity in lymphoma cells caused by EBV. In this research study, we hope to learn if the addition of bortezomib to rituximab treatment can increase the rate of complete remissions and cures of PTLD after organ or stem cell transplant.

Detailed description:
* Both rituximab and bortezomib will be given to participants intravenously. Each cycle of treatment will consist of 21 days. Rituximab will be given on Days 1, 8 and 15 of Cycle 1 and on Day 1 of subsequent cycles. Bortezomib will be given on Days 1, 4, 8 and 11 of every cycle. Participants will receive a maximum of 4 cycles.
* The following study procedures will be performed during each cycle throughout the study: Medical history review; Physical exam; Performance Status; Questionnaire; Blood draws and; PET/CT scans (After cycles 2, 4 and 6 only).
* After Cycle 4, if the study doctor feels the participant has had a complete response to treatment, then they will continue onto the Post-Treatment Surveillance period, which will consist of regular clinic visits over two years.
* However, if the study doctor feels the participant has had a partial response to treatment and that they may benefit from continuing, they will receive an additional two cycles of bortezomib and be given daily tablets of the antiviral drug valganciclovir to help further target EBV.

Arms: arm 1: This is a single arm trial adding the new drug bortezomib to the standard drug rituximab
Interventions: intervention 1: bortezomib intervention 2: rituximab
Intervention descriptions: intervention 1: Given intravenously on days 1, 4, 8 and 11 of every cycle intervention 2: given intravenously on days 1, 8 and 15 of Cycle 1 and on Day 1 of subsequent cycles

Protocol documents:
Clinical trial NCT01065844
Conditions: Carcinoma, Adenoid Cystic Head and Neck Neoplasms
Keywords: Nelfinavir
Sponsor: University of Iowa
Start date: 2009-10-01; Completion date: 2017-11-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the FDA-approved drug nelfinavir (NFV) as an oncologic agent for adenoid cystic cancers of the head and neck.

Specifically, subjects will be asked to take 1250 mg twice daily and follow-up with their medical oncologist as clinically indicated while taking this medication.

Subjects would be evaluated for quality of life issues utilizing the EORTC QLQ-C30 2-page questionnaire.

Subjects would also be evaluated clinically by the oncologist to determine if the NFV was having an anti-neoplastic effect.

The study remains unfunded. Therefore, potential subjects must be willing to provide self-travel to study site. This study requires a screening visit, initial study visit, and monthly follow-up. Subjects are not reimbursed for time, travel, or physician costs.

Detailed description:
The hypothesis of this study is that nelfinavir, by inhibiting the Akt and MAPK pathways, can inhibit adenoid cystic carcinoid growth. These cancers are heavily dependent on these signalling pathways.

Adenoid cystic carcinomas (ACC) are rare and account for about 1% of all head and neck cancers. They stem from salivary glands and are known for their tendency to spread along nerve sheaths (perineural spread). ACC is known for its prolonged clinical course, multiple recurrence and the delayed onset of distant metastases. The median/mean age at presentation is 47-56. Although 5 year disease free survivals (DFS) are 65-70%, the 15 year DFS drops to 30-40%. If followed long enough, 35% of patients will eventually develop metastatic disease.

The most common treatment of ACC is surgery followed by post-operative radiotherapy. When ACC recurs, management options are often limited both by the morbidity and low efficacy of re-irradiation and repeated surgical resection. Reported response rates to chemotherapy are low and when it occurs, the duration of the response is short lived.

In an effort to explore possible targeted therapies for patients with recurrent ACC, Dr. Gupta's lab examined the activation of 3 signaling proteins (EGFR, Akt, and MAPK) in 9 different paraffinized tissue blocks. Initial indications from in vitro studies demonstrates NFV is tumoricidal at clinically achievable concentrations. To explore the clinical benefit of this FDA-approved medication, we seek to implement its off label use in patients who have failed all other therapies and have no other therapeutic options left.

Arms: arm 1: 1250 mg Nelfinavir twice daily Monday-Sunday
Interventions: intervention 1: Nelfinavir
Intervention descriptions: intervention 1: 1250 mg Nelfinavir twice daily Monday - Sunday

Protocol documents:
Clinical trial NCT01182441
Conditions: Atrial Fibrillation Stroke
Keywords: atrial fibrillation stroke TIA trans ischemic attack warfarin Coumadin
Sponsor: Boston Scientific Corporation
Start date: 2010-11-01; Completion date: 2017-11-01
Enrollment: 407 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a prospective, randomized, multicenter study to provide additional information on the safety and efficacy of the WATCHMAN LAA Closure Technology. The purpose of the PREVAIL study was to confirm the efficacy endpoint as demonstrated in the PROTECT AF pivotal study and to further demonstrate that the WATCHMAN LAA Closure Technology is safe and effective in subjects with non-valvular atrial fibrillation who require anticoagulation therapy for potential thrombus formation.

Detailed description:

Arms: arm 1: Subjects assigned to receive the WATCHMAN device. arm 2: Subjects assigned to warfarin therapy.
Interventions: intervention 1: WATCHMAN Device intervention 2: Warfarin
Intervention descriptions: intervention 1: WATCHMAN Left Atrial Appendage Closure Technology intervention 2: Warfarin dosage prescribed by study physician to adequately maintain an INR of 2.0-3.0

Protocol documents:
Clinical trial NCT01781611
Conditions: Systemic Lupus Erythematosus
Keywords: lupus dipyridamole
Sponsor: Oklahoma Medical Research Foundation
Start date: 2013-02-01; Completion date: 2017-11-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Dipyridamole, a medication extensively used in combination with aspirin for stroke prevention, is a promising new treatment for lupus. Dipyridamole has been shown to inhibit certain lymphocyte populations that are over-reactive in lupus and to delay the emergence of lupus-related pathology in mice with lupus. The investigators are interested in investigating the efficacy of dipyridamole in preventing flares in patients with lupus and its impact on biomarkers of disease activity.

Detailed description:
T cells in systemic lupus erythematosus (SLE) express an abnormal phenotype characterized by increased effector functions and deficient regulatory responses. Dipyridamole, a phosphodiesterase inhibitor extensively used in combination with low dose aspirin in secondary stroke prevention, has been proposed as a specific T cell directed treatment for SLE. Dipyridamole inhibits the calcium/calcineurin/NF-AT pathway in SLE T cells in vitro and abrogates expression of cytokines and costimulatory molecules, eventually also affecting B cell responses. Dipyridamole delays the emergence of lupus related pathology in lupus prone mice, but has not yet been studied in humans with SLE. The investigators aim to investigate the efficacy of dipyridamole in the prevention of flares in SLE patients after withdrawal of background immunosuppressive medications. The investigators will additionally evaluate the safety and tolerability of dipyridamole and its impact on quality of life measures in this population. Furthermore, the effect of dipyridamole on T and B cell biomarkers will be examined.

Arms: arm 1: extended release dipyridamole 200mg/aspirin 25mg twice daily for 24 weeks arm 2: half a tablet of a 81mg aspirin twice daily for 24 weeks
Interventions: intervention 1: extended release dipyridamole 200mg/aspirin 25mg intervention 2: 81mg aspirin
Intervention descriptions: intervention 1: one tablet twice daily for 24 weeks intervention 2: half a tablet twice daily for 24 weeks

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT02547233
Conditions: Actinic Keratosis
Sponsor: LEO Pharma
Start date: 2015-11-01; Completion date: 2017-11-01
Enrollment: 437 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the trial is to compare the short term efficacy of LEO 43204 gel with vehicle gel in AK on face or chest when applied topically once daily for 3 consecutive days as field treatment.

Detailed description:

Arms: arm 1: Treatment once daily for 3 days arm 2: Treatment once daily for 3 days
Interventions: intervention 1: LEO 43204 gel intervention 2: Vehicle gel
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents: