ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00542191
Conditions: Breast Cancer
Keywords: Triple negative (ER/PR negative; HER2 negative)
Sponsor: Leo W. Jenkins Cancer Center
Start date: 2007-07-01; Completion date: 2016-08-02
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This neoadjuvant chemotherapy protocol focusing on "triple-negative" breast cancers alone will gather a foundation of primary tumor and axillary lymph nodal response to primary chemotherapy and ongoing correlated disease-free (DFS) and overall survival (OS) outcome data. This comparative data can then be used in building subsequent trials.

Detailed description:
Women with a diagnosed "triple-negative" proxy of basal-like breast cancer confirmed on a core biopsy and larger than 2 cm will be treated neoadjuvantly with the Livingston metronomic regimen of 12 weeks of weekly doxorubicin 24 mg/m2 and daily oral cyclophosphamide 60 mg/m2 followed by 12 successive weeks of taxol 80 mg/m2 and carboplatin AUC 2. Although clinical response will be evaluated prior to surgery, the primary end-point is the pathologic response. Secondary end-points will be DFS and OS based upon standard of care surveillance. A pathologic complete response (pCR) will require no histologic evidence of residual malignant cells seen in the primary tumor area specimen or the lymph nodes. Standard of care surgery and radiation therapy will be undertaken.

Arms: arm 1: Neoadjuvant chemotherapy with metronomic AC followed by weekly TC then surgery
Interventions: intervention 1: Doxorubicin / Cyclophosphamide / Paclitaxel / Carboplatin intervention 2: Definitive Surgery intervention 3: Radiotherapy
Intervention descriptions: intervention 1: DOXORUBICIN 24mg/m2 IV plus CYCLOPHOSPHAMIDE 60mg/m2 PO weekly x 12 successive weeks followed by PACLITAXEL 80mg/m2 IV over 1 hour plus CARBOPLATIN AUC 2 IV weekly x 12 successive weeks intervention 2: Standard of care definitive surgery as determined by medical provider intervention 3: Standard of care RADIATION THERAPY as indicated

Protocol documents:
Clinical trial NCT01743859
Conditions: Acute Myeloid Leukemia
Keywords: Myeloid Leukemia
Sponsor: University of Colorado, Denver
Start date: 2012-12-06; Completion date: 2016-08-03
Enrollment: 37 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to determine the complete remission/complete remission with incomplete recovery of blood counts (CR/CRi) rate for relapsed and refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS) patients.

Detailed description:
AML patients with relapsed and refractory disease have very poor outcomes. Sequential azacitidine and lenalidomide was recently shown by the PI of this study to be well-tolerated and effective in elderly, treatment naïve AML patients. Observations from this study and others that have piloted this combination have suggested that patients who received and failed prior treatments may also respond to this regimen. Therefore, the sequential combination of azacitidine with lenalidomide could potentially improve outcomes for relapsed and refractory AML patients by providing them with a treatment option that is tolerable and potentially clinically synergistic. To determine the efficacy of this combination in this population, we will pilot this phase 2 study.

Arms: arm 1: Patients will receive 7 days of azacitidine followed by 3 weeks of lenalidomide. They will then have 2 weeks off therapy, for a maximum of 12 cycles.
Interventions: intervention 1: Azacitidine intervention 2: Lenalidomide intervention 3: Off Therapy
Intervention descriptions: intervention 1: Enrolled patients will receive 75 mg/m2 of azacitidine subcutaneously (SC) or intravenously (IV) on days 1-7 alone. intervention 2: Beginning on day 8, patients will receive 50 mg of lenalidomide PO, and will take this daily from day 8 through 28. intervention 3: 2 weeks off therapy, then begin sequence again for 12 weeks.

Protocol documents:
Clinical trial NCT02017015
Conditions: Pancreatic Neoplasms
Keywords: Pancreatic cancer Metastatic pancreatic cancer treatment for pancreatic cancer Abraxane clinical research trials Celgene clinical research trials
Sponsor: Celgene
Start date: 2013-12-24; Completion date: 2016-08-03
Enrollment: 83 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the safety and efficacy of nab-paclitaxel combined with gemcitabine in Chinese patients with metastatic pancreatic cancer.

Detailed description:
This is a Phase 2 trial in China to evaluate the safety and efficacy of the combination of nab-paclitaxel and gemcitabine administered in patients diagnosed with metastatic pancreatic adenocarcinoma. This study is designed to be a Chinese bridging study to complement the Global pivotal study (CA-046).

The study consists of three parts: (1) Dose evaluation; (2) Single arm to evaluate efficacy following an optimal Simon two-stage design; and (3) Randomized 2-arm to evaluate the efficacy and safety of nab-paclitaxel plus gemcitabine versus gemcitabine alone. These 3 parts will be carried out sequentially. The Part 3 randomized 2-arm portion will only be carried out if deemed necessary per protocol.

Arms: arm 1: nab-paclitaxel at 125 mg/m\^2, intravenous (IV) infusion over 30 to 40 minutes followed by gemcitabine at 1000 mg/ m\^2 IV infusion over 30 to 40 minutes given once weekly for 3 weeks (Days 1, 8 and 15) followed by a week of rest (28 day cycle).
Interventions: intervention 1: nab-paclitaxel intervention 2: Gemcitabine
Intervention descriptions: intervention 1: nab-paclitaxel at 125 mg/m\^2, by IV infusion over 30 to 40 minutes (maximum infusion time not to exceed 40 minutes) intervention 2: Gemcitabine at 1000 mg/m\^2 IV infusion over 30 to 40 minutes given once weekly for 3 weeks (Days 1, 8 and 15) followed by a week of rest (28 day cycle).

Protocol documents:
Clinical trial NCT02303574
Conditions: Safety, Pharmacokinetics, Pharmacodynamics, Food Effect
Keywords: AZD7986, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Food Effect, First-in-human, Single Ascending Dose, Multiple Ascending Dose, Healthy Subjects
Sponsor: AstraZeneca
Start date: 2014-12-03; Completion date: 2016-08-03
Enrollment: 89 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase I, randomised, single-blind placebo-controlled, 2-part study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of single and multiple oral doses of AZD7986 in healthy volunteers

Detailed description:

Arms: arm 1: In Part 1 up to 8 cohorts with single doses starting with 5 mg AZD7986 as oral solution. In Part 2 up to 5 cohorts with multiple doses of AZD7986 as oral solution arm 2: In Part 1 up to 8 cohorts and in Part 2 up to 5 cohorts with matching placebo to AZD7986 as oral solution
Interventions: intervention 1: AZD7986, oral solution, 1 to 50 mg/mL intervention 2: Placebo, oral solution
Intervention descriptions: intervention 1: Starting dose in single ascending dose part: 5 mg intervention 2: Matching placebo

Protocol documents:
Clinical trial NCT02758171
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2016-05-17; Completion date: 2016-08-03
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective of this trial is to investigate the bioequivalence of one fixed dose combination tablet of empagliflozin/linagliptin (Test, T) compared with the free combination of one empagliflozin tablet and one linagliptin tablet (Reference, R) administered as single dose under fasted conditions.

Detailed description:

Arms: arm 1: One tablet fix dose combination (FDC) arm 2: None
Interventions: intervention 1: Empagliflozin intervention 2: Linagliptin
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02046603
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2014-03-04; Completion date: 2016-08-04
Enrollment: 162 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This open-label study will evaluate the efficacy and safety of tocilizumab as monotherapy or in combination with methotrexate or other non-biologic disease modifying anti-rheumatic drugs (DMARDs) in participants with active rheumatoid arthritis (RA) and an inadequate response to current non-biologic DMARD therapy or the first anti-tumour necrosis factor (anti-TNF) agent. Participants will receive tocilizumab 162 milligrams (mg) subcutaneously once a week for 52 weeks.

Detailed description:

Arms: arm 1: Participants will receive a weekly SC injection of tocilizumab 162 mg as monotherapy for 52 weeks. arm 2: Participants will receive a weekly SC injection of tocilizumab 162 mg in combination with methotrexate or other non-biologic DMARDs for 52 weeks.
Interventions: intervention 1: Tocilizumab intervention 2: DMARDs intervention 3: Oral Corticosteroids intervention 4: Methotrexate
Intervention descriptions: intervention 1: Tocilizumab 162 mg will be administered once a week by SC injection and as a single fixed dose, irrespective of body weight, for the treatment duration of 52 weeks. intervention 2: Treatment with non-biologic DMARDs, at a stable dose that was initiated at least 4 weeks prior to baseline, is permitted during the study. The study protocol does not specify any particular therapy. intervention 3: Stable oral corticosteroids doses (≤10 mg/day prednisone or equivalent) are allowed. The study protocol does not specify any additional detail on types of oral corticosteroids. intervention 4: Methotrexate per investigator's discretion.

Protocol documents:
Clinical trial NCT01201850
Conditions: Radiation Necrosis
Keywords: radiation necrosis Bevacizumab (Avastin®) Central Nervous System Tumors
Sponsor: University of Colorado, Denver
Start date: 2010-06-28; Completion date: 2016-08-04
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is being done to learn about the safety of the study drug bevacizumab(Avastin®), when used to treat radiation necrosis.

The primary objective of this study is to test the feasibility of treating Central Nervous System (CNS) tumor patients suffering from radiation necrosis with bevacizumab every 2 weeks.

The secondary objectives of this study are:

* To evaluate improvement in neurologic symptoms associated with bevacizumab as assessed by clinical evaluation;
* To investigate the neuro-imaging changes in radiation necrosis associated edema, including Mass Resonance (MR) spectroscopy;
* To evaluate changes in corticosteroid use in patients with radiation necrosis following treatment with bevacizumab;
* To evaluate changes in quality of life.

Detailed description:
Treatment Plan:

For patient consented and enrolled on study, bevacizumab will be administered at a dose of 10 mg/kg IV every 2 weeks for a total of 6 doses (3 doses/cycle).

Patients are expected to receive at least 1 cycle (6 weeks) of study treatment unless an unacceptable drug reaction occurs. Patients will receive a second cycle of treatment as long as treatment is tolerated. Response assessment will be performed every 6 weeks (three doses/cycle of study drug) including clinical and radiological assessment. Secondary measures including documentation of total equivalent steroid dose, length of time on steroids, and quality of life using the modified McMaster Health Instrument scale will also be collected while on treatment and 30 days after finishing treatment.

Safety will be assessed by routine physical and laboratory evaluations. Adverse events will be recorded and the severity graded according to the NCI Common Terminology Criteria for Adverse Events (version 4.0).

Arms: arm 1: Once enrolled on study, patients will be treated with bevacizumab (10mg/kg) intravenously (i.v.) every 2 weeks for a total of 6 doses.
Interventions: intervention 1: Bevacizumab (Avastin®)
Intervention descriptions: intervention 1: Once enrolled on study, patients will be treated with bevacizumab (10mg/kg) intravenously (i.v.) every 2 weeks for a total of 6 doses. An MRI will be done after the first cycle (3 doses/ 6weeks) and then again at the end of therapy.

Protocol documents:
Clinical trial NCT01731990
Conditions: Peripheral Artery Disease
Keywords: Peripheral artery disease Intermittent claudication magnetic resonance imaging
Sponsor: Novartis Pharmaceuticals
Start date: 2012-10-30; Completion date: 2016-08-04
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was designed to assess the safety, tolerability and efficacy of ACZ885 on the leg artery structure and physical activity in patients with atherosclerotic peripheral artery disease and leg pain from walking.

Detailed description:

Arms: arm 1: Monthly subcutaneous doses of Canakinumab 150 mg/1 mL for 12 months arm 2: Monthly subcutaneous doses of placebo of Canakinumab 150 mg/1 mL for 12 months
Interventions: intervention 1: Canakinumab (ACZ885) intervention 2: Placebo
Intervention descriptions: intervention 1: Dosage form: solution for injection Strength: 150 mg/1 mL Mode of administration: subcutaneous use. intervention 2: Matching placebo of Canakinumab

Protocol documents:
Clinical trial NCT02436304
Conditions: Otitis Media With Effusion in Children Otitis Media Recurrent
Sponsor: Alcon Research
Start date: 2015-06-19; Completion date: 2016-08-04
Enrollment: 404 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate EXE844 plus tympanostomy tubes compared to tympanostomy tubes only based on sustained clinical cure at end-of-therapy (EOT).

Detailed description:

Arms: arm 1: EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops, twice daily (BID) in each ear for 7 days after Tympanostomy Tube Insertion arm 2: EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion arm 3: Bilateral myringotomy and tympanostomy tube insertion
Interventions: intervention 1: EXE844 Sterile Otic Suspension, 0.3% intervention 2: Tympanostomy Tube Insertion
Intervention descriptions: intervention 1: None intervention 2: Surgical procedure for treating pediatric cases of recurrent or chronic otitis media

Protocol documents:
Clinical trial NCT01801917
Conditions: Polymyositis
Keywords: Polymyositis Myositis PM chronic muscle inflammation inflammatory myopathy inclusion body myositis
Sponsor: Novartis Pharmaceuticals
Start date: 2013-04-24; Completion date: 2016-08-05
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study assessed the efficacy, safety and tolerability of BAF312 administered orally in patients with clinically active polymyositis and also in patients with polymyositis who had shown inadequate response to corticosteroids and or DMARDs (disease modifying antirheumatic drugs).

Detailed description:
This study was stopped prematurely due to overall slow recruitment and no evidence for efficacy in a parallel study in dermatomyositis with an assumed similar pathophysiology. With very small sample sizes per group the overall results for this study including primary and all other efficacy and PD data are inconclusive

Arms: arm 1: 5 placebo tablets daily during non-titration phase arm 2: 1 tablet of BAF312 2 mg + 4 tablets of Placebo daily during non-titration phase arm 3: 5 tablets of BAF312 2 mg daily during non-titration phase
Interventions: intervention 1: Placebo intervention 2: BAF312
Intervention descriptions: intervention 1: Matching placebo tablet for oral administration intervention 2: BAF312 in 4 dosage strengths in tablet form: 0.25 mg, 0.5 mg, 1 mg, 2 mg for oral administration

Protocol documents:
Clinical trial NCT02195895
Conditions: Spinal Cord Injury Bone Loss Osteoporosis
Keywords: Teriparatide Alendronate Alendronic Acid Osteoporosis Bone Fracture Bone Loss Spinal Cord Injury Bone Diseases Metabolic Bone Diseases Musculoskeletal Diseases Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases Nervous System Wounds and Injuries Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions
Sponsor: Northwestern University
Start date: 2014-04-01; Completion date: 2016-08-05
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if a year of alendronate treatment will maintain or increase bone mass density (BMD) compared to baseline BMD values in people with chronic spinal cord injury (SCI).

This study will also investigate 1) if alendronate therapy will increase bone strength in people with chronic SCI, 2) the number of participants with adverse events from alendronate, and 3) the effects of alendronate on serum markers of bone metabolism.

Detailed description:
This extension study will enroll individuals who have completed treatment in the parent protocol "Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury" or in the teriparatide extension protocol. This study will allow those individuals who previously received teriparatide to be treated for a year with alendronate to maintain any bone they may have gained and to possibly increase bone mass further. Termination of teriparatide is followed by bone loss if anti-resorptive therapy is not initiated, so this approach is optimal for continued treatment of the current group of participants.

Arms: arm 1: Drug: Weekly oral alendronate 70 mg for 12 months

Supplements: 1000 mg Calcium and 1000 IU Vitamin D daily for 12 months
Interventions: intervention 1: Alendronate intervention 2: Calcium intervention 3: Vitamin D
Intervention descriptions: intervention 1: Weekly oral alendronate 70 mg for 12 months intervention 2: Daily oral 1000 mg Calcium intervention 3: Daily oral 1000 IU

Protocol documents:
Clinical trial NCT02500979
Conditions: Type 1 Diabetes Mellitus
Keywords: Type 1 Diabetes Mellitus; Pramlintide
Sponsor: AstraZeneca
Start date: 2015-08-17; Completion date: 2016-08-05
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study is designed to investigate the clinical efficacy and safety of pramlintide co-administered as a fixed-dose ratio with basal-bolus SC insulin, delivered simultaneously via 2 separate pumps, in subjects with type 1 diabetes who are failing to achieve the desired level of glycemic control using insulin therapy.

Detailed description:
Potentially eligible subjects with Type 1 diabetes mellitus who are treated with with a basal-bolus insulin regimen through multiple daily injections or insulin pump at a total daily insulin dose ≤60 U, will be eligible. Visit 1 is approximately 3-6 weeks prior to randomization. Given some variability in HbA1c and C-peptide assays, re-testing for HbA1c and C-peptide can be performed within 18 days from the initial visit. Visit 2 is approximately 2-5 weeks prior to randomization. Subjects are on lispro insulin throughout study except during Visit 4 and Visit 5, the domicile 24 hr treatment period, when they are switched to regular insulin U-100.

Screen failed patients may be re-screened for inclusion in the study, as long as re-screening takes place at least 3 months after the original screening visit. If a subject is re-screened, he/she must continue to meet all inclusion/exclusion criteria. All study procedures of initial Visit 1 must be repeated at the re-screening visit.

Arms: arm 1: Pramlintide will be adiministered by sc infusion at a concentration of 1000ug/mL arm 2: Placebo is similar sterile solution without pramlintide.
Interventions: intervention 1: Pramlintide acetate intervention 2: Placebo intervention 3: Lispro insulin U-100 intervention 4: Regular insulin U-100
Intervention descriptions: intervention 1: Pramlintide acetate administered by a separate pump intervention 2: Placebo administered by separate pump intervention 3: Subjects will be stabilized on a separate insulin pump and administered lispro insulin throughout the study, except during both inpatient treatment periods (Visit 4 and Visit 5) intervention 4: Use during two in-patient treatment periods (visits 4 and 5) and administered by separate pump

Protocol documents:
Clinical trial NCT02802735
Conditions: Pharmacokinetics
Keywords: Pharmacokinetics Apremilast Healthy Adult Male Korean Subjects
Sponsor: Amgen
Start date: 2016-06-22; Completion date: 2016-08-05
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This two-part study was designed to evaluate the pharmacokinetics (PK) of single and multiple doses of apremilast in healthy adult Korean males.

Detailed description:
The study will consist of two parts. Part 1 will evaluate the PK of ascending single doses of apremilast. Part 2 will evaluate the PK of apremilast when administered as multiple doses over 14 days.

Arms: arm 1: A single oral dose of 20 mg apremilast. arm 2: A single oral dose of 30 mg apremilast. arm 3: A single oral dose of 40 mg apremilast. arm 4: 30 mg apremilast orally twice a day (BID) for 14 days. arm 5: Matching placebo orally twice a day for 14 days.
Interventions: intervention 1: Apremilast intervention 2: Placebo
Intervention descriptions: intervention 1: Tablet for oral administration intervention 2: Tablet for oral administration

Protocol documents:
Clinical trial NCT01357161
Conditions: Ovarian Cancer
Sponsor: Merck Sharp & Dohme LLC
Start date: 2011-07-26; Completion date: 2016-08-08
Enrollment: 136 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study of the safety and efficacy of adavosertib in combination with paclitaxel plus carboplatin in the treatment of ovarian, fallopian tube, and primary peritoneal tumors with the P53 mutation. In Part 1, a small group of participants will receive adavosertib along with paclitaxel plus carboplatin to establish the tolerability of adavosertib with this combination. In Part 2, participants will be randomly assigned to receive either adavosertib plus paclitaxel and carboplatin OR placebo plus paclitaxel and carboplatin to assess efficacy of adavosertib compared to placebo. The primary hypothesis of the study (Part 2) is that administration of adavosertib in combination with paclitaxel plus carboplatin in participants with platinum sensitive p53 mutant ovarian cancer will result in improvement in progression free survival (PFS) per enhanced Response Evaluation Criteria In Solid Tumors version 1.1 (enhanced RECIST 1.1) compared to participants treated with paclitaxel plus carboplatin alone.

Detailed description:

Arms: arm 1: During the open-label run-in, participants receive 225 mg adavosertib twice daily (BID) starting on Day 1 of Cycle 1 (cycle=21 days) for a total of 5 doses. Participants receive adavosertib in combination with paclitaxel (175 mg/m2) and carboplatin (area under the curve \[AUC\] 5). arm 2: During Part 2, participants receive 225 mg adavosertib BID starting on Day 1 of each 21 day cycle for a total of 5 doses. Participants receive adavosertib in combination with paclitaxel (175 mg/m2) and carboplatin (AUC 5). arm 3: During Part 2, participants receive matched placebo to adavosertib BID starting on Day 1 of each 21 day cycle for a total of 5 doses. Participants receive placebo in combination with paclitaxel (175 mg/m2) and carboplatin (AUC 5).
Interventions: intervention 1: adavosertib intervention 2: Placebo intervention 3: paclitaxel intervention 4: carboplatin
Intervention descriptions: intervention 1: Adavosertib capsules, orally, twice a day (BID) for a total of 5 doses starting on Day 1 of each 3-week cycle intervention 2: placebo to adavosertib, capsule, orally, BID for a total of 5 doses, starting on Day 1 of each 3-week cycle intervention 3: paclitaxel, intravenous (IV) infusion on Day 1 of each 3-week cycle intervention 4: carboplatin, IV infusion on Day 1 of each 3-week cycle

Protocol documents: