ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01595009
Conditions: Neuroendocrine Tumors
Sponsor: Novartis Pharmaceuticals
Start date: 2011-04-27; Completion date: 2016-08-09
Enrollment: 246 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This record combines the results of CRAD001K24133 and CRAD001K24133E1. The purpose of the CRAD001K24133 study was to evaluate the safety profile of everolimus in patients with advanced neuroendocrine tumors of pancreatic origin (pNETs) and to provide access of everolimus to this patient population. Everolimus was taken by participants until disease progression, unacceptable toxicity, death, discontinuation from the trial for any other reason, or when it became commercially available for this indication, or until May 30, 2012, whichever came first. Prior to amendment 1, the study enrolled participants with NET of the lung (L-NETs) and gastrointestinal (GI) (GI-NETs) origin. The core study was stopped (per protocol) because everolimus was approved for pNETs. All ongoing patients with pNETs were switched to commercially available everolimus. For GI and lung NETs, everolimus was not approved at the time the core study was stopped. Therefore, patients with GI or lung NETs were not able to switch to commercial drug. To provide study medication access to these patients beyond 30 May 2012, the open label extension study, CRAD001K24133E1, was conducted. In the extension study, RAD001K24133E1, participants with GI or lung NETs who had not progressed during therapy with everolimus in the core study and who had not suffered from intolerable toxicity, were enrolled and treated with everolimus in order to provide data on long-term safety and efficacy. Patients were treated until it became commercially available in the respective indication or until documented tumor progression, unacceptable toxicity, any other reason or until study end on 31 May 2017, whichever came first.

Detailed description:

Arms: arm 1: Participants received Everolimus 10 mg orally once daily until documented tumor progression, unacceptable toxicity or any other reason.
Interventions: intervention 1: Everolimus (RAD001)
Intervention descriptions: intervention 1: Everolimus was supplied as tablets of 5mg strength.

Protocol documents:
Clinical trial NCT01294319
Conditions: Cortisol Resistance Negative Feedback ACTH Mineralcorticoid Glucocorticoid
Keywords: Cortical Resistance ACTH Glucocorticoid Mifepristone SPIRONOLACTONE Exercise Hypothalamic-Pituitary-Adrenal Axis Healthy Volunteer HV
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date: 2011-01-24; Completion date: 2016-08-10
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study proposes to examine multiple aspects of the hypothalamic-pituitary-adrenal axis in younger endurance trained and sedentary men, and in older sedentary men.

Detailed description:
Adrenocorticotropin (ACTH) secretion is normally exquisitely regulated through endogenous stimulation by corticotrophin-releasing hormone (CRH) and negative feedback inhibition by cortisol, resulting in a circadian rhythm of cortisol. Recent evidence suggests that older men, and younger men who are endurance-trained athletes, both have reduced sensitivity to negative feedback, and perhaps increased basal levels of cortisol and ACTH. To investigate these possibilities, we propose to examine multiple aspects of the hypothalamic-pituitary-adrenal axis in younger endurance trained and sedentary men, and in older sedentary men.

Subjects will collect saliva during two evenings before additional testing, and will on the same evening collect urine for twelve hours, both for cortisol measurements. Blood samples will be collected to evaluate the response to dexamethasone. We also will assess ACTH and cortisol responses to medications that reduce negative inhibition of ACTH. This testing will occur in the evening and will include administration of the glucocorticoid antagonist mifepristone, the mineralocorticoid antagonist spironolactone, and/or a look-alike tablet, on four occasions.

Arms: arm 1: Spironolactone, Then Mifepristone, Then Combined, Then Placebo (SMCP), Then Dexamethasone arm 2: Spironolactone, Then Mifepristone, Then Combined, Then Placebo (SMCP), Then Dexamethasone arm 3: Mifepristone, Then Spironolactone, Then Placebo, Then Combined (MSPC), Then Dexamethasone arm 4: Mifepristone, Then Spironolactone, Then Placebo, Then Combined (MSPC), Then Dexamethasone arm 5: Combined, Then Placebo, Then Spironolactone, Then Mifepristone (CPSM), Then Dexamethasone arm 6: Combined, Then Placebo, Then Spironolactone, Then Mifepristone (CPSM), Then Dexamethasone arm 7: Placebo, Then Combined, Then Mifepristone, Then Spironolactone (PCMS), Then Dexamethasone arm 8: Placebo, Then Combined, Then Mifepristone, Then Spironolactone (PCMS), Then Dexamethasone
Interventions: intervention 1: Mifepristone intervention 2: Placebo intervention 3: Spironolactone intervention 4: Combined intervention 5: Dexamethasone
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None

Protocol documents:
Clinical trial NCT01327885
Conditions: Soft Tissue Sarcoma
Sponsor: Eisai Inc.
Start date: 2011-03-10; Completion date: 2016-08-10
Enrollment: 452 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, open-label, multicenter, Phase 3 study comparing the efficacy and safety of eribulin with dacarbazine in subjects with advanced soft tissue sarcoma who have disease progression within 6 months prior to study enrolment following standard therapies which must have included an anthracycline, unless contraindicated and then at least one additional regimen after failure of the anthracycline.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Eribulin mesylate 1.4 mg/m^2 intravenous intervention 2: Dacarbazine of 850 mg/m^2, or 1,000 mg/m^2, or 1,200 mg/m^2 IV
Intervention descriptions: intervention 1: Administration of eribulin mesylate at a dose of 1.4 mg/m\^2 as an intravenous (IV) bolus infusion over 2-5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days. intervention 2: Administration of dacarbazine at a dose of 850 mg/m\^2, or 1,000 mg/m\^2, or 1,200 mg/m\^2 selected by the Principal Investigator \[PI\] or designee according to the subject's clinical status as an IV infusion over 15-30 minutes on Day 1 of every cycle, where the duration of each cycle is 21 days.

Protocol documents:
Clinical trial NCT01389596
Conditions: Epilepsy, Partial Seizures
Keywords: safety efficacy partial onset seizures pediatric pregabalin placebo-controlled double-blind
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2011-09-27; Completion date: 2016-08-10
Enrollment: 295 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study A0081041 is a double blind, placebo controlled, randomized, parallel group, multicenter study to evaluate the safety and efficacy of two dose levels of pregabalin administered in equally divided daily doses, in either capsule or oral liquid formulation, as adjunctive therapy in pediatric subjects 4 to 16 years of age with partial onset seizures.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Pregabalin add-on therapy intervention 2: Pregabalin add-on therapy intervention 3: Pregabalin add-on therapy
Intervention descriptions: intervention 1: Subjects will be randomized to receive a fixed dose of either placebo, pregabalin Level 1 (maximum 150 mg/day) or pregabalin Level 2 (maximum 600 mg/day) in a 1:1:1 ratio, in addition to the subjects current AED medication regimen. Either capsules or oral liquid form will be administered, depending on subjects preference and ability to swallow capsules, in two equally divided daily doses. The study will have an 8 week baseline period; a 2 week dose escalation period; a 9 week dose maintenance period; and a 1 week dose taper period. intervention 2: Subjects will be randomized to receive a fixed dose of either placebo, pregabalin Level 1 (maximum 150 mg/day) or pregabalin Level 2 (maximum 600 mg/day) in a 1:1:1 ratio, in addition to the subjects current AED medication regimen. Either capsules or oral liquid form will be administered, depending on subjects preference and ability to swallow capsules, in two equally divided daily doses. The study will have an 8 week baseline period; a 2 week dose escalation period; a 9 week dose maintenance period; and a 1 week dose taper period. intervention 3: Subjects will be randomized to receive a fixed dose of either placebo, pregabalin Level 1 (maximum 150 mg/day) or pregabalin Level 2 (maximum 600 mg/day) in a 1:1:1 ratio, in addition to the subjects current AED medication regimen. Either capsules or oral liquid form will be administered, depending on subjects preference and ability to swallow capsules, in two equally divided daily doses. The study will have an 8 week baseline period; a 2 week dose escalation period; a 9 week dose maintenance period; and a 1 week dose taper period.

Protocol documents:
Clinical trial NCT02108951
Conditions: Philidelphia Positive Chronic Myeloid Leukaemia
Keywords: CML Ph-CML leukaemia leukemia chronic myeloid leukemia chronic myeloid leukaemia TKI intolerance tyrosine kinase inhibitor tyrosine kinase inhibitor intolerance
Sponsor: Novartis Pharmaceuticals
Start date: 2014-07-07; Completion date: 2016-08-10
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this Australian study was to assess the efficacy and safety of nilotinib 300mg twice daily in patients with chronic myeloid leukemia chronic phase who were intolerant but responsive to 1st line treatment with imatinib or dasatinib. Eligible patients have been previously treated with imatinib or dasatinib for at least 3 months and are experiencing non-hematologic toxicity whilst having documented responses that meet PBS authority for 1st line treatment of CML without current MR4.5.

Detailed description:
The study was planned to enroll 130 patients to achieve the sample size requirement for a meaning full conclusion. Study got terminated with 20 patients because of slow recruitment. Therefore, due to small sample size, the results cannot be considered clinical significant.

Arms: arm 1: Nilotinib was administered orally at 300 mg BD at approximately 12 hour intervals which had to be taken without food. The capsules were to be swallowed whole with water and no food should have been consumed for at least 2 hours before and at least 1 hour after the dose was taken. Prior to the first dose of nilotinib, patients were required to have an imatinib or dasatinib washout period of at least 3 days. Therapy with nilotinib was to be continued for up to 24 months while on study.
Interventions: intervention 1: Nilotinib
Intervention descriptions: intervention 1: Nilotinib 150mg hard gelatin capsules taken orally

Protocol documents:
Clinical trial NCT02131324
Conditions: Psoriasis
Keywords: Psoriasis
Sponsor: Promius Pharma, LLC
Start date: 2014-05-08; Completion date: 2016-08-11
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the potential of DFD06 cream to suppress the HPA (hypothalamic-pituitary-adrenal) axis as compared to clobetasol propionate cream, 0.05% cream when applied twice daily for 15 days.

Detailed description:
This was a 15-day, randomized, multicenter, comparator-controlled, open-label study. Approximately 50 subjects with moderate to severe plaque psoriasis were to be randomized to treatment with DFD-06 Cream or clobetasol propionate cream in a 1:1 ratio. Study products were applied twice daily for 15 days to all affected areas on the body excluding face, scalp, groin, axillae, and other intertriginous areas. Subject visits were scheduled at Screening, Baseline (Day 1), Day 8, Day 15, and Day 43 (if needed to confirm recovery). Clinical determinations of disease severity were conducted using the Investigator's Global Assessment (IGA) for overall severity at each visit.

Arms: arm 1: applied twice a day for 15 days arm 2: applied twice a day for 15 days
Interventions: intervention 1: DFD06 Cream intervention 2: Clobetasol Propionate Cream 0.05%
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02537015
Conditions: Primary Open-Angle Glaucoma Ocular Hypertension
Sponsor: ForSight Vision5, Inc.
Start date: 2015-08-10; Completion date: 2016-08-11
Enrollment: 81 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study evaluated the long-term (9-months) safety of the Bimatoprost Ocular Insert in participants with Glaucoma or Ocular Hypertension who completed study FSV5-004. All the participants received Bimatoprost Ocular Insert and wore it for approximately 3 months (12 weeks), then had that Insert removed and a new Insert placed for another 26 weeks (approximately 6 months).

Detailed description:

Arms: arm 1: 13 mg Bimatoprost Ocular Insert in each eye used continuously for 12 weeks, then replaced with a new 13 mg Bimatoprost Ocular Insert in each eye used continuously for another 26 weeks.
Interventions: intervention 1: Bimatoprost
Intervention descriptions: intervention 1: Bimatoprost Ocular Insert in each eye used continuously for 12 weeks, then replaced with a new Bimatoprost Ocular Insert in each eye used continuously for another 26 weeks.

Protocol documents:
Clinical trial NCT02741310
Conditions: Healthy Subjects
Sponsor: Amgen
Start date: 2016-02-22; Completion date: 2016-08-11
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study was to assess the effects of subcutaneous sumatriptan alone and the effects of a single dose of erenumab (AMG 334) intravenous (IV) and sumatriptan concomitant therapy on resting blood pressure in healthy adults.

Detailed description:

Arms: arm 1: Participants received a placebo intravenous (IV) infusion on day 1 then 12 mg subcutaneous sumatriptan on day 2 (Part 1). After a 2-day washout participants received another placebo IV infusion on day 4 followed by 12 mg subcutaneous sumatriptan on day 5 (Part 2). arm 2: Participants received a placebo intravenous (IV) infusion on day 1 then 12 mg subcutaneous sumatriptan on day 2 (Part 1). After a 2-day washout participants received 140 mg erenumab IV infusion on day 4 followed by 12 mg subcutaneous sumatriptan on day 5 (Part 2).
Interventions: intervention 1: Placebo intervention 2: Sumatriptan intervention 3: Erenumab
Intervention descriptions: intervention 1: Administered by intravenous infusion intervention 2: Administered by two 6 mg subcutaneous injections 1 hour apart on day 2 and day 5 intervention 3: Administered by intravenous infusion

Protocol documents:
Clinical trial NCT02533505
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Respiratory COPD O2 Consumption
Sponsor: AstraZeneca
Start date: 2015-08-25; Completion date: 2016-08-12
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
A Phase IV study evaluating changes in oxygen consumption and cardiac function in Subjects with Chronic obstructive pulmonary disease (COPD) with resting hyperinflation after administration of Symbicort pMDI 160/4.5 μg.

Detailed description:
Patients with moderate/severe COPD are known to have static hyperinflation and to develop dynamic hyperinflation during exercise. Treatment with inhaled long-acting beta agonists and combination of the long-acting beta agonist (LABA), formoterol and the inhaled corticosteroid, budesonide has been shown to improve IC and decrease lung hyperinflation. In a similar previous pilot single centre study with budesonide/formoterol (Symbicort®) the analysis of cardiac outcomes demonstrated a decrease in maximum volume of oxygen (VO2) compared to placebo. Findings suggested that the use of Symbicort can decrease the cost of breathing and therefore reduce the cardiac demand experienced by COPD patients with hyperinflation at rest. The aim of this study is to investigate whether Symbicort therapy can decrease resting VO2 by decreasing static lung hyperinflation in subjects with COPD and to evaluate changes in cardiac function.

Arms: arm 1: Symbicort pressurized Metered Dose Inhaler (pMDI) arm 2: Placebo of reference drug
Interventions: intervention 1: Budesonide 160 mcg and formoterol fumarate dihydrate 4.5 mcg Inhalation aerosol intervention 2: Matching Placebo pMDI 160/4.5 μg
Intervention descriptions: intervention 1: Subjects will receive a single dose (2 inhalations) of Symbicort pMDI 160/4.5 μg (2 inhalations; total dosage 320/9.0 μg) or placebo (with a spacer) in a cross-over design (a total of 2 doses of Symbicort and 2 doses of placebo over the duration of the study), and assessments will be made before and after dosing at specified timepoints intervention 2: Placebo will be given according at the same dose and schedule as the active comparator - cross-over design.

Protocol documents:
Clinical trial NCT01743560
Conditions: Oestrogen Receptor Positive Advanced Breast Cancer
Keywords: Breast Neoplasms Neoplasms Breast diseases Skin diseases Exemestane Antibiotics, Antineoplastic Everolimus Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Immunosuppressive Agents Physiological Effects of Drugs Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action
Sponsor: Novartis Pharmaceuticals
Start date: 2013-01-31; Completion date: 2016-08-15
Enrollment: 52 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Determine the overall response rate (ORR) at 48 weeks to everolimus (RAD001, 10mg daily p.o.) and exemestane (25mg daily p.o.) treatment in postmenopausal women with oestrogen receptor positive breast cancer who have previous experienced recurrence or progression on non-steroidal aromatase inhibitor (NSAI) therapy.

Detailed description:

Arms: arm 1: Postmenopausal women diagnosed with oestrogen receptor positive locally advanced or metastatic breast cancer will receive RAD001 at a dose of 10mg daily p.o. and exemestane 25mg daily p.o. for 48 weeks.
Interventions: intervention 1: RAD001 intervention 2: Exemestane
Intervention descriptions: intervention 1: All postmenopausal women with oestrogen receptor positive locally advanced or metastatic breast cancer were treated with oral tablet RAD001 at a dose of 10mg daily and oral tablet exemestane 25mg daily. The study treatment for an individual patient was to begin on Study Day 1 and continue until the last patient enrolled completed the study at day 336 or until disease progression; unacceptable toxicity, death or early discontinuation from the study for any other reason, whichever occurs first. intervention 2: All postmenopausal women with oestrogen receptor positive locally advanced or metastatic breast cancer were to be treated with oral tablet RAD001 at a dose of 10mg daily and oral tablet exemestane 25mg daily. The study treatment for an individual patient was to begin on Study Day 1 and continue until the last patient enrolled completed the study at day 336 or until disease progression; unacceptable toxicity, death or early discontinuation from the study for any other reason, whichever occurs first.

Protocol documents:
Clinical trial NCT02715700
Conditions: Human Immunodeficiency Virus (HIV) Infection
Sponsor: Merck Sharp & Dohme LLC
Start date: 2015-09-28; Completion date: 2016-08-15
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the effects of multiple doses of doravirine (MK-1439) on the pharmacokinetics of methadone in participants requiring methadone maintenance therapy. The primary hypothesis is that area under the plasma concentration-time curve to 24 hours postdose (AUC0-24) of (R)-methadone is similar when a maintenance regimen of methadone is administered with or without multiple daily doses of doravirine.

Detailed description:

Arms: arm 1: Participants maintained on a stable methadone regimen (20 to 200 mg once daily) for ≥14 days prior to Day 1 will continue to receive methadone maintenance once per day on Days 1 to 7. From Day 2 to 6, participants will also receive doravirine 100 mg once daily.
Interventions: intervention 1: Methadone intervention 2: Doravirine
Intervention descriptions: intervention 1: Methadone 20 to 200 mg (10 mg/mL if oral solution concentrate) oral tablet once per day. intervention 2: Doravirine 100 mg oral tablet once per day.

Protocol documents:
Clinical trial NCT01653327
Conditions: Mucositis Head and Neck Cancer
Keywords: mucositis head and neck cancer radiation therapy chemoradiation oral pain
Sponsor: Dartmouth-Hitchcock Medical Center
Start date: 2010-06-01; Completion date: 2016-08-16
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
* The primary objective is to determine the reduction in pain score by ketamine mouthwash compared to placebo in head and neck cancer patients with refractory mucositis.
* The secondary objectives are to describe the duration of analgesia and adverse effects associated with ketamine and placebo.

Detailed description:
We would like to determine the effectiveness of ketamine mouthwash in providing pain relief to subjects with head and neck cancer suffering from mucositis, a common adverse event of radiation therapy and chemoradiation therapy. Ketamine is a schedule III controlled substance that is generally used to provide anesthesia for short diagnostic and surgical procedures.

Ten subjects will be randomized to two treatment arms. Group A will receive ketamine on Monday, placebo on Wednesday, and ketamine on Friday. Group B will receive placebo on Monday, ketamine on Wednesday, and placebo on Friday. Each subject will swish the study drug or placebo for 2 minutes and spit it out. The use of non-maintenance mucositis medications such as DLM solution will not be allowed during the clinic visit. Subjects may resume non-maintenance mucositis medications at home.

Subjects will be asked to document adverse effects and pain scores at 30, 45, and 60 minutes after study medication. The Richmond Agitation and Sedation Scale (RASS) will be used to determine a subject's sedation level, if necessary. Treatment will last for up to 6 weeks unless an illness or an event occurs that prevents continuation, intolerance to the agent, adverse events, resolution of mucositis pain, or the decision to withdraw from the study.

Arms: arm 1: Twenty milligrams of ketamine will be dissolved in 4 mL of pharmaceutical cherry syrup and 1 ml of normal saline. arm 2: The placebo will consist of 4 ml of cherry syrup and 1 ml of normal saline.
Interventions: intervention 1: Ketamine intervention 2: Placebo
Intervention descriptions: intervention 1: Twenty milligrams of ketamine will be dissolved in 4 mL of pharmaceutical cherry syrup and 1 ml of normal saline. intervention 2: None

Protocol documents: