ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02229383
Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus Exenatide Diabetes drug Treatment efficacy Placebo Metabolism Cardiovascilar metabolic
Sponsor: AstraZeneca
Start date: 2014-09-06; Completion date: 2016-08-29
Enrollment: 464 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study D5553C00002 is a multicenter, randomized, double-blind, placebo-controlled, parallel group, Phase 3 study to compare the safety and efficacy of exenatide once weekly (EQW) added to titrated basal insulin glargine with or without metformin to placebo added to titrated basal insulin glargine with or without metformin in patients with type 2 diabetes mellitus (T2DM). Eligible patients will be randomized at Visit 5 (Day 1) to receive either EQW added to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, or placebo added to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, during the 28-week treatment period.

Detailed description:

Arms: arm 1: Exenatide 2 mg 1 time per week + titrated basal insulin glargine with or without metformin arm 2: Placebo 2 mg 1 time per week + titrated basal insulin glargine with or without metformin
Interventions: intervention 1: Exenatide intervention 2: Exenatide matching placebo
Intervention descriptions: intervention 1: 2 mg weekly suspension injection intervention 2: Once weekly Placebo injection

Protocol documents:
Clinical trial NCT01677507
Conditions: Glaucoma Healthy
Keywords: glaucoma aqueous humor dynamics intraocular pressure
Sponsor: University of Michigan
Start date: 2012-08-01; Completion date: 2016-08-30
Enrollment: 135 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Glaucoma is a major cause of blindness. The inability to predict a patient's IOP response to medications is a critical barrier for the clinician to consistently provide highly effective IOP-based treatments. Current trial-and error approaches to glaucoma management are inefficient and have not addressed this barrier as there are no predictive factors for drug response. Our long-term goal is to improve outcomes by identifying biomarkers and environmental factors that profile a patient at risk for glaucoma by age-of-onset, rate of disease progression, "poor response" to treatment, and large IOP fluctuation. Our purpose of this research project is to address this critical barrier by focusing on physiological factors that predict IOP response to drugs.

Detailed description:

Arms: arm 1: To compare the variation in response to timolol between individuals arm 2: To compare the variation in response to latanoprost between individuals
Interventions: intervention 1: Variation in eye pressure response to timolol and latanoprost treatment
Intervention descriptions: intervention 1: Arm 1 is to test for variation in eye pressure response to timolol. Arm 2 is to test for variation in eye pressure response to latanoprost.

Protocol documents:
Clinical trial NCT01289678
Conditions: Acute Myelogenous Leukemia
Keywords: acute myelogenous leukemia interleukin-2
Sponsor: Leo W. Jenkins Cancer Center
Start date: 2006-07-01; Completion date: 2016-08-31
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Assess the immunotherapy benefit of interleukin-2 in acute myelogenous leukemia treatment during lymphocyte recovery.

Detailed description:
Upon lymphocyte recovery after myeloablative induction standard chemotherapy pulse Interleukin-2 administered

Arms: arm 1: interleukin-2 therapy during lymphocyte recovery
Interventions: intervention 1: Interleukin-2
Intervention descriptions: intervention 1: Famotine 20mg IV push daily just prior to the aldesleukin (IL-2) IL-2 18 million IU/m2 in 50 mL 5% D5 or NS IVPB over 15 - 30 minutes daily for 5 days

Protocol documents:
Clinical trial NCT01813474
Conditions: Cancer Advanced Solid Malignancies
Keywords: Cancer Tumour Solid Malignancies
Sponsor: AstraZeneca
Start date: 2013-03-25; Completion date: 2016-08-31
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this study will be to investigate the safety and tolerability of olaparib tablet when given orally to Japanese patients with advanced solid malignancies. In addition, the pharmacokinetic profile, MTD (if possible) and efficacy of olaparib will be investigated.

Detailed description:
MTD - maximum tolerated dose

Arms: arm 1: olaparib tablet
Interventions: intervention 1: olaparib
Intervention descriptions: intervention 1: tablet oral

Protocol documents:
Clinical trial NCT01815840
Conditions: Basal Cell Carcinoma
Sponsor: Hoffmann-La Roche
Start date: 2013-04-30; Completion date: 2016-08-31
Enrollment: 229 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized, double-blind, regimen-controlled, phase II, multicenter study will assess the efficacy and safety of two different vismodegib regimens in participants with multiple basal cell carcinoma. Participants will receive vismodegib 150 mg orally once daily either in an intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo (Arm A) or as 24 weeks induction followed by an intermittent schedule of 8 weeks placebo followed by 8 weeks vismodegib (Arm B). Anticipated time on study treatment is 72 weeks.

Detailed description:

Arms: arm 1: Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up arm 2: Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
Interventions: intervention 1: Vismodegib intervention 2: Placebo
Intervention descriptions: intervention 1: Vismodegib 150 mg hard gelatin capsule orally once daily intervention 2: Vismodegib placebo orally once daily

Protocol documents:
Clinical trial NCT01830842
Conditions: Nicotine Addiction
Keywords: Nicotine Smoking Cigarettes Reinforcement Learning fMRI
Sponsor: Duke University
Start date: 2014-02-01; Completion date: 2016-08-31
Enrollment: 54 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to use functional magnetic resonance imaging (fMRI) to investigate the acute and chronic effects of nicotine on motivational behavior and prediction error-related neural activation. Nonsmokers (n = 24) and smokers (n = 24) will undergo fMRI scans on two separate occasions while performing a decision-making task that will elicit prediction error signals in the mesocorticolimbic pathway of the brain. Nonsmokers will be scanned once following an acute dose of nicotine and once following placebo administration. Smokers will be scanned once following smoking as usual and once following 24-hours of smoking abstinence, in order to measure the effects of nicotine withdrawal. The study team hypothesizes that acute nicotine will increase the prediction error signal in nonsmokers compared to placebo, and that nicotine withdrawal will decrease the prediction error signal in smokers compared to the normal satiated condition. Furthermore, nonsmokers (during the placebo condition) will have greater prediction error activation than smokers (during the satiated condition). The results of this study will inform whether the initiation and maintenance of smoking behavior could be facilitated by the effects of nicotine on reinforcement learning.

Detailed description:

Arms: arm 1: Nonsmokers will be measured following a nicotine polacrilex lozenge (2mg) on one occasion and placebo on another occasion. arm 2: Smokers will be measured in a normal satiated condition and following 24-hours of smoking abstinence
Interventions: intervention 1: Nicotine polacrilex intervention 2: Placebo intervention 3: satiety intervention 4: abstinence
Intervention descriptions: intervention 1: nonsmokers will be measured following nicotine administration intervention 2: nonsmokers will be measured following placebo administration intervention 3: smokers will be measured in a smoking satiated condition intervention 4: smokers will be measured following 24-hours of smoking abstinence

Protocol documents:
Clinical trial NCT01846624
Conditions: Acute Myeloid Leukemia (AML) With Multilineage Dysplasia Following Myelodysplastic Syndrome, in Adults AML (Adult) With 11q23 (MLL) Abnormalities AML (Adult) With Del (5q) AML (Adult) With Inv (16) (p13; q22) AML (Adult) With t (16;16) (p13; q22) AML (Adult) With t (8; 21) (q22; q22) Secondary AML (Adult) Untreated AML (Adult)
Sponsor: David Iberri
Start date: 2013-06-01; Completion date: 2016-08-31
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase 2 study evaluates the sequential combination of decitabine then midostaurin for the treatment of newly-diagnosed acute myeloid leukemia (AML) in older patients.

Detailed description:
Treatment with decitabine, a cytidine analog, then midostaurin, a multi-target protein kinase inhibitor (PKI), may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Arms: arm 1: INDUCTION THERAPY Subjects receive decitabine intravenously (IV) over 1 hour on days 1 to 10 and midostaurin orally (PO) twice daily (BID) on days 11 to 28. Treatment repeats every 28 days until documented bone marrow response is achieved or for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients achieving documented bone marrow response by course 6 continue treatment with induction therapy; patients achieving response after course 6 proceed to post-remission therapy.

POST-REMISSION THERAPY Subjects receive decitabine IV over 1 hour on days 1 to 5 and midostaurin PO BID on days 6 to 28. Treatment repeats every 28 days for up to 12 courses (including induction therapy) in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for up to 1 year.
Interventions: intervention 1: Decitabine intervention 2: Midostaurin
Intervention descriptions: intervention 1: Given IV intervention 2: Given PO

Protocol documents:
Clinical trial NCT01898611
Conditions: Frailty Syndrome
Keywords: Frailty Sarcopenia Weight Loss Exercise Aging Ghrelin Elderly
Sponsor: University of Pennsylvania
Start date: 2013-07-01; Completion date: 2016-08-31
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Frailty is a geriatric syndrome leading to physical deterioration including muscle wasting (sarcopenia) and unintentional weight loss. There are currently no approved therapies for frailty. Ghrelin is a hormone produced by the stomach that stimulates appetite centers in the brain. The investigators already know that a single dose of Ghrelin improves food intake immediately after the dose in frail older people. In addition, exercise programs have been shown to improve strength and function in older people. In this study, the investigators are trying to find out if a joint intervention of ghrelin and resistance training will improve walking, balance and leg strength in frail elderly people.

Detailed description:

Arms: arm 1: Ghrelin 7.5 mcg/kg as a once daily subcutaneous dose for 12 weeks plus resistance training arm 2: Placebo as a once daily subcutaneous dose for 12 weeks plus resistance training
Interventions: intervention 1: Ghrelin intervention 2: Placebo
Intervention descriptions: intervention 1: Ghrelin intervention 2: Saline will be used as a placebo

Protocol documents:
Clinical trial NCT02138786
Conditions: Richter's Transformation
Keywords: Richter's Transformation Richter's Syndrome Karyopharm selinexor KPT-330 SIRRT CLL
Sponsor: Karyopharm Therapeutics Inc
Start date: 2014-11-14; Completion date: 2016-08-31
Enrollment: 27 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a multi-center, phase 2, single arm, open-label study of oral selinexor monotherapy in patients with Richter's Transformation, arising in the setting of prior chronic lymphocytic leukemia (CLL), after at least one chemo-immunotherapy regimen for CLL.

Detailed description:
Multi-center, phase 2, single arm, open-label study of oral selinexor monotherapy in patients with Richter's Transformation, arising in the setting of prior CLL, documented by histologically confirmed lymphoma, including diffuse large B-cell (DLBCL) and immunoblastic variants. Eligible patients must have had at least one prior regimen for CLL. Approximately 50 patients are anticipated to be treated in this study. Eligible patients following screening will receive selinexor orally twice weekly at a dose of 60 mg. The selinexor dose may be increased to 80 mg after Cycle 1 unless clinically contraindicated. Patients may continue in multiple treatment cycles at a given dose; there is no maximum treatment duration. Each cycle is 28 days. Dose adjustments will be made as appropriate by the investigator.

Patients who were treated twice weekly for weeks 1-3 under a previous version of the protocol may, at the discretion of the investigator, have had the frequency of selinexor dosing increased to twice weekly for weeks 1-4. If there was no contraindicated toxicity, the selinexor dose may have been increased to 80 mg at Cycle 3.

Arms: arm 1: oral tablets

* 10 mg \& 25 mg (bottled); or
* 20 mg (blister pack)
Interventions: intervention 1: selinexor
Intervention descriptions: intervention 1: * 60 mg dose twice weekly, on Days 1 and 3 of weeks 1-4 of each 4-week cycle; dose may be increased to 80 mg after Cycle 1 unless clinically contraindicated (Protocol V.5.0).
* 60 mg dose twice weekly on Days 1 and 3 of weeks 1-3 of each 4-week cycle; dose may be increased to 80 mg at Cycle 3 Day 1 unless clinically contraindicated (Protocol V.4.0).
* 60 mg/m² dose, based on BSA, twice weekly, on Days 1 and 3 of weeks 1-3 of each 4-week cycle (Protocol V. 3.0).
* 60 mg/m² dose, based on BSA, twice weekly, on Days 1 and 3 of weeks 1-4 of each 4-week cycle (Protocol V. \< 3.0).

Protocol documents:
Clinical trial NCT02480621
Conditions: Ankle Fracture
Sponsor: Jamaica Hospital Medical Center
Start date: 2014-12-01; Completion date: 2016-08-31
Enrollment: 84 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a randomized controlled trial assessing pain control in ankle fractures repaired with open reduction and internal fixation. Patients are consented and enrolled pre-operatively, and randomized to either control or liposomal bupivacaine with bupivacaine administered intra-operatively.

Detailed description:
This study is a prospective, randomized controlled trial assessing pain control in ankle fractures repaired with open reduction and internal fixation. Patients are consented and enrolled pre-operatively, and randomized to either control or liposomal bupivacaine with bupivacaine administered intra-operatively. Patients are to remain blinded to the treatment arm. The surgeon is non-blinded and administers the bupivacaine solution locally, intra-operatively.

Patients pain scores and pain medication usage is documented. A trained research coordinator contacts each patient at 24, 48, and 72 hours post-operatively to assess pain levels on a visual analog scale (VAS) and pain medications taken. Patients return for followup at standard intervals of 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post-operatively to assess healing and functional outcomes. Patients are queried as to satisfaction with pain control at 2 weeks post-operatively. The study will compare outcomes including pain levels, pain medications taken, operating room (OR) and post-anesthesia care unit (PACU) times, length of stay (LOS), satisfaction with pain control, clinical outcomes, and complication rates.

Arms: arm 1: Standard of care: Open Reduction Internal Fixation with no injection of pain medications around the affected ankle. arm 2: Intra-operatively, patients receive a local injection of liposomal bupivacaine with bupivacaine around the affected ankle.
Interventions: intervention 1: Liposomal Bupivacaine with Bupivacaine
Intervention descriptions: intervention 1: Pain medications injected locally during surgery around affected ankle.

Protocol documents:
Clinical trial NCT00628498
Conditions: Hepatic Veno-Occlusive Disease
Keywords: VOD
Sponsor: Jazz Pharmaceuticals
Start date: 2007-12-01; Completion date: 2016-09-01
Enrollment: 1206 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Single arm, open-label study to provide Defibrotide to patients diagnosed with VOD. Defibrotide is no longer available though the Emergency Use IND mechanism (also known as compassionate use, or single patient named use). This protocol is the only mechanism by which Defibrotide can be made available to patients in the U.S.

Detailed description:

Arms: arm 1: Defibrotide 25 mg/kg day given in 4 divided doses approximately every 6 hours
Interventions: intervention 1: Defibrotide intervention 2: Defibrotide
Intervention descriptions: intervention 1: Defibrotide is a single-stranded polydeoxyribonucleotide derived from porcine intestinal mucosa by controlled depolymerisation. Defibrotide has a complex mechanism of action with antithrombotic, anti-ischemic, anti-inflammatory, anti-adhesive and thrombolytic properties but no significant systemic anti-coagulant effects.

Defibrotide is dose intravenously as a 2-hour infusion every 6 hours at a dose of 25 mg/kg/day. Recommended duration of therapy is 21 days. intervention 2: None

Protocol documents:
Clinical trial NCT01176266
Conditions: Hypophosphatasia
Keywords: Hypophosphatasia HPP Bone Disease Soft Bones Low Alkaline Phosphatase Genetic metabolic disorder Alkaline phosphatase Tissue-specific alkaline phosphatase (TNSALP) Rickets Osteomalacia
Sponsor: Alexion Pharmaceuticals, Inc.
Start date: 2010-07-01; Completion date: 2016-09-01
Enrollment: 69 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This clinical trial was conducted to study hypophosphatasia (HPP), a bone disorder caused by gene mutations or changes. These gene mutations cause low levels of an enzyme needed to harden bone. The purpose of this study was to test the safety and efficacy of a study drug called asfotase alfa (human recombinant tissue non-specific alkaline phosphate fusion protein) to see what effects it has on patients 5 years of age or less with HPP.

Detailed description:
Asfotase alfa was formerly referred to as ENB-0040

Hypophosphatasia (HPP) is a life-threatening, genetic, and ultra-rare metabolic disease characterized by defective bone mineralization and impaired phosphate and calcium regulation that can lead to progressive damage to multiple vital organs, including destruction and deformity of bones, profound muscle weakness, seizures, impaired renal function, and respiratory failure. There are limited data available on the natural course of this disease over time, particularly in patients with the juvenile-onset form.

Arms: arm 1: A total of 6 mg/kg/week of asfotase alfa administered by SC injection (either 1 mg/kg asfotase alfa 6 times per week, or 2 mg/kg asfotase alfa 3 times per week)
Interventions: intervention 1: asfotase alfa
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02316847
Conditions: Epilepsy
Keywords: Cluster Seizures Seizures Clusters Acute repetitive seizures
Sponsor: Acorda Therapeutics
Start date: 2014-12-01; Completion date: 2016-09-01
Enrollment: 126 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will assess long-term safety and tolerability of repeat dose diazepam nasal spray in adolescents and adults with cluster seizures, with a focus on potential local effects (changes in nasal mucosa, olfaction, and taste).

Detailed description:

Arms: arm 1: One dose of diazepam nasal spray is two intranasal sprays; one in each nostril using a nasal spray device. The dose is administered while the subject is sitting up or lying down. arm 2: One dose of diazepam nasal spray is two intranasal sprays; one in each nostril using a nasal spray device. The dose is administered while the subject is sitting up or lying down.
Interventions: intervention 1: diazepam nasal spray
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02426918
Conditions: Bacterial Infections
Sponsor: Debiopharm International SA
Start date: 2015-05-01; Completion date: 2016-09-01
Enrollment: 330 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the efficacy of 2 different doses of intravenous and oral Debio 1450 compared with intravenous vancomycin and oral linezolid in the treatment of patients with staphylococcal ABSSSI.

Detailed description:

Arms: arm 1: After 2 doses of Debio 1450 IV (intravenous) therapy, the Debio 1450 320/480 mg daily dose group receives 240 mg Debio 1450 Oral + Linezolid Placebo twice daily (BID). arm 2: After 2 doses of Debio 1450 IV therapy, the Debio 1450 160/240 mg daily dose group receives 120 mg Debio 1450 Oral + Debio 1450 Oral Placebo + Linezolid Placebo BID. arm 3: After 2 doses of Vancomycin IV, the Placebo comparator group receives Debio 1450 Oral Placebo + Linezolid 600 mg BID.
Interventions: intervention 1: Debio 1450 IV intervention 2: Debio 1450 Oral intervention 3: Linezolid intervention 4: Debio 1450 Oral Placebo intervention 5: Linezolid Placebo intervention 6: Vancomycin IV
Intervention descriptions: intervention 1: Intravenous (IV) form of Debio 1450 will be supplied in vials containing 50 mg of active pharmaceutical ingredient (API). Intravenous infusions of Debio 1450 (160 mg and 80 mg) will be administered over a 2-hour period BID every 12 hours within a 2-hour window (12 ± 2 hours). intervention 2: Oral forms of Debio 1450 will be provided as white, opaque, hard gelatin capsules containing 50 mg drug substance (equivalent to 40 mg of Debio 1450). intervention 3: Linezolid for oral administration will be provided as 600-mg film-coated compressed tablets. intervention 4: Debio 1450 placebo will be supplied as white, opaque, hard gelatin capsules. intervention 5: Linezolid placebo will be supplied as film-coated compressed tablets. intervention 6: Vancomycin will be administered BID every 12 ± 2 hours at doses of 1 g or 15 mg/kg as specified in local protocols, with the infusion rate adjusted to 2 hours.

Protocol documents: