ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02445807
Conditions: Chronic Stable Plaque Psoriasis
Sponsor: Promius Pharma, LLC
Start date: 2015-12-01; Completion date: 2016-07-01
Enrollment: 265 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the efficacy and safety of DFD-06 Cream to Vehicle Cream for topical treatment of moderate to severe plaque psoriasis after 3, 7, and 14 days of treatment.

Detailed description:
This study will be a multicenter (approximately 30 sites), randomized, vehicle-controlled, double-blind, and parallel group design. Approximately 264 subjects with moderate to severe plaque psoriasis will be randomized to treatment with DFD-06 Cream or Vehicle Cream. Subjects will use study product twice daily for 14 days. Subject visits are scheduled at Screening, Baseline (Day 1) and Days 4, 8, and 15. Clinical determinations of disease severity will be performed using the total sign score (TSS) for the target lesion and Investigator Global Assessment (IGA) for overall severity.

Arms: arm 1: DFD-06 Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days. arm 2: Vehicle Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.
Interventions: intervention 1: DFD06-Cream intervention 2: Vehicle Cream
Intervention descriptions: intervention 1: Twice daily topical application for 14 days. intervention 2: Twice daily topical application for 14 days.

Protocol documents:
Clinical trial NCT02447848
Conditions: Moderate-to-severe Acute Pain
Sponsor: Talphera, Inc
Start date: 2015-10-01; Completion date: 2016-07-01
Enrollment: 76 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate the safety and efficacy of sufentanil tablet (ST) 30 mcg in the management of moderate-to-severe acute pain in patients in an emergency room (ER) setting.

Detailed description:
The study is a multicenter, open-label trial, in patients 18 years and older, who present to the ER with moderate-to-severe acute pain due to obvious trauma or injury evident on physical examination.

Upon meeting all entrance criteria, patients will be administered up to four doses of sufentanil 30 mcg and remain in the study for 5 hours for safety and efficacy measurements.

Safety will be monitored via periodic measurement of vital signs and continuous monitoring of oxygen saturation, as well as assessment of adverse events (AEs) and the use of concomitant medications.

Efficacy will be assessed by patient reports of pain intensity (PI) and pain relief. A Six-Item Screener (SIS) will be administered before and 1 hour after study drug administration to measure cognitive impairment. The Patient Global Assessment (PGA) and the Healthcare Professional Global Assessment (HPGA) will assess global satisfaction with the method of pain control.

Arms: arm 1: Patients may be administered one tablet every 60 minutes as needed during the study period
Interventions: intervention 1: sufentanil sublingual 30 mcg tablet
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02449291
Conditions: Postoperative Nausea and Vomiting
Sponsor: Acacia Pharma Ltd
Start date: 2015-09-01; Completion date: 2016-07-01
Enrollment: 568 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Double-blind, randomised, parallel-group, placebo-controlled, adaptive, seamless, dose-selecting study to compare the efficacy of APD421 to placebo as treatment of established PONV, in patients who have not had prior PONV prophylaxis.

Detailed description:

Arms: arm 1: Single (standard) dose IV APD421 arm 2: Single (high) dose IV APD421 arm 3: Single IV placebo
Interventions: intervention 1: APD421 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02468583
Conditions: Post-traumatic Osteoarthritis of the Knee
Keywords: Osteoarthritis Post-traumatic Knee Pain Corticosteroid Intra-articular Injection
Sponsor: Pacira Pharmaceuticals, Inc
Start date: 2015-02-01; Completion date: 2016-07-01
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was a double-blind, randomized, parallel group, proof of concept study comparing FX006 to Kenalog®-40 (triamcinolone acetonide injectable suspension, USP) in patients with post-traumatic osteoarthritis of the knee.

Detailed description:
This study was a double-blind, randomized, parallel group, proof of concept study patients with post-traumatic osteoarthritis (PTOA) of the knee. Approximately 124 eligible patients were intended to be randomized to one of the two treatment groups (1:1) and treated with a single intra-articular (IA) injection of:

* 32 mg of FX006
* 40 mg of Kenalog®-40 (triamcinolone acetonide injectable suspension, USP)

Each prospective patient underwent a screening evaluation to confirm a diagnosis of PTOA of the knee and concurrence with all other eligibility criteria. Patients were be treated on Day 1 (Baseline) and returned to the clinic at Weeks 4, 8 and 12 for evaluation of safety and efficacy.

Arms: arm 1: Single 5 mL intra-articular (IA) injection Extended-release formulation arm 2: Single 1 mL intra-articular (IA) injection Immediate-release formulation
Interventions: intervention 1: FX006 32 mg intervention 2: TCA IR 40 mg
Intervention descriptions: intervention 1: Experimental intervention 2: Comparator

Protocol documents:
Clinical trial NCT02474407
Conditions: Refractory Epilepsy
Keywords: Seizures Epilepsy
Sponsor: Acorda Therapeutics
Start date: 2015-06-01; Completion date: 2016-07-01
Enrollment: 78 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a multi-center, open-label, crossover, pharmacokinetic, bio-availability study involving adolescents and adults with refractory (drug-resistant) epilepsy. Cohort 1 comprises the subjects used to determine the relative bioavailability of DZNS versus DRG (Diastat)

Detailed description:
To determine the bioavailability of diazepam nasal spray versus diazepam rectal gel (Diastat®) under conditions of use in adolescent and adult persons with epilepsy (PWE) meeting the definition of refractory epilepsy.

Arms: arm 1: One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device. arm 2: A single rectal dose of diazepam will be administered to subjects according to the Diastat prescribing information.
Interventions: intervention 1: diazepam nasal spray intervention 2: diazepam rectal gel
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02476448
Conditions: Injury of Ureter
Keywords: ureteral jet pelvic surgery cystoscopy
Sponsor: Cecilia Calvo
Start date: 2015-02-01; Completion date: 2016-07-01
Enrollment: 176 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluates 4 different methods to aid surgeons to visualize ureteral jets on cystoscopy.

Detailed description:
This study proposes to test and compare the surgeon's impression/confidence in identifying ureteral jets using 3 other methods in contrast to standard diagnostic cystoscopy: 1) cystoscopy with Dextrose 10% solution, 2) cystoscopy with phenazopyridine and 3) IV sodium fluorescein 4) standard cystoscopy with saline.

Arms: arm 1: Infused into the bladder to allow for visualization of bladder walls and urine jets. arm 2: Infused into the bladder to allow for visualization of bladder walls and colored urine jets. arm 3: Will be administered (orally) preoperatively and will be evaluated for its colorization properties during cystoscopy. arm 4: Will be administered (intravenously) prior to the cystoscopy and will be evaluated for its colorization properties during cystoscopy.
Interventions: intervention 1: Normal saline intervention 2: Phenazopyridine intervention 3: Dextrose 10% intervention 4: Sodium Fluorescein
Intervention descriptions: intervention 1: Used to distend the bladder for cystoscopic evaluation intervention 2: Administered orally preoperatively and assessed during cystoscopy intervention 3: Used to distend the bladder for cystoscopic evaluation intervention 4: Administered intravenously and assessed during cystoscopy

Protocol documents:
Clinical trial NCT02499575
Conditions: Bunion Hallux Rigidus
Keywords: Exparel bupivacaine Hallux valgus deformity bunionectomy
Sponsor: OhioHealth
Start date: 2015-07-01; Completion date: 2016-07-01
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Exparel is an FDA-approved local anesthetic (bupivacaine), in a long-release formulation. In this study the investigators plan to determine the ability of Exparel to control post-operative pain in common first metatarsophalangeal (MTP) joint procedures (bunion surgery, 1st MTP fusion, and cheilectomy).

Detailed description:
The investigators propose a prospective, randomized, single-blinded study of patients who are electing to undergo an outpatient first metatarsophalangeal (MTP) joint procedure (bunionectomy, 1st MTP fusion, or cheilectomy). As a standard, patients undergoing these procedures are given regional anesthesia (adductor canal block plus popliteal block). Patients are then given prescriptions for oral opioids to manage post-operative pain. The purpose of this study is to determine whether a single intrapopliteal administration of Exparel, in conjunction with the standard of care regional block, improves pain relief and therefore decreases use of post-operative opioids.

Arms: arm 1: Group A patients will receive only a pre-operative adductor canal block with 10 mL 0.5% ropivacaine plus a popliteal block with 30 mL 0.5% ropivacaine (total block 40 mL/200 mg). arm 2: Group B patients will receive the standard of care pre-operative adductor and popliteal block as described (40 mL/200 mg of 0.5% ropivacaine) in addition to a postoperative pericapsular injection of Exparel using 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl), per the same total dose as provided in manufacturer recommendations.
Interventions: intervention 1: 0.5% ropivacaine intervention 2: Exparel
Intervention descriptions: intervention 1: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine intervention 2: 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl)

Protocol documents:
Clinical trial NCT02508103
Conditions: Premenstrual Dysphoric Disorder
Keywords: Premenstrual Dysphoric Disorder Premenstrual Syndrome PMS PMDD
Sponsor: University of North Carolina, Chapel Hill
Start date: 2015-07-01; Completion date: 2016-07-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This research study will look at brain and symptom differences among women with severe premenstrual mood symptoms. One goal of this study is to look at the effects of taking a nasal spray containing oxytocin (a hormone made in the brain) on brain areas involved in emotion regulation while viewing pictures during a neuroimaging (fMRI) session. The investigators will also look at whether oxytocin improves premenstrual mood symptoms.

Detailed description:
Purpose: The primary objective of this pilot study is to use functional neuroimaging techniques to begin to identify the central brain networks that may contribute to impairment in emotion regulation, interpersonal relationships, and marital and family function in women with premenstrual dysphoric disorder (PMDD), particularly for those women who also have a history of early life abuse (ELA).

Based on the evidence that the mammalian neuropeptide oxytocin (OT), best known for its role in lactation and parturition, plays a seminal role in social affiliation, emotion regulation, attachment, maternal behavior, trust, and protection against stress; and because OT neural pathways and receptors are prominently expressed in brain regions involved in emotion regulation and maternal/affiliative behavior; the study will: 1) use intranasal OT administration as a probe to assess whether it modifies activation of brain regions involved in emotion regulation in response to an emotional processing task; and 2) whether daily intranasal OT administration during the premenstrual phase improves symptoms in women with PMDD with or without a history of ELA.

Arms: arm 1: Participants were randomized to receive Intransal Oxytocin for late luteal phase administration during one menstrual cycle, then received Intranasal Placebo for late luteal phase administration of a subsequent menstrual cycle.

Intranasal Oxytocin spray (40 IU, 3x/day) for 4-5 days; Intranasal Placebo spray (3x/day) for 4-5 days arm 2: Participants were randomized to receive Intranasal Placebo for late luteal phase administration during one menstrual cycle, then received Intransal Oxytocin for late luteal phase administration of a subsequent menstrual cycle.

Intranasal Oxytocin spray (40 IU, 3x/day) for 4-5 days; Intranasal Placebo spray (3x/day) for 4-5 days
Interventions: intervention 1: Oxytocin intervention 2: Placebo
Intervention descriptions: intervention 1: Intranasal Oxytocin spray (40 IU, 3x/day) self-administered during laboratory testing session and then for 4-5 days until menses begins intervention 2: Intranasal Placebo spray (3x/day) self-administered during laboratory testing session and then for 4-5 days until menses begins

Protocol documents:
Clinical trial NCT02509117
Conditions: Healthy Subjects
Keywords: Alzheimer's disease
Sponsor: Pfizer
Start date: 2015-07-01; Completion date: 2016-07-01
Enrollment: 55 participants; Allocation: RANDOMIZED; Intervention model: 

Brief summary:
The purpose of this study is to evaluate the safety, tolerability, PK and PD of PF-06751979 following oral doses in healthy adult and healthy elderly subjects.

Detailed description:

Arms: arm 1: Single Ascending Dose in 4-way cross-over design (PF-06751979/Placebo). arm 2: Multiple dose administration to Healthy Subjects in parallel cohorts(PF-06751979) arm 3: Multiple dose administration to Healthy Subjects in parallel cohorts(Placebo) arm 4: Multiple dose administration to Healthy Elderly Subjects (PF-06751979) arm 5: Multiple dose administration to Healthy Elderly Subjects (Placebo)
Interventions: intervention 1: PF-06751979 single ascending dose intervention 2: Placebo single dose intervention 3: PF-06751979 multiple ascending dose intervention 4: Placebo multiple dose intervention 5: PF-06751979 multiple dose intervention 6: PF-06751979 multiple dose
Intervention descriptions: intervention 1: PF-06751979 administered as a single dose (solution/suspension) in cross-over fashion. Each subject may receive up to 4 study treatments (placebo and up to 3 doses of PF-06751979). The dose levels are 3 mg, 12 mg, 40 mg, 160 mg. intervention 2: Matched Placebo solution/suspension administered as single dose. intervention 3: PF-06751979 (solution/suspension) administered daily for 14 consecutive days to parallel cohorts. The dose levels are 5 mg, 15 mg, 50 mg. intervention 4: Matched Placebo (solution/suspension)administered daily for 14 consecutive days. intervention 5: PF-06751979 (solution/suspension) administered daily for 14 consecutive days. The dose level is 50 mg. intervention 6: Matched Placebo (suspension/solution) administered daily for 14 consecutive days to parallel cohorts.

Protocol documents:
Clinical trial NCT02531308
Conditions: Diffuse Large B-Cell Lymphoma
Keywords: diffuse large b-cell lymphoma (DLBCL), lymphoma
Sponsor: Rush University Medical Center
Start date: 2015-07-01; Completion date: 2016-07-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Evaluation of impact of metformin on 2 year progression-free survival (PFS) rate in subjects with previously untreated DLBCL when added to standard induction therapy. (R-CHOP)

Detailed description:
Newly diagnosed histologically confirmed CD20 positive previously untreated diffuse large B-cell lymphoma to receive up to 4-6 cycles (21 day cycles) of:

R-CHOP: Rituximab 375 mg/m2 IV infusion Day 1 Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Vincristine 1.4 mg/m2 IV Day 1 (cap @ 2mg) Prednisone 100mg PO daily Days 1-5 Pegfilgrastim 6 mg subcutaneously within 72 if start if cycle Metformin 500 mg PO daily Cycle 1 Days 1-7 Metformin 500 mg PO twice daily Cycle 1 Days 7-21 Metformin 850 mg PO twice daily starting on day 22 and and continuing throughout remainder of cycles plus 22 days post treatment.

Restaging will be done after the 4th cycle is complete. Subjects will be monitored with labs and physical exams throughout the study.

Arms: arm 1: Rituximab 375 mg/m2 IV infusion Day 1 Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Vincristine 1.4 mg/m2 (2 mg cap) IV Day 1 Prednisone 100 mg PO Days 1-5 Pegfilgrastim 6 mg subcutaneous within 72 hours of cyclophosphomide Metformin 500 mg PO daily D 1-7, 500 mg twice daily D8-21, 850 mg twice daily D22 - 30days post study.

Cycles are 21 days. Above treatment given for 4 cycles, then restaging done. If complete response (CR) or partial response (PR), 2 more cycle given; stable disease (SD) or progressive disease (PD)- salvage therapy off study.
Interventions: intervention 1: Metformin intervention 2: Rituximab intervention 3: Cyclophosphamide intervention 4: Doxorubicin intervention 5: Vincristine intervention 6: Prednisone intervention 7: pegfilgrastim
Intervention descriptions: intervention 1: Metformin upregulates AMPK activity which has been shown to have an anti-proliferative effect on lymphoma cells. intervention 2: monoclonal antibody against protein CD20 primarily found on the surface of B-cells intervention 3: Interferes with DNA replication intervention 4: anthracycline antitumor antibiotic intervention 5: Inhibits cell mitosis causing cell death. intervention 6: a synthetic corticosteroid drug that is particularly effective as an immunosuppressant drug. It is used to treat certain inflammatory diseases intervention 7: stimulates the level of white blood cells (neutrophils).

Protocol documents:
Clinical trial NCT02536040
Conditions: Dental Caries
Keywords: silver diamine fluoride diammine silver fluoride children
Sponsor: Advantage Dental Services, LLC
Start date: 2016-01-01; Completion date: 2016-07-01
Enrollment: 66 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being conducted to test whether the use of diammine silver fluoride (also called silver diamine fluoride) hardens the cavity sufficiently so that it arrests.

Detailed description:
Phase III RCT with two arms: (1) 38% diammine silver fluoride; (2) distilled fluoride free water. Subjects are 200 preschool children in good general health with untreated tooth decay. Intervention is topical application of the study drug to the open cavity. Primary outcome is caries activity at 14-21 days.

Arms: arm 1: Topical application of 38% diammine silver fluoride to active cavity arm 2: Topical application of fluoride free water to active cavity
Interventions: intervention 1: 38% diammine silver fluoride intervention 2: Water
Intervention descriptions: intervention 1: treatment of cavity with study agent intervention 2: Fluoride free, distilled water

Protocol documents:
Clinical trial NCT02553928
Conditions: Alzheimer Dementia (AD)
Sponsor: H. Lundbeck A/S
Start date: 2015-10-01; Completion date: 2016-07-01
Enrollment: 62 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Evaluation of the safety and tolerability of a 20 mg once daily dose of memantine compared with 10 mg given twice daily in patients with dementia of Alzheimer's type and MMSE range 5-18.

Detailed description:

Arms: arm 1: Memantine 20 mg once daily, tablets, orally AND Placebo tablets once daily, orally arm 2: Memantine 10 mg twice daily, tablets, orally AND Placebo tablets twice daily, orally
Interventions: intervention 1: Memantine (once daily) intervention 2: Memantine (twice daily)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02563860
Conditions: Rett Syndrome
Keywords: Treatment trial Lovastatin
Sponsor: Montefiore Medical Center
Start date: 2015-07-01; Completion date: 2016-07-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase 2 , open label, dose escalating study of Lovastatin in Rett syndrome.

Detailed description:
Excess neuronal cholesterol plays a role in the pathophysiology of Rett syndrome(RTT) and the investigators hypothesise that inhibition of cholesterol synthesis in the CNS will reduce neuronal cholesterol and lead to improvement in Rett syndrome related symptoms.

Goal: To determine the optimal dosing regiment of Lovastatin for patients with RTT and to identify the most appropriate primary outcome measure for the subsequent Phase 3 study.

Phase 2, dose escalation study.

Primary outcome: Gait speed Secondary outcomes: respiratory function, cognition, EEG (encephalopathy), Rett syndrome severity scale, neurodevelopmental assessment (QOL)

20 ambulatory female patients with genetically confirmed.

Arms: arm 1: Treatment with Lovastatin, dose escalating trial according to the following schedule:

10 mg daily for 8 week 20 mg daily for 8 weeks 40 mg daily for 16 weeks.
Interventions: intervention 1: Lovastatin
Intervention descriptions: intervention 1: dose escallating

Protocol documents:
Clinical trial NCT02600559
Conditions: Otitis Media
Keywords: Otitis media Ear infection Tympanostomy tubes
Sponsor: Otonomy, Inc.
Start date: 2015-10-01; Completion date: 2016-07-01
Enrollment: 501 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an 8-week, multicenter, open-label study in which eligible subjects with a history of otitis media requiring TT placement will receive 6 mg OTO-201 to each ear. The study is designed to evaluate the safety and efficacy of OTO-201 in subjects undergoing TT placement with common concurrent surgeries and any middle ear effusion status.

Detailed description:

Arms: arm 1: Ciprofloxacin
Interventions: intervention 1: OTO-201 (ciprofloxacin)
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02609048
Conditions: Primary Biliary Cirrhosis (PBC)
Keywords: PBC
Sponsor: Gilead Sciences
Start date: 2015-11-04; Completion date: 2016-07-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the effect of seladelpar (MBX-8025) on alkaline phosphatase (AP) levels in participants with primary biliary cirrhosis (PBC).

Detailed description:
Primary:

To evaluate the effect of MBX-8025 on Alkaline Phosphatase (AP) levels

Secondary:

To evaluate the safety and tolerability of MBX-8025 in subjects with Primary Biliary Cirrhosis (PBC) To evaluate the effects of MBX-8025 on Primary Biliary Cirrhosis (PBC) response criteria To evaluate the effects of MBX-8025 on other markers of liver function, lipids, pruritus and Quality of Life (QoL)

Arms: arm 1: Participants received 2 placebo-to-match (PTM) seladelpar capsules, orally, once daily for 12 weeks. arm 2: Participants received seladelpar 50 mg capsule (1 x 50 mg capsule) and a PTM seladelpar capsule, orally, once daily for 12 weeks. arm 3: Participants received seladelpar 200 mg capsules (2 x 100 mg capsules), orally, once daily for 12 weeks.
Interventions: intervention 1: Placebo Comparator intervention 2: Experimental: Seladelpar 50 mg intervention 3: Experimental: Seladelpar / MBX-8025 200 mg
Intervention descriptions: intervention 1: Placebo Capsule intervention 2: Seladelpar 50 mg capsule intervention 3: Seladelpar 100 mg capsules

Protocol documents: