ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01830881
Conditions: Pain Anxiety Nausea
Keywords: pain anxiety surgical abortion midazolam benzodiazepine
Sponsor: Oregon Health and Science University
Start date: 2013-04-01; Completion date: 2014-01-01
Enrollment: 124 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the level of pain, anxiety and side effects that women experience with a surgical abortion and the effect that the anti-anxiety medication, midazolam, might have when used along with ibuprofen and a paracervical block (PCB) instead of the standard pain treatment of only ibuprofen and a PCB.

Detailed description:
Women in the study will be randomized to receive either midazolam or placebo. Every participant will still receive the standard oral medications for pain (ibuprofen) as well as an injection of numbing medicine (lidocaine) near the cervix (PCB). The co-primary outcomes are patient perception of anxiety and pain with uterine aspiration reported on a 100 mm visual analogue scale (VAS). Secondary outcomes include reported anxiety and pain at time points before, during, and after the procedure, as well as subject satisfaction with anxiety and pain control and overall abortion experience. Due to the dose-dependent anterograde amnesic effect of midazolam, we will also investigate the effects on memory and recall, which has not previously been studied. In addition, we will also collect data on side effects frequently associated with oral midazolam such as nausea and sleepiness. Women will also be responsible for completing a one-page survey 1-3 days after the procedure visit and return it by mail using a pre-addressed and stamped envelope.

Arms: arm 1: 5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine arm 2: 5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
Interventions: intervention 1: Midazolam intervention 2: Ibuprofen intervention 3: Placebo-Cherry syrup intervention 4: Lidocaine
Intervention descriptions: intervention 1: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure intervention 2: 800 mg oral ibuprofen 30-60 minutes prior to procedure intervention 3: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure intervention 4: injection of 20 mL 1% lidocaine without epinephrine

Protocol documents:
Clinical trial NCT01838616
Conditions: Back Pain Low Back Pain Neuropathic Pain
Keywords: Severe chronic low back pain Neuropathic pain Constipation
Sponsor: Grünenthal GmbH
Start date: 2013-04-01; Completion date: 2014-01-01
Enrollment: 367 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a clinical effectiveness trial designed to compare the effectiveness, safety, and tolerability of treatment with tapentadol prolonged release with that of oxycodone/naloxone prolonged release in non-opioid pre-treated subjects with severe chronic low back pain with a neuropathic pain component.

Both tapentadol and the opioid oxycodone are effective in chronic severe pain and tapentadol and oxycodone/naloxone have shown advantages in gastrointestinal tolerability versus oxycodone. Therefore, it was of high scientific interest to compare the latter 2 analgesics with respect to gastrointestinal tolerability. Tapentadol may have advantages regarding the neuropathic pain-related symptoms of low back pain due to its 2 mechanisms of action.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Tapentadol Prolonged Release intervention 2: Oxycodone/Naloxone Prolonged Release
Intervention descriptions: intervention 1: All participants started with 50 mg tapentadol hydrochloride prolonged release (twice daily). The dose of tapentadol hydrochloride prolonged release will be adjusted in increments of 50 mg to a level that provided adequate analgesia. Titration will be after a minimum of 3 days on a dose. Participants are permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants will remain on the stable dose for 9 weeks. intervention 2: All participants start with 10 mg/5 mg oxycodone/naloxone (twice daily). The dose of oxycodone/naloxone may be adjusted in increments of 10mg/ 5 mg oxycodone/naloxone to a level that provide adequate analgesia. Titration will be after a minimum of 3 days on a dose. Participants will be permitted a maximum dose of 50 mg/ 20 mg oxycodone/naloxone twice daily a day (100 mg/40 mg total daily dose). After titration participants will remain on the stable dose for 9 weeks.

Protocol documents:
Clinical trial NCT01848054
Conditions: Opioid-Related Disorders Opiate Dependence
Keywords: opioid dependence, buprenorphine/naloxone, sublingual
Sponsor: Orexo AB
Start date: 2013-06-01; Completion date: 2014-01-01
Enrollment: 313 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study was to assess the efficacy of induction treatment with buprenorphine/naloxone (BNX) sublingual tablet s compared with induction treatment with buprenorphine only. The hypothesis is that starting directly on OX219 works equally well (e.g. not significantly worse) as starting on buprenorphine only and switching to OX219 on Day 3.

Detailed description:
This was a prospective, randomized, multicenter, blinded, parallel-group, active-controlled, non-inferiority study conducted at 13 sites within the US. Eligible patients participated in 8 treatment visits on Days 1, 2, 3, 4, 8, 15, 22, and 29. Effectiveness of treatment was assessed as follows:

* Retention in treatment at Day 3
* Clinician and patient assessments of opioid withdrawal symptoms
* Assessment opioid cravings

Arms: arm 1: Day 1-2 (Blinded Induction): BNX sublingual tablets

Day 3-28 (Open-label Maintenance): BNX sublingual tablets arm 2: Day 1-2 (Blinded Induction): Generic buprenorphine sublingual tablets

Day 3-28 (Open-label Maintenance): BNX sublingual tablets
Interventions: intervention 1: Buprenorphine/naloxone sublingual tablets intervention 2: Buprenorphine
Intervention descriptions: intervention 1: Advanced-formulation buprenorphine/naloxone sublingual tablets intervention 2: Buprenorphine sublingual tablets

Protocol documents:
Clinical trial NCT01867216
Conditions: Diabetes Mellitus, Type 2
Sponsor: Eli Lilly and Company
Start date: 2013-06-01; Completion date: 2014-01-01
Enrollment: 66 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to determine the safety of LY2922470, taken as oral capsules, once or twice daily for approximately 28 days, in participants with diabetes. It also aims to determine how long the drug stays in the body and how it affects blood sugar levels. A screening appointment is required within 28 days before the start of the study and a follow up appointment is required approximately 14 days after the last study dose is taken.

Detailed description:

Arms: arm 1: Multiple oral dose of placebo administered to participants with diabetes once or twice daily for 28 days arm 2: Multiple ascending dose of LY292470 (starting at 60 mg) administered orally to participants with diabetes once or twice daily for 28 days
Interventions: intervention 1: Placebo intervention 2: LY2922470
Intervention descriptions: intervention 1: Administered orally as capsules intervention 2: Administered orally as capsules

Protocol documents:
Clinical trial NCT01868438
Conditions: Malaria
Keywords: Pyronaridine artesunate tablet Pyronaridine artesunate granules Pyramax tablet Pyramax granules Bioavailability artemisinin based combination therapy (ACT)
Sponsor: Medicines for Malaria Venture
Start date: 2013-05-01; Completion date: 2014-01-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective of this study is to compare the bioavailability of two formulations (tablets and granules for dispersion) of the antimalarial drug pyronaridine-artesunate \[3:1\] (Pyramax, PA) in healthy adults. The secondary objective is to compare the safety of the two PA formulations and liver function test changes following the first and second administrations.

Detailed description:
This is a Phase I, single centre, open-label, randomised, two-way cross-over study in healthy volunteers to compare the bioavailability of two formulations of pyronaridine-artesunate, in tablet and in granule formulation. The study population will include 60 healthy volunteers, comprising male and female adults aged 20 to 45 years inclusive.

The volunteers will be randomised equally on Day -1 to one of two sequences: Sequence 1 (tablets in Period 1, granules in Period 2), or Sequence 2 (granules in Period 1, tablets in Period 2). The periods will be separated by a 60-day wash-out period. Each of the two pyronaridine-artesunate formulations will be administered as a single dose of either 180:60 mg pyronaridine-artesunate tablets (3 tablets) or 60:20 mg pyronaridine-artesunate granules (9 sachets). The total dose of each formulation administered is 540:180 mg pyronaridine-artesunate.

The study duration from the first study drug administration (Day 1) through to the last follow-up will be approximately 103 days. Screening is to be performed within 28 days before Day 1. Adverse events will be monitored throughout the study (and to resolution if necessary) to assess the general safety and tolerability of the treatments.

Arms: arm 1: Period 1: single administration of pyronaridine-artesunate granules: total dose 540mg pyronaridine + 180mg artesunate.

Period 2: cross-over to single administration of pyronaridine-artesunate tablets: total dose 540mg pyronaridine + 180mg artesunate. arm 2: Period 1: single administration of pyronaridine-artesunate tablets: total dose 540mg pyronaridine + 180mg artesunate.

Period 2: cross-over to single administration of pyronaridine-artesunate granules: total dose 540mg pyronaridine + 180mg artesunate.
Interventions: intervention 1: Pyronaridine-artesunate granules intervention 2: Pyronaridine-artesunate tablets
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01868893
Conditions: Chronic Lymphocytic Leukemia
Sponsor: Genentech, Inc.
Start date: 2013-08-01; Completion date: 2014-01-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a multicenter, open-label, single-arm, expanded access treatment study designed to provide obinutuzumab to patients with previously untreated Chronic Lymphocytic Leukemia (CLL) in combination with chlorambucil and to evaluate the safety and efficacy of obinutuzumab administered in combination with chlorambucil. This study will enroll patients with previously untreated CD20-positive CLL requiring treatment according to the IWCLL guidelines (Hallek et al 2008), as assessed by the investigator.

Detailed description:

Arms: arm 1: Obinutuzumab was administered intravenously for 6 cycles (28-day cycles) as: 100 mg on Day 1, 900 mg on Day 2, and 1000 mg on Days 8 and 15 for Cycle 1; and 1000 mg on Day 1 of Cycles 2 to 6. Chlorambucil was administered orally at a dose of 0.5 mg/kg body weight on Days 1 and 15 for Cycles 1 through 6 (28-day cycles).
Interventions: intervention 1: Obinutuzumab intervention 2: Chlorambucil
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01887418
Conditions: Hypogonadism
Keywords: Hypogonadism Testosterone enanthate
Sponsor: Antares Pharma Inc.
Start date: 2013-09-01; Completion date: 2014-01-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Relative Bioavailability and Safety comparison of 3 formulations of Testosterone Enanthate.

Detailed description:
Standard Pharmacokinetic (PK) analyses of data for serum testosterone were done. Cmax, Area Under Curve (AUC), and Cavg were used for the comparison of relative bioavailability of the treatments and reference arm.

Safety comparisons were based upon the occurrence, severity and rate of treatment emergent adverse events.

Arms: arm 1: QuickShot™Testosterone - Auto-injector device for SC use arm 2: QuickShot™Testosterone- Auto-injector device for SC use arm 3: Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference
Interventions: intervention 1: QuickShot™ - 50 mg Treatment B intervention 2: QuickShot™ - 100 mg Treatment A intervention 3: Delatestryl 200 mg IM Treatment C
Intervention descriptions: intervention 1: QuickShot™ for the delivery of testosterone intervention 2: QuickShot™ for the delivery of testosterone intervention 3: Standard of care

Protocol documents:
Clinical trial NCT01887678
Conditions: Osteoarthritis, Knee
Sponsor: Biologische Heilmittel Heel GmbH
Start date: 2013-06-01; Completion date: 2014-01-01
Enrollment: 287 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this study is to evaluate the effectiveness and safety of a combined Traumeel® / Zeel® injection against placebo (saline) in patients with moderate-to-severe pain associated with osteoarthritis of the knee.

Detailed description:
The primary objective is to demonstrate the superiority of Traumeel® and Zeel® co-administered intra-articular (IA) injections vs placebo IA injections on the change in knee pain in patients with moderate to severe knee pain associated with osteoarthritis.

The secondary objectives are to evaluate reduction of pain and stiffness and change in physical function.

Safety is evaluated by the incidence of treatment emergent adverse events during the treatment period and follow up period for all randomized patients.

Arms: arm 1: Injection volume is 4.2 mL for active study medication (2.0 mL Zeel plus 2.2 mL Traumeel in one intra articular (IA) injection) on treatment days 1, 8 and 15. arm 2: Injection volume of placebo is 4.2 mL as well (taken from the 10.0 mL vial by unblinded staff member, rest to be kept for drug accountability)
Interventions: intervention 1: Traumeel® / Zeel® Injectable Solution intervention 2: Placebo
Intervention descriptions: intervention 1: Injection volume is 4.2 mL for active study medication (2.0 mL Zeel plus 2.2 mL Traumeel in one IA injection) on treatment days 1, 8 and 15. intervention 2: Placebo is an injection of Saline

Protocol documents:
Clinical trial NCT01887990
Conditions: Depression Suicidal Ideation
Sponsor: University of Alabama at Birmingham
Start date: 2012-05-01; Completion date: 2014-01-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is dedicated to achieving better treatments for suicidal thoughts. Specifically, the investigators are studying the effect of a medication called ketamine to quickly treat suicidal thoughts and depression.

Detailed description:
This study is dedicated to achieving better treatments for suicidal thoughts. Specifically, we are studying the effect of a medication called ketamine to quickly treat suicidal thoughts and depression. Patients will be asked to participate in a research study to study how the use of a medication, ketamine, decreases your suicidal thoughts and improves their symptoms of depression. Ketamine is approved by FDA for use at higher doses in anesthesia, and recent clinical research suggests that it might benefit patients with major depressive disorder and suicidal thoughts. During clinical trials with over 10,000 patients, ketamine was proved to be safe as an anesthetic and studies with hundreds of patients with depression have demonstrated safety and lack of lasting side effects. This is a pilot study to test a new use of ketamine: treatment of suicidal thoughts. The study medication will be given in addition to usual psychiatric care.

Arms: arm 1: suicidal ideation and depression (no substance use disorder) 0.2 mg/kg IV ketamine administered as a one time dose arm 2: Suicidal ideation and depression (no substance use disorder) comparable amount of placebo (saline) arm 3: suicidal ideation,depression, opioid use disorder 0.2 mg/kg IV ketamine one time dose arm 4: Patients with suicidal ideation and depression with opioid use disorder who are given comparable amount of placebo (saline) as would have been used with the Ketamine arm
Interventions: intervention 1: Ketamine intervention 2: placebo
Intervention descriptions: intervention 1: single dose IV 0.2 mg/kg ketamine intervention 2: saline infusion

Protocol documents:
Clinical trial NCT01893281
Conditions: Hypogonadism
Sponsor: Eli Lilly and Company
Start date: 2013-07-01; Completion date: 2014-01-01
Enrollment: 78 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate if testosterone solution can raise testosterone hormone levels into the normal range after treatment for up to 9 Weeks, in those participants with a documented history of subtherapeutic levels \[total testosterone \<300 nanograms per deciliter (ng/dL)\] when previously treated with a topical testosterone gel.

Detailed description:

Arms: arm 1: Topical Testosterone Solution 30 milligrams up to 120 milligrams per day (mg/day) administered topically to axillae titrated based on testosterone levels.
Interventions: intervention 1: Topical Testosterone Solution
Intervention descriptions: intervention 1: Administered topically to axillae.

Protocol documents:
Clinical trial NCT01915849
Conditions: Type 2 Diabetes Mellitus
Sponsor: Novartis Pharmaceuticals
Start date: 2013-07-01; Completion date: 2014-01-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of the study was to assess the effect of LIK066 on intestinal glucose absorption immediately after a single dose (immediate effect) and 6 hours following the dose (after multiple daily doses; sustained effect) in patients with type 2 diabetes mellitus (T2DM).

Detailed description:

Arms: arm 1: Period 1- LIK066 15 mg treatment once daily (q.d.) for 4 days. Period 2- Placebo treatment once daily for 4 days Period 3 - LIK066 50 mg treatment once daily (q.d.) for 4 days. Period 4- LIK066 150 mg treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods. arm 2: Period 1- LIK066 50 mg treatment once daily (q.d.) for 4 days. Period 2- LIK066 15 mg treatment once daily (q.d.) for 4 days. Period 3- LIK066 150 mg treatment once daily (q.d.) for 4 days. Period 4- Placebo treatment once daily for 4 days. 14 days washout periods between treatment periods. arm 3: Period 1- LIK066 150 mg treatment once daily (q.d.) for 4 days. Period 2- LIK066 50 mg treatment once daily (q.d.) for 4 days. Period 3- Placebo treatment once daily for 4 days. Period 4- LIK066 15 mg treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods. arm 4: Period 1- Placebo treatment once daily (q.d.) for 4 days. Period 2- LIK066 150 mg treatment once daily (q.d.) for 4 days. Period 3- LIK066 15 mg treatment once daily (q.d.) for 4 days. Period 4- LIK066 50 mg treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods.
Interventions: intervention 1: LIK066 intervention 2: Placebo
Intervention descriptions: intervention 1: LIK066 15 mg, 50 mg and 150 mg intervention 2: None

Protocol documents:
Clinical trial NCT01922271
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Sponsor: Novartis Pharmaceuticals
Start date: 2013-08-01; Completion date: 2014-01-01
Enrollment: 152 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to further figure out differences of glycopyrronium bromide compared to tiotropium in early bronchodilation measured by a comprehensive assessment of lung function that includes hyperinflation and specific airway resistance in patients with moderate to severe COPD.

Detailed description:

Arms: arm 1: Period 1: NVA237 plus placebo to tiotropium on day 1, followed by a 7 day washout. Period 2: tiotropium plus placebo to NVA237 on day 8. Salbutamol was used as rescue medication. arm 2: Period 1: tiotropium plus placebo to NVA237 on day 1, followed by a 7 day washout. Period 2: NVA237 plus placebo to tiotropium on day 8. Salbutamol was used as rescue medication.
Interventions: intervention 1: NVA237 intervention 2: Tiotropium intervention 3: Placebo to NVA237 intervention 4: Placebo to tiotropium intervention 5: Salbutamol
Intervention descriptions: intervention 1: NVA237 44 µg inhalation capsules once daily, delivered via single-dose dry-powder inhaler (SDDPI) intervention 2: Tiotropium 18 μg once daily delivered via HandiHaler® device. intervention 3: Placebo to NVA237 once daily, delivered via single-dose dry-powder inhaler (SDDPI). intervention 4: Placebo to tiotropium once daily delivered via HandiHaler® device intervention 5: Used as resuce medication

Protocol documents:
Clinical trial NCT01941615
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2013-11-01; Completion date: 2014-01-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Investigate the effect of multiple oral doses of BI 207127 + faldaprevir (FDV) on the multiple dose pharmacokinetics of ethinylestradiol and levonorgestrel (Microgynon®) in healthy premenopausal female volunteers.

Detailed description:

Arms: arm 1: Period A: Microgynon®; Period B: Microgynon® + FDV + BI 207127
Interventions: intervention 1: faldaprevir intervention 2: Microgynon® intervention 3: BI 207127
Intervention descriptions: intervention 1: oral doses for 10 days (period B) intervention 2: oral doses for 23 days (period A+B) intervention 3: oral doses for 10 days (period B)

Protocol documents:
Clinical trial NCT01947153
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2013-11-01; Completion date: 2014-01-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of the current study is to demonstrate bioequivalence of two 2.5 mg linagliptin/500 mg metformin fixed dose combination tablets compared to the free combination of the linagliptin 5 mg and metformin 1000 mg in healthy male and female volunteers.

Detailed description:

Arms: arm 1: Linagliptin/Metformin arm 2: Linagliptin and Metformin
Interventions: intervention 1: Metformin intervention 2: Linagliptin intervention 3: Metformin intervention 4: Linagliptin
Intervention descriptions: intervention 1: Free combination intervention 2: Fixed dose combination intervention 3: Combination intervention 4: Free combination

Protocol documents:
Clinical trial NCT01958489
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2013-10-01; Completion date: 2014-01-01
Enrollment: 24 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The main purpose of this study is to look at the effect of evacetrapib on pravastatin levels in the blood when both drugs are taken at the same time. The study will also assess how well the body handles evacetrapib and pravastatin when given at the same time.

This study has two periods in fixed order. Each participant will enroll in both periods. This study will last approximately 25 days, not including screening.

Detailed description:

Arms: arm 1: Single 40 milligram (mg) oral dose of pravastatin administered on Day 1. arm 2: Oral doses of 130 mg evacetrapib administered once daily on Days 2 through 11, with a single oral dose of 40 mg pravastatin coadministered on Day 11.
Interventions: intervention 1: Evacetrapib intervention 2: Pravastatin
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally

Protocol documents: