ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02287623
Conditions: Acute Pain
Sponsor: University of Minnesota
Start date: 2013-05-01; Completion date: 2014-10-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is whether one local anesthetic, liposomal bupivacaine, provides improved pain control and decreased opioid use compared to bupivacaine when injected during a transversus abdominis plane block for donor nephrectomy patients.

Detailed description:
The primary objective of this study is whether one local anesthetic, liposomal bupivacaine, provides improved pain control and decreased opioid use compared to bupivacaine when injected during a transversus abdominis plane block for donor nephrectomy patients.

Background and treatment procedure: Liposomal bupivacaine is a multi vesicular formulation of bupivacaine that has been shown to provide up to 72 hours of analgesia compared to bupivacaine which provides up to 24 hours of analgesia post injection. These two medications have been compared using a infiltration or injection at the site of incision but have yet to be compared when used during a TAP block. A TAP block is an injection of local anesthetic under the covering of the transversus abdominis muscle layer. This layer is found using an ultrasound which is a beam of high frequency sound that allows one to visualize images in the body. Then using this ultrasound we can see our needle as it pierces the covering of the transversus abdominis muscle layer and watch as the local anesthetic is injected into this plane. This is done on both sides of the abdomen to provide analgesia to the skin, muscle, and fascial layers of the abdomen.

Population: Adult patients who are undergoing a donor nephrectomy Rationale: It will be useful to determine if one formulation or the other provides better and longer lasting pain control for patients undergoing abdominal procedures.

Arms: arm 1: Patients will receive a TAP block with liposomal bupivacaine arm 2: Patients will receive a TAP block with bupivacaine
Interventions: intervention 1: liposomal bupivacaine intervention 2: bupivacaine
Intervention descriptions: intervention 1: patients will receive a tap with liposomal bupivacaine intervention 2: patients will receive a tap with bupivacaine

Protocol documents:
Clinical trial NCT02319148
Conditions: Healthy Volunteers
Sponsor: Pfizer
Start date: 2014-07-01; Completion date: 2014-10-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective of the study is to estimate the effects of different strong enzyme (CYP3A4) inhibitors, itraconazole, diltiazem, or verapamil on the single dose pharmacokinetics of PF-00489791 in healthy volunteers. The study will enroll approximately 18 subjects that are randomized to 1 of 3 treatment groups. The study is also intended to determine the safety and tolerability of single-dose PF- 00489791 when it is administered with steady-state itraconazole, diltiazem, or verapamil.

Detailed description:

Arms: arm 1: Treatment B subjects receive single dose administration of 20 mg PF-00489791 and multiple dose administration of itraconazole (200 mg once daily). arm 2: Treatment C subjects receive single dose administration of 20 mg PF-00489791 and multiple dose administration of diltiazem (240 mg once daily). arm 3: Treatment D subjects receive single dose administration of 20 mg PF-00489791 and multiple dose administration of verapamil (240 mg once daily).
Interventions: intervention 1: itraconazole intervention 2: diltiazem intervention 3: SR verapamil intervention 4: PF-00489791
Intervention descriptions: intervention 1: itraconazole dosed at 200 mg intervention 2: diltiazem dosed at 240 mg intervention 3: SR verapamil dosed at 240 mg intervention 4: PF-00489791 20 mg single dose administration

Protocol documents:
Clinical trial NCT02327741
Conditions: Percutaneous Coronary Intervention
Keywords: Dual antiplatelet therapy clopidogrel percutaneous coronary intervention
Sponsor: Shiraz University of Medical Sciences
Start date: 2012-10-01; Completion date: 2014-10-01
Enrollment: 1010 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
1010 patients post stenting were enrolled to receive Plavix more than 12 months and less than that and rate of bleeding, complication and major cardiovascular adverse events ( MACE) were compared to evaluate safety and feasibility of long term Plavix therapy post stenting.

Detailed description:
1010 patients from registry of angioplasty and stenting in Shiraz and Baghiatolah hospital were enrolled and long term Plavix therapy more than and less than 12 months were compared between two groups of patients prospectively and rate of major adverse cardiovascular events ( MACE) (death, myocardial infarction, cerebrovascular accidents and revascularization) and rate of bleeding were compared between 2 groups.Syntax score and American heart association ( AHA) score of coronary involvement were measured and MACE was compared to these scores.

Arms: arm 1: taking plavix more than 12 months arm 2: taking plavix less than 12 months
Interventions: intervention 1: plavix intervention 2: plavix
Intervention descriptions: intervention 1: taking plavix more than 12 months intervention 2: taking plavix less than 12 months

Protocol documents:
Clinical trial NCT02329600
Conditions: Oral Lichen Planus
Sponsor: Cairo University
Start date: 2013-06-01; Completion date: 2014-10-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study included forty individuals divided into 3 groups. 10 control subjects, 15 oral lichen planus (OLP) patients who were treated with topical corticosteroids and 15 oral lichen planus (OLP) patients who were treated with topical corticosteroids and green tea tablets.

Detailed description:
This study included forty individuals divided into 3 groups. Group A; 10 systemically healthy control subjects not receiving medication.

Group B; 15 Patients who were previously diagnosed with OLP presented in acute exacerbation were treated with topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month.

Group C; 15 Patients who were previously diagnosed with OLP presented in acute exacerbation were treated with both topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month in addition to green tea tablets 200 mg (Green tea extract 5:1, El Obour For Modern Pharmaceutical Industries) as one tablet a day also for one month.

Arms: arm 1: 10 systemically healthy control subjects taking no medication. arm 2: 15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month. arm 3: 15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with both topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month in addition to green tea tablets 200 mg (Green tea extract 5:1, El Obour For Modern Pharmaceutical Industries) as one tablet a day also for one month.
Interventions: intervention 1: green tea tablets (Green tea extract 5:1) 200 mg intervention 2: Triamcinolone Acetonide
Intervention descriptions: intervention 1: Green tea is a product made from the Camellia sinensis plant. The fresh leaves are used to make medicine. the green tea extract is presented in a form of tablets 200 mg and is taken orally. intervention 2: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month

Protocol documents:
Clinical trial NCT02387554
Conditions: Hypertension(HTN)
Sponsor: Hanmi Pharmaceutical Company Limited
Start date: 2014-08-01; Completion date: 2014-10-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to investigate the pharmacokinetic interaction and safety between HGP0904, HGP0608 and HGP1405 when administered alone and in combination in healthy male volunteers

Detailed description:

Arms: arm 1: amlodipine + losartan + chlorthalidone arm 2: amlodipine arm 3: losartan arm 4: chlorthalidone
Interventions: intervention 1: HGP0904 intervention 2: HGP0608 intervention 3: HGP1405
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02568644
Conditions: Migraine
Keywords: Migraine Ginger Acute treatment
Sponsor: Federal University of Minas Gerais
Start date: 2014-07-01; Completion date: 2014-10-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main objective of the study was to evaluate ginger efficacy as an adjuvant to ketoprofen for the treatment of headache and other symptoms related with migraine attacks.

Detailed description:
Patients with the diagnosis of migraine according to the International Headache Society (IHS) criteria were enrolled in the study during a migraine attack. Patients received two 200 mg capsules of dry ginger extract (5% active ingredient) or two capsules of placebo (cellulose) in addition to an intravenous dose of ketoprofen (100 milligrams - mg) to treat the migraine attack.

Arms: arm 1: People (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two capsules of ginger extract (containing 5% of gingerols) and intravenous ketoprofen (100mg). arm 2: People (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two placebo capsules (cellulose) and intravenous ketoprofen (100mg).
Interventions: intervention 1: Extract of ginger intervention 2: Cellulose intervention 3: Intravenous ketoprofen
Intervention descriptions: intervention 1: People (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two capsules of ginger extract (containing 5% of gingerols). intervention 2: People (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two placebo capsules (cellulose). intervention 3: People (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received intravenous ketoprofen (100mg).

Protocol documents:
Clinical trial NCT03026803
Conditions: Liver Cancer Hepatocellular Cancer
Sponsor: City of Hope Medical Center
Start date: 2006-11-01; Completion date: 2014-10-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well giving oxaliplatin and capecitabine together works in treating patients with liver cancer.

Detailed description:
Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving these drugs together may kill more tumor cells.

Arms: arm 1: 21 day cycle with Oxaliplatin 50mg/m2 day 1 and day 8 administered IV, Capecitabine 750 mg/m2 bid p.o. daily from day 1 to day 14
Interventions: intervention 1: Oxaliplatin intervention 2: Capecitabine
Intervention descriptions: intervention 1: Given IV intervention 2: Given PO

Protocol documents:
Clinical trial NCT01982630
Conditions: Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2013-11-07; Completion date: 2014-10-03
Enrollment: 87 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety, efficacy, and pharmacokinetics of MK-8521 given once daily compared to placebo and another diabetes drug in participants with Type 2 diabetes mellitus (T2DM).

This study was modified by a protocol amendment to a 2-part trial to further test the safety and tolerability of MK-8521 at higher doses and to compare MK-8521 pharmacokinetics between participants with T2DM and healthy participants. An additional cohort of T2DM participants and a cohort of non-diabetic obese participants has been added.

Detailed description:

Arms: arm 1: Type 2 diabetes mellitus (T2DM) participants received once daily subcutaneous MK-8521 starting at 64 μg on Days 1 to 7 and escalated to 120 μg on Days 8 to 14. arm 2: T2DM participants received once daily subcutaneous MK-8521 starting at 34 μg on Days 1 to 7 and escalated to 72 μg on Days 8 to 14. arm 3: T2DM participants received once daily subcutaneous liraglutide starting at 0.6 mg on Day 1 and 2, escalated to 1.2 mg on Days 3 to 7, and escalated to 1.8 mg on Days 8 to 14. arm 4: T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days. arm 5: T2DM participants received once daily subcutaneous MK-8521 titrated to 300 µg starting at 64 µg and increasing to 120 µg on Day 8, 180 µg on Day 15, 240 µg on Day 20, and 300 µg on Day 25. The total number of dosing days was 29. arm 6: T2DM participants received once daily subcutaneous liraglutide titrated to 1.8 mg starting at 0.6 mg and increasing to 1.2 mg on Day 8, and 1.8 mg on Day 15. The total number of dosing days was 29. arm 7: T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days. arm 8: Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 titrated to 120 µg starting at 64 µg and increasing to 120 µg on Day 8. The total number of dosing days was 14.
Interventions: intervention 1: MK-8521 intervention 2: Liraglutide intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02881008
Conditions: Chronic Hepatitis B
Sponsor: Hepatera Ltd.
Start date: 2012-11-14; Completion date: 2014-10-04
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A randomized, open-label multicentre clinical trial of daily Myrcludex B versus entecavir in patients with HBeAg negative chronic hepatitis B.

Detailed description:
This is a randomized, open-label multicentre clinical trial of daily Myrcludex B versus entecavir in patients with HBeAg negative chronic hepatitis B. Accounting for screen-outs about 76 patients will be screened and 48 of them will be randomized into 6 treatment groups:

Arm A (8 patients): Myrcludex B 0.5 mg / day / sc / 12 weeks Arm B (8 patients): Myrcludex B 1 mg / day / sc / 12 weeks Arm C (8 patients): Myrcludex B 2 mg / day / sc / 12 weeks Arm D (8 patients): Entecavir 0.5 mg / day / orally / 24 weeks Arm E (8 patients): Myrcludex B 5 mg / day / sc / 12 weeks Arm F (8 patients): Myrcludex B 10 mg / day / sc / 24 weeks

The study consists of screening period up to 28 days (Day -28 -1); baseline visit (Day 0), treatment period up to 12 weeks for groups A-C, E and 24 weeks for groups D, F; follow-up period up to 12 weeks for groups A-C, E, F.

Arms: arm 1: Myrcludex B 0.5 mg daily for 12 weeks, followed by 12 weeks follow-up period arm 2: Myrcludex B 1 mg daily for 12 weeks, followed by 12 weeks follow-up period arm 3: Myrcludex B 2 mg daily for 12 weeks, followed by 12 weeks follow-up period arm 4: Entecavir 0.5 mg daily for 24 weeks arm 5: Myrcludex B 5 mg daily for 12 weeks, followed by 12 weeks follow-up period arm 6: Myrcludex B 10 mg daily for 24 weeks, followed by 12 weeks follow-up period
Interventions: intervention 1: Entecavir intervention 2: Myrcludex B
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01597635
Conditions: Lung Injury, Acute
Keywords: rhACE2 Acute Respiratory Distress Syndrome (ARDS) Acute Lung Injury GSK2586881 critical care
Sponsor: GlaxoSmithKline
Start date: 2012-09-01; Completion date: 2014-10-06
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an early phase (phase IIa), randomized, multi-center study in subjects with acute lung injury (ALI) or acute respiratory distress syndrome (ARDS). The purpose of this study is to investigate the safety of GSK2586881 and to determine what effects it has on people with Acute Lung Injury (ALI) or Acute Respiratory Distress Syndrome (ARDS).

The study has two parts: Part A will be an open-label investigation in five subjects. Part B will be a double-blind, placebo controlled investigation and will involve approximately 60 subjects.

Detailed description:
The acute respiratory distress syndrome (ARDS) is a form of severe acute lung injury (ALI) characterized by hypoxemic respiratory failure (the lungs are unable to absorb oxygen to the arterial blood) and non-cardiogenic pulmonary edema (accumulation of fluid in the lungs). The syndrome may be caused by direct or indirect injury to the lungs. It is associated with a mortality rate of up to 40-50%. There are no marketed pharmacologic therapies for this devastating syndrome.

This study aims to assess the safety, tolerability and pharmacodynamics of GSK2586881, a recombinant human angiotensin converting enzyme type 2 (rhACE2).

ACE2 is involved in the Renin-Angiotensin System (RAS), which controls blood pressure, electrolytes and intravascular fluid volume. A key function of rhACE2 is believed to be the cleavage of Angiotensin II (Ang II) to Ang (1-7), which have opposing physiological roles. Elevated levels of Ang II are associated with vasoconstriction, inflammation, fibrosis, vascular leak, and sodium absorption. Ang (1-7) appears to be a counterregulatory protein in the RAS; associated with vasodilation, anti-proliferation, antiinflammation, and reduced vascular leak. It has been observed that levels of Ang II are increased in humans with ALI/ ARDS. It is expected that the reduction of Ang II should have a positive impact on ALI and ARDS.

Arms: arm 1: 4 increasing doses of GSK2586881 given over 2 days arm 2: Repeat Medium-High dose of GSK2586881 (or placebo) over 3 days
Interventions: intervention 1: Dose 1 GSK2586881 intervention 2: Dose 2 GSK2586881 intervention 3: Dose 3 GSK2586881 intervention 4: Dose 4 GSK2586881 intervention 5: Placebo (saline)
Intervention descriptions: intervention 1: Low dose GSK2586881 administered intravenously intervention 2: Medium dose GSK2586881 administered intravenously intervention 3: Medium-High dose GSK2586881 administered intravenously intervention 4: High dose GSK2586881 administered intravenously intervention 5: Administered intravenously to match intervention

Protocol documents:
Clinical trial NCT01294098
Conditions: Femoral Fractures Pain, Postoperative
Keywords: Femoral Fractures Pediatrics Pain, Postoperative
Sponsor: Washington University School of Medicine
Start date: 2011-02-01; Completion date: 2014-10-08
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the efficacy of the use of Marcaine in femoral nerve blocks and hematoma blocks for post operative pain relief for femoral shaft fractures in a pediatric population.

Detailed description:
Children with femur fractures can have severe pain after elastic nail fixation. The current national standard for post operative pain control would be intravenous narcotics. In addition to the use of intravenous narcotics, there are two alternative methods used during the surgery in order to potentially decrease the pain post-operatively. These methods are hematoma block or a femoral nerve block. Both are proven safe and effective in children, however little research has been done to look at the effectiveness of these various methods compared to one another.

Arms: arm 1: this group will only get a pain control anesthesia pump to use for post-operative pain arm 2: this group will be receiving a femoral nerve block during surgery and have a PCA post-operatively arm 3: patient will receive hematoma block during surgery
Interventions: intervention 1: Marcaine
Intervention descriptions: intervention 1: 0.75 cc/kg of 1/4% Marcaine

Protocol documents:
Clinical trial NCT01655069
Conditions: Urinary Bladder, Overactive
Keywords: Overactive bladder (OAB) Solifenacin succinate suspension Phase 3 Pediatric
Sponsor: Astellas Pharma Europe B.V.
Start date: 2012-10-04; Completion date: 2014-10-08
Enrollment: 148 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This was a 40-week study to investigate how safe and effective solifenacin solution was in treating children or adolescents with symptoms of overactive bladder (OAB), who completed study 905-CL-076 (NCT01565707).

Detailed description:
There was a titration period of up to 12 weeks during which the participants would be up or down-titrated based on a combination of efficacy and safety parameters followed by a fixed dose period during which no dose adjustments were allowed. Participants completed a 7-day patient diary prior to every visit (start of 905-CL-076 to end of 905-CL-077, 14 visits). The first visit of this study (905-CL-077) was combined with the last visit of the 4-month study 905-CL-076. At each visit, the participant was required to undertake a number of assessments or examinations to determine whether it is safe for him/her to take part or to continue to take part in the study.

Arms: arm 1: Male and female children aged 5 to less than 12 years old who received placebo in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 247.9 days in children. arm 2: Male and female children aged 5 to less than 12 years old who received solifenacin in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 247.9 days in children. arm 3: Male and female adolescents aged 12 to less than 18 years old who received placebo in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 240.1 days in adolescents. arm 4: Male and female adolescents aged 12 to less than 18 years old who received solifenacin in Study 905- CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 240.1 days in adolescents.
Interventions: intervention 1: Solifenacin succinate suspension
Intervention descriptions: intervention 1: Oral suspension

Protocol documents: