ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01059903
Conditions: Healthy Volunteers
Keywords: Rotigotine Neupro® Transdermal Patch
Sponsor: UCB Pharma
Start date: 2010-01-01; Completion date: 2010-03-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The major aim of this study is to investigate and compare the drug amount delivered to the body after sequential application of two Rotigotine patches of two different formulations

Detailed description:

Arms: arm 1: Rotigotine transdermal patch 4.5 mg/10 cm\^2, test drug product PR2.2.1 followed by Rotigotine transdermal patch 4.5 mg/10 cm\^2, reference drug product PR2.1.1 separated by a washout phase of at least 5 days arm 2: Rotigotine transdermal patch 4.5 mg/10 cm\^2, reference drug product PR2.1.1 followed by Rotigotine transdermal patch 4.5 mg/10 cm\^2, test drug product PR2.2.1 separated by a washout phase of at least 5 days
Interventions: intervention 1: Rotigotine transdermal patch
Intervention descriptions: intervention 1: Rotigotine 4.5 mg/10 cm\^2 patch applied for 24 hours

Protocol documents:
Clinical trial NCT01066026
Conditions: Wrinkles
Keywords: metallic cannula Hyaluronic acid
Sponsor: Brazilan Center for Studies in Dermatology
Start date: 2009-07-01; Completion date: 2010-03-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to assess the safety and efficacy of a new metallic cannula to inject hyaluronic acid for dermal augmentation in the nasolabial folds compared to standard needle.

Detailed description:
This was a monocentric, prospective, randomized, phase II and double-blind study.

At the baseline visits, one investigator rated the severity of nasolabial folds on both left and right sides according to the mentioned scale, and a standard set of six photographs of the face (frontal, left side and right side for both the whole face and the lower face) were taken.

On the day of the injection, the main investigator injected 1ml of dermal filler - hyaluronic acid (Restylane®, Q-Med, Uppsala, Sweden) - for each subject. The injected amount was 0,5ml for the right nasolabial fold and 0,5ml for the left nasolabial fold. The sides will be randomized.

Arms: arm 1: Nasolabial Fold with metallic cannula and hyaluronic acid injected. hyaluronic acid with metallic cannula or standard needle. Hyaluronic acid injected with the new tool arm 2: Nasolabial Fold with standard needle and hyaluronic acid injected. hyaluronic acid with metallic cannula or standard needle.
Interventions: intervention 1: hyaluronic acid with metallic cannula or standard needle. intervention 2: Hyaluronic acid injected with the new tool.
Intervention descriptions: intervention 1: The sides of injection were randomized and both the subject and the evaluator were blind to it. The injections were performed according through two different devices:

* In one of the sides, the hyaluronic acid (Restylane®) was injected in its conventional pharmaceutical presentation, with a standard needle which is part of the product's kit;
* In the other side, the hyaluronic acid (Restylane®) was injected through a metallic cannula, which replaced the needle of the product's kit.

Local analgesia was provided for both applications: topical analgesics 4% Lidocaine, for the application with the standard needle, and nerve block (Lidocaine 2%), where the application was performed with the metallic cannula. intervention 2: hyaluronic acid with metallic cannula.

Protocol documents:
Clinical trial NCT01068717
Conditions: Type 2 Diabetes Mellitus
Sponsor: AstraZeneca
Start date: 2010-03-01; Completion date: 2010-03-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To demonstrate the bioequivalence of a 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) tablet to that of 2.5-mg saxagliptin (Onglyza) and 500-mg metformin (Glucophage, marketed in Canada by Sanofi-Aventis) tablets coadministered to healthy participants in the fasted and fed states.

Detailed description:

Arms: arm 1: Single oral doses of saxagliptin, 2.5 mg, and metformin, 500 mg, administered together as tablets in the fasted state arm 2: Single oral dose of a 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) tablet administered in the fasted state arm 3: Single oral doses of saxagliptin, 2.5 mg, and metformin, 500 mg, administered together as tablets in the fed state arm 4: Single oral dose of saxagliptin, 2.5 mg/metformin, 500 mg, FDC tablet administered in the fed state
Interventions: intervention 1: Saxagliptin, 2.5 mg + Metformin, 500 mg (fasted state) intervention 2: Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fasted state) intervention 3: Saxagliptin, 2.5 mg + Metformin, 500 mg (fed state) intervention 4: Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fed state)
Intervention descriptions: intervention 1: Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin, once daily, 1 week intervention 2: Tablets, oral, 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC), once daily, 1 week intervention 3: Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin, once daily, 1 week intervention 4: Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin FDC, once daily, 1 week

Protocol documents:
Clinical trial NCT01068743
Conditions: Type 2 Diabetes Mellitus
Sponsor: AstraZeneca
Start date: 2010-02-01; Completion date: 2010-03-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To demonstrate bioequivalence of a 2.5 mg saxagliptin/850 mg metformin fixed dose combination (FDC) tablet relative to the 2.5 mg saxagliptin tablet and 850 mg metformin (Glucophage Marketed by Merck-Serono) tablet co-administered to healthy subjects in the fasted and fed condition.

Detailed description:

Arms: arm 1: A single oral dose of 2.5-mg Onglyza tablet and 850-mg Glucophage (marketed by Merck Serono) tablet administered together in the fasted condition. arm 2: A single oral dose of 2.5-mg saxagliptin/850-mg metformin fixed dose combination (FDC) administered in the fasted condition. arm 3: A single oral dose of 2.5-mg Onglyza tablet and 850-mg Glucophage (marketed by Merck Serono) tablet administered together in the fed condition. arm 4: A single oral dose of 2.5-mg saxagliptin/850-mg metformin FDC administered in the fed condition.
Interventions: intervention 1: saxagliptin intervention 2: metformin intervention 3: saxagliptin + metformin (FDC tablet)
Intervention descriptions: intervention 1: Tablets, Oral, 2.5 mg, once daily, single dose intervention 2: Tablets, Oral, 850 mg, once daily, single dose intervention 3: Tablet, oral, (saxagliptin 2.5 mg) (metformin 850 mg), once daily, single dose

Protocol documents:
Clinical trial NCT01075243
Conditions: Post-surgical Dental Pain
Keywords: dental pain paracetamol Post-surgical dental pain
Sponsor: GlaxoSmithKline
Start date: 2009-11-01; Completion date: 2010-03-01
Enrollment: 401 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
GlaxoSmithKline will be conducting this trial to compare analgesic efficacy of paracetamol 1000 mg vs 650 mg. The post-surgical dental pain model will be used to evaluate the analgesic efficacy of paracetamol. Each subject will be enrolled in the study for up to six weeks. The duration of the entire study will be approximately 18 weeks. Each subject will have to come to the clinic for three visits (Screening, Treatment and Follow up visits).

Detailed description:

Arms: arm 1: Paracetamol 1000mg arm 2: Paracetamol 650 mg arm 3: Placebo
Interventions: intervention 1: Paracetamol 1000 mg intervention 2: Paracetamol 650 mg intervention 3: Placebo
Intervention descriptions: intervention 1: Paracetamol 1000mg intervention 2: Paracetamol 650 mg intervention 3: Placebo

Protocol documents:
Clinical trial NCT01082081
Conditions: Post-surgical Dental Pain
Keywords: paracetamol dental pain Post-surgical dental pain
Sponsor: GlaxoSmithKline
Start date: 2009-10-01; Completion date: 2010-03-01
Enrollment: 300 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
GlaxoSmithKline will be conducting this trial to compare analgesics efficacy of paracetamol 1000mg vs 500mg . The post-surgical dental pain model will be used to evaluate the analgesic efficacy of paracetamol. Each subject will be enrolled in the study for up to six weeks. The duration of the entire study will be approximately 16 weeks. Each subject will have to come to the clinic for three visits (Screening, Treatment and Follow up visits).

Detailed description:

Arms: arm 1: Paracetamol 1000 mg arm 2: Paracetamol 500 mg arm 3: Placebo
Interventions: intervention 1: Paracetamol 1000 mg intervention 2: Paracetamol 500 mg intervention 3: Placebo
Intervention descriptions: intervention 1: Paracetamol 1000 mg intervention 2: Paracetamol 500 mg intervention 3: Placebo

Protocol documents:
Clinical trial NCT01106287
Conditions: Type 2 Diabetes
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-10-01; Completion date: 2010-03-01
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and tolerability of single doses of MK-0941 based on assessment of clinical and laboratory adverse experiences

Detailed description:

Arms: arm 1: Period 1: Placebo - Period 2: 80 mg - Period 3: 100 mg - Period 4: Placebo - Period 5: 140 mg arm 2: Period 1: 60 mg - Period 2: 80 mg - Period 3: 100 mg - Period 4: 120 mg - Period 5: Placebo arm 3: Period 1: 60 mg - Period 2: Placebo - Period 3: 100 mg - Period 4: 120 mg - Period 5: 140 mg arm 4: Period 1: 60 mg - Period 2: 80 mg - Period 3: Placebo - Period 4: 120 mg - Period 5: 140 mg
Interventions: intervention 1: MK-0941 intervention 2: Comparator: Placebo
Intervention descriptions: intervention 1: A single 60, 80, 100, 120 or 140 mg oral dose of MK-0941 will be administered in each period intervention 2: a single oral placebo will be administered in the designated period (Periods 1-5)

Protocol documents:
Clinical trial NCT01126359
Conditions: Pain
Keywords: Wound Vacuum Assisted Dressings Lidocaine Dressing change Pain management palliative care
Sponsor: University of Utah
Start date: 2008-08-01; Completion date: 2010-03-01
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this prospective study is to compare pain levels and pain medication dose requirements in patients with topical negative pressure (TNP) dressings removed in a standard manner (i.v. or p.o. pain meds) compared to dressings removed with lidocaine analgesia, via injection retrograde up the suction tube into the foam prior to removal. Our null hypothesis is that there will be no difference in overall pain scores or medication requirements when patients receive a saline, control injection and pain medications, compared to when their dressings are changed with a lidocaine injection into the sponge, with pain medications. Our objective is to disprove this null hypothesis with statistical significance.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Lidocaine intervention 2: Placebo-Saline
Intervention descriptions: intervention 1: Interventional dressing change: iv or po pain medication with injection of 1% lidocaine retrograde up the suction tube into the sponge. intervention 2: Control dressing change: iv or po pain medication and injection of 0.9% normal saline retrograde up the suction tube.

Protocol documents:
Clinical trial NCT01128946
Conditions: Dental Caries
Keywords: Enamel remineralization Fluoride caries
Sponsor: GlaxoSmithKline
Start date: 2009-11-01; Completion date: 2010-03-01
Enrollment: 83 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will use an oral in-situ caries model to study remineralization of enamel due to the action of different combinations of fluoride salts delivered from dentifrices.

Detailed description:

Arms: arm 1: Fluoride toothpaste containing sodium fluoride (NaF) arm 2: Fluoride toothpaste containing stannous fluoride (SnF) and NaF. arm 3: Fluoride toothpaste containing sodium monofluorophosphate (NaMFP) and NaF. arm 4: Low fluoride toothpaste containing NaF
Interventions: intervention 1: NaF intervention 2: SnF intervention 3: NaMFP
Intervention descriptions: intervention 1: Fluoride toothpaste containing sodium fluoride as 1450 parts per million (ppm) F, 675 ppmF, 450 ppmF, 350ppmF. intervention 2: Fluoride toothpaste containing stannous fluoride (1100 ppmF) intervention 3: Fluoride toothpaste containing sodium monofluorophosphate (1000 ppmF)

Protocol documents:
Clinical trial NCT01139801
Conditions: Induction of Labor
Keywords: Cervical Ripening Rate of Cesearean Section
Sponsor: Aultman Health Foundation
Start date: 2009-09-01; Completion date: 2010-03-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to specifically investigate the efficacy of an alternative pharmacologic cervical ripening agent, misoprostol, versus the standard oxytocin, as an adjunct to Foley balloon for induction of the unfavorable cervix.

Detailed description:
The design of this study is a randomized, controlled study with two arms. Both groups will undergo placement of a Foley catheter, through the external and internal os of the cervix, according to standard practice. In group A, receiving intravenous infusion of oxytocin, will serve as the control group as it is standard protocol at Aultman Hospital. Group B, intravaginal placement of misoprostol, will serve as the experimental group. The expected duration of participation begins at induction of labor and concludes at time of delivery.

Arms: arm 1: Foley balloon placement with intravenous low dose oxytocin administration starting 2 milliunits per minute. arm 2: Misoprostol, 25 mcg, is placed intravaginally into the posterior fornix of the vagina in conjunction with Foley balloon placement
Interventions: intervention 1: Oxytocin intervention 2: Misoprostol
Intervention descriptions: intervention 1: Foley balloon placement with intravenous low dose oxytocin administration starting 2 milliunits per minute. intervention 2: Misoprostol, 25 mcg, is placed intravaginally into the posterior fornix of the vagina in conjunction with Foley balloon placement

Protocol documents:
Clinical trial NCT01181167
Conditions: Prevention Venous Thromboembolism
Keywords: Anticoagulants Venous thromboembolism Thromboembolism Thrombosis enoxaparin sodium Embolism Deep vein thrombosis DU-176b edoxaban factor Xa total hip arthroplasty
Sponsor: Daiichi Sankyo Co., Ltd.
Start date: 2009-05-01; Completion date: 2010-03-01
Enrollment: 610 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to assess the efficacy and safety of DU-176b compared with enoxaparin sodium for the prevention of venous thromboembolism in patients after elective total hip arthroplasty.

Detailed description:

Arms: arm 1: DU-176b oral tablets, 30 mg., taken once daily for 2 weeks, initiated within 6 to 24 hours after surgery. arm 2: enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks, initiated within 24 to 36 hours after surgery.
Interventions: intervention 1: edoxaban intervention 2: enoxaparin sodium
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01184417
Conditions: Alcohol Withdrawal
Sponsor: Jonathan Rosenson
Start date: 2009-01-01; Completion date: 2010-03-01
Enrollment: 102 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Intravenous phenobarbital in combination with a symptom-guided standardized lorazepam-based alcohol withdrawal protocol will be associated with decreased need for ICU admission, continuous lorazepam infusion and will not be associated with increased adverse events.

Detailed description:

Arms: arm 1: 10 mg/kg IV phenobarbital in 100 ml saline arm 2: 100 ml saline
Interventions: intervention 1: 10 mg/kg IV phenobarbital in 100 ml saline intervention 2: placebo
Intervention descriptions: intervention 1: 10 mg/kg IV phenobarbital in 100 ml saline intervention 2: 100 m l saline

Protocol documents:
Clinical trial NCT01290978
Conditions: Healthy
Sponsor: Solventum US LLC
Start date: 2010-02-01; Completion date: 2010-03-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to find out if presurgical antiseptic preparations affect how well surgical drapes adhere to skin.

Detailed description:
Adhesive incise drapes are often used to provide a physical sterile barrier between the surrounding skin and the open wound at the beginning of a surgery. This study sought to determine the effect of presurgical skin antiseptic preparation on the adhesion of various incise drapes to the skin.

Arms: arm 1: Applied ChloraPrep on the application site per manufacturer's instruction arm 2: Apply DuraPrep to the application site per manufacturer's instruction
Interventions: intervention 1: ChloraPrep intervention 2: DuraPrep
Intervention descriptions: intervention 1: The application sites (subjects' backs) will be prepped with ChloraPrep according to manufacturer's instruction. Samples of 3 surgical incise drapes will be applied to the prepped sites according to randomization schedule intervention 2: The application sites (subjects' backs) will be prepped with DuraPrep according to manufacturer's instruction. Samples of 3 surgical incise drapes will be applied to the prepped sites according to randomization schedule

Protocol documents:
Clinical trial NCT01362439
Conditions: Schizophrenia
Keywords: Schizophrenia Paliperidone
Sponsor: Janssen-Cilag S.p.A.
Start date: 2009-01-01; Completion date: 2010-03-01
Enrollment: 133 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the effectiveness and safety of paliperidone extended release (ER) in symptomatic participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) who were receiving treatment with any oral (having to do with the mouth) antipsychotic medication and who needed to be switched to paliperidone ER from the current oral antipsychotic therapy due to insufficient efficacy or due to side effects.

Detailed description:
This is an open-label (all people know the identity of the intervention), multi-centric (conducted in more than one center) and non-comparative study of paliperidone ER in participants with schizophrenia who have a previous history of bad adherence to the antipsychotic treatment because of insufficient efficacy and side-effects. All the eligible participants will receive a dose of paliperidone ER in range of 3 to 12 milligram (mg) orally (taken by mouth; to be swallowed) once daily for 13 weeks. Efficacy and safety will primarily be evaluated by Positive and Negative Syndromes Scale (PANSS) and Extrapyramidal Symptom Rating Scale (ESRS), respectively. Participants' safety will be monitored throughout the study.

Arms: arm 1: None
Interventions: intervention 1: Paliperidone ER
Intervention descriptions: intervention 1: Participants will be administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose will be increased or decreased as per Investigator's discretion.

Protocol documents:
Clinical trial NCT01410604
Conditions: Obesity
Keywords: Metformin Obesity Insulin resistance Interleukin six Adiponectin High sensitivity C reactive protein. Tumour Necrosis Factor alpha
Sponsor: Hospital Regional de Alta Especialidad del Bajio
Start date: 2007-01-01; Completion date: 2010-03-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare serum concentrations of inflammatory cytokines, interleukin 6 (IL-6), High-sensitivity C-reactive protein (hs-CRP), adiponectin, and tumour necrosis factor alpha (TNFα), before and after three months treatment with metformin in obese adolescents with insulin resistance (IR).

Detailed description:
The increased prevalence of obesity in pediatric patients is a public health problem particularly because of the difficulties involved with changing lifestyles. Current studies of obese children and adolescents show increased insulin resistance (IR) and chronic inflammatory states. These conditions increase the risk of disability and/or premature death.

The current treatment schemes for obese children are conservative and are focused on changing their lifestyles (exercise and dietary plans). However, metabolic conditions, such as IR, dyslipidemia, and inflammatory processes, are perpetuated.

Metformin is a biguanide that is used for adolescents with diabetes mellitus and polycystic ovarian syndrome. Several clinical trials with metformin for obese pediatric patients have observed decreases in IR, decreases in weight, and improvements in lipid metabolism.

Adipose tissue is not only an energy repository, but also plays an immunological role by the secretion of cytokines. Both overweight adults and adolescents show decreases in adiponectin levels and increases in tumor necrosis factor alpha (TNFα) and interleukin 6 (IL-6). IL-6 can stimulate the production of high-sensitivity C-reactive protein (hs-CRP), which is considered to be a risk marker for the development of cardiovascular disease.

Arms: arm 1: Tablet of 500 mg metformin, oral every 12 hours (total metformin dose of 1 g/day) for 3 months. arm 2: Tablet of 500 mg oral placebo every 12 hours for 3 months.
Interventions: intervention 1: Metformin intervention 2: Placebo
Intervention descriptions: intervention 1: Tablet of 500 mg metformin, oral every 12 hours (total metformin dose of 1 g/day) for 3 months. intervention 2: Tablet of 500 mg oral placebo every 12 hours for 3 months.

Protocol documents: