ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01273818
Conditions: Inguinal Hernia
Keywords: inguinal hernia infection prophylaxis topical gentamicin
Sponsor: Diskapi Teaching and Research Hospital
Start date: 2011-01-01; Completion date: 2013-03-01
Enrollment: 276 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Aim of this study is to measure the effectiveness of topical gentamicin to prevent post-operative infection in inguinal tension-free hernia repair operation.Secondary aim is, if it is effective as a prophylactic agent, to compare it's effect with intra venous single dose cefazolin sodium prophylaxis.

Detailed description:
This study is a single blind prospective randomized trial. To measure and compare the effectiveness intra-operative topical gentamicin application in tension-free inguinal hernia repair in contrast to intravenous peri-operative prophylactic cefazolin sodium and combination of gentamicin and cephazolin this study is designed.

The patients are grouped randomly in to two groups:

* Group1;intravenous cefazolin sodium
* Group2;topical gentamicin
* Group3:topical gentamicin and intravenous cefazolin sodium

As a control group we decided to use the data of control groups ( without any prophylactic agent usage ) of previous studies done in our clinic and medical data base reviews.

Arms: arm 1: 80 mg gentamicin topical application intraoperatively arm 2: Application of 1000 mg cefazolin intra venously 1 hour before surgery arm 3: 1000 mg cefazolin application 1 hour before surgery and topical 80 mg gentamicin intraoperatively
Interventions: intervention 1: Gentamicin and cefazolin intervention 2: Cefazolin intervention 3: Gentamicin
Intervention descriptions: intervention 1: 80 mg topically, intra-operative,single dose and intravenous 1000 mg cefazolin 1 hour before operation intervention 2: 1000 mg cefazolin application intravenously 1 hour before operation intervention 3: 80 mg gentamicin application intraoperatively

Protocol documents:
Clinical trial NCT01301066
Conditions: Dyslipidemia
Sponsor: Kowa Research Institute, Inc.
Start date: 2010-12-01; Completion date: 2013-03-01
Enrollment: 252 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A 12-Week, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Pitavastatin intervention 2: Pravastatin
Intervention descriptions: intervention 1: Pitavastatin 4 mg QD intervention 2: Pravastatin 40 mg QD

Protocol documents:
Clinical trial NCT01307111
Conditions: Pain
Keywords: Misoprostol IUD insertion Nulliparous Women Contraception Family Planning IUD insertion in nulliparous women
Sponsor: University of New Mexico
Start date: 2011-02-01; Completion date: 2013-03-01
Enrollment: 85 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to see if using misoprostol makes the intrauterine device insertion easier and less painful in women who have never had a baby.

Detailed description:
The Intrauterine Device (IUD) is an excellent contraceptive option because of its ease of use, long term duration (5-10 years), low side-effect profile, and the immediate return to fertility after IUD removal. Despite advantages associated with the IUD, the smaller cervical diameter of nulliparous patients may lead to a more difficult and uncomfortable insertion. Some providers have started pre-medicating nulliparous patients with misoprostol prior to IUD insertion because of the drug's known effect as a cervical ripening agent. Limited evidence is available addressing the effect of misoprostol on patient comfort and provider ease of IUD insertion in nulliparous women. The goal of this study is to evaluate whether using misoprostol as a cervical ripening agent in nulliparous patients eases IUD insertion and decreases pain.

Arms: arm 1: Misoprostol 400 micrograms inserted buccally or vaginally, per the participants desire. arm 2: Pills which are identical to the study drug in appearance, taste, and smell.
Interventions: intervention 1: Misoprostol intervention 2: Placebo
Intervention descriptions: intervention 1: 400 micrograms inserted buccally or vaginally, per the participants desire prior to the IUD insertion. intervention 2: Pills which are identical to the study drug in appearance, taste, and smell.

Protocol documents:
Clinical trial NCT01323595
Conditions: Pain
Keywords: Pain control testicular sperm extraction sperm
Sponsor: Weill Medical College of Cornell University
Start date: 2011-01-01; Completion date: 2013-03-01
Enrollment: 78 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
While narcotic medication are commonly used for pain control near the time of surgery, there are significant side effects including constipation, nausea, risk of overdose leading to decreased breathing, and risk of addiction to narcotics. Our goal is to explore alternatives to narcotics for perioperative pain for patients undergoing sperm retrieval surgery. We have designed a prospective randomized clinical trial to evaluate how effective the anti-inflammatory medicine celecoxib(Celebrex©) is for pain control near the time of surgery. Celecoxib is known as a COX-2 inhibitor, a drug that belongs to the non-steroidal anti-inflammatory drug (NSAID) class. It is used to reduce swelling and to treat pain.

Patients will be divided into two groups: the first group receives a celecoxib pill and the second group receives a sugar pill(placebo). Patients and doctors will be unaware of exactly which pills are given. The patient will complete questionnaires for pain level. By comparing the pain levels we can better understand whether celecoxib (Celebrex©) significantly decreases perioperative pain.

Detailed description:
All consecutive patients scheduled to undergo elective, outpatient microsurgical testicular sperm extraction (TESE) beginning in 9/2011 will be invited for participation. Microdissection TESE will be performed unilaterally or bilaterally, through a midline scrotal incision, under general anesthesia.

Participants will be prospectively randomized in a 1:1 ratio to receive 200 mg of celecoxib or placebo b.i.d. in a double-blind fashion, initiated the night prior to surgery, and continued for six days thereafter. The randomization sequence will be generated and implemented by the institutional investigational pharmacy. Placebo medication, identical to the study medication, will also be provided by the institutional pharmacy.

Following surgery, all participants will be asked to complete a take-home post-operative questionnaire recording their maximum pain level on an 11-point visual analog scale (0-10), at specific time intervals over the course of the day, ranging from every six hours on post-operative day (POD) #1 to every 8 hours on POD #2, every 12 hours on POD #3, and every 24 hours on POD #4 to POD #7. Patients will also record the number of 5/500 mg tablets of acetaminophen/hydrocodone used for supplemental pain control from POD #1 to POD #7. Thirdly, patients will record whether or not their pain was adequately controlled at each of the above-mentioned time intervals.

Arms: arm 1: Celecoxib will be given for 6 days after surgery arm 2: Sugar pill for 6 days after surgery.
Interventions: intervention 1: Celecoxib intervention 2: Sugar Pill
Intervention descriptions: intervention 1: Celecoxib 200mg PO BID x 6 days intervention 2: Sugar pill PO BID x 6 days

Protocol documents:
Clinical trial NCT01330381
Conditions: Functional Constipation
Sponsor: Shire
Start date: 2011-04-28; Completion date: 2013-03-01
Enrollment: 215 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy of prucalopride compared to placebo for the treatment of functional constipation in a paediatric population, aged ≥ 6 months to \< 18 years. A 16-week open-label comparator (PEG) controlled part will follow, to document safety and tolerability up to 24 weeks.

Detailed description:

Arms: arm 1: drug arm 2: None arm 3: 4-20g administered as an oral solution once daily
Interventions: intervention 1: prucalopride intervention 2: Placebo intervention 3: PEG 4000
Intervention descriptions: intervention 1: prucalopride

* subjects with weight ≤50kg: 0.04 mg/kg once daily as oral solution of 0.4 mg/ml
* subjects with weight \>50 kg: prucalopride 2 mg tablet once daily intervention 2: Matching oral solution or oral tablets given once daily intervention 3: None

Protocol documents:
Clinical trial NCT01343082
Conditions: Open Angle Glaucoma or Ocular Hypertension
Sponsor: Santen Pharmaceutical Co., Ltd.
Start date: 2011-05-01; Completion date: 2013-03-01
Enrollment: 148 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Safety and IOP (intraocular pressure) lowering effect of DE-111 ophthalmic solution will be evaluated in open-angle glaucoma or ocular hypertension patients, in an open-label, multicenter study.

Detailed description:

Arms: arm 1: DE-111 ophthalmic solution
Interventions: intervention 1: DE-111 ophthalmic solution
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01347073
Conditions: Urea Cycle Disorders
Keywords: Urea Cycle Disorder UCD GT4P Buphenyl hyperammonemia sodium phenylbutyrate
Sponsor: Amgen
Start date: 2011-07-01; Completion date: 2013-03-01
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This non-randomized, open-label study was approximately one year in duration and consisted of a short term NaPBA to HPN-100 switchover part involving two overnight stays followed by a 12-month long term treatment period involving monthly visits.

Detailed description:
This was an open-label study consisting of a 10-day switch-over period during which subjects were switched from their prescribed dose of sodium phenylbutyrate (BUPHENYLTM or NaPBA) to a dose of HPN-100 that delivered the same amount of the active ingredient, PBA, followed by long-term treatment with HPN-100 for up to 12 months. The study was designed to capture information important for evaluating safety, Pharmacokinetics, and efficacy while recognizing sampling limitations in young children and current standard of care. Patients eligible for this study included pediatric patients from 29 days to \< 6 years of age with either a diagnosed or clinically suspected Urea Cycle Disorders (UCD) who are receiving a stable dose of the powder formulation of NaPBA. Subjects were clinically stable and had been receiving a stable dose NaPBA powder for at least 5 days at the time of enrollment.

During the switch-over part of the study, subjects switched from NaPBA to HPN-100 in one step and had two overnight stays with 24 hour blood sampling, the first of which was on Day 1, while still taking NaPBA, and the second of which was on approximately Day 10 while taking HPN-100. Subjects then continued in the long-term treatment phase which was 12 months in duration.

Study acquired from Horizon in 2024.

Arms: arm 1: Switch over from sodium phenylbutyrate to open label HPN-100 oral liquid over 10 days then open label, long term treatment for 12 months
Interventions: intervention 1: HPN-100
Intervention descriptions: intervention 1: HPN-100 is a pro-drug of PAA that combines with glutamine to provide an alternative vehicle for waste nitrogen elimination. It is a liquid with minimal taste and odor. Approximately three teaspoons of HPN-100 (\~17.4 mL) delivers an equivalent amount as PBA that 40 tablets of NaPBA.

Protocol documents:
Clinical trial NCT01351272
Conditions: ADHD
Sponsor: Wuerzburg University Hospital
Start date: 2011-05-01; Completion date: 2013-03-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In this study the investigators will measure the functional brain activity of adult Attention Deficit Hyperactivity Disorder (ADHD) patients, genotyped according to the COMT genotype, during a Working Memory Paradigm, before and after a placebo controlled treatment with MPH for 6 WEEKS. Within this design, the investigators will be able to evaluate the therapeutic effect of MPH treatment on cognitive functions.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Methylphenidate, non-retard intervention 2: Placebo
Intervention descriptions: intervention 1: Medication (methylphenidate, non-retard) will be titrated to optimal response within 6 weeks, with a maximum of 10 mg/day in week 1, 20 mg/day in week 2, 30 mg/day in week 3, 40 mg/day in week 4, 50 mg/day in week 5, and 60 mg/day in week 6, unless adverse effects emerged. After successful adjustment, medication will be maintained until week 6. Dosing will be based on at least two-weekly evaluations by a psychiatrist, including an interview with a review of symptoms and side effects, completion of the Clinical Global Impression (CGI) scale and completion of a standardised Side Effects Rating Scale for psychostimulants (SERS). The maximal daily dosage of MPH is 60 mg. Within this double blind study the same procedure is applied for the placebo condition. intervention 2: None

Protocol documents:
Clinical trial NCT01354691
Conditions: Alzheimer's Disease Dementia Memory Loss Cognitive Impairment
Keywords: Alzheimer's Disease Dementia Memory Loss Cognitive Impairment Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Depression Anxiety
Sponsor: Avraham Pharmaceuticals Ltd
Start date: 2011-02-01; Completion date: 2013-03-01
Enrollment: 200 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
For many, Alzheimer's disease is the number one medical issue facing our aging society. It is a late onset neurodegenerative disease, frequently under diagnosed, that impairs memory and cognitive performance. There are no known treatments that can either prevent or reverse its progression. Consequently, there still remains a need to evaluate treatments which can better stabilize the symptoms of this disease. These symptoms frequently include decreased functional capacity and negative psychological attributes (e,g, depression, anxiety) in association with the memory and cognition deficits. This current study is being done to assess an investigational compound that has been designed to not only improved the cognitive status of affected patients but to also better manage all symptoms. Hence, the ultimate goal is to provide patients with an improved quality of life by slowing the progression of this neurodegenerative disease

Detailed description:
This is a phase II, proof of concept study to evaluate the safety and efficacy of the investigational compound ladostigil versus placebo in mild to moderate Alzheimer's disease patients. The randomized, double-blind, placebo-controlled phase of the trial will be 26 weeks in duration and will involve two cohorts (i.e. one arm receiving ladostigil and one arm receiving placebo). After the initial 26 week period, all participating subjects will receive 26 weeks of treatment with ladostigil (i.e. the open label phase). A total of five territories will be participating in this trial. These include Austria, Croatia, Germany, Serbia and Spain.

Arms: arm 1: Ladostigil capsules 80 mg arm 2: Placebo capsules
Interventions: intervention 1: ladostigil hemitartrate
Intervention descriptions: intervention 1: Final dosage strength of 80mg b.i.d will begin at Day 22 following a 21 day dose escalation phase involving 40mg and 60mg b.i.d dosage strengths. Oral, solid dosage.

Protocol documents:
Clinical trial NCT01357980
Conditions: Detrusor Muscle Hyperactivity
Keywords: Detrusor Muscle Overactivity
Sponsor: Ipsen
Start date: 2011-05-01; Completion date: 2013-03-01
Enrollment: 47 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the efficacy and safety of a single dose of 750 U of Dysport compared to placebo for the improvement in the daily incontinence episode frequency for each administration mode in subjects suffering from neurogenic detrusor overactivity following spinal cord injury or multiple sclerosis.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Botulinum toxin type A intervention 2: Placebo
Intervention descriptions: intervention 1: 750 U intra detrusor injection on Day 1 (single dose) intervention 2: Intra detrusor injection on Day 1 (single dose)

Protocol documents:
Clinical trial NCT01368432
Conditions: TBI Major Depression Other Psychiatric Disorders
Keywords: TBI Depression Mood Behavior
Sponsor: Johns Hopkins University
Start date: 2010-04-01; Completion date: 2013-03-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This research is being done to see if a drug called escitalopram (Lexapro) is helpful to people who are suffering from depression after traumatic brain injury (TBI).

Detailed description:
Despite it's high prevalence, little is known about the pharmacological treatment of depression following Traumatic Brain Injury (TBI). This is because of a lack of randomized controlled studies in the treatment of post-TBI depression. This study is designed to examine the safety and effectiveness of escitalopram in the treatment of post-TBI depression. It will also investigate metabolic changes and neural pathways associated with post-TBI depression and metabolic alterations after treatment through neuroimaging.

Arms: arm 1: Daily for 12 weeks arm 2: Escitalopram 10 mg or 20 mg daily for 12 weeks
Interventions: intervention 1: Escitalopram intervention 2: Placebo
Intervention descriptions: intervention 1: Escitalopram 10 mg or 20 mg daily for 12 weeks by mouth intervention 2: Sugar pill placebo

Protocol documents:
Clinical trial NCT01375374
Conditions: Epilepsy, Partial
Keywords: Vimpat Partial seizures Carbamazepine Hormone levels Lipid levels Lacosamide
Sponsor: UCB Pharma
Start date: 2011-07-01; Completion date: 2013-03-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the trial is to investigate whether changes in lipids and hormonal parameters can be observed in blood when Carbamazepine treatment is replaced with Lacosamide treatment, while Levetiracetam treatment remains unchanged.

Detailed description:

Arms: arm 1: commercial 50 mg (pinkish) and 100 mg (yellow) tablets
Interventions: intervention 1: Lacosamide intervention 2: Levetiracetam
Intervention descriptions: intervention 1: 4-Week Titration Period: start dose Lacosamide (LCM) is 100 mg/day - up-titration of 100 mg/week LCM 8-Week Maintenance Period: dose can change first 4 weeks with 100 mg/week, must remain between 300 mg/day and 600 mg/day. Dose must remain stable last 4 weeks. intervention 2: Levetiracetam (LEV) is taken at a stable dose 30 days before study entry and is ≥ 1000 mg/day at the first visit. The LEV dose may not be changed at any time.

Protocol documents:
Clinical trial NCT01391325
Conditions: Gout
Sponsor: Ardea Biosciences, Inc.
Start date: 2011-07-01; Completion date: 2013-03-01
Enrollment: 1735 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a study of allopurinol in gout patients with hyperuricemia that will evaluate the safety and serum urate (sUA) lowering capability of allopurinol as a urate lowering therapy (ULT) for up to six months. Allopurinol will be dosed according to the local product label, at the discretion of the Investigator, to achieve an optimal, medically appropriate dose for each patient.

Detailed description:

Arms: arm 1: Treatment.
Interventions: intervention 1: Allopurinol
Intervention descriptions: intervention 1: Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label.

Protocol documents:
Clinical trial NCT01411137
Conditions: Parkinson's Disease
Sponsor: Impax Laboratories, LLC
Start date: 2011-08-01; Completion date: 2013-03-01
Enrollment: 43 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The study had three distinct parts and is described as follows:

Part 1:

* To evaluate the dose conversion from CD-LD ER taken alone or in combination with CD-LD IR to IPX066 in subjects with advanced PD
* To evaluate the utility of the Objective Parkinson's Disease Measurement (OPDM), an exploratory computer-based system, in assessing dexterity and mobility in a subset of PD subjects.

Part 2:

• To evaluate the long-term safety and clinical utility of IPX066 under open-label conditions in eligible subjects who successfully completed Part 1 of the study.

Part 3:

• To further evaluate the long-term safety of IPX066 in eligible subjects who successfully completed Part 2.

Detailed description:
Part 1: This study was a multicenter, open-label study. Subjects were to be converted from their previous CD-LD treatment to IPX066 over a 6-week period. Up to 40 subjects were to be enrolled in the study. Enrollment was defined as subjects who received study drug in Part 1 - Visit 1. Subjects were to be entered into one of two cohorts.

Approximately 24 subjects were to enroll in Cohort 1 (non-OPDM subjects) and up to 16 subjects at selected sites were to enroll in Cohort 2 (OPDM subjects). For the subjects enrolled in Cohort 2, along with the OPDM measurements, PK blood samples were also to be collected.

Part 2: Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study.

Part 3: Following the successful completion of Part 2 of the study, eligible subjects could participate in Part 3, an additional 6-month open-label extension study.

Arms: arm 1: Subjects were to receive individualized IPX066 doses orally in an open-label manner using four dosage strengths.
Interventions: intervention 1: IPX066
Intervention descriptions: intervention 1: Subjects were converted from their current treatment to IPX066 over a 6-week period.

Experimental Drug Product: IPX066 (carbidopa-levodopa) extended-release capsules

Protocol documents:
Clinical trial NCT01417078
Conditions: Epilepsy
Sponsor: Acorda Therapeutics
Start date: 2011-09-01; Completion date: 2013-03-01
Enrollment: 31 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the pharmacokinetics of Diazepam Nasal Spray following a single dose in epileptic patients experiencing a seizure episode.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Diazepam
Intervention descriptions: intervention 1: single-dose; dosage in mg, based on patient body weight

Protocol documents: