ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01582880
Conditions: Chemical Injuries Unspecified Complication of Corneal Transplant Autoimmune Diseases Ocular Cicatricial Pemphigoid Stevens Johnson Syndrome Lupus Erythematosus, Systemic Rheumatoid Arthritis Other Autoimmune Diseases
Keywords: Keratoprosthesis sterile cornea ulcer
Sponsor: Joseph B. Ciolino, MD
Start date: 2012-03-01; Completion date: 2014-03-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the pilot study is to test the efficacy and safety of riboflavin/Ultraviolet A (UVA) cross-linked human donor corneas as carriers for the Boston Keratoprosthesis (Boston KPro) in patients with higher risk for corneal melting (keratolysis).

Detailed description:
The corneal cross-linking technique has been shown to strengthen the cornea and resist degradation by the body's own enzymes. The use of highly-resistant donor corneas is meant to eliminate the serious post-operative complication of corneal melting (keratolysis) that repeatedly occurs in Boston KPro patients with severe ocular burns, autoimmune and cicatrizing diseases.

Arms: arm 1: the donor cornea used as a carrier for the Boston Keratoprosthesis will undergo crosslinking treatment before being trephined and prepared for implantation with the Keratoprosthesis.
Interventions: intervention 1: Riboflavin
Intervention descriptions: intervention 1: Used to treat donor cornea before implantation

Protocol documents:
Clinical trial NCT01592773
Conditions: Autism Spectrum Disorder (ASD) Autism Autistic Disorder Asperger's Disorder Asperger's Pediatric Autism Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
Keywords: Autistic Disorder Asperger's Disorder Asperger's Pediatric Autism Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) Pervasive Child Development Disorder
Sponsor: Forest Laboratories
Start date: 2012-10-01; Completion date: 2014-03-01
Enrollment: 747 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this study is to evaluate the long-term safety and tolerability of memantine in the treatment of pediatric patients with autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS).

Detailed description:
This clinical study was a 48-week, multicenter, multinational, open-label extension study in pediatric outpatients with autism, Asperger's Disorder, or PDD-NOS conducted at 106 study centers. Patients were eligible for this long-term extension study if they had:

* completed the open-label Study MEM MD 67,or
* completed the open-label Study MEM-MD-91, or
* completed the double-blind Study MEM-MD-68, or
* discontinued study MEM-MD-68 by meeting requirements for loss of therapeutic response

The weight-based dose limits in this study were as follows:

Group A: ≥ 60 kg; maximum 15 mg/day Group B: 40-59 kg; maximum 9 mg/day Group C: 20-39 kg; maximum 6 mg/day Group D: \< 20 kg; maximum 3 mg/day

The decision to close the study early was based on data from 2 double-blind placebo-controlled studies (MEM-MD-57A and MEM-MD-68) that failed to demonstrate a statistically significant difference between memantine and placebo in the primary efficacy parameter based on Social Responsiveness Scale (SRS) total raw score.

Arms: arm 1: To maintain the blind of the preceding study, patients who participated in MEM-MD-68 (NCT01592747) began this study with 6 weeks of double blind dosing during which all patients were either titrated to or remained on their maximum target dosages. This was followed by up-to 42 weeks of open-label dosing.

Patients who took open-label memantine in study MEM-MD-67 (NCT01999894) or MEM-MD-91(NCT01592786), received up to 48 weeks of open-label memantine at their maximum tolerated weight based target dosage.
Interventions: intervention 1: Memantine Hydrochloride (HCl)
Intervention descriptions: intervention 1: During the 6-week double-blind dosing titration/maintenance period, Memantine extended-release 3-mg and 6-mg capsules; oral administration. Dosing was once daily.

During open-label treatment: Memantine extended-release 3mg capsules; oral administration. The maximum target dosage was identified during the prior studies for each patient. Dosing was once daily.

Protocol documents:
Clinical trial NCT01620177
Conditions: Alcohol Drinking Cannabis
Keywords: Cannabis Marijuana Marihuana Alcohol Driving
Sponsor: Gary R Gaffney
Start date: 2012-07-01; Completion date: 2014-03-01
Enrollment: 98 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to expand understanding of the effects of cannabis on driving performance with and without the presence of low levels of alcohol.

This project will involve the development a of a protocol and driving environment that is sensitive to the effects of cannabis on driving performance by building on prior driving situations used previously for testing the effects of alcohol on driving.

Detailed description:
Individuals will be recruited who are currently users of cannabis and alcohol to participate in this study. They will undergo a physical exam at screening. There will be six study visits where the subject will arrive at the Clinical Research Unit(University of Iowa Hospitals \& Clinics) the night before dosing. At each visit subjects will be receive one of the following six dosing regimens: placebo alcohol with placebo cannabis; placebo alcohol with low-dose cannabis, placebo alcohol with higher-dose of cannabis, low dose alcohol with placebo cannabis; low dose alcohol with low dose cannabis, low dose alcohol with higher-dose of cannabis. After dosing, participants will have provide saliva samples and blood drawn periodically to check cannabis levels and will complete a driving simulation. After completing the drive, additional saliva samples and blood draws will occur and participants will be monitored until it is safe to transport home.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None
Interventions: intervention 1: Alcohol(oral) and placebo intervention 2: Cannabis(THC)(Inhaled) and Placebo
Intervention descriptions: intervention 1: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive intervention 2: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC

Protocol documents:
Clinical trial NCT01629381
Conditions: Venous Thromboembolism Haemorrhage
Keywords: knee arthroscopy venous thromboembolism prevention
Sponsor: University of Padova
Start date: 2012-05-01; Completion date: 2014-03-01
Enrollment: 500 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study Objective: To assess the value of Rivaroxaban for the prevention of venous thromboembolism (VTE) after knee arthroscopy (KA) taking the placebo as standard of reference.

Study Population: Patients undergoing therapeutic KA at the study Centers, irrespective of the type and duration of the procedure, will be eligible for the study.

Study Design: Multicenter, randomized, double blind superiority, phase II trial comparing two arms:

* (R-7d) Rivaroxaban (10 mg od os) for 7 days
* (PL-7d) Placebo for 7 days.

Follow-up: 3-month period after the randomization

Standard of Reference:Placebo will be the standard of reference in accordance to international guidelines

Study length May 2012-December 2012

Total patients number: 500 patients

Primary Efficacy End-Point: Occurrence in the 3-month period after the randomization of at least one of the following events, objectively proven (by means of CCDU; multi-slice chest TC-angio; autopsy, if necessary, or clinical ground):

* All-cause mortality
* Symptomatic VTE
* Asymptomatic proximal DVT

Secondary Efficacy End-point:

• Combined incidence of all DVT plus symptomatic PE

Primary Safety End-point: Incidence of major bleedings.

Secondary Safety End-point: Overall incidence of bleeding

Detailed description:
The treatments will be administered postoperatively (1st dose 8-10 hours after procedure), for prevention of venous thromboembolism after KA.

A bilateral whole-leg colour-coded Doppler ultrasonography (CCDU) is scheduled for all patients at 7 (+1) days of follow-up; additionally, CCDU was due if the patients developed symptoms or signs suggestive of venous thromboembolism earlier.

Statistical \& Analytical Plan and Methodology: In the absence of prophylaxis the incidence of venous thromboembolism (primary efficacy end-point) after KA, as assessed by CCDU, is about 8.0% (combining weighted results of various paper). Prophylaxis with low-molecular weight heparins assures approximately a 60-70% relative risk reduction in this setting. Based on the findings of published trials investigating the efficacy of Rivaroxaban for prevention of venous thromboembolism after elective hip and knee surgery, when using a low-molecular-weight heparin as comparator, investigators can speculate that Rivaroxaban will further reduce this incidence (at least 1.2%).

Arms: arm 1: Oral Rivaroxaban 10 mg od for 7 days arm 2: oral placebo od for 7 days
Interventions: intervention 1: Rivaroxaban intervention 2: placebo
Intervention descriptions: intervention 1: 10 mg os once daily for 1 week intervention 2: 10 mg os once daily for 1 week

Protocol documents:
Clinical trial NCT01635218
Conditions: Moderate Depression Menopausal and Postmenopausal Disorders
Keywords: Depression Perimenopause Postmenopause Homeopathy
Sponsor: Hospital Juarez de Mexico
Start date: 2012-03-01; Completion date: 2014-03-01
Enrollment: 133 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this study was to determine whether individualized homeopathic treatment and fluoxetine are more efficient than placebo for moderate to severe depression in peri- and postmenopausal women.

Detailed description:
Perimenopausal period is characterized by an increased risk of depressive symptoms. Major depression is one of the most disabling medical conditions worldwide. At present, it is becoming more difficult to prove that antidepressants actually work better than placebo in clinical trials.Use of homeopathy to treat depression is widespread, but there is a lack of clinical trails about its efficacy in depression in peri- and postmenopausal women. Previous trials suggest that individualized homeopathic treatments improve depression in general population. The purpose of this study was to determine whether individualized homeopathic treatment and fluoxetine are more efficient than placebo for moderate depression in peri- and postmenopausal women.

Arms: arm 1: Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient. arm 2: Selective serotonin reuptake inhibitor. arm 3: Fluoxetine placebo plus individualized homeopathic placebo
Interventions: intervention 1: Individualized homeopathic treatment intervention 2: Fluoxetine intervention 3: Placebo
Intervention descriptions: intervention 1: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms. intervention 2: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4. intervention 3: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4.

Protocol documents:
Clinical trial NCT01647542
Conditions: Type 2 Diabetes Mellitus
Keywords: Drug therapy
Sponsor: Takeda
Start date: 2012-10-01; Completion date: 2014-03-01
Enrollment: 393 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of TAK-875 in Asia Pacific adults with type 2 diabetes mellitus (T2DM).

Detailed description:
The drug being tested in this study is called TAK-875. TAK-875 is being tested to treat people who have diabetes.

The study will enroll approximately 750 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

* TAK-875 25 mg once daily
* TAK-875 50 mg once daily
* Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient

All participants will be asked to take one tablet at the same time each day throughout the study. All participants will be asked to record any time they have low blood sugar symptoms in a diary.

This multi-centre trial will be conducted the Asia Pacific region. The overall time to participate in this study is 30 weeks. Participants will make 13 visits to the clinic.

Due to potential concerns about liver safety, on balance, the benefits of treating patients with fasiglifam (TAK-875) do not outweigh the potential risks.

For this reason, Takeda has decided voluntarily to terminate the development activities for fasiglifam.

Arms: arm 1: TAK-875 25 mg tablets, orally, once daily for up to 24 weeks. arm 2: TAK-875 50 mg tablets, orally, once daily for up to 24 weeks. arm 3: TAK-875 placebo-matching tablets, orally, once daily for up to 24 weeks.
Interventions: intervention 1: TAK-875 intervention 2: TAK-875 Placebo
Intervention descriptions: intervention 1: TAK-875 tablets intervention 2: TAK-875 placebo-matching tablets

Protocol documents:
Clinical trial NCT01652664
Conditions: Pediatric Glaucoma Elevated IOP in Pediatric Patients Ocular Hypertension in Pediatric Patients
Sponsor: Alcon Research
Start date: 2012-09-01; Completion date: 2014-03-01
Enrollment: 184 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the intraocular pressure (IOP)-lowering efficacy of Travoprost 0.004% POLYQUAD (PQ) ophthalmic solution compared to Timolol ophthalmic solution (0.5% or 0.25%) in pediatric glaucoma patients.

Detailed description:

Arms: arm 1: Travoprost 0.004% PQ ophthalmic solution, 1 drop administered in each eye in the evening with travoprost vehicle administered once daily in the morning for 3 months arm 2: Timolol, 0.5% or 0.25% ophthalmic solution, 1 drop administered in each eye twice daily (once in the morning and once in the evening) for 3 months
Interventions: intervention 1: Travoprost 0.004% PQ ophthalmic solution intervention 2: Timolol, 0.5% or 0.25% ophthalmic solution intervention 3: Travoprost Vehicle
Intervention descriptions: intervention 1: None intervention 2: Patients 2 months to \< 3 years of age received 0.25% intervention 3: Inactive ingredients used to maintain masking

Protocol documents:
Clinical trial NCT01660243
Conditions: Uremic Pruritus
Keywords: Pruritus Renal dialysis Receptors, Opioid, kappa Sleep Disorders Quality of Life
Sponsor: Toray Industries, Inc
Start date: 2012-09-01; Completion date: 2014-03-01
Enrollment: 45 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being conducted to investigate the efficacy of MT-9938 compared with placebo after 2 weeks, to continue to evaluate efficacy for an additional 6 weeks, and to explore the effect of a reduction in itching intensity on health-related Quality of Life(QoL) domains, especially those which recent research suggests have a positive correlation with overall survival for this patient group. The study will consist of the following phases: Screening (1 to 2 weeks), Run in (1 week), double-blind Treatment (8 weeks), Washout (1 week) culminating in a Follow-up Visit (1 week after the last dose).

Detailed description:
This study has been terminated because of insufficient patient recruitment. There were no safety concerns.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Nalfurafine hydrochloride(MT-9938) 2.5μg intervention 2: Nalfurafine hydrochloride(MT-9938) 5μg intervention 3: Nalfurafine hydrochloride(MT-9938) 10μg intervention 4: Placebo
Intervention descriptions: intervention 1: 2.5 μg (2capsules) once daily for 8 weeks intervention 2: 5 μg (2capsules) once daily for 8 weeks intervention 3: 10 μg (2capsules) once daily for 8 weeks intervention 4: Placebo (2capsules) once daily for 8 weeks

Protocol documents:
Clinical trial NCT01662908
Conditions: Deep Vein Thrombosis Venous Thrombosis
Sponsor: Daiichi Sankyo
Start date: 2012-08-01; Completion date: 2014-03-01
Enrollment: 85 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Assess the relative change in thrombus volume as determined by two assessments (Baseline and Day 14-21) with magnetic resonance venography (MRV) in subjects with deep-vein thrombosis (DVT) treated with either an edoxaban monotherapy regimen or a low molecular weight (LMW) heparin/warfarin regimen.

Detailed description:
The classical management of patients with venous thromboembolism (VTE) consists of an initial treatment of at least five days of a (LMW) heparin followed by long-term treatment with a vitamin K antagonist (VKA), such as warfarin. The eTRIS study will address the clinically important question of whether edoxaban monotherapy, without concomitant (LMW) heparin at the time of treatment initiation is comparable to or better than standard treatment with (LMW) heparin/warfarin therapy in subjects with acute symptomatic DVT as assessed by the relative change from baseline in thrombus volume (measured by MRI) at Day 14-21.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: edoxaban tosylate intervention 2: enoxaparin/unfractionated heparin intervention 3: warfarin
Intervention descriptions: intervention 1: edoxaban tosylate (DU-176b), film-coated for oral use, 90 mg once daily (QD) for 10 days (±2 days) followed by 60 mg QD for a total of approximately 90 days of edoxaban treatment intervention 2: enoxaparin - administered by subcutaneous injection;1 mg/kg/ twice daily or 1.5 mg/kg once daily unfractionated heparin - started with 5000 IU bolus intravenous administration, 1300 IU/h continuous infusion, minimum of 5 days of treatment and stopped when target INR (2.0 - 3.0) is achieved. intervention 3: tablet for oral use; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; 90 days treatment.

Protocol documents:
Clinical trial NCT01676220
Conditions: Type 2 Diabetes Mellitus
Sponsor: Sanofi
Start date: 2012-08-01; Completion date: 2014-03-01
Enrollment: 878 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Objective:

To compare the efficacy of a new formulation of insulin glargine and Lantus in terms of change of HbA1c from baseline to endpoint (scheduled at Month 6, Week 26) in participants with type 2 diabetes mellitus

Secondary Objectives:

To compare a new formulation of insulin glargine and Lantus in terms of:

\- occurrence of nocturnal hypoglycemia

Detailed description:
The maximum study duration was up to approximately 54 weeks per participant, consisting of:

* Up to 2 week screening period; it can be exceptionally extended of up to one additional week
* 6-month comparative efficacy and safety treatment period
* 6-month comparative safety extension period
* 2-day post-treatment safety follow-up period

Arms: arm 1: None arm 2: None
Interventions: intervention 1: HOE901-U300 (new formulation of insulin glargine) intervention 2: Lantus (insulin glargine)
Intervention descriptions: intervention 1: HOE901-U300 (new insulin glargine 300 units per milliliter \[U/mL\]) subcutaneous (SC) injection once daily (evening) for 12 months on top of non-insulin antihyperglycemic drug(s). Dose titration seeking fasting plasma glucose 4.4-5.6 millimole per liter (mmol/L) (80 - 100 milligram per deciliter \[mg/dL\]). intervention 2: Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months on top of non-insulin antihyperglycemic drug(s). Dose titration seeking fasting plasma glucose 4.4-5.6 mmol/L (80 - 100 mg/dL).

Protocol documents:
Clinical trial NCT01705145
Conditions: Cystic Fibrosis
Keywords: Cystic Fibrosis
Sponsor: Vertex Pharmaceuticals Incorporated
Start date: 2013-01-01; Completion date: 2014-03-01
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD), of ivacaftor in children with cystic fibrosis (CF) who are 2 through 5 years of age and have a CF Transmembrane Conductance Regulator (CFTR) gating mutation in at least 1 allele.

Part A is designed to evaluate the safety and PK of multiple-dose administration of ivacaftor in participants 2 through 5 years of age and to confirm the doses for Part B. Part B is designed to evaluate the safety, PK, PD, and efficacy of ivacaftor in participants 2 through 5 years of age.

Detailed description:

Arms: arm 1: Part A: Ivacaftor 50 milligram (mg) (for participants weighing less than \[\<\] 14 kilograms \[kg\]) or 75 mg (for participants weighing greater than or equal to \[\>=\] 14 kg) every 12 hours (q12h) from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study..

Part B: Ivacaftor 50 mg (for participants weighing \<14 kg) or 75 mg (for participants weighing \>=14 kg) q12h for 24 weeks during Part B of the study.
Interventions: intervention 1: Ivacaftor
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01705652
Conditions: Prostate Cancer
Keywords: nexrutine prostate cancer
Sponsor: The University of Texas Health Science Center at San Antonio
Start date: 2011-07-01; Completion date: 2014-03-01
Enrollment: 21 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to (1) to determine the rate of PSA decline (the number declining). Tissue will be obtained for ancillary studies and (2) to determine the number of patients with a PSA decline to \<1.0 ng/ml at 3 months in patients receiving Nexrutine® with standard radiation therapy. The Secondary Objective is to confirm the tolerability of this regimen. The Third Objective (Ancillary studies) is To evaluate the molecular response of Nexrutine®. Molecular response is defined as changes in the molecular pathways.

Detailed description:

Arms: arm 1: Surgery Group: Nexrutine 500mg by mouth, three times per day, given prior to surgery. arm 2: Radiation Group: Nexrutine 500mg by mouth, three times per day, given prior to and during radiation treatment.
Interventions: intervention 1: Nexrutine
Intervention descriptions: intervention 1: Nexrutine 500mg by mouth, three times per day, given prior to surgery or prior to and during radiation treatment.

Protocol documents: