ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01592786
Conditions: Autism Spectrum Disorder (ASD) Autism Autistic Disorder Asperger's Disorder Asperger's Pediatric Autism Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
Keywords: Autism Spectrum Disorder (ASD) Autism Autistic Disorder Asperger's Disorder Asperger's Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) Memantine Pediatric Disorder
Sponsor: Forest Laboratories
Start date: 2012-06-01; Completion date: 2013-08-01
Enrollment: 906 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety and tolerability of memantine in pediatric (6-12 years old) patients with autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) and to identify responders for participation in a follow-up randomized withdrawal study.

Detailed description:
This 50-week multicenter and multinational clinical study is comprised of a 2-week screening period, a 6-week open-label dose-titration period followed by a variable duration maintenance period (up to 42 weeks).

Patients with at least 12 weeks of investigational product exposure who meet the protocol specified responder criterion at two consecutive visits separated by at least two weeks are eligible to transition to a randomized withdrawal study. A responder is defined as a patient who demonstrates at least a 10 point improvement (reduction in score) in the Social Responsiveness Scale (SRS) total raw score relative to the Visit 1 total raw score.

Weight based dose limits were selected in this study to ensure that exposure in terms of area under the curve (AUC) was less than the predefined limit of 2100 ng·h/mL which represents a 10-fold lower exposure than observed at the No observed adverse effect level (NOAEL) of 15 mg/kg/day in juvenile rats.

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

Arms: arm 1: Once daily oral administration of open-label memantine for up to 48 weeks: 6-week dose-titration period followed by up to 42-week maintenance period.
Interventions: intervention 1: Memantine Hydrochloride (HCl)
Intervention descriptions: intervention 1: Memantine extended release 3-mg capsules; the dosages studied ranged from 3 - 15 mg/day; weight based dosing in 4 weight groups; oral administration. Dosing is once daily for up to 48 weeks.

Protocol documents:
Clinical trial NCT01598064
Conditions: Liver Cirrhosis Portal Hypertension
Sponsor: Po-Lin Chen, MD
Start date: 2012-04-01; Completion date: 2013-08-01
Enrollment: 49 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Recent studies indicate that probiotics can stimulate intestinal immunity and tighten the junctions of epithelial cells. By these ways, probiotics can reduce bacterial translocation; hence, they can ameliorate systemic inflammatory status. Because cirrhotic patients with portal hypertension often suffer from infections from intestinal flora, the investigators speculate that probiotics will be beneficial to those patients.

Detailed description:
The investigators will recruit appropriate patients, 120 in number, randomly allocate into control and experimental arms. They will be given GK#10 or placebo for 8 weeks. Clinical parameters, such as liver function, renal function, and general conditions will be evaluated at specific time points, week 0, 5, 9, and 13 weeks. Primary outcome measurement will be survival and major complications analysis, and secondary outcome measurement will be liver function evaluation.

The investigators anticipate providing our sponsor with useful results about GK#10. The investigators will make clear the impacts from individual strains, the investigators will validate our speculation that probiotics do no harm to cirrhotic patients with portal hypertension, even be beneficial to them. If the investigators can validate the anticipation, patients can enjoy benefits from our study, and the probiotics may have the potential to sell to the patients in the world.

Arms: arm 1: GK#10 1 pk tid for 8 weeks arm 2: Placebo 1 pack tid for 8 weeks
Interventions: intervention 1: GK#10 intervention 2: Placebo
Intervention descriptions: intervention 1: GK#10, 1 pack tid intervention 2: Placebo 1 pack tid po

Protocol documents:
Clinical trial NCT01600703
Conditions: Hyperlipidemia
Keywords: Intestinal lipoprotein Apolipoprotein B48 and apolipoprotein B100 Pancreatic clamp DPPIV inhibitor
Sponsor: University Health Network, Toronto
Start date: 2012-07-01; Completion date: 2013-08-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Recent studies in both animals and humans has demonstrated that the hormone GLP-1 (glucagon like peptide 1) reduces intestinal production of lipoprotein particles. The investigators therefore hypothesise that the drug sitagliptin which prevents the breakdown of GLP-1 will reduce intestinal lipoprotein production in humans. The investigators are unable to speculate whether sitagliptin will affect hepatic lipoprotein production because of lack of of data from animal studies or in vitro data. Sitagliptin is already an approved treatment for type 2 diabetes.

Detailed description:
Each subject will be studied twice 4-6 weeks apart in random order in this single blinded study. In study A they will receive a single dose of sitagliptin 100mg od. In study B they will receive placebo. A nasoduodenal tube will be sited under fluoroscopic guidance the day prior to the study. On the day of the study regular liquid formula (Great shake plus) will be infused from 4am through the tube to maintain a constant fed state. A pancreatic clamp (octreotide with replacement glucose, insulin and growth hormone) along with saline/sitagliptin will be started at 7am. From 9am an iv bolus of deuterated-glycerol (d5-glycerol) along with a regular infusion of deuterated leucine (L-\[5,5,5-2H3\]. Regular blood samples will be drawn to assess lipoprotein kinetics.

Arms: arm 1: sitagliptin, 100mg, oral, single dose arm 2: Placebo, oral, single dose
Interventions: intervention 1: Sitagliptin intervention 2: Placebo
Intervention descriptions: intervention 1: Sitagliptin, 100mg, oral, single dose intervention 2: Placebo, oral, single dose

Protocol documents:
Clinical trial NCT01626859
Conditions: Schizophrenia
Keywords: Schizophrenia Antipsychotic Agents Mental Disorder Psychotropic Drugs Dopamine Agents Central Nervous System Agents
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2012-05-01; Completion date: 2013-08-01
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate the pharmacokinetics, safety and efficacy of MP-214 in patients with schizophrenia.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: MP-214 3mg intervention 2: MP-214 6mg intervention 3: MP-214 9mg
Intervention descriptions: intervention 1: Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for twelve weeks. intervention 2: Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for twelve weeks. intervention 3: Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for twelve weeks.

Protocol documents:
Clinical trial NCT01642914
Conditions: Chronic Constipation Constipation
Keywords: Chronic Constipation Abdominal Bloating Linaclotide
Sponsor: Forest Laboratories
Start date: 2012-08-01; Completion date: 2013-08-01
Enrollment: 487 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of linaclotide compared with placebo in patients with chronic constipation (CC) and prominent abdominal bloating. This study includes an up to 3-week screening period and a 2-3 week pretreatment period. Patients who are eligible will be randomized to one of two doses of linaclotide or placebo for 12 weeks. This 12-week study will assess the effects of linaclotide on bowel movement frequency, as well as other abdominal and bowel symptoms of CC.

Detailed description:

Arms: arm 1: Linaclotide 290 micrograms arm 2: Linaclotide 145 micrograms arm 3: Matching placebo
Interventions: intervention 1: Linaclotide 290 micrograms intervention 2: Linaclotide 145 micrograms intervention 3: Matching placebo
Intervention descriptions: intervention 1: oral capsule, taken once daily each morning at least 30 minutes before breakfast intervention 2: oral capsule, taken once daily each morning at least 30 minutes before breakfast intervention 3: oral capsule, taken once daily each morning at least 30 minutes before breakfast

Protocol documents:
Clinical trial NCT01644617
Conditions: Rhinitis, Allergic, Perennial Rhinitis, Allergic, Nonseasonal
Sponsor: ALK-Abelló A/S
Start date: 2012-10-01; Completion date: 2013-08-01
Enrollment: 124 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the dose-related effectiveness, the safety and the tolerability of MK-8237, compared to placebo, in the treatment of house dust mite (HDM)-induced allergic rhinitis/rhinoconjunctivitis in adults. The primary hypothesis is that administration of MK-8237, compared to placebo, results in dose-related improvement in the average total nasal symptom score (TNSS) determined during environmental exposure chamber (EEC) challenge.

Detailed description:

Arms: arm 1: Placebo rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks arm 2: MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks arm 3: MK-8237 12 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks
Interventions: intervention 1: Placebo intervention 2: MK-8237 6 DU intervention 3: MK-8237 12 DU
Intervention descriptions: intervention 1: Placebo rapidly dissolving tablets administered sublingually once daily intervention 2: MK-8237 6 DU rapidly dissolving tablets administered sublingually once daily intervention 3: MK-8237 12 DU rapidly dissolving tablets administered sublingually once daily

Protocol documents:
Clinical trial NCT01654601
Conditions: Schizophrenia
Keywords: Schizophrenia
Sponsor: Dong Wha Pharmaceutical Co. Ltd.
Start date: 2012-06-01; Completion date: 2013-08-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To evaluate the pharmacokinetics of oral multiple-dose of DWCZP tablet 100mg.

Detailed description:
A randomized, 2-way crossover, open, phase I study to compare the pharmacokinetics profile of DWCZP tablet 100mg and Clozaril® tablet 100mg after a multiple-dose oral administration in schizophrenia patients.

Arms: arm 1: 1.1st Administration - DWCZP tablet 100mg Mutiple dose

2.2nd Administration - Clozaril tablet 100mg Mutiple dose arm 2: 1.1st Administration - Clozaril tablet 100mg Mutiple dose

2.2nd Administration - DWCZP tablet 100mg Mutiple dose
Interventions: intervention 1: DWCZP intervention 2: Clozaril
Intervention descriptions: intervention 1: Multiple dose intervention 2: multiple-dose

Protocol documents:
Clinical trial NCT01656161
Conditions: Prostate Cancer
Sponsor: Debiopharm International SA
Start date: 2012-07-01; Completion date: 2013-08-01
Enrollment: 120 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary purpose of this study is to evaluate the efficacy of triptorelin embonate 22.5 mg 6-month formulation administered by the subcutaneous (under the skin) route in:

* achieving castrate levels of testosterone (\< 1.735 nmol/L) on Day 29 \[i.e., 28 days after investigational medicinal product (IMP) injection\], and
* in maintaining serum testosterone castrate levels from Month 2 (Day 57) to end of Month 12 (Day 337) in participants with advanced prostate cancer.

Detailed description:

Arms: arm 1: Participants received subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation administered on Day 1 and on Day 169.
Interventions: intervention 1: Triptorelin embonate 22.5 mg
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01661946
Conditions: Diabetic Macular Edema
Keywords: vascular endothelial growth factor macular edema diabetic retinopathy
Sponsor: Queen's University
Start date: 2012-08-01; Completion date: 2013-08-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Currently, two similar medications are available for injection into the eye to treat a variety of eye diseases. These medications are called ranibizumab (Lucentis) and bevacizumab (Avastin). They both have a similar mechanism of action and work equally well, however only ranibizumab was designed for use in the eye. It is significantly more expensive per injection than bevacizumab (by a factor of roughly 40x).

In published studies trends have been noted towards an increased rate of systemic side effects such as heart attacks and strokes. This is presumably due to absorption of the drug(s) from the eye into the bloodstream, however this has never been shown before. The purpose of the investigators study was to compare the bloodstream levels of bevacizumab and ranibizumab at various time points after injection into the eye. This required the creation of a sophisticated assay to measure blood levels of the drugs.

Detailed description:
see above

Arms: arm 1: intravitreal injection of 0.5mg ranibizumab in usual fashion arm 2: intravitreal injection of 1.25mg bevacizumab in usual fashion
Interventions: intervention 1: Bevacizumab intervention 2: Ranibizumab
Intervention descriptions: intervention 1: Bevacizumab is an off-label but cheaper treatment for diabetic macular edema. intervention 2: Ranibizumab is a vascular endothelial growth factor inhibitor designed for ocular use

Protocol documents:
Clinical trial NCT01666210
Conditions: Ocular Inflammation and Pain
Sponsor: Ocular Therapeutix, Inc.
Start date: 2012-10-01; Completion date: 2013-08-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the safety and efficacy of OTX-DP as a sustained release drug (dexamethasone) depot when placed in the canaliculus of the eyelid for the treatment of ocular inflammation and pain in subjects who have undergone cataract extraction with intra-ocular lens implantation.

Detailed description:

Arms: arm 1: Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days arm 2: Placebo punctum plug insertion
Interventions: intervention 1: OTX-DP (Dexamethasone punctum plug) intervention 2: Placebo Vehicle Punctum Plug
Intervention descriptions: intervention 1: Sustained and tapered release of dexamethasone from hydrogel punctum plug intervention 2: Hydrogel punctum plug without dexamethasone

Protocol documents:
Clinical trial NCT01667471
Conditions: Juvenile Idiopathic Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2012-01-01; Completion date: 2013-08-01
Enrollment: 6 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This long-term, open-label extension study will evaluate the safety of RoActemra/Actemra (tocilizumab) in patients with polyarticular-course juvenile idiopathic arthritis who completed the WA19977 core study. Patients aged 9-18 years with at least JIA ACR30 clinical response to RoActemra/Actemra in the core study will be eligible to receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks. Anticipated time on study treatment is 104 weeks.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: tocilizumab [RoActemra/Actemra]
Intervention descriptions: intervention 1: 8 mg/kg iv every 4 weeks, 104 weeks

Protocol documents:
Clinical trial NCT01675050
Conditions: Functional Abdominal Pain
Sponsor: University of Michigan
Start date: 2012-08-01; Completion date: 2013-08-01
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The investigators hypothesize that using Cyproheptadine in a placebo-controlled crossover trial would help relieve abdominal pain associated with (Functional Abdominal Pain (FAP) in children, achieving a greater response than that observed with placebo. In addition to assessing self-report of pain and other symptoms, the investigators also propose to perform experimental somatic pain testing to determine if there is evidence of peripherally-maintained central sensitization in children with FAP. The investigators also hypothesize that there will be an increase in somatic pain threshold after completion of a Cyproheptadine course compared to baseline testing prior to treatment, and compared to placebo. This would allow children with FAP to return to normal function, improve symptoms and overall general well-being

Detailed description:

Arms: arm 1: 4 weeks of cyproheptadine or placebo with crossover to the other arm 2: 4 weeks of cyproheptadine or placebo with crossover to the other
Interventions: intervention 1: Cyproheptadine intervention 2: sugar pill
Intervention descriptions: intervention 1: 4 weeks of cyproheptadine or placebo with crossover to the other intervention 2: 4 weeks of cyproheptadine or placebo with crossover to the other

Protocol documents:
Clinical trial NCT01676701
Conditions: Rheumatoid Arthritis
Sponsor: Eli Lilly and Company
Start date: 2012-09-01; Completion date: 2013-08-01
Enrollment: 8 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the serum concentration of tabalumab after the administration using either prefilled syringe or auto-injector after the initial loading dose and after 12 weeks of treatment. Treatment period is followed by 40 weeks optional safety extension.

Detailed description:

Arms: arm 1: Tabalumab 180 milligram (mg) loading dose administered using auto-injectors at Week 0 as 2 subcutaneous (SC) injections (90 mg each), followed by a 90 mg SC injection every 2 weeks (Q2W) up to Week 12. arm 2: Tabalumab 180 mg loading dose administered using prefilled syringes at Week 0 as 2 SC injections (90 mg each), followed by a 90 mg SC injection Q2W up to Week 12.
Interventions: intervention 1: Tabalumab Auto-Injector intervention 2: Tabalumab Prefilled Syringe
Intervention descriptions: intervention 1: Administered SC by auto-injector intervention 2: Administered SC by prefilled syringe

Protocol documents:
Clinical trial NCT01680900
Conditions: Hot Flushes
Keywords: menopause hot flashes vilazodone
Sponsor: University of Pennsylvania
Start date: 2012-11-01; Completion date: 2013-08-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a pilot study to determine proof in principle that vilazodone, a selective serotonin reuptake inhibitor and 5HT1a agonist, reduces the frequency and severity of menopausal hot flashes relative to placebo. A secondary aim is to evaluate improvement in menopause-related quality of life.

Detailed description:
This is a proposal to conduct a small clinical trial for proof in principle that vilazodone reduces the frequency and severity of menopausal hot flashes. An additional exploratory aim is to identify improvement in menopause-related quality of life. Healthy, perimenopausal women ages 45-60 with an average of 4 or more moderate or severe hot flashes/night sweats per day for 3 screening weeks will be randomized to 8 weeks of treatment in a 2:1 ratio of vilazodone or matching placebo pills. Flexible dosing of vilazodone will start at 10 mg once/day for 7 days, increase to 20 mg/day for 1 more week and increase to 40 mg once/day at week 3 if unimproved. The primary outcome assessments are the frequency and severity of hot flashes at week 4 and week 8 as assessed by prospective daily diaries (using 7-day mean scores from the daily diaries). The secondary outcome is clinical improvement, defined as hot flash frequency \>=50% decrease from baseline. Treatment-emergent adverse events will be monitored and patient ratings of tolerability will be obtained.

Arms: arm 1: vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks arm 2: Placebo capsules matched to the drug dose for 8 weeks
Interventions: intervention 1: vilazodone intervention 2: placebo capsules
Intervention descriptions: intervention 1: capsules once/day for 8 weeks. Dose starts at 10 mg for 7 days, increases to 20 mg/day for 7 days, increases to 40 mg/day at week 3 of unimproved. intervention 2: placebo capsules matched to drug capsules.

Protocol documents:
Clinical trial NCT01681121
Conditions: Narcolepsy
Sponsor: Jazz Pharmaceuticals
Start date: 2012-09-01; Completion date: 2013-08-01
Enrollment: 93 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study to evaluate the safety and effectiveness of ADX-N05 compared to placebo in the treatment of excessive daytime sleepiness in adults with narcolepsy.

Detailed description:

Arms: arm 1: ADX-N05 to be taken once a day for 12 weeks arm 2: Placebo to match ADX-N05 to be taken once a day for 12 weeks
Interventions: intervention 1: ADX-N05 intervention 2: Placebo
Intervention descriptions: intervention 1: 150 mg once a day for 4 weeks followed by 300 mg once a day for 8 weeks intervention 2: One capsule placebo to match ADX-N05 to be taken for 4 weeks followed by 2 capsules placebo to match ADX-N05 to be taken for 8 weeks

Protocol documents:
Clinical trial NCT01681472
Conditions: Colonic Neoplasms
Keywords: Colon cancer 5,10-methylenetetrahydrofolate Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Gastrointestinal Diseases Therapeutic Uses Pharmacokinetics Pharmacodynamics
Sponsor: Isofol Medical AB
Start date: 2012-09-01; Completion date: 2013-08-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the concentration of four different metabolites in the tumor, in adjacent mucosa and in plasma in patients with colon cancer receiving two different doses of Modufolin (arfolitixorin) and Levoleucovorin (Isovorin®), respectively (60 and 200 mg/m2).

Detailed description:
The purpose of this study is to compare the concentration of \[6R\] 5,10-methylene-THF, 5-formyl-THF, 5-methyl-THF and THF in the tumor, in adjacent mucosa and in plasma in patients with colon cancer receiving two different does of Modufolin® and Levoleucovorin (Isovorin®), respectively (60 and 200 mg/m2).

Arms: arm 1: One i.v. bolus injection of study drug after the patient has been anaesthetized. arm 2: One i.v. bolus injection of study drug after the patient has been anaesthetized. arm 3: One i.v. bolus injection of study drug after the patient has been anaesthetized. arm 4: One i.v. bolus injection of study drug after the patient has been anaesthetized.
Interventions: intervention 1: 6R-MTHF (arfolitixorin) 200 mg/m2 intervention 2: Levoleucovorin 200 mg/m2 intervention 3: 6R-MTHF (arfolitixorin) 60 mg/m2 intervention 4: Levoleucovorin 60 mg/m2
Intervention descriptions: intervention 1: i.v. bolus injection intervention 2: i.v. bolus injection intervention 3: i.v. bolus injection intervention 4: i.v. bolus injection

Protocol documents: