ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01258660
Conditions: Contraception
Sponsor: Bayer
Start date: 2006-12-01; Completion date: 2008-01-01
Enrollment: 172 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine and compare the uptake of levomefolate calcium (Metafolin, a registered vitamin supplement) and folic acid in the body during 24 weeks of treatment with a following folate elimination phase of 20 weeks in healthy volunteers seeking contraception. Yasmin (oral contraceptive containing drospirenone and ethinylestradiol) was co-administered over the entire period of 44 weeks.

Detailed description:

Arms: arm 1: Combination EE/DRSP/ Metafolin \[0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin\] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone. arm 2: Yasmin \[0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)\] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
Interventions: intervention 1: EE 0.03 mg/DRSP 3 mg/Metafolin + folic acid placebo intervention 2: EE 0.03 mg/DRSP 3 mg (Yasmin) + folic acid
Intervention descriptions: intervention 1: Combination EE/DRSP/ Metafolin \[0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin\] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone. intervention 2: Yasmin \[0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)\] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.

Protocol documents:
Clinical trial NCT01332305
Conditions: Restless Legs Syndrome
Sponsor: XenoPort, Inc.
Start date: 2007-01-01; Completion date: 2008-01-01
Enrollment: 217 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the study was to generate the data necessary to determine the gabapentin exposure produced by 4 dose levels of GEn (600 mg, 1200 mg, 1800 mg, and 2400 mg) or placebo, and the corresponding relief of symptoms in subjects with Restless Legs Syndrome (RLS).

Detailed description:
This was a multicenter, randomized, double blind, placebo controlled, parallel group study, comparing 4 doses of GEn (XP13512) with placebo given once daily to subjects with RLS. Eligible subjects were randomized in equal numbers into 1 of 5 treatment groups (GEn 600 mg, 1200 mg, 1800 mg, or 2400 mg or placebo) for 12 weeks of treatment. Data from this study will be utilized as part of a larger pharmacokinetic (PK) pharmacodynamic (PD) analysis of data from several studies (XP084/RXP111495) that are part of the GEn RLS clinical development program. Safety and tolerability were also assessed.

Arms: arm 1: GEn (XP13512/GSK1838262) 600 mg arm 2: GEn (XP13512/GSK1838262) 1200 mg arm 3: GEn (XP13512/GSK1838262) 1800 mg arm 4: GEn (XP13512/GSK1838262) 2400 mg arm 5: Placebo
Interventions: intervention 1: GEn (XP13512/GSK1838262) intervention 2: Placebo
Intervention descriptions: intervention 1: Double-Blind Treatment Phase: 600 mg GEn (XP13512) orally, once daily for 3 days followed by 600 or 1200 mg on days 4-6, followed by 600 or 1200 or 1800 mg on days 7-9, followed by 600 or 1200 or 1800 or 2400 mg on days 10-84. Double-Blind Taper Phase: 600 or 1200 or 1800 mg GEn (XP13512) orally, once daily on days 85-86, followed by 600 mg or 1200 mg on days 87-88, followed by 600 mg on days 89-91 intervention 2: Placebo orally once daily

Protocol documents:
Clinical trial NCT01435798
Conditions: Central Neuropathic Pain Allodynia Spinal Cord Injury
Keywords: chronic pain central neuropathic pain spinal cord injury dextromethorphan lidocaine combination therapy analgesia
Sponsor: Brigham and Women's Hospital
Start date: 2003-04-01; Completion date: 2008-01-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This randomized, placebo-controlled, double-blind 4x4 crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of three doses of chronic oral (PO) dextromethorphan compared to placebo in central neuropathic pain following spinal cord injury. Subjects' maximally tolerated doses (MTD) were first determined to establish individual dose-analgesic response relationships in a run-in period; following a washout period, subjects were then randomized to receive an order of four doses of dextromethorphan (including placebo) in a 4x4 Latin square cross-over design.

Detailed description:

Arms: arm 1: 0% MTD Dextromethorphan arm 2: 25% MTD Dextromethorphan arm 3: 50% MTD Dextromethorphan arm 4: 100% MTD Dextromethorphan
Interventions: intervention 1: Dextromethorphan
Intervention descriptions: intervention 1: 0, 25, 50 and 100% of maximum tolerated dose, each administered over a 4 week period

Protocol documents:
Clinical trial NCT01564706
Conditions: Alzheimer Disease
Keywords: Amyloid imaging Positron Emission Tomography 18F-AV-45 florbetapir F 18 Diagnostic imaging
Sponsor: Avid Radiopharmaceuticals
Start date: 2007-10-01; Completion date: 2008-01-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will determine how florbetapir F 18 (18F-AV-45) radioactivity is distributed throughout the body.

Detailed description:

Arms: arm 1: Healthy male or female subjects, between 18 and 85 years of age.
Interventions: intervention 1: florbetapir F 18
Intervention descriptions: intervention 1: IV injection, 370MBq (10mCi), single dose

Protocol documents:
Clinical trial NCT01565291
Conditions: Alzheimer Disease
Keywords: Amyloid imaging Positron Emission Tomography 18F-AV-45 florbetapir F 18 Diagnostic imaging
Sponsor: Avid Radiopharmaceuticals
Start date: 2007-06-01; Completion date: 2008-01-01
Enrollment: 32 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A preliminary study to test how florbetapir F 18 (18F-AV-45) acts in the brains and bodies of healthy elderly people and patients with Alzheimer's Disease (AD) by using a positron emission tomography (PET) scanner.

Detailed description:

Arms: arm 1: Probable AD, National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, with mild/moderate dementia (Mini-Mental State Examination (MMSE) from 10 to 24) arm 2: Cognitively normal with MMSE of 29 or higher; age 50 years or older
Interventions: intervention 1: florbetapir F 18
Intervention descriptions: intervention 1: IV injection, 370MBq (10mCi), single dose

Protocol documents:
Clinical trial NCT02748213
Conditions: Breast Cancer
Sponsor: Hoffmann-La Roche
Start date: 2002-02-01; Completion date: 2008-01-01
Enrollment: 225 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the efficacy and safety of intravenous (IV) trastuzumab (Herceptin) and IV docetaxel (Taxotere), with or without oral capecitabine (Xeloda), in women with previously untreated HER2-positive advanced and/or metastatic breast cancer.

Detailed description:

Arms: arm 1: Participants will receive dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. arm 2: Participants will receive triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal.
Interventions: intervention 1: Xeloda intervention 2: Taxotere intervention 3: Herceptin
Intervention descriptions: intervention 1: Participants will receive oral Xeloda, 950 mg/m\^2 twice a day on Days 1 to 14 of each 21-day cycle. intervention 2: Participants will receive Taxotere, 75 milligrams per meter-squared (mg/m\^2) in the Herceptin + Taxotere + Xeloda arm or 100 mg/m\^2 in the Herceptin + Taxotere arm, via IV infusion on Day 1 of each 21-day cycle. The lower starting dose will be used in the triple-therapy arm. intervention 3: Participants will receive Herceptin, 6 milligrams per kilogram (mg/kg) via IV infusion, on Day 1 of each 21-day cycle. The first dose will be a loading dose of 8 mg/kg in Cycle 1; the dose of 6 mg/kg will be given from Cycle 2 onward.

Protocol documents:
Clinical trial NCT00500071
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Sponsor: Shire
Start date: 2007-06-28; Completion date: 2008-01-02
Enrollment: 318 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Assess the efficacy \& tolerability of Vyvanse when children aged 6-12 years diagnosed with ADHD are dosed to optimal effect.

Detailed description:
Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (lisdexamfetamine dimesylate) in Children aged 6-12 Diagnosed with ADHD

Arms: arm 1: None
Interventions: intervention 1: Vyvanse (lisdexamfetamine dimesylate)
Intervention descriptions: intervention 1: Vyvanse™ 20mg once daily at 7 a.m.; dose increased weekly by 10mg until an acceptable response is achieved. Titration may proceed to a maximum daily dose 70mg/day.

Protocol documents:
Clinical trial NCT00367835
Conditions: ADHD
Sponsor: Shire
Start date: 2006-12-04; Completion date: 2008-01-04
Enrollment: 217 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess efficacy and safety of SPD503(guanfacine hydrochloride) in subjects with ADHD and oppositional symptoms.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: SPD503 (Guanfacine hydrochloride) intervention 2: Placebo
Intervention descriptions: intervention 1: Subjects will start at 1mg tablet each morning and will subsequently be titrated (in 1 mg weekly increments) to optimal dose based upon tolerance and response to investigational product (not to exceed 4 mg/day). intervention 2: Placebo

Protocol documents:
Clinical trial NCT03716024
Conditions: Infectious Skin Disease Bacterial Skin Disease
Keywords: CSSSI
Sponsor: Paratek Pharmaceuticals Inc
Start date: 2007-07-18; Completion date: 2008-01-07
Enrollment: 234 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A Phase II trial to demonstrate the safety and efficacy of PTK 0796 in the treatment of complicated skin and skin structure infections (cSSSI).

Detailed description:
The pharmacologic profile of PTK 0796 in humans suggests that it has the potential to be used safely and effectively for this indication. Data from in vitro and animal studies support this hypothesis.

In PTK 0796-CSSI-0702 the safety and efficacy of PTK 0796 in the treatment of cSSSI will be compared to an antibiotic approved for this indication by FDA. Initial treatment will be administered intravenously with the option for subsequent oral treatment.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: PTK 0796 intervention 2: Linezolid
Intervention descriptions: intervention 1: PTK 0796 100 mg for injection; PTK 0796 capsule 100 mg intervention 2: Pre-mixed 600 mg IV infusion solution; Linezolid 600 mg tablets

Protocol documents:
Clinical trial NCT00727961
Conditions: Ovarian Neoplasms
Sponsor: Merck Sharp & Dohme LLC
Start date: 2004-11-09; Completion date: 2008-01-10
Enrollment: 58 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The aim of this study is to evaluate efficacy and tolerability, and number of positive response to treatment with CAELYX (50 mg/m\^2), administered as monotherapy once per 4 weeks to patients with metastatic epithelial ovarian cancer, resistant to previous platinum therapy.

Detailed description:

Arms: arm 1: Caelyx Intravenous, 50 mg/m\^2, given for 6 cycles
Interventions: intervention 1: Pegylated Liposomal Doxorubicin hydrochloride
Intervention descriptions: intervention 1: Caelyx Intravenous, 50 mg/m\^2 (60 minute infusion) on day 1, every 4 weeks, during 6 cycles

Protocol documents:
Clinical trial NCT00266812
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: temozolomide radiotherapy
Sponsor: Merck Sharp & Dohme LLC
Start date: 2005-03-08; Completion date: 2008-01-16
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase II, randomized, multicenter, open-label study designed to assess the safety and tolerability of concomitant chemotherapy with low-dose temozolomide during whole brain radiation and later on at 14 days on/14 days off schedule in patients with cerebral metastases from non-small cell lung cancer (NSCLC). The response to temozolomide will be evaluated by clinical follow up and Magnetic Resonance Imaging (MRI) performed every 2 months. Progression-free survival at 6 months, duration of overall survival, and quality of life will also be evaluated.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Temozolomide and radiotherapy intervention 2: Whole brain radiotherapy
Intervention descriptions: intervention 1: Oral temozolomide 75mg/m2/day for 14 days, during radiation treatment, and later on temozolomide 100 mg/m2/day at 14 days on/14 days off, until unacceptable toxicity or evidence of disease progression for up to 6 cycles from initial treatment. Radiotherapy (as in Intervention 2). intervention 2: 2 regimens are allowed: a) 20 fractions of 2 Gray each, administered on days 1 to 5, 8 to 12, 15 to 19, and 22 to 26; b) 10 fractions of 3 Gray each, administered on days 1 to 5 and 8 to 12.

Protocol documents:
Clinical trial NCT00345800
Conditions: Narcolepsy With Cataplexy
Keywords: Endocrine Evaluation cataplexy sodium oxybate (xyrem)
Sponsor: UCB Pharma SA
Start date: 2006-04-10; Completion date: 2008-01-22
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To monitor for endocrine changes in response to treatment of cataplexy with Xyrem, to focus on the hypothalamic pituitary axis and to confirm the safety of Xyrem on potential endocrine changes.

Detailed description:

Arms: arm 1: * Active Substance: Sodium Oxybate
* Pharmaceutical form: Oral Solution
* Concentration: 500 mg/mL oral solution from 4.5 to 9 g/day divided into two equal doses during 12 weeks
* Route of administration: Oral
Interventions: intervention 1: Sodium Oxybate (Xyrem)
Intervention descriptions: intervention 1: * Active Substance: Sodium Oxybate
* Pharmaceutical form: Oral Solution
* Concentration: 500 mg/mL oral solution from 4.5 to 9 g/day divided into two equal doses during 12 weeks
* Route of administration: Oral

Protocol documents:
Clinical trial NCT00413634
Conditions: Essential Thrombocythaemia
Sponsor: Shire
Start date: 2006-11-13; Completion date: 2008-01-22
Enrollment: 24 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Age related differences in response to a drug could arise from variation in pharmacokinetic (PK) and/or pharmacodynamic (PD) profiles between age groups. Whilst the efficacy and safety profile of anagrelide is well established through a well-documented clinical trial programme in patients of all ages, no formal studies have been carried out to investigate whether the PK profile of anagrelide and its metabolites is altered with age.

This study is designed to allow comparisons to be made in terms of pharmacokinetics of anagrelide and its metabolites between elderly (≥ 65 years) and young (18-50 years) ET patients

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: anagrelide hydrochloride intervention 2: anagrelide hydrochloride
Intervention descriptions: intervention 1: Anagrelide hydrochloride 0.5 mg per capsule; participants will be stable on an anagrelide treatment regimen and will take capsules from their own prescription except on the PK day when the participant specific anagrelide dose will be administered from a controlled study specific supply. intervention 2: Anagrelide hydrochloride 0.5 mg per capsule; participants will be stable on an anagrelide regimen and will take capsules from their own prescription except on the PK day when the participant specific anagrelide dose will be administered from a controlled study specific supply.

Protocol documents:
Clinical trial NCT00094809
Conditions: Colon Cancer Colorectal Cancer Rectal Cancer
Keywords: Neulasta® pegfilgrastim Advanced Chemotherapy
Sponsor: Amgen
Start date: 2003-02-01; Completion date: 2008-01-23
Enrollment: 252 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to evaluate the safety and effectiveness of pegfilgrastim in reducing grade 3/4 neutropenia when given after one of three chemotherapy regimens (FOIL, FOLFOX or FOLFIRI) in patients with locally advanced or metastatic colorectal cancer. This study is considered to be "investigational" because the time between receiving pegfilgrastim and the next cycle of chemotherapy is only 11 days.

Detailed description:

Arms: arm 1: 6 mg pegfilgrastim arm 2: 6 mg placebo
Interventions: intervention 1: Placebo intervention 2: Pegfilgrastim
Intervention descriptions: intervention 1: Subjects randomized to placebo will receive a 6 mg subcutaneous injection once per cycle at least 24 hours after completion of 5-FU chemotherapy infusion. Subjects will continue to receive one injection per cycle until completion of 4 cycles, or until early termination from the study treatment period, whichever occurs first. intervention 2: Subjects randomized to pegfilgrastim will receive a 6 mg subcutaneous injection once per cycle at least 24 hours after completion of 5-FU chemotherapy infusion. Subjects will continue to receive one injection per cycle until completion of 4 cycles, or until early termination from the study treatment period, whichever occurs first.

Protocol documents:
Clinical trial NCT00422461
Conditions: Hypertension
Keywords: Clinical Trial Randomized Controlled Trial Humans Cyclic Nucleotide Phosphodiesterases Type 5
Sponsor: Pfizer
Start date: 2007-02-27; Completion date: 2008-01-28
Enrollment: 135 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and blood pressure lowering effect of different doses of PF-00489791 in patients with mild to moderate high blood pressure

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: placebo intervention 2: PF-00489791 intervention 3: PF-00489791 intervention 4: PF-00489791
Intervention descriptions: intervention 1: placebo, oral, tablets, once daily, for 28 days intervention 2: PF-00489791 20 mg titrated to 40 mg, oral, tablets, once daily, for 28 days intervention 3: PF-00489791 4 mg, oral, tablets, once daily, for 28 days intervention 4: PF-00489791 10 mg, oral, tablets, once daily, for 28 days

Protocol documents:
Clinical trial NCT00214500
Conditions: Fabry Disease
Keywords: Amicus Therapeutics AT1001 Galafold Migalastat Substrate
Sponsor: Amicus Therapeutics
Start date: 2006-01-02; Completion date: 2008-01-29
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of migalastat hydrochloride (HCl) (migalastat) in participants with Fabry disease.

Detailed description:
This was a Phase 2, open-label study in male participants with Fabry disease. All participants who met initial eligibility criteria underwent a 28-day screening period, including a 14-day run-in with migalastat (150 milligrams \[mg\] migalastat once a day \[QD\] from Days -28 to -15) to assess eligibility for entering the treatment period of the study. Participants who entered the treatment period were required to have α-galactosidase A (α-Gal A) activity responsive to migalastat.

Fifteen participants received at least 1 dose of study drug, however, 6 of these participants did not demonstrate α-Gal A activity responsive to migalastat and were thus screen failures (these participants are hereafter referred to as "dosed screen failures") due to not meeting all inclusion criteria for treatment. Therefore, 9 participants were enrolled into the treatment period (these participants are hereafter referred to as "eligible-enrolled").

Eligible-enrolled participants (those who satisfied the criteria for inclusion in the study) received escalating doses of migalastat twice a day (BID) for 6 weeks (Days 1 to 42), followed by 6 weeks at 1 dose level BID (Days 43 to 84) during the treatment period. Participants could then opt to participate in the extension period. The study consisted of 2 optional extension periods, the first through Week 48 and the second through Week 96. For participants who did not continue into the optional treatment extension, the study included a 2-week follow-up period.

Arms: arm 1: Migalastat was administered orally during the 12-week treatment period and then during the optional 2 treatment extension periods.

Treatment Period:

* Migalastat 25 mg BID for Weeks 1 and 2 (Day 1 through the morning dose on Day 14).
* Migalastat 100 mg BID for Weeks 3 and 4 (Day 15 through the morning dose on Day 28).
* Migalastat 250 mg BID for Weeks 5 and 6 (Day 29 through the morning dose on Day 42).
* Migalastat 25 mg BID for Weeks 6 to 12 (Days 43 to 84).

Extension Period:

* Migalastat 25 mg BID for Weeks 12 through 48.
* Migalastat 50 mg QD for Weeks 48 through 96.
Interventions: intervention 1: migalastat HCl
Intervention descriptions: intervention 1: None

Protocol documents: