ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00645944
Conditions: Insomnia Schizophrenia Schizoaffective Disorder Sleep Disorders
Sponsor: Yale University
Start date: 2008-04-01; Completion date: 2011-04-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The major goal of this project is to investigate established insomnia treatments in a schizophrenia population to see if the improved sleep leads to overall better quality of life. In addition, we hypothesize that the insomnia treatment may also lead to observed improvements in other symptoms associated with schizophrenia such as cognitive impairments, obesity, and negative symptoms.

Detailed description:
The primary aim of this study is to investigate the clinical efficacy of eszopiclone for the treatment of schizophrenia-related insomnia over 8 weeks. A two-week, single-blind placebo phase followed the double-blind phase to evaluate rebound and withdrawal effects after abrupt discontinuation.

Arms: arm 1: Participants assigned to this arm will receive Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks. arm 2: Participants assigned to this arm will receive placebo (an inactive substance or a "sugar pill") to be taken each night for all weeks of the study.
Interventions: intervention 1: Eszopiclone intervention 2: Placebo
Intervention descriptions: intervention 1: Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks. intervention 2: Placebo or inactive substance ("sugar pill")taken each night for all weeks of the study

Protocol documents:
Clinical trial NCT00647699
Conditions: Progressive Keratoconus
Keywords: keratoconus cross-linking riboflavin UVA light cornea
Sponsor: Glaukos Corporation
Start date: 2007-12-01; Completion date: 2011-04-01
Enrollment: 147 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Prospective, randomized multicenter study to determine the safety and effectiveness of performing cornea collagen cross-linking (CXL) using riboflavin and UVA light in eyes with progressive keratoconus.

Detailed description:
This was a sham controlled study for the first three months. Patients had one eye designated as the study eye and were randomized to receive one of two study treatments (CXL or sham) in their study eye. The patients were evaluated at 1, 3, 6, and 12 months. At month 3 or later patients had the option of receiving CXL treatment in both the sham and non-study eye.

Arms: arm 1: riboflavin ophthalmic solution and UVA irradiation arm 2: riboflavin ophthalmic solution without UVA irradiation.
Interventions: intervention 1: riboflavin ophthalmic solution intervention 2: UVA Irradiation
Intervention descriptions: intervention 1: riboflavin 0.1% ophthalmic solution (approximately 32 drops, or 1.6 mL) intervention 2: UVA light (365 nm at an irradiance of 3 mW/cm2) for 30 minutes

Protocol documents:
Clinical trial NCT00654927
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis MS walking leg strength demyelination
Sponsor: Acorda Therapeutics
Start date: 2003-11-01; Completion date: 2011-04-01
Enrollment: 177 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the long-term safety, tolerability and activity of Fampridine-SR in subjects with multiple sclerosis who have previously participated in either an Acorda Therapeutics or an Elan Corporation sponsored protocol. Subjects are eligible regardless of whether they received active drug or placebo during their participation in the previous study.

Detailed description:
Under the original protocol, patients were to have their treatment dose titrated upwards from a starting dose of 10mg b.i.d. to 15mg b.i.d. and then to a stable (maintenance) dose of 20mg b.i.d. The protocol was subsequently revised to lower the maximum maintenance dose. In the most current protocol, all patients were down-titrated to 10mg b.i.d. and maintained at this dose for the greater part of the duration of the study.

Multiple Sclerosis (MS) is a disorder of the body's immune system that affects the central nervous system (CNS). Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the arms and legs. In people with MS, the fatty sheath that surrounds and insulates the nerve fibers (called "myelin") deteriorates, causing nerve impulses to be slowed or stopped. As a result, patients with MS may experience periods of muscle weakness and other symptoms such as numbness, loss of vision, loss of coordination, paralysis, spasticity, mental and physical fatigue and a decrease in the ability to think and/or remember. These periods of illness may come (exacerbations) and go (remissions). Fampridine-SR is an experimental drug that has been reported to possibly improve muscle strength and walking ability for some people with MS. This study will evaluate the effects and possible risks of taking Fampridine-SR in MS patients over a long period of time.

Interventions: intervention 1: Fampridine-SR b.i.d. (Twice Daily)
Intervention descriptions: intervention 1: Dosage form - tablets.

Protocol documents:
Clinical trial NCT00679211
Conditions: Metastatic Breast Cancer
Keywords: HER2-positive breast cancer HER2 MBC Trastuzumab emtansine
Sponsor: Genentech, Inc.
Start date: 2008-08-01; Completion date: 2011-04-01
Enrollment: 110 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Study of trastuzumab emtansine (T-DM1) administered to patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer.

Detailed description:

Arms: arm 1: Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
Interventions: intervention 1: Trastuzumab emtansine [Kadcyla]
Intervention descriptions: intervention 1: Intravenous repeating dose

Protocol documents:
Clinical trial NCT00680017
Conditions: Dyslipidemia Kidney Disease
Keywords: Dyslipidemia Kidney Disease
Sponsor: AstraZeneca
Start date: 2008-06-01; Completion date: 2011-04-01
Enrollment: 280 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate the safety and efficacy of the combination of ABT-335 plus rosuvastatin in dyslipidemic subjects with Chronic Kidney Disease (CKD) Stage 3.

Detailed description:

Arms: arm 1: ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks arm 2: Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks
Interventions: intervention 1: ABT-335 plus rosuvastatin intervention 2: Rosuvastatin
Intervention descriptions: intervention 1: ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks intervention 2: Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks

Protocol documents:
Clinical trial NCT00689793
Conditions: Fatigue Iron Deficiency
Keywords: Fatigue Blood donation Iron deficiency Ferrous sulphate Donation Donors Iron Ferritin Hemoglobin Anemia Anaemia Haemoglobin Don Women blood donors
Sponsor: University of Lausanne
Start date: 2008-11-01; Completion date: 2011-04-01
Enrollment: 154 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the subjective response of iron substitution (Tardyferon®) on fatigue in women blood donors with a mean serum ferritin \< 30ng/ml and to assess variation of ferritin and hemoglobin after a blood donation.

Detailed description:
* Actually, there's no recommendation to check ferritin level in blood donors, even if several studies pointed out the high prevalence of iron deficiency after a blood donation. Furthermore, some clinical trials showed that non-anaemic women with unexplained fatigue may benefit from iron supplementation.
* The purpose of this study is to determine the subjective response of iron substitution (Tardyferon®) on fatigue in women blood donors with a mean serum ferritin \< 30ng/ml and to assess variation of ferritin and hemoglobin after a blood donation.
* We will measure blood count, ferritin level and C-reactive protein at the time of the blood donation and then after a week, a month and 3 months.

A week after the blood donation, donors with a ferritin level \<30 ng/ml and hemoglobin \> 120g/l (non anaemic) will be included in the study and randomised. A one-month iron treatment vs placebo will be introduced. To assess the subjective response on fatigue, the donors will fill in different questionnaires at the time of the blood donation and then after a week, a month and 3 months.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ferrous sulphate intervention 2: Placebo
Intervention descriptions: intervention 1: Volunteers will receive 80 mg/day oral ferrous sulphate (Tardyferon®) for four weeks. Visual analogical scales and questionnaires will be performed at day 0 and 30 to quantify fatigue (" Fatigue Severity Scale"). We will also check depression and anxiety symptoms (" Prime MD ") and health survey (" SF-12 "). An evaluation of the menstruation (" Pictorial Bleeding Assessment Chart " of Jansen) will be performed at day 0 to detect a possible hypermenorrhea (appendix 1-4). A physical test will be performed (Chester Step Test) to assess the VO2 max. Every side effect will be written on follow-up notes. intervention 2: Volunteers will receive 1 pill/day oral placebo for four weeks. Visual analogical scales and questionnaires will be performed at day 0 and 30 to quantify fatigue (" Fatigue Severity Scale"). We will also check depression and anxiety symptoms (" Prime MD ") and health survey (" SF-12 "). An evaluation of the menstruation (" Pictorial Bleeding Assessment Chart " of Jansen) will be performed at day 0 to detect a possible hypermenorrhea (appendix 1-4). A physical test will be performed (Chester Step Test) to assess the VO2 max. Every side effect will be written on follow-up notes.

Protocol documents:
Clinical trial NCT00705133
Conditions: Pulmonary Arterial Hypertension Interstitial Lung Disease Idiopathic Pulmonary Fibrosis
Keywords: pulmonary hypertension pulmonary fibrosis interstitial lung disease
Sponsor: Rajan Saggar
Start date: 2008-07-01; Completion date: 2011-04-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Our hypothesis is that IV or SQ Treprostinil can improve 6 minute walk distance, hemodynamics and quality of life in patients with interstitial lung disease and severe secondary pulmonary arterial hypertension.

Detailed description:
Patients with pulmonary hypertension (PH) complicating pulmonary fibrosis are at increased risk of death. There are no therapies proven to be effective in this population, targeting the pulmonary hypertension. The purpose of this study is to evaluate parenteral treprostinil in an open-label fashion in patients with pulmonary fibrosis and an advanced PH phenotype.

Arms: arm 1: Patients with pulmonary fibrosis with an advanced pulmonary hypertension phenotype will be treated with parenteral treprostinil in an open-label fashion
Interventions: intervention 1: Treprostinil
Intervention descriptions: intervention 1: For both SQ and IV routes, treprostinil will be started in the hospital at 1ng/kg/min and titrated up by 1ng/kg/min every 1-3 days as tolerated

Protocol documents:
Clinical trial NCT00705757
Conditions: Glaucoma Application Site Pigmentation Changes
Keywords: periocular skin pigmentation Lumigan Travatan Xalatan latanoprost bimatoprost travoprost
Sponsor: Summa Health System
Start date: 2008-03-01; Completion date: 2011-04-01
Enrollment: 89 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to study changes in skin color that may be caused by using one of the three eye medicines: Xalatan, Travatan or Lumigan.

Detailed description:
One uncommon side effect of prostaglandin eye drops is a change in color of the skin around the eyes, which is reversible. There are three different brands of the medicine which are equally effective in lowering eye pressure but their likelihood of changing skin color is unknown. Qualifying patients will be randomly assigned to use one of the three eye drops. We will take skin color measurements from several locations on the face over one year to measure pigmentation changes.

Arms: arm 1: Patients assigned to Lumigan/bimatoprost one drop before bedtime (qhs) to affected eye(s) arm 2: Patients assigned to Xalatan/latanoprost one drop before bedtime (qhs) to affected eye(s) arm 3: Patients assigned to Travatan/travoprost one drop before bedtime (qhs) to affected eye(s)
Interventions: intervention 1: latanoprost intervention 2: bimatoprost intervention 3: travoprost
Intervention descriptions: intervention 1: Xalatan/latanoprost 0.005% ophthalmic solution one drop qhs for one year intervention 2: Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year intervention 3: Travatan/travoprost 0.004% ophthalmic solution one drop qhs for one year

Protocol documents:
Clinical trial NCT00717626
Conditions: Hemophilia A
Keywords: Hemophilia Prophylaxis Youth Young Adults Feasibility
Sponsor: The Hospital for Sick Children
Start date: 2008-07-01; Completion date: 2011-04-01
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to test the feasibility of a large-scale clinical trial of once-daily prophylaxis. The secondary objectives are to collect clinical efficacy outcomes so that we can better plan a large-scale study; we will estimate the effect size and variability of effect and resource utilization of once-daily prophylaxis to allow us to set a sample size for a definitive trial.

Detailed description:
Hemophilia is an important and costly disorder; if left untreated, it may have serious consequences. The greatest impact of hemophilia occurs from recurrent bleeding into joints. The consequences of joint bleeding include pain associated with acute bleeding and later chronic arthropathy. Half of affected children with severe hemophilia have joint damage; joint damage is more frequent with increased bleeding. The prevention and treatment of bleeding is very expensive and therefore finding a cost-effective treatment is of high priority.

Worldwide, two major treatment strategies have been used to prevent arthropathy - on demand therapy and factor prophylaxis. The goal of prophylaxis is to convert the severe to the moderate phenotype by providing circulating factor activity of greater than 1%. Patients with greater than 1% circulating factor VIII activity rarely have spontaneous hemarthroses. Therefore, the goal of providing circulating factor at this level is to eliminate spontaneous hemarthroses. The term primary prophylaxis suggests using preventative factor VIII replacement from a very early age. The term secondary prophylaxis is used to describe the application of prophylaxis at a later disease stage. In this study, secondary prophylaxis will be used.

Once-daily prophylaxis is a novel application of hemophilia factor prophylaxis for youth and young adults. Before embarking on a costly definitive trial we feel that it is necessary to demonstrate that subjects will be willing to enroll and will be compliant with the therapy. Moreover, we need to establish an estimate of the effect of once-daily prophylaxis on bleeding rates, quality of life, and joint damage progression in order to design a definitive trial.

Arms: arm 1: Low dose daily prophylaxis using FVIII products (e.g.Kogenate FS, Advate, or Humate-P, Recombinate, Helixate FS)
Interventions: intervention 1: Kogenate FS, Advate, or Humate-P, Recombinate, Helixate FS
Intervention descriptions: intervention 1: Starting at the 4-month visit, subjects will receive 250 units per day (if their weight is \< 50 kg.) or 500 units per day (weight ≥ 50 kg.) of their usual preparation of factor VIII.

Protocol documents:
Clinical trial NCT00723554
Conditions: Pulmonary Arterial Hypertension
Keywords: pulmonary arterial hypertension inhaled therapy power disc-15
Sponsor: Actelion
Start date: 2008-07-01; Completion date: 2011-04-01
Enrollment: 63 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
A Phase IIIb, Multicenter, Open-Label Study of Patients With Pulmonary Arterial Hypertension Treated With Iloprost(Inhalation)Evaluating Safety and Inhalation Times When Converting From Power Disc-6 to Power Disc-15 With the I-neb® Adaptive Aerosol Delivery® System (I-neb® AAD®)

Detailed description:

Arms: arm 1: The study enrolled patients who were already using iloprost with PD-6 without any safety or tolerability concerns, thereby facilitating a direct comparison of the PD-15 to the PD-6.

The single-arm design allowed each patient to serve as his/her own control
Interventions: intervention 1: Iloprost PD-6 intervention 2: Iloprost PD-15
Intervention descriptions: intervention 1: Period 1 (PD-6): study period defined as the 14 days prior to the first dose of study iloprost inhalation with PD-15. Commercial iloprost inhalation solution delivered using the Power Disc-6 with the I-neb® Adaptive Aerosol Delivery (AAD®) system administered 6 to 9 times per day intervention 2: Period 2 (PD-15): study period between the administration of the first dose with PD-15 on Day 1 until Day 28 inclusive.

Period 3 (PD-15): study period from Day 29 until discontinuation of the PD-15. Commercial iloprost inhalation solution delivered using the Power Disc-15 with the I-neb® Adaptive Aerosol Delivery (AAD®) system administered 6 to 9 times per day

Protocol documents:
Clinical trial NCT00764309
Conditions: Scleroderma
Sponsor: Bristol-Myers Squibb
Start date: 2009-01-01; Completion date: 2011-04-01
Enrollment: 47 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to evaluate the safety of Dasatininb in the treatment of scleroderma pulmonary interstitial fibrosis.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: dasatinib
Intervention descriptions: intervention 1: Tablets, Oral, 100 mg, once daily, 6 months

Protocol documents:
Clinical trial NCT00784147
Conditions: HIV
Keywords: HIV CD4 experienced resistant resistance monoclonal antibody infusion ibalizumab TNX355 TNX-355 TMB355 TMB-355
Sponsor: TaiMed Biologics Inc.
Start date: 2008-08-01; Completion date: 2011-04-01
Enrollment: 113 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigational product, ibalizumab, is a humanized IgG4 monoclonal antibody administered via intravenous infusion at 800 mg every 2 weeks or at 2000 mg every 4 weeks. In addition to study drug, all patients will receive an optimized background regimen (OBR), which is a standard-of-care regimen selected by the investigator prior to randomization that is comprised of 2-4 antiretroviral agents. These agents must have been approved by the local regulatory agency or be available through expanded-access programs for treatment of human immunodeficiency virus (HIV).

Detailed description:
The primary objectives of this study are to:

* Evaluate the dose-response relationship of antiviral activity of the ibalizumab dose regimens at Week 24 in order to determine the optimal dose and regimen. The primary evaluation of effectiveness will be based on the proportion of patients achieving undetectable viral loads at Week 24.
* Evaluate the safety and tolerability of two dose regimens of ibalizumab for dose selection

The secondary objectives of this study are to:

* Evaluate changes from Baseline in viral load, CD4+ cell counts, and time to loss of virologic response (TLOVR)
* Characterize HIV-1 sensitivity/susceptibility changes associated with ibalizumab administration in combination with OBR
* Determine the presence and significance of anti-ibalizumab antibodies, if any (immunogenicity of ibalizumab)
* Assess CD4 receptor density and occupancy
* Determine the impact of ibalizumab on quality of life as assessed by patient-reported outcomes on questionnaires
* Evaluate the pharmacokinetic profile of two dose regimens of ibalizumab at steady state

Arms: arm 1: every 2 weeks, combined with an Optimized Background Regimen arm 2: every 4 weeks, combined with an Optimized Background Regimen
Interventions: intervention 1: Ibalizumab intervention 2: Ibalizumab
Intervention descriptions: intervention 1: Ibalizumab 800 mg IV every 2 weeks intervention 2: Ibalizumab 2000 mg IV every 4 weeks

Protocol documents:
Clinical trial NCT00796861
Conditions: Ascites
Keywords: malignant ascites
Sponsor: Milton S. Hershey Medical Center
Start date: 2007-05-01; Completion date: 2011-04-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The study is to see whether treatment with Sunitinib decreases the accumulation of ascites in patients with refractory malignant ascites.

Detailed description:
This is a single arm, non-randomized, phase II pilot study in patients who have stopped cytotoxic and biologic therapy for their neoplasms and are suffering from malignant ascites that requires drainage for comfort. The study will employ a Simon 2-stage optimal design. Initially up to 17 patients would be enrolled. If there are no responses among the first 12 patients, the study would be terminated. Otherwise the trial would be expanded by 23 to a total of 37 patients. If there are 3 or fewer responses by the end of the trial, then no further investigation would be warranted.

Arms: arm 1: Sunitinib (50mg PO daily x 4 wks + 2 wks rest x 3 cycles if able to tolerate tx
Interventions: intervention 1: Sunitinib
Intervention descriptions: intervention 1: Patients will be given Sunitinib 50 mg orally daily for four weeks, followed by a two week holiday. For patients tolerating treatment, three cycles of treatment will be given (18 weeks total).

Protocol documents: