ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01151852
Conditions: Gastrointestinal Stromal Tumors
Keywords: Imatinib Re-challenge
Sponsor: Asan Medical Center
Start date: 2010-06-01; Completion date: 2013-03-01
Enrollment: 81 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to compare the clinical outcomes following resumption of dosing (re-challenge) with Imatinib plus best supportive care versus placebo plus best supportive care in patients with advanced/incurable Gastrointestinal Stromal Tumors following failure of prior imatinib and sunitinib therapies.

Detailed description:

Arms: arm 1: Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent. arm 2: Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.
Interventions: intervention 1: Imatinib intervention 2: Placebo
Intervention descriptions: intervention 1: Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent. intervention 2: Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.

Protocol documents:
Clinical trial NCT01183481
Conditions: Nausea Vomiting
Keywords: nausea vomiting antiemetics radiotherapy Radiation-induced nausea and vomiting
Sponsor: Sunnybrook Health Sciences Centre
Start date: 2011-01-01; Completion date: 2013-03-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this pilot study is to examine the efficacy of Aprepitant given in combination with Granisetron for the prevention of delayed-phase RINV in 84 patients receiving a single 8Gy of moderately emetogenic palliative RT in the RRRP at Sunnybrook Odette Cancer Centre for painful bony metastases from any primary solid tumor. Patients will be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.. Secondary objectives include determining the complete RINV prophylaxis rate (acute and delayed phases), the partial emesis control rate, the safety of the combined regime, QOL issues, the time to the first emetic event and the time to the first use of rescue medication .

Detailed description:

Arms: arm 1: Patients will be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the Palliative radiation therapy.
Interventions: intervention 1: Aprepitant intervention 2: Palliative radiation therapy intervention 3: Granisetron
Intervention descriptions: intervention 1: Patients will be given a single dose of Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment. intervention 2: Moderately emetogenic palliative radiation therapy (RT) will be administered to all patients on the study. intervention 3: Patients will be given a single dose of both Granisetron 2 mg orally on Day 0 (at least one hour before on the day of RT).

Protocol documents:
Clinical trial NCT01188369
Conditions: Diastolic Dysfunction Left Ventricular Hypertrophy
Keywords: levosimendan heart failure inotropics diastolic dysfunction left ventricular hypertrophy aortic valve stenosis
Sponsor: University of Aarhus
Start date: 2010-09-01; Completion date: 2013-03-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a clinical, randomised, double-blinded study in which patients eligible for aortic valve replacement are enrolled. Patients receive infusion of either levosimendan or placebo 4 hours prior to surgery and until the end of surgery.

Detailed description:
Levosimendan or placebo will be infusion for approximately 4 hours prior to aortic valve replacement in patients with severe hypertrophy of the left ventricle and echocardiographic signs of diastolic dysfunction. Outcome measures will be obtained at some of the following:

* Approximately 4 hours prior to surgery. Baseline. Start of levosimendan/placebo infusion
* Immediately before surgery
* After induction of anaesthesia and before "knife time" = start of surgery.
* At the end of surgery: Levosimendan infusion will stop.
* Approximately 4 hours after surgery immediately before extubation.
* Approximately 21 hours after surgery
* Approximately 96 hours after surgery (day 4)
* 6 months after surgery

Outcome measures are comprised of invasive measurements, blood samples, transthoracic echocardiography and transoesophageal echocardiography focusing on measures of systolic and diastolic function of the heart.

Interim analysis will be conducted after 30 included patients.

Arms: arm 1: infusion 0,1ug/kg/min for duration of ca. 4 hours prior to operation and until the end of operation arm 2: Identical placebo
Interventions: intervention 1: levosimendan intervention 2: placebo drug
Intervention descriptions: intervention 1: Intravenous infusion, 0,1ug/kg/min, duration 4 hours prior to operation and until the end of operation. intervention 2: Intravenous infusion, colour identical to levosimendan

Protocol documents:
Clinical trial NCT01188564
Conditions: Hereditary Angioedema
Keywords: Hereditary Angioedema HAE Angioedema Recombinant C1 Inhibitor rhC1INH
Sponsor: Pharming Technologies B.V.
Start date: 2011-01-01; Completion date: 2013-03-01
Enrollment: 75 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being conducted to confirm the efficacy, safety, and immunogenicity of recombinant human C1 inhibitor (rhC1INH) at a dose of 50 U/kg when used for the treatment of acute angioedema attacks in Hereditary Angioedema (HAE) patients.

Detailed description:
HAE is characterized by recurrent localized angioedema caused by uncontrolled activation of the complement and contact systems due to a congenital deficiency of functional C1 inhibitor.

rhC1INH has been developed to offer a more widely available therapeutic alternative to the existing plasma-derived C1INH (pdC1INH) products that have been used in the treatment of acute angioedema attacks patients with HAE.

Patients who have qualified for enrollment in advance and who present to a study center within 5 hours of onset of an attack will be evaluated for eligibility. 75 eligible patients will be randomized (3:2) to receive an intravenous infusion of rhC1INH or saline in a double-blind fashion. Open-label rhC1INH may be provided as rescue medication to patients who do not experience the beginning of relief within 4 hours or who experience life-threatening oropharyngeal-laryngeal angioedema symptoms.

Any patient having received a randomized treatment will be allowed to receive treatment with rhC1INH in an open-label fashion for subsequent eligible attacks.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: rhC1INH intervention 2: Placebo (Saline)
Intervention descriptions: intervention 1: One i.v. injection of rhC1INH at the dose of 50 U/kg, for patients up to 84 kg; one i.v. injection of rhC1INH at the dose of 4200U (2 vials) for patients of 84 kg body weight or greater. intervention 2: One i.v. injection of saline (NaCl 0.9% w/v), equivalent in volume to the active treatment

Protocol documents:
Clinical trial NCT01217476
Conditions: Diabetic Foot Ulcer of Neuropathic Origin
Keywords: Diabetic foot Neuropathic Wound Growth factor
Sponsor: Olympus Biotech Corporation
Start date: 2010-12-01; Completion date: 2013-03-01
Enrollment: 207 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Trafermin is a recombinant human basic fibroblast growth factor (bFGF; original development code, KCB-1), which is manufactured by genetic engineering using Escherichia coli by Kaken Pharmaceutical Co., Ltd. (Tokyo, Japan). Trafermin 0.01% cutaneous spray product kit consisting of a glass bottle containing lyophilized trafermin, a glass bottle with solvent for solution and a spray part to fit the glass bottle after reconstitution of the final product.

We conduct a multinational, randomized, double-blind, placebo controlled, parallel-group, multicentre study consisting of a placebo run-in phase (2w), a treatment phase (max. 12w) and a follow-up phase (3mo+6mo). The primary objective of the study is to demonstrate a superior wound closure rate of diabetic foot ulcers (DFUs) of neuropathic origin after a maximum of 12 weeks topical daily application of trafermin 0.01% spray compared with placebo, in addition to best local care (off-loading, dressings). Approximately 210 patients will be randomized and it is planned that this study will be conducted at approximately 40 investigational sites in Europe.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Trafermin 0.01% spray
Intervention descriptions: intervention 1: For ulcers with a maximum diameter (longest axis) of less or equal to 6 cm, the daily dose of trafermin 0.01% spray is 5 puffs (30 microgram) sprayed onto the wound surface. If the maximum diameter (longest axis) of the ulcer is \>6 cm, the ulcer should be sprayed in two parts, i.e. 5 puffs (30 microgram) sprayed onto each half of the wound surface

Protocol documents:
Clinical trial NCT01219933
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2011-01-01; Completion date: 2013-03-01
Enrollment: 68 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This open-label, single-arm study will assess the use of glucocorticoids (GC) in daily clinical practice and will evaluate the dose reduction of glucocorticoids once low disease activity is achieved in patients with rheumatoid arthritis tre ated with GC and background RoActemra/Actemra (tocilizumab) 8mg/kg intravenously every 4 weeks. In the non-interventional phase, the use of GC in daily clinical Belgian practice will be evaluated and described. This period of maximum 6 mont hs will allow those patients to obtain the inclusion criteria for the secondary interventional phase. In the interventional phase, a systematic GC dose reductio n schedule will be evaluated in patients having achieved low disease activity wh ile receiving the same background therapy with RoActemra/Actemra 8 mg/kg. Methyl prednisolone will be given from a starting dose of \>/= 1 mg to \</=20 mg orally d aily and will be tapered down. The anticipated study duration is up to 13 months

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: methylprednisolone intervention 2: tocilizumab [RoActemra/Actemra]
Intervention descriptions: intervention 1: starting dose \>/= 1 mg and \</= 20 mg orally daily, according to dose-reduction schedule intervention 2: background therapy: 8 mg/kg iv every 4 weeks

Protocol documents:
Clinical trial NCT01243619
Conditions: Esophageal Cancer
Keywords: PET CT radiotherapy
Sponsor: Dana-Farber Cancer Institute
Start date: 2010-08-01; Completion date: 2013-03-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this pilot study is to develop a more advanced software program that will collect, compare and analyze tumor images for evaluation. Another purpose of this study is to learn if a new radio-tracer for tumor imaging called 3'-deoxy-3'(18) F-fluorothymidine (FLT) can improve the evaluation of tumors during a PET/CT scan. This new type of image tracking is meant to improve the visualization of tumor active and size.

Detailed description:
* The following are standard medical procedures that are part of regular cancer care that the participant would probably have done even if they did not join the study: Chemotherapy; physical examination; pregnancy test (if applicable); diagnostic FDG-PET/CT scan before and after treatment to evaluate disease.
* The following diagnostic procedures are being done specifically because of this study: Three FLT-PET/CT scans before, during and after treatment and one FDG PET/CT scan during treatment.
* Participants will be in this research study for approximately 12-14 weeks.

Arms: arm 1: This is a single arm trial, in which all patients receive three FDG-PET scans and three FLT-PET scans, before, during and after pre-operative chemoradiation for esophageal cancer.
Interventions: intervention 1: 3'-deoxy-3'-(18) F-fluorothymidine
Intervention descriptions: intervention 1: Radio-tracer for tumor imaging

Protocol documents:
Clinical trial NCT01249092
Conditions: Primary Biliary Cirrhosis
Keywords: biliary cirrhosis
Sponsor: The Cleveland Clinic
Start date: 2010-11-01; Completion date: 2013-03-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Primary biliary cirrhosis (PBC) is cholestatic liver disease characterized by progressive destruction of small bile ducts within the liver that can lead to end stage liver disease and all its complications.

Although ursodeoxycholic acid (UDCA) is associated with increased survival in many patients with PBC, there is absence of an adequate response to UDCA in a significant proportion of PBC patients.

Tumor necrosis factor alpha (TNF-alpha) is a cytokine that plays an important role in the pathogenesis of PBC. Other fibrosis biomarkers such as tissue metallo proteinase 1 (TIMP-1) are associated with progression of liver fibrosis in PBC. Pentoxifylline (PTX) is a methylxanthine derivative that inhibits pro-inflammatory cytokines and also has shown anti-fibrotic effects in serum of patients with PBC. Furthermore, PTX has well known clinical and safety profiles. The main hypothesis of this study is that therapy with pentoxifylline (PTX) will result in improvement of liver disease in PBC patients who are incomplete responders to UDCA.

The focus of this proposal is on the effectiveness of PTX in improving laboratory parameters of liver disease and levels of cytokines involved in the pathogenesis of the disease in patients with PBC.

Detailed description:

Arms: arm 1: This study is an open label pilot with only one arm.
Interventions: intervention 1: Pentoxifylline
Intervention descriptions: intervention 1: Patients will take 400mg of pentoxifylline three times daily for a total duration of 6 months.

Protocol documents:
Clinical trial NCT01256060
Conditions: Autism Spectrum Disorder
Keywords: Autism Spectrum disorder Oxytocin Clinical Trial Children Pharmacology
Sponsor: Evdokia Anagnostou
Start date: 2010-11-01; Completion date: 2013-03-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Extensive data has been accumulated to suggest that central release of oxytocin is important for social cognition and function, as well as likely involved in anxiety modulation and repetitive behaviors. The principal investigators of this study have previously documented: 1) an association between Autism Spectrum Disorder and a single nuclear polymorphism of the oxytocin receptor gene, 2) ability to measure oxytocin levels in the blood by enzyme immunoassay and 3) preliminary data to support safety and efficacy of intranasal oxytocin in the treatment of social deficits and repetitive behaviors in adults with autism. A medication treatment targeting the core deficits of Autism Spectrum Disorder in childhood is highly valuable because it could influence the developmental trajectory and make further psychosocial interventions possible. In this context, we propose a small dose finding study to confirm that the dose used in the adult study is not more than the maximum tolerated dose in youth. '

Detailed description:

Arms: arm 1: A modified dose finding method will be used to determine safety among four dose levels for Intranasal Oxytocin. Half the dose (0.2 IU/kg /dose) is the minimum dose and two intermediate doses will also be evaluated (0.26 and 0.33 IU/kg / dose) Dose-finding escalations will be done in groups of three patients.Three patients will be studied at the first dose level. If none of these patients experience dose limiting toxicity, the dose will be escalated. If one experiences dose limiting toxicity, up to three more will be accrued at the same level. If none of these experience dose limiting toxicity, the dose will be escalated. If one or more of these experience dose-limiting toxicity, entry at that dose level will be stopped. Up to three more patients will be treated at the next lower dose. If zero out of these experience dose limiting toxicity, an additional three patients will be treated at that dose.
Interventions: intervention 1: Intranasal Oxytocin
Intervention descriptions: intervention 1: We are selecting morning and afternoon dosing to try to influence most hours where youth are in settings with increased potential for social interaction (school, after school). Medication will be administered by the parents before school and early afternoon. All patients will receive their first dose by the study physician to educate parents and themselves on proper administration and determine safety of first dose.

Protocol documents:
Clinical trial NCT01258387
Conditions: Heart Failure
Sponsor: Acorda Therapeutics
Start date: 2010-12-01; Completion date: 2013-03-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Study to determine the safety, tolerability, pharmacokinetics and immunogenicity of single intravenous administrations of GGF2 in patients with heart failure.

Detailed description:
Phase 1, double-blind, placebo-controlled, dose escalation study to determine the safety, tolerability, pharmacokinetics and immunogenicity of single intravenous administrations of GGF2 in cohorts of patients with left ventricular dysfunction and symptomatic heart failure.

Arms: arm 1: Seven dosing cohorts: 2 patients randomized to receive 1 GGF2, 1 placebo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed
Interventions: intervention 1: Glial growth factor 2/ Neuregulin 1β3 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01261624
Conditions: Polyarticular Course Juvenile Idiopathic Arthritis
Keywords: poly JIA
Sponsor: Italfarmaco
Start date: 2010-10-01; Completion date: 2013-03-01
Enrollment: 16 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The present study has been designed in order to evaluate the efficacy and safety of two doses of Givinostat in subjects with polyarticular course JIA

Givinostat ready-to-use suspension especially intended for paediatric administration, will be administered orally at different daily doses.

Patients with an established diagnosis of one of the following JIA forms (Polyarticular JIA rheumatoid factor positive or negative, Oligoarticular extended JIA, Systemic JIA without active systemic features) will be enrolled.

The treatment regimen will remain unchanged for 12 weeks and the clinical response will by assessed by applying the ACR Pediatric response criteria. Patients achieving at least an ACR Pediatric 30 response will continue receiving the assigned dose for 12 further weeks.

After the end of study (week 24) responder patients will be allowed to extend the treatment until they maintain a clinical benefit.

Detailed description:
Non-clinical data on Givinostat, support a potent anti-inflammatory mechanism of action which can potentially slow the arthritic destructive process. This rationale seems to be confirmed by the preliminary evidences collected in a previous Phase II clinical trial conducted in children and young adults with systemic JIA.

The present protocol is aimed at collecting new information on safety and efficacy of two doses of Givinostat for the treatment of JIA.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Givinostat
Intervention descriptions: intervention 1: 1.0 mg/kg daily (0.5 mg/kg twice a day) in fed condition 1.5 mg/kg daily (0.75 mg/kg twice a day) in fed condition

Protocol documents:
Clinical trial NCT01267864
Conditions: Acute Migraine
Keywords: migraine emergency metoclopramide ketorolac valproate
Sponsor: Montefiore Medical Center
Start date: 2010-11-01; Completion date: 2013-03-01
Enrollment: 330 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized study is testing 3 different intravenous medications to see which one is best for acute migraine. The three medications are metoclopramide, valproate, and ketorolac.

Detailed description:
One million patients present to US emergency departments (ED) annually for treatment of acute migraine headache. A variety of parenteral medications are used to treat acute migraine, but none offer rapid and complete headache relief without side effects. Preliminary studies have suggested that intravenous valproate, an anti-epileptic medication with established efficacy as a migraine preventive, may be useful for the treatment of acute migraine. We propose a randomized, comparative efficacy trial in which intravenous valproate is compared to two standard parenteral therapies for acute migraine. There will not be a placebo control. Included subjects will be adults 64 years and younger who meet International Headache Society criteria for acute migraine, who do not have clinical evidence of secondary (organic) headache, and who do not have allergy or contra-indication to the investigational medications. The investigational medications are 1gm of valproate, 10mg of metoclopramide, and 30mg of ketorolac. Patients will be approached for participation and randomized at the time of presentation to the ED. Pain will be assessed on an 11 point (0 to 10) verbal pain scale, validated for use in acute pain trials. Medication will be infused as a slow intravenous drip. The primary outcome will be an improvement in headache intensity one hour after initiation of the intravenous drip. Secondary outcomes include assessments of pain, functional disability, adverse events, and satisfaction with the investigational medication one, two and 24 hours after initiation of the intravenous drip. The primary analysis will use a Student's t-test for independent samples and involve three pair-wise comparisons. Using an alpha of .017 (to account for the three pairwise comparisons), a standard beta, and a validated minimum clinically significant difference on the verbal pain scale, we calculated the need for 330 subjects. An interim analysis will be conducted to determine lack of efficacy of valproate.

Arms: arm 1: Metoclopramide 10mg IVSS arm 2: Ketorolac 30mg IV arm 3: 1gm IV
Interventions: intervention 1: Metoclopramide intervention 2: Ketorolac intervention 3: Valproate
Intervention descriptions: intervention 1: 10mg IVSS intervention 2: 30g IVSS intervention 3: 1gm IVSS

Protocol documents: