ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01012362
Conditions: Breast Cancer Lung Cancer Colon Cancer Pancreatic Cancer Head and Neck Cancer Kidney Cancer Sarcoma Hepatocellular Cancer
Keywords: Solid tumor malignancy breast cancer lung cancer colon cancer pancreatic cancer head and neck cancer kidney cancer sarcoma hepatocellular cancer
Sponsor: Masonic Cancer Center, University of Minnesota
Start date: 2009-12-01; Completion date: 2013-02-01
Enrollment: 31 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
This is a Phase I study; dose escalating the combination of pazopanib when taken daily and ixabepilone when administered on day 1 of a 3 week treatment course.

Detailed description:
Treatment with ixabepilone will be given at an assigned dose as a 3 hour intravenous infusion on day 1 of a 21 day cycle. Treatment with pazopanib will be given at an assigned dose by mouth once a day, beginning on day 1 and continuing daily. Disease assessment will be done every 2 cycles (6 weeks) with treatment continuing until disease progression, unacceptable toxicity or patient refusal.

Arms: arm 1: Patient receives assigned dose level:

Dose Level 1 = 400 milligrams (mg) of pazopanib and ixabepilone 32 mg/m2. Dose Level 2 = 400 milligrams (mg) of pazopanib and ixabepilone 40 mg/m2. Dose Level 3 = 600 milligrams (mg) of pazopanib and ixabepilone 32 mg/m2. Dose Level 4 = 800 milligrams (mg) of pazopanib and ixabepilone 32 mg/m2. arm 2: Dose Level 3 = 600 milligrams (mg) of pazopanib and ixabepilone 32 mg/m2.
Interventions: intervention 1: Pazopanib intervention 2: Ixabepilone
Intervention descriptions: intervention 1: Escalating doses 400-800 mg by mouth once daily beginning day 1 and continuing. intervention 2: Escalating doses 25-32 mg/m2 by intravenous infusion on day 1 of each 21 day cycle

Protocol documents:
Clinical trial NCT01022242
Conditions: Surgical Adhesions
Keywords: Surgical Adhesions Post-surgical adhesions Flexor tendon
Sponsor: Pergamum AB
Start date: 2009-12-01; Completion date: 2013-02-01
Enrollment: 138 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objectives of the study are to assess efficacy, safety, and handling of PXL01 in patients with flexor tendon injury in zone I or II.

Detailed description:
This is a multi-centre, randomized, double blind, parallel study design in patient admitted for flexor tendon repair in zone II.

The patients will undergo 9 visits within the time frame of the study. Patients will be randomized to receive treatment with PXL01 or standard care.

Primary objective is to assess total active motion based on PIP and DIP joints (TAM2) at 12-week visit. Secondary objectives are to assess TAM2 at all time points except for 12 weeks, TAM based on MCP, PIP, and DIP joints (TAM3) at all time points, Total Active Motion in DIP joint (DIPAM), tip-to-crease, grip strength and Total Passive Motion (TPM2 and TPM3).

Before any study-related assessment takes place, patients are given verbal and written information about the study and informed consent is achieved from the patient and/or legal guardian. The study should be carried out in accordance with the Clinical Study Protocol (CSP), ICH guidelines for Good Clinical Practise (GCP), and applicable regulatory requirements.

Arms: arm 1: Placebo is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound. arm 2: PXL01 is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.
Interventions: intervention 1: PXL01 intervention 2: Placebo
Intervention descriptions: intervention 1: PXL01 is a synthetic peptide sequentially derived from human lactoferrin. PXL01 is formulated in a viscous solution of sodium hyaluronate. The drug product is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound. intervention 2: Placebo is a physiological sodium chloride solution, which is clear and colourless.

Protocol documents:
Clinical trial NCT01022853
Conditions: Neoplasms
Sponsor: Boehringer Ingelheim
Start date: 2009-12-01; Completion date: 2013-02-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of the current study is to investigate the Maximum Tolerated Dose (MTD) in terms of safety and tolerability of BI 6727 in combination with fixed dose BIBF 1120, in patients with advanced or metastatic solid tumours.

Detailed description:

Arms: arm 1: Finding Maximum Tolerated Dose of BI 6727 in combination with BIBF 1120
Interventions: intervention 1: BI 6727 intervention 2: BIBF 1120
Intervention descriptions: intervention 1: intravenous each 21 days intervention 2: oral continuously

Protocol documents:
Clinical trial NCT01047241
Conditions: Pain
Keywords: Painful medical procedures
Sponsor: Danish University of Pharmaceutical Sciences
Start date: 2010-04-01; Completion date: 2013-02-01
Enrollment: 50 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The aim of the study is to investigate the absorption and clinical effect of nasal administration of an analgesic nasal spray containing sufentanil+ketamine for pain related to medical procedures in hospitalized children.

Detailed description:
The management of procedural pain in children ranges from physical restraint to pharmacological interventions. Pediatric formulations that permit accurate dosing, are accepted by children and a have a rapid onset of analgesia are lacking. The objectives were to investigate a pediatric formulation of intranasal sufentanil 0.5 mcg/kg and ketamine 0.5 mg/kg for procedural pain and to characterize the pharmacokinetic (PK) profile. Fifty children (≥10 kg) scheduled for a painful procedure were included in this prospective nonrandomized open-label clinical trial. Thirteen of these children had central venous access for drug assay sampling; enabling a compartmental PK analysis using nonlinear mixed-effects models. Pain intensity before and during the procedure was measured using age-appropriate pain scales. Heart rate, oxygen saturation and sedation were recorded.

Arms: arm 1: Intranasal combination of sufentanil and ketamine. Dose of sufentanil 0.5 mcg/kg and ketamine 0.5 mg/kg, single dose.
Interventions: intervention 1: Intranasal sufentanil/ketamine
Intervention descriptions: intervention 1: Nasal spray sufentanil+ketamine, 0,5 microg/kg sufentanil+0,5 mg/kg ketamine, single dose

Protocol documents:
Clinical trial NCT01066143
Conditions: Generalized Anxiety Disorder Seroquel XR
Keywords: Seroquel Generalized Anxiety Disorder fMRI
Sponsor: Mclean Hospital
Start date: 2010-02-01; Completion date: 2013-02-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The 12 week clinical trial of Seroquel in Generalized Anxiety Disorder (GAD) patients will be combined with fMRI experiments.

Detailed description:
Subjects will be recruited from clinic patients and known research subjects at McLean Hospital, as well as by advertisements in the media, flyers, and word of mouth. An initial telephone interview will be conducted to determine if potential subjects meet the basic study requirements. Subjects will be also screened for drug use. If no obvious health problems are present, subjects will be scheduled for an evaluation. Upon arrival at the research unit, each subject will first complete a standardized interview schedule designed to obtain personal and background data such as age, marital status, socio-economic status, education, employment, etc. The Research Assistant will give subjects both verbal and written descriptions of the study procedures. After briefing subjects on the reasons for the research, subjects will be given the opportunity to ask questions. When they are ready, subjects will be asked to sign the written informed consent form approved by the Mclean Institutional Review Board (IRB). Functional magnetic resonance imaging scans to examine brain functioning will be obtained from GAD patients (N=30) at baseline and after 12 weeks. Seroquel XR tablets will be flexibly dosed and begun at a target dose of 50 mg on day 1, 100 mg on day 2, 150 mg on day 3 and 200 mg on day 4 with a maximal daily dose of 400 mg on subsequent days.

Arms: arm 1: None
Interventions: intervention 1: Seroquel XR
Intervention descriptions: intervention 1: Seroquel XR tablets will be flexibly dosed and begun at a target dose of 50 mg on day 1, 100 mg on day 2, 150 mg on day 3 and 200 mg on day 4 with a maximal daily dose of 400 mg on subsequent days.

Protocol documents:
Clinical trial NCT01074437
Conditions: Hemangioma
Sponsor: Seattle Children's Hospital
Start date: 2010-02-01; Completion date: 2013-02-01
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a prospective randomized, double-blind study to compare the clinical efficacy of infantile hemangioma treatment using propranolol with corticosteroids as compared to therapy with corticosteroids and placebo. We hypothesize that a two-month treatment period with propranolol plus corticosteroids is more effective at reducing infantile hemangioma size and vascularity when compared to corticosteroids used without propranolol for the same time period.

Detailed description:
Infantile hemangiomas (IH) are the most common head and neck pediatric tumors. Presence of these tumors can lead to complications of vision and airway compromise, bleeding and disfigurement. Medical treatment of these lesions has traditionally been focused on stopping new blood vessel growth with corticosteroids. Recent reports and our own experience have demonstrated that significant reduction in IH size and vascularity can also occur through the use of propranolol. Our initial experience with propranolol has demonstrated significant efficacy with fewer side effects than corticosteroids. Despite this experience, the standard of care for initial IH medical therapy remains corticosteroids.

This Trial is a direct comparison of traditional IH therapy with corticosteroids to newer therapy with propranolol and corticosteroids.

Arms: arm 1: Group A will receive oral, liquid Prednisolone, which is the standard corticosteroid that we use here at Seattle Children's, and oral liquid placebo. The dose of prednisolone that Group A will receive will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. This is a standard dose for IH treatment. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone. This treatment will be given for two months, as is our standard practice. arm 2: Group B will receive oral liquid prednisolone, and oral propranolol. As in Group A, the dose of prednisolone will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. Oral liquid propranolol will be dosed at 2 mg/kg/day, following initiation in the Cardiology Clinic. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone.
Interventions: intervention 1: Prednisolone (Corticosteroid) intervention 2: Propranolol intervention 3: Placebo
Intervention descriptions: intervention 1: Oral liquid prednisolone. Dose: 1-2mg/kg/day for 7 days, and then dose will be slowly reduced and then stopped after 3 weeks. intervention 2: Oral liquid propranolol will be dosed Oral liquid propranolol will be dosed at 2 mg/kg/day. intervention 3: Liquid placebo will be given during the two month treatment trial.

Protocol documents:
Clinical trial NCT01078675
Conditions: Familial Hypercholesterolaemia
Keywords: Familial Hypercholesterolaemia pediatric
Sponsor: AstraZeneca
Start date: 2010-02-01; Completion date: 2013-02-01
Enrollment: 315 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study is being carried out to see if the study medication, rosuvastatin, is effective in treating familial hypercholesterolaemia in children and adolescents, and to determine the long term (over 2 years) safety, tolerability and efficacy of the study medication in these patients.

This study will also measure levels of drug in the blood and see how well it is tolerated. This is known as pharmacokinetic (PK) analysis.

At baseline only a small number of patients will participate in a single dose PK phase over 24 hours.

In order to see if this medication works, a control group of healthy siblings will help the researchers to compare certain results.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: rosuvastatin calcium intervention 2: rosuvastatin calcium intervention 3: rosuvastatin calcium
Intervention descriptions: intervention 1: 5 mg, oral, once daily, 24 months intervention 2: 10 mg, oral, once daily, 24 months intervention 3: 20 mg, oral, once daily, 24 months

Protocol documents:
Clinical trial NCT01100853
Conditions: Amphetamine Dependence
Keywords: amphetamine dependence amphetamine injection VIVITROL/VIVITROL placebo amphetamine craving
Sponsor: University of Pennsylvania
Start date: 2010-05-01; Completion date: 2013-02-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Until positive results were found with oral naltrexone, no medication has been effective against amphetamine dependence. The primary aim of this pilot study is to replicate the findings of the Swedish team that showed oral Naltrexone prevented relapse to amphetamine addiction and to extend their results by randomizing treatment-seeking amphetamine addicted patients to a 6 month course of VIVITROL (naltrexone for extended-release injectable suspension) or VIVITROL placebo. Patients in each group will receive drug counseling. VIVITROL is administered monthly and may be a better test of efficacy than tablets that must be taken daily.

Detailed description:

Arms: arm 1: Efficacy of 24 week course of Extended Release VIVITROL 380 mg with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections) arm 2: Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
Interventions: intervention 1: VIVITROL injection and VIVITROL Placebo Injection , 24 weeks
Intervention descriptions: intervention 1: Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)

Protocol documents:
Clinical trial NCT01105247
Conditions: B-cell Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma
Keywords: PCI-32765 Lymphoma, B-Cell Leukemia, Lymphoid Leukemia, B-Cell Bruton's Tyrosine Kinase
Sponsor: Pharmacyclics LLC.
Start date: 2010-05-01; Completion date: 2013-02-01
Enrollment: 133 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to establish the safety and efficacy of orally administered PCI-32765 in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: PCI-32765
Intervention descriptions: intervention 1: 420 mg daily or 840 mg daily

Protocol documents:
Clinical trial NCT01107418
Conditions: Malignant Melanoma
Sponsor: Hoffmann-La Roche
Start date: 2010-05-01; Completion date: 2013-02-01
Enrollment: 52 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This open-label study will assess the pharmacokinetics, efficacy and safety of RO5185426 administered as 240mg tablets in previously treated patients with metastatic melanoma. Patients will be randomized to receive one of four dose-levels of RO5185426 \[RG7204; PLEXXIKON; PLX4032\] orally twice daily on days 1 to 15 (morning dose). Starting on day 22, treatment with RO5185426 may be resumed at a dose of 960 mg twice daily and continued until disease progression. Target sample size is \<100 patients.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: RO5185426 intervention 2: RO5185426 intervention 3: RO5185426 intervention 4: RO5185426 intervention 5: RO5185426
Intervention descriptions: intervention 1: dosage b) orally twice daily, days 1-15 (morning dose) intervention 2: dosage c) orally twice daily, days 1-15 (morning dose) intervention 3: dosage d) orally twice daily, days 1-15 (morning dose) intervention 4: 960 mg orally twice daily, from day 22 onward intervention 5: dosage a) orally twice daily, days 1-15 (morning dose)

Protocol documents:
Clinical trial NCT01132326
Conditions: Primary Autonomic Failure Dopamine Beta Hydroxylase Deficiency Non-Diabetic Neuropathy Neurogenic Orthostatic Hypotension
Keywords: Symptomatic NOH
Sponsor: Chelsea Therapeutics
Start date: 2009-01-01; Completion date: 2013-02-01
Enrollment: 350 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Symptomatic NOH in patients with primary autonomic failure is thought to be a consequence of norepinephrine depletion leading to a diminished capacity to effect an appropriate cardiovascular response to an orthostatic challenge resulting in symptomatic cerebral-hypoperfusion. Droxidopa augments norepinephrine levels which should lead to improved cerebral perfusion following orthostatic challenge thereby reducing the symptoms of NOH. The present study will evaluate the long-term safety of droxidopa.

Detailed description:
This is a Phase III, multi-center, open-label study designed to evaluate the long-term safety of droxidopa in subjects with neurogenic orthostatic hypotension (NOH) associated with Primary Autonomic Failure, Dopamine Beta Hydroxylase Deficiency or Non-Diabetic Autonomic Neuropathy.

Patients will be initially treated with droxidopa at their individualized dose identified during the titration phase in Protocol 301. Patients will not require adjustment of their dose, unless their physician feels a dose change will benefit their symptoms, or side effects. At any point in the study a patient's physician may elect to titrate the subject to a higher or lower dose if they feel additional benefit can be safely derived or to deal with any unwanted side-effect.

Patients will return to the clinic for study visits at 1, 3, 6, 9 and 12 months (± 1 week allowed for 1 month visit, ± 2 weeks allowed for subsequent study visits). Patients who prematurely withdraw from the study will be asked to attend the study center for a final assessment At the conclusion of the 12 month treatment period, all patients who benefit from treatment with droxidopa will be offered the option to continue to receive open-label droxidopa through a separate access program.

At any time during the study, patients can schedule a visit with their study physician if they experience a worsening of symptoms and wish to have their dose adjusted or to remove themselves from the trial.

Patients who decide to terminate their participation in the study will receive a phone call 1 month after leaving the trial to follow-up on any new or ongoing adverse events (AEs).

It is a recognized best practice that patients with neurogenic orthostatic hypotension are advised not to lay fully supine because of the associated increased risk of supine hypertension inherent with their condition. Patients participating in this study should be advised to sleep in a semi-recumbent position. .

Patients will attend the study center as out-patients. Patients will be identified using the unique identification number assigned during Protocol 301.

Arms: arm 1: Open-Label Droxidopa
Interventions: intervention 1: Droxidopa
Intervention descriptions: intervention 1: Oral, 100, 200, 300, 400, 500, 600 mg TID, 12 months

Protocol documents:
Clinical trial NCT01137474
Conditions: Type 2 Diabetes
Keywords: Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Angiotensin Receptor Antagonists Angiotensin-Converting Enzyme Inhibitors Hypoglycemic Agents Pharmacologic Actions Physiological Effects of Drugs
Sponsor: AstraZeneca
Start date: 2010-07-01; Completion date: 2013-02-01
Enrollment: 2996 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to learn whether dapagliflozin, after 12 weeks, can improve (decrease) blood pressure in patients with type 2 diabetes with uncontrolled hypertension who are on an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker. The safety of this treatment will also be studied.

Detailed description:

Arms: arm 1: Oral tablets administered as 10 mg once daily for up to 12 weeks arm 2: Oral tablets administered once daily in the morning arm 3: Oral tablets administered as 2.5 mg once daily for up to 12 weeks (Arm discontinued as of Protocol Amendment 8) arm 4: Oral tablets administered as 5 mg once daily for up to 12 weeks (Arm discontinued as of Protocol Amendment 8)
Interventions: intervention 1: Dapagliflozin intervention 2: Placebo-matching dapagliflozin
Intervention descriptions: intervention 1: Oral tablets administered as 2.5, 5, or 10 mg, once daily for up to 12 weeks intervention 2: Oral tablets administered as 0 mg once daily for up to 12 weeks

Protocol documents:
Clinical trial NCT01144377
Conditions: Osteoporosis
Keywords: osteoporosis
Sponsor: Eli Lilly and Company
Start date: 2010-08-01; Completion date: 2013-02-01
Enrollment: 154 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objectives of this study include evaluating the dose response of LY2541546 using bone mineral density (BMD) change from baseline as compared to placebo and evaluating the overall safety and tolerability of LY2541546 following multiple subcutaneous administrations in postmenopausal (PMP) women with low BMD. Following the last dose of study drug, participants will be able to participate in a 12 month extension to collect additional safety and efficacy data (no further treatment will be administered during this extension).

Detailed description:

Arms: arm 1: LY2541546: 180 milligrams (mg) administered subcutaneously every 4 weeks (Q4W) for 52 weeks.

Placebo: administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks. arm 2: LY2541546: 180 milligrams (mg) administered subcutaneously every 2 weeks (Q2W) for 52 weeks. arm 3: LY2541546: 270 milligrams (mg) LY2541546 administered subcutaneously every 2 weeks (Q2W) for 52 weeks. arm 4: LY2541546: 270 milligrams (mg) administered subcutaneously every 12 weeks (Q12W) for 52 weeks.

Placebo: administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks. arm 5: Placebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
Interventions: intervention 1: LY2541546 intervention 2: Placebo
Intervention descriptions: intervention 1: Administered subcutaneously intervention 2: Administered subcutaneously

Protocol documents: