ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01183559
Conditions: Cancer of the Esophagus Adenocarcinoma of the Gastroesophageal Junction Cancer of the Stomach
Sponsor: Fox Chase Cancer Center
Start date: 2008-08-07; Completion date: 2011-08-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to determine the most tolerable and safe dose of ZD6474 (Zactima, Vandetanib) when given with standard chemotherapy, radiation therapy and surgery in patients with cancer of the esophagus

Detailed description:
Epidermal Growth Factor Receptor (EGFR) is known to be an important prognostic factor for patients with esophageal cancer-overexpression is associated with a worse prognosis. Review of the literature demonstrates presence of EGFR expression in up 90% of cases of esophageal cancer. Additionally, Vascular Endothelial Growth factor (VEGF) is commonly overexpressed in esophageal cancer (especially adenocarcinoma) and is linked to the transition from Barrett's esophagus to invasive adenocarcinoma. Esophageal cancers with overexpression of VEGF are associated with a worse prognosis and poorer response to conventional chemoradiation.

Therefore, we feel it would be valuable to add an inhibitor of EGFR and VEGFR to the therapy of esophageal cancer to increase the rate of pathologic complete response and thus improve overall survival. In current trials of ZD6474 in combination with chemotherapy, the dose has been 300mg. We will perform a phase I trial in which we will dose-escalate ZD6474 to determine if this drug is tolerable in combination with cytotoxic chemotherapy and external beam radiation therapy. This would be the first trial in humans in which f these three modalities would be combined. We will determine the maximum tolerated dose of ZD6474 in this small trial and then hope to perform a larger phase II trial, perhaps in the context of the Radiation Therapy Oncology Group (RTOG).

Arms: arm 1: Vandetanib 100 mg (6 patients) or 200 mg (3 patients) orally daily during the conventional 3D-guided conformal radiation therapy plus chemotherapy with carboplatin (AUC 5) on days 1 and 29, paclitaxel 50 mg/m2 i.v. weekly on days 1, 8, 15, 22, 29; and continuous infusion of 5-fluorouracil at 225 mg/m2 for 96 hours Monday-Friday during the radiation.
Interventions: intervention 1: Vandetanib intervention 2: 5 Fluorouracil (FU) intervention 3: Carboplatin intervention 4: Paclitaxel intervention 5: External Beam Radiation Therapy (RT)
Intervention descriptions: intervention 1: Vandetanib 100mg orally escalating to doses of 200 mg daily 7 days a week until completion of radiation therapy intervention 2: 5-FU 225 mg/m2/day continuous infusion over96 hours during radiation therapy intervention 3: Carboplatin AUC=5 days 1 and 29 during radiation therapy intervention 4: Paclitaxel 50 mg/m2 days 1, 8, 15, 22, 29 during radiation therapy intervention 5: External Beam Radiation Therapy(XRT)to a total dose of 4,500 centiGray (cGy) (180 cGy fractions daily) Monday through Friday for five weeks

Protocol documents:
Clinical trial NCT01186705
Conditions: Colon Cancer Rectal Cancer
Keywords: MK-2206 colon rectal 10-068
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2010-08-01; Completion date: 2011-08-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to test a new drug called MK-2206 for metastatic colorectal cancer. This drug is being tested in a subgroup of patients with colorectal cancer whose tumors have changes in certain genes that may make them more likely to respond to this new medication. As tumors develop, the cells within the tumor acquire mutations within genes, allowing them to grow more effectively. We will be testing your tumor for mutations involving two genes - KRAS and PIK3CA. Patients whose tumors have a normal copy of the KRAS gene and a mutation within the PIK3CA gene will be eligible to participate in this study.

This study is a phase 2 study. The goal of a phase 2 study is to find out what effects, good and/or bad, a new treatment has against a certain type of cancer.

Detailed description:

Arms: arm 1: This will be a single-arm, phase II study of the AKT inhibitor MK-2206 in patients with KRAS-wild-type, PIK3CA-mutated, colorectal cancer whose tumors have progressed through standard chemotherapy regimens.
Interventions: intervention 1: MK-2206
Intervention descriptions: intervention 1: Patients will receive MK-2206 orally in a once weekly dose of 200mg. There will be no dose escalation. Patients will be treated until disease progression or unacceptable side effects.

Protocol documents:
Clinical trial NCT01197911
Conditions: Healthy Volunteer
Sponsor: Hoffmann-La Roche
Start date: 2010-09-01; Completion date: 2011-08-01
Enrollment: 38 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This open-label study will assess the effects of hepatic impairment on the pharmacokinetics of a single oral dose of aleglitazar in subjects with mild or moderate hepatic impairment (Child-Pugh class A or B) and in matched control subjects with normal hepatic function. Subjects will receive a single oral dose of aleglitazar, with assessment of the pharmacokinetics of aleglitazar on Days 1-5. Anticipated duration of study for each enrolled subject is approximately 6 weeks.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: aleglitazar
Intervention descriptions: intervention 1: single oral dose

Protocol documents:
Clinical trial NCT01201798
Conditions: Endogenous Anterior Uveitis
Sponsor: Alcon Research
Start date: 2010-10-01; Completion date: 2011-08-01
Enrollment: 111 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to demonstrate that difluprednate 0.05% (Durezol) dosed 4 times daily is noninferior to prednisolone 1% (Pred Forte) dosed 8 times daily for the treatment of endogenous anterior uveitis.

Detailed description:

Arms: arm 1: Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period arm 2: Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
Interventions: intervention 1: Difluprednate 0.05% ophthalmic emulsion intervention 2: Prednisolone acetate 1.0% ophthalmic suspension
Intervention descriptions: intervention 1: 1 drop in study eye, 4 times a day, for 14 days, followed by a 14-day tapering period dependent on the Investigator's determination of adequate response to treatment intervention 2: 1 drop in study eye, 8 times a day, for 14 days, followed by a 14-day tapering period dependent on the Investigator's determination of adequate response to treatment

Protocol documents:
Clinical trial NCT01205230
Conditions: Cancer
Keywords: Esomeprazole Pharmacogenetics Pharmacokinetics Ketoconazole Pazopanib Drug Interaction Safety Solid Tumors
Sponsor: GlaxoSmithKline
Start date: 2010-09-01; Completion date: 2011-08-01
Enrollment: 34 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine how dosing with ketoconazole (Nizoral) or esomeprazole (Nexium) affects the pharmacokinetics of oral pazopanib. The study will also test for safety of pazopanib when administered with ketoconazole or esomeprazole.

Detailed description:
The study is a 2-arm, open-label, repeat-dose, single sequence, crossover, study designed to evaluate the effects of ketoconazole (Arm A) and esomeprazole (Arm B) on the pharmacokinetics (PK) of oral pazopanib in subjects with solid tumor malignancies. This study will compare the PK parameters of oral pazopanib and its metabolite concentrations when given alone and when co-administered with either ketoconazole (Arm A) or esomeprazole (Arm B). Safety assessments (physical examinations, vital signs, 12-lead electrocardiograms, Eastern Cooperative Oncology Group performance status, clinical laboratory assessments, and monitoring of adverse events) will also be evaluated during the study.

Arms: arm 1: Administration of oral pazopanib 400mg (2 200-mg tablets) once-daily each morning for at least 7 consecutive doses during Period 1. Then administration of oral ketoconazole 400 mg (2 - 200 mg tablets) followed immediately by pazopanib 400 mg (2 -200 mg tablets) once-daily each morning for a total of 5 consecutive doses during Period 2. arm 2: Subjects will receive orally administered pazopanib 800mg (4 - 200mg tablets) once-daily each morning for at least 7 consecutive doses in Period 1. In the evening on the last day of Period 1, subjects will take their initial dose of esomeprazole 40 mg (1 - 40 mg capsule) approximately 3 hours after the evening meal. Subjects will continue to receive pazopanib (each morning) and esomeprazole each evening once-daily for a total of 5 consecutive doses.
Interventions: intervention 1: pazopanib
Intervention descriptions: intervention 1: Adenosine triphosphate (ATP)-competitive tyrosine kinase inhibitor of vascular endothelial growth factor receptor (VEGFR)-1, -2, and -3, platelet derivative growth factor receptor (PDGFR)

Protocol documents:
Clinical trial NCT01213836
Conditions: Schizophrenia
Keywords: Stable schizophrenia cognitive functioning
Sponsor: AstraZeneca
Start date: 2010-11-01; Completion date: 2011-08-01
Enrollment: 75 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This will be a phase IV 20 -32 day prospective, double blind, double-dummy, randomised crossover study that will evaluate the effect of quetiapine XR and quetiapine IR on cognitive performance in patients with schizophrenia stabilized on a single antipsychotic medication.

Detailed description:

Arms: arm 1: Patients randomised to Seroquel XR will have treatment for 10-16 days and after that cross-over to treatment with Seroquel IR for 10-16 days arm 2: Patients randomised to Seroquel IR will have treatment for 10-16 days and after that cross-over to treatment with Seroquel XR for 10-16 days
Interventions: intervention 1: Seroquel XR- quetiapine fumarate extended release intervention 2: Seroquel IR - quetiapine fumarate intervention 3: Placebo matching Seroquel XR intervention 4: Placebo matching Seroquel IR
Intervention descriptions: intervention 1: Seroquel XR dose 400-700 mg (in tablet form). The investigator established the dosing schedule for each patient depending on the patient's dose when entering the study. The patients continued on the same dose during the study as they had prior to enrolment. Dose taken once a day for 10-16 days. intervention 2: Seroquel IR dose 400-700 mg (in tablet form). The investigator established the dosing schedule for each patient depending on the patient's dose when entering the study. The patients continued on the same dose during the study as they had prior to enrolment. Dose taken twice a day for 10-16 days. intervention 3: Placebo matching Seroquel XR dose 400-700 mg (in tablet form). Dose taken once a day for 10-16 days. intervention 4: Placebo matching Seroquel IR dose 400-700 mg (in tablet form). Dose taken twice a day for 10-16 days.

Protocol documents:
Clinical trial NCT01215851
Conditions: Pulmonary Tuberculosis
Keywords: Tuberculosis EBA TMC207 pretomanid Early Bactericidal Activity Pulmonary Tuberculosis PA-824 bedaquiline pyrazinamide moxifloxacin ethambutol rifafour
Sponsor: Global Alliance for TB Drug Development
Start date: 2010-10-01; Completion date: 2011-08-01
Enrollment: 85 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of TMC207 alone, TMC207 with pyrazinamide, TMC207 with PA-824, PA-824 with pyrazinamide and PA-824 with moxifloxacin and pyrazinamide, as determined by the rate of change of log CFU in sputum over the time period Day 0-14 in participants with smear positive pulmonary tuberculosis (TB). A control group will receive standard treatment.

Detailed description:

Arms: arm 1: TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg on Day 1; 500mg on Day 2; 400mg on Days 3-14 plus pyrazinamide placebo administered once daily arm 2: TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg on Day 1; 500mg on Day 2; 400mg on Days 3-14 plus pyrazinamide administered once daily in 500mg tablets dosed by weight as follows: \< or = 55kg received 2 tablets/day; \>55kg to 75kg received 3 tablets/day; \>75kg received 4 tablets/day arm 3: PA-824 administered once daily as 200mg tablets and pyrazinamide administered once daily in 500mg tablets dosed by weight as follows: \< or = 55kg received 2 tablets/day; \>55kg to 75kg received 3 tablets/day; \>75kg received 4 tablets/day and moxifloxacin placebo (matched to moxifloxacin tablets) administered once daily arm 4: PA-824 administered once daily as 200mg tablets and pyrazinamide administered once daily in 500mg tablets dosed by weight as follows: \< or = 55kg received 2 tablets/day; \>55kg to 75kg received 3 tablets/day; \>75kg received 4 tablets/day and moxifloxacin administered once daily as 400mg tablets arm 5: Rifafour e-275 administered once daily with each tablet containing 150mg rifampicin, 75mg isoniazid, 400mg pyrazinamide, and 275mg ethambutol and dose by weight as follows: 30kg-37kg received 2 tablets/day; 38kg-54kg received 3 tablets/days; 55kg-70kg received 4 tablets/day; \> or = 71kg received 5 tablets/day arm 6: TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg on Day 1; 500mg on Day 2; 400mg on Days 3-14 plus PA-824 administered once daily as 200mg tablets
Interventions: intervention 1: PA-824 intervention 2: Pyrazinamide intervention 3: TMC207 intervention 4: Rifafour intervention 5: Moxifloxacin
Intervention descriptions: intervention 1: 200 mg tablet, once daily for 14 days intervention 2: Dosed by Weight intervention 3: TMC207 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 intervention 4: Rifafour e-275 intervention 5: moxifloxacin 400 mg

Protocol documents:
Clinical trial NCT01216631
Conditions: Spondylarthropathies
Keywords: seronegative oligoarthritis infliximab intraarticular
Sponsor: University of Leeds
Start date: 2010-09-01; Completion date: 2011-08-01
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this study is to establish the efficacy and duration of effect of intra-articular (IA) infliximab vs intravenous infliximab vs current standard care (IA steroid injections) in seronegative oligoarthritis. All patients will have seronegative arthritis affecting less than 5 joints but including at least one knee. 10 patients will receive IA infliximab injections to the affected knee, 10 will receive IA steroid injections to the affected knee and 10 will receive a course of intravenous infliximab. Patients will not be aware of their group as this is a placebo-controlled study.

Detailed description:

Arms: arm 1: Intra-articular injection of steroid (80mg depomedrone) arm 2: intra-articular injection of 100mg infliximab arm 3: intravenous infusions of infliximab given at 0, 2, 6 and 14 weeks at a dose of 5mg/kg (patient body weight)
Interventions: intervention 1: methylprednisolone intervention 2: Infliximab intervention 3: Infliximab
Intervention descriptions: intervention 1: intra-articular injection of methylprednisolone (80mg given at baseline only) intervention 2: intra-articular injection of 100mg infliximab given at baseline only intervention 3: intravenous infliximab at a dose of 5mg/kg (as per patient weight) given at week 0, 2, 6 and 14

Protocol documents:
Clinical trial NCT01217892
Conditions: Type 2 Diabetes
Keywords: Type 2 diabetes metformin treated inadequate control metformin treatment alone
Sponsor: AstraZeneca
Start date: 2010-11-01; Completion date: 2011-08-01
Enrollment: 400 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being carried out to see if dapagliflozin - administered in a daily dose of 2.5 mg given twice a day or 5 mg twice a day or 10mg once daily - in addition to metformin, is beneficial in diabetes treatment, and if so, how it compares to treatment with metformin alone.

Detailed description:

Arms: arm 1: Dapagliflozin 2.5 mg twice-daily plus open-label metformin arm 2: Dapagliflozin 5.0 mg twice-daily plus open-label metformin arm 3: Dapagliflozin 10 mg once-daily plus open-label metformin arm 4: Placebo plus open-label metformin
Interventions: intervention 1: dapagliflozin intervention 2: dapagliflozin intervention 3: dapagliflozin intervention 4: metformin intervention 5: placebo
Intervention descriptions: intervention 1: 2.5 mg tablet, taken orally, twice daily intervention 2: 5 mg tablet taken orally, twice daily intervention 3: 10 mg tablet taken orally, once daily intervention 4: \>/= 1500 mg total daily dose, tablets taken orally, twice daily intervention 5: placebo

Protocol documents:
Clinical trial NCT01220297
Conditions: Hematologic Diseases Acute-graft-versus-host Disease Leukemia Non-Hodgkin Lymphoma (NHL) Hodgkin Lymphoma
Sponsor: Stanford University
Start date: 2006-08-01; Completion date: 2011-08-01
Enrollment: 3 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A continuation study of sirolimus and mycophenolate mofetil (MMF) for graft-vs-host disease (GvHD) prophylaxis for patients undergoing matched related allogeneic hematopoietic stem cell transplantation (HSCT) for acute and chronic leukemia, myelodysplastic syndrome (MDS), high risk non-Hodgkin lymphoma (NHL), or Hodgkin lymphoma (HL)

Detailed description:
To explore the novel combination of sirolimus and mycophenolate mofetil (MMF) as graft-vs-host disease (GvHD) prevention in human leukocyte antigen (HLA)-matched related donor peripheral blood stem cell (PBSC) or marrow transplantation (BMT), collectively hematopoietic stem cell transplantation (HSCT). This study will report the toxicities associated with this drug combination.

For all treatments and procedures, Study Day is based on the day of HSCT as Day 0.

Arms: arm 1: Carmustine + Etoposide + Cyclophosphamide followed by Sirolimus and Mycophenolate mofetil (MMF) as prophylaxis. arm 2: FTBI + Cyclophosphamide followed by Sirolimus and Mycophenolate mofetil (MMF) as prophylaxis.
Interventions: intervention 1: Sirolimus intervention 2: Mycophenolate mofetil (MMF) intervention 3: Carmustine intervention 4: Etoposide intervention 5: Cyclophosphamide (Cyclo, CY) intervention 6: FTBI
Intervention descriptions: intervention 1: Immunosuppressant administered orally to:

* Adults (age 14 and older), beginning on Day -3 with 12 mg loading dose, followed by 4 mg/day.
* Children \< 13 years or weighing 40 kg, beginning on Day -3 with 3 mg/m² loading dose, followed by 1 mg/ m², rounded to the nearest full milligram.

Daily dosage may be adjusted to maintain a target serum trough level of 3 to 12 ng/ml. Sirolimus dose tapering will begin at Day 100 in the absence of GvHD, with the goal of discontinuation by 6 months. intervention 2: Immunosuppressant given intravenously (IV) at 15 mg/kg 3 times daily, starting on Day 0 ≥ 2 hr after the completion of the HSCT infusion. Dose of MMF will be based on actual body weight, but limited to 15 kg above ideal body weight. MMF dose tapering will begin at Day 100 in the absence of GvHD, with the goal of discontinuation by 6 months. intervention 3: For Carmustine + Etoposide + Cyclophosphamide cohort, chemotherapy administered IV on Day -6 at the lesser of 15 mg/kg or 550 mg/m². intervention 4: For Carmustine + Etoposide + Cyclophosphamide cohort, chemotherapy administered IV on Day -4 at 60 mg/kg intervention 5: Cyclophosphamide is a chemotherapy agent.

For FTBI + Cyclophosphamide cohort, administered IV on Day -3 and -2 at 60 mg/kg.

For Carmustine + Etoposide + Cyclophosphamide cohort, administered IV on Day -2 at 100 mg/kg intervention 6: For FTBI + Cyclophosphamide cohort, administered as 1320 cGy delivered in 11 120 cGy fractions over 4 days starting on Day -7.

Protocol documents:
Clinical trial NCT01226459
Conditions: Androgenetic Alopecia
Keywords: Female Pattern Baldness
Sponsor: Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.
Start date: 2010-09-01; Completion date: 2011-08-01
Enrollment: 404 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a six month clinical trial to evaluate the effectiveness and safety in women with Female Pattern Hair Loss (FPHL), comparing a 5% minoxidil topical foam (MTF) formulation applied once a day versus a topical foam vehicle (placebo) formulation applied once a day.

Detailed description:
This is a phase 3, two-arm, randomized, double-blind, vehicle-controlled, multi-center, 24-week, parallel design trial to evaluate the efficacy and safety in women with Female Pattern Hair Loss (FPHL), comparing the 5% MTF formulation versus the foam vehicle formulation.

This clinical trial is designed to compare the risk/benefit profile of the new 5% MTF formulation applied once a day (OD) versus the foam vehicle formulation applied once a day (OD), using objective efficacy measures and safety assessments.

Study centers will screen a sufficient number of participants so that a minimum of 300 female participants with FPHL will be enrolled, to ensure 260 complete. There will be at least 16 participants enrolled per center at multiple centers located across the US and globally. Approximately 300 participants will be randomly assigned in a 1:1 ratio to use either 5% MTF OD or foam vehicle OD, for 24 weeks for efficacy and safety evaluations.

Participants meeting the inclusion criteria will be randomly assigned in the order of their enrollment at each site. The signing of the informed consent and assignment of a participant number to a subject shall constitute enrollment.

During the trial following enrollment at Baseline, participants will return to the study site at Weeks 1, 6, 12, 18 and 24 for safety assessments, adverse events monitoring, and compliance assessments. At the Week 12 and 24 visits, efficacy assessments will also be conducted, using Target Area Hair Counts (TAHC), measured by macrophotography.

Arms: arm 1: 5% Minoxidil Topical Foam arm 2: Vehicle Topical Foam
Interventions: intervention 1: 5% Minoxidil Topical Foam intervention 2: Vehicle Topical Foam
Intervention descriptions: intervention 1: Dosage Form: 5% Minoxidil Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks intervention 2: Dosage Form: Vehicle Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks

Protocol documents:
Clinical trial NCT01230125
Conditions: Cataract
Keywords: Inflammation Pain Ocular surgery
Sponsor: Bausch & Lomb Incorporated
Start date: 2010-11-01; Completion date: 2011-08-01
Enrollment: 311 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this clinical study is to compare the safety and efficacy of Mapracorat Ophthalmic Suspension, 3% to vehicle for the treatment of postoperative inflammation and pain following cataract surgery.

Detailed description:

Arms: arm 1: Ophthalmic suspension 3% arm 2: Vehicle of mapracorat ophthalmic suspension
Interventions: intervention 1: Mapracorat intervention 2: Vehicle
Intervention descriptions: intervention 1: Instill study medication into study eye per dosing instructions for 14 days intervention 2: Instill study medication into the study eye per dosing instructions for 14 days

Protocol documents: