ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00452361
Conditions: Kidney Transplantation
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Start date: 2007-04-01; Completion date: 2008-08-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate whether conversion from cyclosporine, a calcineurin inhibitor (CI) to sirolimus (SRL) results in improved long-term renal function without a negative impact on safety or immunosuppressive efficacy, and to further examine the potential of SRL to reduce the severity and/or progression of chronic allograft nephropathy (CAN).

Detailed description:
This open-label, randomized, parallel-group, comparative, outpatient study will be conducted in multiple centers in Taiwan.

The study will randomize approximately 120 patients. 80 patients will be randomized to the SRL therapy group (conversion from CI- to SRL-based immunosuppression: group A) and 40 patients to the CI therapy group (continued CI therapy: group B).

Dosage and Administration

SRL Therapy: At the time of randomization on day 1, each patient will have been receiving:

* triple therapy with a CI (tacrolimus or CsA) that began at the time of transplantation or within 2 weeks thereafter AND
* corticosteroids corresponding to a dosage range of 2.5 to 15 mg/day for prednisone or prednisolone (2 to 12 mg/day for methylprednisolone) or the alternate day equivalent for at least 12 weeks before randomization, PLUS
* either MMF (minimum dose 500 mg/day)/MPS (minimum dose 360 mg/day) or AZA (minimum dose 50 mg/day) for at least 12 weeks before randomization.

SRL will be added to the immunosuppressive regimen for Group A. Group B will continue on this CI immunosuppressive regimen.

Arms: arm 1: Sirolimus therapy arm 2: Calcineurin Inhibitor therapy (either cyclosporine or tacrolimus)
Interventions: intervention 1: Sirolimus+MMF or MPS or AZA+Steroid intervention 2: Calcineurin Inhibitors (either cyclosporine or tacrolimus)+MMF or MPS or AZA+Steroid
Intervention descriptions: intervention 1: Corticosteroids will be administered according to local practice, within a daily maintenance dosage range of 2.5 to15 mg for prednisone or prednisolone (2 to 12 mg/day for methylprednisolone) or the alternate day equivalent. intervention 2: The maintenance dose of:

1. MMF will not exceed 1500 mg/day or PMS will not exceed 1080 mg/day
2. AZA will not exceed 75 mg/day

Thereafter, at the discretion of the investigator, MMF/MPS or AZA may be:

1. continued for the entire 104-week period of randomized therapy
2. subsequently discontinued
3. restarted after discontinuation

Protocol documents:
Clinical trial NCT00455520
Conditions: Diabetic Neuropathy
Keywords: Diabetic neuropathy Painful Diabetic Polyneuropathy Polyneuropathy Peripheral neuropathy
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Start date: 2007-04-01; Completion date: 2008-08-01
Enrollment: 395 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of Tapentadol (CG5503) extended release (ER) (base) compared to placebo in patients with moderate to severe pain from diabetic peripheral neuropathy.

Detailed description:
The primary objective of this randomized-withdrawal (randomized means study medication assigned to patients by chance and withdrawal means to stop using), multicenter, double-blind (neither patient nor investigator knows the study medication), placebo-controlled, Phase 3 study is to determine the effectiveness and safety of orally administrated Tapentadol (CG5503) extended release (ER) (base) at doses of 100-250 mg twice daily in patients with moderate to severe pain from diabetic peripheral neuropathy. The study is being conducted for registration and approval of CG5503 in the US and outside US. The trial will consist of two phases: Phase I is open-label and Phase 2 is double- blind. In the Open-Label Phase 1 there will be four periods: screening (to assess eligibility), washout (dependent on the pain medication the patient was previously taking), pain intensity perctoris evaluation (over a 3 day period), and open-label titration (study drug will be titrated to an optimal dose starting with 50 mg twice a day and adjusted to an optimal dose for a period of 3 weeks). Patients with at least a 1-point reduction in the average pain intensity score at the end of the open-label titration period, as compared with pre-titration will be eligible for randomization in the double-blind phase. In the double-blind Phase 2, there will be two periods: double-blind maintenance period (take drug for 12 weeks), and follow-up (a visit within 4 days of the intake of the last dose of study drug and a follow-up call approximately 10-14 days after the intake of the last dose of the study drug). The patient will maintain the dose level achieved at the end of the Phase 1 during the double-blind treatment phase. The study hypothesis is that the study drug will be different from placebo in the change in pain intensity. Titrate Tapentadol (CG5503) extended release (ER) 50 mg to patient's optimal dose ranging between 100mg and 250mg twice a day; Placebo (no active ingredients). All doses of trial treatment will be taken orally with or without food, for a maximum timeframe of 15 weeks.

Arms: arm 1: placebo matching placebo twice daily for 12 weeks arm 2: CG5503 100, 150, 200, 250mg twice daily given for up to 15 weeks
Interventions: intervention 1: CG5503 intervention 2: placebo
Intervention descriptions: intervention 1: 100, 150, 200, 250 mg twice daily given for up to 15 weeks intervention 2: matching placebo twice daily for 12 weeks

Protocol documents:
Clinical trial NCT00457743
Conditions: Gastrointestinal Stromal Tumors
Keywords: Evaluate of RTD for Japanese GIST patients
Sponsor: Pfizer
Start date: 2005-01-01; Completion date: 2008-08-01
Enrollment: 36 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Phase I;To investigate the clinically recommended dose of Sunitinib malate (SU011248) following multiple oral dosing in the first cycle (4 consecutive weeks and 2 weeks rest) by reviewing the safety and tolerability.

Phase II;To determine the objective tumor response and the safety of Sunitinib malate (SU011248) at the clinically recommended dose.

Detailed description:

Arms: arm 1: 25 , 50 or 75 mg/day of SU011248
Interventions: intervention 1: Sunitinib malate (SU011248)
Intervention descriptions: intervention 1: SU011248

Protocol documents:
Clinical trial NCT00462982
Conditions: Kidney Cancer Melanoma (Skin) Metastatic Cancer
Keywords: stage IV melanoma tumors metastatic to brain stage IV renal cell cancer recurrent melanoma recurrent renal cell cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2007-03-01; Completion date: 2008-08-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with brain metastases caused by kidney cancer or melanoma.

Detailed description:
OBJECTIVES:

Primary

* Determine the efficacy of sunitinib malate, in terms of objective radiographic response of brain lesions, in patients with brain metastases secondary to renal cell carcinoma or melanoma.

Secondary

* Determine overall and progression-free survival.

OUTLINE: Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed periodically.

Arms: arm 1: Patients will be treated with 50 mg daily for four out of every six weeks.
Interventions: intervention 1: sunitinib malate
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00463151
Conditions: Colitis, Ulcerative
Keywords: Rebamipide Enema Ulcerative Colitis
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2007-06-01; Completion date: 2008-08-01
Enrollment: 124 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the safety and efficacy of rebamipide by once daily intracolonial administration at 0 (placebo), 60, 150, or 300 mg for 6 weeks in patients with active ulcerative colitis, who are being treated with oral aminosalicylic acid (ASA).

Detailed description:

Arms: arm 1: 0mg rebamipide arm 2: 60mg rebamipide arm 3: 150mg rebamipide arm 4: 300mg rebamipide
Interventions: intervention 1: rebamipide
Intervention descriptions: intervention 1: 0, 60, 150, 300mg of rebamipide per day for 6 weeks into colon

Protocol documents:
Clinical trial NCT00468286
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Sponsor: Ferring Pharmaceuticals
Start date: 2007-05-01; Completion date: 2008-08-01
Enrollment: 133 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will have two treatment groups, evaluating two Degarelix doses. First dose is the initial dose followed by a maintenance dose given every three months. The initial dose given to suppress the testosterone level and the three month maintenance dose to maintain the suppressed testosterone level over one year of treatment.

Detailed description:
An Open-Label, Multi-Centre, Randomized Parallel-Group Dose-Finding Study, Investigating Efficacy and Safety of Two Degarelix Three-Month Dosing Regimens in Patients with Prostrate Cancer Requiring Androgen Ablation Therapy.

Arms: arm 1: Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months. arm 2: Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months.
Interventions: intervention 1: Degarelix intervention 2: Degarelix
Intervention descriptions: intervention 1: Experimental

Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months. intervention 2: Experimental

Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months.

Protocol documents:
Clinical trial NCT00471068
Conditions: Open-angle Glaucoma Ocular Hypertension
Sponsor: Alcon Research
Start date: 2007-03-01; Completion date: 2008-08-01
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the efficacy and safety in patients treated with travoprost versus dorzolamide/timolol maleate combination in patients with open-angle glaucoma or ocular hypertension

Detailed description:

Arms: arm 1: Travatan: 6 weeks treatment with Travatan (travoprost 40 mg/ml eye drops, solution) once daily at 08:00 and placebo (timolol vehicle) once daily at 20:00 in the affected eye(s) arm 2: treatment period of 6 weeks with Cosopt (dorzolamide 20 mg/ml and timolol maleate 5 mg/ml eye drops, solution) twice daily at 08:00 and 20:00 in the affected eye(s)
Interventions: intervention 1: Travatan intervention 2: Cosopt intervention 3: Placebo (Timolol Vehicle)
Intervention descriptions: intervention 1: Travatan: 6 weeks treatment with Travatan (travoprost 40 mg/ml eye drops, solution) once daily at 08:00 and placebo (timolol vehicle) once daily at 20:00 in the affected eye(s) intervention 2: treatment period of 6 weeks with Cosopt (dorzolamide 20 mg/ml and timolol maleate 5 mg/ml eye drops, solution) twice daily at 08:00 and 20:00 in the affected eye(s) intervention 3: Travatan group: 6 weeks treatment with Travatan (travoprost 40 mg/ml eye drops, solution) once daily at 08:00 and placebo (timolol vehicle) once daily at 20:00 in the affected eye(s)

Protocol documents:
Clinical trial NCT00478192
Conditions: Hyponatremia
Keywords: hyponatremia hypervolemic euvolemic edematous conivaptan
Sponsor: Cumberland Pharmaceuticals
Start date: 2007-04-01; Completion date: 2008-08-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is designed to assess the efficacy and safety of multiple infusions of conivaptan in subjects with euvolemic or hypervolemic hyponatremia

Detailed description:

Arms: arm 1: 20 mg conivaptan once a day arm 2: 20 mg conivaptan two times a day arm 3: None
Interventions: intervention 1: Conivaptan intervention 2: Placebo
Intervention descriptions: intervention 1: premix bag intervention 2: premix bag

Protocol documents:
Clinical trial NCT00482001
Conditions: Mental Health Geriatrics
Keywords: Donepezil Driving Cholinesterase Inhibitors Geriatric Psychiatry Psychopharmacology Aricept
Sponsor: Sunnybrook Health Sciences Centre
Start date: 2007-06-01; Completion date: 2008-08-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of the study is to assess the role of cholinesterase inhibitors in affecting the driving ability of cognitively intact seniors using driving simulators. We hypothesize that the use of a cholinesterase inhibitor for two weeks will be associated with improvement in safe driving behavior on a simulated driving task.

Detailed description:
Alzheimer's disease (AD) is the most common cause of dementia, and while it is known that AD poses substantial risks of motor vehicle collisions, many people in the earliest stages of AD continue to drive. Memory problems themselves are poor predictors of who is actually unsafe on the road, and various medications that are used to treat people with AD may impact on their driving abilities. Donepezil is a drug used to treat the memory problems associated with AD. While previous studies have shown that it slows the decline of activities of daily living (eg. shopping, banking, dressing) and may improve the ability of younger pilots to perform on computerized flight simulators, no studies have examined the impact of donepezil on driving abilities in older adults.

The present investigation is a pilot study aiming to determine if donepezil helps healthy older drivers perform on driving simulators. Two Canadian academic centers have different driving simulators - one in Toronto and one in Thunder Bay. At each of these centers, ten healthy men aged 65 to 75 will be randomly assigned to receive either donepezil 5mg/day or identical placebo for two weeks.

Using the driving simulator, we will assess various aspects of driving ability. These measures of driving performance will be compared between those who received the drug and those who received the placebo.

Arms: arm 1: donepezil, capsule, 5mg daily once daily for 14 days arm 2: placebo (cornstarch), capsule, once daily for 14 days
Interventions: intervention 1: donepezil intervention 2: Placebo (cornstarch)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00485433
Conditions: Postoperative Pain
Keywords: hernia unilateral postoperative analgesia
Sponsor: Pacira Pharmaceuticals, Inc
Start date: 2007-06-01; Completion date: 2008-08-01
Enrollment: 98 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate three dose levels of SKY0402 compared with 105 mg of bupivacaine HCl.

Detailed description:
Effective postoperative pain control is a critical element in patient recovery, as the majority of patients may experience significant pain, particularly in the first few days following surgery. Appropriate postoperative pain management contributes to improved healing, faster patient mobilization, shortened hospital stays, and reduced healthcare costs.

Arms: arm 1: Bupivacaine HCl given during hernia repair arm 2: SKY0402 low dose given during hernia repair arm 3: SKY0402 middle dose given during hernia repair arm 4: SKY0402 high dose given during hernia repair
Interventions: intervention 1: Bupivacaine HCl intervention 2: SKY0402
Intervention descriptions: intervention 1: Bupivacaine HCl given during hernia repair intervention 2: SKY0402 given during hernia repair

Protocol documents:
Clinical trial NCT00485758
Conditions: Diabetes Mellitus Type 2
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-07-01; Completion date: 2008-08-01
Enrollment: 796 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to assess the efficacy and tolerability of ER (Extended Release) niacin/laropiprant versus placebo in Type 2 Diabetes Mellitus patients.

Detailed description:

Arms: arm 1: Arm 1: One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, advancing to ER niacin/laropiprant (2g) at Week 4 for the remainder of the study. arm 2: Arm 2: stable lipid-modifying regimen, adding Placebo ER niacin/laropiprant in week 4, for the duration of the study.
Interventions: intervention 1: ER niacin/laropiprant intervention 2: Comparator : placebo (unspecified)
Intervention descriptions: intervention 1: One tablet of ER niacin/laropiprant (1g); advancing to ER niacin/laropiprant (2g) at Week 4 for the remainder of the study 36 Weeks. intervention 2: ER niacin/laropiprant Placebo

Protocol documents:
Clinical trial NCT00489853
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Sponsor: AstraZeneca
Start date: 2007-07-01; Completion date: 2008-08-01
Enrollment: 137 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to investigate the effect on exercise tolerance, lung function and symptoms after treatment with Symbicort, Oxis or placebo in patients with severe chronic obstructive pulmonary disease.

Detailed description:

Arms: arm 1: Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily, then Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Placebo, 1 inhalation twice daily arm 2: Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily, then Placebo, 1 inhalation twice daily arm 3: Placebo, 1 inhalation twice daily, then Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
Interventions: intervention 1: budesonide/formoterol Turbuhaler 320/9µg intervention 2: formoterol Turbuhaler 9µg intervention 3: Placebo
Intervention descriptions: intervention 1: Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms intervention 2: Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily intervention 3: Placebo, 1 inhalation twice daily

Protocol documents:
Clinical trial NCT00489918
Conditions: Osteoporosis
Sponsor: Zosano Pharma Corporation
Start date: 2007-06-01; Completion date: 2008-08-01
Enrollment: 165 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A Multi-center study to determine effects of various doses of Macroflux Parathryroid Hormone (PTH) in women with osteoporosis

Detailed description:

Arms: arm 1: Macroflux® placebo patch arm 2: Macroflux® 20 mcg patch arm 3: Macroflux® 30 mcg patch arm 4: Macroflux® 40 mcg patch arm 5: FORTEO® 20 mcg injection
Interventions: intervention 1: teriparatide intervention 2: teriparatide
Intervention descriptions: intervention 1: Macroflux® patch applied to the abdomen for 30 minutes daily intervention 2: FORTEO® injection administered subcutaneously (SC) either to the abdomen or thigh

Protocol documents:
Clinical trial NCT00522951
Conditions: Brain Metastases
Keywords: MRI Brain Metastasis Gadolinium Imaging Diagnostic Agent
Sponsor: Bayer
Start date: 2007-08-01; Completion date: 2008-08-01
Enrollment: 165 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study is conducted to compare the contrast effect and safety of SH L562BB with ProHance, which has already been approved as a pharmaceutical product of similar indication.

Detailed description:

Arms: arm 1: Participants received first injection (intravenous \[i.v.\]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw arm 2: Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min arm 3: Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
Interventions: intervention 1: Gadobutrol (Gadavist, Gadovist, BAY86-4875) intervention 2: Gadobutrol (Gadavist, Gadovist, BAY86-4875) intervention 3: ProHance
Intervention descriptions: intervention 1: Gadobutrol enhanced MRI (first injection of gadobutrol 0.1 mmol/kg bw, corresponding to a dose of 0.1 mmol/kg bw) intervention 2: Gadobutrol enhanced MRI (second injection of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw) intervention 3: ProHance enhanced MRI (two injections of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw)

Protocol documents:
Clinical trial NCT00524459
Conditions: Breast Cancer
Keywords: stage IIIA breast cancer stage IIIB breast cancer
Sponsor: Roswell Park Cancer Institute
Start date: 2007-05-01; Completion date: 2008-08-01
Enrollment: 6 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving them before surgery may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects of giving liposomal doxorubicin together with docetaxel before surgery and to see how well it works in treating women with locally advanced breast cancer that can be removed by surgery.

Detailed description:
OBJECTIVES:

Primary

* To evaluate the rate of pathological complete response and clinical complete response in women with locally advanced breast cancer treated with pegylated doxorubicin hydrochloride liposome and docetaxel.

Secondary

* To assess the overall clinical local regional response in patients treated with this preoperative chemotherapy regimen.
* To evaluate the number of patients who would have required a mastectomy upfront but who underwent breast conservation therapy instead after neoadjuvant chemotherapy.
* To assess the safety, particularly with regard to neutropenia and cardiac toxicity, of pegylated doxorubicin hydrochloride liposome and docetaxel.

OUTLINE: This is a multicenter study.

Patients receive pegylated doxorubicin hydrochloride liposome IV over 90 minutes and docetaxel IV over 90 minutes on day 1. Patients receive pegylated filgrastim subcutaneously on days 2 or 3 post-chemotherapy in courses 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Within 8 weeks after completion of chemotherapy, patients undergo a lumpectomy or mastectomy to remove the tumor. Some patients may receive additional therapy after surgery, including hormonal therapy, chemotherapy, or radiotherapy.

After completion of study therapy, patients are followed periodically for up to 5 years.

Interventions: intervention 1: docetaxel intervention 2: pegylated liposomal doxorubicin hydrochloride intervention 3: conventional surgery intervention 4: neoadjuvant therapy
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents: