ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00595517
Conditions: Gastric Ulcer Duodenal Ulcer Rheumatoid Arthritis Osteoarthritis Lumbago
Keywords: gastrointestinal GI NSAID Japan Japanese Gastric ulcer duodenal ulcer
Sponsor: AstraZeneca
Start date: 2007-10-01; Completion date: 2009-09-01
Enrollment: 395 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the Safety and tolerability of D961H (Esomeprazole) 20 mg once daily for up to 52 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating AE, clinical laboratory value and vital signs.

Detailed description:

Arms: arm 1: Esomeprazole 20 mg once daily
Interventions: intervention 1: Esomeprazole 20 mg
Intervention descriptions: intervention 1: Esomeprazole 20 mg once daily

Protocol documents:
Clinical trial NCT00614666
Conditions: Coccidioidomycosis
Keywords: coccidioidomycosis Valley Fever nikkomycin Z
Sponsor: University of Arizona
Start date: 2007-09-01; Completion date: 2009-09-01
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if nikkomycin Z is safe when administered at different dose levels for 14 days. The study will also determine blood levels and urinary excretion of nikkomycin Z in relation to dose administered. Patients with mild forms of Valley Fever pneumonia will be eligible to participate and will be allocated to receive treatment with nikkomycin Z (various doses) or a placebo. A secondary goal of this study is to evaluate the effectiveness and dose response of nikkomycin Z in an exploratory analysis.

Detailed description:
Every year there are 50,000 new U.S. cases of coccidioidomycosis (Valley Fever). The majority of these illnesses occur as a result of endemic exposure in Arizona and California. The benefits of antifungal therapy for uncomplicated disease are not currently established. Current therapies for serious and complicated forms of coccidioidomycosis are only partially effective and in themselves are unable to eradicate the fungus from sites of infection, commonly resulting in breakthrough infection and/or relapse. Nikkomycin Z is effective in the mouse model and results in improved microbiological response over fluconazole.

The goals of this study include: 1) Evaluating the safety and tolerance of nikkomycin Z following administration of multiple doses (50 mg Q 12 h to 750 mg Q 8 h) for two week and 2) Evaluating the pharmacokinetics of nikkomycin Z after single and multiple doses in relationship to dose. The study will include patients with uncomplicated Coccidioides pneumonia (mild illness) which will allow exploratory analysis of efficacy and dose response based on biomarkers.

Arms: arm 1: nikkomycin Z 50 mg BID x 14 days arm 2: nikkomycin Z nikkomycin Z 250 mg BID x 14 days arm 3: nikkomycin Z 500 mg BID x 14 days arm 4: nikkomycin Z 750 BID x 14 days arm 5: placebo BID x 14 days
Interventions: intervention 1: nikkomycin Z intervention 2: Placebo
Intervention descriptions: intervention 1: Stage I: Multiple rising doses. Doses packaged on a unit dose basis in 50 and 250 mg capsules. Subjects take 1-3 capsules per dosing block for 14 days unless ADE or study withdrawal. Dose escalation unless a dose-limiting adverse effect is noted. Subjects assigned to BID dosing will receive 28 doses and subjects assigned to TID dosing will receive 42 doses.

* 50 mg BID (n=4) vs placebo capsule BID (n=1)
* 50 mg BID (n=4) vs 250 mg BID (n=4) vs Placebo capsule BID (n=2)
* 250 mg BID (n=4) vs 500 mg BID (n=4) vs Placebo capsule BID (n=2)
* 500 mg BID (n=4) vs Placebo capsule BID (n=1)

At least 4 subjects complete lower dose before randomization includes next higher dose.

Stage II will be a single dose level selected based on pharmacodynamics and safety from Stage I for 20 additional subjects using 4:1 randomization. intervention 2: Placebo comparator

Protocol documents:
Clinical trial NCT00617604
Conditions: De Novo Kidney Transplantation
Keywords: kidney transplant alefacept
Sponsor: Astellas Pharma Inc
Start date: 2007-12-01; Completion date: 2009-09-01
Enrollment: 218 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether alefacept is effective and well tolerated when used with a combination of tacrolimus, mycophenolate mofetil and steroids versus a combination therapy of placebo, tacrolimus and steroids in the prevention of kidney transplant rejection.

Detailed description:

Arms: arm 1: Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment. arm 2: Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
Interventions: intervention 1: Alefacept intervention 2: placebo intervention 3: Tacrolimus intervention 4: Mycophenolate Mofetil intervention 5: Steroids
Intervention descriptions: intervention 1: IV and subcutaneous injection intervention 2: IV and subcutaneous injection intervention 3: The initial daily dose was 0.2 mg/kg orally given in 2 doses commencing 24 hours after completion of surgery. intervention 4: Mycophenolic mofetil was administered as 750 mg twice per day orally intervention 5: Methylprednisolone or equivalent:

Day 0: 500 - 1000 mg IV bolus Day 1: 125 - 250 mg IV bolus

Prednisone or equivalent:

Days 2 - 14: 20 - 30 mg orally Days 15 - 28: 10 - 20 mg orally Days 29 - 60: 10 - 15 mg orally Days 61 onwards: 5 - 10 mg orally

Protocol documents:
Clinical trial NCT00618436
Conditions: Traumatic Brain Injury Subarachnoid Hemorrhage
Keywords: Seizures Traumatic Brain Injury Subarachnoid Hemorrhage
Sponsor: University of Cincinnati
Start date: 2007-08-01; Completion date: 2009-09-01
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To show that the use of intravenous levetiracetam(LEV;Keppra)for seizure prevention in patients in the Neuroscience Intensive Care Unit will result in fewer side effects compared to the current standard of care anticonvulsant and will be at least as effective as the current standard of care in preventing clinical and sub-clinical seizure activity.

Detailed description:
To show that the use of intravenous levetiracetam(LEV;Keppra)for seizure prophylaxis in the Neuroscience Intensive Care Unit will result in fewer adverse effects compared to the current standard of care anticonvulsant(phenytoin) and will be at least as effective as phenytoin in preventing clinical and sub-clinical seizure activity.

Arms: arm 1: Group 1 - The levetiracetam (Keppra®) group will receive a loading dose of 20 mg/kg IV over 15 minutes (rounded to the nearest 250mg) up to a maximum of 2000 mg, then started on maintenance dose (1000 mg, IV BID)as prophylaxis for 7 days. arm 2: Group 2-The phenytoin group will receive a loading dose of 20 mg/kg IV to a maximum of 2000mg, then started on maintenance dose at 5 mg/kg/day (rounded to nearest 100mg dose, IV, divided into three doses a day) as prophylaxis for 7 days. Phenytoin levels are to be checked daily and dose adjusted as needed to maintain therapeutic levels of 10-20 µg/dL.
Interventions: intervention 1: Levetiracetam intervention 2: Phenytoin
Intervention descriptions: intervention 1: Levetiracetam group will receive a loading dose of 20 mg/kg IV(rounded to nearest 250mg) to a maximum of 2000mg, then started on maintenance dose (1000 mg,IV q 12h) as prophylaxis for seven days. intervention 2: The group will receive a loading dose of fosphenytoin 20 mg/kg IV to a maximum of 2000 mg, then started on maintenance dose of 5mg/kg/day, rounded to nearest 100mg dose, IV, q 12h for seven days.

Protocol documents:
Clinical trial NCT00619242
Conditions: Esophageal Cancer
Keywords: Esophageal cancer
Sponsor: University of Chicago
Start date: 2006-06-01; Completion date: 2009-09-01
Enrollment: 3 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To determine whether sorafenib is able to change pre-cancerous cells in a way that we believe is important in the progression of cancer.

Detailed description:
To characterize the effects of sorafenib on specific molecular markers in patients with Barrett's esophagus and high grade intraepithelial neoplasia (HGIN) or carcinoma in situ (CIS).

Arms: arm 1: sorafenib 2 tablets by mouth
Interventions: intervention 1: sorafenib
Intervention descriptions: intervention 1: 2 tablets with water by mouth twice a day for two weeks.

Protocol documents:
Clinical trial NCT00620061
Conditions: Opioid-Induced Bowel Dysfunction
Sponsor: Sucampo Pharma Americas, LLC
Start date: 2007-12-01; Completion date: 2009-09-01
Enrollment: 439 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the long-term safety and efficacy of lubiprostone administration in participants with opioid-induced bowel dysfunction.

Detailed description:

Arms: arm 1: Lubiprostone: 24 mcg capsule twice daily (BID) for 36 weeks
Interventions: intervention 1: Lubiprostone 24
Intervention descriptions: intervention 1: 24 mcg capsules for oral administration

Protocol documents:
Clinical trial NCT00623194
Conditions: Diabetes Diabetes Mellitus, Type 1
Sponsor: Novo Nordisk A/S
Start date: 2008-02-01; Completion date: 2009-09-01
Enrollment: 146 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This trial is conducted in Europe. The aim of this research is to assess the safety of continuous treatment with insulin detemir following participation in trial NN304-1689 (NCT00435019) on antibody development.

Detailed description:

Arms: arm 1: Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
Interventions: intervention 1: insulin detemir intervention 2: insulin aspart
Intervention descriptions: intervention 1: Treat-to-target dose titration scheme (individually adjusted), injection s.c. (under the skin), once or twice daily. intervention 2: Treat-to target dose titration scheme (individually adjusted), injection s.c. (under the skin), at larger meals.

Protocol documents:
Clinical trial NCT00626431
Conditions: Prostate Cancer
Keywords: Lupron Depot prostate cancer leuprolide acetate
Sponsor: Abbott
Start date: 2008-02-01; Completion date: 2009-09-01
Enrollment: 310 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To assess the efficacy and safety of 2 new formulations of leuprolide acetate 45 mg 6-month depot, Formulation A or Formulation B, for the treatment of patients with prostate cancer. A formulation will be deemed successful if the percentage of subjects with suppression of testosterone to \<= 50 ng/dL from Week 4 to Week 48 is not less than 87%, (the lower bound of the 2-sided 90% confidence interval), a protocol-specified criterion.

Detailed description:
A total of 300 male subjects were planned to be enrolled. Subjects were to receive a total of 2 intramuscular (IM) injections of the same formulation, either Formulation A or Formulation B, administered 24 weeks apart. The first 150 subjects were to receive Formulation A for both injections and the next 150 subjects were to receive Formulation B for both injections. The sponsor was to conduct an ongoing review of the primary endpoint data (suppression of testosterone \<= 50 ng/dL) and planned to stop enrollment of Formulation A or Formulation B, or not to administer the second injection of Formulation A or Formulation B, if 15 or more subjects did not achieve testosterone suppression by Week 4 or failed to maintain testosterone suppression during the treatment period.

All analyses and summaries were to be conducted separately for subjects who received Formulation A or Formulation B.

This study was to be conducted at approximately 60-80 investigative sites. Subjects participated in the trial for approximately 14 months.

This trial was to include a Screening Period (up to 4 weeks), a 12-month Treatment Period (two 6-month treatment cycles), and a Follow-Up Period (30 days).

Arms: arm 1: Leuprolide acetate 45 mg, 6-month depot arm 2: Leuprolide acetate, 45 mg, 6-month depot
Interventions: intervention 1: Leuprolide acetate - Formulation A intervention 2: Leuprolide acetate - Formulation B
Intervention descriptions: intervention 1: Leuprolide acetate was administered as 2 intramuscular (IM) injections of Formulation A, 45 mg 6 month depot, 24 weeks apart. intervention 2: Leuprolide acetate was administered as 2 intramuscular (IM) injections of Formulation B, 45 mg 6 month depot, 24 weeks apart.

Protocol documents:
Clinical trial NCT00630409
Conditions: Metastatic Renal Cell Carcinoma
Keywords: Renal cell carcinoma Kidney Cancer Gemcitabine Doxil Chemotherapy
Sponsor: University of Pittsburgh
Start date: 2004-09-01; Completion date: 2009-09-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to test the hypothesis that the combination of gemcitabine and doxil will have clinical activity in patients with metastatic renal cell carcinoma.

Detailed description:
Patients with metastatic renal cell carcinoma who have received prior therapy with sorafenib, sunitinib or temsirolimus and have progressive disease may participate in this study if all eligibility criteria are met. Doxil will be administered on day 1 and gemcitabine on day 1 and 8 of a 21 day cycle. Tumor responses will be evaluated by RECIST. Up to six cycles of study treatment may be administered. Cardiac ejection fraction will be monitored.

Arms: arm 1: Patients will receive 3 cycles of therapy as an outpatient. Each 21-day cycle of therapy will comprise: Gemcitabine: IV on days 1 and 8. Doxil: on day 1. Patients with either responding or stable disease will continue to receive additional 3 cycles of therapy with gemcitabine and Doxil until there is radiological evidence of disease progression or they are unable or unwilling to continue treatment.
Interventions: intervention 1: Gemcitabine intervention 2: Doxil
Intervention descriptions: intervention 1: 800 mg IV day 1 and 8 intervention 2: 24 mg/m2 every 21 days IV

Protocol documents:
Clinical trial NCT00631007
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 diabetes diabetes diabetes mellitus diabetes mellitus, type 2 non-TZD thiazolidinedione selective peroxisome proliferator-activated receptor gamma modulator SPPARM peroxisome proliferator-activated receptor gamma PPAR gamma insulin sensitizer glucose control endocrinopathy hypoglycemic agent sulfonylurea metformin pioglitazone nutritional and metabolic diseases
Sponsor: InteKrin Therapeutics, Inc.
Start date: 2008-02-01; Completion date: 2009-09-01
Enrollment: 367 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 24 week study comparing the efficacy of four dose levels of INT131 besylate with pioglitazone HCl in patients with type 2 diabetes. Eligible patients will be men and women (of non-childbearing potential or using dual barrier methods of contraception) between 30 and 75 years of age who are minimally responsive to treatment with sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy.

Detailed description:

Arms: arm 1: INT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone HCl. arm 2: INT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone HCl arm 3: INT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone HCl arm 4: INT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone HCl arm 5: pioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate arm 6: placebo administered once-daily, matching placebo to INT131 besylate and matching placebo to pioglitazone HCl
Interventions: intervention 1: INT131 besylate intervention 2: Pioglitazone HCl intervention 3: Placebo
Intervention descriptions: intervention 1: Once-daily, oral intervention 2: Once-daily, oral intervention 3: Once-daily, oral

Protocol documents:
Clinical trial NCT00631917
Conditions: Hypertension
Keywords: Hypertension, aliskiren, ramipril, colonoscopy
Sponsor: Novartis
Start date: 2008-02-01; Completion date: 2009-09-01
Enrollment: 774 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the long-term gastrointestinal (GI) safety and efficacy of aliskiren (300 mg) compared to ramipril (10mg) in patients ≥ 50 years with essential hypertension.

Detailed description:

Arms: arm 1: For the first 2 weeks of the study, participants received aliskiren 150 mg once a day and were then forced titrated to aliskiren 300 mg once a day for 52 weeks. Participants also received a placebo capsule to match ramipril once a day for the study duration. arm 2: For the first 2 weeks of the study participants received 5 mg ramipril orally once a day and were then forced titrated to ramipril 10 mg once a day for 52 weeks. Participants also received placebo to aliskiren for the duration of the study.
Interventions: intervention 1: Aliskiren intervention 2: Ramipril intervention 3: Placebo to Ramipril intervention 4: Placebo to Aliskiren
Intervention descriptions: intervention 1: Aliskiren 300 mg once a day intervention 2: Ramipril 10 mg once a day intervention 3: Placebo capsules to match ramipril. intervention 4: Placebo tablets to match aliskiren.

Protocol documents:
Clinical trial NCT00632814
Conditions: Hemophilia A
Keywords: Kogenate, Children, Factor VIII, Hemophilia A, Prophylactic
Sponsor: Bayer
Start date: 2007-06-01; Completion date: 2009-09-01
Enrollment: 32 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A prospective study to evaluate the effect of rFVIII-FS in different prophylactic regimens on bleeding events frequency and development of arthropathy in Previously Treated and Minimally treated Hemophilia A pediatric population.

Detailed description:

Arms: arm 1: rFVIII-FS (Octocog-alfa, antihemophilic factor \[recombinant\]) 70 IU/kg, dosing by injection once per week \[qw\] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week) arm 2: rFVIII-FS (Octocog-alfa, antihemophilic factor \[recombinant\]) 70 IU/kg, dosing by injection twice per week \[biw\] (30 IU/kg \[day 1\] + 40 IU/kg \[day 4\]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week) arm 3: rFVIII-FS (Octocog-alfa, antihemophilic factor \[recombinant\]) 75 IU/kg, dosing by injection three times per week \[tiw\] (3 x 25 IU/kg \[day 1, 3, 5\]) for 9 months. No escalation opportunity for participants in this group
Interventions: intervention 1: rFVIII-FS (Kogenate FS, BAY14-2222) 70 IU/kg, dosing once per week intervention 2: rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg twice per week (30 IU/kg + 40 IU/kg) intervention 3: rFVIII-FS (Kogenate FS, BAY14-2222) 75 IU/kg, dosing three times per week (3 x 25 IU/kg)
Intervention descriptions: intervention 1: rFVIII-FS (Octocog-alfa, antihemophilic factor \[recombinant\]) 70 IU/kg, dosing by injection once per week (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week) intervention 2: rFVIII-FS (Octocog-alfa, antihemophilic factor \[recombinant\]) 70 IU/kg, dosing by injection twice per week (30 IU/kg \[day 1\] + 40 IU/kg \[day 4\]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week) intervention 3: rFVIII-FS (Octocog-alfa, antihemophilic factor \[recombinant\]) 75 IU/kg, dosing by injection three times per week (3 x 25 IU/kg \[day 1, 3, 5\]) for 9 months. No escalation opportunity for patients in this group

Protocol documents:
Clinical trial NCT00636636
Conditions: Neuralgia,Postherpetic
Keywords: Postherpetic Neuralgia (PHN), shingles
Sponsor: Depomed
Start date: 2008-03-01; Completion date: 2009-09-01
Enrollment: 452 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Gabapentin and pregabalin are treatments for some types of neuropathic pain, including postherpetic neuralgia (PHN). However, these treatments usually need to be taken 3 times a day for effective pain control. The purpose of this study is to determine whether a new gabapentin tablet, which only needs to be taken once a day, is safe and effective for the treatment of postherpetic neuralgia.

Detailed description:
The primary study objective is to assess the relative efficacy of G-ER dosed once daily (1800 mg following the evening meal), versus placebo in reducing the mean daily pain score from the baseline week to the end of the efficacy treatment period (Treatment Week 10) in patients with PHN.

Secondary efficacy measures will include changes from baseline in mean weekly sleep interference scores, Short-Form McGill Pain Questionnaire (SF-MPQ), the Neuropathic Pain Scale (NPS), Brief Pain Inventory (BPI), Patient Global Impression of Change (PGIC), and Investigator-Rated Clinical Global Impression of Change (CGIC).

Arms: arm 1: Gabapentin - Extended Release arm 2: Sugar pill
Interventions: intervention 1: Gabapentin Extended Release tablets intervention 2: Placebo
Intervention descriptions: intervention 1: Once-Daily; 300 mg and 600 mg tablets intervention 2: Once daily; 300 mg and 600 mg tablets

Protocol documents:
Clinical trial NCT00638456
Conditions: Eosinophilic Esophagitis
Keywords: Eosinophils Esophagitis Microscopy
Sponsor: Ranjan Dohil
Start date: 2008-02-01; Completion date: 2009-09-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to evaluate whether or not oral viscous budesonide is effective in treating children with Eosinophilic Esophagitis.

Detailed description:

Arms: arm 1: oral viscous budesonide plus Prevacid arm 2: placebo plus Prevacid
Interventions: intervention 1: Budesonide plus Prevacid intervention 2: placebo plus Prevacid
Intervention descriptions: intervention 1: Budesonide is taken daily for three months. In addition, Prevacid is taken twice daily for three months. intervention 2: Placebo is taken daily for three months. In addition, Prevacid is taken twice daily for three months.

Protocol documents: