ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01336140
Conditions: Patients With Severe Chronic Kidney Disease Being Evaluated With Nuclear Stress Testing of the Heart Using the Stress Agent Regadenoson
Keywords: regadenoson chronic kidney disease renal failure lexiscan aminophylline SPECT Myocardial Perfusion Imaging pharmacologic stress test Patients with stage IV or V chronic kidney disease being assessed with nuclear stress testing of the heart using the stress agent regadenoson (Lexiscan ®)
Sponsor: Rush University Medical Center
Start date: 2011-06-01; Completion date: 2012-05-01
Enrollment: 300 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The routine administration of 75 mg of intravenous aminophylline in patients with severe chronic kidney disease undergoing a nuclear stress test with regadenoson (Lexiscan®) can reduce or eliminate the incidence of diarrhea and other side effects related to regadenoson.

Detailed description:
Approximately 300 patients with severe chronic kidney disease who are referred for a nuclear stress testing of the heart with regadenoson (Lexiscan®) will be recruited to participate in the study. Following regadenoson (administered as part of a stress routine test protocol) participants will receive either aminophylline (75 mg - intravenously) or a matching inactive placebo (sterile salt water) injection. Participants will be surveyed for gastrointestinal symptoms and other side effects related to regadenoson. The frequency and severity of such side effects will be compared between the two study groups (aminophylline vs. placebo).

Arms: arm 1: 75 mg of intravenous aminophylline. arm 2: Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
Interventions: intervention 1: Aminophylline intervention 2: Placebo
Intervention descriptions: intervention 1: 75 mg of intravenous aminophylline intervention 2: Matching 0.9 Normal Saline (sterile salt water)administered intravenously.

Protocol documents:
Clinical trial NCT01340066
Conditions: Urinary Incontinence
Keywords: urinary incontinence stress incontinence urge incontinence mixed incontinence
Sponsor: Beech Tree Labs, Inc.
Start date: 2011-04-01; Completion date: 2012-05-01
Enrollment: 94 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if a new drug treatment is effective for the treatment of symptoms of urinary incontinence.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: UISH001 intervention 2: matching placebo
Intervention descriptions: intervention 1: sublingual dosing, 1 drop 3 times a day intervention 2: sublingual dosing,1 drop 3 times a day

Protocol documents:
Clinical trial NCT01341470
Conditions: Healthy Volunteer
Sponsor: Eli Lilly and Company
Start date: 2011-05-01; Completion date: 2012-05-01
Enrollment: 47 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety and tolerability of single and multiple doses of LY2495655 administered subcutaneously and intravenously in Japanese subjects.

Detailed description:

Arms: arm 1: Single 70 milligram (mg) dose LY2495655 administered intravenously (IV) arm 2: 17.5 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses) arm 3: 140 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 doses) arm 4: 420 mg dose of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 doses) arm 5: Single Placebo dose administered intravenously (IV) arm 6: Placebo dose administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses)
Interventions: intervention 1: LY2495655 intervention 2: Placebo
Intervention descriptions: intervention 1: administered intravenously or subcutaneously intervention 2: administered intravenously or subcutaneously

Protocol documents:
Clinical trial NCT01342757
Conditions: Adult Glioblastoma Depression Recurrent Adult Brain Tumor
Sponsor: National Cancer Institute (NCI)
Start date: 2010-12-01; Completion date: 2012-05-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This clinical trial is studying magnetic resonance spectroscopy imaging in predicting response in patients to vorinostat and temozolomide in patients with recurrent, progressive, or newly diagnosed glioblastoma. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Vorinostat may also help temozolomide work better by making tumor cells more sensitive to the drug. Imaging procedures, such as magnetic resonance spectroscopy imaging, may help measure the patient's response to vorinostat and temozolomide and allow doctors to plan better treatment.

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate the strength of the association between magnetic resonance spectroscopy (MRS) imaging measurable biomarkers and response to vorinostat plus temozolomide.

SECONDARY OBJECTIVES:

I. To evaluate MRS-detected inositol and N-acetylaspartate (NAA) levels (at 3 tesla) as indicators of mood alterations as measured by a self-report depression survey (IDS-SR).

OUTLINE:

Patients receive vorinostat orally (PO) once daily (QD) on days -7 to -1 (course 1 only) and days 8-14 and 22-28 and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients previously treated with standard radiotherapy and temozolomide receive maintenance temozolomide PO on days 1-5.

Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicities. Patients undergo magnetic resonance spectroscopy imaging at baseline and at approximately 1 and 8 weeks on treatment. Patients also undergo an Inventory of Depression Symptomatology Self-Reported (IDS-SR) assessment at baseline and periodically during study.

Arms: arm 1: Patients receive vorinostat once daily on days -7 to -1 (course 1 only) and days 8-14 and 22-28 and temozolomide on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients undergo magnetic resonance spectroscopic imaging at baseline and at approximately 1 and 8 weeks on treatment. Patients also undergo a survey administration of Inventory of Depression Symptomatology Self-Reported (IDS-SR) assessment at baseline and periodically during study.
Interventions: intervention 1: vorinostat intervention 2: temozolomide intervention 3: magnetic resonance spectroscopic imaging intervention 4: survey administration
Intervention descriptions: intervention 1: Given orally intervention 2: Given orally intervention 3: Undergo MRI intervention 4: Ancillary studies

Protocol documents:
Clinical trial NCT01345162
Conditions: Hernia
Keywords: Herniotomy
Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Start date: 2010-03-01; Completion date: 2012-05-01
Enrollment: 200 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the study is the assessment and management of Acute Post-herniotomy Pain using two different therapeutical protocols per os: ketorolac versus association of acetaminophene+tramadol.

Detailed description:
Persistent post-herniotomy pain (PPP) affects everyday activities in 5-10% of patients. Even brief intervals of acute pain can induce long-term neuronal remodeling and sensitization, chronic pain and lasting psychological distress. Chronic pain may be caused by intense acute PPP, intraoperative nerve injury and/or ongoing inflammation or mesh response with subsequence damage to nerve structures. The aim of our study is to analyze analgesic efficacy, safety and prevention of persistent postsurgical pain of two different pharmacological strategies.

Arms: arm 1: Patients will be given intraoperative analgesia with Ketorolac and tramadol before the the end of surgery, then Ketorolac postoperative 10mg 1cp x 3/die, from the day of surgery for 4 days after surgery. arm 2: Patients will be given intraoperative analgesia with Ketorolac and tramadol before the the end of surgery, then postoperative Patrol (acetaminophene 325mg+tramadol 37,5mg) 1cp x 3/die for 4 days after surgery.
Interventions: intervention 1: Ketorolac postoperative intervention 2: postoperative Patrol intervention 3: intraoperative analgesia intervention 4: intraoperative analgesia
Intervention descriptions: intervention 1: Ketorolac 10mg 1cp x 3/die intervention 2: acetaminophene 325mg+tramadol 37.5mg, 1cp x 3/die intervention 3: ketorolac 30 mg iv intervention 4: Tramadol 100 mg if Weight over 50 kg, 50 mg if weight below 50 kg

Protocol documents:
Clinical trial NCT01347879
Conditions: Acne Vulgaris
Keywords: Acne vulgaris PDT
Sponsor: Photocure
Start date: 2011-05-01; Completion date: 2012-05-01
Enrollment: 153 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is intended to evaluate the efficacy and safety of Visonac Photodynamic Therapy (PDT) in patients with severe acne, score 4 on global IGA scale. The null hypothesis is that Visonac PDT is equal to vehicle PDT against the alternative hypothesis that Visonac PDT is different compared to vehicle PDT at week 12.

Detailed description:

Arms: arm 1: active treatment with light dose of 37 Joule/cm2 arm 2: Placebo treatment, Light dose 37 Joule/cm2
Interventions: intervention 1: Visonac PDT intervention 2: Vehicle cream with PDT
Intervention descriptions: intervention 1: cream application prior to illumination with red light intervention 2: placebo/vehicle cream application prior to illumination with red light

Protocol documents:
Clinical trial NCT01348763
Conditions: HIV
Keywords: HIV
Sponsor: Imperial College London
Start date: 2011-10-01; Completion date: 2012-05-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase I, open label, prospective, two phase pharmacokinetic study. Subjects currently attending for HIV care at St. Mary's Hospital, London will be eligible.

Detailed description:
The study will describe the steady state pharmacokinetic parameters and short term safety of maraviroc/darunavir/ritonavir dosed at 150/800/100 mg once daily with and without tenofovir/emtricitabine 245/200 mg once daily in HIV-1 infected subjects.

Fifteen HIV-1 infected subjects will be recruited. Eligible subjects will currently be receiving antiretroviral therapy comprising:

* tenofovir/emtricitabine 245/200 mg daily plus
* darunavir/ritonavir 800/100 mg daily

On day 1, subjects will modify their current antiretroviral therapy to the following:

* tenofovir/emtricitabine 245/200 mg daily plus
* darunavir/ritonavir 800/100 mg daily plus
* maraviroc 150 mg daily On day 10 subjects will undergo an intensive pharmacokinetic visit.

On day 11, subjects will modify their current antiretroviral therapy to the following:

* darunavir/ritonavir 800/100 mg daily plus
* maraviroc 150 mg daily (i.e. tenofovir/emtricitabine will be discontinued) On day 20 subjects will undergo an intensive pharmacokinetic visit. Following completion of this study phase, subjects will recommence their usual antiretroviral treatment regimen and attend for a study follow up visit.

Arms: arm 1: Participants will be taking Truvada, Darunavir/r before entering the study. On day 1 they will add maraviroc then on day 11 they will stop the Truvada
Interventions: intervention 1: Maraviroc intervention 2: Truvada intervention 3: Darunavir
Intervention descriptions: intervention 1: Maraviroc 150 mg daily intervention 2: daily until 10. day then stop intervention 3: daily until 10. day then stop

Protocol documents:
Clinical trial NCT01350583
Conditions: Neoplasm Related Pain (Acute) (Chronic)
Keywords: tumor related pain
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Start date: 2010-08-01; Completion date: 2012-05-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to:

* Determine how well people tolerated sodium bicarbonate taken by mouth in higher doses than those usually given for heartburn.
* Determine if sodium bicarbonate can reduce cancer-related pain. Right now, the investigators do not know for sure if these higher doses will be well tolerated or if they will reduce the pain associated with cancer. The investigators are doing this study to see if sodium bicarbonate is well tolerated and if it can reduce the requirements for pain medications.

Detailed description:
The study is a single institution, non-randomized, single arm pilot study to evaluate the efficacy of adjuvant therapy with sodium bicarbonate for tumor related pain. Patients will receive sodium bicarbonate (0.15 g/kg/day for 1 weeks and if tolerated 0.3 g/kg/day for one week and if this dose is tolerated 0.6 g/kg/day) for 4 weeks. The sodium bicarbonate will be provided to the patient as a powder and consumed after it is mixed with about 250 cc (about 1 cup) of water. In consultation with the PI, the patients will be permitted to mix the sodium bicarbonate with a commercially available drink instead of water provided the liquid has an acid/base balance (pH) of 7.4 or greater. Patients with a good tolerance to study therapy and with at least a 30% improvement in pain intensity (by VAS) compared to baseline after 3 weeks of therapy and who wish to continue study therapy will be allowed to continue sodium bicarbonate therapy under the direction of their treating physician. Patients without at least a 30% improvement in pain intensity at 3 weeks will discontinue study therapy.

Arms: arm 1: Dose Escalation
Interventions: intervention 1: Sodium Bicarbonate (NaHCO3)
Intervention descriptions: intervention 1: Treatment consisted of 0.15 g/kg/day Sodium Bicarbonate (NaHCO3) increasing to 0.3 g/kg/day after 1 week if well tolerated. Further dose increment to 0.6 g/kg/day was to be done after 2 weeks of starting sodium bicarbonate if prior dose levels were well tolerated.

Protocol documents:
Clinical trial NCT01358760
Conditions: Vaginal Atrophy
Keywords: Vulvar/vaginal atrophy Atrophic Vaginitis Dehydroepiandrosterone DHEA Prasterone Vaginorm Menopause Intrarosa
Sponsor: EndoCeutics Inc.
Start date: 2011-06-01; Completion date: 2012-05-01
Enrollment: 450 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this Phase III trial is to evaluate the efficacy of intravaginal dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Placebo intervention 2: DHEA intervention 3: DHEA
Intervention descriptions: intervention 1: Placebo vaginal suppository intervention 2: Vaginal suppository containing 0.25% (3.25 mg) DHEA intervention 3: Vaginal suppository containing 0.5% (6.5 mg) DHEA

Protocol documents:
Clinical trial NCT01370603
Conditions: Hypercholesterolemia
Sponsor: Organon and Co
Start date: 2011-09-01; Completion date: 2012-05-01
Enrollment: 328 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine whether ezetimibe/atorvastatin 10 mg/40 mg combination tablet is equivalent to the coadministration of ezetimibe 10 mg and atorvastatin 40 mg in lowering low-density-lipoprotein-cholesterol (LDL-C) after 6 weeks of treatment.

Detailed description:

Arms: arm 1: Medication will be administered in a double dummy fashion as 3 tablets orally on a daily basis, including 10 mg ezetimibe, 40 mg atorvastatin, and placebo to ezetimibe/atorvastatin. arm 2: Medication will be administered in a double dummy fashion as 3 tablets orally on a daily basis, including ezetimibe/atorvastatin 10 mg/40 mg, placebo to ezetimibe, and placebo to atorvastatin.
Interventions: intervention 1: Atorvastatin intervention 2: Ezetimibe intervention 3: Ezetimibe/atorvastatin intervention 4: Placebo to atorvastatin intervention 5: Placebo to ezetimibe intervention 6: Placebo to ezetimibe/atorvastatin
Intervention descriptions: intervention 1: 40 mg tablet administered orally once daily intervention 2: 10 mg tablet administered orally once daily intervention 3: Ezetimibe/atorvastatin 10 mg/40 mg combination tablet administered orally once daily intervention 4: Administered orally once daily intervention 5: Administered orally once daily intervention 6: Administered orally once daily

Protocol documents:
Clinical trial NCT01376557
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes mellitus
Sponsor: Lexicon Pharmaceuticals
Start date: 2011-06-01; Completion date: 2012-05-01
Enrollment: 299 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is intended to assess the effect on HbA1c of different dose regimens of LX4211 in combination with metformin in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control on metformin monotherapy.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: 75 mg LX4211 intervention 2: 200 mg LX4211 intervention 3: 400 mg LX4211 intervention 4: 200 mg LX4211 intervention 5: Placebo
Intervention descriptions: intervention 1: Subjects will receive 75 mg LX4211 once daily intervention 2: Subjects will receive 200 mg LX4211 once daily. intervention 3: Subjects will receive 400 mg LX4211 once daily. intervention 4: Subjects will receive 200 mg LX4211 twice daily. intervention 5: Subjects will receive placebo once daily.

Protocol documents:
Clinical trial NCT01382225
Conditions: Dry Eye Syndrome
Keywords: Dry eyes Ocular discomfort
Sponsor: Alcon Research
Start date: 2011-07-01; Completion date: 2012-05-01
Enrollment: 1936 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to determine if Sodium Hyaluronate, 0.18% is effective in treating the signs and symptoms of dry eye disease.

Detailed description:

Arms: arm 1: Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days arm 2: Inactive ingredients, 1-2 drops instilled in each eye 3-6 times a day for 14 days
Interventions: intervention 1: Sodium Hyaluronate Ophthalmic Solution, 0.18% intervention 2: Vehicle
Intervention descriptions: intervention 1: None intervention 2: Inactive ingredients used as run-in and placebo comparator

Protocol documents:
Clinical trial NCT01396187
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes safety multiple dose intravenous
Sponsor: Pfizer
Start date: 2011-07-01; Completion date: 2012-05-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a trial in subjects with Type 2 diabetes mellitus to study the safety, tolerability and pharmacokinetics of multiple ascending doses of PF-05231023.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: PF-05231023 intervention 2: PF-05231023 intervention 3: PF-05231023 intervention 4: PF-05231023 intervention 5: Placebo
Intervention descriptions: intervention 1: 5 mg IV twice a week for 4 weeks intervention 2: 25 mg IV twice a week for 4 weeks intervention 3: 100 mg IV twice a week for 4 weeks intervention 4: 200 mg IV twice a week for 4 weeks intervention 5: 0.9% w/v sodium chloride injection, United States Pharmacopeia (USP), twice a week IV for 4 weeks

Protocol documents:
Clinical trial NCT01401322
Conditions: Leukemia Relapsed Adult Acute Lymphocytic Leukemia
Sponsor: Stanford University
Start date: 2011-01-01; Completion date: 2012-05-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Time-to-Progression (TTP)

Detailed description:
Determine the time-to-progression (TTP) for subjects with relapsed/refractory acute lymphoblastic leukemia (ALL) receiving single agent lenalidomide 50 mg/day for 28 days/cycle.

Arms: arm 1: Lenalidomide 50 mg daily for 28 consecutive days every 42 days (+/-7 days). Treatment to continue until evidence of disease progression or development of unexpected toxicities not reversed by dose reductions and/or interruptions.
Interventions: intervention 1: Lenalidomide
Intervention descriptions: intervention 1: 50 mg; po

Protocol documents:
Clinical trial NCT01428583
Conditions: Chronic Noncancer Pain
Keywords: Chronic noncancer pain oxycodone naltrexone
Sponsor: Pfizer
Start date: 2010-12-01; Completion date: 2012-05-01
Enrollment: 395 participants; Allocation: ; Intervention model: 

Brief summary:
The study will provide information to assess the benefits versus risks of extended exposure to oxycodone HCl and naltrexone HCl extended-release capsules in a chronic noncancer pain population.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: oxycodone HCl and naltrexone HCl extended-release capsules
Intervention descriptions: intervention 1: Daily dose range of 20 mg to 160 mg of the oxycodone component in a 24 hour time interval, administered twice daily approximately 12 hours apart (At the discretion of the Investigator, oxycodone HCl and naltrexone HCl extended-release capsules may be administered once daily, at 24 hour intervals.)

Protocol documents: