ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00659646
Conditions: Diabetic Foot Ulcer
Keywords: Diabetes ulcers ulcerations infection
Sponsor: Innocoll
Start date: 2008-04-01; Completion date: 2010-02-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether the gentamicin-collagen sponge when combined with standard daily wound care and an oral antibiotic (levofloxacin) is safe and effective in treating moderately infected skin ulcers compared to treatment only with standard daily wound care and an oral antibiotic (levofloxacin).

Detailed description:
Infected skin ulcers with diabetes can be very debilitating because they are difficult to heal. Diabetic ulcers are responsible for frequent health care visits, and are a major predictor of amputation. Diabetic ulcers can be caused by a patient's inability to sense pain or warmth as well as peripheral vascular disease, which causes diminished blood flow to the foot. Early aggressive treatment is necessary to treat infection and ultimately prevent the need for amputation.

Gentamicin is an antibiotic that is effective in treating certain kinds of infection. Collagen is a protein that is found in all mammals. The gentamicin-collagen sponge is a thin flat sponge made out of collagen that comes from cow tendons and containing gentamicin. When applied to an open ulcer, the collagen breaks down and the gentamicin is released into the ulcer, but very little is absorbed into the blood stream. The high levels of gentamicin in the open infected ulcer may help treat the infection.

In this study, all subjects will be given the necessary supplies and taught how to take care their foot ulcer. All subjects will also receive oral an antibiotic (levofloxacin). Additionally, subjects who are randomly assigned to receive the gentamicin-collagen sponge will place a gentamicin-collagen sponge on their ulcer during daily wound care.

Arms: arm 1: Gentamicin sponge applied into wound plus levofloxacin, 750 mg by mouth (po) or intravenous (IV) every 24 hours or, if ulcer culture results show resistance to levofloxacin, alternative antimicrobial therapy as determined by susceptibility testing arm 2: Levofloxacin, 750 mg po or IV every 24 hours or, if ulcer culture results show resistance to levofloxacin, alternative antimicrobial therapy as determined by susceptibility testing
Interventions: intervention 1: gentamicin-collagen sponge and levofloxacin intervention 2: Levofloxacin only
Intervention descriptions: intervention 1: Topical Gentamicin Collagen Sponge: 10 × 10 cm in size And 750 mg tablet po every 24 hours or 750 mg IV administered by slow infusion over 90 minutes every 24 hours. intervention 2: levofloxacin, 750 mg tablet po every 24 hours or 750 mg IV administered by slow infusion over 90 minutes every 24 hours

Protocol documents:
Clinical trial NCT00661089
Conditions: Post-stroke Shoulder Pain and Spasticity
Keywords: stroke shoulder pain spasticity
Sponsor: Shirley Ryan AbilityLab
Start date: 2003-09-01; Completion date: 2010-02-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate whether botulinum toxin type A injected into muscles around the shoulder is effective in treating shoulder pain and improving function in patients with shoulder pain and involuntary muscle tightness after a stroke.

Detailed description:
Subjects with shoulder pain and spasticity at the shoulder following a stroke resulting in hemiplegia are eligible for participation. Following an initial screening visit involving a history and physical examination, subjects will be entered in to the study if they have significant spasticity of shoulder internal rotation/adduction associated with pain rated at least a 4 on the VAS for pain. Subjects will also be given a cognitive screening in which they will be asked to rate pain in hypothetical situations.

Shoulder pain is a frequent complication following hemiplegic stroke, and may result in further disability. Spasticity is also a complication following stroke . Botulinum toxin is used in the treatment of post-stroke spasticity and may also have pain modulating effects. Participants in this study will be asked to make total of 6 visits over a period of approximately 13 weeks. Eligible subjects will be randomized to 100 to 200 units of botulinum toxin type injected into the pectoralis major at the second visit. If there is significant spasticity for shoulder extension, subjects will also receive injections into the teres major. Subjects will be followed up with assessments of pain, functioning, active and passive range of motion and depression following the initial injection. At the 12 weeks post injection visit, the blinding will be broken and subjects initially injected with placebo will be injected with the active drug. This will be done to give all subjects an opportunity to receive the active drug, as well as to assess the effects of any differences with delayed treatment. All subjects will return 4 weeks later to repeat the same assessments above. Subjects will be called at one year post study enrollment for repeat pain ratings and for information regarding subsequent treatments.

.

Arms: arm 1: Injection of Botulinum Toxin type A - onabotulinumtoxinA into specified shoulder muscles at second visit arm 2: Injection of saline into specified shoulder muscles at Visit 2. Blind broken and subjects were offered study drug if initially in the placebo group, at week 12
Interventions: intervention 1: Botulinum Toxin Type A - OnabotulinumtoxinA intervention 2: Placebo (Saline)
Intervention descriptions: intervention 1: 100-200 units injected into the pectoralis major. The teres major may also be injected if tone is noted in shoulder extensors. intervention 2: Equivalent volume of saline without study drug injected into the pectoralis major. Teres major was also injected if tone noted in the shoulder extensors.

Protocol documents:
Clinical trial NCT00666718
Conditions: Diabetes Mellitus, Type 2
Sponsor: Eli Lilly and Company
Start date: 2008-04-01; Completion date: 2010-02-01
Enrollment: 374 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to look at if a basal bolus regimen of insulin lispro protamine suspension (ILPS) provides the same glycemic control as a basal bolus regimen of insulin glargine (when one basal bolus regimen is injected once daily together with insulin lispro injected 2-3 times daily).

Detailed description:

Arms: arm 1: Glargine plus Insulin Lispro (2-3 injections) arm 2: Insulin Lispro Protamine Suspension (ILPS) plus Insulin Lispro (2-3 injections)
Interventions: intervention 1: Insulin Glargine intervention 2: Insulin Lispro Protamine Suspension (ILPS) intervention 3: Insulin Lispro
Intervention descriptions: intervention 1: patient glucose-level dependent, injection, once daily in the evening, 24 weeks intervention 2: patient glucose-level dependent, injection, once daily in the evening, 24 weeks intervention 3: subcutaneous injections prior to meals, 24 weeks

Protocol documents:
Clinical trial NCT00674700
Conditions: Allergic Rhinitis
Keywords: House dust mites allergy
Sponsor: Stallergenes Greer
Start date: 2007-10-01; Completion date: 2010-02-01
Enrollment: 509 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the efficacy of two doses of sublingual immunotherapy (SLIT) administered as allergen-based tablets once daily over a period of 12 months compared to placebo, for reduction of allergic rhinitis symptoms and rescue medication usage

Detailed description:
Allergic rhinitis is a high-prevalence disease in many developed countries, affecting about 10 to 20% of the general population. House dust mite allergens are known to cause perennial allergic rhinitis.

In designing the present study, the guidelines proposed by the World Allergy Organization (WAO) task force for methodology of immunotherapy studies have been taken into consideration.

After a 2-month screening period, patients will be administered the dose of 300 IR- or 500 IR-house dust mite allergen-based tablets or placebo for a period of 12 months. The carry-over effect will be evaluated after a treatment-free follow up period of 12 months.

Arms: arm 1: 300 IR house dust mites allergen extract tablet arm 2: 500 IR house dust mites allergen extract tablet arm 3: Placebo tablet
Interventions: intervention 1: 300 IR house dust mites allergen extract tablet intervention 2: 500 IR house dust mites allergen extract tablet intervention 3: Placebo tablet
Intervention descriptions: intervention 1: One sublingual tablet daily for one year intervention 2: One sublingual tablet daily for one year intervention 3: One sublingual tablet daily for one year

Protocol documents:
Clinical trial NCT00677352
Conditions: Panic Disorder
Keywords: Panic Disorder
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2008-05-01; Completion date: 2010-02-01
Enrollment: 321 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy and safety of sertraline compared to paroxetine in patients with panic disorder.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: sertraline intervention 2: Paroxetine
Intervention descriptions: intervention 1: dosage : 25mg , 50mg , placebo; dosage form : tablet; frequency : once daily after dinner; duration : 14 weeks intervention 2: dosage : 10mg, placebo; dosage form : capsule; frequency : once daily after dinner; duration : 14 weeks

Protocol documents:
Clinical trial NCT00695565
Conditions: Painful Diabetic Neuropathy
Sponsor: Arcion Therapeutics Inc
Start date: 2008-05-01; Completion date: 2010-02-01
Enrollment: 180 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether ARC-4558 is effective in managing pain associated with painful diabetic neuropathy.

Detailed description:

Arms: arm 1: Placebo Gel is vehicle without clonidine arm 2: Clonidine Topical Gel contains 0.1% clonidine hydrochloride
Interventions: intervention 1: Placebo Gel intervention 2: Clonidine Topical Gel (ARC-4558)
Intervention descriptions: intervention 1: TID x 12 weeks intervention 2: TID x 12 weeks

Protocol documents:
Clinical trial NCT00698581
Conditions: Epilepsy
Keywords: Epilepsy; Monotherapy Partial Onset Seizures Adults and Adolescents
Sponsor: UCB Pharma
Start date: 2008-08-01; Completion date: 2010-02-01
Enrollment: 88 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Antiepileptic drugs (AEDs) are the main treatment for epilepsy; however, only a limited number of AEDs are approved for use as monotherapy. The objective of this study is to evaluate the efficacy of Brivaracetam (BRV) in the conversion of partial onset seizure patients from combination treatment to monotherapy

Detailed description:

Arms: arm 1: 50 mg/day arm 2: 100 mg/day
Interventions: intervention 1: Brivaracetam intervention 2: Brivaracetam
Intervention descriptions: intervention 1: 25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg \> 20 mg) for subjects not participating in the follow-up study) intervention 2: 25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg \> 50 mg \> 20 mg) for subjects not participating in the follow-up study)

Protocol documents:
Clinical trial NCT00698841
Conditions: Advanced Cancer
Sponsor: Eli Lilly and Company
Start date: 2009-02-01; Completion date: 2010-02-01
Enrollment: 79 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether corrected QT (QTc) interval changes occur on an electrocardiogram (ECG) when cetuximab is administered to the study population.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Cetuximab
Intervention descriptions: intervention 1: Cetuximab administered by intravenous (IV) infusion at an initial dose of 400 mg/m\^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m\^2 over 60 minutes.

Protocol documents:
Clinical trial NCT00705341
Conditions: Asthma
Keywords: Normal Controls
Sponsor: Johns Hopkins Bloomberg School of Public Health
Start date: 2009-01-01; Completion date: 2010-02-01
Enrollment: 219 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this research is to evaluate the methacholine challenge test as an accurate indicator of asthma in patients receiving treatment for asthma. Phase 1 on the study compares methacholine challenge test results from asthma patients to those from people who do not have asthma. In phase 2, test results for people with asthma on low dose inhaled corticosteroid will be compared to results on high dose inhaled corticosteroids. Both males and females with stable asthma (asthma participants) and without asthma (controls) enrolled. Participants will be between 12 and 69 years of age.

Detailed description:
The study consists of two phases. The first phase is a cross-sectional, case-control study measuring the sensitivity and specificity of methacholine challenge testing for differentiating asthmatic participants from non-asthmatic controls. The second phase is a cross-over, randomized, double-masked trial designed to evaluate the impact of high dose versus low dose inhaled corticosteroids (ICS) on bronchial hyperreactivity (BHR) in asthmatics.

Arms: arm 1: For people with asthma, fluticasone at 250 mcg per day; phase 2 of study arm 2: For people with asthma, fluticasone at 1000 mcg per day; phase 2 of study arm 3: People without asthma will be enrolled to perform 1 methacholine challenge test in phase 1 of the study arm 4: People with asthma will be enrolled to perform 1 methacholine challenge test in phase 1 of the study
Interventions: intervention 1: fluticasone
Intervention descriptions: intervention 1: Inhaled corticosteroid approved for treatment of asthma

Protocol documents:
Clinical trial NCT00707161
Conditions: Cancer Melanoma
Sponsor: University of Utah
Start date: 2005-09-01; Completion date: 2010-02-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The study is a prospective phase II trial of radiation therapy concurrent with cisplatin chemotherapy in the treatment of locally advanced or metastatic melanoma in patients who are deemed to require radiation therapy by treating physicians for purposes of local control or palliation. Eligibility criteria include pathologically confirmed melanoma. Patients will undergo radiation therapy (20 treatments of 2.5 Gy for a total of 50 Gy) concurrent with cisplatin chemotherapy.

Detailed description:
This is a phase II, prospective trial designed to determine the response rate achieved with cisplatin delivered concurrent with radiation therapy in locally advanced or metastatic melanoma.

Radiation therapy will be delivered concurrent with cisplatin chemotherapy as outlined in table 2. Radiation therapy dose will be 50 Gy (2.5 Gy per day, 5 days per week, for 20 treatments). Cisplatin dose will be 100 mg/m2 given i.v. every 3 weeks for a total of 2 doses (days 1 and 22) during radiation.

Surgical resection of residual (or recurrent) melanoma for cure or for palliation may be performed following chemoradiation if deemed appropriate by the treating physicians (surgical resection may be planned following pre-operative chemoradiation or may be performed for salvage due to inadequate response to chemoradiation or for relapse following chemoradiation). Surgical resection will not be performed until at least 4 weeks following chemoradiation (unless deemed emergent by the treating physicians).

If the patient's tumor has inadequate response to chemoradiation then salvage therapies can be used as deemed appropriate by the treating physicians. In order to allow adequate response to radiation therapy, salvage therapies will not be utilized until at least 4 weeks following chemoradiation unless deemed emergent by the treating physicians.

Arms: arm 1: None
Interventions: intervention 1: Radiation Therapy intervention 2: Cisplatin intervention 3: Surgical resection
Intervention descriptions: intervention 1: Radiation therapy will be delivered concurrent with cisplatin chemotherapy as outlined in table 2. Radiation therapy dose will be 50 Gy (2.5 Gy per day, 5 days per week, for 20 treatments). intervention 2: Cisplatin dose will be 100 mg/m2 given i.v. every 3 weeks for a total of 2 doses (days 1 and 22) during radiation. intervention 3: Surgical resection of residual (or recurrent) melanoma for cure or for palliation may be performed following chemoradiation if deemed appropriate by the treating physicians (surgical resection may be planned following pre-operative chemoradiation or may be performed for salvage due to inadequate response to chemoradiation or for relapse following chemoradiation). Surgical resection will not be performed until at least 4 weeks following chemoradiation (unless deemed emergent by the treating physicians).

Protocol documents:
Clinical trial NCT00708214
Conditions: Breast Neoplasms
Sponsor: Boehringer Ingelheim
Start date: 2007-01-01; Completion date: 2010-02-01
Enrollment: 28 participants; Allocation: NON_RANDOMIZED; Intervention model: 

Brief summary:
Progression-free rate after 16 weeks of BIBW 2992 administration in association with letrozole

Detailed description:

Arms: arm 1: To study BIBW 2992 in association with letrozole in hormonoresistant metastatic breast cancer arm 2: Hormonotherapy for metastatic breast cancer
Interventions: intervention 1: BIBW 2992 intervention 2: BIBW 2992 intervention 3: Letrozole intervention 4: Letrozole
Intervention descriptions: intervention 1: BIBW 2992 at high and medium dosages intervention 2: BIBW 2992 at high and medium dosages intervention 3: Letrozole at standard dosage intervention 4: Letrozole at standard dosage

Protocol documents:
Clinical trial NCT00720330
Conditions: Pain Nausea
Keywords: Inguinal Herniorrhaphy Pain assessment Outcomes
Sponsor: The Cleveland Clinic
Start date: 2008-07-01; Completion date: 2010-02-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators are conducting this study to find out if intravenous (injected through the vein) infusion of lidocaine and ketamine administered with general anesthesia is as effective as a paravertebral block in lessening pain after surgery and that both of these techniques are superior to general anesthesia alone in reducing pain immediately after surgery and in the long-term.

Detailed description:
Participants will be randomized into one of three study groups; Group 1 - Paravertebral Group - ropivacaine is injected near the spine before surgery. Midazolam and fentanyl are administered intravenously for sedation. Group 2 - Lidocaine/Ketamine - General anesthesia with lidocaine and ketamine administered intravenously throughout your surgery and for 60 minutes after surgery. Group 3 - General Anesthesia Alone. General anesthesia with placebo administered intravenously throughout surgery and for 60 minutes after surgery. All participants will rate their pain on a scale from 0 to 10 after surgery and on days 1 and 2 after surgery. Participants are called 3 and 6 months after surgery for pain and quality of life assessments

Arms: arm 1: Paravertebral Group - A local anesthetic (ropivacaine) will be injected near the spine before surgery. Participants will also receive midazolam and fentanyl intravenously (through your vein) for sedation arm 2: Participant will receive general anesthesia through the vein before surgery. Lidocaine and ketamine will be administered intravenously throughout surgery and for 60 minutes after surgery. arm 3: General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery
Interventions: intervention 1: ropivacaine intervention 2: Lidocaine/Ketamine intervention 3: placebo
Intervention descriptions: intervention 1: 10 ml 0.5% ropivacaine plus epinephrine will be injected at T11 and L1 as described above (20 ml total) using intravenous midazolam (1-2 mg) and fentanyl (0.5-1 mcg/kg) for sedation intervention 2: Patients will receive a general anesthetic consisting of intravenous induction with lidocaine (1.5 mg/kg), propofol (1.5-2.5 mg/kg), ketamine (0.25 mg/kg), fentanyl (1 mcg/kg), and midazolam (1-2 mg). intervention 3: placebo

Protocol documents:
Clinical trial NCT00727090
Conditions: Hyponatremia
Sponsor: Northwestern University
Start date: 2008-08-01; Completion date: 2010-02-01
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Conivaptan (Vaprisol) is FDA-Approved for the treatment of low serum sodium (hyponatremia), but there are few data in patients with neurologic disease. Very low serum sodium in patients with brain injury can be life-threatening and is associated with cerebral edema (swelling of brain tissue). This can be important in patients with brain hemorrhage, brain tumors, or stroke (cerebral infarction).

This is a pilot study to test the hypothesis that conivaptan (Vaprisol) leads to a greater increase in sodium than usual care. Patients will be randomly assigned to usual care or the lower FDA-approved dose of conivaptan (Vaprisol). We will track the use of other interventions, such as the use of hypertonic saline (concentrated salt solution), diuretics and salt tablets. A blinded co-investigator will record neurologic examination results (NIH Stroke Scale and Glasgow Coma Scale).

Detailed description:

Arms: arm 1: Conivaptan in addition to usual care at the discretion of the attending medical staff arm 2: Usual care by the attending physician staff
Interventions: intervention 1: Conivaptan
Intervention descriptions: intervention 1: Conivaptan 20 mg once, followed by conivaptan 20 mg over 24 hours

Protocol documents:
Clinical trial NCT00743106
Conditions: Partial Nephrectomy
Keywords: nephrectomy fenoldopam atrophic minimally functioning kidney
Sponsor: The Cleveland Clinic
Start date: 2002-09-01; Completion date: 2010-02-01
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial will study the effects of fenoldopam on renal function in patients who have a single kidney undergoing surgery to remove part of that kidney secondary to renal cell carcinoma. The investigators will monitor and evaluate throughout the perioperative course the kidney function. Normally kidney function is predicted to show a worsening followed by an improvement after surgery.

The investigators want to specifically identify if the use of fenoldopam lessens the injury to the kidney with this surgery.

Detailed description:
Prospective, randomized, blinded study-dividing patients into one of two groups: fenoldopam or placebo. The infusion will commence after placing the patient in a lateral/flex position during the operation. The infusion will continue for a total of 24 hours.Study time period will be approximately six weeks from the date of surgery. Specifically, the following pre- and post operative laboratory results will be recorded if available: . Basic metabolic panel - pre-op, post op days 1, 2, 3, 4, and 6 weeks

* Serum osmolality, urine osmolality, urine sodium - pre-op, post op days 1, 3
* Glomerular filtration rate - pre-op, post op days 1, 3, and 6 weeks

Arms: arm 1: Placebo (0.9% Nacl)infusion beginning during surgery and lasting for up to 24 hours arm 2: Fenoldopam (0.1 \~g/kg/min)infusion will commence after placing the patient in a lateral/flex position during the operation. The infusion will continue for a total of 24 hours.
Interventions: intervention 1: Fenoldopam intervention 2: Placebo
Intervention descriptions: intervention 1: Fenoldopam (0.1 \~g/kg/min)started during surgery and lasting for a total of 24 hours intervention 2: Placebo infusion(0.9% Nacl) beginning during surgery and lasting for up 24 hours post surgery

Protocol documents: