ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00631488
Conditions: Diabetes Mellitus, Type 2
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-02-01; Completion date: 2009-01-01
Enrollment: 146 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will test the effectiveness and safety of treatment with MK-0893 in combination with other drugs commonly used to treat type 2 diabetes for a duration up to 13 weeks.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: MK-0893 intervention 2: Sitagliptin intervention 3: Metformin intervention 4: Placebo for MK-0893 intervention 5: Placebo for Sitagliptin intervention 6: Placebo for Metformin
Intervention descriptions: intervention 1: Initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period (4 weeks). intervention 2: Sitagliptin Phosphate administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period (4 weeks). intervention 3: Metformin taken orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin then administered throughout the double-blind treatment period (4 weeks). intervention 4: Matching placebo for MK-0893 was orally administered for the loading dose (200 mg) and for the following daily treatment (40 mg) over the 4 week double blind treatment period. intervention 5: Matching placebo for Sitagliptin (100 mg) administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period (4 weeks). intervention 6: Metformin-matched placebo taken orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin-matched placebo then administered throughout the double-blind treatment period (4 weeks).

Protocol documents:
Clinical trial NCT00631969
Conditions: Erectile Dysfunction
Keywords: Erectile Dysfunction
Sponsor: Bayer
Start date: 2008-04-01; Completion date: 2009-01-01
Enrollment: 362 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study investigates the safety and efficacy of a new dosage form of Vardenafil, an orodispersible tablet (ODT), and compares it to the safety and efficacy of a placebo (inactive) tablet in the treatment of erectile dysfunction. After a 4-week unmedicated phase, patients will receive Vardenafil ODT or matching placebo for 12 weeks. Safety will be determined by laboratory and other evaluations. Efficacy will be determined by the results of different questionnaires and the patient diary that will be used.

Detailed description:

Arms: arm 1: Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day. arm 2: Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Interventions: intervention 1: Vardenafil ODT (STAXYN, BAY38-9456) intervention 2: Placebo
Intervention descriptions: intervention 1: Subjects will receive 12 weeks of PRN (on demand) treatment with Vardenafil 10mg orodispersible tablet (ODT) intervention 2: Subjects will receive 12 weeks of PRN (on demand) treatment with matching placebo tablet

Protocol documents:
Clinical trial NCT00642174
Conditions: Diabetes Mellitus Coronary Artery Disease
Sponsor: Eli Lilly and Company
Start date: 2008-04-01; Completion date: 2009-01-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This trial is designed as a phase 2 randomized, double-blind double dummy, active comparator controlled, two-period two-arm crossover study to enroll 40 patients across multiple centers. The study will compare platelet function following a prasugrel loading dose and 1 week of prasugrel maintenance therapy with high-dose clopidogrel loading dose and 1 week of high-dose clopidogrel maintenance therapy in patients with drug treated type 2 diabetes mellitus who have coronary artery disease. Various assays of platelet function will be used in this study. Platelet function will be studied using the following assays: Accumetrics VerifyNowTM P2Y12, Light Transmittance Aggregometry (LTA), Vasodilator-associated stimulated phosphoprotein (VASP), and Thromboelastography (TEG)-platelet mapping.

Detailed description:

Arms: arm 1: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose. arm 2: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose.
Interventions: intervention 1: prasugrel intervention 2: Clopidogrel
Intervention descriptions: intervention 1: Oral prasugrel 60-mg loading dose, followed by 6-9 days of oral prasugrel 10-mg/day tablet maintenance dose. intervention 2: Oral clopidogrel 600-mg loading dose, followed by 6-9 days of oral clopidogrel 150-mg/day tablet maintenance dose.

Protocol documents:
Clinical trial NCT00643578
Conditions: Asthma
Keywords: formoterol methacholine challenge
Sponsor: University of Florida
Start date: 2008-03-01; Completion date: 2009-01-01
Enrollment: 37 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to find out whether a difference between two doses of formoterol can be detected by methacholine challenge.

Detailed description:
During the screening visit, subjects'vital signs (heart rate, blood pressure and temperature) will be measured and they will perform standard spirometry. If the results of this test are 70% of normal or greater, they will be examined by a physician, and blood (1 teaspoonful) and urine will be collected for routine laboratory tests (CBC and routine urinalysis). If they are a female, a pregnancy test will be performed.

During the second visit, subjects will inhale 1 or 2 doses of formoterol, (Foradil Aerolizer 12 mcg/capsule) a long-acting bronchodilator and 1 hour later, perform a methacholine test.

At the end of the methacholine test, they will be given albuterol to reverse the effects of methacholine. On the third study day, they will repeat the second visit but with the opposite dose of Foradil.

Arms: arm 1: a single dose of 24 mcg of formoterol arm 2: a single dose of 12 mcg of formoterol
Interventions: intervention 1: formoterol intervention 2: formoterol intervention 3: Dry Powder Inhaler (Twisthaler)
Intervention descriptions: intervention 1: a single dose of 24 mcg of formoterol delivered by dry powder inhaler (Twisthaler) intervention 2: a single dose of 12 mcg of formoterol delivered by dry powder inhaler (Twisthaler) intervention 3: subjects inhaled deeply and forcefully and held their breath for 10 seconds for each dose

Protocol documents:
Clinical trial NCT00648167
Conditions: Hyperphosphatemia End-stage Renal Disease
Keywords: ESRD end-stage renal disease end stage renal disease hemodialysis dialysis kidney failure renal failure kidney renal phosphate binder phosphorus
Sponsor: Keryx Biopharmaceuticals
Start date: 2008-03-01; Completion date: 2009-01-01
Enrollment: 55 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is to evaluates the safety and tolerability of Zerenex™ (ferric citrate) as a treatment for hyperphosphatemia in patients with End-Stage Renal Disease.

Detailed description:
The purpose of this study is to evaluate the safety and tolerability of Zerenex™ (ferric citrate) as a treatment for hyperphosphatemia in patients with End-Stage Renal Disease. These patients will be switched to Zerenex™ from their current high dose of phosphate binder and, based on their serum phosphorus levels, will be titrated up from 3.4g/day of Zerenex™ to maximum tolerated and safe doses of Zerenex™. Doses will be adjusted weekly, based on serum phosphorus levels, with the maximum dose administered being approximately 12g/day.

Arms: arm 1: All patients will be switched from their current phosphate binder to Zerenex, and titrated to the maximum tolerated dose (up to about 12g/day) based on their serum phosphorus levels.
Interventions: intervention 1: ferric citrate
Intervention descriptions: intervention 1: ferric citrate will be provided as a 375mg capsule. Dosing and frequency are dependent on patient's serum phosphorus levels. Dosing will occur over the 28-day study.

Protocol documents:
Clinical trial NCT00657553
Conditions: Multiple Myeloma
Sponsor: University of Arkansas
Start date: 2008-02-01; Completion date: 2009-01-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate whether using the drug bortezomib at the start of remission will prevent relapse for a longer period of time.

Detailed description:
Although advances in the treatment of multiple myeloma have led to improved remission rates, the risk for serious relapse is very high. The drug Bortezomib has been highly effective for treatment of the disease in an advanced stage such as post-transplant relapse. Due to the need of maintenance therapies, it is necessary to look to certain drugs that may prolong remission and increase the quality of life. Bortezomib, when taken at the beginning of remission, may prove to be a beneficial maintenance drug for the management of multiple myeloma.

Arms: arm 1: Bortezomib Maintenance Year 1 - bortezomib days 1, 4, 8, 11 every 28 days Year 2 - bortezomib days 1, 4, 8, 11 every 2 months Year 3 - bortezomib days 1, 4, 8, 11 every 3 months arm 2: monitor myeloma parameters every 3-6 months
Interventions: intervention 1: Bortezomib
Intervention descriptions: intervention 1: Year 1:1.0 mg/m2. IV. Days 1, 4, 8, 11 every 4 weeks Year 2: 1.0 mg/m2. IV. Days 1, 4, 8, 11 every 8 weeks Year 3: 1.0 mg/m2. IV. Days 1, 4, 8, 11 every 12 weeks

Protocol documents:
Clinical trial NCT00664560
Conditions: Osteoarthritis
Sponsor: POZEN
Start date: 2008-04-01; Completion date: 2009-01-01
Enrollment: 614 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
We will evaluate the efficacy of PN400 and an active comparator in patients that have Osteoarthritis of the knee.

Detailed description:
3-Month study in subjects 50 years and older with osteoarthritis of the knee. Assessments Western Ontario and McMaster Universities (WOMAC) pain and function and patient global assessment scales.

Arms: arm 1: PN400: 500 mg naproxen/20 mg esomeprazole arm 2: Celecoxib 200 mg arm 3: sugar pill
Interventions: intervention 1: PN 400 (VIMOVO) intervention 2: celebrex intervention 3: Placebo intervention 4: Rescue Antacid
Intervention descriptions: intervention 1: 500 mg naproxen/20 mg esomeprazole bid intervention 2: 200 mg celecoxib qd intervention 3: sugar pill bid intervention 4: Antacid Tablets

Protocol documents:
Clinical trial NCT00665431
Conditions: Osteoarthritis
Sponsor: POZEN
Start date: 2008-04-01; Completion date: 2009-01-01
Enrollment: 610 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
We will evaluate the efficacy of PN 400 and an active comparator in patients that have Osteoarthritis of the knee.

Detailed description:
3-Month study in subjects 50 years and older with osteoarthritis of the knee. Assessments Western Ontario and McMaster Universities (WOMAC) pain and function and patient global assessment scales.

Arms: arm 1: PN400: 500 mg naproxen/20 mg esomeprazole bid arm 2: Celecoxib 200 mg arm 3: sugar pill
Interventions: intervention 1: PN 400 (VIMOVO) intervention 2: celebrex intervention 3: Placebo intervention 4: Rescue Antacid
Intervention descriptions: intervention 1: 500 mg naproxen/20 mg esomeprazole bid intervention 2: 200 mg celecoxib qd intervention 3: sugar pill bid intervention 4: Antacid Tablets

Protocol documents:
Clinical trial NCT00666536
Conditions: Hypertension
Keywords: Hypertension adults Valsartan + Amlodipine Angiotensin Receptor Blockers
Sponsor: Novartis
Start date: 2008-03-01; Completion date: 2009-01-01
Enrollment: 728 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to compare blood pressure lowering efficacy of moderate Valsartan + Amlodipine treatment regimen (160 / 5 mg) with that of aggressive regimen (320 / 10 mg) in patients uncontrolled on ARB monotherapy, other than Valsartan

Detailed description:

Arms: arm 1: Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks) arm 2: Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
Interventions: intervention 1: valsartan and amlodipine intervention 2: valsartan and amlodipine
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00671931
Conditions: Scoliosis
Keywords: dexmedetomidine neuromonitoring spine procedures safe dose 1- safe dose of dexmedetomidine when used in total intravenous anesthesia for procedures require neuromonitoring 2- safe dose of propofol when uses in comination with dexmedetomidine in neuromontoring 3effect of dexmedetomidine on somatosensory evoked potential and motor evoked potentials
Sponsor: Children's Hospital Medical Center, Cincinnati
Start date: 2007-04-01; Completion date: 2009-01-01
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
Reduction of the spinal cord injuries during scoliosis surgery is a major goal of the anesthesia and surgical team. Despite improvement in scoliosis surgery over the years, the development of neurological deficits remains the most feared complication of spine surgery. During scoliosis surgery it is very important to monitor the spinal cord to detect spinal cord injury with surgical manipulation. Continuous or intermittent intraoperative electrophysiological monitoring (neuron-monitoring) is used routinely during these procedures to provide the surgeon with information concerning the integrity of neurological structures at risk. All neuron-monitoring modalities are affected by the anesthetic regimen used. Of the various intravenous anesthetic drugs, the combination of propofol, remifentanil and dexmedetomidine appear to impact neuron-monitoring the least. The current anesthetic practice is to use the three drugs in combination at doses that do not depress the signals but there is no data relating targeted dexmedetomidine and propofol blood levels to neuron-monitoring signals. The lack of data results in wide variability in dosing with consequent variability in patient response.

Hypothesis: Clinically relevant blood levels of dexmedetomidine will affect the amplitude of transcranial motor-evoked potentials (TcMEP) either independently or by interaction with propofol in a dose dependent manner.

Detailed description:

Arms: arm 1: Dexmedetomidine low infusion, Propofol low infusion arm 2: Dexmedetomidine high infusion, Propofol low infusion arm 3: Dexmedetomidine high infusion, Propofol high infusion arm 4: Dexmedetomidine intermediate infusion, Propofol intermediate infusion arm 5: Dexmedetomidine low infusion, Propofol high infusion
Interventions: intervention 1: low dexmedetomidine, low propofol intervention 2: high dexmedetomidine, low propofol intervention 3: Dexmedetomidine intervention 4: Dexmedetomidin intervention 5: Dexmedetomidine
Intervention descriptions: intervention 1: Dexmedetomidine loading dose 0.6 MCG/KG,Propofol infusion 100 MCG/KG/M intervention 2: Dexmedetomidine loading dose 1.1 MCG/KG ,Propofol infusion 100 MCG/KG/M intervention 3: Dexmedetomidine loading dose 0.6 MCG/KG,Propofol infusion 200 MCG/KG/M intervention 4: Dexmedetomidine loading dose 1.1 MCG/KG.Propofol infusion 200 MCG/KG/M intervention 5: Dexmedetomidine loading dose 0.9 mcg/kg,Propofol infusion 140 mcg/kg/min

Protocol documents:
Clinical trial NCT00673361
Conditions: Melanoma
Sponsor: Duke University
Start date: 2007-03-01; Completion date: 2009-01-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This research study is testing the "chemo-switch" strategy in melanoma, using biochemotherapy initially to shrink tumors and then switching to daily low-dose chemotherapy (temozolomide) together with sorafenib. The purpose of this study is to find out what effects (good and bad) biochemotherapy followed by temozolomide plus sorafenib have on melanoma.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Concurrent decrescendo biochemotherapy regimen intervention 2: Low-dose Temozolomide plus Sorafenib
Intervention descriptions: intervention 1: * Temozolomide: 200mg/m\^2, daily, PO, days 1-4
* Vinblastine: 1.5mg/m\^2, daily, IV, days 1-4
* Cisplatin: 20mg/m\^2, daily IV, days 1-4
* IL (interleukin)-2: - 18 milli-International unit (MIU)/m\^2, IVCI (intravenous continual infusion), day 1
* 9 MIU/m\^2, IVCI, day 2
* 4.5 MIU/m\^2, IVCI, days 3 \& 4
* Interferon (IFN) alpha: 5 MIU/m\^2, daily, SC (subcutaneously), days 1-5
* 5-day inpatient regimen, to be repeated every 21 days intervention 2: Temozolomide: 75mg/m\^2, PO, QD (quaque die), 6 weeks on/2 weeks off Sorafenib: 400mg, PO, BID, 8 weeks

Protocol documents:
Clinical trial NCT00674440
Conditions: Congenital Hyperinsulinism Hyperinsulinism Persistent Hyperinsulinemic Hypoglycemia of Infancy CHI PHHI
Keywords: Congenital Hyperinsulinism Hyperinsulinism Persistent Hyperinsulinemic Hypoglycemia of Infancy CHI PHHI F-DOPA L-fluoro-dihydroxyphenylalanine
Sponsor: Children's Hospital of Philadelphia
Start date: 2004-12-01; Completion date: 2009-01-01
Enrollment: 106 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Children with congenital hyperinsulinism (CHI) have low blood sugar, and some of these children may require surgery. In this study, researchers affiliated with the University of Pennsylvania will test how well a radioactive drug (called F-DOPA) can detect a form of hyperinsulinism that may be cured by surgery. Eligible participants in this study will have positron emission tomography (PET) scans with F-DOPA prior to surgery.

Detailed description:
For children with congenital hyperinsulinism (CHI), low blood sugar is caused by cells in the pancreas that release too much insulin. Some children with CHI have these cells throughout their pancreas; others have them located in specific areas of the pancreas. Children who have them located in specific areas of the pancreas may be cured with surgery. F-DOPA is a radioactive drug that may go to these very cells. F-DOPA can also be used for positron emission tomography (or PET), an imaging technique used in nuclear medicine departments. In this study, researchers will test the possibility of using PET with F-DOPA in the diagnosis of children with hyperinsulinism.

Arms: arm 1: Children diagnosed with hyperinsulinism who have failed other non-surgical interventions and are candidates to be scheduled for surgery for partial pancreatectomy. Eligible children will undergo PET imaging with F-DOPA prior to surgery.
Interventions: intervention 1: F-DOPA intervention 2: PET scan
Intervention descriptions: intervention 1: 0.08-0.16 mCi/kg once intervention 2: None

Protocol documents:
Clinical trial NCT00676403
Conditions: Restless Legs Syndrome
Keywords: pregabalin, RLS, efficacy, safety
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2008-04-01; Completion date: 2009-01-01
Enrollment: 137 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To test the effectiveness and tolerability of Lyrica at various dose levels in RLS patients

Detailed description:

Arms: arm 1: Placebo arm 2: investigational treatment arm 3: investigational treatment arm 4: investigational treatment arm 5: investigational treatment arm 6: investigational treatment
Interventions: intervention 1: placebo intervention 2: Pregabalin intervention 3: Pregabalin intervention 4: Pregabalin intervention 5: Pregabalin intervention 6: Pregabalin
Intervention descriptions: intervention 1: Placebo control (capsule), once a day, 1- 3 hours before bedtime for 6 weeks intervention 2: 50 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks intervention 3: 100 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks intervention 4: 150 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks intervention 5: 300 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks intervention 6: 450 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks

Protocol documents:
Clinical trial NCT00680056
Conditions: Pulmonary Disease, Chronic Obstructive Chronic Bronchitis Pulmonary Emphysema
Keywords: Pulmonary Disease, Chronic Obstructive Tiotropium Formoterol Bronchodilator Agents Exercise Tolerance Randomized Controlled Trial [Publication Type] COPD
Sponsor: Federal University of São Paulo
Start date: 2007-11-01; Completion date: 2009-01-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective is to comparatively evaluate the isolated effects of a long-acting beta2-adrenergic (formoterol fumarate 12µg b.i.d. via Aeroliser) and combined with a long-acting anti-cholinergic (tiotropium bromide 18µg o.d via Handihaler) on breathlessness, dynamic hyperinflation and exercise tolerance in patients with advanced, but stable, chronic obstructive pulmonary disease. The study hypothesis is that combining long acting bronchodilators with different action mechanisms would promote synergistic effects on clinical outcomes.

Detailed description:
This will be a single center, randomized, double-blind study consisting of two 2-week treatment periods separated by a 5-7 days washout phase without long-acting bronchodilators. Eligible patients who complete the one week screening phase will be randomized to one of two treatment sequences: 1) Formoterol --\> Formoterol + Tiotropium or 2) Formoterol + Tiotropium --\> Formoterol. During the treatment periods, patients will be allowed to use a short-acting beta2-adrenergic+short-acting anticholinergic as rescue medication (salbutamol+ipratropium via MDI)

Arms: arm 1: Formoterol plus Placebo (Tiotropium) arm 2: Formoterol plus Tiotropium
Interventions: intervention 1: Formoterol plus Placebo (Tiotropium) intervention 2: Formoterol plus Tiotropium
Intervention descriptions: intervention 1: Formoterol 12mcg-capsules (2x/d) + Placebo (Tiotropium) (1x/d). Double-blind medication will be dispensed in HandiHalers and Aerolisers during 2 weeks. intervention 2: Formoterol 12mcg-capsule (2x/dia) + Tiotropium 18mcg-capsule (1x/d). Double-blind medication will be dispensed in HandiHalers and Aerolisers during 2 weeks.

Protocol documents: