ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01499134
Conditions: Peripheral Artery Disease Hypertension
Sponsor: Thomas Jefferson University
Start date: 2011-08-01; Completion date: 2014-06-01
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 26-week, prospective double-blind, randomized pilot trial of nebivolol versus an active control, metoprolol succinate, in patients with established lower-extremity peripheral artery disease, hypertension, and at least moderate risk for coronary artery disease.

Detailed description:
Peripheral arterial disease (PAD) affects up to an estimated 16-29% of men and women over age 50, and is associated with increased cardiovascular morbidity and mortality. Beta-blockers have been shown to reduce the risk of myocardial infarction and death in patients with coronary artery disease (CAD) and are indicated for the treatment of hypertension in patients with PAD. However, there is a theoretical risk that antihypertensive therapy may decrease limb perfusion pressure and therefore exacerbate symptoms of claudication or limb ischemia. Patients with CAD and concomitant PAD are less likely to be prescribed beta-blockers, even though most patients are able to tolerate antihypertensive therapy without worsening of symptoms.

The third generation beta-blocker, nebivolol, has vasodilating properties in addition to beta-adrenergic blockade. This vasodilatory effect is mediated through the L-arginine-nitric oxide-dependent pathway. Nitric oxide is a critical modulator of vascular disease with effects that lead to vasodilatation, endothelial regeneration, inhibition of leukocyte chemotaxis and inhibition of platelet adhesion. This combination of beta-blockade and nitric oxide-dependent vasodilation may enhance effectiveness and tolerability of nebivolol versus other beta-blockers in patients with hypertension, CAD or high-risk state, and PAD.

This study will be a pilot comparative effectiveness study to examine the effect of nebivolol versus metoprolol succinate in patients with lower-extremity PAD and at least moderate risk for CAD on PAD symptoms as measured by both functional and quality of life measures.

Arms: arm 1: nebivolol 1 to 4 capsules daily arm 2: metoprolol 1 to 4 capsules daily
Interventions: intervention 1: nebivolol intervention 2: Metoprolol succinate
Intervention descriptions: intervention 1: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing). intervention 2: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing).

Protocol documents:
Clinical trial NCT01510769
Conditions: Tophaceous Gout
Sponsor: Ardea Biosciences, Inc.
Start date: 2012-01-01; Completion date: 2014-06-01
Enrollment: 330 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the serum uric acid lowering effects, clinical benefits, and safety of lesinurad in combination with febuxostat to febuxostat alone in patients with tophaceaous gout.

Detailed description:
Febuxostat is an XO (Xanthine Oxidase) Inhibitor approved Urate Lowering Therapy (ULT) for patients with gout. Although febuxostat has been demonstrated to be superior to allopurinol in lowering serum urate (sUA) to \< 6mg/dL in 3 randomized, controlled clinical trials, proportions of subjects experiencing a reduction in tophus area and gout flares were not significantly different compared to allopurinol. Although this study will allow subjects who are naïve to ULT to enroll, it is anticipated that the majority of subjects will currently be taking or have previously experienced XO Inhibitor therapy. This trial will enroll a population of subjects with high uric acid body burden, as all must demonstrate the presence of tophi.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Lesinurad intervention 2: Lesinurad intervention 3: Placebo intervention 4: Febuxostat
Intervention descriptions: intervention 1: Tablets, 400 mg once daily (QD) intervention 2: Tablets, 200 mg QD intervention 3: Tablets, Placebo QD intervention 4: 80 mg

Protocol documents:
Clinical trial NCT01511055
Conditions: Ovarian Cancer
Keywords: Ovarian Cancer
Sponsor: Mayo Clinic
Start date: 2012-01-01; Completion date: 2014-06-01
Enrollment: 27 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Prognosis for many carcinomas, including ovarian carcinoma, is dependent on a complete surgical resection, also known as a R0 resection. At present, the ability to perform a complete resection with negative margins is limited by the surgeon's ability to palpate and visualize the tumor and its margins. Therefore, in order to reduce operative morbidity and costs while maintaining or improving surgical and oncologic outcomes, the investigators must develop technologies that improve visualization of the primary tumor and occult metastases, real time, during surgery. Recent research has demonstrated that the use of fluorescent probes that recognize cancer specific antigens can be used for this purpose when visualized using a prototype near-infrared multispectral imaging system.

This investigation will determine if folate-FITC, a fluorescent probe that recognizes the folate receptor (present in \> 90% of ovarian cancers) can facilitate surgical resection and detect tumor nodules not visible to the naked eye.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: EC-17
Intervention descriptions: intervention 1: One-time dose of Folate-FITC (EC-17), 0.1mg/kg IV 2-3 hours prior to surgery.

Protocol documents:
Clinical trial NCT01544309
Conditions: Hypercholesterolemia With Concomitant Type 2 Diabetes
Sponsor: Listen Trial Group
Start date: 2012-03-01; Completion date: 2014-06-01
Enrollment: 1049 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the effect of rosuvastatin and atorvastatin on lipid lowering effect and glucose metabolism in hypercholesterolemia patients with diabetes mellitus.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Atorvastatin intervention 2: Rosuvastatin
Intervention descriptions: intervention 1: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.

(When not reach the LDL-C level of target in the Japan Atherosclerosis Society \[JAS\] Guidelines \[GL\] after 3 months, had the atorvastatin \[ATV\] dose of 20 mg.) intervention 2: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.

(When not reach the LDL-C level of target in JAS GL after 3 months, had the rosuvastatin \[RSV\] dose of 10 mg.)

Protocol documents:
Clinical trial NCT01571596
Conditions: X-linked Hypophosphatemia
Keywords: XLH
Sponsor: Kyowa Kirin Co., Ltd.
Start date: 2012-02-01; Completion date: 2014-06-01
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary purpose of this study is to assess the safety and efficacy of repeated subcutaneous (SC) injections of KRN23 in adult subjects with X-Linked Hypophosphatemia (XLH).

Detailed description:

Arms: arm 1: Escalating doses of KRN23 (0.05, 0.10, 0.30, and 0.60 mg/kg) will be administered SC every 28 days (up to 12 doses)
Interventions: intervention 1: KRN23
Intervention descriptions: intervention 1: Subjects will receive escalating doses of KRN23 administered by SC injection every 28-days (up to 12 doses) based on a dosing algorithm and discretion of Investigator and Sponsor.

Protocol documents:
Clinical trial NCT01572948
Conditions: COPD
Sponsor: University of Alabama at Birmingham
Start date: 2012-06-01; Completion date: 2014-06-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to propose that roflumilast is associated with meaningful reductions in biomarkers of pulmonary inflammation and sputum neutrophilia, including confirmation of previously described results, and correlate these findings with improvement in pulmonary function, sputum scores, and quality of life in stable moderate to severe COPD. The investigators aim to demonstrate this regardless of concomitant medication use, including inhaled corticosteroids. Additionally, the investigators hope to provide a mechanistic pathway by which these effects occur.

Detailed description:

Arms: arm 1: The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient. arm 2: The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models
Interventions: intervention 1: roflumilast intervention 2: placebo
Intervention descriptions: intervention 1: The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models intervention 2: The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient

Protocol documents:
Clinical trial NCT01584843
Conditions: Strabismus
Keywords: Neuromuscular Agents Strabismus Botulinum Toxin Type A
Sponsor: GlaxoSmithKline
Start date: 2012-05-01; Completion date: 2014-06-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary objective is to evaluate the efficacy of single-dose treatment with GSK1358820 compared with non-treatment in patients with strabismus based on angles of strabismus in the primary position.

Detailed description:
Primary objective is to evaluate the efficacy of single-dose treatment with GSK1358820 compared with non-treatment in patients with strabismus based on angles of strabismus in the primary position. Secondary objective is to evaluate the efficacy and safety of repeated-dose treatment with GSK1358820 in patients with strabismus.

Arms: arm 1: Receive no treatment on Week 0 arm 2: Receive 1.25 U of GSK1358820 on Week 0 arm 3: Receive 2.5 U of GSK1358820 on Week 0 arm 4: Receive no treatment on Week 0 arm 5: Receive 2.5 U of GSK1358820 on Week 0 arm 6: Receive 5.0 U of GSK1358820 on Week 0
Interventions: intervention 1: GSK1358820
Intervention descriptions: intervention 1: IM injection of Botulinum Toxin Type A

Protocol documents:
Clinical trial NCT01586312
Conditions: Osteoarthritis, Knee Arthritis of Knee Knee Osteoarthritis
Keywords: Knee degenerative disease osteoarthritis gonarthrosis stem cell cellular therapy regenerative therapy Mesenchymal stem cells Bone marrow musculoskeletal Diseases Mesenchymal Stromal Cells (allogenic)
Sponsor: Red de Terapia Celular
Start date: 2012-04-01; Completion date: 2014-06-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In this study we want to evaluate the clinical use of allogenic mesenchymal stem cells (MSC), obtained from bone marrow of healthy donors, for treatment of knee osteoarthritis. The trial is based in our own previous results with autologous MSC (ongoing NCT01183728 trial). We propose here a multicenter, phase I-II clinical trial, prospective, randomized, blinded, and controlled for the treatment of osteoarthritis (degrees II and III and IV). The assay consists of two arms with 15 patients each one. Patients in the experimental arm will be given an intra-articular transplantation of allogenic MSC, expanded "Ex Vivo" with our GMP-compliant procedure (MSV, PEI No. 10-134, authorized by the Competent Authority; same as in NCT01183728). In the control arm a standard treatment with intra-articular injection of hyaluronic acid shall be given. We shall follow the evolution of pain, disability, quality of life and quantitative changes in structure and composition of cartilage determined by T2-weighted MRI relaxation (Cartigram) for one year.

Detailed description:

Arms: arm 1: Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intraarticular injection of 40 millions MSC. arm 2: Intraarticular injection of hyaluronic acid (60 mg)
Interventions: intervention 1: Allogenic mesenchymal stromal cells injection intervention 2: Hyaluronic Acid
Intervention descriptions: intervention 1: Mesenchymal stem cells prepared from bone marrow of healthy donors and expanded for 3-4 weeks according to our procedure described in PEI Num. 10-134, authorized by the Spanish Medicine Agency intervention 2: Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)

Protocol documents:
Clinical trial NCT01592045
Conditions: Neuroblastoma
Sponsor: United Therapeutics
Start date: 2012-08-01; Completion date: 2014-06-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to compare the pharmacokinetics (blood levels) and safety of chimeric (ch) 14.18 manufactured by two independent drug makers (United Therapeutics \[UTC\] or the National Cancer Institute \[NCI\]).

Detailed description:
This is a multi-center, randomized, open-label, two-sequence, cross-over study for eligible subjects with high-risk neuroblastoma to assess the comparability of ch14.18 manufactured with UTC drug product and ch14.18 manufactured with NCI drug product. Subjects will be randomly allocated to receive ch14.18 manufactured by UTC or NCI during Courses 1 and 2 followed by ch14.18 manufactured by other manufacturer (UTC or NCI) during Courses 3, 4, and 5.

Arms: arm 1: UTC ch14.18 for two courses and NCI ch14.18 for three courses arm 2: NCI ch14.18 for two courses and UTC ch14.18 for three courses
Interventions: intervention 1: ch14.18 -NCI intervention 2: ch14.18-UTC intervention 3: Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) intervention 4: Aldesleukin (IL-2) intervention 5: Isotretinoin
Intervention descriptions: intervention 1: 25 mg/m\^2/day IV for four consecutive days intervention 2: 17.5 mg/m\^2/day IV for four consecutive days intervention 3: GM-CSF will be administered SC at a dose of 250 mcg/m\^2/day for 14 days during Courses 1, 3, and 5. intervention 4: Aldesleukin (IL-2) will be administered IV at a dose of 3 MIU/m\^2/day for the first week and at a dose of 4.5 MIU/m\^2/day for the second week during Courses 2 and 4. intervention 5: Isotretinoin (13-cis-retinoic acid; ISOT) will be administered by mouth over six courses as follows:

If weight \> 12 kg: 80 mg/m\^2/dose twice daily (total daily dose is 160 mg/m\^2/day, divided twice daily).

If weight ≤ 12 kg: 2.67 mg/kg/dose twice daily (total daily dose is 5.33 mg/kg/day, divided twice daily).

Protocol documents:
Clinical trial NCT01603082
Conditions: Acute Coronary Syndrome
Sponsor: AstraZeneca
Start date: 2012-07-01; Completion date: 2014-06-01
Enrollment: 343 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the pharmacodynamic effect of ticagrelor in ACS patients undergoing an Ad Hoc PCI

Detailed description:
A randomized, open-label, multiple-center, parallel group study to compare the platelet inhibition with VerifyNow assay of ticagrelor versus clopidogrel in troponin negative Acute Coronary Syndrome (ACS) subjects undergoing Ad Hoc percutaneous coronary intervention (PCI)

Arms: arm 1: Ticagrelor - 180 mg loading dose arm 2: Clopidogrel - 600 mg loading dose
Interventions: intervention 1: Ticagrelor intervention 2: Clopidogrel
Intervention descriptions: intervention 1: 180 mg loading dose intervention 2: 600 mg loading dose

Protocol documents:
Clinical trial NCT01623271
Conditions: Complex Regional Pain Syndrome I (CRPS I)
Keywords: CRPS I
Sponsor: Massachusetts General Hospital
Start date: 2013-05-01; Completion date: 2014-06-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to see if an FDA-approved drug (Gralise) can help people with certain types of neuropathic pain without causing too many side effects.

Detailed description:
This research is being conducted to see if the drug Gralise can help people with Complex Regional Pain Syndrom Type I (CRPS I) without causing too many side effects. CRPS I is one of the most common conditions of neuropathic pain (pain that results from damage to nerves in the peripheral nervous system). Gralise is approved by the U.S. Food and Drug Administration (FDA) to treat postherpetic neuralgia (a complication of the disease Shingles, which is caused by the chickenpox virus), but is not approved to treat CRPS I.

Arms: arm 1: This is an open label study that involves taking Gralise pills (gastic-retentive gabapentin) for 8 weeks.

Day 1-15: Titration phase- titrate Gralise from 300 mg/day to 1800 mg/day Day 16-42: Maintenance phase- maintain the dose of 1800 mg/day Day 43-56: Taper phase- taper the Gralise from 100 mg/day to 300 mg/day
Interventions: intervention 1: Gabapentin
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01626885
Conditions: Schizophrenia
Keywords: Schizophrenia Antipsychotic Agents Mental Disorder Psychotropic Drugs Dopamine Agents Central Nervous System Agents
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2012-05-01; Completion date: 2014-06-01
Enrollment: 42 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this study is to evaluate the long-term safety, tolerability, and efficacy of MP-214 in patients with receiving multiple drugs schizophrenia.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: MP-214
Intervention descriptions: intervention 1: Patients who meet eligibility criteria will be administered a once daily oral fixed dose (3mg) of MP-214 for four weeks, then flexible dose (1.5-9 mg) of MP-214

Protocol documents:
Clinical trial NCT01654861
Conditions: Metastatic Adenocarcinoma of the Pancreas
Sponsor: Eastern Regional Medical Center
Start date: 2012-06-01; Completion date: 2014-06-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
* The combination of gemcitabine and HDIVC is safe and may favorably change the clinical course for an individual patient.
* The combination of gemcitabine and HDIVC is synergistic in anti-tumor effect as seen in preclinical models, where HDIVC creates a pro-oxidative effect that adds to the anti-tumor effect of gemcitabine.
* The combination of gemcitabine and HDIVC may improve Progression Free Survival (PFS).
* The dosage schema of 1.2 g /kg bolus infusion followed by lower dose of 0.3 g / kg infusion may create sustained elevation in Vitamin C plasma levels for increased cytotoxic effect.
* The addition of HDIVC \& oral supplementation of Vitamin C to standard treatment with gemcitabine may improve quality of life for patients with comparison to prior to treatment start of this protocol.
* CA 19-9 and inflammatory markers may show trends for patients in this trial.

Detailed description:

Arms: arm 1: Gemcitabine (Gemzar), Intravenous and oral Ascorbic Acid (Vitamin C).
Interventions: intervention 1: Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C)
Intervention descriptions: intervention 1: Weeks 1,2,3: IV Gemcitabine 1000 mg / m² over 30 minutes followed by HDIVC 1.2 g / kg: 1.2 g/kg over 90 minutes for a dose ≤90 g and over 120 minutes for a dose \>90g followed by 0.3 g / kg over 120 minutes; Week 4: no treatment.

Protocol documents:
Clinical trial NCT01658514
Conditions: Renal Insufficiency
Sponsor: Elcelyx Therapeutics, Inc.
Start date: 2014-01-01; Completion date: 2014-06-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study evaluated how a single dose of delayed-release metformin (Met DR) behaves in subjects with normal kidney function, mild kidney dysfunction, moderate kidney dysfunction, or severe kidney dysfunction. The safety and tolerability of Met DR was also examined. In addition, this study compared the behavior of a single dose of Met DR with that of extended-release metformin (Met XR) and placebo in subjects with the varying levels of kidney function described above.

Detailed description:

Arms: arm 1: One dose of 1000 mg metformin delayed-release arm 2: One dose of 1000 mg metformin extended-release arm 3: One dose of Placebo
Interventions: intervention 1: Met DR intervention 2: Met XR intervention 3: Placebo
Intervention descriptions: intervention 1: metformin delayed-release tablets intervention 2: metformin extended-release tablets intervention 3: None

Protocol documents:
Clinical trial NCT01662063
Conditions: Rheumatoid Arthritis
Sponsor: Genentech, Inc.
Start date: 2012-08-01; Completion date: 2014-06-01
Enrollment: 218 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This open-label extension study will evaluate the long-term safety and efficacy of SC TCZ in participants with moderate to severe RA who have completed the 97-week WA22762 (NCT01194414) or 96-week NA25220 (NCT01232569) core studies on SC or intravenous (IV) TCZ. Participants will receive TCZ 162 milligrams (mg) SC every week (QW) or every 2 weeks (Q2W) for up to 96 weeks.

Detailed description:

Arms: arm 1: Participants who received IV TCZ in the previous trial will be switched to SC TCZ 162 mg QW, and those who received SC TCZ will continue at their same dosage of SC TCZ 162 mg QW. Tocilizumab will be given for an additional 96 weeks in this open-label extension study. arm 2: Participants who received SC TCZ will continue at their same dosage of SC TCZ 162 mg Q2W. Tocilizumab will be given for an additional 96 weeks in this open-label extension study.
Interventions: intervention 1: Tocilizumab
Intervention descriptions: intervention 1: TCZ will be given as 162 mg SC QW or Q2W for up to 96 weeks.

Protocol documents: