ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00586261
Conditions: Chronic Kidney Disease
Keywords: Kidney Failure, Chronic Renal Insufficiency, Chronic Proteinuria Albuminuria
Sponsor: Mayo Clinic
Start date: 2006-03-01; Completion date: 2009-07-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The hypothesis of the current proposal is that chronic pioglitazone therapy will result in improved endothelial function, decreased inflammation, and preservation of renal function in patients with CKD but without diabetes.

Detailed description:
Despite continued improvements in the outcomes of patients with cardiovascular disease, similar improvements have not been seen in patients with chronic kidney disease (CKD). CKD constitutes one of the highest risk populations for cardiovascular disease. When the creatinine clearance is ≤ 60 ml/min the risk for cardiovascular events is greater than that of diabetes. However, few studies have focused on the prevention or treatment of coronary artery disease (CAD) in CKD patients.

The development of endothelial dysfunction and increased inflammation appear to be critical in the development of atherosclerosis and cardiovascular disease. The broad long-term objective of this grant proposal is to determine unique therapies to reduce endothelial dysfunction and inflammation, and thereby help to prevent cardiovascular disease and preserve renal function in patients with CKD. Thiazolidinediones such as pioglitazone appear to improve endothelial function and decrease inflammation, an effect that may be present in patients with or without diabetes.

To address this hypothesis the following Specific Aims are proposed:

1. To determine the effects of chronic pioglitazone therapy on endothelial function in non-diabetic patients with CKD (creatinine clearance ≤ 60 ml/ min, but not on dialysis)
2. To determine the effects chronic pioglitazone therapy on inflammation and oxidative stress in non-diabetic patients with CKD
3. To determine the effects chronic pioglitazone therapy on progression of renal disease in non-diabetic patients with CKD

Arms: arm 1: Placebo 30 mg daily for 6 months, nitroglycerin was given to check the brachial reactivity. arm 2: Pioglitazone 30 mg daily for 6 months, nitroglycerin was given to check the brachial reactivity.
Interventions: intervention 1: Pioglitazone intervention 2: Placebo intervention 3: Nitroglycerin
Intervention descriptions: intervention 1: Pioglitazone 30 mg daily for 6 months intervention 2: Placebo 30 mg daily for 6 months intervention 3: 0.4 mg sublingual nitroglycerin tablet was given to all patients without a contraindication to check the brachial reactivity.

Protocol documents:
Clinical trial NCT00590590
Conditions: Vulvodynia
Sponsor: Lumara Health, Inc.
Start date: 2007-10-01; Completion date: 2009-07-01
Enrollment: 105 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy and safety of two vaginal products compared with that of placebo to determine if the two products are better than placebo in the relief of vaginal discomfort.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Lidocaine/Diphenhydramine intervention 2: lidocaine intervention 3: placebo
Intervention descriptions: intervention 1: semi solid, twice weekly, 4 months intervention 2: semi solid, twice weekly for 4 months intervention 3: semi solid, twice weekly for 4 months

Protocol documents:
Clinical trial NCT00591227
Conditions: Type 2 Diabetes Mellitus
Sponsor: Rush University Medical Center
Start date: 2008-05-01; Completion date: 2009-07-01
Enrollment: 176 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will examine two questions: 1. Whether insulin treatment of high blood sugar in patients with diabetes while they are in the emergency room will improve how quickly they recover from illness if they need to be hospitalized. 2. Whether immediately beginning long lasting insulin detemir in patients with diabetes when they are admitted to hospital from the emergency room will improve how quickly they recover from the illness which necessitated hospitalization.

Detailed description:

Arms: arm 1: these subjects will be treated with insulin aspart every 2 hours if blood glucose is more than 200 mg/dl during their ER evaluation. If they are admitted to hospital then they will receive a weight-based dose of insulin detemir immediately prior to admission and then every 24 hours thereafter combined with mealtime doses of insulin aspart if they are eating. arm 2: these subjects will receive no insulin per protocol during their ER stay or during a possible inpatient admission. The care for their diabetes will be solely determined by the physician(s) in the ER and by the physician(s) caring for them in the hospital if they are admitted. They may receive no therapy, oral agents or insulin per primary physician preference.
Interventions: intervention 1: insulin aspart intervention 2: insulin detemir
Intervention descriptions: intervention 1: insulin aspart: insulin aspart will be given every 2 hours dosed from 0.05 to 0.15 units per kg weight to patients with a prior history of diabetes if blood glucose is more than 200 mg/dl in the ER.

If subjects are admitted to hospital then they will receive insulin detemir 0.3 units/kg daily and insulin aspart 0.1 units/kg per meal if they are eating. intervention 2: insulin detemir: insulin aspart will be given every 2 hours dosed from 0.05 to 0.15 units per kg weight to patients with a prior history of diabetes if blood glucose is more than 200 mg/dl in the ER.

If subjects are admitted to hospital then they will receive insulin detemir 0.3 units/kg daily and insulin aspart 0.1 units/kg per meal if they are eating.If subjects are admitted to hospital then they will receive insulin detemir 0.3 units/kg daily and insulin aspart 0.1 units/kg per meal if they are eating.

Protocol documents:
Clinical trial NCT00593645
Conditions: Myelodysplastic Syndromes Acute Myeloid Leukemia
Keywords: Conditioning regimens Stem Cell Transplantation Hematopoietic Stem Cell Transplantation Allogeneic Stem Cell Transplantation Nonmyeloablative conditioning Clofarabine Cytarabine Anti-thymocyte globulin
Sponsor: Washington University School of Medicine
Start date: 2007-11-01; Completion date: 2009-07-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will test the combination of clofarabine, cytarabine, and thymoglobulin as a non-myeloablative conditioning regimen for patients with myelodysplastic syndromes or acute myeloid leukemia undergoing allogeneic stem cell transplant.

Detailed description:
Current reduced intensity conditioning regimens have been able to decrease TRM (treatment related mortality) but suffer from increased rates of disease relapse. Disease burden at transplantation, as measured by percent myeloblasts, predicts relapse. Current regimens employ fludarabine and busulfan with various adjutants, but these agents are not part of the usual armamentarium used versus leukemia and have questionable anti-leukemic activity. By substituting clofarabine and cytarabine, a combination with proven anti-leukemic activity in the relapsed and refractory setting as well as activity versus MDS, as the back bone of the regimen we hope overcome residual disease and improve post-transplant relapse rates. Furthermore the principal toxicity of this regimen is myelosuppression, which should be abrogated by the infusion of stem cells. Thymoglobulin is included due to its minimal contribution to toxicity but significant benefits in engraftment, and controlling acute and chronic GVHD, which are major contributors to TRM and disease specific activity in MDS.

Arms: arm 1: * Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2
* Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.
* Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.
* Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused.
Interventions: intervention 1: Clofarabine intervention 2: Cytarabine intervention 3: Thymoglobulin intervention 4: Stem cell infusion
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT00603239
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes exenatide metformin thiazolidinedione Byetta Amylin Lilly
Sponsor: AstraZeneca
Start date: 2008-01-01; Completion date: 2009-07-01
Enrollment: 165 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess safety and efficacy of exenatide in combination with a thiazolidinedione (TZD) and a TZD plus metformin over 26 weeks in adult patients with type 2 diabetes who have not achieved adequate glycemic control.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: exenatide intervention 2: placebo
Intervention descriptions: intervention 1: subcutaneous injection, 5 mcg or 10 mcg, twice a day (BID) intervention 2: subcutaneous injection, volume equivalent to 5 mcg or 10 mcg of active drug, twice a day

Protocol documents:
Clinical trial NCT00605345
Conditions: Anemia
Sponsor: Hoffmann-La Roche
Start date: 2007-12-01; Completion date: 2009-07-01
Enrollment: 71 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This two arm study will compare the efficacy and safety of subcutaneous Mircera versus darbepoetin alfa for the maintenance of hemoglobin levels in kidney transplant recipients with chronic renal anemia. Patients currently receiving maintenance treatment with darbepoetin alfa will be randomized either to receive 4-weekly injections of Mircera with a starting dose (120, 200 or 360 micrograms subcutaneously) derived from the dose of darbepoetin alfa they were receiving in the 2 weeks preceding study start, or to stay on 2-weekly darbepoetin alfa therapy. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Darbepoetin alfa intervention 2: methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention descriptions: intervention 1: As prescribed intervention 2: 120, 200 or 360 micrograms sc 4-weekly (starting dose)

Protocol documents:
Clinical trial NCT00606034
Conditions: Type 2 Diabetes Insulin Resistance
Keywords: Type 2 diabetes Insulin Resistance Continuous Subcutaneous Insulin Infusion U-500 Insulin Omnipod
Sponsor: Mountain Diabetes and Endocrine Center
Start date: 2007-12-01; Completion date: 2009-07-01
Enrollment: 21 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Patients with Type 2 diabetes and severe insulin resistance with very large insulin requirements who have failed all previous insulin regimens using non-concentrated forms of insulin (U100 insulin formulations) will receive 5X concentrated insulin (U500 regular insulin)infused via insulin pump.

Detailed description:
Patients with Type 2 diabetes who have severe insulin resistance and very large insulin requirements (over 1.4 units of insulin /kg/day) often fail insulin regimens with persistent poor blood glucose control when standard U-100 insulin formulations are used. This is due in part to poor absorption of the large insulin volumes required using these less concentrated standard insulin preparations. The hypothesis that using a concentrated form of insulin called U-500 Regular insulin and delivering it by infusion via insulin pump will lower the volume of insulin required and therefore improve insulin absorption, which will lead to improved blood glucose control, will be tested.

Arms: arm 1: All subjects will receive the experimental treatment (U-500 insulin via Omnipod) since they have already failed all other previous insulin treatment regimens.
Interventions: intervention 1: U-500 Insulin delivered by Omnipod (disposable insulin pump)
Intervention descriptions: intervention 1: U-500 insulin (concentrated insulin) will be infused continuously subcutaneously using a disposable insulin pump called an Omnipod; the insulin infusion dosage will be individualized to each subject's needs

Protocol documents:
Clinical trial NCT00607048
Conditions: Neoplasms
Sponsor: Hoffmann-La Roche
Start date: 2007-11-01; Completion date: 2009-07-01
Enrollment: 34 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a dose-finding study; therefore, there is no hypothesis testing

Detailed description:

Arms: arm 1: Schedule A (CP-870,893 administration schedule) arm 2: Schedule B (CP-870,893 administration schedule)
Interventions: intervention 1: Paclitaxel + Carboplatin + CP-870,893 intervention 2: Paclitaxel + Carboplatin + CP-870,893
Intervention descriptions: intervention 1: Paclitaxel is administered intravenously on day 1 of a 21-day cycle at a dose of 175 mg/m\^2. Carboplatin is administered intravenously on day 1 of a 21-day cycle at AUC 6. CP-870,893 is administered intravenously on DAY 3 of a 21-day cycle in escalating doses (0.1 mg/kg and 0.2 mg/kg) intervention 2: Paclitaxel is administered intravenously on day 1 of a 21-day cycle at a dose of 175 mg/m\^2. Carboplatin is administered intravenously on day 1 of a 21-day cycle at AUC 6. CP-870,893 is administered intravenously on DAY 8 of a 21-day cycle in escalating doses (0.1 mg/kg and 0.2 mg/kg)

Protocol documents:
Clinical trial NCT00608894
Conditions: Autoimmune Hepatitis
Keywords: Autoimmune hepatitis Chronic active hepatitis
Sponsor: Veloxis Pharmaceuticals
Start date: 2007-12-01; Completion date: 2009-07-01
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
An open-label, multi-center, prospective, randomized study to evaluate the efficacy, safety and tolerability of LCP-Tacro tablets given once daily vs. azathioprine, each in combination with prednisone, for the treatment of autoimmune hepatitis (AIH).

Detailed description:
An open-label, multi-center, prospective, randomized study to evaluate the efficacy, safety and tolerability of LCP-Tacro tablets given once daily vs. azathioprine for the treatment of autoimmune hepatitis (AIH).

Patients with histologically confirmed chronic hepatitis who fulfill criteria established by the International Autoimmune Hepatitis Group (IAIHG) and Inclusion and Exclusion criteria will be enrolled after having signed an informed consent document.

Up to 60 patients will be randomized (1:1) to receive treatment with LCP-Tacro + prednisone vs. azathioprine (AZA) + prednisone.

* LCP-Tacro will be started at 2 mg once daily (q.d.) with weekly measurement of tacrolimus whole blood trough levels and adjustment of the daily dose of LCP-Tacro to achieve target tacrolimus levels of 3 - 6 ng/mL. Patients with histological evidence of cirrhosis and a Model for End-Stage Liver Disease (MELD) score ≤ 8 will commence LCP-Tacro at a fixed dose of 1 mg once daily, with subsequent dosage adjustments to maintain tacrolimus trough levels at 3 - 6 ng/mL.
* AZA will be started at 50 - 100 mg (approximately 1 mg/kg) once daily (q.d.).

Patients will also commence treatment with prednisone 30 mg/day for one week, then 20 mg/day for one week, then 15 mg/day for two weeks, then 10 mg/day through Month 6.

Arms: arm 1: LCP-Tacro tablets(1,2,and 5mg tacrolimus)+ prednisone tablets(5mg) arm 2: Azathioprine tablets(50mg)+ prednisone tablets(5mg)
Interventions: intervention 1: LCP-Tacro (tacrolimus) intervention 2: Azathioprine
Intervention descriptions: intervention 1: LCP-Tacro(tacrolimus)tablets starting at 2 mg once daily, then adjusted to achieve and maintain target whole blood tacrolimus levels of 3 - 6 ng/mL, plus prednisone 30 mg/day for one week, then 20 mg/day for one week, then 15 mg/day for two weeks, then 10 mg/day through Month 6. intervention 2: Azathioprine tablets 50 - 100 mg (approximately 1 mg/kg) once daily, plus prednisone 30 mg/day for one week, then 20 mg/day for one week, then 15 mg/day for two weeks, then 10 mg/day through Month 6.

Protocol documents:
Clinical trial NCT00615017
Conditions: Severe Sepsis
Keywords: Sepsis septic shock Systemic Inflammatory Response Syndrome
Sponsor: AstraZeneca
Start date: 2008-01-01; Completion date: 2009-07-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a double-blind, placebo-controlled, multi-center, dose-escalation study to assess the safety, tolerability, Pharmacokinetics and Pharmacodynamics of single and multiple ascending intravenous infusions of CytoFab (AZD9773) in adult patients with severe sepsis.

Detailed description:

Arms: arm 1: AZD9773: single infusion of 50 units/kg arm 2: AZD9773: single infusion of 250 units/kg arm 3: AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs arm 4: AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs arm 5: AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs arm 6: Placebo
Interventions: intervention 1: AZD9773 (CytoFab) intervention 2: Placebo
Intervention descriptions: intervention 1: intravenous infusions intervention 2: Placebo

Protocol documents:
Clinical trial NCT00617461
Conditions: Neuralgia, Postherpetic
Keywords: Post-herpetic neuralgia(PHN) Neuropathic pain
Sponsor: XenoPort, Inc.
Start date: 2008-03-01; Completion date: 2009-07-01
Enrollment: 96 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is evaluate the difference between two doses of gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, on pain associated with post-herpetic neuralgia.

Detailed description:
The primary purpose of study PXN110527 was to investigate the efficacy of a high (3600mg/day) dose versus a low (1200mg/day) dose of GEn in subjects with post-herpetic neuralgia (PHN) who have a history of an inadequate response to gabapentin treatment. The study is a cross-over design. Prior to screening subjects are required to have a demonstrated history of an inadequate response (as determined by the investigator) to at least 1800 mg/day of gabapentin. Prior history of treatment with gabapentin includes current treatment at 1800mg/day (2 weeks) or prior treatment with ≥1800mg/day (4 weeks). Subjects could also have been treated with pregabalin monotherapy (150-300mg/day, ≥4 weeks) and had an inadequate response.

Subjects are treated with gabapentin 1800mg/day during the Baseline Period and are randomized if during the Basleline Period they are compliant with gabapentin treatment and have a 24-hour average pain intensity score ≥4.0 based on an 11-point pain intensity numerical rating scale (PI-NRS). Subjects are then randomized to receive gabapentin enacarbil (either 1200mg/day or 3600mg/day in a 1:1 ratio) for Treatment Period 1 (28 days). Followed by a dose of 2400mg/day for 4 days and the alternate fixed dose (either 3600 mg/day or 1200 mg/day) for Treatment Period 2 (28 days).

Arms: arm 1: gabapentin enacarbil 1200mg/day, 4 weeks treatment in either the first or second treatment period arm 2: gabapentin enacarbil 3600mg/day, 4 weeks treatment in either the first or second treatment period
Interventions: intervention 1: GEn 1200mg/day intervention 2: GEn 3600mg/day
Intervention descriptions: intervention 1: 1200mg/day gabapentin enacarbil intervention 2: 3600mg/day gabapentin enacarbil

Protocol documents:
Clinical trial NCT00625365
Conditions: Cardiovascular Disease
Keywords: DEFINITY Safety Survelliance
Sponsor: Lantheus Medical Imaging
Start date: 2008-02-01; Completion date: 2009-07-01
Enrollment: 1060 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this registry study is to gather safety information on the current clinical use of and the safety of DEFINITY®

Detailed description:

Arms: arm 1: Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography
Interventions: intervention 1: DEFINITY®
Intervention descriptions: intervention 1: DEFINITY may be injected by either an intravenous or bolus injection or infusion. Dosage as per standard clinical practice and Package Insert

Protocol documents:
Clinical trial NCT00635570
Conditions: Birth Control Compliance
Keywords: Contraception, Compliance, Acceptability
Sponsor: University of Chicago
Start date: 2008-07-01; Completion date: 2009-07-01
Enrollment: 273 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The ACCEPT study is a Phase IV trial in which women are randomized to either the NuvaRing® vaginal contraceptive ring or a low dose oral contraceptive to assess compliance, side effects, overall acceptability and intent to continue use of the method. The study is focused on the acceptability of the vaginal ring among female undergraduate or graduate students.

Detailed description:
For many women, college is a time of great change that affects one's social and behavioral practices, including sexual behavior. The first part of the NuvaRing ® Acceptability study is an online survey, developed in conjunction with the University of Illinois's Survey Research Laboratory, which examines women's attitudes and beliefs regarding various methods of birth control. The second part of the study is a comparison trial in which the women are randomized to either the NuvaRing ® vaginal contraceptive ring or a low dose oral contraceptive. The women are followed for three months to assess compliance, side effects, overall acceptability and intent to continue use of the method. Ultimately, we would like college women to be well informed about various methods of contraception available to them and to choose the contraceptive method that best suits their lifestyle.

Arms: arm 1: Contraceptive vaginal ring (NuvaRing) arm 2: Oral contraceptive pill (Ortho Tri-cyclen Lo)
Interventions: intervention 1: Ortho Tri-cyclen Lo intervention 2: NuvaRing
Intervention descriptions: intervention 1: Low dose oral contraceptive intervention 2: Contraceptive vaginal ring

Protocol documents:
Clinical trial NCT00637273
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes exenatide once weekly Byetta sitagliptin Januvia thiazolidinedione Amylin Lilly Pioglitazone
Sponsor: AstraZeneca
Start date: 2008-01-01; Completion date: 2009-07-01
Enrollment: 514 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the benefits of exenatide once weekly treatment to those achieved by the approved antidiabetic therapies sitagliptin and pioglitazone in subjects whose type 2 diabetes is managed with metformin therapy alone. The safety and tolerability of the three treatment regimens will also be compared.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: exenatide once weekly intervention 2: sitagliptin intervention 3: pioglitazone intervention 4: placebo tablet intervention 5: placebo once weekly
Intervention descriptions: intervention 1: subcutaneous injection, 2.0mg, once a week intervention 2: oral tablet, 100mg, once a day intervention 3: oral tablet, 45mg, once a day intervention 4: oral tablet, once a day intervention 5: subcutaneous injection, once a week

Protocol documents: