ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01159938
Conditions: Diabetes Mellitus, Type 2
Sponsor: Eli Lilly and Company
Start date: 2010-10-01; Completion date: 2013-02-01
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This Study is looking at whether high blood glucose levels after a meal affect arterial stiffness more or less than low blood glucose levels, and whether certain cardiovascular markers influence the outcome of this.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Lispro
Intervention descriptions: intervention 1: Dosage based on participants with type 2 diabetes mellitus (T2DM) normal morning insulin dose and energy content of participant's normal breakfast. Subcutaneous injection given on one occasion. Administered once on low post prandial day.

Protocol documents:
Clinical trial NCT01161537
Conditions: Cystic Fibrosis
Sponsor: Vertex Pharmaceuticals Incorporated
Start date: 2010-10-01; Completion date: 2013-02-01
Enrollment: 13 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Cystic Fibrosis (CF) is caused by mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. The encoded protein, CFTR, is an epithelial chloride ion channel responsible for aiding in the regulation of salt and water absorption and secretion in various tissues. Although the disease affects multiple organs, the leading cause of mortality is the progressive loss of lung function. Obstruction of airways with thick mucus, chronic bacterial infection of the airways, and inflammatory response are all thought to play a role in causing lung damage. Through its function as a chloride channel, CFTR is believed to be integral in epithelial ion and water transport and hence, maintaining the normal hydration of lung secretions.

VX-770 (ivacaftor) is a potent and selective potentiator of wild-type, G551D, F508del, and R117H forms of human CFTR. Based on in vitro studies and pharmacologic, pharmacokinetic (PK), and safety profiles, VX-770 has been selected for clinical development as a possible treatment for patients with CF.

Hyperpolarized noble gas magnetic resonance imaging (HG-MRI) is a promising new means of assessing lung function by direct imaging of certain non-radioactive isotopes of an inert noble gas, such as helium or xenon. Through this technique, high-resolution 3-dimensional images of lung ventilation can be obtained in both pediatric and adult patients during a single short breath-hold following inhalation of the gas.

This is a 2-part study to evaluate the effect of VX-770 on hyperpolarized helium-3 magnetic resonance imaging (3He-MRI), and to evaluate the safety and efficacy of VX-770 in subjects aged 12 years and older with CF who have the G551D-CFTR mutation. Part A is a single-blind, placebo-controlled study that includes 4 weeks of VX-770 treatment and 4 weeks of placebo treatment. Part B is an open-label, 48 week study of long-term effect of VX 770 on hyperpolarized 3He-MRI.

Detailed description:

Arms: arm 1: Part A: Subjects received placebo tablets matched to VX-770 150 milligram (mg) orally twice daily from Day 1 to 14 (Placebo run-in period), followed by VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), and then placebo tablets matched to VX-770 150 mg orally twice daily from Day 43 to 57 (Placebo washout period) during Part A of the study.

Part B: Subjects received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study. Part B included subjects from Part A and newly enrolled subjects.
Interventions: intervention 1: VX-770 intervention 2: Placebo
Intervention descriptions: intervention 1: Tablet. intervention 2: Tablet.

Protocol documents:
Clinical trial NCT01164475
Conditions: Non-Hodgkin's Lymphoma
Sponsor: Genzyme, a Sanofi Company
Start date: 2010-10-01; Completion date: 2013-02-01
Enrollment: 61 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to compare the responses of 2 different doses of plerixafor in patients with Non-Hodgkin's Lymphoma (NHL) who received an autologous stem cell transplant.

Detailed description:

Arms: arm 1: 10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (greater than or equal to \[\>=\] 5\*10\^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred. arm 2: G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (\>=5\*10\^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
Interventions: intervention 1: Granulocyte-colony stimulating factor (G-CSF) intervention 2: Fixed Dose Plerixafor intervention 3: Weight-Based Plerixafor
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01183013
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2010-08-01; Completion date: 2013-02-01
Enrollment: 936 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective is to demonstrate superior glycaemic control (HbA1c reduction) after 30 weeks of linagliptin/pioglitazone (5/15, 5/30 and 5/45 mg) versus the respective individual monotherapies of pioglitazone (15 mg, 30 mg, or 45 mg, administered orally once daily), and linagliptin (5 mg, administered orally once daily). In addition, durability of treatment effect and safety under chronic treatment conditions will be investigated.

Detailed description:

Arms: arm 1: Pioglitazone Capsules 15 mg once daily arm 2: Pioglitazone Capsules 30 mg once daily arm 3: Pioglitazone Capsules 45 mg once daily arm 4: Linagliptin 5mg Tablets once daily arm 5: Linagliptin 5mg / Pioglitazone 15 mg Tablets once daily arm 6: Linagliptin 5mg / Pioglitazone 30 mg Tablets once daily arm 7: Linagliptin 5mg / Pioglitazone 45 mg Tablets once daily
Interventions: intervention 1: Pioglitazone 15 mg intervention 2: Pioglitazone 45 mg intervention 3: Pioglitazone 30 mg intervention 4: Linagliptin 5mg / Pioglitazone 45 mg FDC intervention 5: Linagliptin 5mg / Pioglitazone 30 mg FDC intervention 6: Linagliptin 5mg intervention 7: Linagliptin 5mg / Pioglitazone 15 mg FDC
Intervention descriptions: intervention 1: Pioglitazone Capsules 15 mg once daily for 30 weeks followed by Pioglitazone Capsules 30 mg once daily for up to 54 weeks intervention 2: Pioglitazone Capsules 30 mg once daily for 6 weeks followed by Pioglitazone Capsules 45 mg once daily for up to 78 weeks intervention 3: Pioglitazone Capsules 30 mg once daily for up to 84 weeks intervention 4: Linagliptin 5mg low dose / Pioglitazone 30 mg Tablets once daily for 6 weeks followed by Linagliptin 5mg low dose / Pioglitazone 45 mg FDC Tablets once daily for up to 78 weeks intervention 5: Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 84 weeks intervention 6: Linagliptin 5mg Tablets low dose once daily for 30 weeks followed by Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 54 weeks intervention 7: Linagliptin 5mg low dose / Pioglitazone 15 mg FDC Tablets once daily for 30 weeks followed by Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 54 weeks

Protocol documents:
Clinical trial NCT01191255
Conditions: Hyperphosphatemia Kidney Failure
Keywords: ESRD end-stage renal disease dialysis hemodialysis peritoneal dialysis hemodialysis (HD) peritoneal dialysis (PD) chronic renal insufficiency phosphate binder kidney failure renal failure
Sponsor: Keryx Biopharmaceuticals
Start date: 2010-10-01; Completion date: 2013-02-01
Enrollment: 441 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
This is up to a 58 week study comparing ferric citrate to active control for 52 weeks in ESRD dialysis patients, and subsequently comparing ferric citrate to placebo for 4 weeks.

Detailed description:
This trial is a three-period, multicenter, safety and efficacy clinical trial. The first period is a two-week Washout Period, the second period is a 52-week randomized, open-label, active control Safety Assessment Period, and the third period is a four-week, randomized, open-label, placebo-controlled Efficacy Assessment Period in only the patients who were randomized to treatment with ferric citrate during the Safety Assessment Period. The primary objectives of this trial are to determine the long-term safety over 52 weeks of up to twelve (12) caplets/day of KRX-0502 (ferric citrate) in patients with ESRD undergoing either hemodialysis or peritoneal dialysis and to determine the efficacy of KRX-0502 (ferric citrate) in the four-week, randomized, open-label, placebo-controlled Efficacy Assessment Period.

Arms: arm 1: PhosLo (calcium acetate) Renvela (sevelamer carbonate) arm 2: Placebo arm 3: ferric citrate
Interventions: intervention 1: ferric citrate, ca acetate, sevelamer carbonate, placebo
Intervention descriptions: intervention 1: All intervention doses will be based on serum phosphorus levels and/or drug label requirements

Protocol documents:
Clinical trial NCT01192698
Conditions: Hepatitis C Cirrhosis
Keywords: cirrhosis hepatitis C
Sponsor: Wake Forest University Health Sciences
Start date: 2009-10-01; Completion date: 2013-02-01
Enrollment: 15 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main goal of this study is to prevent liver allograft infection with Hepatitis C virus in hepatitis C positive patients undergoing liver transplantation. The hypothesis is that patients who receive ribavirin immediately before transplant and intravenous interferon alfa 2b during the anhepatic phase(while the liver is removed)will have sustained virologic response post liver transplant.

Detailed description:
The study is evaluating intravenous interferon given during the anhepatic phase of lvier transplant. Ribavirin was given as well. Serial measurements for HCV RNA were determined 12, 24 72, 96 hrs and 4 weeks after liver transplant.

Arms: arm 1: IV interferon oral ribavirin arm 2: standard of care
Interventions: intervention 1: IV interferon
Intervention descriptions: intervention 1: IV interferon 5MU during anhepatic phase

Protocol documents:
Clinical trial NCT01195662
Conditions: Type 2 Diabetes
Keywords: Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Angiotensin Receptor Inhibitors Angiotensin-Converting Enzyme Inhibitors Antihypertensive Agents Cardiovascular Agents Pharmacological Actions
Sponsor: AstraZeneca
Start date: 2010-10-01; Completion date: 2013-02-01
Enrollment: 2245 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to learn if BMS-512148 (Dapagliflozin), after 12 weeks, can improve (decrease) blood pressure in patients with type 2 diabetes with uncontrolled hypertension who are on an Angiotensin-converting enzyme inhibitor (ACEI) or an Angiotensin Receptor Blocker (ARB).The safety of this treatment will also be studied

Detailed description:

Arms: arm 1: Dapagliflozin 10 mg tablets arm 2: Placebo tablets matching dapagliflozin tablets
Interventions: intervention 1: Dapagliflozin intervention 2: Placebo matching Dapagliflozin
Intervention descriptions: intervention 1: Tablets, Oral, 10 mg, once daily, Up to 12 weeks intervention 2: Tablets, Oral, 0 mg, once daily, Up to 12 weeks

Protocol documents:
Clinical trial NCT01197755
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Sponsor: AstraZeneca
Start date: 2010-09-01; Completion date: 2013-02-01
Enrollment: 323 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the effectiveness of two dosing regimens of fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking methotrexate and have had an inadequate response to a single TNF-alpha antagonist. The study will last for approximately six months.

Detailed description:
Sub-study:

Full title: Optional Genetic Research

Date: 18 June 2010

Version: 1

Objectives: To collect and store, with appropriate consent ,DNA samples for future exploratory research into genes/genetic variation that may influence response (ie, absorption, distribution, metabolism and excretion, safety, tolerability and efficacy) to fostamatinib disodium and/or methotrexate; and/or susceptibility to, progression of and prognosis of RA

Arms: arm 1: Oral Treatment arm 2: Oral Treatment arm 3: Oral Treatment
Interventions: intervention 1: fostamatinib intervention 2: fostamatinib intervention 3: placebo
Intervention descriptions: intervention 1: fostamatinib 100 mg twice daily intervention 2: fostamatinib 100 mg twice daily/150 mg once daily intervention 3: Placebo twice daily

Protocol documents:
Clinical trial NCT01200797
Conditions: Recurrent Fallopian Tube Cancer Recurrent Ovarian Epithelial Cancer Recurrent Primary Peritoneal Cavity Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2010-07-01; Completion date: 2013-02-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well SJG-126 works in treating patients with epithelial ovarian, primary peritoneal, or fallopian tube cancer that did not respond to previous treatment with cisplatin or carboplatin. Drugs used in chemotherapy, such as SJG-136, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Detailed description:
PRIMARY OBJECTIVES:

I. To estimate the overall response rate to SJG-136 in patients with persistent or recurrent platinum-refractory epithelial ovarian, primary peritoneal, or fallopian tube carcinoma.

II. To assess the nature and degree of toxicity of this regimen in these patients.

III. To determine other parameters of response, including progression-free survival, overall survival, and time to progression in patients treated with this regimen.

Correlative Endpoints:

I. To correlate response rates with the degree of DNA adduct formation in peripheral blood mononuclear cells (PBMCs) and tumor cells as measured by the single-cell gel electrophoresis (Comet) assay and γ-H2AX assay.

II. To assess whether the rate of DNA adduct formation in PBMCs correlates with the rate of DNA adduct formation in tumor cells.

III. To evaluate BRCA1 protein expression in archival tissue specimens from the patient's primary tumor reductive surgery.

IV. To determine the ability of BRCA1 protein in repairing/removing DNA-adducts in PBMCs and tumor tissue.

VI. To evaluate the effect of BRCA1 protein expression on the overall response rate to SJG-136.

OUTLINE: This is a multicenter study.

Patients receive SJG-136 IV over 20 minutes on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients undergo blood sample collection at baseline and periodically during study for correlative studies. Tumor tissue samples may also be collected.

After completion of study therapy, patients are followed up for 30 days and then annually thereafter.

Arms: arm 1: Patients receive SJG-136 IV over 20 minutes on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: SJG-136 intervention 2: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given IV intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT01217463
Conditions: Diabetic Foot Ulcer of Neuropathic Origin
Keywords: Diabetic foot Neuropathic Wound Growth factor
Sponsor: Olympus Biotech Corporation
Start date: 2010-11-01; Completion date: 2013-02-01
Enrollment: 201 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Trafermin is a recombinant human basic fibroblast growth factor (bFGF; original development code, KCB-1), which is manufactured by genetic engineering using Escherichia coli by Kaken Pharmaceutical Co., Ltd. (Tokyo, Japan). Trafermin 0.01% cutaneous spray product kit consisting of a glass bottle containing lyophilized trafermin, a glass bottle with solvent for solution and a spray part to fit the glass bottle after reconstitution of the final product.

The investigators conduct a multinational, randomized, double-blind, placebo controlled, parallel-group, multicentre study consisting of a placebo run-in phase (2w), a treatment phase (max. 12w) and a follow-up phase (3mo+6mo). The primary objective of the study is to demonstrate a superior wound closure rate of diabetic foot ulcers (DFUs) of neuropathic origin after 12 weeks topical daily application of trafermin 0.01% spray compared with placebo, in addition to best local care (off-loading, dressings). Approximately 210 patients will be randomized and it is planned that this study will be conducted at approximately 30 investigational sites in an estimated 4 countries in Europe (Czech Republic,France,Hungary,Italy,).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Trafermin 0.01% spray
Intervention descriptions: intervention 1: For ulcers with a maximum diameter (longest axis) of less or equal to 6 cm, the daily dose of trafermin 0.01% spray is 5 puffs (30 microgram) sprayed onto the wound surface. If the maximum diameter (longest axis) of the ulcer is \>6 cm, the ulcer should be sprayed in two parts, i.e. 5 puffs (30 microgram) sprayed onto each half of the wound surface

Protocol documents:
Clinical trial NCT01231581
Conditions: Cancer
Sponsor: GlaxoSmithKline
Start date: 2010-08-01; Completion date: 2013-02-01
Enrollment: 160 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
GSK1120212 is a potent and highly selective inhibitor of MEK phosphorylation and kinase activity and has demonstrated potent anti-proliferative activity against human pancreatic cancer cell lines. This study is a Phase II, randomized placebo-controlled trial of the MEK inhibitor GSK1120212 plus gemcitabine vs. placebo plus gemcitabine in subjects with metastatic pancreatic cancer. Eligible subjects will receive intravenous gemcitabine with oral GSK1120212 or placebo. Therapy will continue until treatment discontinuation criteria are met. The primary objective will be to compare the overall survival of subjects in the GSK1120212 plus gemcitabine arm vs. subjects in the placebo plus gemcitabine arm. Secondary objectives include comparison of progression free survival, overall response rate, and duration of response between the two arms. Exploratory research objectives include the evaluation of population pharmacokinetics as well as blood and tissue based biomarkers. Safety will also be monitored throughout dosing.

Once the determined number of survival events has occurred, if subjects are eligible, they will have the option to enter MEK114375, an open-label, Phase Ib rollover study of GSK1120212 monotherapy or GSK1120212 in combination with other anti-cancer treatments.

Detailed description:

Arms: arm 1: GSK1120212 administered orally plus gemcitabine IV arm 2: Placebo administered orally plus gemcitabine IV
Interventions: intervention 1: GSK1120212 intervention 2: Gemcitabine intervention 3: Placebo
Intervention descriptions: intervention 1: administered orally starting on day 1 followed by a continuous daily dosing of 2.0 mg intervention 2: Intravenous gemcitabine infused over 30 minutes weekly for 7 weeks followed by one week of rest from treatment. Subsequent cycles will consist of 1000 mg/m2 intravenous infusion over 30 minutes on days 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment period. intervention 3: administered orally starting on day 1 followed by a continuous daily dosing of 2.0 mg

Protocol documents:
Clinical trial NCT01234883
Conditions: Dehydration Gastroenteritis
Keywords: dehydration gastroenteritis
Sponsor: Baxter Healthcare Corporation
Start date: 2011-06-01; Completion date: 2013-02-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to compare the efficacy and safety of the use of a multiple electrolyte solution to the use of saline for the treatment of moderate to severe dehydration due to acute gastroenteritis (AGE) in children.

Detailed description:
The primary objective of this study was to compare the efficacy and safety of the use of Plasma Lyte A to the use of NS for the treatment of moderate to severe dehydration and amelioration of metabolic acidosis due to AGE in children (≥ 6 months to \< 11 years of age) by measuring serum bicarbonate levels.

Arms: arm 1: Subjects were randomized to receive either multiple electrolyte solution or saline. These solutions were administered IV at 10-20 mL/kg until the subject appeared clinically rehydrated as assessed by the clinician. The selected dose for these solutions is considered standard of care when treating clinical dehydration in children and is consistent with product labeling. arm 2: Subjects were randomized to receive either multiple electrolyte solution or saline. These solutions were administered IV at 10-20 mL/kg until the subject appeared clinically rehydrated as assessed by the clinician. The selected dose for these solutions is considered standard of care when treating clinical dehydration in children and is consistent with product labeling.
Interventions: intervention 1: multiple electrolyte solution intervention 2: saline
Intervention descriptions: intervention 1: IV multiple electrolyte solution dosed as clinically indicated for rehydration intervention 2: IV solutions dosed as clinically indicated for rehydration

Protocol documents: