ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01562275
Conditions: Neoplasms
Keywords: GDC0973 MEK MEK inhibitor GDC0068 Akt Akt inhibitor
Sponsor: Genentech, Inc.
Start date: 2012-04-01; Completion date: 2015-01-01
Enrollment: 67 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This open-label, multicenter, Phase Ib dose-escalation study will evaluate the safety, tolerability and pharmacokinetics of oral dosing of GDC-0973 and GDC-0068 administered in combination in patients with locally advanced or metastatic solid tumors. Cohorts of patients will receive multiple ascending doses of GDC-0973 and GDC-0068. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

Detailed description:

Arms: arm 1: Participants will receive cobimetinib (GDC-0973) capsules (at a starting dose of 40 mg) and ipatasertib (GDC-0068) capsules (at a starting dose of 200 mg) from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Doses will be increased to identify maximum tolerated dose (MTD) or potential recommended Phase 2 dose (RP2D). Treatment will continue until disease progression, unacceptable toxicity, or any other discontinuation criterion meets. arm 2: Participants will receive cobimetinib (GDC-0973) capsules (at a starting dose of 100 mg) on Days 1, 4, 8, 11, 15, and 18 and ipatasertib (GDC-0068) capsules (at a starting dose of 200 mg) from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Doses will be increased to identify MTD or potential RP2D. Treatment will continue until disease progression, unacceptable toxicity, or any other discontinuation criterion meets. arm 3: Participants will receive cobimetinib (GDC-0973) capsules on Days 1, 4, 8, 11, 15, and 18 and ipatasertib (GDC-0068) capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles, at doses identified as MTD/potential RP2D from Stage 1. Treatment will continue until disease progression, unacceptable toxicity, or any other discontinuation criterion meets. This indication specific cohort will include participants with phosphatase and tensin homolog (PTEN)-loss triple-negative breast cancer and PTEN-loss endometrial carcinoma.
Interventions: intervention 1: Ipatasertib intervention 2: Cobimetinib
Intervention descriptions: intervention 1: multiple doses intervention 2: multiple doses

Protocol documents:
Clinical trial NCT01577966
Conditions: Brain Tumor
Keywords: Patients with brain tumors associated with seizures
Sponsor: University of Alabama at Birmingham
Start date: 2012-01-01; Completion date: 2015-01-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The main purpose of this part of the study is to determine the Central Nervous System bioavailability of sulfasalazine.

Detailed description:
This is a pilot, open-label, non-randomized, study to determine the effect that orally administered sulfasalazine has on glutamate levels as measured by MRS and on epileptiform spiking as measured by simultaneous MEG/EEG. The intent of the dose escalation is to determine an Optimal Biological Dose (OBD) based on changes in tumor glutamate levels. The OBD is defined as the dose that has the maximal reduction in tumor glutamate levels after normalization to uninvolved brain.

Arms: arm 1: None
Interventions: intervention 1: Sulfasalazine
Intervention descriptions: intervention 1: Sulfasalazine has been the parent aminosalicylate in use for over 40 years in the treatment of inflammatory bowel disease. The drug is a conjugate of sulfapyridine linked to 5-aminosalicylic acid. In inflammatory bowel disease, the 5-ASA component is the active moiety

Sulfasalazine is a prodrug that consists of sulfapyridine bonded to mesalamine (5-ASA). Sulfasalazine is cleaved by colonic bacterial azo-reductases into sulfapyridine and the 5-ASA moiety. 5-ASA is metabolized to N-acetyl-5-ASA by an enzyme in the intestinal epithelium and the liver and then excreted in the urine as a mixture of free 5ASA and N-acetyl-5-ASA.

Protocol documents:
Clinical trial NCT01584388
Conditions: Retroperitoneal Fibrosis Autoimmune Pancreatitis Sialadenitis Pseudotumor
Keywords: Type 1 autoimmune pancreatitis IgG4-related sclerosing cholangitis Chronic sclerosing sialadenitis Lacrimal glands Orbital pseudotumor IgG4-related tubulointerstitial nephritis Lymphadenopathy Pachymeningitis Aorta Peri-aortitis Retroperitoneal fibrosis Riedel's thyroiditis
Sponsor: Massachusetts General Hospital
Start date: 2012-04-01; Completion date: 2015-01-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to evaluate the safety and effectiveness of rituximab in IgG4-RD.

Detailed description:
This two-center trial will enroll at total of 30 patients with IgG4-RD. The two participating sites are the Massachusetts General Hospital (Boston, MA) and the Mayo Clinic (Rochester, MN). All patients will receive rituximab 1 gram intravenously times two doses, separated by approximately 15 days. The primary efficacy outcome - disease remission and successful completion of the glucocorticoid taper - will be assessed at six months. Patients will be followed on the protocol for an additional six months after measurement of the primary outcome.

Arms: arm 1: None
Interventions: intervention 1: Rituximab
Intervention descriptions: intervention 1: Rituximab 1000 mg IV times two doses, separated by approximately 15 days.

Protocol documents:
Clinical trial NCT01594125
Conditions: Carcinoma, Hepatocellular
Sponsor: Boehringer Ingelheim
Start date: 2012-05-01; Completion date: 2015-01-01
Enrollment: 30 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the study is to investigate the safety, tolerability, efficacy and pharmacokinetics (PK) for Japanese hepatocellular carcinoma which are not amenable to curative surgery or loco regional therapy

Detailed description:

Arms: arm 1: patients with mild liver dysfunction according to their AST/ALT values and Child-Pugh score arm 2: patients with moderate liver dysfunction according to their AST/ALT values and Child-Pugh score
Interventions: intervention 1: Nintedanib high dose intervention 2: Nintedanib low dose intervention 3: Nintedanib medium dose intervention 4: Nintedanib medium dose intervention 5: Nintedanib high dose
Intervention descriptions: intervention 1: twice daily oral dosing intervention 2: twice daily oral dosing intervention 3: twice daily oral dosing intervention 4: twice daily oral dosing intervention 5: twice daily oral dosing

Protocol documents:
Clinical trial NCT01603940
Conditions: Hypertension Diabetes Mellitus
Keywords: Hypertension Diabetes Mellitus Vascular stiffness Endothelial function
Sponsor: Hospital Universitario Pedro Ernesto
Start date: 2012-05-01; Completion date: 2015-01-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare losartan and benazepril in diabetic patients whose high blood pressure is not controlled by amlodipine and its relationship to statin current use.

Detailed description:
Hypertension and diabetes mellitus are important risk factors for cardiovascular morbidity and mortality. Endothelial dysfunction and vascular rigidity are two pathophysiological mechanisms that may explain this relationship. Recent publications showed that both ACEi (angiotensin-converting enzyme inhibitor-induced) and ARB (angiotensin receptor blocker) were capable of improving vascular stiffness and endothelial function, and that these effects occurred despite blood pressure reduction.

This study main objective is to assess if ARB (losartan) effects are different from ACEi (benazepril) in endothelial function in patients with diabetes mellitus type 2 and blood pressure not controlled by amlodipine and its relationship to statin current use.

Secondary analysis of vascular stiffness will be measured by pulse wave velocity and augmentation index. Echocardiographic parameters, such as indexes of diastolic function, will also be measured.

Arms: arm 1: This group will receive 100 mg of losartan per day. Amlodipine will be maintained. arm 2: This group will receive 20 mg of benazepril per day. Amlodipine will be maintained.
Interventions: intervention 1: Benazepril intervention 2: Losartan
Intervention descriptions: intervention 1: Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks. intervention 2: Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks.

Protocol documents:
Clinical trial NCT01609543
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Sponsor: Hoffmann-La Roche
Start date: 2012-05-01; Completion date: 2015-01-01
Enrollment: 62 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open-label, non-randomized, one-arm study will evaluate the safety and efficacy of Tarceva (erlotinib) as single-agent first-line treatment in patients with locally advanced or metastatic non-small cell lung cancer who show epidermal growth factor receptor (EGFR) activating mutations. Patients will receive Tarceva 150 mg orally daily until disease progression or unacceptable toxicity occurs.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: erlotinib [Tarceva]
Intervention descriptions: intervention 1: 150 mg orally daily, until disease progression, unacceptable toxicity or withdrawal due to any reason

Protocol documents:
Clinical trial NCT01615939
Conditions: Fracture of Foot
Keywords: Sciatic Nerve Block Continuous Nerve Block
Sponsor: Northwestern University
Start date: 2012-06-01; Completion date: 2015-01-01
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the incidence of postoperative symptoms of neurologic injury after a single shot infragluteal-parabiceps sciatic nerve block versus a continuous infragluteal-parabiceps sciatic nerve catheter.

Detailed description:
There are a limited number of prospective studies in the literature examining the risk of neurologic injury and symptoms after sciatic nerve blocks. The incidence of transient neurological symptoms after a continuous catheter is not well reported.

Arms: arm 1: Single shot sciatic nerve blocks will be performed by resident trainees supervised by faculty. Bupivacaine 0.625% with epinephrine 1:300,000 will be injected incrementally in 3-ml aliquots to a total volume of 0.4 ml/kg (minimum, 20 ml; maximum, 35 ml). arm 2: Continuous sciatic nerve block catheters will be performed using an insulated needle connected to the negative lead of a constant current nerve stimulator. The catheter will be advanced under ultrasound guidance. A test dose of 1.5% lidocaine with epinephrine will be injected to confirm catheter placement. All subjects will receive a portable pump that will infuse 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr. The subjects will follow standard protocol discharge instructions in regards to removing the catheter themselves.
Interventions: intervention 1: Bupivacaine intervention 2: Ropivacaine
Intervention descriptions: intervention 1: Bupivacaine 0.625% with epinephrine 1:300,000 intervention 2: 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr.

Protocol documents:
Clinical trial NCT01617655
Conditions: Hypercholesterolaemia
Sponsor: Sanofi
Start date: 2012-06-01; Completion date: 2015-01-01
Enrollment: 107 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9).

Primary Objective of the study:

To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo.

Secondary Objectives:

* To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time points
* To evaluate the effects of alirocumab on other lipid parameters
* To evaluate the safety and tolerability of alirocumab

Detailed description:
The maximum study duration was planned to be 89 weeks per participant including participants who successfully completed the 78-week treatment period had the possibility to join an open-label extension study (LTS13463, NCT01954394) at the end of the treatment period.

Arms: arm 1: Placebo for alirocumab subcutaneous (SC) injection every two weeks (Q2W) on top of stable lipid-modifying therapy (LMT) for 78 weeks. arm 2: Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
Interventions: intervention 1: Alirocumab intervention 2: Placebo (for alirocumab) intervention 3: Lipid Modifying Therapy (LMT)
Intervention descriptions: intervention 1: Solution for subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using auto-injector (also known as pre filled pen). intervention 2: Solution for subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using auto-injector (also known as pre filled pen). intervention 3: Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose with or without other LMT as clinically indicated.

Protocol documents:
Clinical trial NCT01619059
Conditions: Type 2 Diabetes
Sponsor: AstraZeneca
Start date: 2012-06-01; Completion date: 2015-01-01
Enrollment: 315 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to learn if BMS-477118 (Saxagliptin) as part of a triple combination therapy can improve (decrease) hemoglobin A1c in patients with type 2 diabetes after 24 weeks of treatment compared to a 2 drug oral antidiabetic therapy. The safety of this treatment will also be studied.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Saxagliptin intervention 2: Dapagliflozin intervention 3: Metformin IR intervention 4: Placebo matching with Saxagliptin
Intervention descriptions: intervention 1: Tablets, Oral, 5 mg, Once daily, Up to 52 weeks intervention 2: Tablets, Oral, 10 mg, Once daily, Up to 52 weeks intervention 3: Tablets, Oral, ≥ 1500mg, Twice daily, Up to 52 weeks intervention 4: Tablets, Oral, 0 mg, Once daily, Up to 52 weeks

Protocol documents:
Clinical trial NCT01629563
Conditions: Uterine Fibroids
Sponsor: PregLem SA
Start date: 2012-06-01; Completion date: 2015-01-01
Enrollment: 451 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Phase III, multicentre, randomized, double-blind, parallel group, long-term study investigating the efficacy and safety of the 5mg and 10mg doses of PGL4001 for the treatment of uterine myoma.

Detailed description:
The target population is composed of pre-menopausal women with symptomatic uterine myoma(s) characterised by heavy bleeding.The main objective of this study is to assess the sustained efficacy and safety of long term on-off treatment with PGL4001 5 or 10mg doses on uterine bleeding, myoma size, pain and quality of life.

Arms: arm 1: All subjects will be asked to take a 150mg size tablet (PGL4001 5mg or matching placebo: placebo 5) orally daily for repeated periods 84 days. The first treatment course will start on the first 4 days of menstruation and will be orally administered, once daily (1 tablet of 150mg size), for 84 days. The following three treatment courses should be started in the first two days of a menstrual period. arm 2: All subjects will be asked to take a 300mg size tablet (PGL4001 10mg or matching placebo: placebo 10 ) orally daily for repeated periods 84 days. The first treatment course will start on the first 4 days of menstruation and will be orally administered, once daily (1 tablet of 300mg size), for 84 days. The following three treatment courses should be started in the first two days of a menstrual period.
Interventions: intervention 1: PGL4001 5 mg intervention 2: PGL4001 10 mg
Intervention descriptions: intervention 1: PGL4001 5 mg daily administration intervention 2: PGL4001 10mg daily administration

Protocol documents:
Clinical trial NCT01632020
Conditions: Colorectal Neoplasms
Keywords: colorectal tumor colorectal cancer colorectal carcinoma neoplasms, colorectal Metformin
Sponsor: University of Arkansas
Start date: 2012-08-01; Completion date: 2015-01-01
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the effects of short term oral Metformin therapy on biomarkers for tumor growth in subjects with newly diagnosed colon or rectal adenocarcinoma.

It is hypothesized that there are independent actions of Metformin on the outcome of subjects with colorectal cancer (CRC). Also hypothesized is that metformin effects on CRC cell growth will correlate with this drug's effects on markers mentioned above, because the markers are closely related to tumor growth and metastases.

Detailed description:
This is a randomized, double-blinded placebo controlled clinical investigation of the effects of short term oral Metformin therapy on biomarkers for tumor growth in subjects with newly diagnosed colon or rectal adenocarcinoma. Metformin is a well-tolerated drug widely prescribed for treatment of Type 2 diabetes mellitus. Preliminary studies have generated the hypothesis that metformin may have positive effects on both prevention and survival of colon cancer subjects. Clinical trials are ongoing to explore this possibility in breast cancer (NCT01101438). This investigation is the first study of Metformin in colorectal cancer (CRC) patients, and is designed to understand the mechanism of its anti-cancer actions, if any, and its interactions with biomarkers in colorectal cancer patients.

Based upon epidemiological studies, it is hypothesized that there are independent actions of Metformin on the outcome of subjects with CRC. Also hypothesized is that metformin effects on CRC cell growth will correlate with this drug's effects on markers mentioned above, because the markers are closely related to tumor growth and metastases.

Arms: arm 1: Placebo 2 capsules by mouth twice daily; minimum of 10 days, maximum of 21 days arm 2: Metformin 850 mg (2 capsules) by mouth twice daily; minimum of 10 days, maximum of 21 days
Interventions: intervention 1: Placebo intervention 2: Metformin
Intervention descriptions: intervention 1: 2 capsules by mouth twice daily; minimum of 10 days, maximum of 21 days intervention 2: 850 mg (2 capsules) by mouth twice daily; minimum of 10 days, maximum of 21 days

Protocol documents:
Clinical trial NCT01641822
Conditions: Cystic Fibrosis
Sponsor: Gilead Sciences
Start date: 2012-12-01; Completion date: 2015-01-01
Enrollment: 107 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the safety and efficacy of a CAT regimen with aztreonam for inhalation solution (AZLI) and tobramycin inhalation solution (TIS) in adult and pediatric subjects with cystic fibrosis (CF) and pulmonary Pseudomonas aeruginosa (PA) infection. Participants will be enrolled in a 28 day TIS run-in phase, and will be eligible for randomization in the comparative phase if they have not received non-study oral antibiotics for a respiratory event, or IV or inhaled antibiotics for any indication between Visits 2 and 3, have not developed a condition requiring hospitalization or other change in clinical status which, in the opinion of the investigator would preclude their ability to continue in the study, and have demonstrated at least 50% TIS compliance. Participants enrolled in the comparative phase will be randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: AZLI or placebo for 28 days followed by TIS for 28 days.

Detailed description:

Arms: arm 1: Participants will be randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: AZLI for 28 days followed by TIS for 28 days. arm 2: Participants will be randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: placebo to match AZLI for 28 days followed by TIS for 28 days.
Interventions: intervention 1: AZLI intervention 2: Placebo to match AZLI intervention 3: Tobramycin inhalation solution
Intervention descriptions: intervention 1: Aztreonam for Inhalation Solution (AZLI) 75 mg 3 times daily combined with diluent administered using an eFlow nebulizer intervention 2: Placebo to match AZLI 3 times daily combined with diluent administered using an eFlow nebulizer intervention 3: Tobramycin inhalation solution (TIS) 300 mg 2 times daily using a PARI® LC Plus nebulizer and DeVilbiss Pulmo-Aide® air compressor

Protocol documents:
Clinical trial NCT01657461
Conditions: Acute Ischemic Stroke
Sponsor: Medtronic Neurovascular Clinical Affairs
Start date: 2012-12-01; Completion date: 2015-01-01
Enrollment: 196 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary study objective is to determine if subjects experiencing an acute ischemic stroke due to large vessel occlusion, treated with combined IV t-PA and Solitaire Revascularization Device within 6 hours of symptom onset have less stroke-related neurological disability (mRS) than those subjects treated with IV t-PA alone

Detailed description:

Arms: arm 1: Dual IV tPA therapy and adjunctive treatment with the Solitaire revascularization device arm 2: Infusion of intravenous tissue plasminogen activator (IV t-PA)
Interventions: intervention 1: Intravenous (IV) recombinant human tissue plasminogen activator (rtPA) intervention 2: Solitaire revascularization device
Intervention descriptions: intervention 1: Standard therapy with Intravenous (IV) recombinant human tissue plasminogen activator (rtPA) intervention 2: Clot retrieval with the Solitaire revascularization device after patients have received standard therapy with intravenous tissue plasminogen activator

Protocol documents:
Clinical trial NCT01709500
Conditions: Heterozygous Familial Hypercholesterolemia
Sponsor: Regeneron Pharmaceuticals
Start date: 2012-12-01; Completion date: 2015-01-01
Enrollment: 249 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind, placebo-controlled, parallel-group, multi-national study alirocumab (REGN727/SAR236553) in patients with Heterozygous Familial Hypercholesterolemia (heFH) who are not adequately controlled with their Lipid-Modifying Therapy (LMT).

Detailed description:

Arms: arm 1: Alirocumab 75 mg every two weeks (Q2W) added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8. arm 2: Placebo matched to alirocumab SC injection for 78-week treatment duration.
Interventions: intervention 1: LMT (atorvastatin, simvastatin, or rosuvastatin) intervention 2: alirocumab intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: Alirocumab administered as a subcutaneous (SC) injection of 1 mL into the abdomen, thigh, or outer area of the upper arm. intervention 3: Placebo matched to alirocumab administered as a SC injection of 1 mL into the abdomen, thigh, or outer area of the upper arm.

Protocol documents: