ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01163149
Conditions: Hypophosphatasia
Keywords: Hypophosphatasia HPP Bone Disease Soft Bones Low Alkaline Phosphatase genetic metabolic disorder alkaline phosphatase tissue-specific alkaline phosphatase (TNSALP) rickets osteomalacia
Sponsor: Alexion Pharmaceuticals, Inc.
Start date: 2010-06-01; Completion date: 2016-06-01
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This clinical trial was conducted to study hypophosphatasia (HPP), a bone disorder caused by gene mutations or changes. These gene mutations cause low levels of an enzyme needed to harden bone. The purpose of this study was to test the safety and efficacy of two doses of the study drug called asfotase alfa as compared to a control group to see effects on adolescents and adults with HPP.

Detailed description:
Asfotase alfa was formerly referred to as ENB-0040

Hypophosphatasia (HPP) is a life-threatening, genetic, and ultra-rare metabolic disease characterized by defective bone mineralization and impaired phosphate and calcium regulation that can lead to progressive damage to multiple vital organs, including destruction and deformity of bones, profound muscle weakness, seizures, impaired renal function, and respiratory failure. There are limited data available on the natural course of this disease over time, particularly in patients with the juvenile-onset form.

Arms: arm 1: Cohort 1: Daily SC injections of 0.3 mg/kg asfotase alfa (2.1 mg/kg/week total) arm 2: Cohort 2: Daily SC injections of 0.5 mg/kg asfotase alfa (3.5 mg/kg/week total) arm 3: Following completion of the Week 24 visit, all patients (including those randomized to the concurrent control cohort) may be eligible to participate in an open-label extension treatment period. In this extension period, all patients will be treated with daily SC injections of 0.5 mg/kg/day asfotase alfa (a total of 3.5 mg/kg/week) for approximately 24 weeks, then subjects will receive 1 mg/kg/day 6 days/week for an additional 48 weeks or until regulatory approval of the drug.
Interventions: intervention 1: asfotase alfa intervention 2: asfotase alfa
Intervention descriptions: intervention 1: Cohort 1: Daily SC injections of 0.3 mg/kg asfotase alfa (total of 2.1 mg/kg/week) intervention 2: Cohort 2: Daily SC injections of 0.5 mg/kg Asfotase Alfa (3.5 mg/kg/week total)

Protocol documents:
Clinical trial NCT01186562
Conditions: Pancreatitis Diabetes
Keywords: Pancreatitis Pancreatectomy Islet autotransplant Sitagliptin Diabetes
Sponsor: University of Minnesota
Start date: 2010-08-01; Completion date: 2016-06-01
Enrollment: 83 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to test the effects of sitagliptin on the need for insulin (the hormone that lowers blood sugars) by patients who receive a pancreatectomy and islet autotransplant for chronic pancreatitis.

Detailed description:
At the current time, about one-third of patients are insulin independent (do not need to take insulin) after autotransplant, but the other two-thirds still need some insulin. Sitagliptin works by increasing the amount of a hormone called glucagon-like peptide 1, or GLP-1, in the body which then increases the amount of insulin that is made by the beta cells(the insulin producing cell of the islets). GLP-1 might also help protect beta cells from dying under stressful conditions and increase the production of new beta cells.

The primary goal of this study is to see if taking sitagliptin for one year after islet autotransplant increases the number of patients who achieve and maintain insulin independence. Other goals of this study are to see if sitagliptin reduces the amount of insulin injections needed or helps the islets make more insulin.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Sitagliptin intervention 2: Placebo
Intervention descriptions: intervention 1: 100 mg PO daily intervention 2: Placebo

Protocol documents:
Clinical trial NCT01203917
Conditions: Caucasian Patients With EGFR Mutation Positive Advanced NSCLC
Keywords: Gefitinib EGFR TKI efficacy Caucasian patients EGFR mutation positive advanced NSCLC safety
Sponsor: AstraZeneca
Start date: 2010-09-01; Completion date: 2016-06-01
Enrollment: 1060 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is carried out to see how Caucasian patients with lung cancer which has EGFR mutation will respond to gefitinib (IRESSA™) as a first line treatment. Safety data will also be collected and analysed to confirm that treatment with gefitinib is safe and well tolerated.

Detailed description:
An Open Label, Multicentre, Single Arm Study to Characterise the Efficacy, Safety and Tolerability of Gefitinib 250 mg (IRESSA™) as First line Treatment in Caucasian Patients, who have Epidermal Growth Factor Receptor (EGFR) Mutation Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Arms: arm 1: gefitinib 250mg tablet
Interventions: intervention 1: Gefitinib
Intervention descriptions: intervention 1: 250mg tablet oral, once daily until objective disease progression is documented or until other discontinuation criterion is met

Protocol documents:
Clinical trial NCT01203930
Conditions: Chronic Lymphocytic Leukemia (CLL) Small Lymphocytic Lymphoma (SLL)
Keywords: CLL SLL GS-1101 CAL-101 Phosphatidylinositol 3-kinase (PI3K) Rituximab Rituxan
Sponsor: Gilead Sciences
Start date: 2010-10-01; Completion date: 2016-06-01
Enrollment: 105 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is to evaluate the safety and clinical activity of idelalisib alone and in combination with rituximab in patients with CLL or SLL.

This Phase 2 study will be the first time that idelalisib is administered to previously untreated patients with hematologic malignancies. Idelalisib has demonstrated clinical activity as a single agent in relapsed or refractory CLL and SLL with acceptable toxicity, which supports its evaluation in previously untreated patients. The study population is limited to patients over 65 years of age because younger patients are generally appropriate for standard immunochemotherapy regimens that are highly active. Since the mechanism of action of idelalisib is distinct from rituximab, it is hypothesized that the combination will be more active than either agent alone. This study will establish initial safety and clinical activity of idelalisib in combination with rituximab in patients with CLL or SLL. Cohort 2 of this study will establish safety and clinical activity of idelalisib alone in subjects with untreated CLL or SLL.

Detailed description:

Arms: arm 1: This arm consists of 2 cohorts. Participants in Cohort 1 will receive idelalisib for up to twelve 28-day cycles (or development of unacceptable toxicity) plus rituximab (8 doses through the end of Cycle 2). Upon completion of twelve 28-cycles, participants are eligible to remain on idelalisib in a continuation protocol. Participants in Cohort 2 will receive idelalisib until disease progression or development of unacceptable toxicity.
Interventions: intervention 1: Idelalisib intervention 2: Rituximab
Intervention descriptions: intervention 1: Idelalisib 150 mg tablets administered orally twice daily intervention 2: Rituximab 375 mg/m\^2 administered intravenously once weekly x 8 weeks

Protocol documents:
Clinical trial NCT01232452
Conditions: Non-Small-Cell Lung Carcinoma
Keywords: lung cancer advanced non-small cell
Sponsor: Eli Lilly and Company
Start date: 2011-04-01; Completion date: 2016-06-01
Enrollment: 172 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to evaluate the hypothesis that cixutumumab given in combination with cisplatin and pemetrexed is superior to cisplatin and pemetrexed as first-line therapy for patients with advanced nonsquamous non-small cell lung carcinoma (NSCLC).

Detailed description:

Arms: arm 1: Induction Treatment: Pemetrexed 500 mg/m\^2 plus cisplatin 75 mg/m\^2 plus cixutumumab 20 mg/kg given intravenously (IV) on Day 1 of a 21 day cycle for up to 4 cycles. Two additional cycles of cisplatin may be given (6 cycles total) for patients with significant tumor size reduction, after sponsor approval.

Maintenance Therapy: Pemetrexed 500 mg/m\^2 plus cixutumumab 20 mg/kg given IV every 21 days until progression of disease, unacceptable toxicity, or another withdrawal criterion is met. arm 2: Induction Treatment: Pemetrexed 500 mg/m\^2 plus cisplatin 75 mg/m\^2 given intravenously (IV) on Day 1 of a 21 day cycle for up to 4 cycles. Two additional cycles of cisplatin may be given (6 cycles total) for patients with significant tumor size reduction, after sponsor approval.

Maintenance Therapy: Pemetrexed 500 mg/m\^2 given IV every 21 days until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.
Interventions: intervention 1: Pemetrexed intervention 2: Cisplatin intervention 3: Cixutumumab
Intervention descriptions: intervention 1: Administered intravenously (IV) intervention 2: Administered IV intervention 3: Administered IV

Protocol documents:
Clinical trial NCT01252251
Conditions: Uveal Melanoma
Keywords: PASIREOTIDE (SOM230) RAD001 (EVEROLIMUS) eye 10-123
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2010-11-01; Completion date: 2016-06-01
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to find out what effects, good and/or bad, the drugs everolimus and pasireotide have on the patient and on melanoma. Pasireotide is also called SOM-230. Pasireotide is an experimental drug and is not approved by the Food and Drug Administration. Everolimus is also called RAD001. Everolimus is approved for use in the U.S. for kidney cancer. Everolimus is not approved for treatment of melanomas, but early studies show that it may help some patients with melanoma.

Detailed description:

Arms: arm 1: This study will be an open-label, single-arm, phase II study of RAD001 and pasireotide LAR.
Interventions: intervention 1: RAD001 (Everolimus) and Pasireotide (SOM230) LAR
Intervention descriptions: intervention 1: Patients will be treated with SOM-230 (pasireotide) LAR 60mg IM once every 28 days and with RAD001 (Everolimus) 10mg PO daily. Each cycle is 28 days. An optional biopsy may be requested required after weeks of therapy. The biopsy may be performed between days 28 and 42.

Protocol documents:
Clinical trial NCT01399658
Conditions: Cervical Cancer Uterine Cancer Vaginal Cancer Carcinoma of the Vulva
Keywords: Brachytherapy Gynecological cancer
Sponsor: Dana-Farber Cancer Institute
Start date: 2011-09-01; Completion date: 2016-06-01
Enrollment: 93 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Standard therapy for gynecologic cancers involves the use of brachytherapy, also called internal radiation therapy or implant radiation. The treatment being studied consists of standard brachytherapy with the additional use of MRI to guide the insertion of radioactive applicators. The purpose of the study is to find out whether MRI-guided brachytherapy is practical and beneficial when compared to the standard CT-guided brachytherapy placement. The investigators are hoping that this MRI procedure will decrease the risk of giving too high a radiation dose to the bladder or bowel.

Detailed description:
The insertion of the brachytherapy applicator will be administered in the Advanced Multimodality Image-Guided Operating (AMIGO) suite at Brigham and Women's Hospital. Subjects will undergo an MRI scan in the AMIGO suite ensuring proper placement of the applicator. Subjects may have an optional FMISO-PET scan.

Subjects will have a follow-up visit including physical exam, pap smear, and MRI of the pelvis and/or PET scan 90 days after treatment.

Subjects will have a follow-up visit including physical exam, pap smear, and MRI of the pelvis and/or PET scan 180 days after treatment.

Arms: arm 1: Image-guided brachytherapy
Interventions: intervention 1: Image-guided brachytherapy intervention 2: 3'-Deoxy-3'-18f-Fluorothymidine
Intervention descriptions: intervention 1: MRI-guided application of brachytherapy intervention 2: Assessing tumor proliferation in Gynecologic cancer

Protocol documents:
Clinical trial NCT01443546
Conditions: Infertility
Keywords: oocyte donor oocyte recipient ovulation trigger
Sponsor: Weill Medical College of Cornell University
Start date: 2013-01-01; Completion date: 2016-06-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The project is a randomized, controlled, prospective study of oocyte donors comparing the safety and efficacy of triggering ovulation using a combination of two drugs-GnRH agonist and very low dose hCG-versus triggering ovulation with a standard hCG dose alone or a standard GnRH trigger alone.

Detailed description:
The study population will consist of young women, age 21 to 34, presenting to our facility with the desire to donate oocytes and who meet FDA and program requirements for donation.

Participants will be randomized to one of the three treatment interventions for triggering ovulation: 1) a standard dose of hCG, 2) leuprolide acetate 2 mg alone, or 3) a combination of the two drugs in low dosage (leuprolide acetate 2 mg and hCG 1500 IU).

Study participants who choose to repeat oocyte donation during the course of the study trial, and who consent to participate in the trial again, will be randomized in a cross-over manner for any subsequent trials.

Following randomization, the clinical care of study subjects will be the same as for non-participant oocyte donors. Participants in all three study arms will undergo standard ovarian stimulation protocol with gonadotropins, standard individualized adjustment of medication dose, standard criteria for administration of the ovulation trigger dose, and standard egg retrieval procedure.

The recipient population will be recruited from women, age 18 to 55, who present to our center wishing to become pregnant using donor oocytes. All prospective participants who meet the Center for Reproductive Medicine (CRM) criteria be recipients of donated eggs will be eligible to participate, should they wish to do so.

If a prospective recipient consents to participate in the study, then she would be matched with either a donor who is not participating in the study (and is receiving one of our standard triggers for ovulation) or a donor who is participating in the study and whose medication to trigger ovulation has been randomized into one of three groups: standard dose hCG, Leuprolide acetate, or a combination of low dose hCG and Leuprolide acetate.

A recipient who chooses to participate in the study will have no additional tests or procedures over the ones that she would normally do in order to receive donated eggs.

Arms: arm 1: standard dose of hCG for ovulation trigger arm 2: Leuprolide acetate 2 mg ovulation trigger arm 3: Lupron and hCG combined ovulation trigger
Interventions: intervention 1: HCG intervention 2: Lupron Trigger intervention 3: Dual Trigger
Intervention descriptions: intervention 1: hCG Trigger intervention 2: leuprolide acetate 2 mg SQ intervention 3: a combination of the two drugs in low dosage (leuprolide acetate 2 mg and hCG 1500 IU).

Protocol documents:
Clinical trial NCT01492101
Conditions: Locally Recurrent Breast Cancer Metastatic Breast Cancer
Sponsor: Nektar Therapeutics
Start date: 2011-12-01; Completion date: 2016-06-01
Enrollment: 852 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is designed as an open-label, randomized, parallel, two arm, multicenter, international Phase 3 study in patients with recurrent or metastatic breast cancer previously treated with cytotoxic chemotherapy regimens.

The primary study objective is to compare overall survival of patients who receive NKTR-102 given once every 21 days to patients who receive treatment of Physician's Choice selected from a list of seven single-agent intravenous therapies.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: NKTR-102 intervention 2: Treatment of Physician's Choice (TPC)
Intervention descriptions: intervention 1: 145 mg/m2 NKTR-102 will be delivered q21day as a 90-minute intravenous (IV) infusion on day 1 of each treatment cycle. intervention 2: One of the following Treatment of Physician Choice will be administered per standard of care:

eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel

Protocol documents:
Clinical trial NCT01505673
Conditions: Type 2 Diabetes Mellitus Obesity
Keywords: Insulin Glucagon-like peptide Liraglutide Beta-Cell pancreatic steatosis hepatic steatosis
Sponsor: Ildiko Lingvay
Start date: 2012-01-01; Completion date: 2016-06-01
Enrollment: 71 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate whether the addition of liraglutide 1.8 mg/day to a high-dose insulin regimen (\>1.8 units/kg/day) in patients with uncontrolled (HbA1c \>7.5%) type 2 diabetes mellitus will improve blood sugar control.

It also evaluates the effect of liraglutide on liver and pancreatic fat content, explores the mechanism of blood sugar improvement by assessing weight and pancreatic hormone release, and assesses blood pressure, lipid profile, and liver function. Finally it will look at patient quality of life and safety.

Detailed description:
Type 2 diabetes is a progressive disease with incessant beta-cell dysfunction that often ultimately requires insulin treatment. Patients requiring high insulin dosages represent a particular treatment challenge and often have uncontrolled glycemia despite progressive dose increases and are especially prone to insulin related lipotoxicity and weight gain.

Glucagon-like peptide agonists (GLP-1) such as liraglutide have many actions that position them to break the vicious cycle in this population through the following mechanisms: (1) weight loss; (2) improved hepatic steatosis; (3) improved pancreatic steatosis; (4) decreased glucagon levels; (5) improved beta-cell function.

The purpose of the study is to demonstrate that liraglutide is both effective and safe when added to a high dose insulin treatment regimen. Liraglutide will improve glycemic control, weight, metabolic parameters, as well as patient satisfaction, with minimal adverse events. The study also proposes to study the mechanisms through which such improvements might occur, especially beta-cell function, glucagon levels, and hepatic and pancreatic fat content.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Liraglutide intervention 2: Saline
Intervention descriptions: intervention 1: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months intervention 2: Placebo injection of 1.8mg saline once daily for 6-months

Protocol documents:
Clinical trial NCT01598987
Conditions: Renal Function Liver Transplant
Keywords: Paediatric liver transplantation Everolimus Reduced calcineurin inhibitor Cyclosporine, tacrolimus Renal function Composite efficacy endpoint (treated biopsy proven acute rejection death, graft loss) Liver transplant
Sponsor: Novartis Pharmaceuticals
Start date: 2012-10-01; Completion date: 2016-06-01
Enrollment: 56 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study was designed to assess the evolution of renal function and to collect efficacy, safety, and tolerability data of everolimus in co-exposure with reduced CNI in paediatric liver transplant recipients.

Detailed description:
Study is completed (was active and ongoing but no longer recruiting since December 2014). The study Data Monitoring Committee meeting communicated to Novartis the following safety findings in the study population: high rate of premature discontinuation of study medication, high rate of post-transplant lymphoproliferative disease and high rate of related serious infections leading to hospitalization. In light of the safety findings, Novartis followed the DMC recommendation to discontinue the study medication in this age group and to stop enrolling new patients in this study (regardless of age).

Arms: arm 1: Conversion at Baseline from an immunosuppressive regimen which contains either cyclosporine (CsA) or tacrolimus (TAC) with or without mycophenolic acid (MPA), with or without corticosteroids in a regimen which contains everolimus combined reduced dose of either cyclosporine (CsA) or tacrolimus (TAC).

The dosing schedule was twice daily, 12 hours apart.
Interventions: intervention 1: Introduction of everolimus with reduced cyclosporine or tacrolimus dose, the earliest 1 month and the latest 6 months after liver transplantation.
Intervention descriptions: intervention 1: Immunosuppression after liver transplantation. Pediatric transplant recipients received a starting dose of 0.8 mg/m\^2/dose in combination wit Cyclosporine A or 2.0 mg/m\^2/dose in combination with tacrolimus, twice-daily. Thereafter, doses were adjusted to achieve everolimus C-0h blood trough level between 3 to 8 ng/ml.

Protocol documents:
Clinical trial NCT01620762
Conditions: Rhinoconjunctivitis
Keywords: Cat allergy Rhinoconjunctivitis
Sponsor: Circassia Limited
Start date: 2012-10-01; Completion date: 2016-06-01
Enrollment: 1408 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the treatment effect of two treatment regimens of Cat-PAD vs placebo and to evaluates the treatment effect of Cat-PAD on symptoms, rescue medication usage and Quality of Life.

Detailed description:

Arms: arm 1: Cat-PAD Treatment 1 arm 2: Cat-PAD Treatment regimen 2 arm 3: Placebo
Interventions: intervention 1: Cat-PAD intervention 2: Placebo
Intervention descriptions: intervention 1: 1 dose every 4 weeks intervention 2: 1 dose every 4 weeks

Protocol documents: