ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01695668
Conditions: Dry Eyes
Keywords: Graft versus Host Disease (GVHD) dry eyes Bone marrow transplant (BMT) Restasis Lotemax
Sponsor: University of Michigan
Start date: 2011-08-01; Completion date: 2015-02-01
Enrollment: 75 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research is to:

1. Evaluate the safety and efficacy of a steroid eye drop (Lotemax) in patients who have been diagnosed with graft-versus-host disease (GVHD), which is a complication that may occur after bone marrow transplant where the newly transplanted material attacks the patient's body and may cause eye dryness.
2. Assess the safety and efficacy of Lotemax in decreasing the eye's reaction to the process in GVHD before the patient undergoes bone marrow transplant.
3. Compare how well Lotemax works in decreasing the process in GVHD with an immunosuppressive eye drop (Restasis), which has been commonly used in the treatment of this condition.

Detailed description:
Allogeneic bone marrow or peripheral stem cell transplantation result in Graft-versus-Host disease. Ocular symptoms may be the first presentation of GVHD and may be seen in the absence of systemic manifestations. GVHD is categorized into acute and chronic forms as defined by 100 days after the transplant. Acute GVHD is characterized by dermatitis, hepatitis, and enteritis. Chronic GVHD involves the skin, mouth, liver, gastrointestinal tract, lungs, and eyes. Ocular GVHD is a common cause of dry eye symptoms in patients who have undergone bone marrow transplant (BMT), and can be defined as ocular surface disease in the context of GVHD. Dry eyes develop in 76% of acute GVHD patients and between 62.5% and 81.8% of chronic GVHD patients. Current treatment for ocular GVHD includes topical cyclosporine 0.05% (Restasis, Allergan). Topical loteprednol etabonate 0.5% (Lotemax, Bausch and Lomb) has been shown to be safe and efficacious in treatment of inflammatory ocular disorders, but has not been prospectively studied in ocular GVHD.

2\. Hypothesis: We anticipate that topical loteprednol etabonate 0.5% will be safe and efficacious in treatment of ocular GVHD patients, and would add to the armamentarium of therapeutics for this disease. Further, by following the natural progression of the disease prior to a patient's Bone Marrow Transplant (BMT), we may elucidate a new standard of care for these patients - one that involves referral to an ophthalmologist before ocular GVHD symptoms arise.

Arms: arm 1: Loteprednol Etabonate 0.5% arm 2: Cyclosporine
Interventions: intervention 1: Lotemax intervention 2: Restasis
Intervention descriptions: intervention 1: Ophthalmic corticosteroid. It decreases inflammation of the eye intervention 2: Restasis is an immunosuppressive agent. Cyclosporine may reduce inflammation in the eye.

Protocol documents:
Clinical trial NCT01706146
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation reveal xt oral anticoagulation dabigatran rivaroxaban apixaban
Sponsor: Northwestern University
Start date: 2012-10-01; Completion date: 2015-02-01
Enrollment: 59 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Atrial fibrillation (AF) is the most common sustained abnormal rhythm of the heart, affects an estimated 2.5 to 5 million individuals in the US, and can lead to stroke, heart failure, and premature death. For those with AF and other stroke risk factors, chronic anticoagulation is recommended to prevent intracardiac thrombus formation and stroke even if the AF is infrequent or short-lived. This standard of care is based partly on our inability to rapidly recognize and respond to AF recurrences which can often be brief and asymptomatic, but exposes the patient to the risk of anticoagulant-induced hemorrhage even during prolonged periods of sinus rhythm where the risk of stroke is presumably low.

Recent advances in device technology and drug therapy, however, have the potential to change the way the investigators manage AF. The use of a small leadless subcutaneous implantable cardiac monitor with remote data transmission capabilities (Reveal XT, Medtronic Inc.) provides the ability to remotely and continuously evaluate a patient for AF recurrences, even episodes that are brief and asymptomatic. In addition, release of unique oral thrombin inhibitor approved for use in non-valvular AF(Dabigatran \[Pradaxa\], Rivaroxaban \[Xarelto\]) allows for rapid onset anticoagulation within minutes to hours of a single oral dose. Together, these advances allow for continuous AF monitoring with targeted anticoagulation only around the time of an AF episode, thereby reducing the risk of drug-induced hemorrhage while still protecting against stroke.

The aim of this pilot study is to assess the feasibility of intermittent anticoagulation with a rapid-onset oral thrombin inhibitor guided by a continuous AF-sensing implantable cardiac monitor (Reveal XT) with remote data transmission capabilities.

Detailed description:

Arms: arm 1: Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.
Interventions: intervention 1: Non-coumadin Oral Anticoagulant
Intervention descriptions: intervention 1: Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.

Protocol documents:
Clinical trial NCT01733758
Conditions: Diabetes Mellitus, Type 2
Keywords: albiglutide Japanese GSK716155 Type 2 diabetes mellitus glucagon-like peptide 1
Sponsor: GlaxoSmithKline
Start date: 2013-02-01; Completion date: 2015-02-01
Enrollment: 494 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to examine the efficacy and safety of 2 dose levels of weekly subcutaneously injected albiglutide compared with placebo and an open label reference arm of daily subcutaneous injections of liraglutide, in Japanese subjects with Type 2 diabetes mellitus.

Detailed description:

Arms: arm 1: Subjects will be randomly assigned to double blind albiglutide 30 mg weekly treatment for 52 weeks arm 2: Subjects will be randomly assigned to double blind albiglutide 50 mg weekly until Week 52 arm 3: Subjects will be randomly assigned to double blind matching albiglutide placebo administered weekly. Subjects will then cross-over to double-blind treatment with albiglutide 30 mg weekly at Week 24 until Week 52 arm 4: Subjects will be randomly assigned to open-label liraglutide for 52 weeks
Interventions: intervention 1: Albiglutide 30 mg weekly intervention 2: Albiglutide 50 mg weekly intervention 3: Placebo intervention 4: Liraglutide 0.9 mg daily
Intervention descriptions: intervention 1: Albiglutide will be available as a pen injector that delivers 30mg of albiglutide intervention 2: Albiglutide will be available as a pen injector that delivers 50mg of albiglutide intervention 3: Albiglutide matching placebo will be available as a pen injector intervention 4: Liraglutide will be available as prefilled multidose pens that can deliver 0.9 mg dose

Protocol documents:
Clinical trial NCT01769508
Conditions: HER2 Positive Esophagogastric Cancer
Keywords: Esophagogastric Adenocarcinoma 5-Fluorouracil Oxaliplatin Lapatinib Radiation Therapy Surgery
Sponsor: SCRI Development Innovations, LLC
Start date: 2013-02-01; Completion date: 2015-02-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
With improvements in response rate and survival seen for HER2 positive patients treated with HER2 blockade in the metastatic setting, the use of HER2 blockade in the neoadjuvant setting to increase antitumor effect shows promise. Patients with previously untreated localized HER2 positive esophageal, GE junction and gastric adenocarcinomas will be enrolled. Patients meeting all inclusion/exclusion criteria will receive neoadjuvant treatment with concurrent chemotherapy and radiation therapy beginning on day 1 of treatment. During the lead-in safety portion, the optimal dose of lapatinib will be determined.

Detailed description:
This is an open-label, non-randomized, Phase II study with a lead-in safety cohort. The study will evaluate the combination of 5-Fluorouracil, Oxaliplatin and Lapatinib with radiation therapy as neoadjuvant treatment for patients with previously untreated localized HER2 positive esophagogastric adenocarcinomas. Approximately 12 patients will be enrolled in the lead-in cohort to evaluate the safety of the combination. Following the lead-in cohort, Phase II will commence and up to 30 additional patients may be treated. The starting doses will be administered as follows:

5-FU 225 mg/mg2 continuous intravenous (IV) infusion Days 1 - 42 during XRT; Oxaliplatin 85 mg/m2 Days 1, 15 and 29, given by IV infusion, per institutional standard; Lapatinib Continuous PO daily dosing during XRT (final dose determined during lead-in cohort).

Arms: arm 1: Combined Modality Treatment of Radiation therapy, 5-Fluorouracil, Oxaliplatin and Lapatinib followed by Surgery
Interventions: intervention 1: 5-Fluorouracil intervention 2: Oxaliplatin intervention 3: Lapatinib intervention 4: Radiation Therapy
Intervention descriptions: intervention 1: 5-FU, 225 mg/m2 IVCI, during XRT. intervention 2: Oxaliplatin, 85 mg/m2 IV, Days 1, 15, 29. intervention 3: Lapatinib, Continuous PO daily dosing during XRT, dose determined during lead in portion intervention 4: Radiation therapy, 50.4 Gy (1.8 Gy/day or 28 fractions) M-F, Weeks1-6

Protocol documents:
Clinical trial NCT01798706
Conditions: Type 2 Diabetes
Sponsor: Sanofi
Start date: 2013-06-01; Completion date: 2015-02-01
Enrollment: 350 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary objective:

\- To evaluate the effect of lixisenatide versus placebo over a period of 24 weeks on glycemic control, as evaluated by glycosylated hemoglobin (HbA1c) reduction, in older type 2 diabetes participants (T2DM) who are inadequately controlled with their current anti-diabetic treatment regimen.

Main secondary objective:

\- To assess the safety and tolerability of lixisenatide compared to placebo in older T2DM participants (including occurrence of documented (Plasma Glucose PG \< 60 mg/dL) symptomatic hypoglycemia and gastrointestinal side effects).

Other secondary objectives:

* To assess the effect of lixisenatide compared to placebo after 24-week treatment on:

  * Fasting plasma glucose (FPG);
  * During liquid standardized breakfast meal challenge test : 2 hour- Postprandial Plasma Glucose (PPG) and Plasma Glucose Excursion;
  * 7-point Self-monitored plasma glucose (SMPG) profile;
  * Body weight;
  * Change in total daily dose of basal insulin (if taken);
  * Percentage of participants requiring rescue therapy
  * Safety and tolerability;
* To assess lixisenatide pharmacokinetic profile;
* To assess anti-lixisenatide antibody development.

Detailed description:
Approximately 31 weeks including 24 week treatment period.

Arms: arm 1: Lixisenatide 10 mcg once daily (QD) for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg. arm 2: Placebo (matched to lixisenatide) QD for 24 Weeks.
Interventions: intervention 1: Lixisenatide (AVE0010) intervention 2: Placebo intervention 3: Antidiabetic background therapy
Intervention descriptions: intervention 1: Pharmaceutical form: Solution for injection in pre-filled pen administered 30 to 60 minutes before breakfast in the morning

Route of administration: Subcutaneous injection intervention 2: Pharmaceutical form: Solution for injection in pre-filled pen administered 30 to 60 minutes before breakfast in the morning

Route of administration: Subcutaneous injection intervention 3: Participants received a stable regimen of anti-diabetic background therapy for at least 3 months prior to screening, during the placebo run-in period and the 24 week treatment period. Allowed background antidiabetic therapy included metformin, sulfonylurea (except glibenclamide \>10 mg, gliclazide \>160 mg), meglitinides (except repaglinide \>6 mg), pioglitazone and basal insulin. Insulin glargine, neutral protamine hagedorn (NPH) insulin, detemir, lente and ultralente were considered as basal insulin.

Protocol documents:
Clinical trial NCT01800877
Conditions: Hypotension Shock
Keywords: hypotension vasopressors titration tissue perfusion organ failure
Sponsor: Francois Lamontagne
Start date: 2013-04-01; Completion date: 2015-02-01
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to determine if it is better to give vasopressors to patients to maintain a higher blood pressure target versus a lower blood pressure target. This study is important because the information we find out will help us know how best to administer vasopressors in patients with shock in the ICU.

Detailed description:
Patients who are admitted to the intensive care unit (ICU) commonly suffer from shock, a condition that causes life-threatening low blood pressure. Low blood pressure makes it difficult for the body to deliver blood to all of its organs. The standard treatment doctors in the ICU use for their patients is to give medications that help increase blood pressure. These medications are called vasopressors. There can be side effects related to using vasopressors. The purpose of this research study is to determine if it is better to give vasopressors to patients to maintain a higher blood pressure target versus a lower blood pressure target. This study is important because the information we find out will help us know how best to administer vasopressors in patients with shock in the ICU.

Arms: arm 1: In the liberal approach group, we will titrate vasopressors to maintain mean arterial pressures between 75 and 80 mmHg. arm 2: We will titrate vasopressors to maintain mean arterial pressures between 60 and 65 mmHg.
Interventions: intervention 1: Vasopressors
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01803464
Conditions: Cerebral Palsy Muscle Spasticity
Keywords: Botox Muscle strength
Sponsor: University of Delaware
Start date: 2012-03-01; Completion date: 2015-02-01
Enrollment: 29 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Cerebral palsy (CP) is a neuromuscular disorder that affects approximately 800,000 individuals in the U.S. An estimated 70-80% of these individuals have spasticity which affects ambulation and requires management. Therefore, the treatment of spasticity is a primary goal of interventions for children with CP. One treatment widely used to reduce spasticity is Botox because of its ability to temporarily paralyze a muscle. However, no studies have determined the effect of Botox treatment on bone in humans. Also, a low magnitude vibration treatment has been shown to improve bone structure in the lower extremity bones of children with CP. The aims of this study are: 1) to determine the effect of Botox treatment in conjunction with a daily vibration treatment on bone mass and bone structure in children with spastic CP, and 2) to identify the mechanism that underlies the effect of Botox and vibration on bone.

Detailed description:
The investigators have been working with children diagnosed with cerebral palsy (CP) for the past 10 years. The investigators have found that bone structure is markedly underdeveloped and bone strength is severely compromised in children with CP. Also, an increased fracture rate has been observed in the lower extremity bones of children with CP. There is evidence that Botox, which is used to treat spasticity in CP, can improve motor function; however the effect of Botox on human bone is unknown. There is also evidence that low magnitude vibration treatment can improve bone mass and bone structure. The overall goal of this current research study is to investigate the effect and mechanism of action of Botox and vibration on bone in children with CP. The investigators will also examine the effect of Botox on muscle volume.

A total of 36 participants will participate in this study. The investigators will assess bone structure and muscle volume using MRI. The investigators will assess bone mass using dual-energy X-ray absorptiometry (DXA).

Arms: arm 1: Cerebral palsy and Botox + vibration arm 2: Cerebral palsy and Botox arm 3: Cerebral palsy without treatment arm 4: Typically developing
Interventions: intervention 1: Low-magnitude vibration intervention 2: Botox
Intervention descriptions: intervention 1: Children will receive a daily low-magnitude vibration treatment. intervention 2: Children who are candidates to receive Botox as part of their standard of care.

Protocol documents:
Clinical trial NCT01807156
Conditions: Hepatocellular Cancer
Keywords: Tivozanib Advanced hepatocellular cancer Angiogenesis
Sponsor: Emory University
Start date: 2013-03-01; Completion date: 2015-02-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to learn about the effect of the investigational agent tivozanib on the control of the tumor growth in hepatocellular (liver) cancer. The investigators also plan to collect information on the likelihood to develop side effects while on this treatment. Tivozanib is an oral medication (pill) taken once a day. This medication is designed to stop the tumor from developing new blood vessels.

Detailed description:
Angiogenesis is the formation of new blood vessels. Angiogenesis is driven by cytokines including vascular endothelial growth factor. Tivozanib is an oral medication that inhibits vascular endothelial growth factor preventing tumor from developing new blood vessels.

The purpose of this study is to evaluate the effects of tivozanib on hepatocellular (liver) cancer. Participants in the study take tivozanib daily at a dose of 1 mg for 1month. if doing well the dose would be increased to 1.5 mg per day. Patients are monitored for response using CT or MRI scans every 2months. In addition, patients will have blood draws to evaluate the effects of tivozanib on blood vessels.

Arms: arm 1: Patients would receive Tivozanib 1.0 mg/day orally, 3 weeks on, one week off, for one cycle starting day 1. If no adverse event is encountered, patients will continue subsequent cycles of Tivozanib 1.5 mg/day orally; 3 weeks on/1 week off, dosing schedule. Patients will continue on treatment until disease progression, unacceptable toxicity, or patient withdrawal from the study.
Interventions: intervention 1: Tivozanib
Intervention descriptions: intervention 1: Oral medication given daily. No placebo.

Protocol documents:
Clinical trial NCT01822691
Conditions: Myelodysplastic Syndromes
Keywords: myelodysplastic syndromes (MDS) neoplastic stem cell disorders refractory cytopenias dysplastic morphological features acute myeloid leukemia (AML)
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Start date: 2013-07-01; Completion date: 2015-02-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary purpose of this research study is to assess whether the participant's disease, Myelodysplastic Syndromes (MDS), responds favorably to INCB024360. The study will also evaluate the long-term outcomes of the participant's disease after they have finished taking INCB024360.

Detailed description:

Arms: arm 1: Participants were treated with 600 mg orally, twice a day for 16 weeks, unless clear evidence of disease progression or toxicity was evident.
Interventions: intervention 1: INCB024360
Intervention descriptions: intervention 1: INCB024360 is an inhibitor of the enzyme indoleamine 2,3-dioxygenase (IDO) that is proposed for development for the treatment of malignant diseases. Participants were to receive the study drug in 28 day (4 week) cycles of treatment.

Protocol documents:
Clinical trial NCT01839604
Conditions: Advanced Adult Hepatocellular Carcinoma Hepatocellular Carcinoma Metastatic
Keywords: Child-Pugh A to B7, Advanced/Metastatic Hepatocellular Carcinoma, AZD9150, Antisense Oligonucleotide Inhibitor of STAT3
Sponsor: AstraZeneca
Start date: 2013-05-01; Completion date: 2015-02-01
Enrollment: 58 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase I/Ib open-label, multicentre study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of AZD9150 in patients with advanced/metastatic hepatocellular carcinoma.

Detailed description:
A Phase I/Ib, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of AZD9150 in Patients with Advanced/Metastatic Hepatocellular Carcinoma.

Arms: arm 1: There are two parts, dose escalation phase (Part A) and dose expansion phase (Part B).
Interventions: intervention 1: AZD9150
Intervention descriptions: intervention 1: Intravenous infusion over 3 hours.

Protocol documents:
Clinical trial NCT01856933
Conditions: GBM Glioblastoma Multiforme Gliosarcoma
Keywords: GBM Glioblastoma Multiforme Gliosarcoma
Sponsor: Heinrich Elinzano, MD
Start date: 2013-05-01; Completion date: 2015-02-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the effectiveness of Prostate Specific Membrane Antigen (PSMA ADC), as well as its safety and side effects for patients with advanced brain tumors. This study will also study how your body metabolizes (breaks down) PSMA ADC.

Detailed description:
PSMA expression has been demonstrated in the tumor neovasculature of Glioblastoma Multiforme (GBM) by immunohistochemical staining. Strong reactivity to the antibody component of PSMA ADC was observed in the endothelial cells of new tumor blood vessels in GBM. Since the endothelial cells are located on the luminal surface of blood vessels, PSMA ADC does not need to cross the blood brain barrier to reach its target. Following binding and internalization of PSMA ADC, the cytotoxic component of PSMA ADC will be released and destroy the neovasculature that supports tumor growth. Therefore, PSMA ADC may be an active treatment for GBM.

Bevacizumab, an inhibitor of angiogenesis, has been shown to be effective in improving progression-free survival as a single agent. Thus PSMA ADC, which targets tumor angiogenesis by a mechanism different from that of bevacizumab, may be a novel therapeutic modality for GBM.

A phase 2 study of PSMA ADC is proposed for patients with GBM that have progressed after standard treatment that includes radiation, temozolomide and bevacizumab. A phase 1 study of PSMA ADC in prostate cancer is ongoing and a phase 2 dose level of 2.5 mg/kg IV every 3 weeks has been defined. Treatment after bevacizumab failure for patients with GBM is a major unmet medical need. If activity were demonstrated in this trial, a definitive randomized study would be proposed.

Arms: arm 1: 2.5 mg/kg, IV, over 60 minutes every 3 weeks
Interventions: intervention 1: PSMA ADC
Intervention descriptions: intervention 1: 2.5 mg/kg, IV, over 60 minutes every 3 weeks

Protocol documents: