ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00842244
Conditions: Stomach Neoplasms Advanced Gastric Cancer
Sponsor: Pfizer
Start date: 2009-04-01; Completion date: 2012-10-01
Enrollment: 22 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the safe and tolerable dose of axitinib given together with cisplatin and capecitabine in patients with advanced gastric cancer who have not received prior chemotherapy for their advanced cancer.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: axitinib intervention 2: capecitabine intervention 3: cisplatin
Intervention descriptions: intervention 1: Twice daily oral dose of axitinib continuously depending upon side effects observed. Starting dose is 5mg twice daily. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed. intervention 2: Given orally twice daily for 14 days followed by 7 days of drug free period. Starting dose is 1000mg/m\^2 twice daily. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed. intervention 3: Given through a vein on Day 1 of every 21 days. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed. The starting dose is 80 mg/m\^2 on day 1.

Protocol documents:
Clinical trial NCT00844090
Conditions: Apathy Diabetes
Keywords: Apathy Diabetes Self-care behaviors
Sponsor: US Department of Veterans Affairs
Start date: 2009-07-01; Completion date: 2012-10-01
Enrollment: 106 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In spite of several new medications and insulins for the control of blood sugars in patients with diabetes, a large number of patients do not have good control. This likely due to inability to carry out regular activities and self-care behaviors such as taking meds regularly, keeping a good diet, exercise etc. This inability to carry out self care lifestyle changes may be due to a condition called apathy. Apathy is a lack of motivation and persistence. In this study we will attempt to treat apathy with a medication called methylphenidate for 6 months and see if blood sugar/diabetes control improves.

Detailed description:
The incidence of diabetes in the US is at epidemic proportions. A large number of diabetes patients in the VA system have uncontrolled diabetes with high HbA1c. The inability to carry out important self-care behaviors such as measuring blood sugars regularly, following diet, exercise and medication programs may be due to apathy. Apathy is the lack of motivation, persistence and novelty. We have found this to be very prevalent in the VA diabetes population. We now do a randomized placebo controlled trial to see if treatment of apathy with methylphenidate will improve glycemic control in patients with A1c \>8. Treatment will be for 6 months. The primary end point is HbA1c.

Arms: arm 1: placebo tablets arm 2: methylphenidate tablets
Interventions: intervention 1: methylphenidate or placebo
Intervention descriptions: intervention 1: treat apathy to improve diabetes self care behaviors thereby improving glycemic control

Protocol documents:
Clinical trial NCT00856284
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes Mellitus Drug Therapy Hyperinsulinism Hyperglycemia Glucose Intolerance
Sponsor: Takeda
Start date: 2009-03-01; Completion date: 2012-10-01
Enrollment: 2639 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the safety and effectiveness of adding alogliptin, once daily (QD), compared to glipizide with metformin in diabetic patients.

Detailed description:
For patients diagnosed with type 2 diabetes mellitus, metformin is the usual first-line therapy in addition to diet control and exercise. For those patients with inadequate glycemic control with metformin monotherapy or experiencing serious side effects of metformin, sulfonylurea is a popular choice as a second-line oral antidiabetic treatment.

Alogliptin is a dipeptidyl peptidase-4 inhibitor currently being developed by Takeda for use in patients with type 2 diabetes mellitus.

This study is designed to further explore the durability of efficacy and safety of alogliptin compared to glipizide in type 2 diabetes mellitus patients whose blood sugar level is inadequately controlled with metformin therapy.

The duration of this study will be approximately 2 years.

Arms: arm 1: Alogliptin 12.5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. arm 2: Alogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. arm 3: Glipizide 5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. After at least 2 weeks of treatment but prior to Week 20, participants with persistent hyperglycemia (fasting plasma glucose ≥250 mg/dL) underwent a dose titration of glipizide up to 20 mg in 5-mg increments in 4-week intervals.
Interventions: intervention 1: Alogliptin intervention 2: Metformin intervention 3: Glipizide
Intervention descriptions: intervention 1: Alogliptin tablets intervention 2: Metformin tablets intervention 3: Glipizide tablets

Protocol documents:
Clinical trial NCT00867789
Conditions: Abscess
Keywords: abscess outcomes antibiotics incision and drainage skin abscess
Sponsor: Children's Mercy Hospital Kansas City
Start date: 2009-03-01; Completion date: 2012-10-01
Enrollment: 140 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if there is a difference between an antibiotic, trimethoprim-sulfamethoxazole versus placebo in healing outcomes of soft tissue abscesses following incision and drainage.

Detailed description:

Arms: arm 1: Incision and drainage of the abscess and treatment with oral TMP-SMX (100 patients) arm 2: Incision and drainage of the abscess and treatment with oral placebo (100 patients)
Interventions: intervention 1: Trimethoprim-sulfamethoxazole intervention 2: Sugar pill
Intervention descriptions: intervention 1: 10mg/kg/day (based on trimethoprim component), divided twice daily for ten days (maximum dose: 160mg (TMP component) per dose) intervention 2: 10mg/kg/day divided twice daily for ten days. Placebo liquid will contain simple syrup, lactose powder, grape flavor, and food coloring. Placebo capsules will contain lactose powder.

Protocol documents:
Clinical trial NCT00870740
Conditions: Relapsing-Remitting Multiple Sclerosis
Keywords: MS Multiple Sclerosis
Sponsor: Biogen
Start date: 2009-02-01; Completion date: 2012-10-01
Enrollment: 517 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study was to assess the safety and immunogenicity of extended treatment with DAC HYP. This evaluation included the following major components:

* An assessment of safety and immunogenicity of extended treatment with DAC HYP when administered to MS subjects who had completed 52 weeks of active therapy with DAC HYP in Study 201.
* An assessment of safety and immunogenicity during a 6-month washout period from DAC HYP.
* An assessment of safety and immunogenicity during reinitiation of therapy with DAC HYP after a 6-month washout period.
* An assessment of safety and immunogenicity of DAC HYP when administered to MS subjects who previously received placebo during Study 201.

The secondary objective is to assess the durability of the effect of DAC HYP on multiple sclerosis (MS) disease activity as measured by brain magnetic resonance imaging (MRI) scans and clinical MS relapses.

Detailed description:
This study, an extension to Study 205MS201 (NCT00390221), will evaluate the long-term safety, efficacy, and immunogenicity of DAC HYP in MS. In Study 205MS201, study treatment was scheduled to stop at the Week 52 visit. This extension study will provide for the initiation of active therapy with DAC HYP among participants who received placebo during Weeks 0 through 52 in 205MS201. In addition, participants who received active therapy with DAC HYP during Weeks 0 through 52 in Study 205MS201 will continue DAC HYP therapy or resume DAC HYP therapy after a 6-month washout period in this study.

Arms: arm 1: Participants who received placebo in 205MS201 receive DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses. arm 2: Participants who received placebo in 205MS201 receive DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses. arm 3: Participants who received DAC HYP 150 mg SC injection in 205MS201 undergo a washout period (placebo SC every 4 weeks for a total of 5 doses) and then receive DAC HYP 150 mg SC every 4 weeks for a total of 8 doses. arm 4: Participants who received DAC HYP 150 mg SC injection in 205MS201 receive DAC HYP 150 mg SC every 4 weeks for a total of 13 doses. arm 5: Participants who received DAC HYP 300 mg SC in 205MS201 undergo a washout period (placebo SC every 4 weeks for a total of 5 doses) and then receive DAC HYP 300 mg SC every 4 weeks for a total of 8 doses. arm 6: Participants who received DAC HYP 300 mg SC in 205MS201 receive DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
Interventions: intervention 1: BIIB019 (Daclizumab High Yield Process) intervention 2: Placebo
Intervention descriptions: intervention 1: SC injection intervention 2: Placebo SC injection

Protocol documents:
Clinical trial NCT00878800
Conditions: Dose Escalation: Solid Tumors MTD: Soft Tissue Sarcomas
Keywords: Phase I/II trial Solid tumors Soft tissue sarcoma PXD101 Doxorubicin
Sponsor: Valerio Therapeutics
Start date: 2006-12-01; Completion date: 2012-10-01
Enrollment: 41 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Open-label, multicentre, dose-escalation Phase I/II study to evaluate safety, efficacy, pharmacodynamics, and pharmacokinetics of the combination of PXD101 with doxorubicin administered q 3 weeks in patients with advanced solid tumours. Once the Maximum Tolerable Dose has been established, up to a total of 20-40 patients with Soft Tissue Sarcoma may be enrolled at the MTD dose level to examine efficacy and safety in this specific patient population. The trial is stopped if no more than 2 responses are seen among the first 20 of these patients.

Detailed description:

Arms: arm 1: 5-day PXD101 IV schedule with dose escalation combined with 1 day doxorubicin dose escalation IV
Interventions: intervention 1: PXD101 intervention 2: Doxorubicin
Intervention descriptions: intervention 1: Administered in combination with doxorubicin (BelDox) intervention 2: Administered in combination with PXD101 (BelDox)

Protocol documents:
Clinical trial NCT00890552
Conditions: Leukemia Amyloidosis
Sponsor: Stanford University
Start date: 2009-04-01; Completion date: 2012-10-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open-label trial will evaluate the use of lenalidomide; melphalan; and dexamethasone (MDR) to treat newly diagnosed or relapsed AL amyloidosis, over the course of nine 28-day cycles.

Detailed description:
The study will evaluate the 3-drug combination of lenalidomide; melphalan; and dexamethasone (MDR) as the absence of disease progression or toxicity, patients will complete nine 28-day cycles of MDR therapy, with the option of continuing treatment with lenalidomide as single-agent. Patients received up to nine cycles of treatment, with the option to continue on lenalidomide as a single agent if they responded to treatment.

Arms: arm 1: Patients received lenalidomide 10 mg/day orally on days 1-21, melphalan 0.18 mg/kg orally on days 1-4, and dexamethasone 40 mg orally once weekly of a 28-day cycle (MDR treatment).
Interventions: intervention 1: Lenalidomide intervention 2: Melphalan intervention 3: Dexamethasone
Intervention descriptions: intervention 1: Lenalidomide is a a derivative of thalidomide.

Orally-administered lenalidomide 10 mg will be taken daily on days 1 to 21 of 28-day cycle. intervention 2: Melphalan is a phenylalanine derivative of mechlorethamine.

Orally-administered melphalan 0.18 mg/kg will be taken on days 1 to 4 of a 28-day cycle intervention 3: Dexamethasone is an anti-inflammatory and immunosuppressant steroid medication.

Orally-administered dexamethasone 40 mg orally once weekly of a 28-day cycle

Protocol documents:
Clinical trial NCT00893113
Conditions: Erectile Dysfunction Lower Urinary Tract Symptoms
Sponsor: Chesapeake Urology Research Associates
Start date: 2009-06-01; Completion date: 2012-10-01
Enrollment: 74 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to assess the effect of Alfuzosin in treating Erectile Dysfunction in men with mild lower urinary tract symptoms based upon a change from baseline in erectile function (EF) domain of International Index of Erectile Function (IIEF).

Detailed description:
This protocol is a placebo-controlled, double-blind, crossover trial. Patients will be screened and then randomized to Group A or Group B at a 1:1 ratio to receive a placebo tablet once daily or Alfuzosin (10 mg) daily for 12 weeks. Patients will then crossover with the original placebo group receiving Alfuzosin for 12 weeks and the original Alfuzosin group receiving placebo. At every visit the patients will complete an IIEF and an AUA symptom index.

Arms: arm 1: Participants first received 1 Placebo tablet once daily for 12 weeks. Participants then received a 10 mg tablet of Alfuzosin daily for 12 weeks. arm 2: Participants first received a 10 mg tablet of Alfuzosin once daily for 12 weeks. Participants then received 1 Placebo tablet once daily for 12 weeks.
Interventions: intervention 1: Placebo intervention 2: Alfuzosin
Intervention descriptions: intervention 1: Alfuzosin-matched One tablet once daily intervention 2: 10 mg once daily

Protocol documents:
Clinical trial NCT00901199
Conditions: Thalassemia Iron Overload
Keywords: Thalassemia Chelation Iron Overload Thalassemia patients with Iron overload
Sponsor: Elliott Vichinsky
Start date: 2007-09-01; Completion date: 2012-10-01
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a pilot study looking at the safety and efficacy of giving combination chelation with deferasirox and deferoxamine. The hypothesis is that combination chelation is safe in decreasing overall iron in patients with thalassemia.

Detailed description:
This was a phase two pilot clinical trial designed to evaluate the safety and efficacy of the combination of deferasirox and deferoxamine in transfusion dependent thalassemia with a range of systemic iron burden. The duration of combined therapy was 12 months. Changes in liver iron concentration, ferritin, myocardial iron, and serum creatinine was monitored.

Arms: arm 1: All subjects received Deferasirox (Exjade) and Deferoxamine (DFO) dosing based on the iron overload at baseline.
Interventions: intervention 1: Combo Chelation with Deferasirox (Exjade) and Deferoxamine (DFO)
Intervention descriptions: intervention 1: All subjects will be given Deferasirox 20-30 mg/kg for 7 days per week. All subject will be given Deferoxamine 50 mg/kg for 3-7 days per week. The number of days for Deferoxamine will be determined by liver iron concentration at baseline.

Protocol documents:
Clinical trial NCT00908960
Conditions: Advanced Pancreatic, Colon, Lung, Gastric and Ovarian Cancer
Keywords: enoxaparin
Sponsor: Beth Israel Deaconess Medical Center
Start date: 2009-05-01; Completion date: 2012-10-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Research studies have shown a strong association between cancer and blood clots in the veins (also known as deep vein thrombosis). These blood clots can flow to the lungs (pulmonary embolism) which in severe cases may be life threatening. The purpose of this research study is to see if enoxaparin is effective in preventing blood clots in the veins in participants who have cancer of the pancreas, colorectal, non-small cell lung, ovary, or gastric and also have high levels of tissue factor bearing microparticles in their blood (TFMP). TFMP are small particles that are generated from different types of blood cells in the body. In people who have cancer, TFMP are thought to be generated from cancer cells and may represent a risk factor for deep vein thrombosis. Enoxaparin has been used to prevent formation of blood clots in patients after abdominal or orthopedic surgery and in patients who suffer from a severe medical illness. Based on these studies, we are investigating to see if it prevents thrombosis in people with certain types of cancer.

Detailed description:
The study was a randomized phase II trial to evaluate the cumulative incidence of VTE in cancer outpatients. At baseline, measurement of tissue factor-bearing microparticles (TFMP) was performed by impedance-based flow cytometry based on established methods. (Zwicker et al, 2009) Patients were classified as having high or low TFMP levels based on a reference repository of plasmas from sixty cancer patients. The top tercile of tissue factor-bearing microparticle concentrations from the reference specimens (3.5 x 104 microparticles/µl) was considered a cutoff for "high" and corresponds with previously described "detectable" levels. Patients with high levels were randomized (2:1) to enoxaparin 40 mg subcutaneously once daily or observation. Randomization was stratified based on cancer diagnosis. Low TFMP patients were observed without anticoagulation. Both the treating physicians and patients were blinded to microparticle status in the observation arms.

Arms: arm 1: Patients received enoxaparin 40 mg subcutaneously once daily for 2 months (60 days).Only patients with high TFMP status at baseline were randomized to treatment or observation. arm 2: Patients undergo observation until evaluation with a lower extremity ultrasound at 2 months (day 60). Only patients with high TFMP status at baseline were randomized to treatment or observation. arm 3: Patients undergo observation until evaluation with a lower extremity ultrasound at 2 months (day 60). Patients with low TFMP status at baseline were directly assigned to observation.
Interventions: intervention 1: Enoxaparin
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00936377
Conditions: Acute Alcohol Withdrawal
Sponsor: University of Colorado, Denver
Start date: 2009-09-01; Completion date: 2012-10-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to evaluate dexmedetomidine as adjunctive therapy of severe alcohol withdrawal of medical ICU patients. Specifically, this study will assess whether adjunctive dexmedetomidine reduces the doses of conventional agents used for alcohol withdrawal while maintaining patient comfort and safety and will explore if dexmedetomidine exhibits a dose-dependent profile of action when it is used for this indication. In addition, this study will assess the relationships between alcohol withdrawal, therapy with dexmedetomidine, and potential serum biomarkers of alcohol withdrawal.

Detailed description:
The objectives of this randomized, double-blind, placebo controlled, dose escalation study are a) to determine if adding dexmedetomidine to symptom-triggered, standard therapy of severe alcohol withdrawal reduces the dose requirements of conventional sedatives, analgesics, and neuroleptics; maintains patient comfort and safety; and prevents and shortens tracheal intubation; b) to explore whether dexmedetomidine acts in a dose-dependent manner to reduce the dose requirements of conventional sedatives, analgesics, and neuroleptics while maintaining patient comfort; and c) determine the association between alcohol withdrawal and potential serum biomarkers of alcohol withdrawal and assess whether these are expressed differently when dexmedetomidine is used as adjunctive therapy. Dexmedetomidine will be added to existing sedative therapies in an effort to decrease the use of these agents while maintaining patient comfort. The study will randomize twenty-four patients in a double-blind manner to receive placebo or dexmedetomidine at doses of 0.4 or 1.2 µg/kg per hour for a maximum duration of five days. All patients will be managed using an existing institution-specific, symptom-triggered alcohol withdrawal protocol.

Arms: arm 1: Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days arm 2: Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days arm 3: Normal saline
Interventions: intervention 1: Dexmedetomidine intervention 2: Placebo
Intervention descriptions: intervention 1: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days intervention 2: Normal saline for five days.

Protocol documents:
Clinical trial NCT00940498
Conditions: Neoplasms
Keywords: Phase 1 Dose Finding Solid Tumors Tumors PF-05212384
Sponsor: Pfizer
Start date: 2010-01-01; Completion date: 2012-10-01
Enrollment: 78 participants; Allocation: ; Intervention model: 

Brief summary:
This is a two-part study of a compound called PF-05212384 (also known as PKI-587). The purpose of part 1 is to identify the Maximum Tolerated Dose (MTD) of PF-05212384 using a Continual Reassessment Method (CRM). Part 1 will include subjects with any solid tumor. In Part 2 two cohorts will be enrolled. One cohort will assess safety, tolerability and preliminary efficacy in 20 subjects at the MTD and will include subjects with breast cancer, ovarian cancer, endometrial cancer, colorectal cancer renal cancer or glioblastoma (a type of brain tumor). The other cohort will include 5 to 15 subjects with any type of tumor who consent to provide tumor biopsies while participating in the study.

Detailed description:

Arms: arm 1: PF-05212384 (also known as PKI-587)
Interventions: intervention 1: PF-05212384 (also known as PKI-587)
Intervention descriptions: intervention 1: Intravenous dosing once weekly infusion

Protocol documents: