ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01326533
Conditions: Pre-diabetes
Keywords: pre-diabetes hydroxychloroquine frequently sampled intravenous glucose tolerance testing insulin resistance insulin secretion glucose tolerance
Sponsor: University of Pittsburgh
Start date: 2011-03-01; Completion date: 2014-12-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the short-term effects of the antimalarial medication, hydroxychloroquine (HCQ), compared with placebo using frequently sampled intravenous glucose tolerance testing (FSIGTT) methodology to study changes in insulin secretion and glucose tolerance in subjects at risk for developing Type 2 diabetes.

Detailed description:
Diabetes is approaching epidemic proportions in the United States. This study evaluates the mechanisms of action of a generic drug that may have effects on glucose metabolism.

Arms: arm 1: Thirteen weeks of daily hydroxychloroquine following FSIGTT testing arm 2: Thirteen weeks of daily placebo following FSIGTT testing
Interventions: intervention 1: hydroxychloroquine intervention 2: Placebo
Intervention descriptions: intervention 1: Thirteen weeks of oral hydroxychloroquine (400 mg/day) provided as capsules intervention 2: Thirteen weeks of oral placebo provided as capsules

Protocol documents:
Clinical trial NCT01331291
Conditions: Glioblastoma
Keywords: bosutinib SKI-606
Sponsor: Massachusetts General Hospital
Start date: 2011-04-01; Completion date: 2014-12-01
Enrollment: 36 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
For many brain tumors, one reason that chemotherapy drugs might not be effective is that the drug may not be able to get into the brain tumor and kill the cancer cells. The brain is protected by a layer called the blood brain barrier. This barrier prevents substances from entering. The purpose of this research study is to determine if bosutinib can get past the blood brain barrier and into the brain tumor, and to see how well bosutinib works in killing cancer cells.

Detailed description:
\- Arm A: Participants will receive daily doses of bosutinib orally for 7-9 days prior to surgery. On the day of the scheduled surgery (either craniotomy or surgical resection as planned by the treating doctor), participants will take the bosutinib within 6-12 hours of the surgery. During the surgery, tissue samples of the tumor will be collected to test the levels of bosutinib in the brain. A contrast-enhanced MRI or CT scan will be done within days after the surgery. Daily dosing of bosutinib will resume after a recovery period of 10 days. From then on, the study will be divided into 28-day cycles.

The following tests/procedures will be performed regularly during cycles of study treatment: medical history; physical exam; blood tests; contrast-enhanced CT or MRI scans (even numbered cycles only).

* Arm B: Participants will receive daily doses of bosutinib. The study is divided int 28-day cycles. There are no breaks from taking bosutinib between treatment cycles. The following tests/procedures will be performed regularly during cycles of study treatment: medical history; physical exam; blood tests; contrast-enhanced CT or MRI scans (even numbered cycles only).
* Participants may continue to receive daily bosutinib until their disease worsens, they experience unmanageable side-effects, or they decide to stop treatment.

Arms: arm 1: Patients who are surgical candidates. Participants are given oral bosutinib, 400mg daily, for 7-9 days prior to resection. After at least 10 days elapsed post-operatively, bosutinib dosing was resumed. arm 2: Patients that are not surgical candidates. Participants are given oral bosutinib, 400 mg daily in 28 day cycles until disease progression, intolerability or withdrawal of consent.
Interventions: intervention 1: bosutinib
Intervention descriptions: intervention 1: Taken orally

Protocol documents:
Clinical trial NCT01334125
Conditions: Diabetes Mellitus
Keywords: Double Diabetes Type 1 diabetes Type 2 diabetes Obesity Acanthosis nigricans Diabetes associated autoantibodies
Sponsor: University of Massachusetts, Worcester
Start date: 2011-02-01; Completion date: 2014-12-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The significance of this project is to investigate the effects of adjunctive metformin therapy in children and adolescents with double diabetes. Double diabetes describes a clinical state where an individual possesses features of both type 1 and type 2 diabetes. There is a paucity of data on the role of adjunctive metformin therapy in children and adolescents with double diabetes. To help fill this knowledge gap, the investigators propose a randomized, double-blind, placebo-controlled trial of metformin in double diabetes. Specifically, the investigators will evaluate changes in hemoglobin A1c and anthropometry in patients with a diagnosis of type 1 diabetes who also have features of type 2 diabetes or metabolic syndrome as well as patients with type 2 diabetes who possess diabetes-associated autoantibodies. This will help determine the safety profile, and efficacy of adjunctive metformin therapy in these subjects.

Detailed description:
In this 12-month clinical trial, a 3-month run-in period will precede the interventional phase of the study. All patients will be placed on treat-to-target insulin regimen alone during the run-in phase. At the end of the 3-month run-in period, all participants will continue on treat-to-target insulin regimen, and will then be randomized to either of the 2 arms of the study: an experimental arm, consisting of treat-to-target insulin regimen plus metformin, and a control arm consisting of treat-to-target insulin regimen plus placebo. Both the physicians and patients will be blinded to the oral agents being administered to patients.

Arms: arm 1: Metformin 1000 mg once daily by mouth for 9 months arm 2: 2 capsules once daily by mouth for 9 months
Interventions: intervention 1: Metformin intervention 2: Placebo
Intervention descriptions: intervention 1: Metformin 1000 mg once daily by mouth for 9 months intervention 2: 2 capsules once daily by mouth for 9 months

Protocol documents:
Clinical trial NCT01346072
Conditions: Cardiovascular Diseases Heart Diseases Heart Failure
Keywords: tolvaptan copeptin heart failure vasopressin antagonist
Sponsor: University of North Carolina, Chapel Hill
Start date: 2011-04-01; Completion date: 2014-12-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This pilot study will investigate the association between levels of the peptide copeptin and response to tolvaptan, a drug that blocks the action of the water retaining hormone vasopressin. The study will enroll stable outpatients with CHF with reduced LVEF (≤45) selected by targeting upper and lower quartile copeptin levels at screening (10 each). The treatment phase of the study will be a prospective, single-arm, open label protocol. All patients will receive active therapy consisting of a single oral dose of 30 mg of tolvaptan with body weight, fluid intake, and urine output monitored in a research unit for 24 hours.

For analysis of study endpoints, patients in the single intervention arm will be stratified by a prospectively determined cut-point of copeptin level into two groups (≥10 versus \<10 pmol/L). The copeptin level used for the two group stratification will be the blinded copeptin value obtained at baseline from the hospital phase prior to administration of tolvaptan.

Detailed description:
The study screening strategy will be designed to enroll an enriched patient population by identifying patients at the high or low end of the spectrum of copeptin levels for outpatients with stable heart failure. This will be accomplished by blinded review of copeptin levels obtained during screening.

The primary endpoints for analysis will be 24 hour urine output and the change in body weight over 24 hours during the inpatient stay.

Arms: arm 1: Single arm study
Interventions: intervention 1: tolvaptan
Intervention descriptions: intervention 1: oral, 30 mg, single dose, one time administration

Protocol documents:
Clinical trial NCT01358175
Conditions: Ankylosing Spondylitis
Keywords: Ankylosing spondylitis AS ASAS inflammatory back pain
Sponsor: Novartis Pharmaceuticals
Start date: 2011-10-01; Completion date: 2014-12-01
Enrollment: 371 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the efficacy and safety of secukinumab in patients with active ankylosing spondylitis who are intolerant to or have had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor therapy.

Detailed description:

Arms: arm 1: Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study. arm 2: Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study. arm 3: Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
Interventions: intervention 1: Secukinumab (75 mg) intervention 2: Secukinumab (150 mg) intervention 3: Placebo
Intervention descriptions: intervention 1: Secukinumab (75 mg) intervention 2: Secukinumab (150 mg) intervention 3: Placebo

Protocol documents:
Clinical trial NCT01365195
Conditions: Colorectal Surgery
Keywords: opioid Fentanyl Anesthetic adjuvant Pain management Perioperative outcomes Constipation Ileus Colorectal
Sponsor: Cedars-Sinai Medical Center
Start date: 2011-05-01; Completion date: 2014-12-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research is to evaluate the effectiveness of ketamine as an analgesic adjuvant in decreasing the narcotic (opioids) analgesics during surgery, on pain management and on the later recovery after surgery in patients undergoing colorectal surgery.

Detailed description:
Adjuvant is a drug that has few or no pharmacological effects by itself, but may increase the effectiveness or strength of other drugs when given at the same time.

Arms: arm 1: Loading and Infusion:

Saline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate arm 2: Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min arm 3: Loading: 1 mg/Kg Infusion: 10 mcg/kg/min
Interventions: intervention 1: Placebo intervention 2: Ketamine high-dose intervention 3: Ketamine low-dose
Intervention descriptions: intervention 1: Loading and Infusion: Saline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate intervention 2: Loading: 1 mg/Kg Infusion: 10 mcg/kg/min intervention 3: Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min

Protocol documents:
Clinical trial NCT01370694
Conditions: Follicular Lymphoma
Sponsor: Merck Sharp & Dohme LLC
Start date: 2011-08-19; Completion date: 2014-12-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the safety, pharmacokinetics, and anti-tumor activity of MK-8808 in combination with cyclophosphamide, vincristine, and prednisolone (CVP), and as a single agent, for participants with B-lymphocyte antigen cluster of differentiation 20 (CD20)-positive follicular lymphoma who have had no prior chemotherapy. The primary study hypothesis is that MK-8808 will be safe and well tolerated in combination with CVP and as a single agent.

Detailed description:
The study was terminated early by the Sponsor due to business reasons. All participants were discontinued from MK-8808 + CVP, but could continue to receive maintenance therapy with MabThera™ (rituximab) per standard of care.

Arms: arm 1: Participants received MK-8808 375 mg/m\^2 intravenously (IV) + cyclophosphamide 750 mg/m\^2 IV + vincristine 1.4 mg/m\^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m\^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m\^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
Interventions: intervention 1: MK-8808 intervention 2: cyclophosphamide intervention 3: vincristine intervention 4: prednisolone
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT01385748
Conditions: Oral Mucositis
Sponsor: Valerio Therapeutics
Start date: 2010-04-01; Completion date: 2014-12-01
Enrollment: 183 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of Clonidine Lauriad® to treat chemoradiation therapy induced severe oral mucositis in patients with head and neck cancer.

Detailed description:

Arms: arm 1: 50µg muco-adhesive buccal tablets, once de day, every day up to 8 weeks arm 2: 100µg muco-adhesive buccal tablets, once a day, every day up to 8 weeks arm 3: Placebo muco-adhesive buccal tablets, once a day, every day up to 8 weeks
Interventions: intervention 1: Clonidine Lauriad® 50µg intervention 2: Clonidine Lauriad® 100µg intervention 3: Placebo Lauriad®
Intervention descriptions: intervention 1: 50µg muco-adhesive buccal tablet once day every day up to 8 weeks intervention 2: 100µg muco-adhesive buccal tablets, once a day, every day up to 8 weeks intervention 3: placebo muco-adhesive buccal tablets, once a day, every day up to 8 weeks

Protocol documents:
Clinical trial NCT01387672
Conditions: Osteoporosis
Keywords: postmenopausal osteoporosis bone turnover nitrate headache
Sponsor: University of Toronto
Start date: 2011-09-01; Completion date: 2014-12-01
Enrollment: 265 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Purpose: NABT: To compare five widely available nitrate formulations: (1) 15 of nitroglycerin (NTG) ointment, (2) 0.3 mg and (3) 0.6 mg of sublingual NTG, (4) 20 mg of isosorbide mononitrate (an oral tablet), and (5) 160 mg of glycerol trinitrate (a patch), for their efficacy on markers of bone formation and resorption and for the incidence and severity of headache they cause.

Hypothesis: There is one ideal nitrate preparation which balances the clinical efficacy in bone remodeling against the common side effect of headache.

NABT-B: To determine if nitrates affect markers of bone formation (serum BALP and P1NP) and resorption (serum CTX and urine NTX) in women who have recently discontinued treatment with alendronate, risedronate or zoledronate.

Detailed description:

Arms: arm 1: Nitroglycerin Ointment 2% USP arm 2: Nitroglycerin Extended Release Patch 160mg arm 3: Nitroglycerin 0.3mg Sublingual Tablet arm 4: Nitroglycerin 0.6mg Sublingual Tablet arm 5: Isosorbide Mononitrate 20mg Oral Tablet arm 6: Placebo Ointment
Interventions: intervention 1: Nitrates (NABT Main trial) intervention 2: Placebo
Intervention descriptions: intervention 1: nitroglycerin; isosorbide mononitrate intervention 2: Placebo ointment

Protocol documents:
Clinical trial NCT01395537
Conditions: Adenocarcinoma of the Esophagus Adenocarcinoma of the Gastroesophageal Junction
Sponsor: Case Comprehensive Cancer Center
Start date: 2011-08-01; Completion date: 2014-12-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Since lapatinib inhibits both EGFR and HER2 receptors, it is an attractive agent for the treatment of esophageal and GEJ tumors.

PURPOSE: Lapatinib is currently approved for HER2 positive metastatic breast cancer in combination with capecitabine or letrozole. It is hoped that by giving lapatinib and carboplatin and paclitaxel together, their combined effects will further slow or stop the cancer cells from growing.

Detailed description:
OBJECTIVES:

1. Phase I: To assess the toxicity and feasibility of the addition of lapatinib to carboplatin and paclitaxel in patients with recurrent/metastatic adenocarcinoma of the esophagus and gastroesophageal junction.
2. Phase II: To assess the response rate to this regimen.

OUTLINE:

1. There will be an initial phase I safety cohort studies requiring up to 12 patients, followed by a phase II cohort using the lapatinib dose defined in phase I. Carboplatin and paclitaxel doses will not be escalated.

   The initial dose of lapatinib of 750 mg daily by mouth will be given to 6 patients. There will be no dose escalation of the lapatinib above 1000 mg daily. The lapatinib dose for the phase II cohort of this trial will be based only on toxicities experienced during the first cycle (3 weeks) of treatment.
2. Phase II: Once the optimal lapatinib dose has been chosen, all remaining patients will initiate treatment at this dose level. Patients with stable or responding disease after 6 cycles will continue treatment with lapatinib alone until progression of disease or intolerable side effects. Feasibility, toxicity and response rate of this combination will be assessed.

PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study.

Arms: arm 1: None
Interventions: intervention 1: Carboplatin AUC intervention 2: Paclitaxel intervention 3: lapatinib
Intervention descriptions: intervention 1: Carboplatin AUC 6 IV over 30 minutes on day one of a three week cycle. This will be continued for 6 cycles or until progression of disease or intolerable side effects. intervention 2: Paclitaxel 175 mg/m2 IV over 3 hours day one of a three week cycle. This will be continued for 6 cycles or until progression of disease or intolerable side effects. intervention 3: Lapatinib should be taken once daily, at the same time daily, on an empty stomach, either 1 hour before, or 1 hour after meals.

Protocol documents:
Clinical trial NCT01411501
Conditions: Constipation
Keywords: Acupuncture Functional constipation
Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Start date: 2011-09-01; Completion date: 2014-12-01
Enrollment: 684 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A multi-center clinical trial done recently by us(NCT00508482) shows that needling on ST25 has the same effect as lactulose in unaided self-defecation frequency of a week and has better effect in symptoms improvement (in press). The object is to evaluate whether acupuncture is effective for functional constipation. As an explanatory research, it took one single point as its intervention and sham acupuncture as its control group (patients were blinded). On the basis of its confirmed effect, we are taking a pragmatic randomized controlled trial to further evaluate whether acupuncture is more effective than routine treatment. Acupuncture prescriptions used in this trial are individually prescribed according to syndrome differentiation, which can improve clinical effect. .

Detailed description:
functional constipation,acupuncture,effects and safety,pragmatic RCT

Arms: arm 1: the points formula of back-shu point combination with front-mu point. arm 2: the points formula of He-points arm 3: the formula of He-point,back-shu point and front-mu point arm 4: oral use of mosapride citrate
Interventions: intervention 1: acupuncture intervention 2: mosapride citrate
Intervention descriptions: intervention 1: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).

Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.

Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks. intervention 2: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal

Protocol documents:
Clinical trial NCT01413360
Conditions: Chronic Hepatitis Chronic Hepatitis C Chronic Alcoholic Hepatitis
Sponsor: Seoul National University Hospital
Start date: 2011-08-01; Completion date: 2014-12-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The investigators will evaluate the efficacy of high dose vitamin C in chronic hepatitis patients whose serum liver enzymes are elevated more than upper limit.

Detailed description:
The changes of laboratory findings including serum transaminase levels, serum albumin levels, Child-Pugh score, MELD score, and APRI score will be evaluated.

Arms: arm 1: High dose vitamin C
Interventions: intervention 1: High dose vitamin C
Intervention descriptions: intervention 1: Vitamin C, 3g per day (tid), with meal, per oral with water 100mL

Protocol documents:
Clinical trial NCT01416025
Conditions: Fungal Infection
Keywords: Voriconazole Therapeutic drug monitoring Hematopoietic stem cell transplant Hematologic malignancy Invasive mould infection
Sponsor: Johns Hopkins University
Start date: 2012-01-01; Completion date: 2014-12-01
Enrollment: 29 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a prospective, multicenter, randomized trial to study therapeutic drug monitoring (TDM) of voriconazole among patients with an invasive mould infection (IMI). The primary objective of this study will be to assess the effect of prospective voriconazole TDM on the composite of adverse events (AE) and clinical response.

Detailed description:
This is a prospective study of patients who receive voriconazole as treatment for an IMI (proven, probable, and possible by the EORTC/MSG definitions), other than zygomycosis. Patients will be randomized to receive either standard dosing or dosing based on TDM, stratified by whether initial voriconazole therapy is PO or IV. Assessment of outcomes will be made 42 days after start of voriconazole. An additional follow up for safety reporting will be performed 4weeks after completion of voriconazole

The patients will be randomized to:

* Prospective TDM: voriconazole dose will be adjusted based on per protocol obtained TDM levels, and
* Standard dosing: standard doses of voriconazole will be used.

In the prospective TDM arm, voriconazole TDM will be performed in real time at each site and results will be reported to treating physicians for dose adjustment. All efforts will be taken to obtain results within 24 hours of blood sample collection. In the standard dosing arm, blood samples will be collected, stored, and batched for voriconazole levels to be tested retrospectively. Voriconazole plasma levels will be measured by validated high performance liquid chromatography (HPLC) assays as detailed. Voriconazole trough levels will be performed on Day Baseline/Screening, 5, 14, 28, and 42.

Voriconazole peak level will be measured on Day 5. Trough voriconazole levels will be obtained in case of an event, defined as suspected drug-associated toxicity and/or clinical failure.

Assessment of AEs for all patients will be monitored during the study and response to treatment will be assessed. The composite of overall AE/clinical failure will be assessed on day 42.

Arms: arm 1: Voriconazole dose will be adjusted based on per protocol obtained TDM levels arm 2: Standard doses of voriconazole will be used
Interventions: intervention 1: Prospective TDM Arm
Intervention descriptions: intervention 1: Voriconazole dose will be adjusted based on per protocol obtained TDM levels

Protocol documents: