ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00813098
Conditions: Irritable Bowel Syndrome
Sponsor: Lexicon Pharmaceuticals
Start date: 2008-12-01; Completion date: 2010-08-01
Enrollment: 155 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the safety, tolerability, and effectiveness of LX1031 versus a placebo control in subjects with non-constipating irritable bowel syndrome.

Detailed description:

Arms: arm 1: A high dose of LX1031; daily oral intake for 28 days arm 2: A low dose of LX1031; daily oral intake for 28 days arm 3: Matching placebo dosing with daily oral intake
Interventions: intervention 1: LX1031 High Dose intervention 2: LX1031 Low Dose intervention 3: Placebo
Intervention descriptions: intervention 1: A high dose of LX1031; daily oral intake for 28 days intervention 2: A low dose of LX1031; daily oral intake for 28 days. intervention 3: Matching placebo dosing with daily oral intake

Protocol documents:
Clinical trial NCT00815685
Conditions: Cancer Cachexia
Keywords: n-3 fatty acids nutritional treatment molecular pathogenesis
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Start date: 2007-07-01; Completion date: 2010-08-01
Enrollment: 36 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The data collected through this pilot study will allow us to increase our understanding of cancer cachexia and the effect of Eicosapentaenoic Acid (EPA) on cancer cachexia. Our long-term goal is to improve nutritional treatment and reduce illness in the cancer patient population.

Detailed description:
People who have cancer can get what is called cancer cachexia (CC). The symptoms of CC include getting full quickly when eating (early satiety), loss of appetite, weakness resulting in weight loss and loss of lean body mass. Even a weight loss of 5% in cancer patients reflects poor health, hospitalization, and a higher rate of illness. Research shows that the elderly are at higher risk for deficiency of vitamins and trace minerals. Other pre-existing chronic diseases and drug therapies in this population may increase the needs of certain nutrients. Recent studies have also shown that advanced malnutrition is much more difficult to treat in the elderly than in younger adults, and the consequences of failure to treat it delays recovery and can decrease function and quality of life. At this time, the ways to treat CC include giving medications to increase appetite and giving nutritional supplements that are high in calories and protein.

Recent studies have shown that certain types of fats that are present in fish, walnuts and other foods that we eat called Eicosapentaenoic acid (EPA) may help with weight gain, especially gain in muscle and improve quality of life in patients with pancreatic cancer. However, EPA has never been studied in prevention of cancer cachexia in cancer patients showing early signs of weight loss. Based on these early, small studies, it is clear that we need to study if and how EPA can prevent loss of muscle and weight in cancer patients and prevent this from becoming worse.

Arms: arm 1: None
Interventions: intervention 1: Eicosapentaenoic Acid
Intervention descriptions: intervention 1: Participants will receive Lovaza at a dose of 4 g for 6 weeks. Participants will be examined at six weeks for change in protein status as indicated by change in morphological (Height, weight, body mass index, body composition, lean body mass, body fat %), and biochemical (serum prealbumin) markers of protein status and immunological cytokines (Il-6, TNF- α) markers implicated in cancer cachexia. At baseline, 3 and 6 weeks, participants will undergo interviews and laboratory analysis for determining compliance and treatment-related toxicity.

Protocol documents:
Clinical trial NCT00818753
Conditions: Heart Catheterization
Sponsor: Boehringer Ingelheim
Start date: 2009-01-01; Completion date: 2010-08-01
Enrollment: 53 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess whether two doses of dabigatran etexilate (110 mg twice daily (b.i.d) and 150 mg twice daily (b.i.d)) as compared to unfractionated heparin (UFH), both in addition to a standard dual antiplatelet regimen, provide sufficient anticoagulation in the setting of elective percutaneous coronary intervention (PCI).

Detailed description:

Arms: arm 1: experimental drug therapy in this indication arm 2: experimental drug therapy in this indication arm 3: standard therapy in this indication as comparator
Interventions: intervention 1: dabigatran 110 mg intervention 2: dabigatran 150 mg intervention 3: unfractionated heparin
Intervention descriptions: intervention 1: comparison of different dabigatran dosages with unfractionated heparin intervention 2: comparison of different dabigatran dosages with unfractionated heparin intervention 3: comparison of different dosages dabigatran with unfractionated heparin

Protocol documents:
Clinical trial NCT00825786
Conditions: Local Anesthetic
Keywords: surgery for arm hand or elbow mepivacaine ropivacaine hand surgery elbow surgery forearm surgery
Sponsor: The Cleveland Clinic
Start date: 2008-09-01; Completion date: 2010-08-01
Enrollment: 103 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will test the hypothesis that sequential injection of 1.5% mepivacaine followed 90 seconds later by 0.5% ropivacaine in ultrasound guided supraclavicular block provides a quicker onset and a longer duration of analgesia than an equi-dose mixture of the two local anesthetics.

Detailed description:
Patients will be randomized into one of two groups, Group M: Ropivacaine and Mepivacaine - subject will receive two injections before surgery begins. These two injections will consist of the mixture of mepivacaine (15 ml) and ropivacaine (15 ml).

Group S: Mepivacaine followed by Ropivacaine. Subjects will receive two injections before surgery begins. One injection will contain mepivacaine (15 ml) and the other will contain ropivacaine (15 ml).

On the first, second, and third mornings after surgery,subjects will be asked to rate their pain on a scale of 1 to 10. If the subject is discharged from the hospital, a telephone call will be made to the subject's home to collect this information.

Arms: arm 1: combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence; arm 2: sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1.
Interventions: intervention 1: Ropivacaine intervention 2: Mepivacaine
Intervention descriptions: intervention 1: ropivacaine (15 ml). intervention 2: One syringe will contain mepivacaine (15 ml)

Protocol documents:
Clinical trial NCT00826176
Conditions: Anesthesia, General Neuromuscular Blockade
Sponsor: Merck Sharp & Dohme LLC
Start date: 2010-01-01; Completion date: 2010-08-01
Enrollment: 164 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The present trial is set up to evaluate the efficacy and safety of 4.0 mg.kg-1 sugammadex in Chinese and Caucasian subjects for registration purposes in China.

Detailed description:

Arms: arm 1: At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Caucasian subjects living in Europe. arm 2: At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Chinese subjects living in China.
Interventions: intervention 1: Sugammadex
Intervention descriptions: intervention 1: After induction of anesthesia an intubation dose of 0.6 mg/kg rocuronium was to be administered. Maintenance doses of 0.1-0.2 mg/kg rocuronium intravenous (IV) could have been administered if necessary. At 1-2 PTC after the last administration of rocuronium, an IV single bolus dose of 4.0 mg/kg sugammadex was to be administered.

Protocol documents:
Clinical trial NCT00830375
Conditions: Compulsive Buying
Keywords: Buying Shopping Impulse Control
Sponsor: University of Minnesota
Start date: 2008-12-01; Completion date: 2010-08-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an 8-week, open-labe study of memantine in the treatment of compulsive buying.

Detailed description:
The goal of the proposed study is to evaluate the efficacy of memantine in the treatment of compulsive buying. Sixteen subjects meeting criteria for compulsive buying will receive 8 weeks of open-label memantine. The hypothesis to be tested is that memantine will be effective and well tolerated in patients with compulsive buying. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.

Arms: arm 1: 10-30mg, memantine
Interventions: intervention 1: Memantine
Intervention descriptions: intervention 1: 10-30mg, by mouth, daily

Protocol documents:
Clinical trial NCT00831779
Conditions: Type 2 Diabetes Mellitus
Sponsor: AstraZeneca
Start date: 2009-04-01; Completion date: 2010-08-01
Enrollment: 116 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effects of dapagliflozin on insulin sensitivity

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Dapagliflozin intervention 2: Placebo
Intervention descriptions: intervention 1: Tablets, Oral, 5 mg, once daily, 12 weeks intervention 2: Tablets, Oral, 0 mg, Once daily, 12 weeks

Protocol documents:
Clinical trial NCT00837590
Conditions: Pre-diabetes Obesity
Keywords: Vascular function Glucose tolerance Obesity Pre-diabetes
Sponsor: Indiana University
Start date: 2009-03-01; Completion date: 2010-08-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Aims:

1. Does inflammation contribute importantly to concurrent defects in vascular and metabolic dysfunction in human pre-diabetic obesity?
2. Are there benefits of anti-inflammatory treatment strategies in pre-diabetic obesity in the context of existing treatment with metformin?
3. Are there benefits of anti-inflammatory treatment strategies in pre-diabetic obesity in the context of existing treatment with lisinopril?

Detailed description:
We set out to pursue the following Aims:

1. Does inflammation contribute importantly to concurrent defects in vascular and metabolic dysfunction in human pre-diabetic obesity? Pilot studies were performed exploring the acute actions of salsalate on vascular function, the chronic actions of salasate in obese individuals, and actions of chronic salsalate to prevent vascular dysfunction induced by fatty acids in lean individuals.
2. Are there benefits of anti-inflammatory treatment strategies in pre-diabetic obesity in the context of existing treatment with metformin? No studies were performed
3. Are there benefits of anti-inflammatory treatment strategies in pre-diabetic obesity in the context of existing treatment with lisinopril? No studies were performed

The intent of the current project is to efficiently and at low cost generate preliminary data along each of these lines of questioning, studying the minimum number of subjects required to assess the viability of the question using the current measurement approaches.

Arms: arm 1: Nondiabetic lean and obese subjects will be studied in this arm. Subjects will be studied at baseline and after a single dose of oral salsalate. arm 2: Obese subjects will be studied in this arm. Subjects will be studied at baseline and after 2 months' treatment with oral salsalate. arm 3: Lean subjects will be studied in this arm. Subjects will be studied at baseline and after 2 months' treatment with oral salsalate. The effects of an acute fatty acid infusion on vascular function will be measured on both occasions.
Interventions: intervention 1: Chronic salsalate intervention 2: Acute Salsalate
Intervention descriptions: intervention 1: Subjects will receive 2 months of treatment with 4 gram/day of oral salsalate divided into 3 doses. intervention 2: Subjects will receive a single oral dose of 2 gram of oral salsalate

Protocol documents:
Clinical trial NCT00845871
Conditions: Transfusional Hemosiderosis
Keywords: Exjade deferasirox palatability tolerability food iron overload Serum Iron overload due to transfusions
Sponsor: Novartis Pharmaceuticals
Start date: 2009-05-01; Completion date: 2010-08-01
Enrollment: 65 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single-arm, open-label, multi-center study enrolled 65 patients from approximately 20 centers. All patients who met the study criteria and were taking, beginning or resuming treatment with Deferasirox were allowed. The study will began with a one month run-in phase, where all patients were instructed to take Deferasirox according to their physician's prescribing information.

Detailed description:
Following the run-in phase, patients entered a three month, assessment phase. During the assessment phase, patients were given five general options for taking Deferasirox including with or without meals, crushed and added to a soft food or mixed in a liquid of choice.

Arms: arm 1: Participants were administered daily with deferasirox starting dose of 20 mg/kg orally to a maximum dose of 40 mg/kg/day.
Interventions: intervention 1: deferasirox:
Intervention descriptions: intervention 1: Participants were administered daily with deferasirox starting dose of 20 mg/kg orally to a maximum dose of 40 mg/kg/day.

Protocol documents:
Clinical trial NCT00857714
Conditions: Ductal Carcinoma in Situ
Keywords: DCIS breast
Sponsor: Indiana University
Start date: 2009-04-01; Completion date: 2010-08-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to establish the utility of lapatinib in the treatment of DCIS, particularly ER-negative DCIS.

Detailed description:
Ductal carcinoma in situ (DCIS) of the breast is a pre-malignant lesion of the breast, which is associated with a marked increase in the likelihood of developing invasive breast cancer. Since DCIS tends to be associated with microcalcifications, it is detected with an increased frequency in patients being screened with mammographic techniques. The treatment of DCIS is based on a number of parameters; local treatment depends on the size of the lesion, grade and margins. The only systemic treatment currently available is in the form of endocrine therapy; it depends on the expression of estrogen receptor (ER). Randomized trials have shown that the treatment of DCIS with breast conserving therapy and radiation is as effective as simple mastectomy.

The efficacy of tamoxifen in reducing the incidence of further invasive or non-invasive breast cancer has been established. In addition to surgery (with or without radiation), patients with ER positive disease also receive anti-estrogen therapy. Current guidelines do not recommend any additional therapy for ER-negative DCIS.

The rationale for the proposed study is based on the observations that HER2 is expressed at high levels in higher grades of DCIS, which typically lack ER. In addition, an inverse relationship between ER expression and the expression of EGFR has also been demonstrated. Lapatinib is active against both these receptors and may have therapeutic action in ER negative DCIS.

We propose to treat the patients with drug in the interval between biopsy diagnosis and definitive surgery.

Interventions: intervention 1: lapatinib
Intervention descriptions: intervention 1: 1500 mg lapatinib for 14-21 days

Protocol documents:
Clinical trial NCT00885495
Conditions: HIV Infections
Keywords: HIV dyslipidemia statins protease inhibitors
Sponsor: University of Cincinnati
Start date: 2009-01-01; Completion date: 2010-08-01
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a phase I, open-label, controlled drug interaction study to determine the effects of darunavir plus ritonavir on the pharmacokinetics of the hydroxymethylglutaryl coenzyme A (HMG-CoA) reductase inhibitor, rosuvastatin, in HIV-1-seronegative subjects.

Detailed description:
Twelve HIV-negative healthy volunteers will be randomized to one of two groups. Group 1 would receive rosuvastatin 10mg daily (Treatment A) in interval 1 for 7 days, followed by a washout period of at least 7 days. In interval 2, darunavir/ritonavir 600/100mg bid (Treatment B) would be administered for 7 days, followed by another 7 day washout period. Lastly, in interval 3 subjects will administer darunavir/ritonavir and rosuvastatin (Treatment C) for total of 7 days. Group 2 will administer Treatment B in interval 1 for 7 days, followed by a washout period of 7 days, then treatment A in interval 2 for 7 days followed by another 7 day washout period. Group 2 would then co-administer rosuvastatin and darunavir/ritonavir for the last 7 days. Intensive PK sampling will be performed on day 7, 21 and 35 following a meal.

Arms: arm 1: Darunavir+ritonavir x 7 days; Rosuvastatin x 7 days; Combination x 7 days arm 2: Rosuvastatin x 7 days; darunavir+ritonavir x 7 days; Combination x 7 days
Interventions: intervention 1: darunavir, ritonavir, rosuvastatin intervention 2: rosuvastatin, darunavir, ritonavir
Intervention descriptions: intervention 1: darunavir 600 mg twice daily for 7 days ritonavir 100 mg twice daily for 7 days rosuvastatin 10 mg once daily for 7 days Combination of all three drugs for 7 days intervention 2: rosuvastatin 10 mg daily for 7 days; darunavir 600 mg twice daily for 7 days with ritonavir 100 mg twice daily for 7 days; Combination of all three for 7 days

Protocol documents:
Clinical trial NCT00887965
Conditions: Low Bone Mass Low Bone Mineral Density Osteoporosis Postmenopausal Osteoporosis
Keywords: Low Bone Mass Low Bone Mineral Density Osteoporosis Postmenopausal Osteoporosis Bone Biopsy Transiliac Crest Bone Histology Histomorphometry
Sponsor: Amgen
Start date: 2009-06-01; Completion date: 2010-08-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To characterize the effects of discontinuation of denosumab therapy on variables of bone histology in postmenopausal women with low bone mass or osteoporosis. Patients who have received denosumab and completed study 20050179 (NCT00293813), completed study 20050141 (NCT00330460), completed study 20060237 (NCT00515463), completed study 20030216 (NCT00089791) but did not enroll in study 20060289 (NCT00523341) will be included in this study. Patients who will participate in the off-treatment imaging study for 20080747 (NCT00890981) are also eligible.

Detailed description:

Arms: arm 1: Participants who had previously received denosumab received a transiliac crest bone biopsy performed following standard labeling procedures with tetracycline or tetracycline derivative.
Interventions: intervention 1: Previous denosumab
Intervention descriptions: intervention 1: Participants who had previously received denosumab received a transiliac crest bone biopsy performed following standard labeling procedures with tetracycline or tetracycline derivative.

Protocol documents:
Clinical trial NCT00912288
Conditions: Alzheimer Disease
Keywords: Alzheimer disease moderate-to-severe memantine safety and efficacy
Sponsor: Pfizer
Start date: 2009-09-01; Completion date: 2010-08-01
Enrollment: 86 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
No Dimebon clinical data exist yet in patients with disease that has advanced to the moderate-to-severe stage. Therefore, this study evaluates the safety and efficacy of Dimebon in patients with moderate-to-severe AD who are receiving existing background therapy with memantine.

Detailed description:
This study was terminated on May 7, 2010 due to modification of the dimebon development plan following the lack of demonstration of efficacy in the completed DIM14 (CONNECTION) Study. The study was not terminated due to any safety findings. Dimebon has been well-tolerated in clinical trials. Demonstration of efficacy for dimebon in Alzheimer's disease is pending completion of the ongoing DIM18 (CONCERT) Study.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Dimebon 20 mg po TID intervention 2: Placebo po TID
Intervention descriptions: intervention 1: Dimebon 10 mg po TID for 1 week followed by Dimebon 20 mg TID for 25 weeks intervention 2: Placebo (matched to Dimebon) po for 26 weeks

Protocol documents:
Clinical trial NCT00925548
Conditions: Breast Cancer
Keywords: Phase III trial randomized cancer vaccine MUC1 BLP25 advanced breast cancer postmenopausal breast cancer immunotherapy of breast cancer Inoperable locally advanced, recurrent, or metastatic endocrine-sensitive Breast Cancer
Sponsor: EMD Serono
Start date: 2009-09-01; Completion date: 2010-08-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
EMD Serono has decided to permanently terminate the trial EMR 200038-010 (STRIDE) in the indication of breast cancer following the clinical hold on the investigational new drug application for tecemotide (L-BLP25).

Detailed description:
The purpose of the study is to determine whether the addition of the experimental mucinous glycoprotein 1 (MUC1) antigen-specific cancer immunotherapy tecemotide (L-BLP25) to hormonal treatment is effective in prolonging progression-free survival in postmenopausal women with endocrine-sensitive inoperable locally advanced, recurrent or metastatic breast cancer.

Arms: arm 1: Investigational Arm:

* Pretreatment (Single Dose): 300 milligrams per square meter (mg/m\^2) up to a maximum dose of 600 mg of intravenous cyclophosphamide
* tecemotide (L-BLP25) plus Hormonal Therapy (Standard Dose) arm 2: Control Arm:

* Pretreatment (Single Dose): sodium chloride (NaCl) 9 grams per liter (g/L) infusion
* Placebo plus Hormonal Therapy (Standard Dose)
Interventions: intervention 1: Tecemotide (L-BLP25) and Hormonal Treatment intervention 2: Placebo of tecemotide (L-BLP25) and Hormonal Treatment intervention 3: cyclophosphamide intervention 4: sodium chloride (NaCl)
Intervention descriptions: intervention 1: Investigational Arm:

Pretreatment (Single Dose) 300 mg/m\^2 of intravenous cyclophosphamide in investigational arm to a maximum of 600 milligrams (mg).

Primary treatment phase:

Hormonal treatment plus 8 consecutive weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms)\* (Week 1 to 8).

Maintenance treatment phase:

Hormonal treatment plus vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms)\* at six-week intervals beginning at Week 14 and continued until Progressive Disease (PD).

\*calculated as mass of lipopeptide (antigen) intervention 2: Control Arm:

Pretreatment (Single Dose) NaCl 9 g/L infusion as a substitute for cyclophosphamide.

Primary treatment phase:

Hormonal therapy plus 8 consecutive weekly subcutaneous placebo doses (Week 1 to 8).

Maintenance treatment phase:

Hormonal therapy plus placebo doses at six-week intervals beginning at Week 14 and continued until Progressive Disease (PD). intervention 3: 300 mg/m\^2 (to a maximum of 600 mg) of intravenous cyclophosphamide. intervention 4: NaCl 9 g/L infusion

Protocol documents: