ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01409564
Conditions: Alzheimer's Dementia
Keywords: Alzheimer's dementia Cilostazol
Sponsor: Seoul National University Hospital
Start date: 2010-05-01; Completion date: 2013-07-01
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the effects of cilostazol augmentation in mild to moderate Alzheimer disease patients with subcortical white matter hyperintensities (WMHI) treated by donepezil.

Dementia is the most disabling disease in the old age. The prevalence of dementia is 5-10% of the elders. AchEIs (donepezil, galantamine, rivastigmine) are used to treat mild to moderate dementia, but these drugs only relate to symptomatic improvement and the response rates are less than 30%.

Cilostazol is a cyclic adenosine monophosphate phosphodiesterase 3 inhibitor (PDE3I) and used as antiplatelet agent in subcortical vascular disease (WMHI). And it upregulates phosphorylation of cyclic adenosine monophosphate-pathway response element binding protein (CREB) which plays a crucial role in memory enhancement and synaptic plasticity related to neurodegeneration prevention.

The investigators will try cilostazol augmentation in dementia patients with WMHI receiving donepezil to see the addictive effects of cilostazol using cognitive tasks and PET imaging.

Detailed description:

Arms: arm 1: Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation. arm 2: Placebo group means dementia patients group receiving donepezil with placebo.
Interventions: intervention 1: Cilostazol intervention 2: Placebo
Intervention descriptions: intervention 1: Cilostazol 100mg bid per day will be administered orally and the period is total 24 weeks. The first week is a period for increasing the quantity, and during this period, cilostazol 50mg bid per day will be administered orally. intervention 2: Placebo with similar shape and color to cilostazol 100mg bid per day will be administered orally and the period is total 24 weeks. The first week is a period for increasing the quantity, and during this period, placebo 50mg bid per day will be administered orally.

Protocol documents:
Clinical trial NCT01431300
Conditions: Healthy
Keywords: central veins thorax superior vena cava Central vein imaging
Sponsor: Duke University
Start date: 2011-08-01; Completion date: 2013-07-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the image quality of Ablavar-enhanced MR angiography of the central veins of the chest, and to determine whether dose reduction can be performed while maintaining image quality. This will be a prospective randomized study, in which healthy volunteers will be recruited to undergo a central veins magnetic resonance angiogram (MRA). They will receive either the FDA-approved dose or a lower dose of Ablavar. Quantitative and qualitative analysis will be performed on the images.

Detailed description:

Arms: arm 1: FDA-approved dose for lower extremity arterial imaging arm 2: None arm 3: None
Interventions: intervention 1: gadofosveset
Intervention descriptions: intervention 1: Intravenous administration of the specified dosage of gadolinium contrast agent

Protocol documents:
Clinical trial NCT01432236
Conditions: Fibromyalgia
Keywords: Pregabalin Lyrica depression
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2011-10-01; Completion date: 2013-07-01
Enrollment: 197 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The intent of this study is to identify and treat fibromyalgia subjects with comorbid depression who are receiving an SSRI (selective serotonin reuptake inhibitor) or SNRI (selective norepinephrine reuptake inhibitor) primarily for their depression and to determine whether pregabalin demonstrates improvement relative to placebo in improving pain associated with fibromyalgia.

Detailed description:

Arms: arm 1: Group 1 as Pregabalin vs. Placebo (cross over study in which period one has this group) arm 2: Group 2 as placebo vs. pregabalin (cross over study in which period two will have this group)
Interventions: intervention 1: Pregabalin intervention 2: placebo
Intervention descriptions: intervention 1: Pregabalin 300 or 450 mg/day dosed BID ( twice a day) for 14 weeks; 150 mg/day starting dose intervention 2: placebo capsules twice a day for 14 weeks

Protocol documents:
Clinical trial NCT01440920
Conditions: Acute Myeloid Leukemia
Keywords: Acute myeloid leukemia WT1
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2011-09-01; Completion date: 2013-07-01
Enrollment: 9 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the safety, tolerability of OCV-501 in patients with acute myeloid leukemia (AML) who achieved complete remission after induction regimen and who completed a standard consolidation therapy.

Detailed description:

Arms: arm 1: 0.3 mg arm 2: 1 mg arm 3: 3 mg
Interventions: intervention 1: OCV-501 intervention 2: OCV-501 intervention 3: OCV-501
Intervention descriptions: intervention 1: subcutaneously administered once a week, 4 times at the dose of 0.3 mg intervention 2: subcutaneously administered once a week, 4 times at the dose of 1 mg intervention 3: subcutaneously administered once a week, 4 times at the dose of 3 mg

Protocol documents:
Clinical trial NCT01441570
Conditions: Transplant; Failure, Kidney Hypertension
Keywords: kidney transplant hypertension nebivolol metoprolol bystolic toprol
Sponsor: Brigham and Women's Hospital
Start date: 2012-02-01; Completion date: 2013-07-01
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In an open label analysis, nebivolol has been shown to have a positive impact on quality of life in the general hypertensive population. That is, patients treated with nebivolol reported less side effects compared to those treated with metoprolol. Also, more nebivolol treated patients reached normalization of blood pressure. Although there is no data, it is believed that the impact would be similar in renal transplant recipients.

The primary goal of this study is to determine if nebivolol will improve the quality of life measurements of kidney transplant recipients as compared to those treated with metoprolol succinate. This will be measured by comparing the scores of four quality of life questionnaires taken before and after 12 weeks of treatment with study drug. Other aims of this study are to determine if the use of nebivolol is cost-effective in the renal transplant recipient; determine if there is a change in urine protein excretion and renal function with the use of nebivolol; and determine the number of patients that maintain or achieve a target blood pressure of ≤ 120/80 mmHg.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Nebivolol intervention 2: Metoprolol succinate
Intervention descriptions: intervention 1: Subject will take nebivolol daily for 12 weeks. intervention 2: Subject will take metoprolol succinate daily for 12 weeks.

Protocol documents:
Clinical trial NCT01443858
Conditions: Smoking Cessation
Keywords: Smoking Cessation Cigarette Smoking Meclizine Nicotine Patch
Sponsor: Duke University
Start date: 2011-08-01; Completion date: 2013-07-01
Enrollment: 146 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate whether meclizine, an antihistamine used to prevent or treat motion sickness, can help smokers quit smoking. This study will also investigate the potential relationship between genes you have inherited and success in quitting smoking.

Detailed description:

Arms: arm 1: Subjects in this group will take placebo meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Placebo meclizine will be administered in two doses each day. arm 2: Subjects in this group will take 25mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day. arm 3: Subjects in this group will take 50mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.
Interventions: intervention 1: Meclizine intervention 2: Nicotine Patch intervention 3: Placebo
Intervention descriptions: intervention 1: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner. intervention 2: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.

Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week. intervention 3: Pre-Quit Period: In this group, participants will take placebo capsules daily during the three week pre-quit period. The placebo will be taken in two doses daily, one capsule with breakfast and one with dinner.

Protocol documents:
Clinical trial NCT01451398
Conditions: Type 2 Diabetes
Sponsor: Mannkind Corporation
Start date: 2011-11-01; Completion date: 2013-07-01
Enrollment: 353 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Insulin-naive subjects with Type 2 Diabetes Mellitus who are sub-optimally controlled on either maximum tolerated dose of metformin or maximum tolerated dose of metformin plus one or two other oral anti-diabetic medications will have either Prandial Technosphere® Insulin or Technosphere Powder (placebo) added to their oral antidiabetic drugs.

Detailed description:

Arms: arm 1: Technosphere® Insulin powder administered via the Gen2 inhaler added to 2 or more stable OADs arm 2: Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable OADs
Interventions: intervention 1: Technosphere® Insulin intervention 2: Technosphere Powder
Intervention descriptions: intervention 1: Technosphere® Insulin Inhalation Powder intervention 2: Placebo Comparator

Protocol documents:
Clinical trial NCT01451827
Conditions: Autosomal Dominant Polycystic Kidney Disease
Keywords: Kidney Disease Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease PKD ADPKD
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2011-10-01; Completion date: 2013-07-01
Enrollment: 178 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the short-term effects of two tolvaptan formulations in patients with ADPKD.

Detailed description:

Arms: arm 1: Tolvaptan MR 50 mg capsule and 2 placebo IR tablets ( 8 AM) and 1 placebo IR tablet (4 PM) daily. arm 2: Tolvaptan MR 80 mg capsule and 2 placebo IR tablets (8 AM) and 1 placebo IR tablet (4 PM) daily. arm 3: Two tolvaptan IR 30-mg tablets and 1 placebo MR capsule (8 AM) and 1 tolvaptan IR 30-mg tablet (4 PM) daily. arm 4: Placebo MR capsule and 2 placebo IR tablets (8 AM) and 1 placebo IR tablet (4 PM) daily.
Interventions: intervention 1: Tolvaptan MR intervention 2: Tolvaptan IR intervention 3: Placebo
Intervention descriptions: intervention 1: 50/80 mg capsules intervention 2: 60/30 mg capsules intervention 3: tablet

Protocol documents:
Clinical trial NCT01456195
Conditions: Diabetes Mellitus, Type 2
Keywords: Drug Therapy
Sponsor: Takeda
Start date: 2011-11-01; Completion date: 2013-07-01
Enrollment: 421 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the efficacy and safety of TAK-875 (fasiglifam), once daily (QD), in participants with type 2 diabetes mellitus (T2DM).

Detailed description:
TAK-875 is being developed at Takeda Development Center, Inc. as an adjunct to diet and exercise to improve glycemic control in patients with T2DM.

This study will investigate TAK-875 in participants with type 2 diabetes mellitus who have been treated with only diet and exercise for at least 12 weeks prior to Screening, who have taken ≤7 days of any antidiabetic agent within the 12 weeks prior to Screening, and whose glycemic control is inadequate.

Arms: arm 1: Fasiglifam placebo-matching tablets, orally, once daily for up to 24 weeks. arm 2: Fasiglifam 25 mg, tablets, orally, once daily for up to 24 weeks. arm 3: Fasiglifam 50 mg, tablets, orally, once daily for up to 24 weeks.
Interventions: intervention 1: Placebo intervention 2: Fasiglifam
Intervention descriptions: intervention 1: Fasiglifam placebo-matching tablets intervention 2: Fasiglifam tablets

Protocol documents:
Clinical trial NCT01457703
Conditions: Obesity
Keywords: LH pulsatility Obesity Reproduction
Sponsor: University of Colorado, Denver
Start date: 2010-06-01; Completion date: 2013-07-01
Enrollment: 62 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine why obese women have lower hormone levels and less fertility than women of normal body weight. The proposal will examine the reproductive system at the level of the brain and the ovary to define the changes that happen leading to lowered hormone production. Women will be studied throughout a menstrual cycle and given medications that will test how well their pituitary gland can make hormones that stimulate the ovary (luteinizing hormone (LH) and follicle stimulating hormone (FSH)). They will also be given a medication to abolish estrogen production in the body and their response to this medication will be assessed. Finally, the ovary's ability to produce progesterone after ovulation will be examined.

--Hypotheses:

1. Obese women have reduced pituitary sensitivity to exogenous gonadotropin-releasing hormone (GnRH), but normal clearance of exogenous LH. (comparative study of obese compared to normal weight women)
2. Obese women have abnormally increased sensitivity to estradiol negative feedback which will be reversed by an aromatase inhibitor. (comparative study of obese compared to normal weight women)

Detailed description:
AIM 1: test the hypothesis that reduced pituitary sensitivity to GnRH-induced LH and FSH secretion causes the relative hypogonadotropic hypogonadism of obesity AIM 2: test the hypothesis that the hypothalamic-pituitary axis is abnormally sensitive to estradiol negative feedback in obesity

Arms: arm 1: Group 2:

* BMI ≥30 kg/m2
* History of regular menstrual cycles every 25-40 days

Gonadorelin-GnRH (Lutrepulse), GnRH antagonists - Cetrorelix (Cetrotide), Recombinant LH (Luveris) were administered in Aim 1. GnRH or gonadorelin (Lutrepulse) and Letrozole were administered in Aim 2. arm 2: * BMI 18-25 kg/m2
* History of regular menstrual cycles every 25-35 days

Gonadorelin-GnRH (Lutrepulse), GnRH antagonists - Cetrorelix (Cetrotide), Recombinant LH (Luveris) were administered in Aim 1. GnRH or gonadorelin (Lutrepulse) and Letrozole were administered in Aim 2.
Interventions: intervention 1: Cetrorelix intervention 2: Gonadorelin-GnRH intervention 3: Recombinant LH intervention 4: Letrozole
Intervention descriptions: intervention 1: Abolishes pituitary sensitivity to GnRH. intervention 2: GnRH is used to stimulate the pituitary gland to produce LH and FSH. intervention 3: Used to stimulate ovarian function in women. intervention 4: An aromatase inhibitor.

Protocol documents:
Clinical trial NCT01458288
Conditions: Multiple Myeloma Non-hodgkin's Lymphoma Hodgkin's Disease
Sponsor: GPCR Therapeutics, Inc.
Start date: 2012-10-01; Completion date: 2013-07-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This Phase II study is to Evaluate the Safety, Pharmacokinetics, and Hematopoietic Stem Cell Mobilization of TG-0054 alone or in combination with G-CSF in Patients with Multiple Myeloma, Non-Hodgkin Lymphoma or Hodgkin Disease.

Detailed description:

Arms: arm 1: TG-0054 (3.14 mg/kg)
Interventions: intervention 1: TG-0054
Intervention descriptions: intervention 1: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of four leukapheresis sessions)

Protocol documents:
Clinical trial NCT01474772
Conditions: Diabetic Peripheral Neuropathy
Keywords: Diabetic Peripheral Neuropathy Pain on Walking Pregabalin
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2011-10-01; Completion date: 2013-07-01
Enrollment: 217 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The intent of this study is to treat subjects with painful Diabetic Peripheral Neuropathy (DPN) who also have pain on walking and to determine whether or not pregabalin demonstrates improvement relative to placebo on the following: reducing DPN pain, reducing pain on walking, and providing other benefits associated with daily activities and quality of life.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Pregabalin intervention 2: placebo
Intervention descriptions: intervention 1: 150-300 mg/day given in 3 divided doses as capsules intervention 2: matching placebo capsules given in 3 divided doses

Protocol documents:
Clinical trial NCT01485380
Conditions: Dexmedetomidine Induced Sedation
Keywords: Dexmedetomidine Sleep MRI-PET EEG
Sponsor: Massachusetts General Hospital
Start date: 2012-09-01; Completion date: 2013-07-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The investigators are doing this research study to find out how and where dexmedetomidine, a sedative anesthetic, acts in the brain. The investigators will do this by using a machine that records the brains electrical activity, called an electroencephalogram (EEG), and brain imaging scans to look at the brain.

Detailed description:

Arms: arm 1: Subjects recruited into this study will be required to undergo two magnetic resonance imaging- positron emission tomography (MRI-PET) scans of the brain in addition to high density electroencephalogram (EEG) acquisition. The first scan will be a baseline scan while the second scan will be performed while dexmedetomidine is being infused.
Interventions: intervention 1: dexmedetomidine
Intervention descriptions: intervention 1: The dexmedetomidine infusion will be individualized to each study participant by a target plasma concentration where loss of consciousness is initially observed. Loss of consciousness will be assayed by specific auditory and verbal stimuli.

Protocol documents:
Clinical trial NCT01498419
Conditions: Pulmonary Tuberculosis
Keywords: Tuberculosis Serial Sputum Colony Counts Colony Forming Units Time to Sputum Culture Positivity PA824 pretomanid
Sponsor: Global Alliance for TB Drug Development
Start date: 2012-03-01; Completion date: 2013-07-01
Enrollment: 207 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the mycobactericidal activity of the moxifloxacin plus PA-824 plus pyrazinamide regimen after 8 weeks of treatment.

Detailed description:

Arms: arm 1: Drug Sensitive Participants: One moxifloxacin (M) 400 mg tablet plus one Pretomanid (PA-824) 100 mg tablet plus three pyrazinamide 500 mg tablets taken once daily for 8 weeks arm 2: Drug Sensitive Participants: One moxifloxacin (M) 400 mg tablet plus one Pretomanid (PA-824) 200 mg tablet plus three pyrazinamide 500 mg tablets taken once daily for 8 weeks arm 3: Drug Sensitive Participants: Rifafour was administered orally once daily for 8 weeks according to weight: 30 kg to 37 kg: two tablets; 38 kg to 54 kg: three tablets; 55 kg to 70 kg: four tablets; ≥71 kg: five tablets arm 4: Multi Drug-Resistant Participants: One moxifloxacin (M) 400 mg tablet plus one Pretomanid (PA-824) 200 mg tablet plus three pyrazinamide 500 mg tablets taken once daily for 8 weeks
Interventions: intervention 1: Moxifloxacin (M) intervention 2: Pretomid (Pa) intervention 3: Pyrazinamide (Z) intervention 4: Rifafour
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: 2 tablets, 38-54 kg: 3 tablets, 55-70 kg: 4 tablets: 71 kg and over: 5 tablets

Protocol documents:
Clinical trial NCT01498549
Conditions: Addiction
Keywords: Abstinent cocaine users cognitive testing
Sponsor: Yale University
Start date: 2011-12-01; Completion date: 2013-07-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The overall goal of this study is to determine if atomoxetine treatment improves selective cognitive functions in abstinent cocaine users, compared to healthy controls. The study will also test if a functional variation of the NET promoter polymorphic region (NETpPR) moderates the cognitive effects of atomoxetine.

Detailed description:
This will be a double-blind, placebo-controlled, crossover study, with cocaine use (cocaine users vs. healthy controls) and NET AAGG4 status (L4/ L4 vs. L4/S4 or S4/ S4 genotype) as the between-subject factors. Similar to previous studies, we propose to compare individuals with two copies of the L4 allele to participants with at least one S4 allele because only less than two percent of the general population is homozygous for the S4 allele. Forty cocaine users and 40 healthy controls will participate in 3 test sessions, where they will be assigned to 40 mg atomoxetine, 80 mg atomoxetine, or placebo. Outcome measures will include physiological, subjective, and cognitive performance measures.

To date this study has 35 completers and currently in data analysis. (January 2016)

Arms: arm 1: Atomoxetine compared to the sugar pill arm 2: Sugar pill compared to atomoxetine
Interventions: intervention 1: Atomoxetine intervention 2: Sugar Pill
Intervention descriptions: intervention 1: Atomoxetine 40mg and 80mg compared to the sugar pill intervention 2: Sugar pill compared to Atomoxetine 40mg and 80mg.

Protocol documents: