ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT04474405
Conditions: Alzheimer Disease
Sponsor: Avid Radiopharmaceuticals
Start date: 2013-08-16; Completion date: 2013-12-09
Enrollment: 36 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This early phase 1 study explored the brain uptake, retention, and safety of flortaucipir and obtained preliminary information regarding dosimetry of flortaucipir.

Detailed description:

Arms: arm 1: Subjects receiving a brain PET scan after flortaucipir administration arm 2: Subjects receiving a whole body PET scan after flortaucipir administration arm 3: Magnetic resonance imaging (MRI) scans and amyloid scans for subjects previously participating in Study T807000 (NCT01733355)
Interventions: intervention 1: Flortaucipir F18 intervention 2: Brain PET Scan intervention 3: Whole body PET scan intervention 4: Florbetapir F 18 intervention 5: Brain MRI
Intervention descriptions: intervention 1: IV injection, 370 MBq (10 mCi), single dose intervention 2: positron emission tomography (PET) scan of the brain starting immediately after administration (60 minute dynamic imaging plus 4 frames x 5 minutes at approximately 80 minutes post-dose). intervention 3: positron emission tomography (PET) scan of the body from the vertex of the head to the thighs starting immediately following injection and repeated over 6 hours intervention 4: IV injection, 370 MBq (10 mCi), single dose intervention 5: Volume-based T1-weighted Magnetic Resonance Imaging (MRI) of the brain

Protocol documents:
Clinical trial NCT01436162
Conditions: Major Depressive Disorder
Sponsor: Shire
Start date: 2011-10-19; Completion date: 2013-12-10
Enrollment: 1105 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will examine SPD489 in subjects aged 18-65 with major depressive disorder (MDD) who are taking certain types of antidepressants but continue to have residual depression symptoms. Eligible patients will remain on their antidepressant but will be randomized to either receive supplemental SPD489 or placebo (i.e. sugar pill). The purpose of this study is to help answer the following questions:

* How safe is SPD489 for the supplemental treatment of depression and what are the side effects that might be related to it?
* Can supplemental SPD489 help patients who still have residual depression symptoms while taking an antidepressant?
* How much SPD489 should be given to patients with depression who are also taking an antidepressant?
* How does SPD489 compare to placebo in depressed patients who are also taking an antidepressant?

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Antidepressant + SPD489 (Lisdexamfetamine dimesylate ) intervention 2: Antidepressant + Placebo
Intervention descriptions: intervention 1: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily + SPD489 (oral, 20, 30, 50 or 70 mg, once daily) for 8 weeks intervention 2: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks

Protocol documents:
Clinical trial NCT01850602
Conditions: Hemodialysis Hyperphosphatemia
Keywords: Hemodialysis Hyperphosphatemia
Sponsor: Kissei Pharmaceutical Co., Ltd.
Start date: 2013-04-23; Completion date: 2013-12-10
Enrollment: 213 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of PA21 in hemodialysis patients with hyperphosphatemia

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: PA21 intervention 2: Sevelamer hydrochloride
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00445887
Conditions: Ovarian Carcinoma
Sponsor: Gynecologic Oncology Group
Start date: 2008-03-10; Completion date: 2013-12-11
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase II trial is studying how well levonorgestrel works in preventing ovarian cancer in patients at high risk for ovarian cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of levonorgestrel may prevent ovarian cancer.

Detailed description:
PRIMARY OBJECTIVES:

I. Determine the impact of levonorgestrel on the relative frequency of apoptosis in the ovarian epithelium of patients at high risk for ovarian cancer.

SECONDARY OBJECTIVES:

I. Estimate the impact of this drug on proliferation and transforming growth factor-beta (TGF-beta) expression in the ovarian epithelium of these patients.

II. Assess the safety of this drug in these patients.

OUTLINE: This is a prospective, randomized, placebo-controlled, double-blind study. Patients are stratified according to menopausal status (premenopausal vs postmenopausal). Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive oral levonorgestrel once daily.

ARM II: Patients receive oral placebo once daily.

In both arms, treatment continues for 4-6 weeks in the absence of disease progression or unacceptable toxicity, including on the day of surgery. Patients then undergo prophylactic salpingo-oophorectomy. After completion of study therapy, patients are followed at 1 year.

NOTE: \* Patients who are unable to have surgery completed during the expected 4-6 weeks, may continue levonorgestrel or placebo for a time period no \> 5 months. Patients unable to undergo surgery within 5 months are removed from the study.

Arms: arm 1: Patients receive oral levonorgestrel once daily. arm 2: Patients receive oral placebo once daily.
Interventions: intervention 1: Laboratory Biomarker Analysis intervention 2: Levonorgestrel intervention 3: Placebo
Intervention descriptions: intervention 1: Correlative studies intervention 2: Given orally intervention 3: Given orally

Protocol documents:
Clinical trial NCT01717287
Conditions: HIV Infection
Sponsor: Merck Sharp & Dohme LLC
Start date: 2012-11-16; Completion date: 2013-12-11
Enrollment: 32 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This multicenter, open-label, noncomparative study evaluates two oral formulations of raltegravir (MK-0518, film-coated tablet and chewable tablet) in combination with other antiretroviral agents for safety, tolerability, and antiretroviral activity in treatment-naive or treatment-experienced Russian children and adolescents infected with human immunodeficiency virus-1 (HIV-1).

As raltegravir is indicated in combination with other antiretroviral therapies (ARTs) for the treatment of HIV-1 infection in pediatric patients in the United States (US), this study is designed to gain local treatment experience on the use

of raltegravir in the pediatric HIV-infected population in Russia.

Detailed description:

Arms: arm 1: Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks arm 2: Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
Interventions: intervention 1: Raltegravir Film-coated Tablet intervention 2: Raltegravir Chewable Tablet intervention 3: Other Anti-Retroviral Therapy
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: At baseline, the investigator selected the other anti-retroviral therapies to be used in combination with raltegravir based on current treatment guidelines, the participant's treatment history, and prior anti-retroviral resistance testing

Protocol documents:
Clinical trial NCT04123665
Conditions: Gingivitis
Keywords: Oral Health Antiplaque Gingivitis
Sponsor: GlaxoSmithKline
Start date: 2013-05-28; Completion date: 2013-12-11
Enrollment: 98 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate and compare the gingival health of a test dentifrice (0.454% weight by weight \[w/w\] stannous fluoride) to a negative control dentifrice by comparing modified gingival index, bleeding index and plaque index scores.

Detailed description:
This will be a single-center, examiner-blinded, randomized, stratified, two-treatment parallel group, 24-week clinical study in healthy adult volunteers with moderate gingivitis. Eligible participants will be stratified based on gender and baseline mean whole mouth modified gingival index (MGI) score (Low: less than or equal to \[\<=\] 2.00/High greater than \[\>\]2.00) to ensure a balance in gingivitis across both treatment groups, and then randomized into one of two treatment groups. Treatment effect will be evaluated by comparing MGI , bleeding index and plaque index scores after 12 and 24 weeks use of a dentifrice containing 0.454% w/w stannous fluoride to a negative control dentifrice. During the 24 week treatment period, participants will apply a full ribbon of dentifrice to the head of a study toothbrush and brush their teeth in their usual manner at home for one timed minute twice daily (morning and evening) and record on their study diary completed brushings.

Arms: arm 1: In this arm, participants will apply a full ribbon of dentifrice ( 0.454% w/w stannous fluoride) to the bristles of a study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) and record on their study diary completed brushings. arm 2: In this arm, participants will apply a full ribbon of negative control dentifrice (1000 ppm fluoride as sodium monofluorophosphate \[SMFP\] to the bristles of a study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) and record on their study diary completed brushings.
Interventions: intervention 1: Stannous fluoride intervention 2: Sodium monofluorophosphate
Intervention descriptions: intervention 1: In this arm, participants will apply a full ribbon of dentifrice ( 0.454% w/w stannous fluoride) to the bristles of a study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) and record on their study diary completed brushings. intervention 2: In this arm, participants will apply a full ribbon of negative control dentifrice (1000 ppm fluoride as SMFP to the bristles of a study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) and record on their study diary completed brushings.

Protocol documents:
Clinical trial NCT01469377
Conditions: Major Depressive Disorder
Keywords: Major depressive disorder Depression
Sponsor: Forest Laboratories
Start date: 2011-12-15; Completion date: 2013-12-12
Enrollment: 819 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
An outpatient study to evaluate the safety and efficacy of cariprazine as adjunct to antidepressant therapy (ADT) in participants with major depressive disorder (MDD) who have an inadequate response to ADT alone. This clinical study compared cariprazine + ADT with placebo + ADT in outpatients with a diagnosis of MDD and an inadequate response to ADT. The study consisted of approximately 2 weeks of screening and washout followed by 8 weeks of double-blind treatment followed by a 1 week safety follow-up.

Detailed description:

Arms: arm 1: Participants received placebo orally once a day for 8 weeks. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment. arm 2: Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2 and 1.0 mg on Days 3-7. At the investigator's discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 1.0 or 1.5 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 1.0, 1.5, or 2.0 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment. arm 3: Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2, 1.0 mg on Day 3, 1.5 mg on Day 4, and 2.0 mg on Days 5-7. At the investigator's discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 2.0 or 3.0 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 2.0, 3.0, or 4.5 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.
Interventions: intervention 1: Placebo intervention 2: Cariprazine
Intervention descriptions: intervention 1: Placebo was supplied in capsules intervention 2: Cariprazine was supplied in capsules.

Protocol documents:
Clinical trial NCT01979185
Conditions: Healthy
Sponsor: Shire
Start date: 2013-11-18; Completion date: 2013-12-13
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a randomized, open-label study to evaluate the effect of a single dose of SSP-004184 on the pharmacokinetics of a single dose of simvastatin in healthy adult subjects.

Detailed description:

Arms: arm 1: Administered as a single oral 20 mg dose on Day 1. arm 2: Simvastatin (20 mg) + SSP-004184SS (30 mg/kg) administered concomitantly as a single oral dose on Day 1.
Interventions: intervention 1: Simvastatin intervention 2: SSP-004184SS
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01888497
Conditions: Healthy
Keywords: Sleeplessness
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2013-07-29; Completion date: 2013-12-14
Enrollment: 59 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will examine the next-day residual effects of a nighttime dose of gabapentin 250 mg, diphenhydramine citrate 76 mg and triazolam 0.5 mg compared to placebo and each other on simulated driving performance in normal volunteer subjects. It will also examine other measures of next-day performance and next-day sleepiness.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Gabapentin intervention 2: Diphenhydramine citrate intervention 3: Triazolam intervention 4: Placebo
Intervention descriptions: intervention 1: 250 mg, oral, prior to bedtime on the night before performance testing intervention 2: 76 mg, oral, prior to bedtime on the night before performance testing intervention 3: 0.5 mg, oral, prior to bedtime on the night before performance testing intervention 4: Oral, prior to bedtime on the night before performance testing

Protocol documents:
Clinical trial NCT01937975
Conditions: Chronic Hepatitis C Renal Impairment
Sponsor: Merck Sharp & Dohme LLC
Start date: 2013-09-06; Completion date: 2013-12-17
Enrollment: 24 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Grazoprevir (MK-5172) and Elbasvir (MK-8742) were studied as the principal components of combination oral therapy for hepatitis C virus (HCV). The study examined the pharmacokinetic (PK) profiles of Grazoprevir and Elbasvir following 10 days of dosing in participants with end stage renal disease (ESRD) on hemodialysis (HD) or participants with severe renal impairment. Both groups were compared to healthy matched controls.

Detailed description:

Arms: arm 1: Participants with End Stage Renal Disease on hemodialysis received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.. arm 2: Participants with Severe Renal Impairment (estimated glomerular filtration rate \<30 mL/min/1.73 m\^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. arm 3: Healthy participants (estimated glomerular filtration rate \>=80 mL/min/1.73 m\^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
Interventions: intervention 1: Grazoprevir intervention 2: Elbasvir
Intervention descriptions: intervention 1: 100 mg oral tablet administered once a day for 10 days intervention 2: 50 mg oral tablet administered once a day for 10 days

Protocol documents:
Clinical trial NCT00321100
Conditions: Colorectal Neoplasms
Keywords: metastatic colorectal cancer initial therapy
Sponsor: Fox Chase Cancer Center
Start date: 2006-04-12; Completion date: 2013-12-18
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the objective response rate of patients with previously untreated metastatic colorectal cancer treated with the combination of cetuximab, capecitabine, and oxaliplatin with out without bevacizumab.

Detailed description:
Research has shown that the more drug treatments patients with cancer of the colon or rectum receive, the longer they live. One uses the drugs capecitabine and oxaliplatin which all patients on this study will receive. Bevacizumab is an antibody which blocks blood flow to tumors and increases how long patients with colorectal cancer live. However, it can increase the risk of stroke and heart attack. Bevacizumab is currently a standard part of treatment for colorectal cancer. Cetuximab is an antibody which blocks a protein called EGFR which shrinks colorectal cancer. It may be helpful with initial chemotherapy and with bevacizumab. One goal of this study is to find out the response rate (chance of tumor shrinking) with two treatments for colorectal cancer. All patients will get capecitabine, oxaliplatin and cetuximab. Half will receive bevacizumab. All drugs in this study are approved to treat colorectal cancer. This research study is being done to find the best, safest way to combine these therapies.

Arms: arm 1: Cetuximab 400 mg/m2 IV initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly of each 21 day cycle; Oxaliplatin 130mg/m2 IV day 1 of each 21 day cycle; Capecitabine 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle; Bevacizumab 7.5mg/kg IV day 1 of each 21 day cycle arm 2: Cetuximab 400 mg/m2 IV initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly of each 21 day cycle; Oxaliplatin 130mg/m2 IV day 1 of each 21 day cycle; Capecitabine 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle
Interventions: intervention 1: bevacizumab intervention 2: cetuximab intervention 3: Oxaliplatin intervention 4: Capecitabine
Intervention descriptions: intervention 1: Bevacizumab 7.5mg/kg IV day 1 of each 21 day cycle intervention 2: Cetuximab 400mg/m2 IV initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly each 21 day cycle intervention 3: Oxaliplatin 130mg/m2 IV day 1 every 21 days intervention 4: Capecitabine 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle

Protocol documents:
Clinical trial NCT01370616
Conditions: Infection; Diabetic Foot
Keywords: Infection Diabetes complications Diabetes wound infection Soft tissue infection Osteomyelitis Diabetes mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2011-09-02; Completion date: 2013-12-18
Enrollment: 565 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study compared ertapenem sodium to piperacillin/tazobactam sodium for the treatment of moderate to severe diabetic foot infections. The primary hypothesis was that treatment with ertapenem sodium is non-inferior to treatment with piperacillin/tazobactam sodium, in achieving clinical improvement or cure.

Detailed description:

Arms: arm 1: Participants received 1.0 g intravenous (IV) ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28 arm 2: Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
Interventions: intervention 1: Ertapenem sodium intervention 2: Piperacillin/tazobactam sodium intervention 3: Piperacillin/tazobactam-matching placebo intervention 4: Amoxicillin/clavulunate potassium
Intervention descriptions: intervention 1: Ertapenem sodium, 1.0 g IV daily over 30 minutes at Hour 0 for 5 to 28 days intervention 2: Piperacillin/tazobactam sodium, 4.5 g, IV every 8 hours, given over 30 minutes at Hours 0, 8, and 16 for 5 to 28 days intervention 3: Placebo, IV over 30 minutes, 2 times per day at Hours 8 and 16 for 5 to 28 days intervention 4: If clinically indicated, participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28

Protocol documents:
Clinical trial NCT01763918
Conditions: Hyperlipidemia
Keywords: High cholesterol, Treatment for high cholesterol, Lowering cholesterol, Lowering high cholesterol, Hypercholesterolemia
Sponsor: Amgen
Start date: 2013-02-07; Completion date: 2013-12-19
Enrollment: 331 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneously once every 2 weeks (Q2W) and once monthly (QM), compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in adults with heterozygous familial hypercholesterolemia (HeFH).

Detailed description:

Arms: arm 1: Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks. arm 2: Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks. arm 3: Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks. arm 4: Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
Interventions: intervention 1: Evolocumab intervention 2: Placebo
Intervention descriptions: intervention 1: Administered by subcutaneous injection intervention 2: Administered by subcutaneous injection

Protocol documents:
Clinical trial NCT01382303
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes pentoxifylline proteinuria
Sponsor: Ajou University School of Medicine
Start date: 2010-10-25; Completion date: 2013-12-20
Enrollment: 174 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This multi-center, randomized controlled study aims to evaluate the effects of pentoxifylline on proteinuria in Korean type 2 diabetic patients.

Detailed description:
The investigators will recruit adults patients with type 2 diabetes aged over 20 years with spot urine albumin to creatinine ratio over 30mg/g in two consecutive measurements.

Enrolled patients will be randomly assigned to receive pentoxifylline (400mg three times daily) or placebo for 24 weeks.

Fasting blood and spot urine will be collected at baseline, 12 weeks and 24 weeks.

The investigators will evaluate the impact of pentoxifylline on proteinuria in type 2 diabetic patients.

Arms: arm 1: Pentoxifylline 400mg three times a day arm 2: placebo tablet
Interventions: intervention 1: Pentoxifylline intervention 2: Placebo
Intervention descriptions: intervention 1: Pentoxifylline 400mg three times a day intervention 2: placebo tablet three times a day

Protocol documents: