ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00613106
Conditions: Osteoarthritis Rheumatoid Arthritis Chronic Low Back Pain Chronic Regional Pain Syndrome Chronic Soft Tissue Pain
Sponsor: Amgen
Start date: 2007-09-01; Completion date: 2008-10-01
Enrollment: 179 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety of long-term treatment with HZT-501.

Detailed description:
Subject who have completed the 24-week Treatment Period of Horizon Protocol HZ-CA-301 or HZ-CA-303 without developing an upper gastrointestinal ulcer and who are expected to continue to require daily administration of an NSAID for the next 6 months will receive treatment with the same study medication received while participating in HZ-CA-301 or HZ-CA-303.

Study with completed results acquired from Horizon in 2024.

Arms: arm 1: HZT-501: ibuprofen 800mg/famotidine 26.6mg arm 2: Ibuprofen 800mg
Interventions: intervention 1: HZT-501 intervention 2: Ibuprofen
Intervention descriptions: intervention 1: Ibuprofen 800mg/famotidine 26.6 mg administered orally 3 times daily for 2 weeks intervention 2: Ibuprofen 800mg administered orally 3 times daily for at least 28 weeks

Protocol documents:
Clinical trial NCT00618722
Conditions: Moderate or Severe Submental Fullness
Sponsor: Kythera Biopharmaceuticals
Start date: 2007-08-01; Completion date: 2008-10-01
Enrollment: 85 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the safety and potential efficacy of deoxycholic acid injection compared to placebo for the reduction of submental fat (fat below the chin).

Detailed description:
The trial included an initial cohort (3 participants in each arm) to evaluate safety followed by expansion to a second, larger cohort if adequate safety was determined in the initial cohort. Data from both cohorts was pooled for analysis.

Arms: arm 1: Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. arm 2: Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. arm 3: Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. arm 4: Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
Interventions: intervention 1: Deoxycholic Acid Injection intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00619385
Conditions: Healthy
Keywords: Pharmacokinetics
Sponsor: Repros Therapeutics Inc.
Start date: 2008-02-01; Completion date: 2008-10-01
Enrollment: 25 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Dose escalating study of 7 daily doses of Proellex at 100 mg, 150 mg and 200 mg

Detailed description:
This is an open-label, single-center, outpatient, unblinded, multi-dose study of the safety and pharmacokinetic properties of Proellex®. Six female subjects will each receive seven daily doses of Proellex® in separate, rising doses. Dosing must be accomplished between menstrual periods. The first six women will complete the 100 mg visit schedule before the next six women will begin the 150 mg visit schedule. Blood will be collected at pre-dose, and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 24 and 36 (Day 7 only) hrs post-dose on Day 1 and Day 7. Subjects will be allowed to leave the clinic between the 12 and 24 hr and the 24 and 36 hr PK blood draws. Subjects will be discharged from the study after a one month follow-up visit. Safety will be assessed throughout the study.

Arms: arm 1: Proellex 100 mg daily for 7 days arm 2: Proellex 150 mg daily for 7 days arm 3: Proellex 200 mg daily for 7 days
Interventions: intervention 1: Proellex
Intervention descriptions: intervention 1: Proellex 25 mg capsules 100 mg, 150 mg or 200mg daily for 7 days

Protocol documents:
Clinical trial NCT00623779
Conditions: Persistent or Permanent Non-valvular Atrial Fibrillation
Sponsor: AstraZeneca
Start date: 2007-10-01; Completion date: 2008-10-01
Enrollment: 128 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the safety and tolerability of AZD0837 in patients with atrial fibrillation who are unable or unwilling to take vitamin K antagonist therapy for up to 3 months.

Detailed description:

Interventions: intervention 1: AZD0837 intervention 2: Aspirin
Intervention descriptions: intervention 1: ER formulation intervention 2: Oral form

Protocol documents:
Clinical trial NCT00624013
Conditions: Diabetes Depression
Keywords: Diabetes Depression diabetes outcomes quality of life
Sponsor: Charles Drew University of Medicine and Science
Start date: 2006-09-01; Completion date: 2008-10-01
Enrollment: 89 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This proposed study will test the following hypothesis: Treating depression in Hispanics and African Americans with diabetes will improve their HbA1c and quality of life while on intervention and six months after intervention.

Detailed description:
The medication to be used will be sertraline (Zoloft). Sertraline (Zoloft)has been proven in clinical trials to be an effective and well tolerated prescription medication that improves the quality and enjoyment of life for adults suffering from depression . Sertraline is an antidepressant and a member of the family of medications known as selective serotonin reuptake inhibitors (SSRIs). It has excellent tolerability and minimal drug-drug intereactions.

The hypothesis will be tested by the following specific aims:

1. To determine if treating mild to moderate depression with sertraline (Zoloft) in patients with diabetes improves HbA1c.
2. To determine if treating mild to moderate depression with sertraline (Zoloft) in patients with diabetes improves quality of life.

If our hypothesis proves correct and this treatment of depression is efficient and easy in a county hospital population of African Americans and Hispanics, researchers can move forward in finding fast and efficient means of diagnosing depression in vulnerable populations, including low-literate patients. This study is critical in that it stands to improve the HBA1c (and other metabolic parameters) and quality of life of our underserved minority community, which sadly suffers from a higher rate of almost every disease, including diabetes. Treating mild to moderate depression in a county hospital population of African Americans and Hispanics may improve quality of life and reduce/prevent complications and early death. Secondary outcomes include reduced hospitalizations, fewer missed appointments, and improved adherence to medication.

Arms: arm 1: Placebo 50 mg up to 100 mg daily for 6 months arm 2: Sertraline (Zoloft) 50 mg up to 100 mg daily for 6 months
Interventions: intervention 1: sertraline intervention 2: Placebo
Intervention descriptions: intervention 1: 50 mg up to 100 mg daily for 6 months intervention 2: 50 mg up to 100 mg daily for 6 months

Protocol documents:
Clinical trial NCT00630487
Conditions: Growth Hormone Deficiency
Sponsor: Pfizer
Start date: 2008-05-01; Completion date: 2008-10-01
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will investigate the effect on growth hormone replacement in patients with isolated growth hormone deficiency on body composition, especially visceral fat mass.

Detailed description:
The study was terminated on 15-Dec-2008 due to poor recruitment. Although 9 Patients were enrolled, no patient was randomized nor treated with somatropin. No safety reasons contributed to the termination.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Placebo intervention 2: Somatropin
Intervention descriptions: intervention 1: Patients of Placebo Group will be treated with placebo sub-cutaneous in the same way as Somatropin during the double blind treatment phase. To maintain blind subject will be measured in the same way as the treatment group for IGF-I- Levels. Central lab will randomize placebo patients to dose change or maintenance of dose. This will ensure continued blinding of the study to patients and personnel. intervention 2: Fixed doses for patients: MALE: \< 45y 0,4 mg, \> 45y 0,2mg FEMALE: \< 45y 0,5mg, \>45y 0,3mg. for the first 4 weeks half of the dose will be given. After that dose will be increased to the targeted maintenance dose according to IGF-I Levels +/- 2 SD of age adjusted reference range. In case of side effects dosage will remain on half-dose (during the first 4 weeks) or reduced to half dose (after the first 4 weeks). At week 52 patients have the opportunity to switch to open label study restarting with half the given fixed dose which will be adjusted to full dose after 4 weeks.

Protocol documents:
Clinical trial NCT00631189
Conditions: Type IIa and IIb Hypercholesterolaemia
Keywords: dyslipidemia
Sponsor: AstraZeneca
Start date: 2007-10-01; Completion date: 2008-10-01
Enrollment: 668 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of Rosuvastatin 5 mg as an hypercholesterolemia treatment comparatively at 2 other statins: Pravastatin 40 mg and Atorvastatin 10 mg. Treatment efficacy will be evaluated by the percentage of LDL-C variation after 8 weeks of treatment.

Detailed description:

Arms: arm 1: Rosuvastatin and Pravastatin arm 2: Rosuvastatin and Atorvastatin
Interventions: intervention 1: Rosuvastatin intervention 2: Pravastatin intervention 3: Atorvastatin
Intervention descriptions: intervention 1: 5mg oral intervention 2: 40mg oral intervention 3: 10mg oral

Protocol documents:
Clinical trial NCT00634842
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2008-02-01; Completion date: 2008-10-01
Enrollment: 244 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in the United States of America. The aim of this trial is to explore how different fasting blood glucose targets affect glucose control in patients with type 2 diabetes, when patients are empowered to do dose adjustments themselves.

Detailed description:

Arms: arm 1: Aggressive FPG (fasting plasma glucose) titration target range group arm 2: Conventional FPG (fasting plasma glucose) titration target range group
Interventions: intervention 1: insulin detemir intervention 2: insulin detemir
Intervention descriptions: intervention 1: Treat-to-target dose titration scheme, s.c. injection, once daily. Fasting plasma glucose (FPG) titration target range of 70-90 mg/dL intervention 2: Treat-to-target dose titration scheme, s.c. injection, once daily. Fasting plasma glucose (FPG) titration target range of 80-110 mg/dL

Protocol documents:
Clinical trial NCT00636207
Conditions: Asthma
Sponsor: Organon and Co
Start date: 2007-08-01; Completion date: 2008-10-01
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to evaluate the safety, tolerability and pharmacokinetics of inhaled Montelukast (MK-0476) in participants with mild or moderate asthma.

Detailed description:

Arms: arm 1: Participants receive Montelukast inhalation powder, 0.1 mg.

* Part I: Administered as a single dose followed by at least a 3-day washout period. arm 2: Participants receive Montelukast inhalation powder, 0.3 mg.

* Part I: Administered as a single dose followed by at least a 3-day washout period. arm 3: Participants receive Montelukast inhalation powder, 1 mg.

* Part I: Administered as a single dose followed by at least a 3-day washout period.
* Part II: Administered once daily (QD) for 5 days followed by at least a 3-day washout period. arm 4: Participants receive Montelukast inhalation powder, 3 mg.

* Part I: Administered as a single dose followed by at least a 3-day washout period.
* Part II: Administered QD for 5 days followed by at least a 3-day washout period.
* Part III: Administered QD for 10 days followed by at least a 7-day washout period. arm 5: Participants receive Montelukast inhalation powder, 10 mg.

* Part I: Administered as a single dose followed by at least a 3-day washout period.
* Part II: Administered QD for 5 days followed by at least a 3-day washout period.
* Part III: Administered QD for 10 days followed by at least a 7-day washout period. arm 6: Participants receive Placebo to Montelukast inhalation powder.

* Part I: Administered as a single dose followed by at least a 3-day washout period.
* Part II: Administered QD for 5 days followed by at least a 3-day washout period.
* Part III: Administered QD for 10 days followed by at least a 7-day washout period.
Interventions: intervention 1: Montelukast intervention 2: Placebo
Intervention descriptions: intervention 1: Montelukast dry powder inhaler, 0.1 mg, 0.3 mg, 1 mg, 3 mg or 10 mg intervention 2: Placebo dry powder inhaler

Protocol documents:
Clinical trial NCT00636818
Conditions: Attention Deficit Hyperactivity Disorder
Sponsor: Eli Lilly and Company
Start date: 2008-03-01; Completion date: 2008-10-01
Enrollment: 45 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this clinical study is to assess overall safety and tolerability as measured by discontinuation rate due to adverse events in doses up to 120 mg/day in relation to global clinical studies in adult subjects who meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV™) criteria for Attention-Deficit/Hyperactivity Disorder (ADHD).

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Atomoxetine
Intervention descriptions: intervention 1: Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.

Protocol documents:
Clinical trial NCT00639158
Conditions: Dyslipidemias Coronary Heart Disease Combined (Atherogenic) Dyslipidemia Mixed Dyslipidemia
Sponsor: Abbott
Start date: 2008-02-01; Completion date: 2008-10-01
Enrollment: 543 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to compare the safety and efficacy of ABT-335 (investigational drug) coadministered with atorvastatin and ezetimibe to atorvastatin coadministered with ezetimibe in subjects with abnormal lipid (fat) levels in the blood.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: ABT-335 intervention 2: placebo intervention 3: atorvastatin intervention 4: ezetimibe
Intervention descriptions: intervention 1: 135 mg capsule, daily, 12 weeks intervention 2: placebo capsule, daily, 12 weeks intervention 3: 40 mg, tablet, daily, 12 weeks intervention 4: 10 mg capsule, daily, 12 weeks

Protocol documents:
Clinical trial NCT00639223
Conditions: Hypercholesterolemia Statin-Associated Myopathy
Keywords: Statin related myalgia Hyperlipidemia Red yeast rice Cardiovascular Diseases Nutritional and Metabolic Diseases
Sponsor: University of Pennsylvania
Start date: 2008-01-01; Completion date: 2008-10-01
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will examine the effect of red yeast rice extract compared to pravastatin on muscle related complaints in individuals with high cholesterol who have previously been unable to tolerate statin medications due to muscle pain. The study will determine whether red yeast is associated with a lower level of muscle related complaints compared to pravastatin.

Detailed description:
20 million Americans are actively treated with statins at an annual cost of 16 billion dollars. Statins are effective therapeutic agents for reducing LDL cholesterol and have documented effectiveness. However, a significant subset of patients (5-18%), cannot tolerate lipid lowering statin therapy due to intolerable muscle-related symptoms characterized by muscle pain and/or weakness. These symptoms affect quality of life and lead to poor adherence.

Patients may seek alternative therapies to manage hypercholesterolemia if they have been intolerant of statin therapy. One commonly used alternative treatment option is the Chinese herb red yeast rice extract. Several small studies performed in China, have suggested this treatment is efficacious and well tolerated. In the U.S. red yeast rice is sold over the counter a dietary supplement.

The objective of this study is to critically examine the safety and efficacy of the Chinese herb red yeast rice as an alternative lipid lowering therapy, in a statin intolerant population.

This objective will be operationalized by a double-blind randomized trial, comparing the effect of red yeast rice extract, to that of pravastatin on the level of myalgia in subjects with a prior history of statin-induced myalgias.

The specific aims include:

1. Determine the relative rates of withdrawal from treatment in subjects receiving red yeast rice compared to pravastatin.
2. Determine if red yeast rice is associated with a lower level of muscle pain (myalgia) symptoms compared to pravastatin as measured by the Brief Pain Inventory, a validated pain questionnaire.
3. Determine if red yeast rice is associated with a lower level of muscle weakness compared to pravastatin as measured by a dynamometry, a validated muscle strength testing method.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Red Yeast Rice intervention 2: Pravastatin intervention 3: Lifestyle modification program
Intervention descriptions: intervention 1: Four 600mg capsules twice daily for 12 weeks intervention 2: One 20mg capsule twice daily for 12 weeks intervention 3: Weekly sessions each lasting 3 1/2 hours for 12 weeks

Protocol documents:
Clinical trial NCT00640835
Conditions: Opioid-Related Disorders
Keywords: Opioid dependence
Sponsor: Indivior Inc.
Start date: 2008-02-01; Completion date: 2008-10-01
Enrollment: 382 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and tolerability on the oral mucosa of buprenorphine/naloxone film strips administered either sublingually or buccally daily for 12 weeks in opioid dependent individuals who are already on a stable regimen of buprenorphine/naloxone.

Detailed description:
Buprenorphine and naloxone soluble film was developed as an alternative dosage form to Suboxone (buprenorphine and naloxone) sublingual tablets and was evaluated for both sublingual and buccal administration. The soluble film dosage is expected to provide the following enhancements and potential advantages over the current Suboxone (buprenorphine and naloxone) product:

* mitigation against unintentional pediatric exposure by providing child-resistant packaging in unit dose format.
* improvement in subject convenience and compliance by ensuring rapid disintegration.
* protection against diversion by providing a dosage form that is very difficult for the subject to remove from the sublingual or buccal mucosa after administration. This provides assurance to the caregiver that the dose has actually been taken appropriately in a supervised setting.
* provision of a unit dose product format for hospital and institutional use.
* decreased product damage during shipping as compared to Suboxone tablets.

Arms: arm 1: Buprenorphine/naloxone film strip administered sublingually arm 2: Buprenorphine/naloxone film strip administered buccally
Interventions: intervention 1: Buprenorphine/naloxone Film Strip intervention 2: Buprenorphine/naloxone Film Strip
Intervention descriptions: intervention 1: Buprenorphine/naloxone dosed between 4/1 mg to 32/8 mg once a day for 12 weeks by sublingual route intervention 2: Buprenorphine/naloxone dosed between 4/1 mg to 32/8 mg once a day for 12 weeks by buccal route

Protocol documents:
Clinical trial NCT00646646
Conditions: Saccadic Eye Movements
Keywords: Sedation Eye Movements
Sponsor: University of Alabama at Birmingham
Start date: 2007-04-01; Completion date: 2008-10-01
Enrollment: 65 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether sedation affects saccadic eye movements.

Detailed description:

Arms: arm 1: active drug arm 2: sedative arm 3: Sedative arm 4: placebo control
Interventions: intervention 1: propofol intervention 2: dexmedetomidine intervention 3: Midazolam intervention 4: saline placebo
Intervention descriptions: intervention 1: sedative intervention 2: Sedative intervention 3: sedative intervention 4: saline placebo

Protocol documents:
Clinical trial NCT00654511
Conditions: Tonsillitis
Keywords: Dexmedetomidine, fentanyl, tonsillectomy and adenoidectomy,
Sponsor: Children's National Research Institute
Start date: 2005-01-01; Completion date: 2008-10-01
Enrollment: 101 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is:

1. To compare dexmedetomidine with fentanyl in terms of intra-operative hemodynamics and post-operative analgesia.
2. To determine an analgesic dose response relationship for dexmedetomidine.
3. Compare recovery characteristics of dexmedetomidine to fentanyl.

Detailed description:

Arms: arm 1: Fentanyl 1 micrograms (mcg)/kilogram (kg) arm 2: Fentanyl 2 micrograms (mcg)/kilogram (kg) arm 3: Dexmedetomidine 2 micrograms (mcg)/kilogram (kg) arm 4: Dexmedetomidine 4 micrograms (mcg)/kilogram (kg)
Interventions: intervention 1: Fentanyl intervention 2: Fentanyl intervention 3: Dexmedetomidine intervention 4: Dexmedetomidine
Intervention descriptions: intervention 1: Fentanyl 1mcg/kg, Intravenous (IV) intervention 2: Fentanyl 2mcg/kg, Intravenous (IV) intervention 3: Dexmedetomidine, 2mcg/kg, Intravenous (IV) intervention 4: Dexmedetomidine, 4mcg/kg Intravenous (IV)

Protocol documents:
Clinical trial NCT00655642
Conditions: Nausea
Sponsor: Vanderbilt University
Start date: 2007-03-01; Completion date: 2008-10-01
Enrollment: 171 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to compare the effectiveness of ondansetron, metoclopramide, and promethazine for the treatment of nausea in the adult emergency department population.

We hypothesize that a single intravenous dose of ondansetron is more effective in reducing nausea than a single IV dose of metoclopramide, promethazine or normal saline placebo in undifferentiated adult emergency department patients.

Detailed description:

Arms: arm 1: Ondansetron 4 mg intravenous administration arm 2: Metoclopramide 10 mg intravenous administration arm 3: Promethazine 10 mg intravenous administration arm 4: Volume-matched saline placebo
Interventions: intervention 1: Ondansetron intervention 2: Metoclopramide intervention 3: Promethazine intervention 4: Normal Saline
Intervention descriptions: intervention 1: 4 mg intravenous dose administered over 2 minutes through a peripheral intravenous catheter intervention 2: 10 mg intravenous dose administered over 2 minutes through a peripheral intravenous catheter intervention 3: 12.5 mg intravenous dose administered over 2 minutes through a peripheral intravenous catheter intervention 4: Volume matched isotonic sodium chloride solution dose administered over 2 minutes through a peripheral intravenous catheter

Protocol documents: