ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00512902
Conditions: Alveolitis Systemic Sclerosis
Keywords: active alveolitis in systemic sclerosis
Sponsor: University of California, Los Angeles
Start date: 2007-08-01; Completion date: 2008-12-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the safety and tolerability of imatinib (gleevec) in subjects who have systemic sclerosis. Imatinib has been approved by the FDA for the treatment of newly diagnosed adult patients with CML (newly diagnosed adult patients and for the treatment of patients with an accelerated phase. Imatinib is also approved for the treatment of patients with a certain type of gastrointestinal cancer (called stromal tumors) but it has not been approved to treat systemic sclerosis. Imatinib works by interfering with an enzyme called tyrosine phosphatase resulting in suppression of the immune system. It als interferes with a protein called platelet derived growth factor receptor (PDGFr) that has been linked to increased fibrosis.

Detailed description:
Systemic sclerosis is a rare, progressive disease that leads to hardening and tightening of the skin and connective tissues. It usually begins with a few dry patches of skin on the hands or face that begin getting thicker and harder. These patches then spread to other areas of the skin. In some cases, systemic sclerosis also affects the blood vessels an internal organs. Systemic sclerosis is one of a group of arthritic conditions called connective tissue disorders, a person's antibodies are directed against their own tissues.

Arms: arm 1: SSc patients receiving Imatinib (Gleevec, up to 600 mg) QD PO for up to 1 year.
Interventions: intervention 1: Imatinib intervention 2: Imatinib
Intervention descriptions: intervention 1: All subjects will receive gleevec. Subjects will have a clinic visit every 2 weeks for the first 20 weeks and then they will have one every 4 weeks for the remainder of the study. Gleevec will be taken by mouth everyday. It will be increased to a maximum of 600 mg every day. It will be increased 100 mg at each visit for the first 12 weeks. Your participation may last up to 1 year and participants will have approximately 18 clinic visits. intervention 2: Up to 600 mg QD PO for up to 1 year.

Protocol documents:
Clinical trial NCT00514501
Conditions: Acute Coronary Syndrome
Sponsor: Molecular Insight Pharmaceuticals, Inc.
Start date: 2007-05-01; Completion date: 2008-12-01
Enrollment: 510 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label phase 2 study recruiting low, moderate, and high likelihood ACS patients from approximately 60 centers. Patients will be imaged with iodofiltic acid I 123 for the detection of myocardial ischemia. Readers independent of the clinical study centers will review results of imaging studies in a blinded fashion at an imaging core lab. The resulting independent reading of the images will be compared against the truth standard for ACS.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Iodofiltic acid I 123
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00516386
Conditions: Anorexia Nervosa
Keywords: Adolescents Anorexia nervosa (AN) Bone formation markers Insulin like growth factor-1 (IGF-I)
Sponsor: Massachusetts General Hospital
Start date: 2007-03-01; Completion date: 2008-12-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to determine whether giving insulin like growth factor-I (IGF-I) to adolescent low weight girls is safe and whether this increases levels of bone formation markers.

Detailed description:
Adolescents with anorexia nervosa (AN) are at high risk for low bone mineral density at a time when healthy adolescents are rapidly accruing bone, with implications for peak bone mass and fracture risk in later life. They are also deficient in insulin-like growth factor I (IGF-I), the bone trophic factor made in the liver in response to growth hormone (GH), despite elevated levels GH. It is possible that deficiency of IGF-I, a hormone very important for the maintenance of skeletal integrity, may contribute to the severe osteopenia seen in AN. The physiologic effects of rhIGF-I treatment in adolescents with AN had not been studied. The goal of this proposal was to investigate the acute effects of rhIGF-I on bone metabolism in adolescent girls with AN.

Specific Aim: It was hypothesized that adolescent AN patients, being IGF-I deficient, would respond to exogenously administered rhIGF-I with elevations in biochemical indices of bone turnover. Therefore, rhIGF-I was administered to AN patients by subcutaneous injection over 10 days with concomitant measurement of indices of bone turnover, and calcium regulatory hormones.

Arms: arm 1: Adolescent girls with AN meeting inclusion criteria were administered recombinant human (rh) rhIGF-1 at a dose of 35-40 mcg/k twice daily by subcutaneous injections for a 7-10 day period.
Interventions: intervention 1: RhIGF-1
Intervention descriptions: intervention 1: 35-40 mcg/k/dose twice daily SC

Protocol documents:
Clinical trial NCT00520351
Conditions: Myopia
Sponsor: University of Waterloo
Start date: 2007-08-01; Completion date: 2008-12-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of the study is to evaluate and compare, on a daily wear basis, the performance of two contact lens care solutions when used with silicone hydrogel soft contact lenses with regards to comfort and dryness symptoms.

Detailed description:
The purpose of the study is to evaluate and compare, on a daily wear basis, the performance of two contact lens care solutions when used with silicone hydrogel soft contact lenses with regards to comfort and dryness symptoms by observing changes within the cornea and collecting subjective ratings

Arms: arm 1: None arm 2: None
Interventions: intervention 1: ClearCare intervention 2: Optifree Replenish
Intervention descriptions: intervention 1: contact lens care system intervention 2: contact lens care system

Protocol documents:
Clinical trial NCT00529087
Conditions: Constipation
Keywords: Opioid-Induced Constipation
Sponsor: Bausch Health Americas, Inc.
Start date: 2007-08-01; Completion date: 2008-12-01
Enrollment: 460 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of the protocol is to evaluate the safety, efficacy, and tolerability of subcutaneous MOA-728 versus placebo in subjects with chronic non-malignant pain who have Opioid-Induced Constipation (OIC).

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: N-methylnaltrexone bromide (MOA-728) intervention 2: placebo
Intervention descriptions: intervention 1: Subcutaneous intervention 2: placebo

Protocol documents:
Clinical trial NCT00529555
Conditions: Adult Periodontitis
Sponsor: Sunstar Americas
Start date: 2006-01-01; Completion date: 2008-12-01
Enrollment: 602 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Periodontal disease (commonly called gum disease) is generally treated by deep cleaning of the root surfaces of the teeth. This is also called scaling and root planing. Placing a topical antibiotic into the periodontal pocket at the time of scaling and root planing may help reduce pocket depth and thus help the periodontal disease. Periocline (minocycline HCl) 2.1% gel is a topical antibiotic approved in a number of countries for this use, and is now being tested in the US.

Detailed description:

Arms: arm 1: sham treatment arm 2: Placebo arm 3: Minocycline HCL 2.1%
Interventions: intervention 1: minocycline HCl 2.1% intervention 2: Scaling and root planing
Intervention descriptions: intervention 1: Minocycline HCl 2.1% gel as an adjunct to scaling and root planing. Dosing is by topical delivery into gingival pockets at baseline, 2 weeks, 4 weeks, 3 months and 6 months. intervention 2: scaling and root planing

Protocol documents:
Clinical trial NCT00540423
Conditions: Chronic Idiopathic Thrombocytopenic Purpura Purpura, Thrombocytopenic, Idiopathic
Keywords: thrombopoietin, immunosuppressive therapy, eltrombopag, idiopathic thrombocytopenic purpura, blood platelet, splenectomy
Sponsor: GlaxoSmithKline
Start date: 2007-09-01; Completion date: 2008-12-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase II/III multicenter study comprising of the double-blind, followed by open-label phases to evaluate and compare the efficacy and tolerability of eltrombopag (SB-497115-GR) in chronic ITP patients

Detailed description:

Arms: arm 1: Subject will initiate treatment with SB-497115-GR 12.5mg once a day. Based on the subjects platelet count at each visit, the dose of SB-497115-GR may be adjusted at 12.5mg, 25mg or 50mg. arm 2: Subject will initiate treatment with SB-497115-GR 12.5mg matching placebo once a day. Based on the subjects platelet count at each visit, the dose of SB-497115-GR 12.5mg matching placebo may be increased to 2 tablet of SB-497115-GR 12.5mg matching placebo.
Interventions: intervention 1: SB-497115-GR 12.5mg intervention 2: SB-497115-GR 25mg intervention 3: SB-497115-GR 12.5mg matching placebo intervention 4: SB-497115-GR 50 mg
Intervention descriptions: intervention 1: SB-497115-GR 12.5mg tablet once a day intervention 2: SB-497115-GR 25mg tablet once a day intervention 3: SB-497115-GR 12.5mg matching placebo x1 or 2 tablet once a day intervention 4: SB-497115-GR 25mg tablet x2 once a day

Protocol documents:
Clinical trial NCT00542750
Conditions: Cannabis Dependence
Keywords: Cannabis Marijuana Pharmacotherapy Adolescent
Sponsor: Medical University of South Carolina
Start date: 2008-01-01; Completion date: 2008-12-01
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this pilot study is to determine the feasibility of conducting a trial of N-Acetylcysteine in cannabis dependent adolescents.

Detailed description:
This project involves investigation of oral N-acetylcysteine (NAC) as a potential pharmacologic agent for treatment of cannabis dependence in adolescents. Cannabis dependence continues to be a major problem among adolescents in the United States. To date, psychosocial interventions have produced only small to modest effect sizes in controlled trials, and minimal work has been done to investigate the potential role for pharmacotherapy for cannabis dependence. Translating preclinical research suggesting a role for NAC in cocaine dependent individuals, our research group has developed preliminary evidence of decreased cocaine use and cue reactivity in humans taking NAC. Preclinical research has additionally demonstrated significant parallels in glutamatergic dysfunction in the nucleus accumbens (the proposed target of NAC treatment) between habitual cocaine and marijuana users. NAC is an inexpensive, long-available agent with a favorable tolerability profile in adults and children. However, it has not yet been studied in cannabis dependent adolescents. Hence, we are undertaking an open-label pilot trial of NAC in adolescents with cannabis dependence.

The primary specific aims of the proposed project are:

1. To assess the feasibility of conducting a trial of NAC in cannabis dependent adolescents.
2. To assess the safety and tolerability of NAC in cannabis dependent adolescents

   The secondary specific aim of the proposed project is:
3. To gather variability information to assist in design of a larger-scale, adequately powered clinical trial of NAC in cannabis dependent adolescents.

Primary hypotheses

1. It will be feasible to recruit and retain cannabis dependent adolescents in a trial of NAC.
2. NAC will be well tolerated among cannabis dependent adolescents.

   Secondary hypothesis
3. Adequate variability information will be gathered to design a larger-scale, adequately powered clinical trial of NAC in cannabis dependent adolescents.

Twenty-four adolescents between 12 and 20 years old will be recruited in this study. Results from this project will be used to design further studies.

Arms: arm 1: All participants will receive N-Acetylcysteine 1200 mg twice daily during four weeks of participation. Tolerability, marijuana use, and reactivity to marijuana cues will be investigated.
Interventions: intervention 1: N-Acetylcysteine
Intervention descriptions: intervention 1: N-Acetylcysteine 1200 mg twice daily for four weeks

Protocol documents:
Clinical trial NCT00546000
Conditions: Atopic Dermatitis
Sponsor: Fougera Pharmaceuticals Inc.
Start date: 2007-07-01; Completion date: 2008-12-01
Enrollment: 56 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A multi-center, open-label, Phase IV, unblinded study using Cutivate (fluticasone propionate, 0.05%)lotion and it's possible effects on the HPA axis of infants diagnosed with atopic dermatitis.

Detailed description:

Arms: arm 1: Receive between 22 and 29 days of Cutivate lotion treatment
Interventions: intervention 1: Fluticasone propionate 0.05% lotion
Intervention descriptions: intervention 1: Daily applications

Protocol documents:
Clinical trial NCT00551200
Conditions: Urea Cycle Disorders
Keywords: Buphenyl Sodium Phenylbutyrate Urea Cycle Disorder UCD
Sponsor: Amgen
Start date: 2007-10-01; Completion date: 2008-12-01
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether HPN-100 is safe and tolerable in subjects with Urea Cycle Disorders.

Detailed description:
When protein is broken down in the body, nitrogen is formed. In healthy individuals, the body combines this nitrogen with other molecules to create a harmless substance called urea, which is excreted in the urine. Patients with Urea Cycle Disorders (UCD) are unable to create as much urea from nitrogen, and therefore, toxic levels of nitrogen can accumulate in the body, causing harm. To treat these patients, doctors usually have the patient consume less protein and supplement certain amino acids that may be lacking. A drug called Buphenyl® is sometimes prescribed as an adjunctive treatment for the chronic maintenance of UCD patients in order to keep ammonia levels down. Some issues with Buphenyl® include a high pill burden (up to 40 pills per day), bad taste and odor, and high sodium content. Like Buphenyl®, HPN-100 provides an alternate way for the body to dispose of nitrogen, other than through the urea cycle. Unlike Buphenyl®, HPN-100 is an odorless, tasteless, concentrated oil that does not contain large amounts of sodium.

Study acquired from Horizon in 2024.

Arms: arm 1: Buphenyl treatment for one week was followed by dose escalation to HPN-100. Dose of Buphenyl was gradually decreased while HPN-100 dose was gradually increased until subject reached dosing of 100% HPN-100. HPN-100 at 100% of the dose was given for 1 week before subject was switched back to original Buphenyl treatment.
Interventions: intervention 1: HPN-100 intervention 2: BUPHENYL®
Intervention descriptions: intervention 1: Subjects will be taking prescribed dose of Buphenyl® TID (not to exceed 20g/day) at least two weeks prior to enrollment. Subjects will take prescribed dose of Buphenyl® TID for first week of study, and then switch over to HPN-100 TID during a dose-escalation phase. The dose of HPN-100 will be increased and the dose of Buphenyl® will be decreased each week by 50 mg/kg until entire daily dose of phenylbutyrate is HPN-100. Target HPN-100 dose will contain the same amount of phenylbutyrate as the subject's prescribed daily dose of Buphenyl®. Subject will take HPN-100 alone for one week and then switch back to previous dose of Buphenyl for the last week of the study. intervention 2: BUPHENYL® (sodium phenylbutyrate) tablets and powder have been approved for marketing in the United States since 1996 as an adjunctive therapy in the long-term management of patients with UCDs involving deficiencies of CPS, OTC, or ASS.

Protocol documents:
Clinical trial NCT00566462
Conditions: Parkinson's Disease
Sponsor: Eisai Inc.
Start date: 2007-10-01; Completion date: 2008-12-01
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a two-arm, double-blind, placebo-controlled study.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: perampanel intervention 2: placebo
Intervention descriptions: intervention 1: 2 mg/d for 14 days followed by 4 mg/d for 14 days intervention 2: Matching placebo for for 14 days followed by 4 mg/d for 14 days

Protocol documents:
Clinical trial NCT00570349
Conditions: Cystic Fibrosis
Keywords: Inhaled Nitric oxide Cystic Fibrosis
Sponsor: Mallinckrodt
Start date: 2004-07-01; Completion date: 2008-12-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the trial is to assess the safety and tolerability of inhaled nitric oxide (NO) when administered by nasal cannula over a 44 hour period to clinically stable Cystic Fibrosis (CF) subjects. Toxicity is to be defined as a drop in oxygen saturations, a decline in forced expiratory volume in one second (FEV1), or an increase in methemoglobin.

Detailed description:
Cystic fibrosis (CF) is an autosomal recessive disorder caused by mutations in the gene encoding the cystic fibrosis transmembrane conductance regulator (CFTR) protein. A cycle of chronic, persistent infections with CF-related pathogens and an excessive inflammatory response progressively damages the airways and lung parenchyma, resulting in widespread bronchiectasis and ultimately, respiratory failure. Despite tremendous advances in understanding the CF gene and the CFTR protein, it is not known exactly how mutations in the gene and defects in CFTR lead to persistent airway infection and inflammation.

Inhaled nitric oxide (NO) has potential to be an effective treatment in CF lung disease. Inhaled NO has been studied in other airways diseases characterized by infection and /or inflammation such as COPD and idiopathic pulmonary fibrosis.

NO has been shown to activate CFTR and alternative chloride channels, thereby increasing chloride current in epithelial cells. Therefore, NO treatment may be beneficial in individuals with CF.

Arms: arm 1: Subjects in the low dose cohort receive 20 part per million (ppm) of nitric oxide via nasal cannula over a 44 hour period. arm 2: Subjects in the high dose cohort receive 40 ppm of nitric oxide via nasal cannula over a 44 hour period. arm 3: 100% Nitrogen (placebo) will be administer at 20 ppm or 40 ppm via nasal cannula over a 44 hour period.
Interventions: intervention 1: Nitric Oxide for Inhalation intervention 2: Nitric Oxide for Inhalation intervention 3: Nitrogen
Intervention descriptions: intervention 1: Nitric oxide will be administered at 20 ppm via nasal cannula over a 44 hour period. intervention 2: Nitric oxide will be administered at 40 ppm via nasal cannula over a 44 hours period. intervention 3: 100% nitrogen (placebo) will be administered at 20 ppm or 40 ppm via nasal cannula over a 44 hour period.

Protocol documents:
Clinical trial NCT00580489
Conditions: Pain Relief Adverse Events
Keywords: helicopter aeromedical pain relief analgesia fentanyl morphine adverse events
Sponsor: MetroHealth Medical Center
Start date: 2006-08-01; Completion date: 2008-12-01
Enrollment: 204 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is exempt from informed consent by the MetroHealth Medical Center institutional review board (IRB), because two standards of care are used and there is no increased clinical risk to the patient due to the study. The researchers randomize either fentanyl or morphine to be given to trauma patients and record how their pain scale is treated along with observing for adverse events. They are looking to see if the hypothesized benefits of fentanyl (which is much more expensive than morphine) actually exist.

Detailed description:
Periodic reports are made to the IRB.

Arms: arm 1: Morphine given to trauma patients transported by helicopter arm 2: Fentanyl given to trauma patients transported by helicopter
Interventions: intervention 1: either fentanyl or morphine
Intervention descriptions: intervention 1: either morphine 4mg IV or fentanyl 50mcg IV

Protocol documents:
Clinical trial NCT00583947
Conditions: Asthma
Keywords: Asthma Respiratory Tract Diseases
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2008-01-01; Completion date: 2008-12-01
Enrollment: 53 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To determine the safety and tolerability of Arformoterol Tartrate in children with asthma

Detailed description:
A randomized, double-blind two-way crossover study of three cumulative doses of arformoterol (7.5 ug per nebulization) and levalbuterol (0.63 mg per nebulization) given over a one hour period, followed by a single open-label treatment day with three cumulative doses of arformoterol 15 ug in subjects 2-11 years of age with asthma. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Arms: arm 1: Cross-over phase: one day active treatment with arformoterol 7.5 microgram per nebulization followed by a 7 day washout. Then a one day active treatment with levalbuterol 0.63 milligram per nebulization.

Open-label phase: Following another 7 day washout, one day treatment with arformoterol 15 micrograms per nebulization. arm 2: Cross-over phase: one day active treatment with levalbuterol 0.63 milligram per nebulization followed by a 7 day washout. Then a one day active treatment with arformoterol 7.5 micrograms per nebulization.

Open-label phase: Following another 7 day washout, one day treatment with arformoterol 15 micrograms per nebulization.
Interventions: intervention 1: arformoterol intervention 2: levalbuterol
Intervention descriptions: intervention 1: Arformoterol is given at a 7.5 ug per dosing during the cross-over phase and 15 ug per dosing during the open-label phase. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes). intervention 2: Levalbuterol is given at a 0.63 mg per dosing during the cross-over phase. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes).

Protocol documents:
Clinical trial NCT00585104
Conditions: Heart Failure
Sponsor: University of Utah
Start date: 2006-09-01; Completion date: 2008-12-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will test the hypothesis that mechanical efficiency as measured by pressure-volume loop assessment should improve during short-term treatment with intravenous levosimendan.

Levosimendan (SimdaxTM, Abbott Laboratories, Abbott Park, IL) is a calcium sensitizer which has been shown to have beneficial hemodynamic effects in patients with decompensated congestive heart failure (CHF). Levosimendan is a new calcium sensitizer that binds to troponin C. This agent is approved in Europe for treatment of heart failure patients. In the United States, this agent is currently under phase III investigation for intravenous treatment of patients with acutely decompensated HF who have dyspnea at rest or with minimal activity. Levosimendan has been studied in these patients with acute HF and is considered experimental in the United States for this population.

Detailed description:

Arms: arm 1: All randomized patients receive drug.
Interventions: intervention 1: levosimendan
Intervention descriptions: intervention 1: 10-minute infusion

Protocol documents: