ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00827931
Conditions: Biliary Tract Surgical Procedures Pancreaticoduodenectomy Esophagectomy Colectomy Gastrectomy
Keywords: tranexamic acid major abdominal surgery blood loss
Sponsor: Pfizer
Start date: 2009-09-01; Completion date: 2011-05-01
Enrollment: 94 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Tranexamic acid has been shown to reduce postoperative blood losses and transfusion requirements in various types of major surgery (orthopedic surgery, spine surgery, cardiopulmonary bypass, liver resections, and gynecological cancers).The current trial is being conducted to compare the efficacy of tranexamic acid plus standard of care versus standard of care in reduction of blood loss in patients undergoing major abdominal surgeries.

Detailed description:

Arms: arm 1: end of the operation and on the mornings of the first, second, fourth and seventh postoperative days. arm 2: Standard of Care
Interventions: intervention 1: Tranexamic acid + Standard of Care intervention 2: Standard of Care
Intervention descriptions: intervention 1: Tranexamic acid given slowly intravenously (15 mg/kg body weight) 15 minutes before surgery followed by a second dose at three hour interval from first dose and third dose at three hour interval from the second + standard of care (Standard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss) intervention 2: Standard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss

Protocol documents:
Clinical trial NCT00827983
Conditions: In Vitro Fertilization
Keywords: Luteal Phase Support in IVF patients
Sponsor: IBSA Institut Biochimique SA
Start date: 2009-01-01; Completion date: 2011-05-01
Enrollment: 683 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Prospective, open, randomised, parallel, multicentre, two arm trial comparing a new form of luteal support (S.C.) to an approved comparator (vaginal gel).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Progesterone intervention 2: Progesterone
Intervention descriptions: intervention 1: 25 mg, s.c., once à day intervention 2: 90 mg, vaginally, once à day

Protocol documents:
Clinical trial NCT00830167
Conditions: Fibromyalgia
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2009-03-01; Completion date: 2011-05-01
Enrollment: 498 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study, will compare pregabalin with placebo for the duration of 15 weeks to evaluate the efficacy and safety of pregabalin in patients with fibromyalgia.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Placebo intervention 2: Pregabalin
Intervention descriptions: intervention 1: Dosage: placebo, oral administration, Treatment duration: 15 weeks (3-week titration and 12-week fixed dose) intervention 2: Dosage: 300 or 450 mg/day (150 or 225 mg bid), oral administration, Treatment duration: 15 weeks (3-week titration and 12-week fixed dose)

Protocol documents:
Clinical trial NCT00840294
Conditions: Elevated Prostate Specific Antigen
Keywords: Men with Elevated PSA
Sponsor: University of Chicago
Start date: 2009-01-01; Completion date: 2011-05-01
Enrollment: 85 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the impact of an empiric course of antibiotics for men with an elevated prostate-specific antigen (PSA) level.

Detailed description:
Study Objectives:

Primary Objective: To assess the impact of ciprofloxacin on the change in PSA from baseline/randomization to prostate biopsy

Secondary Objective: To assess the impact of ciprofloxacin on the overall infectious complications following prostate biopsy

The impact of observation versus ciprofloxacin on PSA levels will be assessed by PSA change from baseline. The first PSA measurement will be at the study entry and randomization. The second PSA measurement will be immediately prior to prostate biopsy, which will occur 21-45 days following randomization.

Arms: arm 1: Observation only for 2 weeks arm 2: Ciprofloxacin 500 mg twice daily for 2 weeks
Interventions: intervention 1: Ciprofloxacin
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00842829
Conditions: Cancer Pain Breakthrough Pain
Keywords: Breakthrough Cancer Pain
Sponsor: Cephalon
Start date: 2009-01-01; Completion date: 2011-05-01
Enrollment: 330 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Breakthrough cancer pain (BTcP) is a common problem in patients with cancer. Fentanyl Buccal Tablet (FBT) is used for the treatment of BTP in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain. FBT treatment should be individually titrated to an effective dose that provides adequate analgesia and minimizes undesirable effects. To reach the safest effective dose for the individual patient as soon as possible, the dose titration process is critical. The aim of this study, conducted under pragmatic conditions in a large-scale population of cancer patients is to compare the proportion of patients reaching an effective FBT dose after titration starting with either a 100 mcg dose or a 200 mcg dose.

Detailed description:

Arms: arm 1: During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 100 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days. Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days). The length of the Continuation Period (when applicable) varied from country to country, up to until FBT was commercially available in that country. arm 2: During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days. Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days). The length of the Continuation Period (when applicable) varied from country to country, up to until FBT was commercially available in that country.
Interventions: intervention 1: Fentanyl Buccal Tablet (FBT)
Intervention descriptions: intervention 1: FBTs were self-administered by participants via the oral mucosa. During the open-label dose titration period, participants used 1 to 4 tablets of the 100 mcg or 200 mcg strength to individually titrate upwards to an effective dose through the range of available strengths (i.e. 100, 200, 400, 600, or 800 mcg). For the open-label treatment and continuation periods, single dose tablets at the effective dose identified during the titration period were used. The maximum dose allowed per breakthrough pain (BTP) episode was 800 mcg. On any single day, participants were not to use FBT for more than 4 BTP episodes.

Protocol documents:
Clinical trial NCT00843791
Conditions: Obesity Insulin Resistance
Keywords: obesity
Sponsor: Oregon Health and Science University
Start date: 2009-02-01; Completion date: 2011-05-01
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to learn more about how insulin resistance (inability to process glucose correctly resulting in mildly elevated glucose levels) affects the hormone ghrelin.

Detailed description:
Insulin resistance suppresses fasting ghrelin levels and impairs postprandial ghrelin suppression. Improved insulin sensitivity with a thiazolidinedione will raise ghrelin levels, enhance meal-related suppression, but not change the ratio of total to active ghrelin or result in an alteration of ghrelin structure.

Arms: arm 1: Treatment with placebo for 3 months before spectroscopy, hyperinsulinemic-euglycemic clamp, control diet, blood sampling. arm 2: Treatment with pioglitazone for 3 months before hyperinsulinemic-euglycemic clamp, control diet with blood sampling and spectroscopy.
Interventions: intervention 1: placebo intervention 2: pioglitazone
Intervention descriptions: intervention 1: treatment with placebo for 3 months intervention 2: treatment with 30mg daily for two weeks then 45mg every day with pioglitazone for three months

Protocol documents:
Clinical trial NCT00844831
Conditions: Constipation
Keywords: Constipation small intestinal bacterial overgrowth stool bacteria
Sponsor: University of Louisville
Start date: 2009-05-01; Completion date: 2011-05-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Patients with constipation often have bloating and abdominal distension. It is unclear if this is related to intestinal bacteria. Hypothesis: treatment for constipation may reduce small bowel and colon bacteria colonization, a change in the balance of stool microorganisms, and improve the symptoms of dyspepsia and constipation.

Detailed description:
This is an open-label study to collect data on upper and lower GI symptoms, hydrogen breath test, stool PCR, and serum before and after 4 weeks of lubiprostone 24 mcg by mouth twice a day for 4 weeks.

Arms: arm 1: Subjects receive lubiprostone and bacteria is measured before and after
Interventions: intervention 1: Lubiprostone
Intervention descriptions: intervention 1: 24 mcg bid for 28 days

Protocol documents:
Clinical trial NCT00862745
Conditions: Urge Urinary Incontinence Overactive Bladder
Sponsor: University of California, San Francisco
Start date: 2009-01-01; Completion date: 2011-05-01
Enrollment: 645 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Six hundred and thirty-six women diagnosed with urge urinary incontinence (UUI) by a three-item self-administered questionnaire (3IQ) will be randomized to 12 weeks of fesoterodine or matching placebo. The study will take place at up to 14 clinical sites in the US. All participants who complete the 12-week randomized trial will be offered open-label fesoterodine for an additional 9 months.

The hypothesis of the randomized controlled trial is that among women diagnosed with urge incontinence using the 3IQ, fesoterodine is more effective than placebo in reducing the mean number of urge incontinence episodes per day.

Detailed description:

Arms: arm 1: fesoterodine 4 mg (1 tablet) for 2 weeks with the option to increase to fesoterodine 8 mg or stay at fesoterodine 4 mg for 10 weeks for a total of 12 weeks of study medication. arm 2: placebo (an identical pill that contains no medication) 1 tablet daily for 2 weeks followed by the option to increase the placebo pill daily for 10 weeks for a total of 12 weeks of study placebo medication.
Interventions: intervention 1: Fesoterodine intervention 2: Matching Placebo
Intervention descriptions: intervention 1: Participants will be instructed to take one tablet of blinded study medication once a day, orally, for 12 weeks. They will start with a 4 mg dose of study medication and will have the option of doubling that dose after 2 or 4 weeks if they wish. At the end of the 12 week blinded trial, participants will be offered open-label fesoterodine (Toviaz™), for 9 months beginning at 4 mg with participant directed dose adjustment. intervention 2: Participants will be instructed to take one tablet of blinded study medication once a day, orally, for 12 weeks. They will start with a 4 mg dose of study medication and will have the option of doubling that dose after 2 or 4 weeks if they wish. At the end of the 12 week blinded trial, participants will be offered open-label fesoterodine (Toviaz™), for 9 months beginning at 4 mg with participant directed dose adjustment.

Protocol documents:
Clinical trial NCT00881530
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2009-03-01; Completion date: 2011-05-01
Enrollment: 660 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the current study is to investigate the safety and efficacy of BI 10773 in 2 different doses compared to Metformin or to Sitagliptin given for 78 weeks in different modalities of treatment in patients with type 2 diabetes mellitus.

Detailed description:

Arms: arm 1: 100 mg arm 2: 2000 mg arm 3: lower dose arm 4: higher dose
Interventions: intervention 1: BI 10773 intervention 2: Metformin intervention 3: BI 10773 intervention 4: Sitagliptin
Intervention descriptions: intervention 1: BI 10773 high dose once daily intervention 2: open label comparator intervention 3: BI 10773 low dose once daily intervention 4: open label comparator

Protocol documents:
Clinical trial NCT00885482
Conditions: HIV Infections
Keywords: HIV/AIDS HAART Simplification Atazanavir Lamivudine treatment experienced
Sponsor: Catholic University of the Sacred Heart
Start date: 2009-05-01; Completion date: 2011-05-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Objectives of the study:

1. To verify the safety of the study treatment, defined as the persistent control of the virus' replication at 48 weeks after the simplification to lamivudine + atazanavir with ritonavir.
2. To collect relevant information about the safety and the metabolic impact of this strategy in order to eventually design a non-inferiority randomized controlled trial for the evaluation of the safety and the efficacy of this strategy in the future.

Detailed description:
Combined antiretroviral therapy has greatly improved the natural history of HIV infection/AIDS. Yet, it is associated with important short- and long- term side effects. In particular, nucleoside and nucleotide analogs may cause anemia, pancreatitis, mitochondrial dysfunction, lactic acidosis, lipoatrophy and reduction of renal function or of bone density.

Our study aims to verify the safety and efficacy of a simplification of a dual therapy (Lamivudine plus Atazanavir with Ritonavir), confiding on the potency and high genetic barrier of ritonavir-boosted agents.

Arms: arm 1: Treatment simplification from a "standard" combined antiretroviral therapy including 2 NRTIs and Atazanavir with Ritonavir to Lamivudine plus Atazanavir with Ritonavir. Treatment simplification from three-drugs- to two-drugs-based antiretroviral therapy.
Interventions: intervention 1: Lamiduvine (Epivir) intervention 2: Atazanavir (Reyataz) intervention 3: Ritonavir (Norvir)
Intervention descriptions: intervention 1: Epivir 300 mg intervention 2: Reyataz 300 mg intervention 3: Norvir 100 mg

Protocol documents:
Clinical trial NCT00895895
Conditions: Alzheimer Disease
Sponsor: Pfizer
Start date: 2009-05-01; Completion date: 2011-05-01
Enrollment: 526 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will evaluate the efficacy and safety of an investigational drug called SAM-531 at three dosage levels. Subjects will receive either one of the 3 dosage levels of SAM-531, donepezil or placebo for the first 24 weeks of the study (period I). Subjects who receive placebo for period I will be assigned to receive the highest dose of SAM-531 SAM-531 for the remaining 28 weeks of the study, while subjects who received one of the three SAM-531 dosage levels or donepezil in period I will continue with the same study drug (period II).

Detailed description:
The study was stopped (date of termination was 13April2011) due to a 6 month interim analysis: all of the 3 SAM-531 dosage levels were declared futile. There were no safety concerns.

Arms: arm 1: Placebo arm 2: SAM-531 1.5 mg arm 3: SAM-531 3.0 mg arm 4: SAM-531 5.0 mg arm 5: Donepezil
Interventions: intervention 1: Placebo intervention 2: SAM-531 1.5 mg intervention 3: SAM-531 3.0 mg intervention 4: SAM-531 5.0 mg intervention 5: Donepezil
Intervention descriptions: intervention 1: Capsules SAM-531 placebo and 5 mg tablet encapsulated Donepezil placebo capsules, once a day during 24 weeks. intervention 2: Capsules SAM-531 1.5 mg, once a day during 52 weeks. intervention 3: Capsules SAM-531 3.0 mg, once a day during 52 weeks. intervention 4: Capsules SAM-531 5.0 mg, once a day during 24 weeks or 52 weeks. intervention 5: Encapsulated Donepezil 5 mg tablets, once a day during 52 weeks. After Day 42, the dose can up titrated up to 10 mg of Donepezil.

Protocol documents:
Clinical trial NCT00907426
Conditions: Hypotrichosis
Keywords: eyelashes
Sponsor: Allergan
Start date: 2009-08-01; Completion date: 2011-05-01
Enrollment: 368 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This one-year study evaluates the long-term safety and effectiveness of bimatoprost solution application to the eyelid margin (where the eyelashes meet the skin) to treat hypotrichosis of the eyelashes (inadequate or not enough eyelashes). There will be two different types of subjects participating in the study 1)those with inadequate eyelashes due to natural causes or 2) those with inadequate eyelashes following a complete course of chemotherapy treatment. There will be two treatment periods of six months each. Subjects will receive either the study medication or vehicle in either of the two treatment periods.

Detailed description:

Arms: arm 1: Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin. arm 2: Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin. arm 3: Treatment period one (0-6 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin.
Interventions: intervention 1: Bimatoprost 0.03% solution intervention 2: Vehicle solution
Intervention descriptions: intervention 1: Once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). intervention 2: Once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).

Protocol documents:
Clinical trial NCT00918957
Conditions: Cystic Fibrosis
Keywords: Tobramycin Inhalation Powder Cystic fibrosis Lung diseases Anti-Bacterial Agents Treatment of infections with P. aeruginosa in cystic fibrosis subjects
Sponsor: Novartis Pharmaceuticals
Start date: 2009-06-01; Completion date: 2011-05-01
Enrollment: 62 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to show how well tobramycin inhalation powder works and how safe it is when produced by a modified manufacturing process

Detailed description:

Arms: arm 1: Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment. arm 2: Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.), in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
Interventions: intervention 1: Tobramycin Inhalation Powder intervention 2: Placebo
Intervention descriptions: intervention 1: Tobramycin Inhalation Powder as produced by a modified manufacturing process TIP. TIP was provided in hard capsules each containing 28 mg active ingredient (tobramycin); Capsules were packaged in blister cards and administered by the T-326 Inhaler. intervention 2: Placebo inhalation powder consisting of the excipients used for TIP. Placebo was provided in hard capsules, containing 20 mg placebo powder, which were packaged in blister cards, matching in appearance to TIP. Capsules were administered by the T-326 Inhaler.

Protocol documents:
Clinical trial NCT00921843
Conditions: Anesthesia
Keywords: Pediatric patients undergoing surgery
Sponsor: Washington University School of Medicine
Start date: 2009-05-01; Completion date: 2011-05-01
Enrollment: 61 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will determine the pharmacokinetics of intravenous (IV) methadone in children undergoing surgery.

Detailed description:

Arms: arm 1: Methadone 0.1mg/kg arm 2: Methadone 0.2mg/kg arm 3: Methadone 0.3mg/kg arm 4: No methadone
Interventions: intervention 1: Methadone 0.1mg/kg intervention 2: Methadone 0.2mg/kg intervention 3: Methadone 0.3mg/kg intervention 4: Control
Intervention descriptions: intervention 1: Subjects will receive methadone as their intraoperative opioid. intervention 2: Subjects will receive methadone as their intraoperative opioid. intervention 3: Subjects will receive methadone as their intraoperative opioid. intervention 4: Subjects will not receive methadone as their intraoperative opioid.

Protocol documents:
Clinical trial NCT00941798
Conditions: Asthma
Keywords: Asthma LABA Safety
Sponsor: Novartis Pharmaceuticals
Start date: 2009-07-01; Completion date: 2011-05-01
Enrollment: 2283 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study CQMF149A2210 evaluated the safety of QMF149 Twisthaler® 500/400 μg, a fixed dose combination of indacaterol 500 μg, a once daily β2 agonist, and mometasone furoate 400 μg, an inhaled corticosteroid (ICS) that is approved for use in the treatment of asthma. The objective of this safety trial was to assess the effect of treatment on the incidence of serious asthma exacerbations, defined as asthma related hospitalization and/or intubation and/or death. This was an event driven trial.

Detailed description:

Arms: arm 1: QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD) arm 2: Mometasone Twisthaler®, 400 µg QD
Interventions: intervention 1: QMF149 Twisthaler® intervention 2: Mometasone Twisthaler®
Intervention descriptions: intervention 1: Once daily via multi-dose dry-powder inhaler intervention 2: Once daily via multi-dose dry-powder inhaler

Protocol documents: