ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02027272
Conditions: Eclampsia
Keywords: Eclampsia
Sponsor: University of Mississippi Medical Center
Start date: 2012-02-01; Completion date: 2013-12-01
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a double blinded, placebo-controlled trial to determine if IV dexamethasone more quickly than placebo assists resolution of Posterior Reversible Encephalopathy Syndrome (PRES) encountered in eclamptic patients. All patients regardless of assignment to placebo or steroid will receive standard therapy to include magnesium sulfate, blood pressure medications and diuretics. We hypothesize that the addition of dexamethasone to standard therapy will accelerate CNS recovery more quickly than standard management without dexamethasone.

Detailed description:
30 eclamptic patients who do not require steroids for fetal lung maturation purposes will be randomized to placebo or steroid. This includes patients with eclampsia encountered antepartum prior to 23 weeks gestation, postpartum eclampsia, undelivered patients encountered after 33 weeks gestation who would not be candidates for fetal lung maturation steroids, or patients not eligible for repeat steroid administration in the 23-34 week gestational window. Planned enrollment in this pilot study is up to 30 patients with at least 12 in each group.

Arms: arm 1: Dexamethasone 12 mg, 2 doses, 12 hours apart. arm 2: Placebo, 2 doses, 12 hours apart
Interventions: intervention 1: Dexamethasone
Intervention descriptions: intervention 1: Intravenous Dexamethasone 12 mg, 2 doses, 12 hours apart

Protocol documents:
Clinical trial NCT02080312
Conditions: Meniere's Disease
Keywords: Meniere's disease endolymphatic hydrops
Sponsor: University of California, San Diego
Start date: 2012-01-01; Completion date: 2013-12-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a pilot study of patients with clinical symptoms of Ménière's disease using injection of diluted magnetic resonance imaging (MRI) contrast agent into the ear to evaluate inner ear structures.

The goal is to reproduce imaging findings described by non-United States (US) institutions, improve on image quality with decreased scan time and evaluate the dynamics of the contrast movement into the inner ear structures.

Detailed description:
Participants will be scheduled for study sessions on 2 consecutive days to include consent, baseline audiometric evaluation, intra-tympanic contrast administration, serial MR imaging, and follow-up audiometry evaluation in the injected ear.

Participants over 59 years old or who have medical conditions will have a blood test to check kidney function to ensure they can safely receive the contrast.

Arms: arm 1: Magnevist (gadopentetate dimeglumine, Bayer Health Care) will be diluted eightfold with sterile saline (1:7 v/v) in a 1 ml syringe and injected intra-tympanically with a 23-25g needle up to 0.4 ml or less if contrast reflux is noted under direct visualization. Anesthesia with topical phenol is available for this procedure.
Interventions: intervention 1: Magnevist (gadopentetate dimeglumine)
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02107274
Conditions: Bronchiectasis
Keywords: Azithromycin Bronchiectasis Macrolide Inflammation Pulmonary
Sponsor: Penang Hospital, Malaysia
Start date: 2011-11-01; Completion date: 2013-12-01
Enrollment: 78 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Bronchiectasis is a chronic lung condition characterised primarily by dilatation of the airways. Only a small number of clinical studies have been conducted investigating the use of macrolides to treat non-cystic fibrosis bronchiectasis. The purpose of this study is to determine the efficacy of 12 weeks treatment with azithromycin in adult patients with non-cystic fibrosis bronchiectasis.

Detailed description:
Previous studies of various macrolides with small sample sizes have reported some benefit with the reduction of sputum volume in bronchiectasis patients. However, macrolide therapy could not yet be confidently used to treat bronchiectasis, given the diffuse nature of these findings. These studies have had a wide range of hypotheses, and have not necessarily focused on the anti-inflammatory effects of macrolides. Furthermore, these studies are few in number, and not all have been placebo-controlled or double-blinded. This, combined with the small sample sizes used, limits the reliability of these results. This study aims to expand on these limited published findings by investigating a larger sample population with different endpoints. Sputum volume and quality of life have been selected as important variables to aid in assessing efficacy.

This study aims to be independent of previous studies in a number of ways. This is the only study of bronchiectasis patients to formally investigate quality of life after treatment with a macrolide, and the potential carryover effect of azithromycin therapy. This study will also expand on the findings of previous studies of macrolides in bronchiectasis by incorporating a larger sample size into the trial.

Arms: arm 1: Patients randomised to the treatment arm are to receive 1000 mg of azithromycin once a week for 12 weeks followed by placebo for azithromycin once weekly for another 12 weeks arm 2: In Part One of the study participants will be randomised to receive 12 weeks of either placebo or azithromycin in a 1:1 ratio in a double-blinded fashion. After 12 weeks, in Part Two of the study, all participants will receive placebo in a double-blinded fashion for an additional 12 weeks.
Interventions: intervention 1: Azithromycin intervention 2: Placebo for Azithromycin
Intervention descriptions: intervention 1: Azithromycin (C38H72N2O12 MW 749) is a 15-membered azalide, a subclass of macrolide antibiotics intervention 2: In Part One of the study participants will be randomised to receive 12 weeks of either placebo or azithromycin in a 1:1 ratio in a double-blinded fashion. After 12 weeks, in Part Two of the study, all participants will receive placebo in a double-blinded fashion for an additional 12 weeks.

Protocol documents:
Clinical trial NCT02222129
Conditions: Pain, Postoperative
Keywords: Randomized controlled trial anesthetics-local bupivacaine analgesia Pain, Postoperative
Sponsor: Knight, Richard, M.D.
Start date: 2012-12-01; Completion date: 2013-12-01
Enrollment: 206 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A prospective, randomized comparison of bupivacaine to liposomal bupivacaine given by local injection at all the wound sites in patients undergoing robotic-assisted or laparoscopic urologic surgeries in an effort to determine which method reduced postoperative opioid use the most.

Detailed description:
Liposomal bupivacaine was developed to extend the duration of efficacy of bupivacaine from the typical 6 - 8 hours up to 72 hours. The prolonged duration of liposomal bupivacaine was initially demonstrated in mice in 1994. Two randomized controlled trials using liposomal bupivacaine for bunionectomy and hemorrhoidectomy resulted in FDA approval for its use in humans. More recently, liposomal bupivacaine has also been found to improve pain control for patients undergoing total knee arthroplasty. Infiltration of a local anesthetic into laparoscopic port sites is a common practice that has been shown in some studies to improve postoperative pain. To compare liposomal bupivacaine and 0.25% bupivacaine for local analgesia following laparoscopic and robotic urologic surgery, a randomized comparison-controlled trial was performed.

Arms: arm 1: Surgical site infiltration of 0.25% bupivacaine. arm 2: Surgical site infiltration of liposomal bupivacaine.
Interventions: intervention 1: Bupivacaine intervention 2: liposomal bupivacaine
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02237989
Conditions: Knee Osteoarthritis
Keywords: knee osteoarthritis, native collagen type 2, paracetamol
Sponsor: Eskisehir Osmangazi University
Start date: 2013-01-01; Completion date: 2013-12-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The aim of this study was to evaluate symptomatic efficacy of native collagen type 2 on joint pain and function and its effects on urinary biological markers related to cartilage degeneration in patients with knee osteoarthritis.

Detailed description:
39 patients diagnosed with knee osteoarthritis were separated into two groups. The 1st group includes 19 patients given 1500mg/day paracetamol, the 2nd group consists of 20 patients given 1500mg/day paracetamol and 10mg/day native collagen type 2 for three months.Pretreatment and posttreatment Visual Analog Scale, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), 20-m walking time and Short Form-36 (SF-36), Coll2-1, Coll2-1NO2 and Fibulin-3 levels in urine were compared.

Arms: arm 1: The 1st group includes 19 patients given 1500mg/day paracetamol for three months arm 2: The 2nd group consists of 20 patients given 1500mg/day paracetamol and 10mg/day native collagen type 2 for three months
Interventions: intervention 1: paracetamol intervention 2: paracetamol+native collagen type 2
Intervention descriptions: intervention 1: 1500 mg intervention 2: paracetamol (1500 mg) + native collagen type 2 (10mg)

Protocol documents:
Clinical trial NCT02485158
Conditions: Healthy
Keywords: Subjective Effects Alcohol Amphetamine THC Personality
Sponsor: University of Chicago
Start date: 2013-07-01; Completion date: 2013-12-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to examine whether individual differences in acute responses to drugs co-vary across three drugs from different drug classes: alcohol, amphetamine and delta-9-tetrahydrocannabinol (THC). The investigators hypothesize that individuals who experience greater rewarding effects from one drug will also experience more rewarding effects from the other drugs.

Detailed description:
Here, the investigators aim to investigate whether individuals exhibit similar responses to three different drugs from different classes. This study used a within-subjects design (total N = 24). All subjects received alcohol, amphetamine and delta-9-tetrahydrocannabinol (THC) in a double-blind, double-dummy fashion. Subjects completed six sessions wherein they received either alcohol, amphetamine, or THC, or corresponding placebos, on separate days. Subjects completed questionnaires about mood, general drug effects, and specific drug effects.

Arms: arm 1: All healthy adult volunteers attended 6 sessions in which they received 20mg AMP, 0.8g/kg ALC, and 7.5mg THC, alternating with three placebo sessions. arm 2: All healthy adult volunteers attended 6 sessions in which they received 20mg AMP, 0.8g/kg ALC, and 7.5mg THC, alternating with three placebo sessions.
Interventions: intervention 1: THC intervention 2: AMP intervention 3: ALC intervention 4: Placebo capsules intervention 5: Placebo beverage
Intervention descriptions: intervention 1: This is a within-subjects, double-blind, placebo controlled design. We administered oral THC to healthy volunteers to measure their subjective response, which we later compared to their responses to two other drugs. intervention 2: This is a within-subjects, double-blind, placebo controlled design. We administered AMP to healthy volunteers to measure their subjective response, which we later compared to their responses to two other drugs. intervention 3: This is a within-subjects, double-blind, placebo controlled design. We administered alcohol to healthy volunteers to measure their subjective response, which we later compared to their responses to two other drugs. intervention 4: This is a within-subjects, double-blind, placebo controlled design. We administered size 00 gelatin capsules containing dextrose to healthy volunteers as a control for when they received either amphetamine or THC. intervention 5: This is a within-subjects, double-blind, placebo controlled design. We administered a drink containing cranberry juice plus 1% alcohol added as a taste mask.

Protocol documents:
Clinical trial NCT01140451
Conditions: Cystic Fibrosis
Sponsor: PTC Therapeutics
Start date: 2010-08-12; Completion date: 2013-12-02
Enrollment: 191 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Cystic fibrosis (CF) is a genetic disorder caused by a mutation in the gene that makes the cystic fibrosis transmembrane conductance regulator (CFTR) protein. A specific type of mutation called a nonsense (premature stop codon) mutation is the cause of CF in approximately 10% of patients with the disease. Ataluren is an orally delivered investigational drug that has the potential to overcome the effects of the nonsense mutation. This study is a Phase 3 extension trial that will evaluate the long-term safety of ataluren in adult and pediatric participants with nonsense mutation CF (nmCF), as determined by adverse events and laboratory abnormalities. The study will also assess changes in pulmonary function, CF pulmonary exacerbations, health-related quality of life, antibiotic use for CF-related infections, CF-related disruptions to daily living, body weight, and CF pathophysiology. Funding source for this study is the FDA OOPD.

Detailed description:
This Phase 3, open-label, safety and efficacy study will be performed at sites in North America, Europe, and Israel. The study will enroll up to approximately 208 participants with nmCF who participated in a previous Phase 3 study of ataluren (PTC124-GD-009-CF \[Study 009\], NCT00803205). Participants will receive study drug 3 times per day (TID) (at breakfast, lunch, and dinner) for approximately 48 weeks (approximately 1 year). Study assessments will be performed at clinic visits every 8 weeks.

Arms: arm 1: Participants who received double-blind ataluren during Study 009 will continue to receive open-label ataluren 3 times per day TID: 10 milligram (mg)/kilogram (kg) of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total dose 40 mg/kg/day), for up to 96 weeks. Participants will be followed for 4 weeks after treatment. arm 2: Participants who received double-blind placebo during Study 009 will receive open-label ataluren TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total dose 40 mg/kg/day), for up to 96 weeks. Participants will be followed for 4 weeks after treatment.
Interventions: intervention 1: Ataluren
Intervention descriptions: intervention 1: Ataluren will be provided as a vanilla-flavored powder to be mixed with water or milk.

Protocol documents:
Clinical trial NCT01268046
Conditions: Memory Loss Cognitive Changes Postmenopausal Symptoms
Keywords: aging postmenopausal women estrogen memory
Sponsor: Massachusetts General Hospital
Start date: 2009-11-01; Completion date: 2013-12-02
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will focus on how estrogen affects parts of the brain associated with memory and how the effect of estrogen is altered with aging in postmenopausal women.

Detailed description:
The broad goal of this proposal is to determine the effect of aging on areas of the brain whose function is impacted by gonadal steroids in women. The overarching hypothesis is that aging differentially alters the effects of estrogen on the brain. Our preliminary data indicated that aging alters the effect of estrogen on brain regions involved in cognition and thus, the current study focused on the impact of aging on functional changes induced by estrogen in cortical and subcortical areas associated with verbal working memory and declarative/episodic memory.

As our model, we will use women in whom the absence of gonadal function makes it possible to control the duration and amount of estrogen exposure, specifically postmenopausal women who are younger (45-55) or older (65-80) who receive either oral or transdermal estradiol to achieve premenopausal early follicular phase estradiol levels.. We evaluate the effects of low dose estrogen exposure at 48 hr and 1 month to determine whether the short-term changes in brain regions involved in cognition with low dose estrogen exposure seen in our preliminary studies are confirmed and whether changes with short-term estrogen exposure persist with more prolonged exposure, a finding that would have enormous clinical relevance. These studies, using sophisticated neuroimaging tools (structural and functional magnetic resonance imaging \[MRI\] and \[18F\] 2-fluoro-2-deoxy-D-glucose positron emission tomography \[FDG-PET\]), provide a unique window into the brain in women.

Arms: arm 1: transdermal estrogen patch OR estradiol oral capsule for 1 month arm 2: transdermal estrogen patch OR estradiol oral capsule for 1 month arm 3: transdermal placebo patch for 1 month or placebo oral capsule for 1 month arm 4: transdermal placebo patch for 1 month or placebo oral capsule for 1 month
Interventions: intervention 1: Estradiol oral capsule intervention 2: transderman estrogen patch intervention 3: trasdermal placebo patch intervention 4: placebo oral capsule
Intervention descriptions: intervention 1: 1 oral capsule (1 mg estradiol) administered daily for one month intervention 2: transdermal estrogen patch (50 mcg/day) for one month intervention 3: transdermal placebo patch with patch change every 84 hr for one month intervention 4: placebo oral capsule administered daily for one month.

Protocol documents:
Clinical trial NCT01575769
Conditions: Juvenile Idiopathic Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2012-01-19; Completion date: 2013-12-03
Enrollment: 41 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This long-term, interventional, open-label extension study will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients from Poland and Russia with polyarticular-course juvenile idiopathic arthritis who completed the WA19977 study. Patients will receive RoActemra/Actemra 8 mg/kg every 4 weeks. The anticipated time on study treatment is 104 weeks.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: RoActemra/Actemra (tocilizumab)
Intervention descriptions: intervention 1: Tocilizumab 8 mg/kg every 4 weeks for 104 weeks

Protocol documents:
Clinical trial NCT01850641
Conditions: Hemodialysis Hyperphosphatemia
Keywords: Hemodialysis Hyperphosphatemia
Sponsor: Kissei Pharmaceutical Co., Ltd.
Start date: 2013-04-29; Completion date: 2013-12-03
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to investigate the safety and efficacy when administering PA21 with calcium carbonate in hemodialysis patients with hyperphosphatemia for 12 weeks.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: PA21
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01892384
Conditions: Schizophrenia
Sponsor: Boehringer Ingelheim
Start date: 2013-06-28; Completion date: 2013-12-05
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the current study is to investigate the safety and tolerability of BI 409306 in schizophrenic patients following oral administration of multiple low, medium, and high doses over 14 days.

A secondary objective is the exploration of the pharmacokinetics and pharmacodynamics of BI 409306 in schizophrenic patients.

Detailed description:

Arms: arm 1: low dose, once daily arm 2: medium dose, once daily arm 3: high dose, once daily arm 4: placebo, once daily
Interventions: intervention 1: Placebo intervention 2: BI 409306
Intervention descriptions: intervention 1: matching placebo intervention 2: BI 409306

Protocol documents:
Clinical trial NCT00171730
Conditions: Acromegaly
Keywords: Acromegaly Pasireotide GH IGF-1
Sponsor: Novartis Pharmaceuticals
Start date: 2004-08-24; Completion date: 2013-12-06
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Acromegaly is a rare, serious condition characterized by chronic hypersecretion of growth hormone (GH), generally caused by a GH-secreting pituitary adenoma. The study assessed the long-term safety and efficacy of pasireotide in participants with acromegaly.

Detailed description:

Arms: arm 1: Participants received pasireotide as a daily subcutaneous (s.c) injection, every 12 hours at 9:00 AM and 9:00 PM at the dose at which the biochemical control was achieved (either 200, 400, or 600 microgram (μg)) for as long as the participant benefited from the treatment, and there were no safety or tolerability concerns (median duration of 22.7 months).
Interventions: intervention 1: Pasireotide
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01405924
Conditions: Nausea Vomiting
Sponsor: Merck Sharp & Dohme LLC
Start date: 2011-10-25; Completion date: 2013-12-06
Enrollment: 111 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will assess the efficacy of a single dose of intravenous (IV) fosaprepitant (MK-0517, EMEND® IV) as salvage therapy when added to a 5-hydroxytryptamine receptor 3 antagonist (5-HT3 RA) and dexamethasone for the prevention of chemotherapy-induced vomiting (CIV) in participants who experienced CIV in the first cycle of moderately emetic chemotherapy (MEC). The primary hypothesis is that there will be no vomiting and no retching in at least 20% of participants during the second cycle of MEC in participants who previously experienced vomiting during the first cycle of MEC.

Detailed description:

Arms: arm 1: Women with breast cancer receiving anthracycline-cyclophosphamide (AC)-like chemotherapy and women with gynecological cancer receiving carboplatin-paclitaxel (CT) chemotherapy receive fosaprepitant 150 mg administered intravenously (IV) on Day 1 of Cycle 2 of chemotherapy
Interventions: intervention 1: Fosaprepitant dimeglumine intervention 2: 5-HT3 RA intervention 3: Dexamethasone intervention 4: Rescue medication
Intervention descriptions: intervention 1: Fosaprepitant 150 mg, IV on Day 1 of chemotherapy in Cycle 2 intervention 2: 5-HT3 RA will be administered at the same dosage in Cycle 2 of chemotherapy as was used for each particpant in Cycle 1 of chemotherapy. intervention 3: Dexamethasone will be administered at the same dosage in Cycle 2 of chemotherapy as was used for each particpant in Cycle 1 of chemotherapy. intervention 4: Rescue medication is defined as any medication used to relieve the symptoms of established nausea or vomiting. Multiple medications are permitted by the protocol and may be taken by the participant, including 5-HT3 antagonists, phenothiazines and benzodiazepines.

Protocol documents:
Clinical trial NCT01853982
Conditions: Ventilator-Associated Pneumonia (VAP)
Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Start date: 2013-06-14; Completion date: 2013-12-08
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 3, multicenter, prospective, randomized, open-label, study to compare the safety and efficacy of intravenous (IV) ceftolozane/tazobactam with that of IV piperacillin/tazobactam in the treatment of ventilator-associated pneumonia (VAP) in adult participants .

Detailed description:

Arms: arm 1: 3000 milligrams (mg) ceftolozane/tazobactam (comprised of 2000 mg ceftolozane and 1000 mg tazobactam), administered intravenously (IV), every 8 hours for 8 days arm 2: 4500 mg piperacillin/tazobactam (comprised of 4000 mg piperacillin and 500 mg tazobactam), administered IV, every 6 hours for 8 days
Interventions: intervention 1: Ceftolozane/Tazobactam intervention 2: Piperacillin/Tazobactam
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents: