ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01474213
Conditions: Intubation; Difficult
Keywords: dexmedetomidine remifentanil awake nasotracheal fibreoptic intubation oral maxillofacial surgery difficult airway adult
Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Start date: 2011-11-01; Completion date: 2012-01-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the sedation effect of dexmedetomidine and target controlled remifentanil for awake nasotracheal fibreoptic intubation in patients undergoing oral maxillofacial surgery.

Detailed description:
Awake fibreoptic nasotracheal intubation is an effective technique for the management of patients with difficult airways undergoing oral maxillofacial surgery. Both optimal intubating conditions and patient comfort are paramount while preparing the patient for fibreoptic intubation. One challenge associated with procedure is to provide adequate sedation while maintaining patients' airway ventilation. Dexmedetomidine, because of its sedative,analgesic properties and minimal influence on patients' ventilation, might be a useful management for it. While with the development of target controlled infusion (TCI) technology, remifentanil sedation becomes a potential sedation in clinical practice.

Arms: arm 1: a loading dose (1.5mcg/kg) infused over10 min followed by a continuous infusion of 0.7 μg/kg/h arm 2: The initial target was 3.0 ng/ml and the TCI was adjusted by 0.5 ng/ml after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was acheived.
Interventions: intervention 1: dexmedetomidine group intervention 2: remifentanil group
Intervention descriptions: intervention 1: 1-1.5cmg/kg dexmedetomidine infusion within 10 minutes, while followed by maintainly infusing 0.7cmg/kg/min dexmedetomidine intervention 2: target controlled 3.5-4ng/ml remifentanil infused(blood plasma concentration)

Protocol documents:
Clinical trial NCT01476202
Conditions: Smoking Cessation
Keywords: craving, provoked craving, smoking cessation, nicotine replacement therapy, NRT
Sponsor: GlaxoSmithKline
Start date: 2011-11-01; Completion date: 2012-01-01
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to assess the ability of the mint nicotine mouth strip to relieve provoked cigarette craving in light smokers compared to nicotine lozenge and nicotine gum.

Detailed description:

Arms: arm 1: single dose arm 2: single dose arm 3: single dose
Interventions: intervention 1: nicotine
Intervention descriptions: intervention 1: nicotine in the form of a mouth strip, lozenge and gum

Protocol documents:
Clinical trial NCT01479270
Conditions: Pain, Postoperative Anesthesia
Keywords: recovery postoperative pain laparoscopy hysterectomy ropivacaine TAP block local anesthesia
Sponsor: MetroHealth Medical Center
Start date: 2011-05-01; Completion date: 2012-01-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The Transversus Abdominal Plane (TAP) block has been used with good success to decrease postoperative pain following laparatomy. If the TAP block provides any improvement in the quality of recovery following laparoscopic hysterectomy, it could decrease the need for postoperative narcotics and allow for more outpatient hysterectomy procedures.

Detailed description:

Arms: arm 1: 20mL of 0.25% Ropivacaine with Epinephrine 1:200,000 is injected into bilateral transversus abdominal planes under ultrasound guidance. arm 2: Patients randomized to this arm have band aids applied to sites on lateral abdomen without injection.
Interventions: intervention 1: TAP Block
Intervention descriptions: intervention 1: Bilateral transversus abdominal plane injection under ultrasound guidance, done at conclusion of hysterectomy procedure, prior to emergence from general anesthesia

Protocol documents:
Clinical trial NCT01566084
Conditions: Hypertension
Sponsor: University of Colorado, Boulder
Start date: 2009-02-01; Completion date: 2012-01-01
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The investigators hypothesize that reducing salt in the diet will improve the function of blood vessels in middle aged and older adults with moderately elevated systolic blood pressure, by increasing the amount of BH4 and nitric oxide in your blood vessels and reducing the amount of oxidative stress.

Detailed description:
The improvement in blood vessel function will be determined over a 10 week period. Subjects will be randomly assigned to either a 'low salt' condition (placebo pills + 1200 mg dietary sodium) or a 'normal salt' condition (2300 mg sodium chloride pills + 1200 mg dietary sodium) and monitored for 5 weeks. After the initial set of 5 weeks, the subjects are switched into the opposite condition, completing the cross-over study design. During weeks 1-4 and 6-9, subjects are monitored weekly with 24 hour urine collections and diet logs. The assessment of the primary outcome (blood vessel function) is completed during weeks 5 and 10. BH4 and ascorbic acid are also administered during weeks 5 and 10 to measure the effects of sodium intake on endogenous BH4 levels and vascular oxidative stress.

Arms: arm 1: Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of slow sodium tablets to bring them back up to a normal salt intake. Subjects then cross-over to the low sodium condition in the second half of the study. arm 2: Subjects on a 1200 mg salt diet are given placebo pills in order to maintain them on a low salt diet. Subjects then cross-over to the normal sodium condition in the second half of the study.
Interventions: intervention 1: Slow sodium tablets intervention 2: placebo
Intervention descriptions: intervention 1: The normal salt condition is maintained with 2300 mg / day in the form of slowly released salt (NaCl) tablets. intervention 2: Placebo tablets are administered to maintain the low sodium condition.

Protocol documents:
Clinical trial NCT01612702
Conditions: Osteoarthritis, Knee
Keywords: postoperative nausea and vomiting postoperative pain
Sponsor: Tae Kyun Kim
Start date: 2011-04-01; Completion date: 2012-01-01
Enrollment: 291 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was conducted to determine the efficacy of an additional preemptive, single, low-dose dexamethasone in terms of incidence and severity of postoperative nausea/vomiting (PONV), pain level, and the safety in terms of wound complications in patients managed with our antiemetic protocol based on Ramosetron following TKA.

Detailed description:
Postoperative pain and emesis can cause postoperative systemic complications and delay recovery and rehabilitation in patients following total knee arthroplasty (TKA). Furthermore, patients who suffered from severe postoperative pain and emesis tend to be dissatisfied with their surgical treatments. Although contemporary protocols to control perioperative pain and emesis after TKA have been reported to substantially reduce postoperative pain and emesis compared with traditional measures, pain and emesis after TKA remain to be a challenging issue for patients and health care providers. In our previous study, the use of Ramosetron was found to reduce postoperative emetic events, but the antiemetic effects by Ramosetron were incomplete. In search of a further antiemetic measure, we identified the use of dexamethasone as the additional measure fortifying our antiemetic protocol using Ramosetron.

Arms: arm 1: dexamethasone 10 mg administration 1 hour before surgery arm 2: No dexamethasone
Interventions: intervention 1: Dexamethasone
Intervention descriptions: intervention 1: Dexamethasone 10 mg intravenous administration

Protocol documents:
Clinical trial NCT01649505
Conditions: Breast Cancer Perioperative/Postoperative Complications
Sponsor: OHSU Knight Cancer Institute
Start date: 2011-01-01; Completion date: 2012-01-01
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the efficacy of an alternative surgical technique and the use of fibrin sealant in preventing post-operative seroma formation. A seroma is a build-up of clear bodily fluids in a place on the body where tissue has been removed by surgery. Seromas can happen after breast surgeries. Seromas can appear about 7 to 10 days after surgery, after the drainage tubes have been removed. The breast area involved in the surgery may have a spot that's swollen and feels like there is liquid under the skin

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate differing surgical techniques (sharp dissection v. electrosurgical, use of fibrin glue) in latissimus dorsi donor flap harvest and their effect, if any on the prevention of post-operative seromas.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo sharp dissection technique with fibrin sealant closure.

ARM II: Patients undergo standard electrocoagulation dissection technique.

After completion of study treatment, patients are followed up for 90-180 days.

Arms: arm 1: Patients undergo sharp dissection technique with fibrin sealant closure. arm 2: Patients undergo standard electrocoagulation dissection technique.
Interventions: intervention 1: fibrin sealant (Beriplast P, TISSEEL VH) intervention 2: breast reconstruction intervention 3: breast reconstruction
Intervention descriptions: intervention 1: Applied topically intervention 2: Undergo sharp dissection technique intervention 3: Undergo electrocoagulation dissection technique

Protocol documents:
Clinical trial NCT01749605
Conditions: Uncomplicated Bacterial Cystitis
Sponsor: University of Iowa
Start date: 2010-10-01; Completion date: 2012-01-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Pilot study to compare the efficacy and safety of 3-day, twice-daily regimens of nitrofurantoin and ciprofloxacin in emergency department (ED) patients presenting with UBC.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days intervention 2: ciprofloxacin 250 mg BID x 3 days
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01850394
Conditions: Primary Osteoarthritis of Knee Nos
Sponsor: Mahidol University
Start date: 2010-01-01; Completion date: 2012-01-01
Enrollment: 152 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine 1) the effective dosage of intra-articular tranexamic acid injection for controlling blood loss and blood transfusion requirement in conventional total knee replacement, and 2) whether the blood loss reduction effect depended on the dose of tranexamic acid used.

Detailed description:

Arms: arm 1: physiologic saline 25 ml arm 2: A total of 25-ml solution with 250-mg tranexamic acid arm 3: A total of 25-ml solution with 500-mg tranexamic acid
Interventions: intervention 1: Tranexamic Acid intervention 2: Physiologic saline
Intervention descriptions: intervention 1: Inject tranexamic acid solution intra-articularly after fascia closure intervention 2: Use physiologic saline for mixing with tranexamic acid or use alone in placebo group

Protocol documents:
Clinical trial NCT02151994
Conditions: Hypertension and Chronic Heart Failure
Keywords: BIA 5-1058 hypertension chronic heart failure cardiovascular disorders
Sponsor: Bial - Portela C S.A.
Start date: 2011-03-01; Completion date: 2012-01-01
Enrollment: 124 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to to assess the safety and tolerability of BIA 5 1058 after single and multiple oral doses

Detailed description:
This was a Phase 1, double blind, randomised, placebo-controlled combined single ascending dose (SAD), including food interaction (food effect, FE) analysis, and multiple ascending dose (MAD) study.

SAD: This part consisted of an eligibility screening period, one study period involving administration of single doses of BIA 5-1058 or placebo according to a randomized design, and a follow-up period. Nine sequential groups of 8 healthy young male subjects were dosed. Within each group, 6 subjects were randomised to receive BIA 5-1058 and 2 subjects were randomised to receive placebo. In this first-in-human study, the subjects participating at the lowest dose level of 5 mg were dosed according to a sentinel dosing design to ensure optimal safety. Initially, 2 subjects were dosed; 1 subject with BIA 5-1058 and 1 subject with placebo. After the safety and tolerability results of the first 24 h following dosing for the initial subjects had been found to be acceptable to the MI, the other 6 subjects of the lowest dose level were dosed.

MAD: This part consisted of an eligibility screening period, one study period involving administration of multiple doses of BIA 5-1058 or placebo once daily for 10 days, and a follow-up period. Five sequential groups of 8 healthy young male subjects were dosed.

Within each group, 6 subjects were randomised to receive BIA 5-1058 and 2 subjects were randomised to receive placebo.

The starting dose of 50 mg was chosen taking into consideration the dose range of the previous SAD sequential groups and was approved by the IEC. Escalation to the next higher dose and the determination of the next dose level was based on safety, tolerability and available PK results of the previously administered dose

FE: This part consisted of an eligibility screening period, an open-label two-way crossover study period, and a follow-up period. One group of 12 subjects received single doses of 400 mg BIA 5-1058 during 2 treatment periods, once after having fasted overnight and once after consumption of a high fat breakfast. Each treatment was separated by a period of at least 7 days. The treatment sequence was determined by randomisation.

Arms: arm 1: BIA 5-1058 (5, 25 and 100 mg) tablets arm 2: tablets, visually matching active medication
Interventions: intervention 1: BIA 5-1058 intervention 2: Placebo
Intervention descriptions: intervention 1: oral administration intervention 2: oral administration

Protocol documents:
Clinical trial NCT02170376
Conditions: Parkinson's Disease (PD)
Keywords: Parkinson's disease (PD) BIA 9-1067 Opicapone
Sponsor: Bial - Portela C S.A.
Start date: 2011-09-01; Completion date: 2012-01-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the effect of repeated dosing of once-daily 25, 50 and 75 mg opicapone (OPC, development code BIA 9-1067) on the levodopa pharmacokinetics (PK), in comparison to placebo and 200 mg entacapone (ENT).

Detailed description:
This study was a single-centre, randomized, double-blind, gender-balanced, placebo-controlled study in 4 groups of 20 healthy subjects each (10 male and 10 female). The clinical part included a screening examination within 3 weeks before the first institutionalization, an ambulatory period of 11 days (from Day 1 evening to Day 11 evening), during which the subjects returned to the clinical unit every evening, followed by an institutionalization of 1.5 days (from Day 11 evening to Day 13 morning (i.e. 14 h after the third administration of levodopa/carbidopa). Then, a follow-up visit at 5 to 9 days after collection of the last PK blood sample (i.e. Day 13). The maximum total duration of the clinical study, including the 21-day screening period and the post-study follow-up, was expected to be about 39 to 43 days.

Arms: arm 1: Placebo once-daily for 11 days 200 mg entacapone concomitantly with levodopa/carbidopa on Day 12 arm 2: 25 mg BIA 9-1067 once-daily for 11 days Placebo concomitantly with levodopa/carbidopa on Day 12 arm 3: 50 mg 9-1067 once-daily for 11 days Placebo concomitantly with levodopa/carbidopa on Day 12 arm 4: 75 mg 9-1067 once-daily for 11 days placebo concomitantly with levodopa/carbidopa on Day 12 arm 5: placebo once-daily for 11 days placebo concomitantly with levodopa/carbidopa on Day 12
Interventions: intervention 1: BIA 9-1067 intervention 2: Entacapone intervention 3: Placebo intervention 4: Levodopa/carbidopa
Intervention descriptions: intervention 1: BIA 9-1067 25 mg and 50 mg intervention 2: Entacapone (ENT), over-encapsulated tablet 200 mg intervention 3: PLC, placebo intervention 4: Levodopa/carbidopa, tablet 100/25 mg

Protocol documents:
Clinical trial NCT01320033
Conditions: Acne Vulgaris
Keywords: acne vulgaris inflammatory lesions
Sponsor: Galderma R&D
Start date: 2011-03-29; Completion date: 2012-01-03
Enrollment: 662 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objectives of the study is to show CD2475/101 40mg tablets taken once a day for 16 weeks is superior to the placebo in Change from baseline to Week 16(Last Observation Carry Forward, Intent To Treat) in inflammatory lesion counts.

Detailed description:
Investigator's global assessment and lesion count will be performed at each study visit.

Arms: arm 1: Participants receive 40 mg of CD2475/101 oral tablet plus placebo capsule orally once daily for 16 weeks. arm 2: Participants receive 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks. arm 3: Participants receive matching placebo tablet plus placebo capsule orally once daily for 16 weeks.
Interventions: intervention 1: CD2475/101 40 mg intervention 2: Doxycycline 100 mg intervention 3: Placebo
Intervention descriptions: intervention 1: Participants receive 40 mg of CD2475/101 tablets once a day for 16 weeks. intervention 2: Participants receive 100 mg of Doxycycline capsule once a day for 16 weeks intervention 3: Participants receive matching placebo tablet, matching placebo capsule once a day for 16 weeks.

Protocol documents:
Clinical trial NCT00697463
Conditions: Menopause Fracture Osteoporosis
Keywords: Teriparatide Forteo Osteopenia Osteoporosis Fracture Low Bone Density Premenopausal women
Sponsor: Columbia University
Start date: 2008-08-20; Completion date: 2012-01-03
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Idiopathic osteoporosis (IOP) is an uncommon disorder in which otherwise healthy young individuals sustain one or more low-trauma fractures. Teriparatide \[PTH(1-34)\], which is FDA approved for treatment of osteoporosis in men and postmenopausal women, works by stimulating bone formation. The investigators hypothesize that teriparatide will significantly increase bone density (BMD) and improve bone structure in premenopausal women with IOP.

Detailed description:
Idiopathic osteoporosis (IOP) is an uncommon disorder in which otherwise healthy young individuals sustain one or more low-trauma fractures. In studies of IOP in men, histomorphometric indices of bone formation are depressed, and affected men respond to PTH(1-34) with robust increases in lumbar spine (LS) bone mineral density (BMD). This is the beginning of the third year of an R01 (AR4989603) investigating the etiology and pathogenesis, as well as the histomorphometric and bone microarchitectural features of IOP in premenopausal women. There is evidence of markedly decreased bone formation and microarchitectural deterioration with decreased mechanical competence/strength.

Teriparatide \[PTH(1-34)\] is an anabolic agent that stimulates bone formation and improves bone microarchitecture. Based on findings, the investigators hypothesize that teriparatide will significantly increase BMD and improve microarchitecture in premenopausal women with IOP.

This is an open-label study of carefully characterized premenopausal women with IOP who are participating in a NIH-funded study and who have fragility fractures or very low bone density. Participants in the study will receive 18-24 months of teriparatide and the effects on BMD and microstructure, bone mechanical competence, and bone turnover will be assessed. In order to assess whether teriparatide stimulates bone formation to the same extent in women with IOP as it does in normal women, the study will compare the short-term changes (2 and 4 weeks) in biochemical markers of bone formation in response to teriparatide between women with IOP and normal women who are participating in another NIH-funded study as controls.

Arms: arm 1: Each subject will receive 20 micrograms of Teriparatide (PTH 1-34) subcutaneously daily for 18 -24 months
Interventions: intervention 1: Teriparatide (PTH 1-34)
Intervention descriptions: intervention 1: 20 micrograms subcutaneous injection daily

Protocol documents:
Clinical trial NCT01353898
Conditions: HIV-1 Infection
Sponsor: Merck Sharp & Dohme LLC
Start date: 2011-06-21; Completion date: 2012-01-03
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a two part study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MK-1972 in participants with HIV-1 infections. In Part 1, participants will be randomized to receive MK-1972 (at one of 5 different dose levels given once or twice per day) or placebo. Part II will begin after the results of Part I are known; participants will be randomized to receive MK-1972 (only one dose level, twice per day) or placebo. The primary hypotheses are that MK-1972 at the studied doses is safe and well tolerated in HIV-1 infected males; and that MK-1972 has superior antiretroviral activity compared to placebo.

Detailed description:

Arms: arm 1: Ten capsules containing a total daily dose of 50 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I) arm 2: Ten capsules containing a total daily dose of 200 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I) arm 3: Ten capsules containing a total daily dose of 800 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I) arm 4: Ten capsules containing a total daily dose of 25 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I) arm 5: Ten capsules containing a total daily dose of 100 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I) arm 6: Ten capsules containing placebo were taken orally, twice per day for 10 days (Part I) arm 7: Ten capsules containing a total daily dose of 800 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part II) arm 8: Ten capsules containing placebo were taken orally, twice per day for 10 days (Part II)
Interventions: intervention 1: MK-1972 intervention 2: Placebo to MK-1972
Intervention descriptions: intervention 1: MK-1972 will be supplied as 25 and 100 mg capsules, and will be given orally, at a dose dependent on the treatment arm; participants will take ten capsules (active drug and/or placebo) once or twice per day for 10 days intervention 2: Placebo will be supplied as matching 25 and 100 mg capsules, and will be given orally, at a dose dependent on the treatment arm; participants will take ten capsules (active drug and/or placebo) once or twice per day for 10 days

Protocol documents: