ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01445847
Conditions: Laryngospasm
Keywords: Laryngospasm Lidocaine
Sponsor: King Saud University
Start date: 2012-01-01; Completion date: 2012-04-01
Enrollment: 134 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In the literature, we found no randomized clinical trials addressing the using of IV lidocaine as prophylaxis for postoperative laryngospasm among adults.

The aim of this study was to assess the effects of IV lidocaine on the incidence of postoperative laryngospasm of adults patients.

Detailed description:
During anesthesia practice, one of the common complications of airway management is laryngospasm. The etiology of laryngospasm is unknown but may be due to insufficient depth of anesthesia during tracheal intubation, light plane of anesthesia during tracheal extubation, pain, or presence of airway irritant like laryngoscope blade, irritated volatile agent, suction catheter, surgical debris, mucus, blood, or other foreign body. Laryngospasm occurs in both genders and all ages. Incidence of laryngospasm was reported to the Australian incident monitoring study (AIMS) was 5% with of 22% of them without an attributable cause.

Currently, there is no proven prophylaxis for laryngospasm and the known treatments of laryngospasm are used post-occurrence. However, elimination of factors that lead to laryngospasm is the most indispensable item for reduction of its incidence.

Intravenous (IV) lidocaine interrupts nerve conduction by blocking sodium channels. Recent meta-analysis study showed that IV lidocaine was able to prevent laryngospasm in children. However, in the literature, we found no randomized clinical trials addressing the using of IV lidocaine as prophylaxis for postoperative laryngospasm among adults.

The aim of this study was to assess the effects of IV lidocaine on the incidence of postoperative laryngospasm of adults patients.

Arms: arm 1: Lidocaine 1% was prepared in 10 mL syringe= 10 mg/mL, dosage was 1mg/kg, one bolus or 10 mL/kg, with range of 2mg could be added or missed. The maximum dose is 100 mg for patients with weight of more than 100 arm 2: Normal saline was prepared in 10 mL syringe, dosage was 1 mL/10 kg.
Interventions: intervention 1: Lidocaine intervention 2: Placebo
Intervention descriptions: intervention 1: 1 mg/kg or 1 mL/10 kg prior to extubation period. Injection of Lidocaine will be immediately when inhalational agent (Desflurane) is discontinued. intervention 2: 1 mL/10 kg prior to extubation period. Injection of placebo will be immediately when inhalational agent (Desflurane) is discontinued.

Protocol documents:
Clinical trial NCT01448525
Conditions: Hypotrichosis
Sponsor: Allergan
Start date: 2011-10-01; Completion date: 2012-04-01
Enrollment: 88 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine patient satisfaction with LATISSE® treatment for increasing eyelash prominence.

Detailed description:

Arms: arm 1: One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks. arm 2: One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
Interventions: intervention 1: bimatoprost ophthalmic solution 0.03% intervention 2: bimatoprost vehicle solution
Intervention descriptions: intervention 1: One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks. intervention 2: One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.

Protocol documents:
Clinical trial NCT01454531
Conditions: Allergic Rhinoconjunctivitis
Sponsor: ALK-Abelló A/S
Start date: 2011-06-01; Completion date: 2012-04-01
Enrollment: 199 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the tolerability of AVANZ.

Detailed description:
To assess the tolerability of the up-dosing phase of AVANZ Phleum pratense. The frequency of patients with adverse reactions will be the study primary endpoint.

Arms: arm 1: AVANZ Phleum pratense up-dosing phase (300, 600, 3000, 6000 and 15,000 SQ+) + one 15,000 SQ+ maintenance injection
Interventions: intervention 1: AVANZ Phleum pratense
Intervention descriptions: intervention 1: AVANZ Phleum pratense up-dosing phase (300, 600, 3000, 6000 and 15,000 SQ+) + one 15,000 SQ+ maintenance injection

Protocol documents:
Clinical trial NCT01466062
Conditions: Respiratory Syncytial Virus Infection
Keywords: Immunocompromised medical conditions Respiratory Syncytial Virus Infection Infant Newborn Young children
Sponsor: AbbVie (prior sponsor, Abbott)
Start date: 2011-08-01; Completion date: 2012-04-01
Enrollment: 28 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate safety, efficacy and pharmacokinetics of palivizumab in children at the age of 24 months or less with immunocompromised medical conditions.

Detailed description:

Arms: arm 1: 15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of severe respiratory syncytial virus (RSV) during the RSV season.
Interventions: intervention 1: Palivizumab
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01469182
Conditions: Allergy
Keywords: Immunology
Sponsor: ALK-Abelló A/S
Start date: 2011-11-01; Completion date: 2012-04-01
Enrollment: 914 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study assessed the safety profile of short ragweed (Ambrosia artemisiifolia) in participants with ragweed-induced rhinoconjunctivitis with or without asthma. The primary objective was to compare treatment-emergent adverse events (AEs) for participants treated with short ragweed allergy immunotherapy tablet (AIT) with those treated with placebo.

Detailed description:

Arms: arm 1: 12 Units short ragweed (Ambrosia artemisiifolia) Major Allergen 1 (Amb a 1-U) extract in an AIT, sublingual, once daily. arm 2: Matching placebo tablet, sublingual, once daily.
Interventions: intervention 1: SCH 39641 intervention 2: Placebo for SCH 39641
Intervention descriptions: intervention 1: Rapidly dissolving tablet sublingually once daily intervention 2: Rapidly dissolving tablet sublingually once daily

Protocol documents:
Clinical trial NCT01477892
Conditions: Infant, Preterm
Sponsor: Seoul National University Hospital
Start date: 2011-12-01; Completion date: 2012-04-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate safety and efficacy of continuous infusion of remifentanil in preterm infant with mechanical ventilator for control of procedural pain using two different dosage of remifentanil.

Detailed description:

Arms: arm 1: continuous infusion of remifentanil 0.1mcg/kg/min arm 2: continuous infusion of remifentanil 0.25mcg/kg/min
Interventions: intervention 1: low dose remifentanil
Intervention descriptions: intervention 1: non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control

Protocol documents:
Clinical trial NCT01479517
Conditions: Anesthesia
Keywords: operative dental procedure
Sponsor: St. Renatus, LLC
Start date: 2012-01-01; Completion date: 2012-04-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy of and recommended dosing regimen for unilateral administration of Kovacaine Mist in inducing pulpal anesthesia of the maxillary teeth for dental procedures.

Detailed description:
This is a Phase II single-center, open-label clinical trial with three dosing regimens, designed to determine the efficacy and optimal dose of the Kovacaine Mist intranasal delivery system for inducing pulpal anesthesia of maxillary teeth numbers 4-13 (maxillary right second premolar to maxillary left second premolar). Kovacaine will be administered intranasally on the same side of the midline as the tooth on which the procedure will be performed in three dosing cohorts \[four 100 μL, two 200 μL, or one 200 μL spray(s)\] of 10 subjects each. The first cohort receiving 4 sprays will be completed before initiating study of the remaining two cohorts, which will be treated using a randomized, parallel-group design. Administration: Subjects in the 4- and 2-spray cohorts will be administered the same total dose of 12 mg tetracaine HCl/0.2 mg oxymetazoline HCl. The 4-spray cohort will be treated with a sequence of four 100-μL sprays at intervals of 4 minutes. The 2-spray cohort will be treated with a sequence of two 200 μL sprays 4 minutes apart. The 1-spray cohort will be administered one 200 μL spray, a total dose of 6 mg tetracaine HCl/0.1 mg oxymetazoline HCl, which is half the dose of the 2-spray cohort. Rescue: If the study drug does not provide sufficient anesthesia to allow for completion of the dental procedure, a rescue injection of articaine will be administered.

Arms: arm 1: Total dose: 12 mg tetracaine/0.2 mg oxymetazoline arm 2: Total dose: 12 mg tetracaine/0.2 mg oxymetazoline arm 3: Total dose: 6 mg tetracaine/0.1 mg oxymetazoline
Interventions: intervention 1: Kovacaine Mist 0.1 mL x 4 sprays intervention 2: Kovacaine Mist 0.2 mL x 2 sprays intervention 3: Kovacaine Mist 0.2 mL x 1 spray
Intervention descriptions: intervention 1: Dose = 4 intranasal sprays of study drug delivered at 4-minute intervals. intervention 2: Dose = 2 intranasal sprays of study drug delivered at 4-minute intervals. intervention 3: Dose = 1 intranasal spray of study drug

Protocol documents:
Clinical trial NCT01510704
Conditions: Postoperative Nausea and Vomiting
Sponsor: Acacia Pharma Ltd
Start date: 2012-01-01; Completion date: 2012-04-01
Enrollment: 215 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the efficacy and safety of different doses of APD421 in the prevention of post-operative nausea and vomiting (PONV) in adult patients at moderate to high-risk of PONV. Patients must be undergoing elective surgery under general anaesthesia (hysterectomy (any surgical technique), cholecystectomy (any surgical technique) or "other" elective surgery scheduled to last at least one hour from induction of anaesthesia), requiring at least one overnight stay in hospital, and have at least 2 of the following risk factors for PONV: Past history of PONV and/or motion sickness; Non-smoking status; Female gender; Planned opiate use for post-operative analgesia.

Detailed description:

Arms: arm 1: None arm 2: 1mg dose level arm 3: 5mg dose level arm 4: 20mg dose level
Interventions: intervention 1: APD421 intervention 2: Placebo
Intervention descriptions: intervention 1: IV intervention 2: IV

Protocol documents:
Clinical trial NCT01530464
Conditions: High Altitude Pulmonary Hypertension
Keywords: High altitude induced fatigue High altitude induced pulmonary Hypertension
Sponsor: Thies Schroeder
Start date: 2012-02-01; Completion date: 2012-04-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a Phase I, three period, two sequence, open-label, randomized, crossover study, with the primary objective of testing the safety and tolerability of combined oral doses of aminophylline and ambrisentan in healthy human subjects. The secondary objective is to assess the pharmacokinetic profiles of theophylline (aminophylline) and ambrisentan when administered alone or in combination. It is hypothesized that the combination of these drugs is generally safe, and that no drug interaction can be observed.

Detailed description:
This is a Phase I, three period, two sequence, single-center, open-label, randomized, crossover study design. Periods I and II consist of the oral administration of either a single dose of aminophylline or ambrisentan alone, followed by a 48 hour wash out interval. Subsequently, Period III consists of the simultaneous administration of both drugs. All subjects are to be confined to the Duke Clinical Research Unit throughout all treatment periods \[Study Day -1 to Study Day 6 (discharge)\]. A sufficient number of healthy adult subjects will be consented in order to enroll 24 and complete 16 subjects who complete all three periods. Replacement of subjects is permitted, if necessary.

Qualified subjects will be randomized into one of two sequences consisting of three Periods as indicated below:

-------------Period 1-----Period 2-----Period 3

Sequence A: Treatment 1 Treatment 2 Treatment 3

Sequence B: Treatment 2 Treatment 1 Treatment 3

TREATMENTS:

Treatment 1: Aminophylline 500 mg (corresponding to 395 mg theophylline).

Treatment 2: Ambrisentan 5 mg.

Treatment 3: Aminophylline, 500 mg plus Ambrisentan, 5 mg.

After completion of each treatment period, the subjects will proceed to the next period provided no Stopping Rules criteria have been met

Arms: arm 1: None arm 2: None arm 3: Treatment 3: Aminophylline, 500 mg plus Ambrisentan, 5 mg
Interventions: intervention 1: Aminophylline intervention 2: Ambrisentan intervention 3: Aminophylline plus ambrisentan
Intervention descriptions: intervention 1: Drug will be administered as a single oral dose of 500mg, followed by a 48h washout period. intervention 2: Drug will be administered as a single dose of 5mg, followed by a 48h washout period intervention 3: Drugs will be given as single doses of 500mg (aminophylline) and 5mg (ambrisentan), followed by a 48h washout period

Protocol documents:
Clinical trial NCT01552772
Conditions: Schizophrenia
Keywords: Safety Tolerability Schizophrenia Aripiprazole
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2012-01-01; Completion date: 2012-04-01
Enrollment: 60 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will test the safety of an aripiprazole injection in subjects with schizophrenia that are currently taking oral antipsychotic medication other than aripiprazole. Subjects in this study will receive one injection of aripiprazole and will need to stop taking their other antipsychotic medication two weeks after the injection. The study will last one month. Subjects will be required to come to a clinic for evaluations and drug and urine collection five times during the course of the study.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Aripiprazole IM Depot
Intervention descriptions: intervention 1: 400 mg intramuscular injection of aripiprazole

Protocol documents:
Clinical trial NCT01561963
Conditions: Healthy Subjects
Keywords: Apremilast drug interaction pharmacokinetics
Sponsor: Amgen
Start date: 2012-02-01; Completion date: 2012-04-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate how the pharmacokinetics of apremilast may be affected by a single intravenous dose of rifampin and multiple oral doses of rifampin.

Detailed description:

Arms: arm 1: Participants received the following 3 treatment regimens:

* A single oral dose of 30 mg apremilast on Day 1 (Period 1);
* A single oral dose of 30 mg apremilast followed 5 minutes later by a 30-minute intravenous infusion of 600 mg rifampin on Day 5 (Period 2);
* Once daily oral doses of 600 mg rifampin for 15 days (from Day 7 to Day 21) with a single oral dose of 30 mg apremilast co-administered with the rifampin dose on Day 20 (Period 3).
Interventions: intervention 1: Apremilast intervention 2: Rifampin Oral Capsules intervention 3: Rifampin IV Solution
Intervention descriptions: intervention 1: Tablets for oral administration intervention 2: Capsules for oral administration intervention 3: Intravenous (IV) solution

Protocol documents:
Clinical trial NCT01591616
Conditions: Periodontal Disease
Sponsor: Dentsply International
Start date: 2010-04-01; Completion date: 2012-04-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To establish Oraqix is safe when used on adolescent volunteers.

Detailed description:
This is a single-center, uncontrolled, open-label, single administration patient study. Male and female subjects aged 6 through 17 years of age in need of primary tooth extraction will be recruited from the Principal Investigator's database and may be supplemented by advertising. Subjects who withdraw from the study prematurely will be replaced.

Subjects will undergo an initial screening visit at which eligibility will be determined. After completion of informed consent/assent a physical examination, vitals, 12-lead ECG, and dental examination will be conducted. A medical history will be documented and a blood sample will be collected for analysis of biochemistry, hematology and as appropriate, serum pregnancy assessment for females.

Subjects will return to the office approximately 1 to 10 days after Visit 1 for Visit 2. At Visit 2, study treatment will be administered and PK blood samples will be collected for analysis, and monitored for safety parameters. Up to a total of five cartridges of Oraqix® will be administered to the oral cavity in the area of the tooth extraction, based on the body weight of the subject. No more than five cartridges will be dispensed, since this is the maximum dose for this agent. The final sample will be collected 4 hours after administration of study material. An abbreviated dental examination will be conducted, any adverse events (AEs) will be documented and the subject will be discharged from the clinic.

All subjects will be contacted by telephone approximately 24 hours after administration of study treatment. Study personnel will enquire about the occurrence of any AEs that have occurred since leaving the office. If appropriate, further follow-up of AEs will be arranged. In the absence of any ongoing AEs requiring follow up the subject will be considered to have completed the study at the completion of the telephone call.

Arms: arm 1: None
Interventions: intervention 1: lidocaine and prilocaine
Intervention descriptions: intervention 1: Appropriate dose of Oraqix based on weight will be given before tooth extraction

Protocol documents:
Clinical trial NCT01634191
Conditions: Healthy Volunteer
Keywords: Apremilast pharmacokinetic safety Pharmacokinetics and safety in healthy volunteer subjects
Sponsor: Amgen
Start date: 2012-02-01; Completion date: 2012-04-01
Enrollment: 36 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the effects of age and sex on the pharmacokinetics and safety of a single oral dose of 30 mg apremilast in healthy adults.

Detailed description:
This is an open-label, parallel group study where eligible elderly adults (aged 65-85 years inclusive) and younger adults (aged 18-55 years inclusive) and who are matched to the elderly participants by sex and body mass index (BMI) (± 10%) will receive a single dose of 30 mg apremilast under fasting conditions.

Arms: arm 1: Participants aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1. arm 2: Participants aged 18 to 55 years received a single oral dose of 30 mg apremilast on Day 1.
Interventions: intervention 1: Apremilast
Intervention descriptions: intervention 1: One oral 30 mg dose of apremilast

Protocol documents:
Clinical trial NCT01925469
Conditions: Pain Relief Analgesia
Keywords: Hysterosalpingogram HSG Pain relief Analgesia Benzocaine
Sponsor: University of Pennsylvania
Start date: 2011-12-01; Completion date: 2012-04-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to assess the utility of benzocaine spray versus a placebo spray in alleviating pain during and after hysterosalpingogram (HSG).

Detailed description:
Hysterosalpingography (HSG) is a radiographic evaluation during which a radio-opaque medium is inserted through the cervical canal in order to define the size and shape of the uterine cavity and patency of the fallopian tubes. The utility of HSG is an integral part of the evaluation of infertile women for intrauterine pathology. In some cases, HSG can be a painful procedure. Poor pain control can limit the quality of the study due to inability to complete the procedure in cases of extreme discomfort. There is little consensus regarding pain control during HSG, although a number of approaches have been studied. Patients undergoing HSG are typically advised to premedicate with ibuprofen, which is consistent with the current standard of care. This study will assess pain control using a benzocaine spray (in addition to ibuprofen) in patients undergoing routine HSG at the Hospital of the University of Pennsylvania. All patients who present to the Hospital of the University of Pennsylvania for HSG will be eligible for the study. Benzocaine spray versus a placebo spray will be applied to a tenaculum (a surgical hooklike instrument used to grasp and hold the cervix). The tenaculum will then be applied to the cervix prior to HSG and pain relief will be assessed at 3 time intervals: 0, 5, and 30 minutes. The primary outcome is the mean difference in patients pain score and will be measured using the Visual Analogue Scale (VAS) which has been shown to be a valid and reliable scale. The secondary outcome will assess patient satisfaction in each group using a validated patient satisfaction survey. The study design will be prospective, randomized, placebo controlled, and double blinded.

Arms: arm 1: Benzocaine spray (14%), an FDA approved drug, will be used to assess whether this provides additional pain relief at time of hysterosalpingogram. arm 2: A saline placebo spray will be used in the placebo group.
Interventions: intervention 1: Benzocaine intervention 2: Saline spray
Intervention descriptions: intervention 1: None intervention 2: A saline spray will be used in the placebo group

Protocol documents:
Clinical trial NCT02331589
Conditions: Fatigue
Keywords: Fatigue Panax ginseng Chronic hepatitis Non-alcoholic Fatty Liver Disease Adiponectin
Sponsor: Chuncheon Sacred Heart Hospital
Start date: 2011-08-01; Completion date: 2012-04-01
Enrollment: 75 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Background: Korea red ginseng (KRG) has anti-carcinogenic activity, anti-oxidant activity, and cancer related anti-fatigue.

Methods: Seventy five patients with non-alcoholic hepatitis were prospectively randomized to receive 3 weeks of KRG or placebo. Liver function test, pro-inflammatory cytokines, adiponectin, fatigue severity scale, and antioxidant activity were check and compared.

Detailed description:
Fatigue Severity Scale

We used to be KRUPP's fatigue severity scale. The survey has nine questions as following: (1) my motivation is lower, when I am fatigued (2) exercise brings on my fatigue (3) I am easily fatigued (4) fatigue interferes with my physical functioning (5) fatigue causes frequent problems for me (6) my fatigue prevents sustained physical functioning (7) fatigue interferes with carrying out certain duties and responsibilities (8) fatigue is among my 3 most disabling symptoms (9) fatigue interferes with my work, family, or social life. All subjects scored each question on a 7-point scale (1 = strongly disagree to 4 = neither disagree nor agree to 7 = strongly agree). All fatigue severity scale calculated and collected by one research nurse (C.W.K) in the Department of Internal Medicine.

Arms: arm 1: KRG capsule (3,000 mg/day) for 3 weeks arm 2: placebo (for KRG) for 3 weeks
Interventions: intervention 1: KRG (Korea Red ginseng) intervention 2: Placebo (for KRG)
Intervention descriptions: intervention 1: 3 weeks of KRG capsule (3,000 mg/day) intervention 2: Placebos with same shape and size were manufactured and at Korea Ginseng Corporation

Protocol documents: