ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00927888
Conditions: Pain, Postoperative
Sponsor: Stanford University
Start date: 2007-08-01; Completion date: 2010-08-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the study is to quantify postoperative pain after functional endoscopic sinus surgery (FESS) and investigate whether preemptive analgesia may positively impact intraoperative anesthetic management, decrease patient postoperative pain and discomfort, and improve patient functional outcomes.

Detailed description:
The sphenopalatine ganglion block (SPGB) with local anesthetic is used to treat facial pain and headache of various etiologies and has been widely used during functional endoscopic sinus surgery (FESS). The purpose of this study was to investigate whether preemptive SPGB may positively impact postoperative pain and functional outcomes after FESS.

A prospective, double-blind randomized placebo-controlled study was performed. 60 patients (18 to 70 yrs), undergoing general anesthesia for bilateral FESS, were randomly assigned to receive SPGB with either 2 ml 0.25% bupivacaine with epinephrine 1:100,000 (BP, treatment group) or normal saline (NS, control group). SPGB was performed preemptively 10 min before the start of surgery. Pre- and post operative (day#0, day#7, day#30) visual analogue pain scale, SNOT-20, CT \& Endoscopic scores were compared between the two groups.

Arms: arm 1: 3 ml of 0.25% Bupivacaine with Epi 1:100,000 (A block) arm 2: Normal saline with Epi 1:100,000 (B block)
Interventions: intervention 1: Bupivacaine Block intervention 2: Placebo
Intervention descriptions: intervention 1: Bupivacaine local anesthesia block prior to start of FESS procedure. intervention 2: placebo is identical in appearance in comparison to active drug.

Protocol documents:
Clinical trial NCT00934362
Conditions: Cystic Fibrosis
Sponsor: University of North Carolina, Chapel Hill
Start date: 2008-10-01; Completion date: 2010-08-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Mucus clearance is impaired in cystic fibrosis. Inhaled surfactants may reduce adhesive forces between mucus and airway surfaces and improve mucus clearance. This in turn my improve lung health. The investigators propose to measure mucus clearance before and after lucinactant or vehicle administration in patients with cystic fibrosis.

Detailed description:
This single-center pilot study is designed as a double-blind, randomized, cross-over clinical trial to evaluate the effects of inhaled lucinactant, an investigational peptide-containing synthetic surfactant (6 ml of 20 mg total phospholipid (TPL)/mL solution x 5 doses) in patients with mild to moderate CF lung disease. Lucinactant and vehicle will be delivered via a 510k approved vibrating mesh nebulizer, the Pari eFlowTM. The study duration corresponds to a 2-10 day screening phase, followed by a 20 day post-randomization phase that consists of two treatment periods (3 days each) and a washout period (14 days). A total of 16 patients will be enrolled and randomly assigned to one of two treatment sequences (Lucinactant followed by vehicle or vehicle followed by lucinactant). The primary outcome will be the rate of MC, as assessed via gamma scintigraphy, post-lucinactant and post vehicle. Secondary outcomes will include the rate of cough clearance (CC), lung clearance index (LCI), absolute change from baseline in FEV1 after 5 doses of study medication, CF-specific quality of life score (via CFQ-R instrument), in vitro assessments of sputum rheology, and various safety parameters.

Arms: arm 1: Active treatment first, then washout period, then placebo treatment arm 2: 0.9% NaCl vehicle treatment first, then washout period, then lucinactant treatment
Interventions: intervention 1: Lucinactant first intervention 2: Placebo first
Intervention descriptions: intervention 1: lucinactant 120 mg (20 mg/ml) x 5 doses over 24 hours, then washout period x 14 days, then vehicle x 5 doses over 24 hrs intervention 2: 6 mL normal saline x 5 doses over 24 hours, then washout period x 14 days, then lucinactant x 5 doses over 24 hours

Protocol documents:
Clinical trial NCT00935220
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2009-06-01; Completion date: 2010-08-01
Enrollment: 41 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this trial is to investigate the pharmacokinetics and pharmacodynamics of linagliptin (BI 1356) 5 mg administered orally in patients with Type 2 diabetes mellitus of African American origin.

Detailed description:

Arms: arm 1: Pharmacokinetic (PK)/Pharmacodynamic (PD) investigation
Interventions: intervention 1: linagliptin QD (once daily) for 7 days
Intervention descriptions: intervention 1: dipeptidyl peptidase IV (DPP-4) activity will be measured as PD response to drug administration

Protocol documents:
Clinical trial NCT00937378
Conditions: Nocturia
Sponsor: Serenity Pharmaceuticals, Inc.
Start date: 2009-06-01; Completion date: 2010-08-01
Enrollment: 326 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate a treatment of nocturia. The hypothesis is that SER120 will decrease the number of nocturic episodes compared to placebo.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: SER120 intervention 2: Placebo
Intervention descriptions: intervention 1: Nasal Spray, once a day intervention 2: Nasal Spray

Protocol documents:
Clinical trial NCT00939341
Conditions: Asthma
Keywords: Symbicort SMART
Sponsor: AstraZeneca
Start date: 2009-07-01; Completion date: 2010-08-01
Enrollment: 862 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to compare whether Symbicort Maintenance \& Reliever Therapy (SMART) is more effective in uncontrolled asthmatic patients than their current therapy in a real life situation.

Detailed description:

Arms: arm 1: Symbicort Turbuhaler 160/4.5 µg delivered dose
Interventions: intervention 1: Symbicort (Budesonide/Formoterol)
Intervention descriptions: intervention 1: Turbuhaler 160/4.5 µg delivered dose, twice daily (one inhalation in the morning and one inhalation in the evening) and as need (prn) in response to symptoms

Protocol documents:
Clinical trial NCT00939783
Conditions: Alzheimer's Disease
Sponsor: Pfizer
Start date: 2009-09-01; Completion date: 2010-08-01
Enrollment: 649 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the long-term safety and tolerability of Dimebon in patients with Alzheimer's disease.

Detailed description:
This study was terminated on May 7, 2010 as part of modification of the dimebon development plan following lack of demonstration of efficacy in the completed DIM14 (CONNECTION) Study. The study was not terminated due to any safety findings. Dimebon has been well -tolerated in clinical trials. Demonstration of efficacy for dimebon in Alzheimer's disease is pending completion of the ongoing DIM18 (CONCERT) Study.

Arms: arm 1: 10 mg TID for Week 1, followed by 20 mg TID for remainder of study
Interventions: intervention 1: Dimebon
Intervention descriptions: intervention 1: Tablet for oral administration

Protocol documents:
Clinical trial NCT00948818
Conditions: Irritable Bowel Syndrome Characterized by Constipation
Keywords: Irritable Bowel Syndrome Constipation Linaclotide
Sponsor: Forest Laboratories
Start date: 2009-07-01; Completion date: 2010-08-01
Enrollment: 803 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with irritable bowel syndrome with constipation (IBS-C).

The primary efficacy parameter is the percentage of patients in each treatment group that meet the protocol definition for Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder.

Detailed description:

Arms: arm 1: Linaclotide 290 micrograms arm 2: Matching placebo
Interventions: intervention 1: Linaclotide 290 micrograms intervention 2: Matching placebo
Intervention descriptions: intervention 1: Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study intervention 2: Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study

Protocol documents:
Clinical trial NCT00949975
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Lung Respiratory disease Efficacy Safety and tolerability Placebo-controlled Pharmacokinetics COPD
Sponsor: AstraZeneca
Start date: 2009-07-01; Completion date: 2010-08-01
Enrollment: 838 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective is to evaluate the dose-response relationship and efficacy of AZD9668 at 3 dose levels compared with placebo in symptomatic COPD patients by assessing effects on lung function and symptoms of COPD.

Detailed description:

Arms: arm 1: AZD9668 active treatment arm 2: AZD9668 active treatment arm 3: AZD9668 active treatment arm 4: AZD9668 placebo treatment
Interventions: intervention 1: AZD9668 intervention 2: AZD9668 intervention 3: AZD9668 intervention 4: AZD9668 Placebo
Intervention descriptions: intervention 1: 2 x 30 mg oral tablets twice daily (bid) for 12 weeks intervention 2: 2 x 10 mg oral tablets twice daily (bid) for 12 weeks intervention 3: 2 x 2.5 mg oral tablets twice daily (bid) for 12 weeks intervention 4: 2 x Matched placebo to oral tablet twice daily (bid) for 12 weeks

Protocol documents:
Clinical trial NCT00952653
Conditions: Major Depressive Disorder
Keywords: depression
Sponsor: Pfizer
Start date: 2010-06-01; Completion date: 2010-08-01
Enrollment: 28 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The main purpose of this study is to evaluate the effect of desvenlafaxine administered as DVS SR on the pharmacokinetics of midazolam in healthy male and female subjects. The amount of drug in the body and the effect of the drug will also be evaluated.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Desvenlafaxine Succinate Sustained Release intervention 2: Midazolam
Intervention descriptions: intervention 1: 50 mg DVS SR tablet days 1-6, period 2 only. intervention 2: 4 mg midazolam (2 mL midazolam syrup) day 1, period 1 and day 6, period 2.

Protocol documents:
Clinical trial NCT00954681
Conditions: Cannabis Dependence
Keywords: Cannabis quetiapine
Sponsor: New York State Psychiatric Institute
Start date: 2009-08-01; Completion date: 2010-08-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Marijuana is the most commonly used illicit drug in the United States. However, the treatment options for cannabis dependence are limited; notably, no effective pharmacotherapy has been developed. Conceptually, the ideal medication treatment for cannabis dependence would:

1. be safe when administered to patients actively using cannabis
2. reduce cannabis intake and promote abstinence
3. treat the symptoms of cannabis withdrawal
4. reduce craving and relapse risk
5. have a low abuse liability.

Detailed description:
Conceptually, the pharmacodynamic and clinical actions of quetiapine suggest that it may be useful for cannabis dependence. By antagonizing dopamine, quetiapine may interfere with the reinforcing effects of cannabis, while serotonin type 2A, histamine type 1, and adrenergic receptor antagonism may reduce cannabis withdrawal symptoms, primarily by sedating and anxiolytic effects. The proposed research project is an open-label pilot study to evaluate the tolerability and ideal target dosing range for quetiapine treatment of cannabis dependence over an eight-week period. The purpose of this pilot study is to obtain preliminary data regarding the potential efficacy, tolerability and safety of quetiapine treatment of cannabis dependence before conducting a larger double-blind trial.

Arms: arm 1: Open label treatment with quetiapine
Interventions: intervention 1: quetiapine
Intervention descriptions: intervention 1: Quetiapine treatment from 25 mg daily to 300 mg twice daily

Protocol documents:
Clinical trial NCT00958035
Conditions: Hypotrichosis
Sponsor: Allergan
Start date: 2009-11-01; Completion date: 2010-08-01
Enrollment: 89 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of bimatoprost solution 0.03% once daily to the upper eyelid margins (where the eyelashes meet the skin) compared with vehicle in increasing overall eyelash prominence in self-identified African American/ethnic black subjects exhibiting hypotrichosis of the eyelashes (inadequate or not enough eyelashes).

Detailed description:

Arms: arm 1: bimatoprost ophthalmic 0.03% solution arm 2: vehicle sterile solution
Interventions: intervention 1: bimatoprost ophthalmic 0.03% solution intervention 2: vehicle sterile solution (placebo)
Intervention descriptions: intervention 1: Apply one drop of study medication along the upper eyelid margin once daily in the evening intervention 2: Apply one drop of study medication along the upper eyelid margin once daily in the evening

Protocol documents:
Clinical trial NCT00961896
Conditions: Treatment for Basal Cell Carcinomas (BCCs) in Gorlin Syndrome Patients
Keywords: Basal Cell Carcinoma Gorlin Syndrome, Gorlin-Goltz Syndrome, Basal Cell Nevus Syndrome, Nevoid Basal Cell Carcinoma Syndrome, Basal Cell Carcinoma Nevus Syndrome
Sponsor: Novartis Pharmaceuticals
Start date: 2009-07-01; Completion date: 2010-08-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Part I was a double-blind, randomized, vehicle-controlled Proof of Concept (PoC) study to evaluate the safety, local tolerability, pharmacokinetics and pharmacodynamics of multiple topical administrations of LDE225 (a specific Smoothened inhibitor) on skin basal cell carcinomas in Gorlin's syndrome patients.

Following a 21-day screening period, patients were exposed to multiple doses of topically applied LDE225 twice daily for 4 weeks in a double-blind manner. The patients returned weekly for visits where each BCC was clinically evaluated and digital photographs taken. Local safety and tolerability was also assessed. After the last application of treatment, biopsies were taken from treated (both vehicle and LDE225) BCCs (three per patient) for histology, biomarker evaluation and for pharmacokinetics (skin exposure). In addition, a biopsy from LDE225-treated uninvolved perilesional skin was taken for pharmacokinetic evaluation. In total, 4 biopsies were taken: 2 for histology and biomarker and 2 for PK.

Part II of this study consisted of a 21-day screening period, a baseline period (directly before commencing the treatment period) and a treatment period of 6 or 9 weeks, depending on randomization. A clinical assessment was performed on site on the last treatment day and if a full clinical response had been observed, approximately 3 weeks after the last treatment an excision of the BCC(s) would have been performed. The study completion visit occurred either 1 week after the excision (when this visit was planned) or 1 week after the last treatment. For a subset of patients, skin biopsies were collected on the last treatment day and an excision of a BCC was also performed at that same visit.

Detailed description:

Arms: arm 1: Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant. arm 2: Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant. arm 3: Participants were exposed to topically applied 0.25% LDE225 cream twice daily for 6 weeks. arm 4: Participants were exposed to topically applied 0.75% LDE225 cream twice daily where some basal cell carcinomas (BCCs) were teated for 6 weeks and some BCCs were treated for 9 weeks.
Interventions: intervention 1: Vehicle intervention 2: LDE225 0.25% intervention 3: LDE225 0.75%
Intervention descriptions: intervention 1: Placebo cream intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00963040
Conditions: Chronic Daily Headache
Keywords: intranasal oxytocin acute headache treatment chronic daily headache
Sponsor: MedVadis Research Corporation
Start date: 2009-11-01; Completion date: 2010-08-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this prospective, randomized, double-blind, parallel-group, placebo-controlled study is to determine the effectiveness of intranasal oxytocin in subjects suffering from chronic daily headache.

Detailed description:
The TI004 and TI005 studies both used a randomized, double-blind, placebo-controlled, parallel-group study design. A protocol-specified interim analysis was performed after completion of the first 40 subjects, resulting in termination of the TI004 study and development of the TI005 protocol, which included the following changes from the TI004 protocol:

1. Increase in oxytocin dose from 32 to 64 IU;
2. Extension of the in-clinic observation period from 2 hours post-dose to 4-hours post-dose;
3. Reduction in sample size from 40 to 20 subjects;
4. Elimination of the laboratory measurements during the screening visit, allowing V1 and V2 potentially to be combined, expediting study completion;
5. Adding in-clinic observation and assessment at 3 hours and 4 hours post-dose and out-of-clinic assessment at 8 hours post-dose.

The primary outcome measure is the reduction in headache intensity after drug administration; secondary outcome measures are the headache symptoms, nausea, vomiting, photophobia, and phonophobia. Additional secondary outcome measures are intake of rescue medication and patient satisfaction over a period of 24 hours.

Arms: arm 1: Treated group arm 2: Placebo group arm 3: None arm 4: None
Interventions: intervention 1: Syntocinon intervention 2: Sterile water intervention 3: Syntocinon intervention 4: Sterile water
Intervention descriptions: intervention 1: 4 actuations in each nostril for a total dose of 32 IU intervention 2: 4 actuations in each nostril intervention 3: 8 actuations in each nostril for a total dose of 64 IU intervention 4: 8 actuations in each nostril

Protocol documents:
Clinical trial NCT00969501
Conditions: Osteoarthritis
Sponsor: Georgia Institute for Clinical Research, LLC
Start date: 2009-08-01; Completion date: 2010-08-01
Enrollment: 32 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The hypothesis of this study is that by using 3 injections of EUFLEXXA, there will be an improvement in pain levels and range of motion.

Detailed description:
To demonstrate that EUFLEXXA is safe for the treatment of chronic shoulder pain associated with osteoarthritis.

Arms: arm 1: ACTIVE CONTROL
Interventions: intervention 1: EUFLEXXA
Intervention descriptions: intervention 1: 2.5 mL of EUFLEXXA (per injection) x 3 injections

Protocol documents:
Clinical trial NCT00982280
Conditions: Chronic Pain Osteoarthritis
Keywords: Osteoarthritis pain assessment tapentadol centrally acting analgesic
Sponsor: Grünenthal GmbH
Start date: 2009-09-01; Completion date: 2010-08-01
Enrollment: 82 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The main objective of the study is to evaluate the effectiveness, tolerability, and safety of tapentadol hydrochloride prolonged release (PR) in participants suffering from severe chronic pain due to osteoarthritis of the knee who are taking WHO Step III analgesics and show lack of tolerability. This is a clinical effectiveness trial designed to establish a link between anticipated clinical outcomes and the clinical practice by means of selected measures of clinical and subject-reported outcome. The trial will compare the effectiveness of previous analgesic treatment (WHO Step III) with that of tapentadol hydrochloride PR treatment during defined periods of evaluation.

Detailed description:
The trial will last up to 13 weeks for each subject and includes:

* One week of observation under previous analgesic treatment.
* Twelve weeks of treatment with tapentadol hydrochloride PR.

Arms: arm 1: Tapentadol PR was given orally twice a day. A maximum of 2 oral Tapentadol IR tablets per day, with a minimum of a 4 hour interval between doses, were taken if there were acute pain episodes. The total daily dose of Tapentadol PR and IR were not permitted to exceed 500 mg per day.
Interventions: intervention 1: Tapentadol PR
Intervention descriptions: intervention 1: Tapentadol Prolonged Release (PR) Titration and Optimal Dose Period: Starting at 50 mg, 100 mg or 150 mg Tapentadol PR twice daily, adjusting at 50 mg PR steps (upwards or downwards) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. Participants were not permitted to exceed 500 mg of Tapentadol per day.

Maintenance Period: Participants continuing on the dose established in the previous period.

Protocol documents:
Clinical trial NCT00990288
Conditions: Blood Loss
Keywords: To decrease blood loss during knee surgery
Sponsor: Hospital for Special Surgery, New York
Start date: 2007-10-01; Completion date: 2010-08-01
Enrollment: 196 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if the agent, Floseal, can decrease the amount of blood patients lose after total knee replacement (TKR) surgery. If this product can be found to have an effect on bleeding, it may potentially reduce the problems associated with bleeding after knee replacement surgery such as pain, stiffness, and the need to have a blood transfusion. The subject's overall participation will be over a period of 6 weeks.

Detailed description:
This is a prospective double blind randomized clinical trial of patients requiring unilateral total knee arthroplasty. The patients will be randomized intra-operatively to receiving Floseal or no treatment.

Both the patient and the observers will be blinded to whether the subject received Floseal or no treatment. Only the operating surgeons will be aware of whether Floseal or no treatment was given.

As was performed in the pilot study, randomization of Floseal or no treatment will be performed using the sealed envelope technique. Randomization will occur at the time of surgery. The statistician is responsible for maintaining the randomization schedule and issuing the sealed envelopes. The inner envelope will contain whether Floseal or no treatment is to be given on a card which will be counter-signed by the surgeon at the time of surgery. The inner envelope will then be sealed, followed by sealing of the outer envelope. Following the procedure, the surgeon will then take the sealed and signed envelope to surgeon who will store and file it in a locked cabinet in his office. The patients study number will be on the outside surface of the envelopes.

Arms: arm 1: 2 vials of Floseal applied once at the end of surgery arm 2: No intervention.
Interventions: intervention 1: Hemostatic Matrix
Intervention descriptions: intervention 1: FloSeal will be administered following the cementing of all knee components. Prior to release of the tourniquet and after the cement has cured, it will be applied to cut, exposed bone ends as well as the intra-articular soft tissues by the use of a delivery syringe, Direct manual pressure with a gauze sponge will be applied following its application for 2 minutes, ensuring that it adheres to the bleeding bone surface.

Protocol documents: