ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01604278
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Indacaterol Glycopyrronium Bromide COPD bronchodilation
Sponsor: Novartis Pharmaceuticals
Start date: 2012-05-01; Completion date: 2013-01-01
Enrollment: 449 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study assessed the efficacy, safety and tolerability of the co-administration of NVA237 plus indacaterol taken once daily versus indacaterol taken once daily in patients with moderate to severe Chronic Obstructive Pulmonary Disease.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: NVA237 50 µg and indacaterol 150 µg intervention 2: Placebo to NVA237 and indacaterol 150 µg
Intervention descriptions: intervention 1: NVA237 50 µg and indacaterol 150 µg supplied as blistered capsules for inhalation. intervention 2: Placebo to NVA237 and indacaterol 150 µg supplied as blistered capsules for inhalation.

Protocol documents:
Clinical trial NCT01613326
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Sponsor: Novartis Pharmaceuticals
Start date: 2012-06-01; Completion date: 2013-01-01
Enrollment: 657 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study compared the efficacy and safety of NVA237 with tiotropium in patients with moderate to severe COPD. Tiotropium belongs to the same drug class as NVA237.

Detailed description:
This was a randomized, blinded, double-dummy, parallel-group 12-week study to assess the efficacy, safety, and tolerability of NVA237 (50 μg o.d.) compared to tiotropium (18 μg o.d.) in patients with chronic obstructive pulmonary disease (COPD).

Arms: arm 1: NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication. arm 2: Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
Interventions: intervention 1: NVA237 intervention 2: Tiotropium intervention 3: Placebo to tiotropium intervention 4: Placebo to NVA237 intervention 5: salbutamol/albuterol
Intervention descriptions: intervention 1: NVA237 50 μg inhalation capsules once a day, delivered via SDDPI intervention 2: Tiotropium 18 μg once a day delivered via HandiHaler® device intervention 3: Placebo to tiotropium 18 μg o.d. once a day delivered via HandiHaler® device. intervention 4: Placebo to NVA237 50 μg once a day delivered via SDDPI intervention 5: salbutamol/albuterol given as a rescue medication via inhaler when needed

Protocol documents:
Clinical trial NCT01618214
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2012-06-01; Completion date: 2013-01-01
Enrollment: 344 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Asia. The aim of this trial is to compare BIAsp 30 twice daily individually adjusted by the subject versus BIAsp 30 twice daily individually adjusted by the investigator both combined with oral antidiabetic drugs (OADs) in subjects with type 2 diabetes inadequately controlled with premixed human insulin. Subjects to continue their OAD background treatment: Metformin plus/minus alpha-glucosidase inhibitor.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: biphasic insulin aspart 30
Intervention descriptions: intervention 1: Dose individually adjusted, administered subcutaneously (s.c., under the skin) twice daily.

Protocol documents:
Clinical trial NCT01621633
Conditions: Hepatic Impairment
Keywords: hepatic impairment
Sponsor: Novartis Pharmaceuticals
Start date: 2012-09-01; Completion date: 2013-01-01
Enrollment: 32 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study to characterize the pharmacokinetics as well as safety and tolerability of a single oral dose of LCZ696 200 mg in subjects with mild and moderate hepatic impairment compared to matched healthy subjects

Detailed description:

Arms: arm 1: LCZ696 200 mg, given as a single oral dose arm 2: LCZ696 200 mg, given as a single oral dose arm 3: LCZ696 200 mg, given as a single oral dose. Each healthy volunteer will match in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in groups 1 and 2
Interventions: intervention 1: LCZ696
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01650519
Conditions: Arthroscopic Knee Surgery
Keywords: knee surgery, arthroscopy; orthopaedic, orthopedic surgery
Sponsor: Cumberland Pharmaceuticals
Start date: 2012-09-01; Completion date: 2013-01-01
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The intent of this study is to assess the analgesic efficacy of IV ibuprofen when administered at induction of anesthesia. Results from this pilot study will be used to design and determine the appropriate statistical power for a larger, multi-center randomized study.

Detailed description:
Non-steroidal anti-inflammatory drugs(NSAIDs) are an effective adjunct to opioid analgesia for moderate-severe pain, with improvement in the quality of pain relief and consistent evidence of opioid dose sparing. NSAIDs alone could provide effective analgesia post-surgery when mild-moderate pain is expected. There is also evidence that the use of NSAIDs, by avoiding or decreasing the need for opioids, can lead to a reduction in the incidence of adverse events which are commonly attributed to, or exacerbated by, opioids.

The intent of this study is to assess the analgesic efficacy of IV ibuprofen when administered at induction of anesthesia. Results from this pilot study will be used to design and determine the appropriate statistical power for a larger, multi-center randomized study.

Arms: arm 1: Intravenous ibuprofen (800 mg) administered intravenously over 10 minutes at study hour 0 and again at study hour 4 (Ibuprofen arm) and a corresponding volume of normal saline (ketorolac arm) will be administered intravenously over no less than 15 seconds at the end of the arthroscopic procedure arm 2: A corresponding volume of normal saline (Ibuprofen arm) administered intravenously over 10 minutes at study hour 0 and again at study hour 4 and 30 mg ketorolac for patients \< 65 years of age (15 mg ketorolac for patients \> 65 years of age) (ketorolac arm) will be administered intravenously over no less than 15 seconds at the end of the arthroscopic procedure
Interventions: intervention 1: IV ibuprofen intervention 2: IV ketorolac
Intervention descriptions: intervention 1: 800 mg intravenous ibuprofen administered intravenously over 10 minutes. intervention 2: 30 mg ketorolac for patients \< 65 years of age (15 mg ketorolac for patients \> 65 years of age) administered intravenously over no less than 15 seconds

Protocol documents:
Clinical trial NCT01650584
Conditions: Dry Eye Disease
Sponsor: Bausch & Lomb Incorporated
Start date: 2012-06-01; Completion date: 2013-01-01
Enrollment: 35 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To assess the comfort preference of ISTA Tears vs Systane in patients with dry eye disease (DED)

Detailed description:

Arms: arm 1: Sterile ophthalmic solution arm 2: Sterile ophthalmic solution
Interventions: intervention 1: ISTA Tears intervention 2: Systane
Intervention descriptions: intervention 1: sterile ophthalmic solution intervention 2: Sterile ophthalmic solution

Protocol documents:
Clinical trial NCT01660815
Conditions: Alzheimer's Disease
Sponsor: Avid Radiopharmaceuticals
Start date: 2012-08-01; Completion date: 2013-01-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will determine how florbetapir (18F) (18F-AV-45) radioactivity is distributed throughout the body of Japanese subjects.

Detailed description:

Arms: arm 1: Cognitively normal, healthy volunteers at least 45 years of age.
Interventions: intervention 1: florbetapir (18F)
Intervention descriptions: intervention 1: IV injection, 370 MBq (10mCi), single dose

Protocol documents:
Clinical trial NCT01666119
Conditions: Opioid Dependence
Keywords: Opioid dependence Suboxone addiction BEMA Buprenorphine NX oral transmucosal
Sponsor: BioDelivery Sciences International
Start date: 2012-08-01; Completion date: 2013-01-01
Enrollment: 249 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open label study in opioid dependent subjects maintained on a stabilized dose of Suboxone tablets or films. The purpose is to assess the safety and tolerability of BEMA Buprenorphine NX administered once daily for 12 weeks to opioid dependent subjects stabilized on Suboxone (buprenorphine/naloxone) tablets or films.

Eligible subjects will be converted to an approximately equal dose of BEMA Buprenorphine NX. This dose will be taken throughout the 12-week treatment period with dose adjustments as clinically indicated for either the control of opioid dependence or adverse events (AEs).

Detailed description:
This is an open label study in opioid dependent subjects maintained on a stabilized dose of Suboxone tablets or films.

Eligible subjects will be converted to an approximately equal dose of BEMA Buprenorphine NX. This dose will be taken throughout the 12-week treatment period with dose adjustments as clinically indicated for either the control of opioid dependence or adverse events (AEs). Subjects will be monitored for evidence of buccal irritation attributed to the application of the BEMA Buprenorphine NX film and opioid dependence control according to the Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction - A Treatment Improvement Protocol (TIP 40) guidelines for the use of buprenorphine in the management of opioid dependence.

The total duration of participation for each subject will be up to approximately 18 weeks and includes a Screening period (subjects continue to take Suboxone tablets or films), Baseline visit, a 12-week open label treatment period (subjects take BEMA Buprenorphine NX films and at the Day 84 visit, subjects will return to their prior Suboxone treatment), and a Follow-up Visit.

Vital signs, pulse oximetry, opioid withdrawal symptoms, adverse events (AEs), oral examinations, and concomitant medications will be assessed at intervals throughout the study. Clinical laboratory assessments, urine toxicology and buprenorphine testing, and 12-lead electrocardiograms (ECGs) will also be performed.

Arms: arm 1: BEMA Buprenorphine NX films (3.5/0.6 mg and 5.25/0.9 mg buprenorphine/naloxone)will be provided in 3.361 and 5.447 cm2 film sizes, respectively.
Interventions: intervention 1: BEMA Buprenorphine NX films
Intervention descriptions: intervention 1: BEMA Buprenorphine NX films (3.5/0.6 mg and 5.25/0.9 mg buprenorphine/naloxone) will be provided in 3.361 and 5.447 cm2 film sizes, respectively.

Protocol documents:
Clinical trial NCT01666197
Conditions: Ankle Sprain
Keywords: Acute Joint Pain
Sponsor: Novartis
Start date: 2012-08-01; Completion date: 2013-01-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy of diclofenac potassium 25 mg tablet compared with placebo taken three times a day in subjects with acute ankle sprains under 'in-use' conditions, in particular with regard to pain relief.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: diclofenac potassium 25 mg tablet intervention 2: placebo
Intervention descriptions: intervention 1: diclofenac potassium 25 mg tablet intervention 2: placebo

Protocol documents:
Clinical trial NCT01688596
Conditions: Pain, Postoperative
Keywords: Local Anesthesia Pain Laparoscopic hysterectomy Trocar site Port site
Sponsor: Milton S. Hershey Medical Center
Start date: 2012-09-01; Completion date: 2013-01-01
Enrollment: 135 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to assess if injection of local anesthetic to the laparoscopic trocar sites after a hysterectomy will make a difference in a patient's pain after surgery.

Detailed description:
The growing interest in minimally invasive gynecologic surgeries have increased the number of patients undergoing laparoscopic hysterectomies. Although many patients are being discharged home the same day of surgery, majority of patients complain of immediate postoperative pain after a laparoscopic hysterectomy. Since postoperative pain is usually transient and improves over a short period of time, infiltration of local anesthetic to trocar insertion sites might alleviate the patient's discomfort during the recovery period. Immediate post-operative pain relief further facilitates early discharge and faster patient recovery.

Published data regarding the effects of preemptive port site local anesthesia in gynecologic operative laparoscopy have been limited and controversial. Visceral pain control through afferent nerve block could minimize pain perception especially during the first postoperative hours. This study aims to assess the influence of infiltration of local anesthetic to trocar insertion sites after laparoscopic hysterectomy on postoperative pain.

Arms: arm 1: The "No Treatment" group includes patients undergoing laparoscopic hysterectomy without local infiltration of bupivacaine. arm 2: The "Bupivacaine Arm" includes all patients who will receive bupivacaine injection on their trocar sites after the laparoscopic hysterectomy is completed. Bupivacaine (0.25%) will be injected through the closed incisions ensuring subcutaneous tissue, fascia, muscle and pre-peritoneal space of the trocar incision sites are infiltrated. All incisions 8 mm and greater are injected with 10 cc while all incisions 5 mm or less are infiltrated with 5 cc.
Interventions: intervention 1: Bupivacaine
Intervention descriptions: intervention 1: Bupivacaine (0.25%) will be injected through the closed trocar incisions after completion of the laparoscopic hysterectomy case.

Protocol documents:
Clinical trial NCT01698814
Conditions: Allergic Conjunctivitis
Keywords: ocular safety allergic conjunctivitis
Sponsor: Alcon Research
Start date: 2012-10-01; Completion date: 2013-01-01
Enrollment: 518 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to evaluate the ocular safety of an investigational ophthalmic solution in subjects 2 years of age and older with asymptomatic eyes when administered once daily in both eyes for up to 6 weeks.

Detailed description:

Arms: arm 1: AL-4943A Ophthalmic Solution, one drop instilled in both eyes once daily for up to 6 weeks arm 2: AL-4943A Ophthalmic Solution Vehicle, one drop instilled in both eyes once daily for up to 6 weeks
Interventions: intervention 1: AL-4943A Ophthalmic Solution intervention 2: AL-4943A Ophthalmic Solution Vehicle
Intervention descriptions: intervention 1: None intervention 2: Inactive ingredients used as placebo

Protocol documents:
Clinical trial NCT01703858
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2012-09-01; Completion date: 2013-01-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of the trial is to investigate the relative bioavailability, influence of pantoprazole coadministration and food effect of different oral formulations of BI 113608 in healthy male subjects

Detailed description:

Arms: arm 1: powder in the bottle for oral solution, oral administration with 240 mL water arm 2: conventional tablet formulation arm 3: conventional tablet formulation, fed arm 4: conventional tablet after pantoprazole administration arm 5: conventional tablet formulation, fasted, 0:30 min before fat breakfast
Interventions: intervention 1: BI 113608 PIB intervention 2: BI 113608 intervention 3: BI 113608 intervention 4: BI 113608 intervention 5: pantoprazole 40 mg STADA intervention 6: BI 113608
Intervention descriptions: intervention 1: powder for oral solution intervention 2: conventional tablet formulation intervention 3: conventional tablet formulation intervention 4: conventional tablet formulation intervention 5: film-coated tablet intervention 6: conventional tablet formulation

Protocol documents:
Clinical trial NCT01704846
Conditions: Hepatitis C
Sponsor: Boehringer Ingelheim
Start date: 2012-10-01; Completion date: 2013-01-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective is to investigate the bioequivalence of 2 dose strengths of 40 mg and 120 mg BI 201335 NA soft gelatine capsules.

Detailed description:

Arms: arm 1: Test - Reference - Reference - Test arm 2: Reference - Test - Test - Reference
Interventions: intervention 1: BI 201335 NA 120 mg capsule intervention 2: BI 201335 NA 120 mg capsule intervention 3: BI 201335 NA 40 mg capsule intervention 4: BI 201335 NA 40 mg capsule
Intervention descriptions: intervention 1: 1capsule of BI 201335 NA 120 mg capsule intervention 2: 1 capsule of BI 201335 NA 120 mg capsule intervention 3: 3 capsules of BI 201335 NA 40 mg capsule intervention 4: 3 capsules of BI 201335 NA 40 mg capsule

Protocol documents:
Clinical trial NCT01725451
Conditions: Healthy Participants
Sponsor: Eli Lilly and Company
Start date: 2012-11-01; Completion date: 2013-01-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will evaluate the effect of deodorant and antiperspirant use and the presence of underarm hair on the absorption of testosterone. Each participant in this study will receive 6 single doses of 30 milligrams (mg) testosterone applied as a solution to each underarm. There is a minimum one day washout period between each dose. This study will last approximately 24 days not including screening. Screening is required within 30 days prior to the start of the study.

Detailed description:

Arms: arm 1: No deodorant or antiperspirant: Single 30 mg dose of testosterone applied topically to each unshaved axilla in 1 of 6 treatment periods. arm 2: Deodorant spray applied to unshaved axillae. At least 2 minutes wait time. Then, single 30 mg dose of testosterone applied topically to each axilla in 1 of 6 treatment periods. arm 3: Deodorant antiperspirant combination spray applied to unshaved axillae. At least 2 minutes wait time. Then, single 30 mg dose of testosterone applied topically to each axilla in 1 of 6 treatment periods. arm 4: Deodorant antiperspirant combination stick applied to unshaved axillae. At least 2 minutes wait time. Then, single 30 mg dose of testosterone applied topically to each axilla in 1 of 6 treatment periods. arm 5: No deodorant or antiperspirant: Single 30 mg dose of testosterone applied topically to each shaved axilla in 1 of 6 treatment periods. arm 6: Deodorant antiperspirant combination spray applied to shaved axillae. At least 2 minutes wait time. Then, single 30 mg dose of testosterone applied topically to each axilla in 1 of 6 treatment periods.
Interventions: intervention 1: Testosterone intervention 2: Deodorant Spray intervention 3: Deodorant and Antiperspirant Combination Spray intervention 4: Deodorant and Antiperspirant Combination Stick
Intervention descriptions: intervention 1: Administered topically to axillae intervention 2: Administered topically to axillae intervention 3: Administered topically to axillae intervention 4: Administered topically to axillae

Protocol documents:
Clinical trial NCT01737840
Conditions: Dyspepsia
Keywords: dyspepsia pantoprazole ranitidine emergency department
Sponsor: Akdeniz University
Start date: 2012-10-01; Completion date: 2013-01-01
Enrollment: 66 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The H0 hypothesis of the study is there is no difference between pantoprazole and ranitidine in treating patients presented with dyspepsia to the emergency department.

The H1 hypothesis is there is difference between pantoprazole and ranitidine in treating patients presented with dyspepsia to the emergency department.

Detailed description:
Dyspepsia is one of the common complaints in emergency department. Proton pomp inhibitors, H2 receptor blockers and anti-acids are common drugs for treating dyspepsia in emergency department. However there is no study in the emergency department comparing the effectiveness of these drugs. So the investigators planned this study which drug is effective in these patients in order to provide a cost-effective treatment in dyspeptic patients.

Arms: arm 1: Intravenous pantoprazole 40 mg flacon arm 2: Intravenous ranitidine 50 mg
Interventions: intervention 1: Pantoprazole intervention 2: Ranitidine
Intervention descriptions: intervention 1: 33 patients intervention 2: 33 patients

Protocol documents:
Clinical trial NCT01786551
Conditions: Systemic Proinflammatory State
Sponsor: Brigham and Women's Hospital
Start date: 2010-03-01; Completion date: 2013-01-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to investigate the effect of mineralocorticoid receptor (MR) blockade in healthy participants in a systemic proinflammatory state after a meal high in fat and glucose, which is associated with the pathogenesis of atherosclerosis.

Participants will include normal-weight, healthy males (Body Mass Index (BMI) ≤ 25 kg/m\^2) between the ages of 18-45, without hypertension and clinical evidence of metabolic, cardiovascular or any other kind of diseases. After a 12-hour (h) fast, participants will be assigned to a combination of oral fat-loading test (OFLT) and oral glucose tolerance test (OGTT) (day 1), followed by a two-week treatment with 50 mg eplerenone. After two weeks, participants will receive the second OFLT/OGTT treatment (day 15). Starting 5 days prior to the first intervention (day1), the participant's usual diet (ad lib) will be supplemented with 2 bullion broths each day. Standardization of sodium intake is necessary as variations in dietary sodium intake may affect outcome measures. We will evaluate the following parameters at day 1 and day 15 of the study. Prior to OFLT/OGTT, and 2h, 4h thereafter, we will measure a parameter of vascular and systemic inflammation: interleukin-6 (IL-6).

Detailed description:

Arms: arm 1: Eplerenone 50 mg daily for 14 days
Interventions: intervention 1: Eplerenone
Intervention descriptions: intervention 1: 50 mg daily for 14 days

Protocol documents: