ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01792635
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 Diabetes Mellitus Pharmacodynamics Safety & Tolerability
Sponsor: Pfizer
Start date: 2012-12-01; Completion date: 2014-05-01
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to assess the safety, tolerability and pharmacodynamics of 6 weeks of oral doses of PF-05175157 provided as monotherapy in subjects with type 2 diabetes mellitus.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: PF-05175157 intervention 2: Placebo
Intervention descriptions: intervention 1: PF-05175157 will be administered at 200 mg twice a day for 43 days. intervention 2: Placebo tablets matched to PF-05175157 will be administered twice a day for 43 days.

Protocol documents:
Clinical trial NCT01793883
Conditions: Influenza
Keywords: Influenza Laninamivir Octanoate
Sponsor: Biota Scientific Management Pty Ltd
Start date: 2013-05-01; Completion date: 2014-05-01
Enrollment: 639 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Phase 2 protocol is designed to compare two dose levels of laninamivir octanoate versus placebo. The objectives are to obtain safety and efficacy in adults aged 18 to 64 years who present to clinic with symptomatic presumptive influenza A or B infection.

Detailed description:
Approximately 636 subjects will be randomized into the Study.

Following confirmation of circulating influenza in the local area, eligible subjects with recent onset of symptomatic presumptive influenza A or B infection will be enrolled in the study. Subjects must be randomized within 40 hours of the first symptom onset. Subjects will be randomized to placebo, 40 or 80 mg of laninamivir octanoate.

The study will be conducted on an outpatient basis. The first dose of study drug will be administered via inhalation within 4 hours of randomization in the clinic, followed by a second dose at home. Participants will be followed for 14 days to assess efficacy, virology and safety. Outpatient visits to the investigational site are scheduled on Days 2 (optional PK Sub-study Visit) 3, 5, 8, 15. An End of study visit will be performed on Day 29.

Arms: arm 1: 40 mg Laninamivir Octanoate and matching placebo arm 2: 80 mg Laninamivir arm 3: Matching Placebo
Interventions: intervention 1: 40 mg Laninamivir Octanoate intervention 2: 80 mg Laninamivir Octanoate intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01806051
Conditions: Phenylketonuria (PKU)
Sponsor: Dr. Linda Randolph
Start date: 2013-03-01; Completion date: 2014-05-01
Enrollment: 6 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This self-controlled, prospective, pilot study is designed to gather information regarding the diurnal variation (changes that occur each day) in the levels of plasma phenylalanine (Phe) and tyrosine in patients with phenylketonuria (PKU) and in the non-PKU population.

Detailed description:
Phenylketonuria (PKU) is a rare genetic metabolic disease caused by a mutation that codes for an enzyme that converts the essential amino acid phenylalanine (Phe) into tyrosine. An absence or deficiency of this enzyme activity results in a Phe elevation, where higher Phe levels result in neurological damage. Diurnal variations of Phe levels have been observed in PKU patients in a 24-hour period.

As Kuvan has shown to stabilize Phe levels in PKU patients over time, our hypothesis is that this can be demonstrated within a 24-hour period of observation and indicate therefore that Kuvan may correlate with a lower plasma Phe variability. This study on PKU patients' diurnal variation will also provide important information as to the current method of blood Phe monitoring in a clinical setting to learn more about the optimal way to measure Phe concentration.

The study will last about 4 weeks (6 study visits) for the PKU participants and about 1 week (2 study visits) for the control group.

Participants will be required to follow a recommended diet, complete a dietary log, and undergo several blood draws, including a 24-Hour Blood Assessment in which blood will be obtained 8 times throughout the day.

Arms: arm 1: * Subjects will be administered Kuvan once daily.
* They will undergo several blood draws, including a 24-Hour Blood Assessment (at Study Visit #2 before the commencement of Kuvan), plasma Phe/Tyr draws (at Study Visits #3, 4, and 5), and another 24-Hour Blood Assessment (at Study Visit #6). arm 2: * Subjects allocated into this group will be healthy, non-PKU individuals that may be a relative (ex: sibling) of a PKU participant, but they don't have to be a blood relation.
* These subjects will undergo a 24-Hour Blood Assessment (at Study Visit #2).
Interventions: intervention 1: Kuvan
Intervention descriptions: intervention 1: Only PKU participants (Arm 1) will be administered Kuvan once daily either at a dose of 20 mg/kg/day (if the PKU participant is not currently taking Kuvan) or at the subject's regular dose (if the PKU participant is currently taking Kuvan). They will remain on Kuvan for 4 weeks.

Protocol documents:
Clinical trial NCT01823679
Conditions: Squamous Cell Carcinoma of the Skin Recurrent Skin Cancer
Sponsor: Stanford University
Start date: 2013-03-01; Completion date: 2014-05-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Phase 2 evaluation of capecitabine in patients with advanced or recurrent squamous cell carcinoma of the skin.

Detailed description:
Participants are to receive 500 mg/m² of capecitabine orally (PO) twice daily (BID) on days 1 to 14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 2 years.

Arms: arm 1: Participants will receive oral capecitabine twice-a-day (BID) as 500 mg/m² doses on days 1 to 14.

Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Capecitabine
Intervention descriptions: intervention 1: Given orally

Protocol documents:
Clinical trial NCT01827592
Conditions: Chronic Idiopathic Constipation
Sponsor: Ferring Pharmaceuticals
Start date: 2013-04-01; Completion date: 2014-05-01
Enrollment: 376 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Efficacy and Safety Trial of elobixibat in Patients with Chronic Idiopathic Constipation treated for 26 Weeks.

Detailed description:
The present trial was designed to determine the efficacy and safety of elobixibat treatment (at both doses of 5 mg and 10 mg/day) compared to placebo treatment for 26-week Treatment Period in patients with chronic idiopathic constipation. Patients were followed-up for 2 weeks after end of the Treatment Period.

The assessment of primary and key secondary end points was done for patients who completed the first 12 weeks of Treatment Period. Incidence of Adverse Events (AEs) were reported till 2 weeks after end of the treatment.

The trial was early terminated due to a distribution issue with the trial medication.

Arms: arm 1: Elobixibat 10 mg/day arm 2: Elobixibat 5 mg/day arm 3: Placebo
Interventions: intervention 1: Elobixibat 10 mg intervention 2: Elobixibat 5 mg intervention 3: Placebo
Intervention descriptions: intervention 1: Elobixibat 10 mg/day intervention 2: Elobixibat 5 mg/day intervention 3: Placebo

Protocol documents:
Clinical trial NCT01830790
Conditions: Age-related Macular Degeneration
Sponsor: Duke University
Start date: 2013-03-01; Completion date: 2014-05-01
Enrollment: 10 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Choroidal thinning has been hypothesized to partake in the pathogenesis of age-related macular degeneration (AMD), but it is not known if increasing choroidal thickness may potentially alter the disease course. Past studies have shown that a single dose of the phosphodiesterase type-5 inhibitor sildenafil citrate can increase choroidal thickness in young healthy patients. The investigators hypothesize that sildenafil may also increase choroidal thickness in eyes with AMD and perhaps potentially reduce AMD progression. Alternatively, if sildenafil has minimal effect on choroidal thickness in eyes in patients with AMD, such results may suggest that choroidal vascular compliance or stiffness is reduced in this condition. Patients seen at the Duke Eye Center with a diagnosis of AMD or age-matched control subjects with no macular pathology will be administered a single 100mg oral dose of sildenafil citrate (Viagra®; Pfizer), and undergo EDI-OCT imaging before and after treatment. Images obtained will be used to measure choroidal thickness, as well as central macular thickness (CMT) and macular volume (MV). Choroidal thickness changes after a single-dose sildenafil treatment in AMD patients will be compared with age-matched control subjects using standard statistical methods. By also correlating choroidal thickness changes with functional (visual acuity) and anatomical (CMT \& MV) changes, the investigators hope to further their understanding of the choroid's role in aging and AMD pathogenesis. The safety of a single dose of sildenafil citrate will be addressed by excluding any patients with risk factors or using medications that are contraindicated for sildenafil as determined by careful informed consent and a study questionnaire.

Detailed description:

Arms: arm 1: Healthy individuals \>65 years old without ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness arm 2: Age-related macular degeneration (AMD) patients \>65 years old without other ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness
Interventions: intervention 1: Sildenafil citrate
Intervention descriptions: intervention 1: Single dose of 100mg Sildenafil citrate

Protocol documents:
Clinical trial NCT01839279
Conditions: Spasticity
Sponsor: Acorda Therapeutics
Start date: 2013-04-01; Completion date: 2014-05-01
Enrollment: 136 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a single-center, partial-blind, randomized, placebo-controlled, parallel design study with a nested crossover comparison to define the ECG effects of tizanidine compared to placebo and the positive control, moxifloxacin, in healthy men and women. The study will be conducted in a Phase 1 unit with sufficient facilities to house subjects as required by the protocol.

Detailed description:

Arms: arm 1: Oral dose of 2 and 4 milligram (mg) tablets arm 2: Placebo followed by a single dose 400 mg moxifloxacin tablets. arm 3: Single dose of 400 mg moxifloxacin followed by placebo.
Interventions: intervention 1: Tizanidine intervention 2: Placebo intervention 3: Moxifloxacin
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01854268
Conditions: Cough
Keywords: cough
Sponsor: University of Florida
Start date: 2013-05-01; Completion date: 2014-05-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Cough is a defensive behavior that involves three stages. A large inspiratory phase, a compression phase where the vocal folds close and subglottal pressure is developed, and an expiratory phase. Cough serves to protect the upper and lower airways from material such as liquids, solids, or saliva, that have been aspirated. There are two types of cough: voluntary and reflex cough. Voluntary cough involves a cough to command. Reflex cough is a cough that is generated secondary to a stimulus in or near the airway. There has been some research regarding the differences between voluntary and reflex cough. However, no research has described the differences in airflow or movement pattern (kinematics) between the two types of cough. This study seeks to determine the respiratory kinematics and airflow differences between voluntary and reflex cough in healthy participants.

Detailed description:
As a participant, completion of this study will require the following:

Investigators will first place cotton elastic bands around your chest and abdomen so that measures of chest wall and abdominal movements can be measured. Then, tests of your breathing made from pulmonary function testing will be completed.

Investigators will then have you complete a maximum inspiration followed by a maximum expiration three times.

Investigators will ask you to produce a voluntary cough three times into a facemask which is attached to a computer.

Then the investigators will provide you with nebulized water (FOG) through the facemask for up to a minute three times. You will have a minute break in between each presentation.

Finally, the investigators will provide you with a nebulized dose of Capsaicin, which is derived from hot peppers, through the same facemask used in all of the above tasks. You will receive three doses of capsaicin and be provided with water at any time during the study.

Arms: arm 1: Single treatment consisting of healthy adults.
Interventions: intervention 1: Healthy adults who receive capsaicin
Intervention descriptions: intervention 1: Participants will be seated in a comfortable chair and fitted with cotton elastic bands designed to measure changes in chest wall and abdominal movement during cough. The participant will hold a facemask attached to a pneumotachograph, nebulized, and dosimeter. The participant will receive 3 nebulized doses of 200 microMolar capsaicin through the facemask. The participants will have a minute in between each presentation and water will be available at all times.

Protocol documents:
Clinical trial NCT01862614
Conditions: Anesthetic Effectiveness
Keywords: Degree of pulpal anesthesia obtained. Primary infiltration in the lower first molar. Buffered local anesthetic.
Sponsor: Ohio State University
Start date: 2013-04-01; Completion date: 2014-05-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Infiltration (injecting next to the tooth) injections are common in dentistry and a number of studies have shown that articaine anesthetic, when injected next to a lower molar, is more effective than a local anesthetic injection of lidocaine. However success rates have not been as high as hoped for. No objective study has addressed the success rate of buffering articaine in a mandibular primary buccal infiltration of the first molar. Therefore, the purpose of this prospective, randomized, double-blind, crossover study is to compare the degree of pulpal anesthesia obtained with a buffered 4% articaine with 1:100,000 epinephrine solution versus a non-buffered 4% articaine with 1:100,000 epinephrine solution as a primary infiltration in the mandibular first molar. The investigators will also record the pain of injection and postoperative pain.

Detailed description:
Using a crossover design, 80 adult subjects will receive two injections consisting of a primary mandibular first molar infiltration of 1.8 mL of non-buffered 4% articaine with 1:100,000 epinephrine, and 1.8 mL of buffered 4% articaine with 1:100,000 in two separate appointments spaced at least one week apart. With the crossover design, 160 infiltrations will be given for the first molar and each subject will serve as his or her own control. Eighty infiltrations will be administered on the mandibular left side and 80 administered on the mandibular right side. The order of the two injections will be assigned randomly and the dentist and subject will be blinded about which anesthetic the subject is given. The anesthetics used in this study are not experimental. An electric pulp tester (EPT) will be used to test the lower first molar for anesthesia starting 30 seconds after the injection; and testing every 30 seconds for the first five minutes. After five minutes the EPT will be used to test the lower first molar every minute and the contralateral control canine every 5 minutes for a grand total of sixty minutes. The pain of injection and postoperative pain will be recorded in a survey. Patients will report any postoperative pain or discomfort on a Visual Analog Scale (VAS) for three days following each appointment. The data will be statistically analyzed.

Arms: arm 1: Subjects received an infiltration injection of 1.8cc buffered 4% articaine. arm 2: Subjects received an infiltration injection of 1.8cc 4% articaine (unbuffered).
Interventions: intervention 1: Articaine Hydrochloride + Epinephrine intervention 2: Buffered Articaine Hydrochloride + Epinephrine
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01874145
Conditions: Relapsing-Remitting Multiple Sclerosis
Keywords: Multiple Sclerosis Relapsing-Remitting Multiple Sclerosis Glatiramer Acetate Glatiramer
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2013-06-01; Completion date: 2014-05-01
Enrollment: 209 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an open-label, randomized, multi-center, parallel-arm study to assess the safety and tolerability of a daily dose of Glatiramer Acetate (GA) 40 mg/mL three times a week (TIW) administered subcutaneously (SC) as compared to GA 20 mg/mL every day (QD) administered SC.

Detailed description:
The study will comprise of a Core study and an Extension phase. During the Core study, subjects will be evaluated at study sites for 5 scheduled visits at Months: -1 (Screening), 0 (Baseline), 1, 2, and 4 (Termination/Early Termination). Subjects who complete all scheduled visits will have final procedures and assessments performed at the final visit (Month 4, Termination visit). Subjects who withdraw from the study before completing the 4 months evaluation period will have Early Termination (ET) procedures and assessments performed at their final visit.

During the Extension phase, all subjects will be offered to continue treatment with GA 40 mg/mL TIW. Subjects will be evaluated every 4 months until this dose strength is commercially available for the treatment of Relapsing-Remitting Multiple Sclerosis (RRMS) patients or until the development of this GA dose regimen is stopped by the Sponsor, the last visit of this phase will be called Termination/ET-Extension visit.

Arms: arm 1: Glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core study. arm 2: Glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week (TIW) for the 4 months of the core study.

During the Extension period, all participants to continue treatment with GA 40 mg/mL TIW until this dose regimen is commercially available for the treatment of RRMS patients.
Interventions: intervention 1: GA 20 mg/mL intervention 2: GA 40 mg/mL
Intervention descriptions: intervention 1: Glatiramer acetate (GA) 20 mg/mL subcutaneous (SC) injection, the commercial product, is a single-use pre-filled syringe (PFS) containing 1.0 ml of a clear, colorless to slightly yellow, sterile, non-pyrogenic solution. intervention 2: Glatiramer acetate (GA) 40 mg/mL subcutaneous (SC) injection, is a single-use pre-filled syringe (PFS) containing 1.0 ml of a clear, colorless to slightly yellow, sterile, non-pyrogenic solution.

Protocol documents:
Clinical trial NCT01892020
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2013-06-01; Completion date: 2014-05-01
Enrollment: 161 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This trial is conducted in Asia. The aim of the trial is to investigate the efficacy and safety of biphasic insulin aspart 50 (BIAsp 50) twice daily versus biphasic human insulin 50 (BHI 50) twice daily, both in combination with metformin, in Chinese subjects with type 2 diabetes mellitus.

Detailed description:

Arms: arm 1: Group A will receive BIAsp 50 BID during the first 4 weeks (treatment period 1) then switch to BHI 50 BID for further 4 weeks (treatment period 2) arm 2: Group B will receive BHI 50 BID during the first 4 weeks (treatment period 1), then switch to BIAsp 50 BID for further 4 weeks (treatment period 2)
Interventions: intervention 1: biphasic insulin aspart 50 intervention 2: biphasic human insulin 50
Intervention descriptions: intervention 1: Administered subcutaneously (s.c., under the skin) twice daily (BID). Dose individually adjusted. All subjects will receive metformin in combination with trial insulin. intervention 2: Administered subcutaneously (s.c., under the skin) twice daily (BID). Dose individually adjusted. All subjects will receive metformin in combination with trial insulin.

Protocol documents:
Clinical trial NCT01904149
Conditions: Acute Pain
Keywords: Moderate to severe acute pain Postoperative pain Abdominal hysterectomy Analgesics Dexketoprofen Tramadol
Sponsor: Menarini Group
Start date: 2013-05-01; Completion date: 2014-05-01
Enrollment: 606 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study aims to evaluate the analgesic efficacy of single and repeated doses of fixed combination of dexketoprofen trometamol (DKP) and tramadol hydrochloride (TRAM) in comparison to the single agents (and placebo for the single dose phase only).

Approximately 600 female patients presenting moderate to severe pain after a total/subtotal abdominal hysterectomy are eligible to be randomised provided that they experience moderate to severe pain on the day after surgery.

Detailed description:
In this clinical trial patients were randomized to the described 6 treatment arms, where each arm define the treatment to be received in the first single dose phase (lasting 8 hours after the 1st treatment intake) and in the subsequent multiple-dose phase (lasting from the second treatment intake up to the 8 hours after the last intake). Namely:

* DKP/TRAM followed by DKP/TRAM;
* DKP followed by DKP;
* TRAM followed by TRAM;
* placebo followed by DKP;
* placebo followed by TRAM;
* placebo followed by DKP/TRAM;

The analyses of endpoints pertinent to the single dose phase were performed combining all the 3 treatment arms including placebo into one group, which resulted in the following 4 analysis groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo.

The analysis of endpoints pertinent to the multiple dose phase were performed combining the treatment arms including the same active treatment, which resulted in the following 3 analysis groups: DKP/TRAM, DEXKETOPROFEN, and TRAMADOL.

Arms: arm 1: Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses arm 2: Dexketoprofen-single dose followed by Dexketoprofen-multiple doses arm 3: Tramadol-single dose followed by Tramadol-multiple doses arm 4: Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses arm 5: Placebo single dose followed by Dexketoprofen-multiple doses arm 6: Placebo single dose followed by Tramadol-multiple doses
Interventions: intervention 1: Placebo intervention 2: Dexketoprofen-single dose intervention 3: Tramadol-single dose intervention 4: Dexketoprofen/Tramadol-single dose intervention 5: Dexketoprofen-multiple doses intervention 6: Tramadol-multiple doses intervention 7: Dexketoprofen/Tramadol-multiple doses
Intervention descriptions: intervention 1: Placebo single oral dose (first 8 hours) intervention 2: Dexketoprofen single oral dose (first 8 hours) intervention 3: Tramadol single oral dose (first 8 hours) intervention 4: Dexketoprofen/Tramadol single oral dose (first 8 hours) intervention 5: Dexketoprofen multiple oral doses t.i.d. for 3 days (total 6 doses) intervention 6: Tramadol multiple oral doses t.i.d. for 3 days (total 6 doses) intervention 7: Dexketoprofen/Tramadol multiple oral doses t.i.d. for 3 days (total 6 doses)

Protocol documents: