ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01905631
Conditions: Pruritus Atopic Dermatitis
Keywords: Pruritus Atopic Dermatitis
Sponsor: The Center for Clinical and Cosmetic Research
Start date: 2013-07-01; Completion date: 2013-09-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To demonstrate the ability of Aurstat to reduce pruritus in subjects with mild to moderate atopic dermatitis. Efficacy results will be based on subject assessment, IGA, and photographic evidence based on ordinal scales for tolerability.

Detailed description:
This 3-day study will enroll subjects with mild to moderate atopic dermatitis, as defined by the Hanifin criteria.

All subjects will be screened for study enrollment at the baseline visit. Those meeting inclusion/exclusion criteria will be fully consented (or assented) using an IRB-approved ICF. Subjects will then be randomized to either the treatment or control study arm. Those in the treatment arm will be instructed on product application technique and study instructions at baseline. Subjects will apply Aurstat BID, or as needed, to determine frequency of use as a surrogate marker for duration of therapy effect to affected, qualifying atopic dermatitis lesions.

The investigator will assess treatment response using an ordinal scale for tolerability and an IGA scale for disease severity ratings. Subjects will assess treatment response using a VAS to rate pruritus and an ordinal scale to assess tolerability. Photography assessments will be obtained. All adverse events will be captured.

Arms: arm 1: Subjects will apply nothing for the entire three days of the trial. Subjects will also fill out a study diary assessing adverse events or other events they experience during the trial. arm 2: Subjects will apply Aurstat Anti-Itch Hydrogel 2 times daily or as needed for up to three days to reduce itching. Subjects will also fill out a study diary assessing adverse events or other events they experience during the trial.
Interventions: intervention 1: Aurstat Anti-Itch Hydrogel (Aurstat)
Intervention descriptions: intervention 1: Subjects will apply Aurstat Anti-Itch Hydrogel 2 times daily or as needed for up to three days to reduce itching. Subjects will also fill out a study diary assessing adverse events or other events they experience during the trial.

Protocol documents:
Clinical trial NCT01908582
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2013-07-01; Completion date: 2013-09-01
Enrollment: 26 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The main purpose of this study is to determine how much evacetrapib gets into the blood stream and how long it takes the body to get rid of it when given with rifampin. The safety and tolerability of the two drugs, given together, will also be evaluated. The study will also look at blood cholesterol levels and levels of a hormone called cortisol before and after taking rifampin. Information about any side effects that may occur will also be collected.

For each participant, this study will include 2 periods in fixed order. The study will last approximately 29 days.

Detailed description:

Arms: arm 1: Period 1:

130 milligram (mg) evacetrapib administered orally, once on Day 1 arm 2: Period 2:

Rifampin: 600 mg administered orally, once daily (QD) for 14 days (Days 9 to 22)

Evacetrapib: 130 mg administered orally once on Day 16
Interventions: intervention 1: Evacetrapib intervention 2: Rifampin
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally

Protocol documents:
Clinical trial NCT01920854
Conditions: Kidney Failure, Chronic Therapy; Hemodialysis
Keywords: Soluble Ferric Pyrophosphate, Pharmacokinetics, Iron, Hemodialysis
Sponsor: Rockwell Medical Technologies, Inc.
Start date: 2013-06-01; Completion date: 2013-09-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the pharmacokinetics of fixed ascending doses of intravenously administered Soluble Ferric Pyrophosphate

Detailed description:
* A total of 48 healthy volunteers will be studied.
* Depending on the safety profile at completion of the highest dose cohort, an additional 2 cohorts of subjects may be studied.
* Doses of SFP may be modified, depending on the PK and safety findings at each dose level.
* Cohorts may be dropped for safety or tolerability after discussion with the sponsor.
* There will be 6 active and 2 placebo subjects in each study cohort.
* Subjects in Cohorts 1-3 will receive ascending doses of SFP by intravenous infusion over 4 hours.
* Subjects in Cohorts 4-6 will receive ascending doses of SFP by intravenous infusion over 12 hours.

All subjects will be confined in the CRC for 1 day prior to study drug administration and for 2 additional days for safety assessments and completion of test procedures.

Arms: arm 1: Group/Cohort Designation: Ascending doses of SFP. Each subject will receive a defined dose of SFP IV administered under double-blind conditions. Pharmacokinetics of iron will be measured using a validated assay for iron and transferrin bound iron. arm 2: Group/Cohort Designation: Each subject will receive placebo IV administered under double-blind conditions.
Interventions: intervention 1: soluble ferric pyrophosphate intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01962987
Conditions: Actinic Keratosis
Sponsor: Actavis Inc.
Start date: 2013-03-01; Completion date: 2013-09-01
Enrollment: 476 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the relative efficacy and safety of the test formulation diclofenac sodium gel 3% (Actavis) to the marketed formulation Solaraze® (diclofenac sodium) Gel 3% (Fougera Pharms) in the treatment of the actinic keratosis

Detailed description:

Arms: arm 1: The diclofenac sodium 3% test gel is applied to lesion areas twice daily. It is to be smoothed onto the affected skin gently. The amount needed depends upon the size of the lesion site. Assure that enough Test Gel is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site. arm 2: The Reference diclofenac sodium 3% gel (Solaraze®) is applied to lesion areas twice daily. It is to be smoothed onto the affected skin gently. The amount needed depends upon the size of the lesion site. Assure that enough Reference (Solaraze®) Gel is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site. arm 3: The placebo gel (contains no active ingredient) is applied to lesion areas twice daily. It is to be smoothed onto the affected skin gently. The amount needed depends upon the size of the lesion site. Assure that enough placebo gel is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.
Interventions: intervention 1: Diclofenac sodium intervention 2: Placebo
Intervention descriptions: intervention 1: Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days. intervention 2: Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days.

Protocol documents:
Clinical trial NCT01982695
Conditions: Duchenne Muscular Dystrophy (DMD) Cardiomyopathy
Keywords: Duchenne muscular Dystrophy (DMD) Cardiomyopathy Losartan Lisinopril
Sponsor: Nationwide Children's Hospital
Start date: 2009-03-01; Completion date: 2013-09-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is a double-blind randomized clinical trial of lisinopril versus losartan for the treatment of cardiomyopathy in Duchenne Muscular Dystrophy (DMD). Both drugs are known to be effective for the treatment of dilated cardiomyopathy. ACEi have been reported to delay the onset and progression of left ventricle dysfunction in children with DMD. Multiple studies show therapeutic efficacy of losartan in animals with cardiomyopathy related to muscular dystrophy and in patients with cardiomyopathy from diverse causes. ARBs are often reserved for patients in whom heart failure is not adequately treated or where side effects preclude the use of an ACEi. However, in DMD, losartan might be a better choice as a first line drug because of studies demonstrating a potential benefit for skeletal muscle in the mdx mouse. Considering that both skeletal and cardiac muscles are major contributors of the disability of DMD, a drug that could improve both heart and skeletal muscles simultaneously would need consideration as the drug of choice for the cardiomyopathic DMD patient.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Losartan intervention 2: Lisinopril
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02114892
Conditions: Metabolic Syndrome X
Keywords: metabolic syndrome central obesity resveratrol insulin secretion insulin sensitivity
Sponsor: University of Guadalajara
Start date: 2012-04-01; Completion date: 2013-09-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The Metabolic Syndrome is a high prevalence disease worldwide. About a quarter of the adult population suffers the disease.

Resveratrol is a substance found in many plants, including grapes, nuts and wine, but it's also found in Polygonum cuspidatum. There is evidence that resveratrol consumption has beneficial effects on glucose and lipids metabolism, blood pressure and body weight.

The aim of this study was to evaluate the effect of resveratrol on metabolic syndrome, insulin sensitivity and insulin secretion.

The investigators hypothesis was that the administration of resveratrol modifies the metabolic syndrome, insulin sensitivity and insulin secretion.

Detailed description:
A randomized, double-blind, placebo-controlled clinical trial was carried out in 24 patients with a diagnosis of metabolic syndrome in accordance with the International Diabetes Federation (IDF). Waist circumference, glucose, insulin levels, lipid profile, creatinine and acid uric were evaluated after a 75 g of dextrose load.

12 received resveratrol, 500 mg, three times per day (1500 mg) before meals during 3 months.

The remaining 12 patients received placebo with the same prescription.

Area Under the Curve of glucose and insulin was calculated as well as total insulin secretion (insulinogenic index), first-phase of insulin secretion (Stumvoll index) and insulin sensitivity (Matsuda index).

This protocol was approved by a local ethics committee and written informed consent was obtained from all volunteers.

Results are presented as mean and standard deviation. Intra and inter group differences were tested using the Wilcoxon signed-rank and Mann-Whitney U-test respectively; p≤0.05 was considered significant.

Arms: arm 1: Resveratrol capsules, 500 mg, three times per day before meals during 90 days arm 2: Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days
Interventions: intervention 1: Resveratrol intervention 2: Placebo
Intervention descriptions: intervention 1: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day. intervention 2: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg

Protocol documents:
Clinical trial NCT02154048
Conditions: Surgery, Hand
Sponsor: Duke University
Start date: 2012-04-01; Completion date: 2013-09-01
Enrollment: 5 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether the addition of dexamethasone prolongs analgesia when added to long-acting local anesthetic during single-injection supraclavicular block for outpatient hand surgery.

Detailed description:
The goal for pain control after surgery is to provide the best possible pain control for the longest period of time with the least amount of side effects. One type of pain medication is called local anesthetic, which is a numbing medication that is injected in the area surrounding nerves to block pain. This injection is called a nerve block. Ropivacaine is a local anesthetic that is commonly used for nerve blocks and will be used in this study. The effects of ropivacaine may last for 8 to 12 hours after surgery. Recent research studies have shown that adding a medication called dexamethasone (a steroid) may increase the time that the nerve block will provide pain control. The purpose of this study is to see if adding dexamethasone to ropivacaine and injecting this around the nerves during a supraclavicular brachial plexus block increases the duration of pain relief as compared to both placebo control and systemic control groups.

Arms: arm 1: This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an IV preservative-free dexamethasone 8 mg injection. arm 2: This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an intravenous (IV) normal saline placebo injection. arm 3: This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with both 1:400,000 epinephrine and preservative-free dexamethasone 8mg and an IV normal saline placebo injection.
Interventions: intervention 1: Ropivacaine intervention 2: Dexamethasone intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02449902
Conditions: Menopause Vulvovaginal Atrophy Painful Intercourse Dyspareunia
Keywords: VVA Postmenopausal Painful Sex
Sponsor: TherapeuticsMD
Start date: 2013-07-01; Completion date: 2013-09-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study was designed to evaluate the efficacy and safety of TX-12-004-HR 10 μg in treating moderate to severe symptoms of vaginal atrophy associated with menopause after 14 days of treatment, and to estimate the effect size and variability of vulvovaginal atrophy endpoints. In addition, the systemic exposure to estradiol from single and multiple doses of TX-12-004-HR was to be investigated.

Detailed description:
This study was a randomized, double-blind, placebo-controlled trial to evaluate safety and efficacy of the TX-12-004-HR formulation in reducing moderate to severe symptoms of vaginal atrophy associated with menopause and to investigate the systemic exposure to estradiol following once daily intravaginal administrations of TX-12-004-HR for 14 days.

Postmenopausal subjects who met the study entry criteria were randomized to one of two treatment groups (TX-12-004-HR or Placebo). During the Screening period subjects were asked to self-assess the symptoms of vulvar and/or vaginal atrophy, including vaginal dryness, vaginal and/or vulvar irritation/itching, dysuria, vaginal pain associated with sexual activity and vaginal bleeding associated with sexual activity. Subjects with at least one self-assessed moderate to severe symptom of vulvar and/or vaginal atrophy identified by the subject as being most bothersome to her were eligible to participate in the study.

Arms: arm 1: Estradiol 10 μg vaginal softgel capsule arm 2: Placebo vaginal softgel capsule
Interventions: intervention 1: Estradiol intervention 2: placebo
Intervention descriptions: intervention 1: 1 10 µg capsule inserted vaginally for 14 days. intervention 2: 1 placebo capsule inserted vaginally for 14 days.

Protocol documents:
Clinical trial NCT02777268
Conditions: Healthy Subjects
Sponsor: Neurocrine UK Limited
Start date: 2013-07-01; Completion date: 2013-09-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This was a single centre, open-label, randomised, 5-way crossover study.

Detailed description:
This was a single centre, open-label, randomised, 5-way crossover study design to compare the PK of Infacort® versus immediate-release hydrocortisone tablets and to evaluate the dose proportionality of 0.5 mg, 2 mg, 5 mg and 10 mg Infacort®. The study was conducted in 1 cohort of 16 healthy male subjects and comprised a Screening Visit, 5 treatment periods (Treatment Periods 1 to 5) and a Post-study Visit.

Arms: arm 1: Multi-particulate granules from 1 (0.5 mg) capsule arm 2: Multi-particulate granules from 1 (2 mg) capsule arm 3: Multi-particulate granules from 1 (5 mg) capsule arm 4: Multi-particulate granules from 1 (10 mg) capsule arm 5: 1 (10 mg) tablet
Interventions: intervention 1: Infacort intervention 2: Hydrocortisone
Intervention descriptions: intervention 1: Multi-particulate granules intervention 2: Tablet

Protocol documents:
Clinical trial NCT01678131
Conditions: Chronic Hepatitis C
Sponsor: Merck Sharp & Dohme LLC
Start date: 2012-10-30; Completion date: 2013-09-02
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the technical feasibility of using fine needle aspiration (FNA) of liver tissue to obtain vaniprevir (MK-7009) liver pharmacokinetic (PK) data, working towards identifying a minimally invasive, reproducible platform to measure liver PK. The study will be done in 2 parts. In Part 1, participants will be randomized to one of five FNA/core needle biopsy (CNB) time-point collection sequences. In Part 2, participants will be randomized to one of two possible doses of vaniprevir and will be assigned to one of five FNA/CNB time-point collection sequences; participants in Part 2 will also receive background therapy with pegylated interferon alpha-2b (Peg-IFN alpha-2b) and ribavirin (RBV). The primary hypothesis is that there is a greater than 80% posterior probability that vaniprevir concentrations are successfully obtained at least 60% of the time from FNA liver samples collected at 2 of 3 specified timepoints.

Detailed description:

Arms: arm 1: Participants received 600 mg vaniprevir only on days 1-7, and had postdose liver biopsy done by FNA and CNB from Day 7 up to Day 10. arm 2: Participants received 600 mg vaniprevir on Days 1-7; Peg-IFN alpha-2b once a week, RBV daily from Day 1 up to Day 21; and had postdose liver biopsy done by FNA and CNB from Day 7 up to Day 10. arm 3: Participants received 300 mg vaniprevir from Days 1-7; Peg-IFN alpha-2b once a week, RBV daily from Day 1 up to Day 21; and had postdose liver biopsy done by FNA and CNB from Day 7 up to Day 10.
Interventions: intervention 1: Vaniprevir 600 mg intervention 2: Peg-IFN alfa-2b intervention 3: Ribavirin intervention 4: Liver samples from FNA intervention 5: Vaniprevir 300 mg intervention 6: Liver samples from CNB
Intervention descriptions: intervention 1: Vaniprevir capsules, were administered orally, twice per day (BID) to achieve a final daily dose of 600 mg on Days 1 through 6; and a single dose of 600 mg, orally, on Day 7. intervention 2: Peg-IFN alfa-2b was administered at 1.5 µg/kg per week by subcutaneous injections on Days 1, 8, 15 and 21 intervention 3: Ribavirin capsules were administered on Days 1-21, orally, twice daily for a total daily dose of 600 - 1400 mg, depending on the participant's weight intervention 4: Liver samples were collected from Day 7 up to Day 10 by FNA at 3 of 5 specified postdose timepoints. intervention 5: Vaniprevir capsules were administered orally, twice per day to achieve a final daily dose of 300 mg on Days 1 through 6; and a single dose of 300 mg, orally, on Day 7. intervention 6: Liver samples were collected from Day 8 up to Day 10 by CNB at 1 of 3 specified postdose timepoints.

Protocol documents:
Clinical trial NCT01456052
Conditions: Ulcerative Colitis
Sponsor: Lexicon Pharmaceuticals
Start date: 2012-01-30; Completion date: 2013-09-03
Enrollment: 59 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter, placebo-controlled, parallel-group, pilot study to evaluate safety and preliminary effectiveness of two blinded dose levels of telotristat etiprate (LX1606) in participants with acute, mild to moderate ulcerative colitis on 5-aminosalicylic acid/mesalamine therapy.

Detailed description:

Arms: arm 1: 500 mg telotristat etiprate (LX1606) administered orally once daily (QD). arm 2: 500 mg telotristat etiprate (LX1606) administered orally three times daily (TID). arm 3: Matching placebo administered orally.
Interventions: intervention 1: Telotristat Etiprate intervention 2: Placebo
Intervention descriptions: intervention 1: 500 mg telotristat etiprate (LX1606) administered orally. intervention 2: Matching placebo administered orally.

Protocol documents:
Clinical trial NCT01554176
Conditions: Major Depressive Disorder, Recurrent
Keywords: Current depressive episode moderate to severe
Sponsor: Merck Sharp & Dohme LLC
Start date: 2012-05-18; Completion date: 2013-09-03
Enrollment: 129 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of filorexant (MK-6096) versus placebo as adjunctive treatment for major depressive disorder (MDD), in participants who are partial responders to antidepressant monotherapy with one of identified selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), or bupropion. The primary hypothesis of the study is that filorexant is superior to placebo as augmentation therapy with respect to change from baseline to Week 6 in the Montgomery Asberg Depression Rating Scale (MADRS) total score.

Detailed description:
Participants will continue to take their pretrial antidepressant medication as prescribed throughout the trial. Participants will be randomized in a 1:1 ratio to receive filorexant or placebo for a 6-week treatment period. Following completion of the treatment period, participants will enter a 2-week double-blind run-out period. During the run-out period, participants who received placebo in the 6-week treatment period will continue to receive placebo and participants who received filorexant in the 6-week treatment period will be randomized to receive either filorexant or placebo in a 1:1 ratio.

Arms: arm 1: Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks. arm 2: Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks. arm 3: Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered filorexant 10 mg once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase. arm 4: Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase. arm 5: Run-out Phase: Following completion of the 6-week Treatment Phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received placebo once daily during the Treatment Phase.
Interventions: intervention 1: Filorexant intervention 2: Placebo
Intervention descriptions: intervention 1: Filorexant, one 10 mg tablet, orally, once daily at bedtime intervention 2: Placebo, one tablet, orally, once daily at bedtime

Protocol documents: