ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02355028
Conditions: Exudative Age-Related Macular Degeneration
Keywords: LHA510 PoC Age-related macular degeneration
Sponsor: Alcon, a Novartis Company
Start date: 2015-03-03; Completion date: 2016-10-18
Enrollment: 136 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy of 84 successive days of topically administered LHA510 compared to vehicle in reducing the number of patients requiring intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) therapy (Lucentis®) for recurrence of active choroidal neovascularization (CNV).

Detailed description:
On Day -1, patients will receive an IVT Lucentis® injection in the study eye, and then will be randomized to receive either topical LHA510 ophthalmic suspension or vehicle in a 1:1 ratio for 84 days. Patients with recurrence of active CNV in the study eye during the study will receive rescue IVT Lucentis® injections. Following the treatment period, subjects will return for a follow-up visit and a disposition visit. Only one eye (designated as the study eye) will be dosed with either topical LHA510 or vehicle per patient.

Arms: arm 1: LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy. arm 2: LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
Interventions: intervention 1: LHA510 ophthalmic suspension intervention 2: LHA510 vehicle intervention 3: Ranibizumab ophthalmic solution
Intervention descriptions: intervention 1: None intervention 2: Inactive ingredients used as a placebo comparator intervention 3: For intravitreal (IVT) injection

Protocol documents:
Clinical trial NCT02395133
Conditions: Atopic Dermatitis
Keywords: Eczema
Sponsor: Regeneron Pharmaceuticals
Start date: 2015-03-25; Completion date: 2016-10-18
Enrollment: 422 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study was to assess the ability of different Dupilumab dose regimens, administered as monotherapy, to maintain the treatment response achieved after 16 weeks of initial treatment with Dupilumab monotherapy compared to placebo.

Detailed description:

Arms: arm 1: Subcutaneous injection of Placebo (for Dupilumab) was administered once weekly (QW) from Week 1 (Day 1) to Week 36. arm 2: Subcutaneous injection of Dupilumab 300 milligram (mg) alternatively with placebo (matched to Dupilumab) was administered once every eight week (Q8W) from Week 1 to Week 36. arm 3: Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) was administered once every four week (Q4W) from Week 1 to Week 36. arm 4: Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) was administered once every week (QW) or twice a week (Q2W) from Week 1 to Week 36.
Interventions: intervention 1: Dupilumab intervention 2: Placebo
Intervention descriptions: intervention 1: Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) was administered. intervention 2: Subcutaneous injection of Placebo (for Dupilumab) was administered once weekly (QW).

Protocol documents:
Clinical trial NCT02106832
Conditions: Bronchiectasis
Keywords: Ciprofloxacin Dry Powder for Inhalation Exacerbation Bronchiectasis
Sponsor: Bayer
Start date: 2014-04-30; Completion date: 2016-10-19
Enrollment: 521 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate if the time to first pulmonary exacerbation of bronchiectasis or its frequency can be prolonged by inhalation of ciprofloxacin for 28 days every other 28 days or for 14 days every other 14 days over 48 weeks.

Detailed description:
Number of participants with Adverse events will be covered in Adverse Events section.

Arms: arm 1: Subjects received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles). arm 2: Subjects received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles). arm 3: Subjects received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 cycles). arm 4: Subjects received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 cycles).
Interventions: intervention 1: Ciprofloxacin (BAYQ3939) dry powder for inhalation intervention 2: Ciprofloxacin (BAYQ3939) dry powder for inhalation intervention 3: Placebo intervention 4: Placebo
Intervention descriptions: intervention 1: Ciprofloxacin dry powder for inhalation (DPI) 32.5 mg inhaled twice daily in cycles of 28 days on-treatment and 28 days off-treatment. intervention 2: Ciprofloxacin DPI 32.5 mg inhaled twice daily in cycles of 14 days on-treatment and 14 days off-treatment. intervention 3: Matching placebo inhaled twice daily intermittently for 28 days on / 28 days off intervention 4: Matching placebo inhaled twice daily intermittently for 14 days on / 14 days off

Protocol documents:
Clinical trial NCT02831569
Conditions: Pain
Sponsor: Boehringer Ingelheim
Start date: 2016-07-27; Completion date: 2016-10-19
Enrollment: 80 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, single-group, multi-centre trial to confirm the safety and efficacy of loxoprofen sodium/methocarbamol ( IP-TN) when administered orally for 2 weeks to patients with low back pain, scapulohumeral periarthritis, or cervico-omo-brachial syndrome associated with muscle strain. More than 90 patients will be screened to enroll approximately 80 patients in the trial.

After giving written informed consent, patients will be enrolled in the trial. Patients who are considered eligible for the trial by the Investigator after consent and complete the trial procedures and assessments at Visit 1 will receive the trial medication and enter the open-label treatment period of 2 weeks. Patients who complete the open-label treatment period will enter the follow-up period of 1 week and complete the trial after confirmation at the last visit (or phone interview).

Detailed description:

Arms: arm 1: fixed dose combination (FDC) tablets
Interventions: intervention 1: Loxoprofen sodium intervention 2: Methocarbamol
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02104947
Conditions: Hemorrhage
Sponsor: Boehringer Ingelheim
Start date: 2014-05-06; Completion date: 2016-10-20
Enrollment: 503 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Evaluate the reversal of the anticoagulant effects of dabigatran by IV administration of 5.0g idarucizumab in patients treated with dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures.

Detailed description:

Arms: arm 1: idarucizumab Only 1 treatment, no placebo or comparator
Interventions: intervention 1: idarucizumab
Intervention descriptions: intervention 1: idarucizumab

Protocol documents:
Clinical trial NCT02166047
Conditions: Chronic Hepatitis B
Keywords: Hepatitis B HBV GS-9620 TLR-7 Agonist
Sponsor: Gilead Sciences
Start date: 2014-06-30; Completion date: 2016-10-20
Enrollment: 162 participants; Allocation: RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of vesatolimod in participants with chronic hepatitis B (CHB) infection currently being treated with oral antivirals (OAV).

Participants will be randomized in 3 sequential cohorts (Cohorts A, B, and C). Within each cohort, participants will be randomized in a 1:3:3:3 ratio to placebo or one of the doses of vesatolimod (1, 2, or 4 mg).

Detailed description:

Arms: arm 1: Placebo tablet once a week for 4 weeks arm 2: Vesatolimod 1 mg tablet once a week for 4 weeks arm 3: Vesatolimod 2 mg tablet once a week for 4 weeks arm 4: Vesatolimod 4 mg tablet once a week for 4 weeks arm 5: Placebo tablet once a week for 8 weeks arm 6: Vesatolimod 1 mg tablet once a week for 8 weeks arm 7: Vesatolimod 2 mg tablet once a week for 8 weeks arm 8: Vesatolimod 4 mg tablet once a week for 8 weeks arm 9: Placebo tablet once a week for 12 weeks arm 10: Vesatolimod 1 mg tablet once a week for 12 weeks arm 11: Vesatolimod 2 mg tablet once a week for 12 weeks arm 12: Vesatolimod 4 mg tablet once a week for 12 weeks
Interventions: intervention 1: Vesatolimod intervention 2: Placebo
Intervention descriptions: intervention 1: Vesatolimod tablet administered orally intervention 2: Placebo to match vesatolimod tablet administered orally

Protocol documents:
Clinical trial NCT02476890
Conditions: Refractory Chronic Cough
Sponsor: Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Start date: 2015-10-28; Completion date: 2016-10-20
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective of this study was to assess the effect of a single dose of gefapixant 100 mg on cough reflex sensitivity to various challenge agents (capsaicin, citric acid, adenosine triphosphate \[ATP\], and distilled water) in healthy and chronic cough participants.

Detailed description:
The study had a Screening period to determine participant inclusion, two Baseline Visits, and two treatment periods with a minimum 48-hour washout between the treatment periods. At Baseline and during each treatment period, cough sensitivity was measured by standard clinical methodology incorporating four cough challenges. Daytime cough monitoring was performed at Baseline and during each of the two treatment periods (chronic cough participants only).

Arms: arm 1: Healthy participants in Sequence A received a single dose of placebo in treatment Period 1 then a single dose of gefapixant 100 mg in treatment Period 2. There was a minimum 48-hr washout between Periods 1 \& 2. arm 2: Healthy participants in Sequence B received a single dose of gefapixant 100 mg in treatment Period 1 then a single dose of placebo in treatment Period 2. There was a minimum 48-hr washout between Periods 1 \& 2. arm 3: Chronic Cough participants in Sequence A received a single dose of placebo in treatment Period 1 then a single dose of gefapixant 100 mg in treatment Period 2. There was a minimum 48-hr washout between Periods 1 \& 2. arm 4: Chronic Cough participants in Sequence B received a single dose of gefapixant 100 mg in treatment Period 1 then a single dose of placebo in treatment Period 2. There was a minimum 48-hr washout between Periods 1 \& 2.
Interventions: intervention 1: Gefapixant 100 mg intervention 2: Placebo
Intervention descriptions: intervention 1: Gefapixant 100 mg (2 x 50 mg tablets), administered orally as a single dose in treatment Period 1 or treatment Period 2 intervention 2: Placebo (two tablets matching gefapixant 50 mg), administered orally as a single dose in treatment Period 1 or treatment Period 2

Protocol documents:
Clinical trial NCT02619409
Conditions: Arthropathy of Hip Arthropathy of Knee
Sponsor: Medical University of South Carolina
Start date: 2016-02-11; Completion date: 2016-10-20
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Bupivacaine spinal is commonly performed as the primary anesthetic for orthopedic procedures. In some cases the duration of the block is inadequate. An epinephrine wash is sometimes performed to prolong the duration of the block. The epinephrine wash may prolong the duration of the block, and if it does, to what extent?

Detailed description:

Arms: arm 1: The bupivacaine only group will receive bupivacaine 0.5% 3cc plus sterile saline 0.1cc. arm 2: The EPI25 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.025cc, and sterile saline 0.075cc. arm 3: The EPI50 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.05cc, and sterile saline 0.05cc. arm 4: The EPI75 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.075 cc, and sterile saline 0.025%. arm 5: The EPI100 group will receive bupivacaine 0.5% 3cc, and epinephrine 1:1000 0.1cc
Interventions: intervention 1: Bupivacaine Only intervention 2: EPI25 intervention 3: EPI50 group intervention 4: EPI75 group intervention 5: EPI100 group
Intervention descriptions: intervention 1: The bupivacaine only group will receive bupivacaine 0.5% 3cc plus sterile saline 0.1cc. intervention 2: The EPI25 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.025cc, and sterile saline 0.075cc. intervention 3: The EPI50 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.05cc, and sterile saline 0.05cc intervention 4: The EPI75 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.075cc, and sterile saline 0.025%. intervention 5: The EPI100 group will receive bupivacaine 0.5% 3cc, and epinephrine 1:1000 0.1cc.

Protocol documents:
Clinical trial NCT02645617
Conditions: Dental Caries
Sponsor: Advantage Dental Services, LLC
Start date: 2016-03-30; Completion date: 2016-10-20
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to confirm the safety of Advantage Anti-Caries Varnish.

Detailed description:
This is an open-label Phase 1 study. The active ingredients are Povidone Iodine and Sodium Fluoride \[Therametrics Technologies, Inc, Noblesville, IN, USA\]. The oral soft tissues and teeth of the children will be examined and the test varnish to the teeth. The child will be re-examined at 24-48 hours for the presence of adverse oral soft tissue changes. At the follow-up, a qualified dental provider will ask questions focused on adverse events.

Arms: arm 1: Dental varnish containing povidone iodine and sodium fluoride
Interventions: intervention 1: Varnish
Intervention descriptions: intervention 1: Topical application to the teeth

Protocol documents:
Clinical trial NCT02785770
Conditions: Healthy
Sponsor: Pfizer
Start date: 2016-06-29; Completion date: 2016-10-20
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a study designed to ascertain the effect of PF-04447943 on QT interval in healthy adult subjects. This is conducted as part of standard drug development.

Detailed description:

Arms: arm 1: 25 mg of PF-04447943 arm 2: 100 mg of PF-04447943 arm 3: Matching placebo for PF-04447943 arm 4: 400 mg of moxifloxacin
Interventions: intervention 1: PF-04447943 intervention 2: Placebo intervention 3: Moxifloxacin
Intervention descriptions: intervention 1: Single oral dose of PF-04447943 administered as an extemporaneously prepared solution intervention 2: Single oral dose of matching placebo for PF-04447943 administered as an extemporaneously prepared solution intervention 3: Single oral dose of moxifloxacin administered as tablet

Protocol documents:
Clinical trial NCT02259010
Conditions: Advanced Solid Tumors Relapsed/Refractory Lymphoma
Sponsor: Millennium Pharmaceuticals, Inc.
Start date: 2014-10-22; Completion date: 2016-10-21
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will assess the effect of multi-dose administration of itraconazole on the single-dose pharmacokinetics (PK) of alisertib.

Detailed description:
The drug being tested in this study is called alisertib. Alisertib is being tested in adult participants with advanced solid tumors or relapsed refactory lymphoma. The study will look at the effect of the pharmacokinetics (how the drug moves through the body) of alisertib in the presence and absence of itraconazole.

This is an open label study. Participants will receive:

* Alisertib tablets 30 mg in Part A and 50 mg in Part B
* Itraconazole oral solution 200 mg in Part A

Participation in Part A is approximately 25 days. Part B participation is repeating 21-day cycles. The maximum duration of treatment with alisertib will be 12 months (approximately 16 cycles) unless it is determined by the investigator, with agreement by the sponsor, that a participant would derive clinical benefit from continued treatment beyond 12 months.

This multi-center study will take place in the United States.

Arms: arm 1: All participants were to complete Part A prior to Part B. Part A: Alisertib 30 mg, tablets, orally, on Days 1 and 10 plus itraconazole, 200 mg, oral solution, once daily on Days 5 to 13. Part A and B were separated by a washout period of at least 10 days (and up to 4 weeks). Part B: Alisertib 50 mg, tablets, orally, twice daily, for 7 days in 21-day cycles until disease progression or unacceptable toxicity (up to 16 cycles).
Interventions: intervention 1: Alisertib intervention 2: Itraconazole
Intervention descriptions: intervention 1: Alisertib tablets intervention 2: Itraconazole oral solution

Protocol documents:
Clinical trial NCT01027143
Conditions: Asthma Obesity
Keywords: Asthma Obesity Pharmacogenetics Nutrigenetics
Sponsor: Nemours Children's Clinic
Start date: 2010-07-01; Completion date: 2016-10-22
Enrollment: 143 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This project will assess the effectiveness of omega-3 fatty acid supplementation in controlling asthma symptoms among obese asthmatics, and will assess if a person's genes influence response to treatment (personalized medicine). This project may improve our ability to treat asthma and our understanding of the link between obesity and asthma.

Detailed description:
Obesity increases the risk for asthma diagnosis in children and adults. With obesity on the rise, a better understanding of this association may become critically important to public health. We will determine the impact of fish oil-derived Eicosapentaenoic acid (EPA) and Docosahexaenoic acid (DHA) on asthma control among obese asthmatics. These omega-3 fatty acids have been shown to: reduce inflammation important to asthma and improve asthma outcomes in an inconsistent manner across previous smaller studies - results that are consistent with a pharmacogenetic influence. There exists evidence that omega-3 fatty acid response displays a pharmacogenetic response related to ALOX5 genotype. Preliminary data suggests that obese individuals are at greater risk for possessing this same ALOX5 variant and thus obese asthmatics may be more responsive to fish oil. We will determine (in a sub-aim) if there exists an ALOX5 genotype-related response effect with fish oil. This will be the largest clinical trial of omega-3 fatty acid for the treatment of asthma, and the first applying pharmacogenetic/nutrigenetic analysis.

Arms: arm 1: 3 softgels (EPA, DHA) twice daily arm 2: Soybean oil: 3 matched softgel caps twice daily
Interventions: intervention 1: omega-3 polyunsaturated fatty acids intervention 2: Omega-3 Fatty Acid
Intervention descriptions: intervention 1: ProEPA Xtra 1000mg softgels: 3 softgels twice daily intervention 2: Soybean oil: 3(age 12-25) matched softgel caps twice daily

Protocol documents:
Clinical trial NCT01555125
Conditions: Moderate to Severe Plaque-type Psoriasis
Keywords: Psoriasis
Sponsor: Novartis Pharmaceuticals
Start date: 2012-05-08; Completion date: 2016-10-24
Enrollment: 177 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to demonstrate efficacy of secukinumab at Week 12 based on PASI and IGA response rates versus placebo in subjects with moderate to severe chronic plaque-type psoriasis.

Detailed description:

Arms: arm 1: Drug arm 2: Drug arm 3: None
Interventions: intervention 1: secukinumab 150 mg intervention 2: secukinumab 300 mg intervention 3: placebo
Intervention descriptions: intervention 1: After the data base lock of week 52 data has been performed, subjects will receive secukinumab 150 mg treatment as open label for the remainder of the extension treatment period intervention 2: After the data base lock of week 52 data has been performed, subjects will receive secukinumab 300 mg treatment as open label for the remainder of the extension treatment period intervention 3: Subjects who were on placebo at Week 52 cannot continue in the extension treatment period

Protocol documents:
Clinical trial NCT01693068
Conditions: N-Ras Mutated Locally Advanced or Metastasis Malignant Cutaneous Melanoma
Keywords: Cutaneous Melanoma Dacarbazine Pimasertib N-Ras
Sponsor: EMD Serono
Start date: 2012-12-05; Completion date: 2016-10-24
Enrollment: 194 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 2, multicenter, randomized, controlled, open-label trial of pimasertib versus dacarbazine aimed to confirm the activity of pimasertib in previously untreated subjects with N-Ras mutated locally advanced or metastatic malignant cutaneous melanoma by comparing the progression-free survival (PFS) of subjects treated with either pimasertib or dacarbazine and by getting a better understanding of the efficacy, safety, pharmacogenomics (PGx) and their relationship with pimasertib exposure.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Pimasertib intervention 2: Dacarbazine
Intervention descriptions: intervention 1: Subjects will receive pimasertib orally as monotherapy at a dose of 60 milligram (mg) twice daily continuously. Treatment will consist of repeated 21-day cycles which will continue until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurs first. intervention 2: Subjects will receive dacarbazine intravenously at dose of 1000 milligram per square meter (mg/m\^2) of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurs first. Eligible subjects with documented tumor progression on dacarbazine will offer to switch to pimasertib treatment.

Protocol documents: