ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02507388
Conditions: Neovascular Age-Related Macular Degeneration
Keywords: AMD nAMD wetAMD Age-Related Macular Degeneration
Sponsor: Alcon Research
Start date: 2015-08-24; Completion date: 2016-09-06
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the systemic pharmacokinetics (PK) and safety of 2 different doses of brolucizumab (3 milligrams (mg)/50 microliters (μL) and 6 mg/50 μL) when administered at 4-week intervals for a total of 3 intravitreal injections in subjects with neovascular age-related macular degeneration (AMD).

Detailed description:
This study has 2 arms with a 1:1 randomization. Randomization will be stratified by Japanese ethnicity. Half of the subjects in each arm will be of Japanese ethnicity. The other half of the subjects in each arm will be non-Japanese. Subjects in both arms will have visits at Screening, Day 0 (Baseline), Day 1 (24 hours post first injection), Day 3, Day 14, Day 21, Day 28, Day 56, Day 57 (24 hours post the injection on Day 56) and Day 84.

Arms: arm 1: Brolucizumab 3 mg/50 μL administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection arm 2: Brolucizumab 6 mg/50 μL administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection
Interventions: intervention 1: Brolucizumab 3 mg/50 μL intervention 2: Brolucizumab 6 mg/50 μL
Intervention descriptions: intervention 1: Administered as an intravitreal injection intervention 2: Administered as an intravitreal injection

Protocol documents:
Clinical trial NCT02551731
Conditions: Spasms, Infantile
Sponsor: INSYS Therapeutics Inc
Start date: 2016-01-27; Completion date: 2016-09-06
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Infantile Spasms (IS) is a diagnosis described as a fairly rare and terrible form of epilepsy that usually strikes children in the first year of life. There is a great need for safe and effective therapies in the treatment of IS. This need is even more important for infants and toddlers still sick after being treated with medicine that is already available.

This is a multi-center study to evaluate the efficacy and safety of Cannabidiol Oral Solution (CBD) in the treatment of children aged 6 months through 36 months with a diagnosis of infantile spasms who have not responded to first line therapies.

The overall study duration is expected to be 64 weeks for those subjects who respond to CBD treatment. The maximum possible study duration for each patient is approximately 64 weeks, however a subject will be deemed to have completed the study after 58 weeks.

Detailed description:
A protocol amendment in May 2016 created two parts to this trial: Part A (the extended treatment period) and Part B (the safety treatment period), whose objectives are as follows:

Primary Part A: To evaluate the efficacy of Cannabidiol Oral Solution in treating refractory infantile spasms (IS).

Secondary:

Part A:

* To evaluate the safety of Cannabidiol Oral Solution in treating refractory infantile spasms.

Part B:

* To assess the long-term safety of Cannabidiol Oral Solution as an adjunctive treatment for subjects with Infantile Spasms (IS)
* To establish the continued efficacy of Cannabidiol Oral Solution in maintaining seizure control in subjects with IS
* To assess the global status of subjects taking Cannabidiol Oral Solution for an extended period of time determined by various qualitative assessments
* To monitor for changes in plasma levels of Cannabidiol Oral Solution during long-term treatment of subjects with IS

Arms: arm 1: The dose of Cannabidiol Oral Solution will begin at 20 mg/kg/day \[10 mg/kg twice per day (BID)\], will be adjusted at any time if the investigator feels the safety or well-being of the participant is at risk, and will be titrated up or down according to protocol-stipulated parameters and at the investigator's discretion after Day 14 to enhance efficacy. Dose will not exceed 40 mg/kg/day.
Interventions: intervention 1: Cannabidiol Oral Solution
Intervention descriptions: intervention 1: 20 or 40 mg/kg/day BID

Protocol documents:
Clinical trial NCT03825939
Conditions: Blood Loss
Keywords: Total hip arthroplasty Total knee arthroplasty
Sponsor: NYU Langone Health
Start date: 2015-04-21; Completion date: 2016-09-06
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This research study aims to study the use of tranexamic acid (TXA) in total joint replacement (arthroplasty) of the hip (THR) and knee (TKR).

Detailed description:
Tranexamic Acid (TXA) is given to stop or reduce heavy bleeding. It works by stopping clots from breaking down and by decreasing unwanted bleeding. It is used in many types of surgeries to help reduce surgical complications such as blood loss and blood transfusions.

In orthopaedic surgeries, such as in total hip and knee replacements, TXA has been shown to effectively reduce blood loss and transfusion requirements without an increased risk of side effects such as deep venous thrombosis (DVT) or pulmonary embolism (PE). The ability to decrease blood loss is crucial, as other studies have shown that reducing blood loss decreases morbidity and mortality in patients.

Although, many TXA dosing regimens have been studied - all of which have been useful at reducing blood loss and decreasing transfusion requirements - the best TXA dosing regimen and the most cost-effective method of TXA administration for patients have yet to be determined. Moreover, a thorough and rigorous study on the use and effects of topical and intravenous TXA and the effect of TXA on patient outcomes has yet to be conducted.

Therefore, this research study aims to address those concerns in order to understand how best to use TXA to reduce surgical complications in patients undergoing total joint replacements.

Arms: arm 1: * 1g TXA administered intravenous piggyback at start of surgery OR
* 1g TXA administered intravenous piggyback at start and at time of closure of surgery arm 2: \- IV 0.9% sterile saline arm 3: * 1g TXA administered intravenous piggyback at start of surgery OR
* 1g TXA administered intravenous piggyback at start and at time of closure of surgery
* IV 0.9% sterile saline
Interventions: intervention 1: Intravenous Placebo intervention 2: Intravenous Tranexamic Acid
Intervention descriptions: intervention 1: IV 0.9% sterile saline intervention 2: 1g TXA IVPB (intravenous piggyback)

Protocol documents:
Clinical trial NCT02668783
Conditions: Moderate to Severe Primary Dysmenorrhea
Sponsor: Organon and Co
Start date: 2016-02-11; Completion date: 2016-09-07
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the etonogestrel (ENG) + 17β-estradiol (E2) vaginal ring's efficacy compared to a placebo vaginal ring in the treatment of dysmenorrhea at Treatment Cycle 2. In addition, this study will assess the safety and tolerability of the ENG-E2 vaginal rings. Primary hypothesis: Relative to the placebo ring, the ENG-E2 vaginal ring results in a greater proportion of participants with a ≥3 point reduction in peak pelvic pain score and no increase in the number of rescue pain relief (ibuprofen) tablets taken at Treatment Cycle 2 as compared to baseline.

Detailed description:

Arms: arm 1: Participants will receive 4 cycles (or 6 cycles if also participating in the extension) of ENG-E2 125 μg/300 μg. Each cycle will consist of 21 days of vaginal ring use followed by 7 ring-free days. arm 2: Participants will receive 4 cycles (or 6 cycles if also participating in the extension) of placebo. Each cycle will consist of 21 days of placebo vaginal ring use followed by 7 ring-free days.
Interventions: intervention 1: Etonogestrel (ENG) 125 μg + 17β-estradiol (E2) 300 μg vaginal ring intervention 2: Placebo vaginal ring intervention 3: Ibuprofen
Intervention descriptions: intervention 1: Up to 4 cycles (or 6 cycles if also participating in the extension) of ENG-E2 125 μg/300 μg administered intravaginally. Each cycle will consist of 21 days of vaginal ring use followed by 7 ring-free days. intervention 2: Up to 4 cycles (or 6 cycles if also participating in the extension) of placebo administered intravaginally. Each cycle will consist of 21 days of placebo vaginal ring use followed by 7 ring-free days. intervention 3: Ibuprofen tablets, to be taken orally, will be provided for use as rescue medication for dysmenorrhea treatment throughout the study. Participants may take 400 mg every 4 hours as needed for pelvic pain/cramping, or as instructed by their physician according to local labeling for relief of menstrual pain.

Protocol documents:
Clinical trial NCT02045862
Conditions: Urinary Bladder Overactive Overactive Bladder Urgency Incontinence Urinary Bladder Diseases\Urologic Diseases
Keywords: Solifenacin Succinate Mirabegron Urinary Incontinence Combination Therapy Urgency Nocturia Overactive Bladder
Sponsor: Astellas Pharma Europe B.V.
Start date: 2014-03-17; Completion date: 2016-09-08
Enrollment: 1829 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to examine how well the combination of two medicines (solifenacin succinate and mirabegron) worked compared to each medicine alone in the treatment of bladder problems, and how safe they were for long term use.

Detailed description:

Arms: arm 1: Participants received mirabegron 50 mg once a day for 52 weeks. arm 2: Participants received solifenacin 5 mg once a day for 52 weeks. arm 3: Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Interventions: intervention 1: Solifenacin succinate intervention 2: Mirabegron intervention 3: Placebo to match solifenacin intervention 4: Placebo to match mirabegron
Intervention descriptions: intervention 1: Participants received solifenacin 5 mg orally once a day at the same time each day. intervention 2: Participants received mirabegron 50 mg orally once a day at the same time each day. intervention 3: Participants received placebo to match solifenacin 5 mg orally once a day at the same time each day. This intervention was given to maintain the blind during the study. intervention 4: Participants received placebo to match mirabegron 50 mg orally once a day at the same time each day. This intervention was given to maintain the blind during the study.

Protocol documents:
Clinical trial NCT02110147
Conditions: Hereditary Orotic Aciduria
Sponsor: Wellstat Therapeutics
Start date: 2014-04-01; Completion date: 2016-09-08
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This protocol has two parts - the Main Study which is 42 days in length and the Treatment Extension which allows the patients who complete the Main Study to continue receiving treatment with uridine triacetate. The purpose of this study is to replace oral administration of uridine with oral administration of uridine triacetate in patients with hereditary orotic aciduria who have received (or would reasonably be expected to receive) clinical benefit from treatment with exogenous uridine. It is also to document the continued clinical benefit of exogenous uridine when patients are switched from oral administration of uridine to oral administration of uridine triacetate.

Detailed description:
Data to be collected during the Main Study include demographic, baseline disease information and medical history including all prior disease-directed therapy. In addition, vital signs, laboratory values and adverse events information will be collected and recorded. Urine samples will be obtained and measured for orotic acid and orotidine levels. Systemic levels of uridine will be evaluated from plasma samples collected at set timepoints.

Upon successful completion of the Main Study and entry into the Treatment Extension, physical exams and vital signs will be performed every six (6) months. Additionally, plasma samples to measure systemic levels of uridine and urine samples to measure levels of orotic acid and orotidine will be collected every (6) six months.

Arms: arm 1: Replacement therapy for oral uridine with oral administration of uridine triacetate in patients with hereditary orotic aciduria who have received (or would reasonably be expected to receive) clinical benefit from treatment with exogenous uridine. The starting dose of uridine triacetate will be 60 mg/kg/day which may be escalated to 300 mg/kg/day of oral uridine triacetate. The dose may be given once a day or as equally divided doses twice a day.
Interventions: intervention 1: uridine triacetate
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02330549
Conditions: Prediabetic State Non-alcoholic Fatty Liver Disease Type 2 Diabetes Mellitus
Sponsor: Tobira Therapeutics, Inc.
Start date: 2015-07-17; Completion date: 2016-09-08
Enrollment: 45 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A Phase 2a, randomized, double-blind, placebo-controlled, multi-center study of cenicriviroc (CVC) to be conducted in approximately 50 adult obese subjects \[body mass index (BMI) ≥ 30 kg/m\^2\] with prediabetes or type 2 diabetes mellitus and suspected NALFD.

Detailed description:
Approximately 50 adult obese subjects (BMI ≥ 30 kg/m2) with prediabetes or type 2 diabetes mellitus and suspected NALFD will be randomized into the study.

Eligible subjects will receive either CVC (n=25) or matching placebo (n=25), once daily (QD) for 24 weeks, followed by a safety follow-up visit 4 weeks after last intake of study medication.

Arms: arm 1: Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks. arm 2: Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
Interventions: intervention 1: Cenicriviroc 150 mg intervention 2: Placebo
Intervention descriptions: intervention 1: Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food. intervention 2: Placebo-matching CVC administered orally once daily and taken every morning with food.

Protocol documents:
Clinical trial NCT02553772
Conditions: Dry Eye Syndromes
Sponsor: Allergan
Start date: 2016-01-06; Completion date: 2016-09-09
Enrollment: 242 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of a new eye drop formulation in patients with dry eye disease.

Detailed description:

Arms: arm 1: Carboxymethylcellulose based eye drop \[Omega-3 (OM3) Tear\] administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days. arm 2: Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
Interventions: intervention 1: Carboxymethylcellulose Based Eye Drop intervention 2: Carboxymethylcellulose Sodium 0.5%
Intervention descriptions: intervention 1: Carboxymethylcellulose based eye drop (OM3 Tear) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days. intervention 2: Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.

Protocol documents:
Clinical trial NCT02655679
Conditions: Dermatitis, Atopic
Keywords: Eczema
Sponsor: Vitae Pharmaceuticals, Inc.
Start date: 2015-12-15; Completion date: 2016-09-09
Enrollment: 104 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary clinical efficacy of VTP-38543 administered as a cream, twice-daily, for 28 days in otherwise healthy adult male and female participants with mild to moderate atopic dermatitis.

Detailed description:
This is a randomized, double-blind, vehicle-controlled study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary clinical efficacy of VTP-38543 following twice-daily, every twelve hours (Q12h) administration for 28 days in otherwise healthy adult male and female participants with mild to moderate atopic dermatitis.

Evaluation of three ascending doses in three dose panels is planned for this trial. Dose Panel 1 (VTP-38543 0.05%) and Panel 2 (VTP-38543 0.15%) will each enroll 30 participants and randomize 20 to VTP-38543 and 10 to matching vehicle control (Vehicle without Transcutol®P). Dose Panel 3 (VTP-38543 1%) will enroll 40 participants and randomize 20 to VTP-38543 and 20 to matching vehicle control (Vehicle with Transcutol®P). A total of approximately 100 participants will participate in the trial.

Arms: arm 1: VTP-38543 0.05% administered topically every 12 hours for 28 days. arm 2: VTP-38543 0.15% administered topically every 12 hours for 28 days. arm 3: Vehicle without Transcutol®P administered topically every 12 hours for 28 days. arm 4: VTP-38543 1% administered topically every 12 hours for 28 days. arm 5: Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
Interventions: intervention 1: VTP-38543 intervention 2: Vehicle with Transcutol®P intervention 3: Vehicle without Transcutol®P
Intervention descriptions: intervention 1: VTP-38543 topical cream intervention 2: Vehicle matching VTP-38543 cream with Transcutol®P intervention 3: Vehicle matching VTP-38543 cream without Transcutol®P

Protocol documents:
Clinical trial NCT02780700
Conditions: Colorectal Neoplasms
Sponsor: Boehringer Ingelheim
Start date: 2016-07-05; Completion date: 2016-09-09
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this Phase II study is to assess the efficacy and safety of nintedanib alone or in combination with capecitabine for patients with refractory metastatic colorectal cancer (mCRC) after failure of at least 2 lines of standard treatment

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Nintedanib intervention 2: Capecitabine
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02792517
Conditions: Headache, Migraine
Sponsor: Amgen
Start date: 2016-02-12; Completion date: 2016-09-09
Enrollment: 41 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A pharmacokinetic drug interaction study of erenumab and an oral contraceptive containing progestin and estrogen.

Detailed description:
A pharmacokinetic (PK) drug interaction study of erenumab and an oral contraceptive containing progestin and estrogen. All participants will receive an oral contraceptive containing progestin and estrogen throughout the duration of the study. Participants will also receive a single dose of erenumab, administered by a healthcare provider in cycle 3. Serial PK samples will be collected at specified time points to characterize the PK of the oral contraceptive progestin and estrogen components with and without the presence of erenumab.

The study consists of three 28-day cycles and a follow-up period. The first 28 day cycle is an acclimation period when participants initiate oral contraception (Cycle 1). During Cycle 2 and 3 the PK of ethinyl estradiol (EE) and active metabolites of norgestimate (ie, norelgestromin \[NGMN\] and norgestrel \[NG\]) will be characterized following the last active dose of oral contraceptive in each cycle (cycle day 21). Erenumab will be given in cycle 3 (cycle day 10); 24-hour PK characterization of norgestimate and EE metabolites will occur 11 days after administration of erenumab, which will maximize the potential for detecting a drug-drug interaction.

Arms: arm 1: Participants received a combination oral contraceptive for 3 28-day cycles during the study.

A single 140 mg dose of erenumab was administered subcutaneously to the abdomen on day 10 of cycle 3 by a healthcare provider.
Interventions: intervention 1: Erenumab intervention 2: Ethynil Estradiol/Norgestimate Oral Contraceptive
Intervention descriptions: intervention 1: A single dose of erenumab administered in the abdomen. intervention 2: Ethynil estradiol (EE)/norgestimate combination oral contraceptive is a 28-tablet cycle in which 1 oral tablet is taken daily; each containing 0.250 mg norgestimate and 0.035 mg EE for 21 days, after which a tablet only containing inert ingredients is taken for last 7 days of the 28 day cycle.

Protocol documents:
Clinical trial NCT02234687
Conditions: Post-traumatic Stress Disorder
Keywords: post-traumatic stress disorder
Sponsor: NYU Langone Health
Start date: 2014-09-01; Completion date: 2016-09-11
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In this study, we propose to employ a randomized, double-blind, placebo-controlled, outpatient clinical trial to test the efficacy, safety, and tolerability of a 160 mg and 40 mg challenge of the mGlu2/3 agonist pomaglumetad methionil relative to placebo in modulating fear-potentiated startle response and behavior in adults with post-traumatic stress disorder (PTSD) (N=30). Each participant will receive a single dose of the study drug (40 mg vs 160 mg vs placebo in a 1:1:1 ratio).

Detailed description:

Arms: arm 1: Placebo, one dose arm 2: Pomaglumetad Methionil 40mg, one dose, one time arm 3: Pomaglumetad Methionil 160mg, one dose, one time
Interventions: intervention 1: Pomaglumetad Methionil 160mg intervention 2: Pomaglumetad Methionil 40mg intervention 3: Placebo
Intervention descriptions: intervention 1: Pomaglumetad Methionil 160mg, one dose, one time intervention 2: Pomaglumetad Methionil 40mg, one dose, one time intervention 3: Placebo, one dose, one time

Protocol documents:
Clinical trial NCT01345669
Conditions: Head and Neck Neoplasms
Sponsor: Boehringer Ingelheim
Start date: 2011-10-17; Completion date: 2016-09-12
Enrollment: 617 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomised, double-blind phase III trial will be performed in patients with head and neck squamous cell carcinoma (HNSCC). The objectives of the trial are to compare the efficacy and safety of afatinib (BIBW 2992) with placebo as adjuvant therapy to patients who have received definitive chemo-radiotherapy.

Detailed description:

Arms: arm 1: Once daily arm 2: Once daily
Interventions: intervention 1: Placebo intervention 2: Afatinib
Intervention descriptions: intervention 1: Once daily intervention 2: Once daily

Protocol documents:
Clinical trial NCT01865812
Conditions: Primary Biliary Cirrhosis
Sponsor: Intercept Pharmaceuticals
Start date: 2013-12-03; Completion date: 2016-09-12
Enrollment: 27 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to determine if OCA had an effect on cholesterol levels in the blood in participants with primary biliary cirrhosis (PBC).

Detailed description:
This was a phase 2, open-label, multicenter study evaluating the effects of OCA on lipoprotein metabolism in participants with PBC; in particular, OCA's effects on high-density lipoprotein cholesterol. Nuclear magnetic resonance spectroscopy was utilized to quantify the changes in lipoprotein particle sizes and concentrations. Components of reverse cholesterol transport were also assessed.

Arms: arm 1: Obeticholic acid, oral administration, 10 milligrams (mg), 8 weeks
Interventions: intervention 1: Obeticholic Acid
Intervention descriptions: intervention 1: All participants were treated with OCA (oral administration, 10 mg, once daily \[QD\]) for 8 weeks and continued their prestudy dose of ursodeoxycholic acid (UDCA). After completion of the 8-week Primary Treatment Phase of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter an open-label, long-term safety extension phase, during which they could receive 10 mg OCA QD for up to 2 years.

Protocol documents: