ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01996839
Conditions: Inflammation Pain Cataract
Sponsor: Bausch & Lomb Incorporated
Start date: 2013-12-01; Completion date: 2014-07-01
Enrollment: 514 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate ophthalmic gel

Detailed description:
The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate ophthalmic gel, 0.38% (BID and TID) for the treatment of postoperative inflammation and pain following cataract surgery.

Arms: arm 1: Loteprednol Etabonate Gel 0.38% administered two times daily (BID). arm 2: Vehicle of Loteprednol Etabonate Gel 0.38% administered two times daily (BID). arm 3: Loteprednol Gel 0.38% administered three times daily (TID). arm 4: Vehicle of Loteprednol Etabonate Gel 0.38% administered three times daily (TID).
Interventions: intervention 1: Loteprednol Etabonate Gel (BID) intervention 2: Loteprednol Etabonate Gel (TID) intervention 3: Vehicle (BID) intervention 4: Vehicle (TID)
Intervention descriptions: intervention 1: One drop of LE gel instilled into the study eye two times per day (BID) for 14 days intervention 2: One drop of LE gel instilled into the study eye three times per day (TID) for 14 days. intervention 3: One drop of vehicle instilled into the study eye two times per day (BID) for 14 days intervention 4: One drop of vehicle instilled into the study eye three times per day (TID) for 14 days

Protocol documents:
Clinical trial NCT01998984
Conditions: Actinic Keratosis
Sponsor: LEO Pharma
Start date: 2014-01-01; Completion date: 2014-07-01
Enrollment: 266 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomised, double-blind, parallel groups, vehicle controlled, 8-week phase 2 trial. The objective is to evaluate efficacy of ingenol mebutate gel 0.06 % after once daily treatment for 2, 3 or 4 consecutive days compared to vehicle gel

Detailed description:

Arms: arm 1: Placebo and drug arm 2: Placebo and drug arm 3: Placebo arm 4: Drug
Interventions: intervention 1: ingenol mebutate intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02005211
Conditions: Healthy Japanese Young and Elderly Male and Non-fertile Female Volunteers
Keywords: AZD3293 Healthy volunteers Young volunteers Elderly volunteers Japanese volunteers Phase 1 Single and multiple ascending dose study
Sponsor: AstraZeneca
Start date: 2013-12-01; Completion date: 2014-07-01
Enrollment: 114 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study consists of two parts, ie, single dose part with young healthy subjects (Part 1) and single and multiple dose part with elderly healthy subjects (Part 2), to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD3293 following single and multiple ascending dose administration to healthy subjects.

Detailed description:
This is a Phase I, randomised, double-blind, placebo-controlled, single centre study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD3293 following single and multiple ascending dose administration to healthy subjects. This study consists of two parts, ie, single dose part with young healthy subjects (Part 1) and single and multiple dose part with elderly healthy subjects (Part 2). The study design allows a gradual escalation of dosage levels between sequential cohorts with safety monitoring to ensure the safety of the healthy subjects.

Arms: arm 1: AZD3293 will be administered as single dose of an oral solution in Part 1 and single and multiple doses of an oral solution in Part 2. The ascending doses are planned to be 15, 50 and 150 mg for young subjects in Part 1 and 15 and 50 mg for elderly subjects in Part 2. Before proceeding to next dose level, safety, tolerability and pharmacokinetic data from the previous cohort(s) will be evaluated by a Safety Review Committee. Part 2 will start after confirming safety and tolerability in Part 1. arm 2: Placebo given (2 subjects in each cohort)
Interventions: intervention 1: AZD3293 intervention 2: Placebo
Intervention descriptions: intervention 1: Oral solution intervention 2: Oral solution

Protocol documents:
Clinical trial NCT02024529
Conditions: Osteoarthritis of the Knee
Keywords: Osteoarthritis osteoarthritis of the knee
Sponsor: Ampio Pharmaceuticals. Inc.
Start date: 2014-01-01; Completion date: 2014-07-01
Enrollment: 538 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy of an Intra-Articular Injection of Ampion™ in Adults with pain due to osteoarthritis of the knee.

Detailed description:
A Randomized, Placebo-controlled, Double-Blind Study to Evaluate the Efficacy and Safety of an Intra-Articular Injection of Ampion™ in Adults with pain due to osteoarthritis of the knee.

The primary study objective was to evaluate the efficacy of 4 mL Ampion versus 4 mL saline intra-articular (IA) injection in treating knee pain when administered to subjects suffering from osteoarthritis (OA) of the knee (OAK).

The secondary study objectives included evaluation of the safety of an IA injection of Ampion vs saline, efficacy of IA injection of Ampion vs saline in improving knee function.

Arms: arm 1: 4 mL injection of Ampion arm 2: 4 mL injection of placebo
Interventions: intervention 1: 4 mL injection of Ampion intervention 2: 4 mL Injection of Placebo
Intervention descriptions: intervention 1: 4 mL injection of Ampion intervention 2: 4 mL Injection of Placebo

Protocol documents:
Clinical trial NCT02028065
Conditions: Hypersensitivity Anaphylaxis
Keywords: reversal of neuromuscular blockade
Sponsor: Merck Sharp & Dohme LLC
Start date: 2014-01-03; Completion date: 2014-07-01
Enrollment: 382 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the potential for hypersensitivity symptoms upon repeat exposure to sugammadex. Healthy participants will be randomized to one of three treatment arms: sugammadex 4 mg/kg, sugammadex 16 mg/kg or placebo. Participants will receive 3 single intravenous (IV) doses of their randomized treatment, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3. Participants will be confined at the study center from the day before each dose until completion of the 24-hour post dose assessments.

Detailed description:

Arms: arm 1: Administration of 3 single IV doses of sugammadex 4 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3 arm 2: Administration of 3 single IV doses of sugammadex 16 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3 arm 3: Administration of 3 single IV doses of placebo, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
Interventions: intervention 1: Sugammadex intervention 2: Placebo
Intervention descriptions: intervention 1: Sugammadex 4 mg/kg or 16 mg/kg administered as a single IV bolus over 10 seconds intervention 2: Placebo administered as a single IV bolus over 10 seconds

Protocol documents:
Clinical trial NCT02054702
Conditions: Schizophrenia
Keywords: Schizophrenia Mental Disorders Psychotic Disorders Antipsychotic Cognitive testing
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2014-02-01; Completion date: 2014-07-01
Enrollment: 97 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to explore changes in efficacy, cognitive functioning, and safety of flexibly-dosed Brexpiprazole monotherapy in subjects with acute schizophrenia

Detailed description:

Arms: arm 1: Treatment (6 weeks) Up to 4 mg/day, once daily dose, tablets, orally arm 2: Aripiprazole - Up to 20 mg/day, once daily dose, tablets, orally
Interventions: intervention 1: Brexpiprazole intervention 2: Aripiprazole
Intervention descriptions: intervention 1: Treatment (6 weeks) Up to 4 mg/day, once daily dose, tablets, orally intervention 2: Up to 20 mg/day, once daily dose, tablets, orally

Protocol documents:
Clinical trial NCT02058537
Conditions: Eosinophilic Esophagitis (EoE)
Sponsor: University of Iowa
Start date: 2014-02-01; Completion date: 2014-07-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary goals of this study are to ease the symptoms of patients with Eosinophilic Esophagitis (EoE) and to test the effectiveness of the drug bethanechol in relieving those symptoms.

Detailed description:

Arms: arm 1: Oral administration of 25 milligrams of bethanechol taken twice daily for a minimum of 7 days. Total dose taken daily for a minimum of 7 days is 50 mg.
Interventions: intervention 1: Bethanechol
Intervention descriptions: intervention 1: Due to the fact that this study has only 1 arm and all study subjects will receive the study drug in the same manner and dose, there are no other details to cover.

Protocol documents:
Clinical trial NCT02079649
Conditions: Allergic Conjunctivitis
Keywords: Allergic conjunctivitis Red eyes Eyelid swelling Ragweed Allergies Itchy eyes Ocular redness Chemosis Tearing Watery eyes
Sponsor: Alcon Research
Start date: 2014-04-01; Completion date: 2014-07-01
Enrollment: 224 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate two investigational ophthalmic solutions for reduction in ocular redness in subjects with allergic conjunctivitis.

Detailed description:
Eligible subjects attended 8 study visits, 5 of which included a 3-hour period of ragweed exposure in an Environmental Exposure Chamber. At the sixth visit, subjects received study product and began dosing for up to 9 days. The final visit was the final day of dosing. Participation in this study lasted up to 68 days.

Arms: arm 1: AL-53817 Ophthalmic Solution, 0.1%, 1 drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9) arm 2: AL-78843 Ophthalmic Solution, 0.03%, 1 drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9) arm 3: Dexamethasone Ophthalmic Suspension, 0.1%, 1 drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9) arm 4: AL-53817 Vehicle, 1 drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
Interventions: intervention 1: AL-53817 Ophthalmic Solution, 0.1% intervention 2: AL-78843 Ophthalmic Solution, 0.03% intervention 3: Dexamethasone Ophthalmic Suspension, 0.1% intervention 4: AL-53817 Vehicle
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: Inactive ingredients used for masking purposes

Protocol documents:
Clinical trial NCT02082262
Conditions: Conjunctivitis, Allergic
Sponsor: Allergan
Start date: 2014-03-01; Completion date: 2014-07-01
Enrollment: 140 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the safety and efficacy of AGN-229666 for the treatment of seasonal or perennial allergic conjunctivitis.

Detailed description:

Arms: arm 1: One to two drops of AGN-229666 twice daily in each eye for 10 weeks.
Interventions: intervention 1: AGN-229666
Intervention descriptions: intervention 1: One to two drops of AGN-229666 twice daily in each eye for 10 weeks.

Protocol documents:
Clinical trial NCT02083406
Conditions: Malaria
Keywords: Malaria Bio-availability
Sponsor: Medicines for Malaria Venture
Start date: 2014-07-01; Completion date: 2014-07-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A single dose study to investigate how different formulations of OZ439 co-administered with PQP tablest are processed by the body when taken without food

Detailed description:

Arms: arm 1: 800mg OZ439 prototype formulation 1 and 960mg PQP single doses arm 2: 800mg OZ439 prototype formulation 2 and 960mg PQP single doses arm 3: 800mg OZ439 prototype formulation 3 and 960mg PQP single doses
Interventions: intervention 1: 800mg OZ439 prototype formulation 1 intervention 2: 800mg OZ439 prototype formulation 2 intervention 3: 800mg OZ439 prototype formulation 3 intervention 4: 960mg PQP
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT02084056
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2014-04-01; Completion date: 2014-07-01
Enrollment: 74 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this trial is to demonstrate bioequivalence of a newly developed fixed dose combination (FDC) tablet containing linagliptin and metformin extended release compared to the free combination of linagliptin and metformin extended release.

Detailed description:

Arms: arm 1: Linagliptin/Metformin FDC followed by single tablets of linagliptin and metformin, fasted arm 2: single tablets of linagliptin and metformin followed by Linagliptin/Metformin FDC, fasted arm 3: Linagliptin/Metformin FDC followed by single tablets of linagliptin and metformin, fed arm 4: single tablets of linagliptin and metformin followed by Linagliptin/Metformin FDC, fed
Interventions: intervention 1: Linagliptin intervention 2: Metformin intervention 3: Linagliptin/Metformin FDC
Intervention descriptions: intervention 1: Linagliptin intervention 2: Metformin intervention 3: Linagliptin/Metformin FDC

Protocol documents:
Clinical trial NCT02084082
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2014-04-01; Completion date: 2014-07-01
Enrollment: 68 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this trial is to demonstrate bioequivalence of a newly developed fixed dose combination (FDC) tablet containing linagliptin and metformin extended release compared to the free combination of linagliptin and metformin extended release, both under fed and fasted conditions.

Detailed description:

Arms: arm 1: Linagliptin/Metformin ER FDC followed by single tablets of linagliptin and metformin ER, fasted condition arm 2: single tablets of linagliptin and metformin ER followed by Linagliptin/Metformin ER FDC, fasted condition arm 3: Linagliptin/Metformin ER FDC followed by single tablets of linagliptin and metformin ER, fed condition arm 4: single tablets of linagliptin and metformin ER followed by Linagliptin/Metformin ER FDC, fed condition
Interventions: intervention 1: Linagliptin/Metformin ER FDC intervention 2: Linagliptin intervention 3: Metformin ER
Intervention descriptions: intervention 1: 1x Linagliptin/Metformin FDC tablet intervention 2: 1x Linagliptin tablet intervention 3: 2x Metformin ER tablets

Protocol documents:
Clinical trial NCT02097537
Conditions: Asthma
Sponsor: Santen Pharmaceutical Co., Ltd.
Start date: 2014-02-01; Completion date: 2014-07-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The Purpose of this study is to evaluate the safety and efficacy of SK-1211 inhalation challenge in children with bronchial asthma.

Detailed description:

Arms: arm 1: children with bronchial asthma
Interventions: intervention 1: Methacholine Chloride (SK-1211)
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02099461
Conditions: Healthy Volunteer, Female, Breast
Sponsor: Amgen
Start date: 2014-04-01; Completion date: 2014-07-01
Enrollment: 82 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate whether administration of denosumab results in a decrease compared to the control group in proliferation of mammary epithelial cells as measured by the Ki-67 proliferation index.

Detailed description:

Arms: arm 1: Participants received no treatment and underwent percutaneous core needle breast biopsies on Day 1 and Day 28. arm 2: Participants received 60 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 (prior to study treatment) and Day 28. arm 3: Participants received 120 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 (prior to study treatment) and Day 28.
Interventions: intervention 1: Denosumab intervention 2: Percutaneous core needle breast biopsy
Intervention descriptions: intervention 1: Single sucutaneous dose intervention 2: None

Protocol documents:
Clinical trial NCT02106923
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2014-04-01; Completion date: 2014-07-01
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this trial is to demonstrate the relative bioavailability of 2 newly developed fixed dose combinations (FDC) tablets containing empagliflozin \& metformin XR and the single tablets of empagliflozin and metformin XR when administered singularly

Detailed description:

Arms: arm 1: 1 fixed dose combination (FDC) tablet vs 3 single tablets under fasted conditions arm 2: 1 fixed dose combination (FDC) tablet vs 3 single tablets under fed conditions arm 3: 2 fixed dose combination (FDC) tablets vs 4 single tablets under fasted conditions
Interventions: intervention 1: 1 tablet Empagliflozin/2 tablets Metformin XR intervention 2: 10 mg Empagliflozin/1000 mg Metformin XR intervention 3: 1 tablet 10 mg Empagliflozin/3 tablets Metformin XR intervention 4: 2 tablets 5 mg Empagliflozin/750 Metformin XR intervention 5: 1 tablet Empagliflozin/2 tablets Metformin XR intervention 6: 10 mg Empagliflozin/1000 mg Metformin XR
Intervention descriptions: intervention 1: Active Comparator: 1 x Empagliflozin/2x Metformin XR tablets intervention 2: Experimental: high dose Empagliflozin/Metformin XR, FDC tablet intervention 3: Active Comparator: 1 x Empagliflozin/3 x Metformin XR tablets intervention 4: Experimental:2 x low dose Empagliflozin/Metformin XR FDC tablets intervention 5: Active Comparator: 1 x Empagliflozin/2x Metformin XR tablets intervention 6: Experimental: high dose Empagliflozin/Metformin XR, FDC tablet

Protocol documents:
Clinical trial NCT02107014
Conditions: Fibromyalgia
Sponsor: University of Alabama at Birmingham
Start date: 2014-03-01; Completion date: 2014-07-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
We have found that low dose naltrexone (LDN) can substantially reduce pain associated with fibromyalgia syndrome. We believe LDN may work via novel anti-inflammatory channels. The purpose of this study is to determine if LDN lowers inflammatory markers in individuals with fibromyalgia.

Detailed description:
Eligible women with Fibromyalgia (FM) will be enrolled into a 10-week drug trial. During the first two weeks, a baseline phase will be used to collect data on immune function and symptoms. LDN will be administered for 8 weeks. Although there is no placebo arm built-in, participants will be advised that they may receive a placebo during the trial. Participants will provide twice daily symptom reports using an android tablet device and Dooblo SurveyToGo survey software. Participants will also provide a blood sample twice every week for the duration of the study. Plasma inflammatory markers will be tested using a luminex based 63-plex inflammatory assay panel.

The primary aim of the study is to test if 8 weeks of LDN administration is associated with a reduction in pro-inflammatory markers in plasma in women with FM.

Arms: arm 1: Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Interventions: intervention 1: Low Dose Naltrexone
Intervention descriptions: intervention 1: Naltrexone 4.5 mg p.o. nocte

Protocol documents:
Clinical trial NCT02107313
Conditions: Healthy Volunteers
Sponsor: Prana Biotechnology Limited
Start date: 2014-05-01; Completion date: 2014-07-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study is designed to determine the pharmacokinetic (PK) profile of a single oral dose of PBT2 administered to healthy volunteers in the presence and absence of food.

Detailed description:
The study will be conducted in 2 dosing periods, with participants being randomised to receive PBT2 250 mg with or without food in the first dosing period, followed by a 7 day washout period before receiving the opposite fed/fasted condition to that allocated in the first dosing period. Pharmacokinetic samples will be collected during each dosing period, along with safety monitoring assessments.

Arms: arm 1: PBT2 250 mg is administered orally following a high fat breakfast arm 2: PBT2 250 mg is administered orally following a 10 hour period of fasting
Interventions: intervention 1: Fed Cohort PBT2 intervention 2: Fasted Cohort PBT2
Intervention descriptions: intervention 1: PBT2 250 mg is administered orally following a period of fasting for 10 hours and a high fat breakfast. intervention 2: PBT2 250 mg is administered orally after a period of fasting of 10 hours and without food

Protocol documents:
Clinical trial NCT02108171
Conditions: Benign Neoplasm of Vocal Fold - Glottis
Keywords: intranasal dexmedetomidine early recovery suspension laryngoscopy
Sponsor: Guangzhou First People's Hospital
Start date: 2014-03-01; Completion date: 2014-07-01
Enrollment: 81 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Most patients with preoperative varying degrees of stress, anxiety, which makes the stress response in patients and affect the normal conduct of anesthesia and surgery.The sympathetic system hyperexcitability prone to cause adverse cardiovascular events and affect postoperative recovery. However, phenobarbital, as the traditional premedication, has less sedative, weak anxiolytic and other shortcomings. Midazolam accompanied by inhibition of respiration,excessive sedation, easily induced delirium,prolonged recovery time and so on. Dexmedetomidine is a highly selective α2-adrenergic receptor agonist, it has sedative, anxiolytic, no inhibition of respiration, and also colorless, odorless, non-mucosal stimulation, nasal drip ease of administration, patient acceptance, comfortable. Therefore, dexmedetomidine as premedication has certain advantages. The purpose of this research is to study sedative effect, safety and the impact of anesthesia recovery period of intranasal dexmedetomidine premedication for suspension laryngoscopy.

Detailed description:
All patients received intranasal dexmedetomidine (1μg.kg-1) or placebo at approximately 45 min before induction of anesthesia.The study drug was prepared in a 1-ml syringe.An equal volume of dexmedetomidine or placebo was dropped into each nostril by a blinded research assistant in the supine position.Automatic sphygmomanometer measure blood pressure.Oxygen saturation and heart rate were measured by a pulse oximeter. Respiratory rate, sedation score and anxiety levels regularly assessed. Patients with general anesthesia, suspension laryngoscopy surgery and postoperative care, standard monitoring are unified.

Arms: arm 1: intranasal dexmedetomidine arm 2: intranasal saline
Interventions: intervention 1: Dexmedetomidine intervention 2: placebo
Intervention descriptions: intervention 1: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia. intervention 2: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia.

Protocol documents: