ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01596504
Conditions: Type 2 Diabetes Mellitus
Sponsor: Sanofi
Start date: 2012-05-01; Completion date: 2013-07-01
Enrollment: 142 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Objective:

\- To investigate the effects of repeated subcutaneous doses of lixisenatide 20 μg once daily (QD) as compared to liraglutide 1.2 mg QD or 1.8 mg QD in reducing post-prandial plasma glucose (PPG) assessed as area under the plasma glucose-concentration-time curve (AUC) after a standardized breakfast at the end of a 8-week treatment period in participants with type 2 diabetes mellitus (T2DM) not adequately controlled with insulin glargine (± metformin).

Secondary Objectives:

* To assess the effects of lixisenatide 20 μg QD as compared to liraglutide 1.2 QD or 1.8 mg QD after an 8-week treatment period in participants with T2DM not adequately controlled with insulin glargine (± metformin) on:

  * Post-prandial C-peptide, glucagon and appetite perceptions after a standardized breakfast,
  * Appetite perceptions after standardized dinner,
  * Gastric emptying after a standardized labelled test meal,
  * Fasting plasma glucose, 24-hour plasma glucose profile,
  * Glycosylated hemoglobin (HbA1c),
  * Insulin glargine dose,
  * 7-point self monitored plasma glucose (SMPG),
  * Body weight and waist circumference,
  * 24-hour heart rate and blood pressure,
* To assess lixisenatide and liraglutide safety and tolerability as add on treatment to insulin glargine (± metformin).

Detailed description:
Up to 2-week screening period

* A run-in period of 12 weeks at maximum including a forced titration with insulin glargine up to 11 weeks and 1 baseline pharmacodynamic assessment week
* A 8-week treatment(s) period(s) up to Day 57
* Follow-up: 7 ±2 days after the last treatment day
* Total study duration approximately 14 weeks up to 23 weeks

Arms: arm 1: Subcutaneous injection of lixisenatide10 μg once daily (QD) for 2 weeks followed by 20 μg QD for 6 weeks under fasted conditions, on top of insulin glargine with or without metformin. arm 2: Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks under fasted conditions, on top of insulin glargine with or without metformin. arm 3: Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks under fasted conditions, on top of insulin glargine with or without metformin.
Interventions: intervention 1: Lixisenatide (AVE0010) intervention 2: Liraglutide intervention 3: Insulin Glargine intervention 4: Metformin
Intervention descriptions: intervention 1: Pharmaceutical form: solution for injection self-administered with a pen-like injector (OptiClik®).

Route of administration: subcutaneous intervention 2: Pharmaceutical form:solution for injection

Route of administration: subcutaneous intervention 3: Doses to be adjusted to maintain a fasting self-measured plasma glucose (SMPG) between 4.4 to 5.6 mmol/L (80 to 100 mg/dL) intervention 4: If previously taken metformin to be continued at stable dose throughout the study

Protocol documents:
Clinical trial NCT01605136
Conditions: Erythropoietic Protoporphyria
Keywords: Erythropoietic Protoporphyria EPP Afamelanotide
Sponsor: Clinuvel Pharmaceuticals Limited
Start date: 2012-05-01; Completion date: 2013-07-01
Enrollment: 93 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized placebo-controlled study to be conducted in two parallel study arms for a six month period (three doses). Between 75 and 100 eligible patients will be enrolled. Patients will receive afamelanotide (16 mg implants) or placebo according to the following dosing regimen:

* Group A will be administered afamelanotide implants on Days 0, 60 and 120
* Group B will be administered placebo implants on Days 0, 60 and 120

The number and severity of phototoxic reactions, the type and duration of sun exposure, treatment-emergent adverse events and the use of concomitant medication will be recorded by patients in study diaries between Days 0 and 180. Quality of life will be measured using the DLQI and EPP-QoL at Days 0, 60, 120 and 180. Participants will visit the clinic on Days 60, 120 and 180 for assessments of adverse events.

A subset of patients will be photoprovoked on the lower back and dorsal surface of the hand and the minimal symptom dose (MSD) will be determined on Days 0, 30, 60, 90 and 120.

Detailed description:
Afamelanotide is a man-made drug being studied for use as a preventative medication for Erythropoietic Protoporphyria (EPP) sufferers. It is a synthetically produced analogue of human alpha melanocyte stimulating hormone (alpha-MSH) and is available in Europe.

The purpose of this study is to look at the type and duration of sun exposure when patients are exposed to light. This study will also look at how the drug is tolerated when taken by people with EPP.

The study will involve the use of an implant, which comes in the form of a small rod to be administered under the skin. The implant may contain the study drug afamelanotide or a placebo (inactive medication).

Over 620 subjects have been treated with afamelanotide to date with no serious safety concerns identified. For this study, afamelanotide has been formulated as a controlled release depot injection (implant). This means that the afamelanotide will be released slowly into the body over a few days.

This study aims to confirm the photoprotective properties if afamelanotide demonstrated in the earlier Phase II and phase III studies.

Arms: arm 1: One 16mg subcutaneous implant every 2 months for 6 months. arm 2: One placebo subcutaneous implant every 2 months for 6 months.
Interventions: intervention 1: Afamelanotide intervention 2: Placebo
Intervention descriptions: intervention 1: One 16mg subcutaneous implant every 2 months for 6 months. intervention 2: One placebo subcutaneous implant every 2 months for 6 months

Protocol documents:
Clinical trial NCT01607398
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Japan COPD CAT placebo serum Adoair250 anti-inflammatory sputum
Sponsor: GlaxoSmithKline
Start date: 2012-05-01; Completion date: 2013-07-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will be conducted in a respiratory specialist institute in Japan, with standardized techniques and data assurance checks to optimize data quality. The licensed dosage and administration of Adoair in Japan will be applied in this study. Each subject will receive treatment options in a randomized blinded fashion. Subjects will be randomized following a 4-week wash-out phase to take either Adoair 50/250mcg twice daily or placebo twice daily for 12 weeks.

Detailed description:
This is a randomised, double-blind, placebo-controlled, two-arm, parallel-group, 12-week-treatment study in Japanese patients with COPD.

At Visit 1, patients confirmed to be fulfilling all the inclusion criteria and not meeting any of the exclusion criteria will start the 4-week run-in period. During the entire study period, including the run-in period, the only drug allowed to use in addition to the study drug will be oxitropium (short-acting anticholinergic drug) as relief medication. At the end of the run-in period (Visit 2), subjects eligible for randomisation will be evenly randomised to one of the following two treatment groups and start the 12-week treatment period.

* ADOAIR®250 one inhalation twice daily from the DISKUS inhaler
* Placebo one inhalation twice daily from the DISKUS inhaler

Study completers will be defined as subjects who have completed all examinations, assessments, and study procedures in the study period, including the run-in period and the follow-up period. At completion/discontinuation of the treatment period, subjects will be switched to appropriate COPD treatment at the discretion of the investigator (or subinvestigator).

Arms: arm 1: ADOAIR 250mcg inhalations, twice daily, from week0 - 12 arm 2: Placebo inhalation, twice daily, from week0 -12
Interventions: intervention 1: ADOAIR250 intervention 2: Placebo
Intervention descriptions: intervention 1: 250 mcg inhalation, twice daily, from week0 -12. intervention 2: Placebo inhalation, twice daily, from week0 -12.

Protocol documents:
Clinical trial NCT01609478
Conditions: Asthma
Keywords: asthma
Sponsor: Novartis Pharmaceuticals
Start date: 2012-08-01; Completion date: 2013-07-01
Enrollment: 335 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To provide the efficacy, safety and pharmacokinetics of indacaterol acetate in patients with persistent asthma to support dose selection of indacaterol in fixed dose combination QMF149.

Detailed description:

Arms: arm 1: indacaterol acetate 75 µg od delivered via Concept 1 inhaler

Background therapy: mometasone furoate 200 mcg od arm 2: indacaterol acetate 150 µg od delivered via Concept 1 inhaler

Background therapy: mometasone furoate 200 mcg od arm 3: placebo delivered via Concept 1 inhaler

Background therapy: mometasone furoate 200 mcg od
Interventions: intervention 1: indacaterol intervention 2: placebo intervention 3: mometasone furoate
Intervention descriptions: intervention 1: indacaterol acetate 75 µg or indacaterol acetate 150 µg delivered via Concept 1 inhaler intervention 2: placebo delivered via Concept 1 inhaler intervention 3: via Twisthaler inhaler

Protocol documents:
Clinical trial NCT01615198
Conditions: Essential Hypertension
Keywords: Hypertension, blood pressure, LCZ696, dual inhibitor, neprilysin, NEP inhibition, vasopeptidase, ARNi, angiotensin receptor
Sponsor: Novartis Pharmaceuticals
Start date: 2012-08-01; Completion date: 2013-07-01
Enrollment: 588 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to access the efficacy and safety of LCZ696 compared to olmesartan in elderly Asian patients for the treatment of hypertension.

Detailed description:

Arms: arm 1: Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd. arm 2: Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
Interventions: intervention 1: Olmesartan intervention 2: Placebo intervention 3: LCZ696
Intervention descriptions: intervention 1: 10 mg, 20 mg, 40 mg capsules intervention 2: Matching placebo of LCZ696 tablet, matching placebo of Olmesartan capsule intervention 3: 100 mg, 200 mg tablets

Protocol documents:
Clinical trial NCT01615731
Conditions: Abortion, Induced
Keywords: Mifepristone Induced Abortion Dilation and Evacuation Cervical preparation Osmotic dilators
Sponsor: Stanford University
Start date: 2012-05-01; Completion date: 2013-07-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A common practice for preparation for surgical abortion after 19 weeks gestation is the placement of multiple sets of osmostic dilators 1-2 days prior to the procedure. The investigators aim to study the addition of mifepristone as an adjunct to cervical dilation prior to abortion between 19-24 weeks gestation, and its potential to minimize the number of painful procedures and time in clinic (or away from work/home) that multiple sets of dilators can require. The investigators hypothesize that one set of dilators with mifepristone will result in similar procedure times and decreased "total" time as two sets of dilators.

Detailed description:

Arms: arm 1: Two sets of osmotic dilators inserted 1 and 2 days pre-op arm 2: One set of dilators plus mifepristone
Interventions: intervention 1: Mifepristone intervention 2: Hygroscopic cervical dilators intervention 3: Misoprostol intervention 4: Intra-amniotic digoxin
Intervention descriptions: intervention 1: 200mg Mifepristone orally intervention 2: Dilapan-S osmostic cervical dilators inserted through the internal os intervention 3: 400mcg buccal misoprostol 90 minutes pre-op intervention 4: 1mg digoxin administered intra-amniotically \~24 hours pre-op

Protocol documents:
Clinical trial NCT01631864
Conditions: Hypertension Concurrent Obesity
Keywords: Hypertension, obesity, insulin sensitivity, lipolysis, LCZ696
Sponsor: Novartis Pharmaceuticals
Start date: 2012-10-01; Completion date: 2013-07-01
Enrollment: 98 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study investigated the effects of LCZ696 on insulin sensitivity, lipolysis, and oxidative metabolism in obese hypertensive subjects.

Detailed description:

Arms: arm 1: LCZ696 400 mg plus placebo to amlodipine once daily for 8 weeks arm 2: amlodipine 10 mg plus placebo to LCZ696 once daily for 8 weeks
Interventions: intervention 1: LCZ696 intervention 2: amlodipine intervention 3: Placebo
Intervention descriptions: intervention 1: LCZ696 was provided as 400 mg tablets. intervention 2: amlodipine was provided as 5 mg tablets. intervention 3: Matching placebo to LCZ696 and amlodipine.

Protocol documents:
Clinical trial NCT01640054
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Sponsor: AstraZeneca
Start date: 2012-07-01; Completion date: 2013-07-01
Enrollment: 115 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the long term safety and tolerability of fostamatinib in patients in Asia with rheumatoid arthritis (RA).

Detailed description:
(OSKIRA-Asia-1X): A Long-term Study to Assess the Safety of Fostamatinib in the Treatment of Rheumatoid Arthritis in Asia

Arms: arm 1: Open label Oral treatment 100mg once daily
Interventions: intervention 1: Fostamatinib
Intervention descriptions: intervention 1: Fostamatinib 100mg once daily

Protocol documents:
Clinical trial NCT01644474
Conditions: Hypercholesterolemia
Sponsor: Sanofi
Start date: 2012-07-01; Completion date: 2013-07-01
Enrollment: 103 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9).

Primary Objective of the study:

To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab in comparison with ezetimibe after 24 weeks of treatment in participants with hypercholesterolemia.

Secondary Objectives:

* To evaluate the effect of alirocumab in comparison with ezetimibe on LDL-C at other time points
* To evaluate the effect of alirocumab on other lipid parameters
* To evaluate the safety and tolerability of alirocumab

Detailed description:
The maximum study duration was 34 weeks per participant, including a 24-week randomized treatment period.

Arms: arm 1: Oral ezetimibe 10 mg capsule daily and subcutaneous (SC) placebo injection for alirocumab every 2 weeks (Q2W) for 24 weeks. arm 2: SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
Interventions: intervention 1: Alirocumab intervention 2: Ezetimibe intervention 3: Placebo (for Alirocumab) intervention 4: Placebo (for Ezetimibe)
Intervention descriptions: intervention 1: 1 mL subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using the autoinjector. intervention 2: One over-encapsulated tablet orally once daily at approximately the same time of the day with or without food. intervention 3: 1 mL subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self--injection or by another designated person using the autoinjector. intervention 4: One capsule orally once daily at approximately the same time of the day with or without food..

Protocol documents:
Clinical trial NCT01654536
Conditions: Perennial Allergic Rhinitis
Keywords: PAR
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2012-09-01; Completion date: 2013-07-01
Enrollment: 737 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 6 month, multicenter, randomized, open label, parallel group, study to evaluate the nasal safety of ciclesonide nasal aerosol and ciclesonide aqueous nasal spray administered once daily to male and female subjects 12 years and older diagnosed with PAR.

Detailed description:
This is a 6 month, multicenter, randomized, open label, parallel group, safety study of ciclesonide nasal aerosol and ciclesonide aqueous nasal spray administered once daily to male and female subjects 12 years and older diagnosed with PAR. The objectives of this study are to evaluate the nasal and ocular safety of once daily dosing with ciclesonide nasal aerosol (Zetonna) 74 mcg and ciclesonide aqueous nasal spray (Omnaris) 200 mcg in subjects 12 years and older with PAR.

Arms: arm 1: ciclesonide nasal aerosol 74 mcg arm 2: ciclesonide nasal spray 200 mcg
Interventions: intervention 1: ciclesonide nasal aerosol intervention 2: ciclesonide nasal spray
Intervention descriptions: intervention 1: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol) intervention 2: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)

Protocol documents:
Clinical trial NCT01658826
Conditions: Genital Herpes
Keywords: AIC316 Viral shedding
Sponsor: AiCuris Anti-infective Cures AG
Start date: 2012-10-01; Completion date: 2013-07-01
Enrollment: 91 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The aim of the study is to evaluate the safety and efficacy of "AIC316 (pritelivir)" 100 mg once daily compared to valacyclovir 500 mg once daily for the prevention of HSV-2 genital shedding.

Detailed description:
Enrolled patients with Mucocutaneous genital HSV, will be randomized to receive either AIC326 or Valacyclovir first and then will be crossed over to receive the opposite Intervention. The study will consist of two treatment periods of 28 days separated by a washout period of 28 days.

Arms: arm 1: Participants first received AIC316 100 mg once daily for 28 days. After a washout period of 28 days, they then received Valacyclovir 500 mg once daily for 28 days. arm 2: Participants first received Valacyclovir 500 mg once daily for 28 days. After a washout period of 28 days, they then received AIC316 100 mg once daily for 28 days.
Interventions: intervention 1: AIC316 intervention 2: Valacyclovir
Intervention descriptions: intervention 1: 100 mg oral administration intervention 2: 500 mg oral administration

Protocol documents:
Clinical trial NCT01658839
Conditions: Glaucoma Ocular Hypertension
Keywords: pediatric glaucoma pediatric ocular hypertension travoprost
Sponsor: Alcon Research
Start date: 2013-01-01; Completion date: 2013-07-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to assess the safety and describe the steady-state plasma pharmacokinetic (PK) profiles of Travoprost ophthalmic solution, 0.004% (new formulation) following a once daily administration for 7 days in pediatric glaucoma or ocular hypertension patients.

Detailed description:

Arms: arm 1: Travoprost ophthalmic solution, 0.004% (new formulation), one drop administered topically in the inferior cul-de-sac of the eye each morning at 9 AM (± 60 minutes) for 7 days
Interventions: intervention 1: Travoprost ophthalmic solution, 0.004% (new formulation)
Intervention descriptions: intervention 1: Travoprost ophthalmic solution, 0.004%, new formulation

Protocol documents:
Clinical trial NCT01697969
Conditions: Allergic Conjunctivitis
Keywords: allergic conjunctivitis Pataday Olopatadine
Sponsor: Alcon Research
Start date: 2012-09-01; Completion date: 2013-07-01
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to descriptively evaluate the corneal structures of allergic conjunctivitis patients.

Detailed description:
Heidelberg Retina Tomograph (HRT) will be used to descriptively evaluate the corneal structures and assess the immune cell status of allergic conjunctivitis patients pre- and post-treatment with olopatadine 0.2% in relation to a normative database.

Arms: arm 1: Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily in both eyes for 14 days
Interventions: intervention 1: Olopatadine hydrochloride ophthalmic solution, 0.2%
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01698333
Conditions: Plaque Psoriasis
Keywords: 122-0551 steroid HPA
Sponsor: Therapeutics, Inc.
Start date: 2012-04-01; Completion date: 2013-07-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Adrenal suppression effects of corticosteroids are among the most important safety concerns for this group of products. This study is designed to determine the adrenal effects of the investigational formulation of 122-0551 and characterize the steady state pharmacokinetics of the formulation.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: 122-0551
Intervention descriptions: intervention 1: Applied twice daily for 2 weeks

Protocol documents:
Clinical trial NCT01701024
Conditions: Acne
Keywords: Acne
Sponsor: Bausch Health Americas, Inc.
Start date: 2012-10-01; Completion date: 2013-07-01
Enrollment: 498 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to compare the efficacy and safety and tolerability of ACYC Gel and vehicle in the treatment of subjects with Acne Vulgaris.

Detailed description:
The primary objective of this study is to compare the efficacy and safety and tolerability of ACYC Gel and vehicle in the treatment of subjects with Acne Vulgaris

Arms: arm 1: ACYC active, topically applied to the face for 12 weeks arm 2: ACYC vehicle (placebo), topically applied to the face for 12 weeks
Interventions: intervention 1: ACYC intervention 2: ACYC vehicle
Intervention descriptions: intervention 1: ACYC active, topically applied to the face for 12 weeks intervention 2: ACYC vehicle (placebo), topically applied to the face for 12 weeks

Protocol documents:
Clinical trial NCT01706159
Conditions: Inflammation Ulcerative Colitis
Sponsor: Novo Nordisk A/S
Start date: 2012-10-01; Completion date: 2013-07-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Europe. The aim of the trial is to investigate the effect of recombinant factor XIII (rFXIII) administered to subjects with mild to moderate active ulcerative colitis (UC).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: catridecacog intervention 2: placebo
Intervention descriptions: intervention 1: Catridecacog (recombinant factor XIII, rFXIII) will be administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week at a dose of 35 IU/kg intervention 2: Placebo will be administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week.

Protocol documents: