ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02008942
Conditions: Diabetes Mellitus, Type 2
Sponsor: PLx Pharma
Start date: 2014-01-01; Completion date: 2014-04-01
Enrollment: 57 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will determine if aspirin from PL2200, an investigational product, gets into the blood stream as quickly as enteric coated aspirin, and to test whether PL2200 is able to prevent blood clots as effectively as enteric coated aspirin, when administered to patients with diabetes

Detailed description:

Arms: arm 1: PL2200 Aspirin Capsules arm 2: Enteric-coated aspirin caplets
Interventions: intervention 1: PL2200 Aspirin Capsules intervention 2: Enteric-coated aspirin caplets
Intervention descriptions: intervention 1: 325 mg aspirin; once per day for 10 days intervention 2: 325 mg aspirin; once per day for 10 days

Protocol documents:
Clinical trial NCT02039817
Conditions: Renal Impairment Renal Insufficiency Kidney Disease Kidney Diseases
Keywords: pharmacokinetics pharmacodynamics renal impairment
Sponsor: Conatus Pharmaceuticals Inc.
Start date: 2014-01-01; Completion date: 2014-04-01
Enrollment: 16 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an open-label, parallel-group study to compare the pharmacokinetics and pharmacodynamics of IDN-6556 following a single 50 mg oral dose of IDN-6556 in subjects with severe renal impairment and matched healthy volunteers with normal renal function.

Detailed description:

Arms: arm 1: All subjects receive a single 50 mg oral dose of IDN-6556 arm 2: All subjects receive a single 50 mg oral dose of IDN-6556
Interventions: intervention 1: IDN-6556
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02044367
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2014-01-01; Completion date: 2014-04-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To investigate the relative bioavailability of dabigatran etexilate as pellets on food and of dabigatran etexilate as granules resolved in reconstitution solution, each with dabigatran etexilate as capsule following oral administration. To evaluate acceptability and palatability of Pellets sprinkled on food and Oral Liquid Formulation

Detailed description:

Arms: arm 1: multiple dose of dabigatran arm 2: multiple dose of dabigatran arm 3: multiple dose of dabigatran
Interventions: intervention 1: Dabigatran etexilate intervention 2: Dabigatran etexilate intervention 3: Dabigatran etexilate
Intervention descriptions: intervention 1: Pellets (multiple dose of dabigatran) intervention 2: Granules resolved in reconstitution solution (multiple dose of dabigatran) intervention 3: Hard capsule (multiple dose of dabigatran)

Protocol documents:
Clinical trial NCT02051296
Conditions: Chronic Pain Post-operative Pain
Sponsor: VA Palo Alto Health Care System
Start date: 2012-01-01; Completion date: 2014-04-01
Enrollment: 131 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators are looking at whether peri-operative minocycline will reduce the duration of pain after minor hand surgery: carpal tunnel release and trigger finger release.

The investigators' hypothesis is that minocycline will reduce post-operative pain.

Detailed description:
This is a double blinded randomized controlled trial. Patients are given 100mg of minocycline 2 hours prior to their procedure and then 100mg two times a day for 5 days. The subjects are then contacted daily to check their level of pain. The investigators' outcome of interest is time to pain resolution.

The investigators will perform a futility analysis to assess if a larger trial would be a reasonable next step after this pilot study.

Arms: arm 1: perioperative minocycline for 5 days, starting 2 hours prior to surgery then 100mg BID arm 2: PLacebo
Interventions: intervention 1: Minocycline intervention 2: placebo
Intervention descriptions: intervention 1: RCT blinded placebo trial intervention 2: RCT blinded placebo trial

Protocol documents:
Clinical trial NCT02064907
Conditions: Bioavailability
Keywords: Drug therapy
Sponsor: Takeda
Start date: 2014-02-01; Completion date: 2014-04-01
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to assess the pharmacokinetics (PK) and Pharmacodynamics (PD) of dexlansoprazole delayed-release orally disintegrating (OD) tablets administered on the tongue and swallowed without water.

Detailed description:
The drug being tested in this study is called dexlansoprazole. Dexlansoprazole is being tested to see if two different forms of the medication react the same way in the human body. This study will look at biological samples from people who take an orally disintegrating tablet of dexlansoprazole compared to a swallowed capsule of dexlansoprazole.

The study will enroll approximately 52 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups. Both treatment groups will receive both forms of dexlansoprazole at different time periods:

* Two dexlansoprazole 30 mg orally disintegrating tablets for 5 days
* One dexlansoprazole 60 mg capsule for 5 days.

All participants will be asked to take two tablets or one capsule at the same time each day throughout each treatment period of the study.

This single-centre trial will be conducted in the United States. Participants will make 3 visits to the clinic including two 6-day periods of confinement to the clinic, and will be contacted by telephone 5 to 10 days after last dose of study drug for a follow-up assessment.

The overall time to participate in this study is up to 57 days.

Arms: arm 1: Two Dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days in Period 1, followed by a 7 day washout period, followed by one dexlansoprazole 60 mg, capsule, orally, once daily for 5 days in Period 2. arm 2: Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days in Period 1, followed by a 7 day washout period, followed by two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days in Period 2.
Interventions: intervention 1: Dexlansoprazole Delayed Release Orally Disintegrating Tablets intervention 2: Dexlansoprazole Delayed Release Capsules
Intervention descriptions: intervention 1: Dexlansoprazole delayed-release, orally disintegrating (OD) tablets intervention 2: Dexlansoprazole delayed-release capsules

Protocol documents:
Clinical trial NCT02074358
Conditions: Anticoagulation
Sponsor: Bristol-Myers Squibb
Start date: 2014-02-01; Completion date: 2014-04-01
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to assess the effect of two 4-Factor PCC formulations on Apixaban pharmacodynamics in healthy adult subjects.

Detailed description:

Arms: arm 1: Apixaban 10 mg Tablet orally \[Day 1-Day 3: twice daily (BID), Day 4: Single Dose (SD)\] followed 3hr later by Saline solution (placebo) 0 IU/kg infusion for 30 min Intravenously arm 2: Apixaban 10 mg Tablet orally \[Day 1-Day 3: twice daily (BID), Day 4: Single Dose (SD)\] followed 3hr later by a Cofact (4-Factor PCC) 50 IU/kg infusion for 30 min Intravenously arm 3: Apixaban 10 mg Tablet orally \[Day 1-Day 3: twice daily (BID), Day 4: Single Dose (SD)\] followed 3hr later by a Beriplex P/N (4-Factor PCC) 50 IU/kg infusion for 30 min Intravenously
Interventions: intervention 1: Apixaban intervention 2: Cofact (4-Factor PCC) intervention 3: Beriplex P/N (4-Factor PCC) intervention 4: Placebo (Saline solution)
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT02084069
Conditions: Heart Valve Diseases
Sponsor: Urmia University of Medical Sciences
Start date: 2013-01-01; Completion date: 2014-04-01
Enrollment: 58 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the investigation is to determine whether Atrovastatin as anti-inflammatory agent can be effective in preventing from atrial fibrillation incidence in patients whom undergone open cardiac surgery for their heart valve repair.

Detailed description:

Arms: arm 1: Atorvastatin 40 mg once daily from 3 days before surgery up to five days after surgery arm 2: Placebo
Interventions: intervention 1: Atorvastatin
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02093390
Conditions: Prostate Cancer Endometriosis
Sponsor: Millennium Pharmaceuticals, Inc.
Start date: 2014-03-01; Completion date: 2014-04-01
Enrollment: 40 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a nonrandomized, open-label, fixed-sequence, 2-arm study designed to assess the effect of multiple doses of fluconazole or atorvastatin on the single-dose pharmacokinetics of TAK-385 in healthy adult subjects.

Detailed description:
The drug being tested in this study is called TAK-385. TAK-385 was being tested to assess if the way it is processed the body changes when it administered with other medications (fluconazole or atorvastatin). This study looked at lab results in people who took TAK-385.

The study enrolled 40 patients. Participants were assigned to one of the two treatment groups:

* TAK-385 40 mg and fluconazole 400 mg on Day 6 and 200 mg on Days 7 to 14
* TAK-385 40 mg and atorvastatin 80 mg on Days 6-14

Participants in the fluconazole arm were administered TAK-385 on Days 1 and 10 and fluconazole on Days 6 through 14. Participants in the atorvastatin arm were administered TAK-385 on Days 1 and 10 and atorvastatin on Days 6 through 14.

This single-center trial was conducted in the United States. The overall time to participate in this study was 4 weeks. Participants made multiple visits to the clinic, including one 16-day period of confinement to the clinic, and a final visit 7 days after last dose of study drug for a follow-up assessment.

Arms: arm 1: TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on Day 10 then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14. arm 2: TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on Days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on Day 10 then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
Interventions: intervention 1: TAK-385 intervention 2: Fluconazole intervention 3: Atorvastatin
Intervention descriptions: intervention 1: TAK-385 tablets intervention 2: Fluconazole tablets intervention 3: Atorvastatin tablets

Protocol documents:
Clinical trial NCT02111252
Conditions: Influenza
Keywords: Drug Therapy
Sponsor: Takeda
Start date: 2014-03-01; Completion date: 2014-04-01
Enrollment: 55 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This clinical trial is a phase 1/2 study of a single intramuscular injection of TAK-850 in healthy Japanese adult participants

Detailed description:
The primary objective of this study is to evaluate the safety and immunogenicity of a single intramuscular injection of TAK-850 for 22 days in healthy Japanese adults

Arms: arm 1: A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin \[HA\] antigen per strain) is injected into the deltoid muscle.
Interventions: intervention 1: TAK-850
Intervention descriptions: intervention 1: TAK-850 injection

Protocol documents:
Clinical trial NCT02118831
Conditions: Age-related Macular Degeneration Diabetic Macular Edema Retinal Vein Occlusion
Keywords: macular degeneration diabetic macular edema vein occlusion vascular endothelial growth factor
Sponsor: California Retina Consultants
Start date: 2012-03-01; Completion date: 2014-04-01
Enrollment: 56 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Comparable data for bevacizumab and aflibercept are lacking, as are studies comparing the systemic levels of ranibizumab, bevacizumab, and aflibercept and their relative effects on circulating vascular endothelial growth factor. In the present prospective study, the investigators evaluated serum drug levels and plasma free vascular endothelial growth factor (VEGF) levels in patients with neovascular age-related macular degeneration following intravitreal injections of ranibizumab, bevacizumab and aflibercept.

Detailed description:

Arms: arm 1: Blood samples will be collected from patients receiving aflibercept following the first and third dose of standard care therapy. arm 2: Blood samples will be collected from patients receiving bevacizumab following the first and third dose of standard care therapy. arm 3: Blood samples will be collected from patients receiving ranibizumab following the first and third dose of standard care therapy.
Interventions: intervention 1: Blood Sample Collection intervention 2: Aflibercept intervention 3: Bevacizumab intervention 4: Ranibizumab
Intervention descriptions: intervention 1: Subjects will have their blood drawn for analysis following their first and third injections of anti-VEGF. intervention 2: an intravitreal injection of Aflibercept administered three times on a monthly basis. intervention 3: an intravitreal injection of Bevacizumab administered three times on a monthly basis. intervention 4: an intravitreal injection of Ranibizumab administered three times on a monthly basis.

Protocol documents:
Clinical trial NCT02119286
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: long acting beta2- receptor agonist long acting muscarininc receptor antagonist dry powder inhaler safety COPD inhaled corticosteroid efficacy fluticasone furoate/vilanterol umeclidinium bromide
Sponsor: GlaxoSmithKline
Start date: 2013-10-01; Completion date: 2014-04-01
Enrollment: 620 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
After screening, subjects will enter a 4 week open-label run-in period with fluticasone furoate (FF)/vilanterol (VI) 100/25 mcg administered once daily via dry powder inhaler (DPI). Subjects will then be randomized to receive any one of the 3 treatments (umeclidinium bromide \[UMEC\] \[62.5 mcg\] administered once daily via a DPI; OR UMEC \[125 mcg\] administered once daily via a DPI; OR matching placebo administered once daily via a DPI), while continuing treatment with open label FF/VI 100/25 mcg during a 12-week treatment period. There will be a total of eight scheduled clinic visits at Pre-Screening (Visit0), Screening (Visit 1), blinded treatment Day 1(Visit2), 2(Visit3), 28 (Visit4), 56 (Visit5), 84 (Visit6) and 85 (Visit7). A follow-up phone contact will be conducted approximately 7 days after the last clinic visit. The total duration of subject participation in the study from Screening to Follow-up will be approximately 17 weeks.

Detailed description:

Arms: arm 1: Subjects received one inhalation of FF/VI 100/25 mcg via DPI followed by one inhalation UMEC (62.5mcg) via DPI once-daily in the morning for 12 weeks. arm 2: Subjects received one inhalation of FF/VI 100/25 mcg via DPI followed by one inhalation of UMEC (125mcg) via a DPI once-daily in the morning for 12 weeks. arm 3: Subjects received one inhalation of FF/VI 100/25 mcg via DPI followed by one inhalation of matching placebo via a DPI once-daily in the morning for 12 weeks.
Interventions: intervention 1: FF intervention 2: VI intervention 3: UMEC intervention 4: Placebo
Intervention descriptions: intervention 1: Dry white powder containing 100mcg of Fluticasone Furoate blended with lactose per blister was administered by DPI. intervention 2: Dry white powder containing 25mcg of Vilanterol micronised drug (as the 'M' salt triphenylacetate) blended with lactose and magnesium stearate per blister was administered by DPI. intervention 3: Umeclidinium bromide in a powder blend with lactose and magnesium stearate was used at two different doses 62.5mcg and 125mcg. intervention 4: The matching placebo DPI identical in appearance to the inhaler containing active study medication.

Protocol documents:
Clinical trial NCT02174510
Conditions: Schizophrenia
Keywords: pharmacokinetic lurasidone single dose
Sponsor: Sumitomo Pharma (Suzhou) Co., Ltd.
Start date: 2014-03-01; Completion date: 2014-04-01
Enrollment: 37 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the pharmacokinetic (PK) characteristics of lurasidone after single oral administration of different doses in healthy Chinese subjects.

To evaluate the safety and tolerability of lurasidone after single oral administration of different doses in healthy Chinese subjects.

Detailed description:
Single administration, double-blinded, placebo-controlled (3 subjects in each group will take placebo) and 3 dose groups (20 mg, 40 mg and 80 mg). There are three groups which are 20mg lurasidone or placebo, 40mg lurasidone or placebo and 80mg lurasidone or placebo.

This study comprises a screening period (between signing of the informed consent form and Day -2), baseline period (Day -1), treatment period (Days 1-3) and ending of study examination period (Days 8-11 after the last sample collection for PK evaluation).

Arms: arm 1: single oral lurasidone in 30 minutes after beginning of the over 350 kcal breakfast on day 1.The subjects will be follow up on day 8 to 11. arm 2: single oral lurasidone in 30 minutes after beginning of the over 350 kcal breakfast on day 1.The subjects will be follow up on day 8 to 11. arm 3: single oral lurasidone in 30 minutes after beginning of the over 350 kcal breakfast on day 1.The subjects will be follow up on day 8 to 11.
Interventions: intervention 1: 20mg lurasidone intervention 2: 40mg lurasidone intervention 3: 80mg lurasidone intervention 4: placebo
Intervention descriptions: intervention 1: single oral lurasidone or placebo in 30 minutes after beginning of the over 350 kcal breakfast on day 1. intervention 2: single oral lurasidone or placebo in 30 minutes after beginning of the over 350 kcal breakfast on day 1. intervention 3: single oral lurasidone or placebo in 30 minutes after beginning of the over 350 kcal breakfast on day 1. intervention 4: None

Protocol documents:
Clinical trial NCT02174523
Conditions: Schizophrenia
Keywords: pharmacokinetic lurasidone multiple dose
Sponsor: Sumitomo Pharma (Suzhou) Co., Ltd.
Start date: 2014-04-01; Completion date: 2014-04-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the pharmacokinetic (PK) characteristics after multiple oral administration of 40 mg lurasidone in healthy Chinese subjects.

To evaluate the safety and tolerance after multiple oral administration of 40 mg lurasidone in healthy Chinese subjects.

Detailed description:
Single oral administration of 40 mg study drug lurasidone or placebo after the over 350 kcal breakfast on Day 1. Administration was suspended on Days 2 and 3. Continuous oral administration of 40 mg study drug lurasidone or placebo, once daily between Day 4 and Day 8.

Arms: arm 1: Single oral administration of 40 mg study drug lurasidone after the over 350 kcal breakfast on Day 1. Administration was suspended on Days 2 and 3. Continuous oral administration of 40 mg study drug lurasidone, once daily between Day 4 and Day 8. arm 2: Single oral administration of 40 mg study drug placebo after the over 350 kcal breakfast on Day 1. Administration was suspended on Days 2 and 3. Continuous oral administration of 40 mg placebo, once daily between Day 4 and Day 8.
Interventions: intervention 1: 40mg lurasidone intervention 2: placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02235987
Conditions: Acromegaly
Sponsor: Aspireo Pharmaceuticals Limited
Start date: 2012-10-01; Completion date: 2014-04-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The study is designed to investigate the safety, tolerability and efficacy of DG3173 in untreated acromegaly patients. Twenty patients received ascending single doses of DG3173 and one dose of octreotide, the current gold standard of medical therapy for acromegaly, with each patient receiving all doses of DG3173 as well as octreotide.

Detailed description:

Arms: arm 1: Interventions: octreotide and DG3173. Eligible patients are to receive 300 µg octreotide as active comparator, followed by four ascending doses of 100 µg, 300 µg, 900 µg and 1800 µg DG3173. All treatments will be administered consecutively to all patients as single subcutaneous bolus injections.
Interventions: intervention 1: octreotide intervention 2: DG3173
Intervention descriptions: intervention 1: Eligible patients are to receive 300 µg octreotide as active comparator, followed by four ascending doses of 100 µg, 300 µg, 900 µg and 1800 µg DG3173. All treatments will be administered consecutively to all patients as single subcutaneous bolus injections. intervention 2: Eligible patients are to receive 300 µg octreotide as active comparator, followed by four ascending doses of 100 µg, 300 µg, 900 µg and 1800 µg DG3173. All treatments will be administered consecutively to all patients as single subcutaneous bolus injections.

Protocol documents:
Clinical trial NCT02305017
Conditions: Parkinson's Disease
Sponsor: Bial - Portela C S.A.
Start date: 2014-03-01; Completion date: 2014-04-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Single-centre, open-label, randomised, two-way cross-over study consisting of 2 periods separated by a washout period of 14 days or more.

Detailed description:
Single-centre, open-label, randomised, two-way cross-over study consisting of 2 periods separated by a washout period of 14 days or more. In one period, subjects received three single-doses of 1 g paracetamol separated by 6 hours and 1.5 hours after the last paracetamol dose a single-dose of 50 mg OPC was administered.In the other period, a single-dose of 50 mg OPC was administered alone.

Arms: arm 1: Period 1 BIA 9-1067 (Opicapone, OPC) + Paracetamol; Period 2 BIA 9-1067 (Opicapone, OPC) arm 2: Period 1 BIA 9-1067 (Opicapone, OPC) Period 2 BIA 9-1067 (Opicapone, OPC) + Paracetamol;
Interventions: intervention 1: BIA 9-1067 intervention 2: Paracetamol
Intervention descriptions: intervention 1: BIA 9-1067 50 mg intervention 2: Paracetamol 1g

Protocol documents:
Clinical trial NCT02305329
Conditions: Epilepsy
Sponsor: Bial - Portela C S.A.
Start date: 2014-02-01; Completion date: 2014-04-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Single-centre, open-label, randomized, two-sequence, two-way crossover study. The study consisted of two consecutive single-dose treatment periods separated by a washout period of 10 to 14 days or more.

Detailed description:
Single-centre, open-label, randomized, two-sequence, two-way crossover study. The study consisted of two consecutive single-dose treatment periods separated by a washout period of 10 to 14 days or more. In Group 1 the volunteers received a single oral dose of 25 mg OPC. In Group 2 the volunteers received a single oral dose of 50 mg OPC

Arms: arm 1: Period 1 - 5x5 mg OPC Period 2 - 1x25 mg OPC arm 2: Period 1 - 1x25 mg OPC Period 2 - 5x5 mg OPC arm 3: Period 1 - 2x25 mg OPC Period 2 - 1x50 mg OPC arm 4: Period 1 - 1x50 mg OPC Period 2 - 2x25 mg OPC
Interventions: intervention 1: BIA 9-1067
Intervention descriptions: intervention 1: None

Protocol documents: