ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01379508
Conditions: Chronic Hepatitis B
Sponsor: Novartis Pharmaceuticals
Start date: 2011-03-21; Completion date: 2015-12-10
Enrollment: 241 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety following the Roadmap Concept strategy with an initial monotherapy using either telbivudine or tenofovir in HBeAg negative CHB patients. The data from the study should allow for the validation of the Roadmap concept in a prospective manner, for both telbivudine and tenofovir treated HBeAg negative CHB patients. As part of a post-approval commitment to the European Health Authorities, the data will also be used to provide an optimized clinical treatment strategy for better clinical use of telbivudine in European HBeAg negative patients. Furthermore, the data from the study will contribute to a better scientific understanding, disease management and treatment of HBeAg negative CHB patients.

Detailed description:

Arms: arm 1: telbivudine 600 mg tablet orally (p.o.) once daily for up to 156 weeks. Patients with HBV DNA ≥ 300 copies/mL at Week 24 were to initiate add-on therapy with tenofovir 300 mg tablets p.o. once daily for the remaining weeks of treatment. The investigator was to initiate tenofovir add-on therapy within 2 weeks of central laboratory confirmation. Patients with HBV DNA \< 300 copies/mL at Week 24 were to continue to receive telbivudine monotherapy arm 2: tenofovir 300 mg tablets p.o. once daily for up to 156 weeks. Patients with HBV DNA ≥ 300 copies/mL at Week 24 were to initiate add-on therapy with telbivudine 600 mg tablet p.o. once daily for the remaining weeks of treatment. The investigator was to initiate telbivudine add-on therapy within 2 weeks of central laboratory confirmation. Patients with HBV DNA \< 300 copies/mL at Week 24 were to continue to receive tenofovir monotherapy
Interventions: intervention 1: telbivudine intervention 2: tenofovir disoproxil fumarate
Intervention descriptions: intervention 1: 600 mg film-coated tablets taken as 600 mg once daily intervention 2: 300 mg tablets taken as 300 mg once daily

Protocol documents:
Clinical trial NCT02597998
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2015-09-15; Completion date: 2015-12-11
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The aim of this study is to assess the mass balance recovery from excreta of carbon 14 labelled BI409306 (\[14C\] BI 409306) in healthy, CYP2C19 genotyped subjects and to provide plasma, urine and faecal samples for metabolite profiling and structural identification.

Detailed description:

Arms: arm 1: 14C-BI 409306 oral solution
Interventions: intervention 1: 14C-BI 409306
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01446874
Conditions: Post-operative Pneumonia Lung Cancer Esophageal Cancer
Keywords: Incidence of post-operative pneumonia in patients undergoing surgery for primary lung cancer or primary esophageal cancer
Sponsor: Washington University School of Medicine
Start date: 2011-09-22; Completion date: 2015-12-13
Enrollment: 150 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Postoperative pneumonia is a major complication in patients undergoing thoracic surgery. It leads to considerable morbidity and contributes to perioperative morbidity. There is evidence in literature that supports the use of strategies for improved oral hygiene and specialized endotracheal tubes in preventing ventilator associated pneumonia (VAP) in mechanically ventilated patients. This study aims at utilizing a combination of these interventions in the perioperative period in patients undergoing planned thoracic surgical procedures.

Detailed description:

Arms: arm 1: -Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution arm 2: * Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution
* The intensive toothbrushing regimen and chlorhexidine mouthwash will be continued for the duration of the hospitalization or a minimum of 5 days postoperatively in the study group. arm 3: * Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution
* The intensive toothbrushing regimen and chlorhexidine mouthwash will be continued for the duration of the hospitalization or a minimum of 5 days postoperatively in the study group.
Interventions: intervention 1: 0.12% chlorhexidine solution
Intervention descriptions: intervention 1: Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution and for the duration of the hospitalization or 5 days postoperatively.

Protocol documents:
Clinical trial NCT02145468
Conditions: Acute Coronary Syndrome
Keywords: Myocardial infarction Acute coronary syndrome Cardiovascular disease p38 mitogen-activated protein kinase (MAPK) inhibitor NSTEMI Losmapimod STEMI
Sponsor: GlaxoSmithKline
Start date: 2014-06-03; Completion date: 2015-12-14
Enrollment: 3503 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Losmapimod is a new anti-inflammatory medication which potentially may benefit patients with Acute Coronary Syndrome, (ACS), a condition which includes heart attack. There is a growing understanding that the inflammatory response to ACS is integral to the subsequent evolution of plaque instability. Losmapimod inhibits p38 mitogen activated protein kinase (MAPK), an enzyme which may play a central role in inflammation in the setting of heart attack. Inhibition of p38 MAPK may stabilize atherosclerotic plaques, reduce the risk of subsequent plaque rupture, indirectly improve vascular function and prevent subsequent thrombosis, and thus reduce infarct size and the risk of subsequent cardiac events. This study will test whether losmapimod can safely reduce the risk of a subsequent cardiovascular event (such as death, heart attack, or near heart attack requiring urgent treatment ) when started immediately after ACS (specifically, heart attack). Patients who present with heart attack and qualify for the study will be randomly assigned to receive 3 months treatment with either losmapimod twice daily or placebo, which will be administered in addition to the usual standard of care therapies for heart attack. Following the in-hospital period, subjects will return for outpatient visits at 4 and 12 weeks, as well as a follow up visit at 24 weeks.

Detailed description:

Arms: arm 1: Losmapimod 7.5 mg twice daily oral tablet arm 2: Placebo twice daily oral tablet
Interventions: intervention 1: Losmapimod 7.5 mg twice daily intervention 2: Placebo twice daily intervention 3: Standard therapy
Intervention descriptions: intervention 1: Subjects will receive Losmapimod 7.5 mg as film-coated, round, plain faced tablets. intervention 2: Subjects will receive placebo as film-coated, round, plain faced tablets. intervention 3: Subjects will receive standard therapy consistent with the appropriate guidelines from professional societies. The standard therapy includes nitrates, morphine sulfate, beta adrenergic blockers, renin-angiotensin aldosterone inhibitors, other anti-ischemic therapies, and analgesic therapy.

Protocol documents:
Clinical trial NCT02574845
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2015-10-12; Completion date: 2015-12-14
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective of this trial is to investigate the relative bioavailability of rosuvastatin when given alone (Reference treatment, R) compared to when given together with one of the three different doses of metformin (10 mg, Test treatment 1 (T1); 50 mg (T2); 500 mg (T3)) or one of the two doses of furosemide (1 mg (T4); 5 mg (T5)).

Detailed description:

Arms: arm 1: 1film-coated tablet as single dose, fasted arm 2: Rosuvastatin: 1 film-coated tablet as single dose (10 mg), fasted / Metformin HCl (10 mg) as single dose, fasted arm 3: Rosuvastatin: 1 film-coated tablet as single dose (10 mg), fasted / Metformin HCl (50 mg) as single dose, fasted arm 4: Rosuvastatin: 1 film-coated tablet as single dose (10 mg), fasted / Metformin HCl (500 mg) as single dose, fasted arm 5: Rosuvastatin: 1 film-coated tablet as single dose (10 mg), fasted / Furosemide: (1 mg) as single dose, fasted arm 6: Rosuvastatin: 1 film-coated tablet as single dose (10 mg), fasted / Furosemide: (5 mg) as single dose, fasted
Interventions: intervention 1: Rosuvastatin intervention 2: Metformin HCl intervention 3: Furosemide
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00202644
Conditions: Thrombocythemia, Hemorrhagic
Sponsor: Shire
Start date: 2006-01-13; Completion date: 2015-12-15
Enrollment: 150 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Essential thrombocythaemia is a disorder of bone marrow, which causes too many platelets to be produced. Platelets are small cells carried around in the blood, which help form blood clots. When patients have too many platelets, there is a risk of blood clots forming unnecessarily and excessive bleeding. The aim of this study is to gain additional information on the safety profile of Anagrelide (Xagrid(r)) and Hydroxyurea (also known as hydroxycarbamide).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Anagrelide intervention 2: Hydroxyurea
Intervention descriptions: intervention 1: Anagrelide hydrochloride 0.5mg capsules;initial dose administered will be 1.0mg/day administered as 0.5mg bid. The dose will be titrated such that the total daily dose is incremented by no more than 0.5mg per week as required depending on platelet reduction versus adverse event profile. intervention 2: Hydroxyurea is 500mg hydroxycarbamide capsules; initial dose is 1000mg/day, administered in two divided doses (500mg/dose). Dose titrated to effect to achieve a response.

Protocol documents:
Clinical trial NCT01630811
Conditions: Autism
Keywords: Adults
Sponsor: Sutter Health
Start date: 2012-01-24; Completion date: 2015-12-15
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Primary: Demonstrate reduced frequency and intensity of maladaptive behaviors as measured by the Aberrant Behavior Checklist (ABC) Irritability subscale in subjects given Nuedexta 8 weeks over subjects given placebo.

Secondary: Demonstrate a trend towards reduced aggressive behavior as measured by Overt Aggression Scale (OAS).

Detailed description:
This is a randomized placebo-controlled crossover study. The parents, neuropsychologists, clinical research coordinator (CRC) and PI will be blinded as to whether subjects are on placebo or Nuedexta.

Nuedexta will be given once daily for 7 days. If well-tolerated, it will be given every 12 hours for the next 7 weeks. Patients may also remain on the once-daily dose if desired.

The study will last 44 weeks. This includes 20 weeks for study enrollment, 8 weeks of treatment/placebo, 4 weeks for washout, and a second 8 week-period of treatment/placebo followed by 4 weeks of washout.

Subjects will be randomized to 8 weeks of Nuedexta/placebo. After the 8 week follow-up visit, there will be a 4 week washout period. At week 12 (second baseline), the groups will crossover for another 8 weeks of Nuedexta/placebo. Study endpoints will be measured in the both groups at weeks 8, 12, and 20. A final study visit will occur at week 24.

Arms: arm 1: Nuedexta (Dextromethorphan hydrobromide 20 mg/quinidine sulfate 10 mg), oral, once daily arm 2: Oral, once daily
Interventions: intervention 1: Nuedexta intervention 2: Placebo
Intervention descriptions: intervention 1: Nuedexta (Dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg) will be given once daily for 7 days. If well-tolerated, it will be given every 12 hours for the next 7 weeks. intervention 2: Placebo will be given once daily for 7 days.

Protocol documents:
Clinical trial NCT01677286
Conditions: Amyloidosis
Keywords: AL Amyloidosis Primary Amyloidosis Hereditary Amyloidosis Familial Amyloidosis SSA Amyloidosis Senile Systemic Amyloidosis AA Amyloidosis Secondary Amyloidosis Localized Amyloidosis Systemic Amyloidosis
Sponsor: Boston University
Start date: 2012-07-01; Completion date: 2015-12-15
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The tetracycline antibiotic doxycycline disrupts A beta amyloid fibrils (AB) in Alzheimer's disease, transthyretin (ATTR) amyloid fibrils in familial amyloidotic polyneuropathy, and immunoglobulin light chain (AL) amyloid fibrils in transgenic mouse models of disease. If untreated, amyloid deposits impair organ function, affecting the morbidity and mortality of patients.

This single-center, twelve-month, open-label, prospective, pilot phase II study aims to determine whether doxycycline reduces amyloid deposits and improves organ function in patients with systemic or localized amyloidosis.

The investigators plan to enroll patients with measurable amyloid disease according to internationally-accepted diagnostic criteria. Patients must have stable organ function at enrollment. Eligible subjects not receiving active treatments for amyloidosis affecting their kidneys, heart, aerodigestive tracts, peripheral or autonomic nervous system(s), lungs, eyes, skin, bladder, or breasts will undergo evaluations at baseline, 6 months, and 12 months - or more frequently as clinically indicated.

Over 45 years experience indicates doxycycline is a safe, well tolerated antibiotic. The investigators will use standard grading systems to assess doxycycline response following twelve months of treatment.

Detailed description:
In transgenic animal models of disease, the tetracycline antibiotic doxycycline disrupts A beta amyloid fibrils (AB) in Alzheimer's disease, transthyretin (ATTR) amyloid fibrils in familial amyloidotic polyneuropathy, and immunoglobulin light chain (AL) amyloid fibrils.

The aim of this single-center, 12-month open label, prospective phase II study was to determine a) the safety and tolerability of prolonged full dose doxycycline in patients with amyloidosis, and b) the effect of doxycycline treatment on amyloid-induced organ dysfunction.

We enrolled 25 patients with measurable organ dysfunction caused by amyloid deposition who were not receiving active treatment to control their amyloid production. All 25 subjects received doxycycline 100 mg by both twice daily for up to 12 months depending on their tolerance of the antibiotic. The primary endpoint, defined by the organ most affected by amyloid, was measured at baseline, 6 and 12 months along with safety laboratory values.

Arms: arm 1: Open-label doxycycline 100 mg twice daily by mouth will be administered to subjects for 12 months.
Interventions: intervention 1: Doxycycline 100 mg po bid x 12 months
Intervention descriptions: intervention 1: 100mg by mouth twice daily for 1 year.

Protocol documents:
Clinical trial NCT01988103
Conditions: Psoriasis Psoriatic Arthritis Psoriasis Arthropatica
Keywords: Psoriasis; Psoriatic Arthritis
Sponsor: Amgen
Start date: 2013-07-09; Completion date: 2015-12-15
Enrollment: 254 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will test the clinical effectiveness and safety of two orally administered doses of apremilast compared to placebo in Japanese patients with moderate-to-severe plaque-type psoriasis.

Detailed description:
This is a phase 2b, multicenter, randomized, double-blind, placebo-controlled study of the efficacy and safety of apremilast 20 mg twice a day (BID), apremilast 30 mg BID, and placebo in Japanese participants with moderate to severe plaque psoriasis.

Arms: arm 1: Apremilast 20 mg tablets orally twice a day (BID) arm 2: Apremilast 30 mg tablets orally BID arm 3: Identically-appearing placebo tablets BID for 16 weeks followed by participants being re-randomized in a blinded fasion to apremilast 20 mg or 30mg tablets BID for 52 weeks
Interventions: intervention 1: Apremilast intervention 2: Apremilast intervention 3: Placebo
Intervention descriptions: intervention 1: 20 mg tablet BID for 68 weeks intervention 2: 20 mg tablet BID for 68 weeks intervention 3: Placebo tablet BID for 16 weeks

Protocol documents:
Clinical trial NCT02318693
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2015-02-04; Completion date: 2015-12-15
Enrollment: 53 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study of the efficacy of sitagliptin and glibenclamide in a short-term treatment on the glucose variability using continuous glucose monitoring (CGM) in Japanese participants with type 2 diabetes mellitus (T2DM). The primary hypothesis is that treatment with sitagliptin will be superior to treatment with glibenclamide in the change from baseline in mean amplitude of glycemic excursions (MAGE) through continuous glucose monitoring (CGM) after 13 days of treatment.

Detailed description:

Arms: arm 1: Sitagliptin 50 mg administered orally once daily before breakfast for 14 days. arm 2: Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days. TDD = Total daily dose.
Interventions: intervention 1: Sitagliptin intervention 2: Glibenclamide
Intervention descriptions: intervention 1: Sitagliptin 50 mg orally once a day before breakfast for 14 days intervention 2: Glibenclamide 1.25 mg orally twice a day (2.5 mg/day) before breakfast and dinner for 14 days

Protocol documents:
Clinical trial NCT02509624
Conditions: Diabetic Kidney Disease
Sponsor: Gilead Sciences
Start date: 2015-08-18; Completion date: 2015-12-15
Enrollment: 52 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the pharmacokinetics (PK) of selonsertib in participants with impaired hepatic function relative to matched, healthy controls.

Detailed description:

Arms: arm 1: Participants with moderate hepatic impairment and matched healthy controls will receive a single dose of selonsertib on Day 1. arm 2: Participants with severe hepatic impairment and matched healthy controls will receive a single dose of selonsertib on Day 1. arm 3: Participants with mild hepatic impairment and matched healthy controls will receive a single dose of selonsertib on Day 1.
Interventions: intervention 1: Selonsertib
Intervention descriptions: intervention 1: 6 mg tablets administered orally in fed state

Protocol documents:
Clinical trial NCT01179048
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2010-08-31; Completion date: 2015-12-17
Enrollment: 9341 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Africa, Asia, Europe, and North and South America. The aim of this trial is to determine the long term effect of liraglutide on cardiovascular events in subjects with type 2 diabetes.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: liraglutide intervention 2: placebo
Intervention descriptions: intervention 1: Maximum dose of 1.8 mg liraglutide, injected subcutaneously (under the skin) once daily. Administered in addition to the subject's standard treatment intervention 2: Maximum dose of 1.8 mg placebo, injected subcutaneously (under the skin) once daily. Administered in addition to the subject's standard treatment

Protocol documents:
Clinical trial NCT02175966
Conditions: Hepatitis C
Sponsor: Bristol-Myers Squibb
Start date: 2014-07-28; Completion date: 2015-12-17
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine whether the combination of Daclatasvir (DCV), Asunaprevir (ASV), BMS-791325 and Sofosbuvir is effective and safe in treating Hepatitis-C virus.

Detailed description:
Allocation:

Initial Therapy: Randomized Controlled Trial: Participants are assigned to intervention groups by chance

Rescue Therapy: Nonrandomized Trial: Participants are expressly assigned to intervention groups through a non-random method such as physician choice

Number of Arms:

Initial Therapy: 2 Groups

Rescue Therapy: 2 Groups

Arms: arm 1: Initial Therapy:

Daclatasvir/Asunaprevir/BMS-791325 \[30 mg (as the free base)/200 mg/75 mg (as the free base)\] film coated Fixed Dose Combination tablet twice daily orally for 4 weeks

Sofosbuvir 400 mg tablet once daily orally for 4 weeks arm 2: Initial Therapy

Daclatasvir/Asunaprevir/BMS-791325 \[30 mg (as the free base)/200 mg/75 mg (as the free base)\] film coated Fixed Dose Combination tablet twice daily orally for 6 weeks

Sofosbuvir 400 mg tablet once daily orally for 6 weeks arm 3: Daclatasvir/Asunaprevir/BMS-791325 \[30 mg (as the free base)/200 mg/75 mg (as the free base)\] film coated Fixed Dose Combination tablet twice daily orally for 12 weeks

Ribavirin 200 mg tablets twice daily (1000 or 1200 mg per day based on weight) orally for 12 weeks

With or without Peginterferon α-2a 180 µg solution for injection subcutaneously once weekly for 12 weeks arm 4: Sofosbuvir 400 mg tablet once daily orally for 12 weeks

Ribavirin 200 mg tablets twice daily (1000 or 1200 mg per day based on weight) orally for 12 weeks

Peginterferon α-2a 180 µg solution for injection subcutaneously once weekly for 12 weeks
Interventions: intervention 1: DCV/ASV/BMS-791325 intervention 2: Ribavirin intervention 3: Sofosbuvir intervention 4: Peginterferon α-2a
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT02173158
Conditions: Familial Hypercholesterolemia - Homozygous
Sponsor: Aegerion Pharmaceuticals, Inc.
Start date: 2014-04-02; Completion date: 2015-12-17
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Study to Evaluate the Efficacy and Safety of Lomitapide in Japanese Patients with Homozygous Familial Hypercholesterolemia (HoFH) on Concurrent Lipid-Lowering Therapy.

Detailed description:
This is a Phase 3, single-arm, open-label, multicenter clinical trial to evaluate both the efficacy and long-term safety of lomitapide in Japanese patients with HoFH receiving maximally-tolerated, stable lipid-lowering therapy. This study is comprised of a run-in period, a primary 26-week Efficacy Phase, and a 30-week Safety Phase.

Arms: arm 1: Maximum tolerated dose of lomitapide (up to 60mg/day) in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.
Interventions: intervention 1: lomitapide
Intervention descriptions: intervention 1: None

Protocol documents: