ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01852175
Conditions: Coronary Artery Disease
Keywords: Coronary artery disease Dual antiplatelet therapy prasugrel ticagrelor
Sponsor: University of Florida
Start date: 2012-01-01; Completion date: 2014-07-01
Enrollment: 110 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Recently, two P2Y12 receptor inhibitors have been approved for clinical use: prasugrel and ticagrelor. Both prasugrel and ticagrelor have shown to be associated with more potent antiplatelet effects compared with clopidogrel and are associated with an improved net clinical benefit. However, to date there are limited head-to-head comparisons of these two new agents.

Detailed description:
Dual antiplatelet therapy consisting of aspirin and clopidogrel is the cornerstone of treatment for prevention of thrombotic events in patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI). However, there are a considerable number of patients who continue to have recurrent ischemic events despite this treatment regimen. These observations underscore the need for more potent antiplatelet therapies. Recently, two P2Y12 receptor inhibitors have been approved for clinical use: prasugrel and ticagrelor. Both prasugrel and ticagrelor have shown to be associated with more potent antiplatelet effects compared with clopidogrel. These more favorable pharmacodynamic effects translate into reduced ischemic event rates, at the expense of an increased risk of bleeding in patients with acute coronary syndromes. Overall, these drugs are associated with an improved net clinical benefit. These findings from large-scale clinical investigations have led to approval of prasugrel and ticagrelor. However, to date there are limited head-to-head comparisons of these two new agents.

Arms: arm 1: Prasugrel 60mg loading dose and 10 mg maintenance dose arm 2: Ticagrelor 180mg loading dose and 90mg bid maintenance dose
Interventions: intervention 1: Prasugrel intervention 2: Ticagrelor
Intervention descriptions: intervention 1: Prasugrel 60mg loading dose and 10mg maintenance dose intervention 2: Ticagrelor 180mg loading dose and 90mg bid maintenance dose

Protocol documents:
Clinical trial NCT01856686
Conditions: ADD ADHD
Keywords: ADD ADHD Proteins Dietary Nutrition QEEG ERP ICA
Sponsor: Spanish Foundation for Neurometrics Development
Start date: 2013-12-01; Completion date: 2014-07-01
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Multicenter, Prospective, randomized, comparative and controlled study about the beneficial effects in behavior and brain connectivity of different dietary patterns in 100 children with ADHD between 7 and 12 years, followed up for 3 months of nutritional therapy.

Detailed description:
The investigators collect electroencephalogram (EEG), event related potentials (ERP) data, and behavior parameters in ADD/ADHD children that not take stimulants or other drugs during study. They would only follow some nutritional recommendations based on increasing the amount of dietary protein and fast carbohydrates decrease. The duration of the study will be 6 months, 3 months for recruitment and 3 months for dietary treatment.

Arms: arm 1: This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes. arm 2: the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements
Interventions: intervention 1: BP22042013 intervention 2: Low carbohydrate diet
Intervention descriptions: intervention 1: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes. intervention 2: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements

Protocol documents:
Clinical trial NCT01871285
Conditions: Pain
Keywords: ATC, Opioid, withdrawal, switch
Sponsor: BioDelivery Sciences International
Start date: 2013-06-01; Completion date: 2014-07-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary aim of this study is to determine if chronic pain subjects on around-the-clock opioids who are receiving 100 to 220 mg oral morphine sulfate equivalent (MSE) can be safely transitioned on to buprenorphine hydrochloride (HCl) buccal film at 50% of their MSE dose without inducing opioid withdrawal or reversing analgesic effects.

Detailed description:

Arms: arm 1: Morning and evening dose of buprenorphine HCl buccal film (300 μg) + placebo capsule in one period, and then placebo film + over-encapsulated ATC opioid (morphine sulfate or oxycodone) at 50% MSE daily dose in the alternate period arm 2: Morning and evening dose of buprenorphine HCl buccal film (450 μg) + placebo capsule in one period, and then placebo film + over-encapsulated ATC opioid (morphine sulfate or oxycodone) at 50% MSE daily dose in the alternate period
Interventions: intervention 1: Buprenorphine intervention 2: Placebo film intervention 3: Oxycodone intervention 4: Morphine sulfate intervention 5: Placebo capsule
Intervention descriptions: intervention 1: None intervention 2: Matching placebo buccal film intervention 3: Oxycodone extended-release (ER) or immediate-release (IR) 5, 10, 15, 20, and 30 mg over-encapsulated oral tablets intervention 4: Morphine sulfate 15, 30, and 60 mg ER or 15 and 30 mg IR over-encapsulated oral tablets intervention 5: Oral placebo capsules matching the over-encapsulated morphine sulfate and oxycodone tablets

Protocol documents:
Clinical trial NCT01885910
Conditions: Acne Vulgaris
Sponsor: Derm Research, PLLC
Start date: 2013-07-01; Completion date: 2014-07-01
Enrollment: 32 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This pilot study will explore if continuation of treatment of treatment with Aczone 5% gel following combination treatment with with doxycycline and Aczone 5% gel can maintain therapeutic response.

Detailed description:
This is a two-center, open-label pilot study. The study is apprised of 7 study visits: Baseline and Weeks 4, 8, 12, 16, 20 and 24. All subjects will receive Aczone 5% gel BID and doxycycline 100mg by mouth once daily at Baseline. Those subjects achieving treatment response (i.e., IGA of 0, 1 or 2) at Week 12 will continue treatment with Aczone 5% gel BID at Week 12. Subjects not achieving treatment response will discontinue study participation.

Arms: arm 1: Subjects will start treatment with doxycycline 100mg once daily and Aczone 5% gel applied to the face twice daily and those who improve significantly are continued on Aczone gel alone to see if it can maintain therapeutic response
Interventions: intervention 1: Doxycycline 100mg intervention 2: Aczone 5% gel
Intervention descriptions: intervention 1: Doxycycline 100mg by mouth once daily intervention 2: Aczone 5% gel twice daily

Protocol documents:
Clinical trial NCT01900249
Conditions: Keratoconjunctivitis Sicca
Sponsor: Rigel Pharmaceuticals
Start date: 2013-07-01; Completion date: 2014-07-01
Enrollment: 204 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether 0.2% and 0.5% R348 Ophthalmic Solutions are safe and effective in the treatment of Patients with Keratoconjunctivitis Sicca.

Detailed description:

Arms: arm 1: R348 Ophthalmic Solution, 0.2% arm 2: R348 Ophthalmic Solution, 0.5% arm 3: Placebo Ophthalmic Solution, 1 drop per eye twice a day for 12 weeks.
Interventions: intervention 1: R348 Ophthalmic Solution, 0.2% intervention 2: R348 Ophthalmic Solution, 0.5% intervention 3: Placebo
Intervention descriptions: intervention 1: R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks. intervention 2: R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks. intervention 3: Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks.

Protocol documents:
Clinical trial NCT01911273
Conditions: Carcinoma, Hepatocellular
Keywords: Hepatocellular carcinoma monoclonal antibody ALK-1 best supportive care
Sponsor: Pfizer
Start date: 2013-10-01; Completion date: 2014-07-01
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of the study is to explore whether treatment with PF-03446962 and best supportive care is better than placebo plus best supportive care in prolonging survival of patients affected by recurrent liver cancer. In addition, the study will explore if adding PF-03446962 to best supportive care is safe, how PF-03446962 is metabolized, if there are patients' characteristics (biomarkers) that may predict response to PF-03446962, and if PF-03446962 has any effect on the patients' quality of life.

Detailed description:
This study was terminated on June 24th, 2014 due to change in strategy of PF-03446962 clinical development. There were no safety or efficacy concerns regarding the study behind the decision to terminate the trial. The study was on temporary halt since March 10th and there are currently no patients on treatment or in the process of being randomized

Arms: arm 1: None arm 2: Placebo, IV, every 2 weeks, until disease progression, patient refusal or unacceptable toxicity, whichever occurs first
Interventions: intervention 1: PF-03446962 intervention 2: Best Supportive Care intervention 3: Placebo intervention 4: Best Supportive Care
Intervention descriptions: intervention 1: PF 03446962 7 mg/kg, IV, every 2 weeks, until disease progression, patient refusal or unacceptable toxicity, whichever occurs first intervention 2: BSC may include medications and supportive measures deemed necessary to palliate disease related symptoms and improve quality of life intervention 3: Placebo will consist of Saline (0.9% w/v Sodium Chloride Injection, USP or NS) intervention 4: BSC may include medications and supportive measures deemed necessary to palliate disease related symptoms and improve quality of life.

Protocol documents:
Clinical trial NCT01936896
Conditions: Acute Myocardial Infarction
Keywords: Acute myocardial infarction Heart Failure Inflammation
Sponsor: Virginia Commonwealth University
Start date: 2013-12-01; Completion date: 2014-07-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Acute myocardial infarction is characterized by an intense inflammatory response.

The degree of the response influences clinical outcome, with 'more' inflammation promoting heart failure. In this study we plan to determine whether treatment with plasma derived alpha-1 antitrypsin will quench the inflammatory response in patients with acute ST-segment elevation myocardial infarction (STEMI).

Detailed description:

Arms: arm 1: We will use plasma derived AAT 60 mg/Kg, single infusion, within 12 hours of hospital admission for ST-segment elevation myocardial infarction (STEMI)
Interventions: intervention 1: Alpha 1-Antitrypsin
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01937507
Conditions: Metastatic Breast Cancer
Sponsor: Western Regional Medical Center
Start date: 2012-12-01; Completion date: 2014-07-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Deliver oxliplatin and 5-FU via HAI to breast cancer patients with liver-only or liver-predominant metastases who have failed at least one line of systemic chemotherapy in metastatic setting.

Detailed description:
In this pilot study, the investigators will deliver oxliplatin and 5-FU via HAI to breast cancer patients with liver-only or liver-predominant metastases who have failed at least one line of systemic chemotherapy in metastatic setting. The investigators hypothesize that HAI chemotherapy will be able to convert some patients to surgical resection candidates, or/and to overcome chemo-resistance of liver metastases to systemic i.v. chemotherapy for some clinically fit, heavily pre-treated patients.

Arms: arm 1: Hepatic Artery Infusion with Oxaliplatin, 5FU, and Folinic Acid
Interventions: intervention 1: HAI with FOLFOX
Intervention descriptions: intervention 1: HAI with FOLFOX q 3 weeks

Protocol documents:
Clinical trial NCT01942785
Conditions: Major Depressive Disorder Irritability
Sponsor: H. Lundbeck A/S
Start date: 2013-10-01; Completion date: 2014-07-01
Enrollment: 55 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To explore the anti-impulsive and anti-aggressive properties of brexpiprazole in a naturalistic setting of depressed patients with irritability.

Detailed description:

Arms: arm 1: Brexpiprazole adjunct to open-label commercially available Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin Norepinephrine Reuptake Inhibitor (SNRI) antidepressant treatment (ADT)
Interventions: intervention 1: Brexpiprazole
Intervention descriptions: intervention 1: 2-3 mg/day, once daily dose, tablets, for oral use. The patients received 1mg/day brexpiprazole during Week 1 and 2mg/day during Week 2 (up-titration) and from Weeks 3 to 6 they received 3mg/day; depending on tolerability the dose could be reduced to 2mg/day based on the investigator's judgement.

Protocol documents:
Clinical trial NCT01963793
Conditions: Pruritus
Keywords: Pruritus
Sponsor: LEO Pharma
Start date: 2013-10-01; Completion date: 2014-07-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Topical Aprepitant in Prurigo Patients - An Exploratory Phase IIa Trial With Topically Applied Aprepitant in Patients With Prurigo

Detailed description:

Arms: arm 1: placebo (on defined treatment area on left side of the body) / aprepitant (on defined treatment area on right side of the body) arm 2: aprepitant (on a treatment area on the left side of the body) / placebo (on a treatment area on the right side of the body)
Interventions: intervention 1: Aprepitant intervention 2: Placebo
Intervention descriptions: intervention 1: Aprepitant gel (10 mg/g) intervention 2: gel without active component

Protocol documents:
Clinical trial NCT01967069
Conditions: Psoriasis
Sponsor: Primus Pharmaceuticals
Start date: 2013-11-01; Completion date: 2014-07-01
Enrollment: 277 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objectives of this study are to compare the efficacy and safety of DFD01 Spray to Vehicle Spray for topical treatment of moderate plaque psoriasis

Detailed description:

Arms: arm 1: DFD01 Spray twice daily arm 2: Vehicle Spray twice daily
Interventions: intervention 1: DFD01 Spray intervention 2: Vehicle Spray
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01973205
Conditions: Acute Migraine
Keywords: Migraine acetaminophen aspirin
Sponsor: Novartis
Start date: 2013-10-01; Completion date: 2014-07-01
Enrollment: 900 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the efficacy and safety of acetaminophen and aspirin versus placebo in the acute treatment of migraine

Detailed description:

Arms: arm 1: 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets arm 2: 2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg
Interventions: intervention 1: Acetaminophen 250 mg and Aspirin 250 mg intervention 2: Placebo
Intervention descriptions: intervention 1: 2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg intervention 2: 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets

Protocol documents:
Clinical trial NCT01974245
Conditions: Chronic Kidney Disease
Keywords: Cholecalciferol Kidney diseases
Sponsor: Federal University of São Paulo
Start date: 2012-07-01; Completion date: 2014-07-01
Enrollment: 55 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Hypovitaminosis D is highly prevalent among patients with chronic kidney disease, especially in those undergoing dialysis. The loss of protein to the dialysis solution seems to contribute significantly to the reduced serum levels of vitamin D in these patients. As a result of the disease and the dialysis procedure, there is high prevalence of chronic inflammation and high risk of infections. There is evidence in other populations, that vitamin D has immunomodulatory effects by stimulating the production of cathelicidin, an antimicrobial peptide and suppressing the production of proinflammatory cytokines. Thus, this study aims to investigate the effects of cholecalciferol supplementation on immunological markers in patients in hemodialysis and peritoneal dialysis with hypovitaminosis D . This is a randomized, double-blind, placebo-controlled trial in which patients who have vitamin D deficiency \[25 (OH) D \<20 ng / mL\] will be allocated to the intervention group (cholecalciferol) or control (placebo). Patients will receive supplemented 100,000 IU / week cholecalciferol a period of 12 weeks. Before and after the intervention will be determined 25(OH)D, cathelicidin, interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α) and C-reactive protein serum. In monocytes, we will evaluate cathelicidin, IL-6 and TNF-α, 25(OH)D receptor and α 1-hydroxylase enzyme expression.

Detailed description:

Arms: arm 1: 100 drops/week for 12 weeks arm 2: Drug: Cholecalciferol - 100,000 IU/week
Interventions: intervention 1: Cholecalciferol intervention 2: Placebo
Intervention descriptions: intervention 1: 100,000 IU/week for 12 weeks intervention 2: 100 drops/ week for 12 weeks

Protocol documents:
Clinical trial NCT01975246
Conditions: Hypertension
Sponsor: Boehringer Ingelheim
Start date: 2013-11-01; Completion date: 2014-07-01
Enrollment: 309 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multi-centre, randomised, double-blind, active-controlled, parallel-group comparative trial to compare the fixed dose combination (FDC) of telmisartan 80 mg +hydrochlorothiazide 12.5 mg and amlodipine 5 mg (T80/A5/H12.5 mg) to telmisartan 80 mg+ amlodipine 5 mg (T80/A5 mg) in blood pressure lowering effect at week 8, the end of the double-blind period in essential hypertensive patients who fail to respond adequately to telmisartan 80 mg+ amlodipine 5 mg. Patients are assigned to one of the two groups after a 6-week open-label run-in period taking T80/A5 mg.

Detailed description:

Arms: arm 1: telmisartan 80 mg + amlodipine 5 mg fixed dose combination (FDC) and hydrochlorothiazide (HCTZ) 12.5 mg tablet arm 2: telmisartan 80 mg + amlodipine 5 mg fixed dose combination (FDC) and placebo matching hydrochlorothiazide 12.5 mg tablet
Interventions: intervention 1: Telmisartan + amlodipine intervention 2: hydrochlorothiazide intervention 3: Telmisartan + amlodipine intervention 4: Placebo
Intervention descriptions: intervention 1: FDC tablet intervention 2: tablet intervention 3: FDC tablet intervention 4: placebo matching hydrochlorothiazide tablet

Protocol documents:
Clinical trial NCT01984294
Conditions: Chronic HCV Infection
Keywords: HCV genotype 1 HCV Sustained Virologic Response Direct-Acting Antiviral Combination Therapy GS-7977 GS-5885 Ribavirin Open Label Sofosbuvir Treatment-Naive Protease Inhibitors PI Treatment experienced Cirrhotic
Sponsor: Gilead Sciences
Start date: 2013-10-01; Completion date: 2014-07-01
Enrollment: 101 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) or LDV/SOF plus GS-9669 in treatment-naive or treatment-experienced participants with chronic genotype 1 hepatitis C virus (HCV) infection. A total of 90 participants are planned to be enrolled in the study for 8 weeks of treatment, approximately 60 having had prior treatment with a regimen containing pegylated interferon (PEG) and RBV for ≥ 12 weeks. Randomization will be stratified by treatment-naive versus treatment-experienced and by HCV genotype (1a versus 1b).

Detailed description:

Arms: arm 1: Participants will receive LDV/SOF plus RBV for 8 weeks. arm 2: Participants will receive LDV/SOF plus GS-9669 250 mg for 8 weeks. arm 3: Participants will receive LDV/SOF plus GS-9669 500 mg (2 x 250 mg) for 8 weeks.
Interventions: intervention 1: LDV/SOF intervention 2: RBV intervention 3: GS-9669
Intervention descriptions: intervention 1: Ledipasvir/sofosbuvir (LDV/SOF) 90/400 mg FDC tablet administered orally once daily intervention 2: Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) intervention 3: GS-9669 tablet(s) administered orally once daily

Protocol documents:
Clinical trial NCT01985321
Conditions: Recurrent Herpes Labialis
Keywords: herpes labialis cold sore
Sponsor: Topical Remedy
Start date: 2013-11-01; Completion date: 2014-07-01
Enrollment: 469 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if Merlin, a mixture of ethanol and glycolic acid, is safe and effective in the treatment of cold sores.

Subjects who meet the requirements to participate in the study will be put randomly, and equally, into one of two groups: 1) a group receiving Merlin to treat their cold sore; or 2)a group receiving a placebo of just ethanol to treat their cold sore. Neither the subject nor the site will know which treatment they will be getting. Once the subject has been assigned to a treatment group, they will be given a kit containing a bottle of the treatment and special swabs to apply the liquid. The subject will be told to take the kit home and wait until they think they are starting to get a cold sore.

Once a subject begins to feel something or see something that they think is the start of a cold sore, they are to immediately call the clinic. Once the clinic confirms that the subject is in fact starting to get a cold sore, the subject will be told to open the kit and begin treatment. From the start of treatment, there will be twelve (12) treatments, with either Merlin or placebo, applied six (6) hours apart, up to 3 per day, over the next 96 hours (4 days). Each treatment of Merlin or placebo is made up of three (3) applications given twenty (20) minutes apart, for a total of thirty-six (36) applications. FOr each application, the subject will use the special swab to put the Merlin or placebo solution on their cold sore.

Subjects will need to report daily to the clinic for a minimum of 3 consecutive days, until either the cold sore is completely healed or 14 days from the start of treatment, whichever comes first. At each clinic visit the cold sore will be observed to determine at what stage it is at or if it has healed. The subject will also be asked how they are feeling.

Subjects will also be told to record in a diary the time of each application of Merlin or placebo. They will also be asked to record how much pain, if any, related to the cold sore, that they are feeling.

Detailed description:

Arms: arm 1: 36 applications over a 96 hour period arm 2: 36 applications over a 96 hour period
Interventions: intervention 1: ethanol/glycolic acid solution intervention 2: Placebo/Ethanol
Intervention descriptions: intervention 1: ethanol/glycolic acid solution intervention 2: ethanol solution

Protocol documents: