ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02596451
Conditions: Osteoarthritis
Sponsor: Glenmark Pharmaceuticals Ltd. India
Start date: 2015-08-01; Completion date: 2016-03-01
Enrollment: 1164 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Therapeutic Equivalence of Diclofenac Sodium Gel, 1% (Glenmark Pharmaceuticals Ltd) to Voltaren® Gel (Diclofenac Sodium topical gel) 1% (Novartis Consumer Health, Inc) in Patients with Osteoarthritis (OA) of the Knee

Detailed description:

Arms: arm 1: apply gel to the target knee arm 2: apply gel to the target knee arm 3: apply gel to the target knee
Interventions: intervention 1: Diclofenac Sodium gel, 1% intervention 2: Voltaren® Gel intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02656420
Conditions: Environmental Carcinogenesis
Sponsor: Johns Hopkins Bloomberg School of Public Health
Start date: 2016-01-01; Completion date: 2016-03-01
Enrollment: 170 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will examine the extent to which lower doses of a broccoli-derived beverage enhance the detoxication of air pollutants excreted in urine as compared to an maximal dose shown to be effective previously.

Detailed description:
This is a 10-day placebo control Phase II broccoli sprout intervention to be conducted in Qidong, P.R. China. Up to twelve hundred people from the farming townships will be screened and one hundred seventy eligible individuals will be enrolled in the study. Participants will be randomized into 4 treatment groups: one will receive a juice beverage containing a standard dose of glucoraphanin- and sulforaphane-rich broccoli sprout powder mixed in pineapple juice, lime juice and water, the second will receive one-half dose, the third one-fifth dose and the fourth group will receive placebo beverage containing pineapple juice, lime juice and water. Participants will drink their assigned beverage every evening and provide consecutive 12-hour urine collections throughout the duration of the study.

Arms: arm 1: Beverage (100 mL) containing pineapple juice, lime juice and water. Nightly for 10 days. arm 2: Beverage (100 mL) containing glucoraphanin-rich (600 micromole) and sulforaphane-rich (40 micromole) broccoli sprout powder mixed in pineapple juice, lime juice and water. Nightly for 10 days. arm 3: Beverage (100 mL) containing glucoraphanin-rich (300 micromole) and sulforaphane-rich (20 micromole) broccoli sprout powder mixed in pineapple juice, lime juice and water. Nightly for 10 days. arm 4: Beverage (100 mL) containing glucoraphanin-rich (120 micromole) and sulforaphane-rich (8 micromole) broccoli sprout powder mixed in pineapple juice, lime juice and water. Nightly for 10 days.
Interventions: intervention 1: Broccoli Sprout-derived Beverage intervention 2: Placebos
Intervention descriptions: intervention 1: Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebos. intervention 2: Placebo as comparison to broccoli sprout-derived beverages

Protocol documents:
Clinical trial NCT02667704
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2016-02-01; Completion date: 2016-03-01
Enrollment: 13 participants; Allocation: NON_RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The trial was designed to investigate whether, and to which extent, multiple doses of bosentan may influence the plasma levels of nintedanib administered as a single dose.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Bosentan intervention 2: Nintedanib
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02670343
Conditions: Hypogonadism
Sponsor: Clarus Therapeutics, Inc.
Start date: 2016-01-01; Completion date: 2016-03-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
An open-label, single oral TU dose study was conducted in eight (8) hypogonadal men at a single study site. Each study participant received a single oral TU dose immediately prior to a standardized breakfast meal comprised of 800 to 1000 calories and approximately 30 g of fat. Blood samples were collected 30 minutes prior dose administration and at 0 pre-dose and post dose at the following hours post-dose; 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours.

Detailed description:
This open-label, single oral dose, phlebotomy study was designed to clarify the issue of the influence of blood collection tubes on T, DHT, TU and DHTU measurements by collecting blood samples into various collection tubes from a small number of hypogonadal men dosed with a single oral TU dose in the form of a SEDDS formulation.

Arms: arm 1: A single dose of oral testosterone undecanoate equivalent to 200 mg of testosterone in the form of two soft gelatin capsules containing 158 mg of testosterone undecanoate will be administered to each subject.
Interventions: intervention 1: Oral Testosterone Undecanoate
Intervention descriptions: intervention 1: Subjects will receive a single dose containing 158 mg of testosterone undecanoate, equivalent to 200 mg testosterone.

Protocol documents:
Clinical trial NCT02679469
Conditions: Alcohol Dependence
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2016-02-01; Completion date: 2016-03-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The safety, tolerability, and pharmacokinetics of nalmefene at a single oral dose of 10 mg in healthy Japanese male subjects will be evaluated.

Detailed description:

Arms: arm 1: nalmefene 10 mg tablet
Interventions: intervention 1: nalmefene hydrochloride 10 mg
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02690727
Conditions: Healthy
Keywords: Fasting Fed condition Pharmacokinetics
Sponsor: Rhizen Pharmaceuticals SA
Start date: 2016-02-01; Completion date: 2016-03-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a single centre, open label, randomized, two-treatment, two-period, two-sequence, single dose crossover food effect study in 18 subjects. The subjects will receive the study medication under either fed or fast during each treatment period.

Detailed description:
The present study will be conducted in healthy male volunteers. A single oral dose will be administered to the subject in each treatment period (under either fasting or fed state). Each treatment period will be separated by at least 7 calendar days. Post dose PK blood samples will be collected in each treatment period to evaluate the food effect on bioavailability of RP6530. The safety and tolerability of single dose will also be evaluated.

Arms: arm 1: A single dose of RP6530 following fast condition arm 2: A single dose of RP6530 following fed condition
Interventions: intervention 1: RP6530
Intervention descriptions: intervention 1: Single oral dose

Protocol documents:
Clinical trial NCT02822287
Conditions: Common Cold
Sponsor: GlaxoSmithKline
Start date: 2016-02-01; Completion date: 2016-03-01
Enrollment: 58 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a 1-treatment arm, open label design. This 1-day study includes a screening on day of attendance at clinic, followed by a washout period of 30 minutes to 8 hours (if participants are eligible for dosing the same day). The study also includes a supervised dosing with 10 mL oral solution and a 1 hour in-clinic evaluation period.

Detailed description:

Arms: arm 1: Participants will be orally administered with the clear oral solution containing 2% acetylcysteine (g/mL) in a 100 mL amber glass bottle over 1 minute or less using an oral syringe.
Interventions: intervention 1: Acetylcystine
Intervention descriptions: intervention 1: Clear oral solution containing 2% acetylcysteine (g/mL) in a 100 mL amber glass bottle.

Protocol documents:
Clinical trial NCT02848729
Conditions: Pain
Keywords: Post-surgical pain Pharmacokinetics
Sponsor: Mallinckrodt
Start date: 2016-02-01; Completion date: 2016-03-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Morphine is the opioid used to treat pain after surgery. Acetaminophen (called APAP) can reduce the amount of opioids needed for this.

The problem is that morphine slows down digestion. That can delay pain relief from APAP pills. It can even change what the body does to the drug \[pharmacokinetics (PK)\].

Some doctors have started using intravenous (IV) APAP with morphine, instead of the pills.

This study will measure the PK of APAP pills and IV when used with morphine in healthy volunteers.

IV APAP will likely be more effective and cause fewer side effects when used with morphine to treat pain after surgery.

Detailed description:
Acetaminophen can significantly reduce the use of opioid analgesics when both are used concomitantly for treating moderate to severe pain. The use of IV acetaminophen used concomitantly with opioids has increased in practice for postsurgical pain relief over orally administered acetaminophen because it provides an immediate peak plasma concentration and is believed to provide a faster analgesic effect. Opioids used to treat pain inhibit gastrointestinal motility, including delaying gastric emptying. In patients receiving opioids the absorption of orally administered acetaminophen may be delayed and could result in gastric accumulation of acetaminophen thereby markedly changing the pharmacokinetic profile. The opioid-induced inhibition of gastrointestinal motility would not be expected to affect IV acetaminophen pharmacokinetics. Thus coadministered IV acetaminophen with opioid would yield better outcome in efficacy and reduced risk of side effects comparing with coadministration of oral acetaminophen and opioids.

Arms: arm 1: Treatment A = 4 repeat doses of 1,000 mg oral acetaminophen (2 x 500 mg tablets) and an IV infusion of saline every 6 hours (Hours -6, 0, 6, and 12), and 2 infusions of intravenous (IV) morphine (0.125 mg/kg) at Hours 0 and 6 arm 2: Treatment B = 4 repeat doses of IV acetaminophen (1,000 mg/100 mL) and 2 placebo tablets every 6 hours (Hours -6, 0, 6, and 12), and 2 infusions of IV morphine (0.125 mg/kg) at Hours 0 and 6.
Interventions: intervention 1: Oral Acetaminophen intervention 2: IV Acetaminophen intervention 3: IV Morphine intervention 4: Placebo Tablets intervention 5: Saline
Intervention descriptions: intervention 1: Acetaminophen for oral administration (2 tablets, 500 mg/tablet) intervention 2: Acetaminophen for intravenous (IV) administration (1,000 mg/100 mL) intervention 3: Morphine for IV administration (0.125 mg/kg) intervention 4: Placebo tablets matching oral acetaminophen intervention 5: Saline placebo matching IV acetaminophen

Protocol documents:
Clinical trial NCT03031795
Conditions: Contraception
Keywords: intrauterine device
Sponsor: OhioHealth
Start date: 2014-07-01; Completion date: 2016-03-01
Enrollment: 71 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Ketorolac is a non-steroidal anti-inflammatory drug (NSAID), similar to ibuprofen but it is used to treat more severe pain. Ketorolac (Trade name: Toradol) is typically used after surgical procedures. When taken orally, it should not cause sedation. The purpose of this study is to determine if oral ketorolac is effective at reducing pain during IUD placement versus a placebo tablet.

Detailed description:
In the United States, 10% of women choose an intrauterine device (IUD) for contraception. With typical use, unintended pregnancy rates in the first year of IUD contraception are 0.8% (Copper T) and 0.2% (LNG). It is known that long-acting, reversible contraception methods reduce the long-term cost of unintended pregnancies. A common deterrent to intrauterine contraception is the fear of pain during placement. Methods of pain relief during IUD insertion must be fast-acting but have minimal sedation. There have been many attempts to find effective pain relief during IUD placement. Neither ibuprofen nor naproxen have been shown to be effective in reducing pain. Misoprostol has been used to increase cervical ripening; however, pain was not decreased, and side effects of nausea and vomiting were increased. Ketorolac is a nonsteroidal anti-inflammatory drug (NSAID) that works by reversibly inhibiting cyclooxygenase-1 and 2.Time to peak plasma concentration ketorolac in the oral form is 44 minutes. Studies have shown that one dose of ketorolac can be as potent as morphine. Ketorolac is also well established for pain control in the immediate post-operative period. A recent study showed that intramuscular ketorolac wais effective in reducing pain after IUD insertion, but 20% of the participants reported that after the procedure, the injection site was as painful as the IUD placement. The current study was designed to evaluate if there is reduced pain during IUD placement using oral ketorolac 40-60 minutes before the procedure compared to a placebo.

Arms: arm 1: ketorolac, oral, 20 mg, 1 dose, 45 minutes prior to IUD placement arm 2: look alike placebo
Interventions: intervention 1: Ketorolac intervention 2: Placebo
Intervention descriptions: intervention 1: Oral Tablet intervention 2: Oral Tablet

Protocol documents:
Clinical trial NCT04079517
Conditions: Breast Cancer Mammographic Density
Keywords: Tamoxifen Low-dose Randomized Clinical Trial
Sponsor: Karolinska Institutet
Start date: 2015-03-01; Completion date: 2016-03-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A feasibility study, randomising to either 10 or 20 mg of tamoxifen. The primary aim is to identify the time to mammographic density change and piloting the procedures. It is known that a density change is seen after 12 months of 20 mg of tamoxifen, but the clinical experience indicates that an effect of drugs influencing mammographic density could be seen already after a few months. The second aim is to evaluate if there is a density change from 10 mg of tamoxifen equivalent to 20 mg.

Detailed description:
The investigators want to conduct a feasibility study including 42 women who will be randomised to either 10 or 20 mg of daily oral tamoxifen. The primary aim of the study is to identify the time to mammographic density change and piloting the procedures. It is known that a density change is seen after 12 months of 20 mg of daily tamoxifen, but the clinical experience indicates that an effect of drugs influencing mammographic density could be seen already after a few months. The second aim of the pilot study is to see if there is a density change from 10 mg of tamoxifen equivalent to 20 mg and if there is a difference in adverse reactions between the two doses. Interim analysis will be performed at 6 months, monitoring both safety and level of mammographic density change.

Arms: arm 1: Randomised dose of daily oral Tamoxifen 10mg, for 180 days arm 2: Randomised dose of daily oral Tamoxifen 20mg, for 180 days
Interventions: intervention 1: Tamoxifen
Intervention descriptions: intervention 1: A registered SERM drug, Tamoxifen.

Protocol documents:
Clinical trial NCT01994720
Conditions: Acute Ischaemic Stroke Transient Ischaemic Attack
Keywords: Acute ischaemic stroke. Transient ischaemic attack.
Sponsor: AstraZeneca
Start date: 2014-01-07; Completion date: 2016-03-02
Enrollment: 13307 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to compare the effect of 90-day treatment with ticagrelor (180 mg \[two 90 mg tablets\] loading dose on Day 1 followed by 90 mg twice daily maintenance dose for the remainder of the study) vs acetylsalicylic acid (ASA)-aspirin (300 mg \[three 100 mg tablets\] loading dose on Day 1 followed by 100 mg once daily maintenance dose for the remainder of the study) for the prevention of major vascular events (composite of stroke, myocardial infarction \[MI\], and death) in patients with acute ischaemic stroke or transient ischaemic attack (TIA).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: ticagrelor intervention 2: Acetylsalicylic acid (ASA)
Intervention descriptions: intervention 1: ticagrelor, 180 mg (two tablets of 90 mg) loading dose on Day 1 followed by 90 mg twice daily. intervention 2: ASA, 300 mg (three tablets of 100 mg) on Day 1, followed by 100 mg once daily.

Protocol documents:
Clinical trial NCT01828476
Conditions: Prostate Cancer
Keywords: prostate cancer hormone-resistant prostate cancer recurrent prostate cancer stage IV prostate cancer
Sponsor: Rutgers, The State University of New Jersey
Start date: 2013-06-01; Completion date: 2016-03-03
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the effect of combining abiraterone with medicines that may block some of the ways that cells become resistant to abiraterone. The investigators hope that these combinations of medicines will result in prostrate cancer cells dying.

This study will see if overcoming diseases resistance to abiraterone will restore sensitivity to androgen deprivation therapy.

Detailed description:
Subjects will be either treated on one of the earlier dosing regimens or randomly assigned to one of two groups or ARMs of this study.

ARM A will receive Abiraterone with ABT-263.

ARM B will receive Abiraterone with both ABT-263 and Hydroxychloroquine

In the beginning of the study a total of 18 patients may get one of three dose levels. A total of nine (9) patients per each arm will be started at a low dose and given increasing doses if no side effects are seen. In this part of the study three patients will be enrolled at each dose level for each individual arm starting with Arm A followed by Arm B.

Arms: arm 1: Abiraterone with ABT-263 arm 2: Abiraterone with both ABT-263 and Hydroxychloroquine
Interventions: intervention 1: Abiraterone intervention 2: ABT-263 intervention 3: Hydroxychloroquine
Intervention descriptions: intervention 1: ARM A(Abiraterone with ABT-263) and ARM B(Abiraterone with both ABT-263 and Hydroxychloroquine) intervention 2: ARM A(Abiraterone with ABT-263) and ARM B(Abiraterone with both ABT-263 and Hydroxychloroquine) intervention 3: ARM B(Abiraterone with both ABT-263 and Hydroxychloroquine)

Protocol documents:
Clinical trial NCT01173016
Conditions: Hurler Syndrome
Keywords: mucopolysaccharide IH (MPS IH)
Sponsor: Masonic Cancer Center, University of Minnesota
Start date: 2012-05-29; Completion date: 2016-03-04
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a single center pilot study in which Laronidase will be given weekly for two years in patients with Hurler syndrome, also known as mucopolysaccharide IH (MPS I, Hurler syndrome), that have previously been treated with an allogeneic transplant.

Detailed description:
This 2-year open-label pilot study of laronidase includes patients (age 5-13 years) who are at least 2 years post-hematopoietic cell transplantation (HCT) and donor engrafted. Outcomes are assessed semi-annually and compared to historic controls. Eligible patients will receive Laronidase as an infusion over several hours once a week at a local site. The dosing of enzyme will be the standard doses recommended by Genzyme.

The findings of this Pilot Study will be used to assess whether a subsequent larger study can be conducted.

Arms: arm 1: Patients with Mucopolysaccharidosis type IH (MPS I, Hurler syndrome) treated with a prior allogeneic transplant \>2 years previously and treated with Laronidase weekly for 2 years after transplant.
Interventions: intervention 1: Laronidase
Intervention descriptions: intervention 1: Laronidase 0.58 mg/kg intravenously (IV) once a week for a maximum of 2 years

Protocol documents:
Clinical trial NCT02397707
Conditions: HCV Infection
Sponsor: Gilead Sciences
Start date: 2015-03-24; Completion date: 2016-03-04
Enrollment: 33 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of a single dose of voxilaprevir (formerly GS-9857) in participants with normal hepatic function, moderate hepatic impairment and severe hepatic impairment. Participants in the healthy control group will be matched to participants with impaired hepatic function by gender, age (± 10 years), and body mass index (± 15%).

Detailed description:

Arms: arm 1: Participants with moderate hepatic impairment and matched healthy controls will receive a single dose of voxilaprevir on Day 1. arm 2: Participants with severe hepatic impairment and matched healthy controls will receive a single dose of voxilaprevir on Day 1.
Interventions: intervention 1: Voxilaprevir
Intervention descriptions: intervention 1: 100 mg tablet administered orally

Protocol documents:
Clinical trial NCT02750943
Conditions: Gingivitis
Sponsor: GlaxoSmithKline
Start date: 2015-11-01; Completion date: 2016-03-04
Enrollment: 253 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This will be a single-center, 12 week, examiner-blind, randomized, stratified (gender and baseline mean whole mouth MGI score), two-treatment, parallel group, clinical study in healthy adult volunteers with moderate gingivitis. This study will evaluate the efficacy of a dentifrice containing 0.454% weight by weight (w/w) stannous fluoride to control gingivitis and gingival bleeding following 12 weeks twice daily brushing, compared to a negative control dentifrice.

Detailed description:

Arms: arm 1: Participants will apply a full ribbon of dentifrice containing 0.454% w/w stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) arm 2: Participants will apply a full ribbon of dentifrice containing Dentifrice containing 1000ppm fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening)
Interventions: intervention 1: Stannous Fluoride intervention 2: Sodium Monofluorophosphate
Intervention descriptions: intervention 1: Dentifrice containing 0.454% w/w stannous fluoride intervention 2: Dentifrice containing 1000ppm fluoride as sodium monofluorophosphate

Protocol documents:
Clinical trial NCT01678898
Conditions: Fabry Disease
Keywords: Fabry disease Alpha galactosidase deficiency Metabolic storage disease
Sponsor: Protalix
Start date: 2012-10-01; Completion date: 2016-03-06
Enrollment: 18 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is the first human treatment with PRX-102, an enzyme being developed as a long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease (alpha galactosidase deficiency). The safety, tolerability, and exploratory efficacy will be evaluated in this study of increasing doses. Patients will be treated with infusions every two weeks for 12 months.

Detailed description:
Under the PB-102-F01 study protocol, patients will be enrolled into one of three PRX-102 dosing groups (0.2 mg/kg, 1.0 mg/kg, 2.0 mg/kg) and receive PRX-102 as an intravenous infusion every 2 weeks for 12 weeks (3 months). Patients who finish the PB-102-F01 study will be enrolled in the PB-102-F02 extension study and receive the same dose they had received in the PB-102-F01 study for an additional 38 weeks (9 months).

Arms: arm 1: PRX-102 0.2 mg/kg every 2 weeks arm 2: PRX-102 1 mg/kg every 2 weeks arm 3: PRX-102 2 mg/kg every 2 weeks
Interventions: intervention 1: PRX-102
Intervention descriptions: intervention 1: None

Protocol documents: