ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02020031
Conditions: Arthropathy of Knee Joint
Keywords: Revision knee joint
Sponsor: Mayo Clinic
Start date: 2013-12-01; Completion date: 2015-06-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether or not giving a lower dose of antibiotics (Vancomycin) in the area where it is needed (the knee joint) is more effective at preventing infection than the current standard dose which is given intravenously (IV) through a wrist vein.

Detailed description:
Patients were assigned to one of two groups by chance (like a coin toss):

* GROUP 1 - Received 500mg of vancomycin into the tibia (shin) bone of the leg being operated on.
* GROUP 2 - Received 1g of vancomycin, which is the amount normally given to patients.

For both groups, the revision knee replacement will then be carried out as normal.

OTHER ANTIBIOTICS All patients received cefazolin IV (an antibiotic used to prevent infection) prior to the beginning of surgery to ensure effective preventive antibiotics. The patient will also received 3 postoperative doses of cefazolin over a 24-hour period (4 doses in total). This is standard of care for all total knee replacement surgeries.

TISSUE SAMPLES

* Ten (10) tissue samples were taken during the surgery, consisting of both bone and fat beneath the skin. Each sample were very small, around the size of a pinhead.
* In addition, a drain sample was taken from the knee joint drain fluid to measure vancomycin concentration the morning following surgery.
* These samples were frozen and sent to a lab for analysis.

Arms: arm 1: Vancomycin 500mg is given via intraosseous regional administration (IORA) into a proximal tibial cannula, after tourniquet inflation and immediately prior to skin incision. arm 2: Vancomycin 1g is administered via forearm vein, given over a one-hour infusion, timed to finish approximately 30 minutes prior to tourniquet inflation.
Interventions: intervention 1: Vancomycin
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02030574
Conditions: Invasive Bladder Cancer Bladder Cancer
Sponsor: Brown University
Start date: 2014-07-01; Completion date: 2015-06-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The standard treatment of muscle invasive bladder cancer is to administer chemotherapy for approximately 3 months then to have surgery to remove the bladder. Chemotherapy may reduce the size of the cancer in your bladder before surgery and can also help to reduce the chance that your bladder cancer will come back (metastasize) in other parts of your body after bladder surgery.

This study will involve testing cisplatin in lower weekly doses with gemcitabine.The purpose of this study is to test the effects, good and bad, of low dose weekly cisplatin and gemcitabine.

Detailed description:

Arms: arm 1: 1 Cycle = 21 days. GC x 4 cycles ----\> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8
Interventions: intervention 1: Gemcitabine and fractionated cisplatin (combination treatment)
Intervention descriptions: intervention 1: 1 Cycle = 21 days. GC x 4 cycles ----\> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8

Protocol documents:
Clinical trial NCT02041520
Conditions: HIV/AIDS
Keywords: Seropositive HIV Omega 3 fatty acids Oxidative stress
Sponsor: Coordinación de Investigación en Salud, Mexico
Start date: 2013-01-01; Completion date: 2015-06-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Introduction: Highly active antiretroviral therapy (HAART) has showed its effectiveness in the prevention of complications in seropositive for HIV patients. However, they develop some manifestations such as lipodystrophy, dyslipidemia, and glucose intolerance increasing cardiovascular risk.

Clinical trials in general population and in patients on hemodialysis have demonstrated a significant reduction in cardiovascular events using fish oil. Omega-3 fatty acids are believed to be beneficial in prevention of atherosclerosis reducing lipids levels specially triglycerides. Also in general populations it has been described a benefit effect of omega 3 acids on oxidative stress.

Objective: to know the effect of omega 3 acids on different markers of oxidative stress in seropositive HIV patients.

Methods: We will perform a randomized parallel controlled clinical trial in seropositive HIV patients from 20 to 55 years old on clinical score A1, A2, B1 or B2 who received HAART. They will be randomly assigned to receive omega 3 fatty acids 2.4 g (Zonelabs, Marblehead MA) or placebo for 6 months. At baseline anthropometric measurements, lipid profile, glucose and stress oxidative levels (nitric oxide, malondialdehyde, total glutathion, and lipid peroxidation products) will be evaluated.

Sample size was calculated according to different variables. We selected the biggest one calculated for a difference in nitric oxide of 25% after treatment between groups and a standard deviation (SD) value of 10µmol/L. Whit this information we obtained a sample size of 31 patients per group for an 80% statistical power with α= 0.05. Assuming a 15% patient lost, a sample size of 35 per group was considered.

Detailed description:

Arms: arm 1: omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months. arm 2: Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1)
Interventions: intervention 1: omega 3 fatty acids intervention 2: placebo
Intervention descriptions: intervention 1: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up. intervention 2: olive oil in similar presentation of omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up.

Protocol documents:
Clinical trial NCT02042911
Conditions: Chronic Lymphocytic Leukemia
Sponsor: SymBio Pharmaceuticals
Start date: 2013-01-01; Completion date: 2015-06-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to investigate safety and efficacy of SyB L-0501 after 2-day intravenous infusion at a dose of 100 mg/m2/day to patients with chronic lymphocytic leukemia.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: SyB L-0501
Intervention descriptions: intervention 1: SyB L-0501 is administered at 100 mg/m2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.

Protocol documents:
Clinical trial NCT02048072
Conditions: Multiple Sclerosis Autonomic Nervous System Dysfunction
Keywords: relapsing remitting multiple sclerosis fingolimod Gilenya autonomic nervous system
Sponsor: Jochen Vehoff
Start date: 2013-07-01; Completion date: 2015-06-01
Enrollment: 33 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is designed to primarily evaluate the impact of Gilenya (Fingolimod) on the autonomic nervous system in patients being treated for the first time with Gilenya (Fingolimod). Effects on the cardiovascular system will be studied as well. The study is conducted to answer the question, if, and if yes, what impact the treatment with Gilenya (Fingolimod) has on the autonomic nervous system. To our knowledge little is known about the effects of Gilenya (Fingolimod) on the autonomic nervous system. We do know of rare, but potentially clinically and therapeutically relevant cardiovascular adverse events of Gilenya (Fingolimod). From a scientific point of view the mechanisms by which this is mediated are of interest. Maybe a better understanding of these mechanisms might even be of clinical relevance (e.g. risk stratification).

The impact of Gilenya (Fingolimod) on the autonomic nervous system is quantitavely measured, using a state-of-the-art technique. Non-invasive blood pressure measurement is performed with the Finometer Pro (Finapres Medical Systems, NL) under different paradigms (breathing at rest, deep breath, valsalva maneuver, active standing). In addition the sympathetic skin reaction is performed. The non-invasive blood pressure measurements are done by continuous, plethysmographic blood pressure measurement at the index finger, while the patient is performing the tasks mentioned above. By interpreting the blood pressure curve, heart rate and blood pressure variability are calculated. The sympathetic skin reaction consists of measuring the change of electric conductibility of the skin (palms and soles) after an electric stimulus of a peripheral nerve. These parameters allow to assess the functionality of four important autonomic functional systems (orthostasis, sympathetic adrenergic, sympathetic cholinergic, parasympathetic cholinergic). Normative data has been acquired in our lab.

Our hypothethis is, that there will be a change of heart rate variability at t4,5h compared to baseline (t0) for the parameter "RMSSD" under "normal breathing".

Detailed description:

Arms: arm 1: Autonomic testing during first dose adminstration of Gilenya.
Interventions: intervention 1: Gilenya
Intervention descriptions: intervention 1: Autonomic testing during first dose administration of Gilenya.

Protocol documents:
Clinical trial NCT02058147
Conditions: Type 2 Diabetes
Sponsor: Sanofi
Start date: 2014-02-01; Completion date: 2015-06-01
Enrollment: 1170 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Objective:

To compare the insulin glargine/lixisenatide fixed ratio combination to lixisenatide alone and to insulin glargine alone (on top of metformin treatment) in glycated hemoglobin (HbA1c) change from baseline to Week 30.

Secondary Objective:

To compare the overall efficacy and safety of insulin glargine/lixisenatide fixed ratio combination (FRC) to insulin glargine alone and to lixisenatide alone (on top of metformin treatment) over a 30 week treatment period in participants with type 2 diabetes.

Detailed description:
Approximately 37 weeks including up to 6 weeks of screening, 30-week treatment period, and a 3 days follow-up period.

Arms: arm 1: FRC once daily (QD) for 30 weeks. Dose individually adjusted. arm 2: Insulin glargine QD for 30 weeks. Dose individually adjusted. arm 3: Lixisenatide 10 mcg QD for 2 weeks, then 20 mcg QD (maintenance dose).
Interventions: intervention 1: Insulin glargine/lixisenatide Fixed Ratio Combination intervention 2: Insulin glargine (HOE901) intervention 3: Lixisenatide (AVE0010) intervention 4: Metformin
Intervention descriptions: intervention 1: Insulin glargine/Lixisenatide FRC was self-administered by subcutaneous (SC) injection in the morning within one hour before breakfast using one of the 2 prefilled disposable SoloStar® pen-injectors: Pen A containing 100 U/mL insulin glargine (Lantus, 100 U/mL) and 50 mcg/mL lixisenatide in a ratio of 2 U:1 mcg, used for administration of doses from 10 U to 40 U (10 U/5mcg to 40 U/20mcg). Pen B containing 100 U/mL insulin glargine (Lantus, 100 U/mL) and 33 mcg/mL lixisenatide in a ratio of 3 U:1 mcg, used to administer doses from 41 U to 60 U (41 U/13 mcg to 60 U/20 mcg). The starting dose was 10 U/5 mcg. Dose was then adjusted individually to reach and maintain fasting self-monitored plasma glucose (SMPG) of 80 mg/dL to 100 mg/dL (4.4 mmol/L to 5.6 mmol/L) while avoiding hypoglycemia. intervention 2: Insulin glargine (100 U/mL) was self-administered by SC injection at approximately the same time every day. Dose was adjusted individually to reach and maintain fasting SMPG of 80 mg/dL to 100 mg/dL (4.4 mmol/L to 5.6 mmol/L) while avoiding hypoglycemia. intervention 3: Lixisenatide was self-administered by SC injection within 0 to 60 minutes before breakfast or evening meal. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg. intervention 4: Pharmaceutical form: Tablet; Route of administration: Oral administration.

Protocol documents:
Clinical trial NCT02084706
Conditions: Trigger Finger
Sponsor: Brigham and Women's Hospital
Start date: 2014-03-01; Completion date: 2015-06-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Jet-injection (J-tip) is a rapid, minimally invasive delivery system that can be used for the subdermal injection of lidocaine solution for anesthetic purposes. The device has been found effective in pain reduction during IV catheterization in adults and children and lumbar puncture in children when compared to placebo saline-jet injection. \[1-4\].

We believe that administering local anesthetic via J-tip prior to triamcinolone(40 mg/ml) injection could mitigate pain that occurs during and immediately following injection while preserving the post-injection pain relief of anesthetic injection. Furthermore, pre-placement of the jet-injected local anesthetic may obviate the need for the inclusion of local anesthetic into the triamcinolone injection. This would decrease the amount of fluid injected, which could have positive pain modulation by decreased tissue disruption.

Objective: To evaluate the effectiveness of needle free jet injection (J-tip) administration of 2% lidocaine in reduction of the pain experienced during trigger digit 40 mg/ml triamcinolone injection.

Hypothesis: Needle free jet injection (J-tip) administration of 2% lidocaine will prove an equal or superior means of pain reduction when compared to 2% lidocaine injection in the setting of trigger digit triamcinolone injections.

Detailed description:

Arms: arm 1: Group one subjects will receive an injection of 0.5mL (20 g) of Triamcinolone and 0.5 mL of 2% Lidocaine over the A1 pulley. arm 2: Group two subjects will receive a needle free "J-tip" administration of 0.5mL of 2% lidocaine prior (2-10 minutes) to needle injection of 0.5mL of Triamcinolone (20 g) over the A1 pulley.
Interventions: intervention 1: Triamcinolone (20 g) and 2% Lidocaine injection over the A1 pulley intervention 2: 2% Lidocaine intervention 3: Triamcinolone (20 g) intervention 4: J-tip lidocaine administration intervention 5: Triamcinolone (20 g) Injection over the A1 pulley.
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None

Protocol documents:
Clinical trial NCT02107196
Conditions: Irritable Bowel Syndrome With Diarrhea
Keywords: Irritable Bowel Syndrome Colon, irritable Bowel disease Diarrhea
Sponsor: Menarini Group
Start date: 2014-03-01; Completion date: 2015-06-01
Enrollment: 535 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Irritable Bowel Syndrome with diarrhoea (IBS-D) is a functional gastrointestinal disorder characterised by chronic or recurrent abdominal pain or discomfort and diarrhoea. This trial aims at the evaluation of the efficacy and safety of oral ibodutant 10 mg once daily as compared to placebo in women with IBS-D over a 12-week treatment period.

Detailed description:
The study evaluates the efficacy and safety of ibodutant 10 mg, given once daily for 12 weeks in comparison with placebo in female IBS-D patients. Randomisation to ibodutant and placebo will be 1:1. Efficacy is evaluated in terms of weekly response for abdominal pain intensity and stool consistency over 12 weeks of treatment in at least 50% of the weeks of treatment.

The clinical phase of the study comprises up to 2 weeks of screening for patient's eligibility, a 2-week run-in period (treatment-free) for IBS severity assessment, a 12-week double-blind treatment period, a 4-week randomised withdrawal (RW) period and a 2-week safety follow-up, resulting in a maximum 22-week overall duration of the study for each patient.

Patients report their IBS-related symptoms daily in a telephone-based electronic diary from run-in until end of treatment.

Arms: arm 1: Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will be re-randomised at week 13 in a 1:1 ratio to either ibodutant 10 mg or placebo for additional 4 weeks of treatment. arm 2: Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the placebo arm will be mock-re-randomised (switch in blinded conditions) to ibodutant at week 13 for additional 4 weeks of treatment.
Interventions: intervention 1: Ibodutant 10 mg intervention 2: Placebo
Intervention descriptions: intervention 1: Oral tablet, to be given once daily. intervention 2: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily.

Protocol documents:
Clinical trial NCT02114268
Conditions: Respiratory Syncytial Virus Infections
Keywords: Respiratory Syncytial Virus, RSV
Sponsor: MedImmune LLC
Start date: 2014-04-01; Completion date: 2015-06-01
Enrollment: 342 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to evaluate the safety, tolerability and pharmacokinetics of an extended half-life anti-respiratory syncytial virus (RSV) monoclonal antibody compared to placebo when administered to healthy adult participants.

Detailed description:
This was a phase 1, randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability and pharmacokinetics of MEDI8897 compared to placebo when administered to healthy adult participants. There were 136 participants randomized to receive MEDI8897 or placebo at one site. Investigational product was delivered intravenously (IV) to 3 cohorts and intramuscularly (IM) to 2 cohorts. 4 different dose levels of investigational product were evaluated across the 5 cohorts. Participants were followed for approximately 1 year.

Arms: arm 1: Participants received a single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1. arm 2: Participants received a single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1. arm 3: Participants received a single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1. arm 4: Participants received a single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1. arm 5: Participants received a single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1. arm 6: Participants received placebo on Day 1.
Interventions: intervention 1: MEDI8897 Intravenous intervention 2: Placebo intervention 3: MEDI8897 Intravenous intervention 4: MEDI8897 Intravenous intervention 5: MEDI8897 Intramuscular intervention 6: MEDI8897 Intramuscular
Intervention descriptions: intervention 1: Participants received a single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1. intervention 2: Participants received placebo on Day 1. intervention 3: Participants received a single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1. intervention 4: Participants received a single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1. intervention 5: Participants received a single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1. intervention 6: Participants received a single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.

Protocol documents:
Clinical trial NCT02126878
Conditions: Bursitis
Sponsor: West Virginia University
Start date: 2014-04-01; Completion date: 2015-06-01
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Inflammation of the trochanteric bursa is a common cause of hip pain. A bursa is a closed fluid filled sac or sac-like cavity found between tissues that function as a gliding surface to reduce friction. Bursitis is the inflammation of the bursa. Inflammation between the trochanteric process of the femur and gluteus medius tendon/ iliotibial tract is the cause of trochanteric bursitis. Several treatments exist for trochanteric bursitis, including a local steroid injection. The injection consists of a mixture of local anesthetic and steroid medications. The steroid is routinely mixed with a local anesthetic. The anesthetic acts to diluent the steroid as well as act as a pain reliever. Various steroid preparations have been used, at varying doses, for trochanteric bursitis. The steroid preparation, triamcinolone is commonly used for various reasons. Besides the procedure associated and injection site risks, risks associated with the use of steroids, though rare, exist. Short term, the steroid can raise blood sugar levels and should be used with caution and be appropriately monitored in diabetics. Additionally, the steroid can suppress the immune system. Long-term risks are related to the dose and frequency of use. These risks include thinning of the skin, easy bruising, weight gain, elevated blood pressure, cataract formation, thinning of bones and joints. Studies have shown the effectiveness of local steroid injections for trochanteric bursitis. Unfortunately, there is limited data on the ideal dose of the steroid preparation. Triamcinolone of 40mg/ mL is commonly used, but, studies have shown effectiveness at various doses, ranging 20 to 160 mg/mL. The aim of this study is to evaluate and compare the effectiveness of local steroid injections of various steroid dosages for the treatment of trochanteric bursitis.

Detailed description:

Arms: arm 1: 20mg/ 2ml and local anesthetic arm 2: 40mg/ 2ml with local anesthetic arm 3: 80mg/ 2ml and local anesthetic
Interventions: intervention 1: Kenalog
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02128542
Conditions: Hepatitis C Virus Infection
Keywords: Veterans HCV
Sponsor: Gilead Sciences
Start date: 2014-06-01; Completion date: 2015-06-01
Enrollment: 66 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will examine the safety, tolerability, and antiviral efficacy of sofosbuvir (SOF)+ribavirin (RBV) in treatment-naive and treatment-experienced United States Veterans with compensated cirrhosis and genotype 2 HCV infection.

Detailed description:

Arms: arm 1: Participants will receive sofosbuvir+RBV for 12 weeks.
Interventions: intervention 1: Sofosbuvir intervention 2: RBV
Intervention descriptions: intervention 1: Sofosbuvir 400 mg 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)

Protocol documents: