ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01242020
Conditions: Obesity
Sponsor: University of Pennsylvania
Start date: 2011-01-01; Completion date: 2011-05-01
Enrollment: 6 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test a method of imaging (taking a picture) of the abdomen (belly), neck, thigh and calf (lower leg) areas of the body, using ultrasound along with a drug which makes the pictures look clearer. Ultrasound is a type of imaging that uses sound waves to create a picture of the inside of the human body. Two sets of pictures will be taken on two different days to see if the results are the same each time.

DEFINITY® is a drug given intravenously (through the vein). DEFINITY® is approved by the FDA to be used as an ultrasound contrast agent (makes the pictures look clearer) while taking pictures of the heart. In this study, DEFINITY® will be used while taking pictures of blood vessels in your abdomen (belly), neck, thigh and calf (lower leg). Since this use of DEFINITY® is different than the use approved by the FDA, this study will be performed under an FDA Investigational New Drug (IND) application.

Detailed description:

Arms: arm 1: "Lean" defined as (BMI ≥18 and ≤25) arm 2: Obese grade I-II defined as (BMI\>30 and ≤35)
Interventions: intervention 1: Perflutren Lipid Microsphere Injectable Suspension
Intervention descriptions: intervention 1: 1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used

Protocol documents:
Clinical trial NCT01246791
Conditions: Healthy
Keywords: NPC-01 Pharmacokinetics Healthy female volunteer Norethisterone Ethinyl Estradiol
Sponsor: Nobelpharma
Start date: 2010-11-01; Completion date: 2011-05-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the pharmacokinetic profiles of norethisterone and ethinyl estradiol after single oral administration of NPC-01 in healthy female volunteers.

Pharmacokinetics of norethisterone and ethinyl estradiol will be evaluated on the basis of AUC, Cmax, tmax, t1/2, MRT, kel and AUC∞.

Detailed description:

Arms: arm 1: Single oral administration of NPC-01
Interventions: intervention 1: NPC-01
Intervention descriptions: intervention 1: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition

Protocol documents:
Clinical trial NCT01247675
Conditions: Adult Growth Hormone Deficiency
Sponsor: Ascendis Pharma A/S
Start date: 2010-11-01; Completion date: 2011-05-01
Enrollment: 37 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study investigates the safety, tolerability, pharmacokinetic profile (PK), and pharmacodynamic response (PD) of three different doses of ACP-001 given once-a-week compared to one dose-level of an approved daily human growth hormone product over a period of 4 weeks (4 weekly administrations versus 28 daily administrations) in adults with Growth Hormone Deficiency.

Detailed description:

Arms: arm 1: Once weekly subcutaneous injection of ACP-001 equivalent to 0.02 mg hGH/kg/week for 4 weeks arm 2: Once weekly subcutaneous injection of ACP-001 equivalent to 0.04 mg hGH/kg/week for 4 weeks arm 3: Once weekly subcutaneous injection of ACP-001 equivalent to 0.08 mg hGH/kg/week for 4 weeks arm 4: Once daily subcutaneous injection of human Growth Hormone (Omnitrope) equivalent to 0.04 mg hGH/kg/week for 4 weeks
Interventions: intervention 1: ACP-001 (TransCon hGH) intervention 2: ACP-001 (TransCon hGH) intervention 3: ACP-001 (TransCon hGH) intervention 4: Omnitrope
Intervention descriptions: intervention 1: s.c., weekly injection intervention 2: s.c., weekly injection intervention 3: s.c., weekly injection intervention 4: s.c., daily injection

Protocol documents:
Clinical trial NCT01250145
Conditions: Osteoporosis, Postmenopausal
Sponsor: Eli Lilly and Company
Start date: 2010-11-01; Completion date: 2011-05-01
Enrollment: 251 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study is a Phase 1, multi-center, 2-part, subject- and investigator-blind, randomized, placebo-controlled, multiple dose study of transdermal teriparatide (80-µg dose) in healthy postmenopausal women. Part A will examine the cumulative irritation and adherence of the transdermal patch, and Part B will examine skin sensitization and adherence. Two separate groups of subjects will be enrolled for Part A and Part B of the study. All screening procedures will take place up to 28 days prior to enrollment.

Detailed description:

Arms: arm 1: Part A:

Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days

Part B:

Induction phase: Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks

Rest phase: 2 weeks with no patch application

Challenge phase: 80 microgram active patch given once for at least 6 hours
Interventions: intervention 1: LY333334 intervention 2: Placebo
Intervention descriptions: intervention 1: Transdermal patch intervention 2: Transdermal patch

Protocol documents:
Clinical trial NCT01250717
Conditions: Prostate Cancer
Keywords: prostatectomy docetaxel
Sponsor: Beth Israel Deaconess Medical Center
Start date: 2001-01-01; Completion date: 2011-05-01
Enrollment: 28 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to determine if the combination of chemotherapy and hormone therapy is safe and helpful for patients who plan to have their high-risk prostate cancer surgically removed. Some physicians believe that patients with high risk cancer that is located in one area, may have an early but small spread of the cancer outside of the prostate, and perhaps even to distant organs. Therefore, better treatments for the entire body are needed to improve the ability of surgery or other local therapies to cure prostate cancer. Since chemotherapy is beginning to demonstrate increasing activity in advanced prostate cancer patients, it is possible that using chemotherapy combined with hormonal therapy earlier in the course of localized but high risk patients might improve the outcomes for these patients.

Detailed description:
* Participants will receive treatment in the outpatient clinic, where the docetaxel chemotherapy will be placed in a bag of fluid and will be given by vein every three weeks. Participants will take Decadron (dexamethasone) by mouth 12 hours and 1 hour before docetaxel and again 12 hours after docetaxel. They will also take estramustine and casodex by mouth at home. Zoladex (or lupron) will be given subcutaneously (under the skin) 4 times every three months. They will also be started on coumadin beginning at the time of the first docetaxel infusion and continuing until 3 weeks after the 4th cycle of chemotherapy.
* After 2 months (or cycles) of therapy, participants will be evaluated in order to assess the response and toxicity of treatment, including a review of medical history, physical examination, blood tests, including PSA. If there is no evidence of progression or excessive toxicity, treatment will continue for 2 more months in the same manner.
* At the end of 4 months of chemotherapy, participants will be reassessed by the medical oncologist and urologist regarding surgery to remove the prostate.

Arms: arm 1: Docetaxel,Dexamethasone,Estramustine,Zoladex,Casodex,Prostatectomy
Interventions: intervention 1: Docetaxel intervention 2: Dexamethasone intervention 3: Estramustine intervention 4: Zoladex intervention 5: Casodex intervention 6: Radical Prostatectomy
Intervention descriptions: intervention 1: Given by an IV infusion over 1 hour on day 2 of a three-week cycle intervention 2: Orally 12 hours and 1 hour before docetaxel and again 12 hours after docetaxel intervention 3: Taken orally three times a day for 5 days for the first part of every three week cycle intervention 4: Given subcutaneously for 4 doses every three months intervention 5: Taken orally once a day for 6 months intervention 6: after the chemo and hormonal therapy all patients have a radiacal prostatectomy

Protocol documents:
Clinical trial NCT01250990
Conditions: Dyslipidemias
Keywords: Niacin HDL Reverse cholesterol transport
Sponsor: University of Pennsylvania
Start date: 2010-11-01; Completion date: 2011-05-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study looks at whether niacin improves reverse cholesterol transport (RCT) in healthy volunteers. 3H-Cholesterol will be used to measure RCT by analyzing changes in the tracer activity in total plasma, lipoproteins, red blood cells (RBCs) and stool. The hypothesis is that niacin augments reverse cholesterol transport.

Detailed description:
The study will use 3H-cholesterol bound to albumin (particulate cholesterol) to assess the ability of high density lipoprotein (HDL) to transport cholesterol to the liver to be eliminated. This process is called Reverse Cholesterol transport and is one of the main mechanisms by which HDL protect against atherosclerotic cardiovascular disease. The availability of a method to assess RCT is important for the development of new drugs which affect RCT and may result in useful treatments for atherosclerosis.

This study will evaluate the use of radiolabeled particulate cholesterol administered intravenously in association with albumin, as a method to study reverse cholesterol transport (RCT) in humans before and after treatment by niacin by analyzing changes in the tracer activity in total plasma and lipoproteins. The study population is healthy volunteers.

Arms: arm 1: Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated. arm 2: Placebo tablet with 50 mg niacin for the first 4 weeks to maintain blinding of the study team and subjects, changed to pure placebo after that.
Interventions: intervention 1: Niacin intervention 2: Placebo
Intervention descriptions: intervention 1: Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated. intervention 2: Placebo

Protocol documents:
Clinical trial NCT01256294
Conditions: Renal Transplant
Keywords: Renal transplant kidney transplant immunosuppressive therapy anti-rejection medication pharmacokinetics tacrolimus
Sponsor: Novartis
Start date: 2010-10-01; Completion date: 2011-05-01
Enrollment: 71 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The study is designed to compare the pharmacokinetics of generic tacrolimus (Sandoz) to branded tacrolimus (Prograf) in stable renal transplant patients.

Detailed description:

Arms: arm 1: In Period 1 (Days 1-14) participants received branded tacrolimus (Prograf) orally twice a day and in Period 2 (Days 15 - 28) participants received generic tacrolimus (Sandoz) orally twice a day. Participants received the same stable dosage of tacrolimus they had been taking prior to enrollment (on a milligram for milligram basis). arm 2: In Period 1 (Days 1 - 14) participants received generic tacrolimus (Sandoz) orally twice a day and in Period 2 (Days 15 - 28) participants received branded tacrolimus (Prograf) orally twice a day. Participants received the same stable dosage of tacrolimus they had been taking prior to enrollment (on a milligram for milligram basis).
Interventions: intervention 1: Generic Tacrolimus intervention 2: Branded Tacrolimus
Intervention descriptions: intervention 1: Generic Sandoz tacrolimus supplied as capsules of 0.5 mg, 1 mg and 5 mg dose strengths. intervention 2: Capsules supplied at dose strengths of 0.5 mg, 1 mg, and 5 mg.

Protocol documents:
Clinical trial NCT01276327
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2011-01-01; Completion date: 2011-05-01
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of the current study is to establish the bioequivalence of linagliptin/ pioglitazone fixed dose combination tablet compared to single tablets of linagliptin and pioglitazone administered together.

Detailed description:

Arms: arm 1: Fixed-Dose-Combination-Tablet, oral administration with 240 mL water arm 2: Tablets, oral administration with 240 mL water for each treatment arm 3: Fixed-Dose-Combination-Tablet, oral administration with 240 mL water arm 4: Tablets, oral administration with 240 mL water for each treatment
Interventions: intervention 1: Linagliptin + Pioglitazone intervention 2: Linagliptin + Pioglitazone intervention 3: Linagliptin/Pioglitazone intervention 4: Linagliptin/Pioglitazone
Intervention descriptions: intervention 1: Medium doses, oral administration intervention 2: Medium doses, oral administration intervention 3: Medium dose oral administration intervention 4: Medium dose oral administration

Protocol documents:
Clinical trial NCT01277341
Conditions: Seasonal Allergic Rhinitis
Sponsor: Bausch & Lomb Incorporated
Start date: 2010-12-01; Completion date: 2011-05-01
Enrollment: 601 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an efficacy study of bepotastine besilate nasal spray in seasonal allergic rhinitis.

Detailed description:

Arms: arm 1: Bepotastine Besilate Nasal Spray 2% Twice a day arm 2: Bepotastine Besilate Nasal Spray 3% Twice a day arm 3: Bepotastine Besilate Nasal Spray 4% Twice a day arm 4: Placebo nasal spray
Interventions: intervention 1: Bepotastine Besilate Nasal Spray 2% Twice a day intervention 2: Bepotastine Besilate Nasal Spray 3% Twice a day intervention 3: Bepotastine Besilate Nasal Spray 4% Twice a day intervention 4: Placebo Nasal Spray
Intervention descriptions: intervention 1: nasal spray intervention 2: nasal spray intervention 3: nasal spray intervention 4: nasal spray

Protocol documents:
Clinical trial NCT01284504
Conditions: Colorectal Cancer Colon Cancer
Sponsor: Stanford University
Start date: 2011-01-01; Completion date: 2011-05-01
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The proposed study aims to investigate how the administration of a drug known to reduce inflammation in humans, Celecoxib, will effect the peri-operative inflammatory response of a patient undergoing primary tumor resection surgery for colon cancer. The proposed project is an exploratory study, and will use data from blood samples and tumor samples to attempt to elucidate the immune and inflammatory response in colon cancer patients undergoing primary resection of their tumors.

Detailed description:
This study is the first to assess the perioperative time course of systemic inflammation and immunity in colon cancer patients and evaluate the effect of anti-inflammatory treatment with celecoxib on this response. In addition, evaluation of the effect of short-term preoperative administration of celecoxib on tumor immunogenicity will help us to understand how tumor-enhancing inflammation and anti-tumor immunity can be differentially affected by COX-2 inhibitors. The knowledge gained as a result of this research will help us to set up the infrastructure for a method to monitor the immunoinflammatory status of colon cancer patients with a longer term goal of designing interventions to suppress tumor-enhancing inflammation and vitalize anti-tumor immunity in the perioperative period. The long-term objective is to use these novel tools in order to improve cancer-specific survival in patients with colon cancer after primary tumor resection.

Arms: arm 1: Celecoxib, 200 mg tab arm 2: placebo, tab
Interventions: intervention 1: Celecoxib intervention 2: placebo
Intervention descriptions: intervention 1: 200 mg tablet oral intervention 2: Placebo, tab

Protocol documents:
Clinical trial NCT01297062
Conditions: Healthy Subjects
Keywords: Diabetes exenatide Amylin Lilly QT interval
Sponsor: AstraZeneca
Start date: 2011-02-01; Completion date: 2011-05-01
Enrollment: 94 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Compare the effect of exenatide (therapeutic and supratherapeutic concentrations), moxifloxacin and placebo on the QT interval.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Exenatide intervention 2: Moxifloxacin intervention 3: Placebo comparator
Intervention descriptions: intervention 1: IV Exenatide (therapeutic and supratherapeutic concentrations) intervention 2: Oral Moxifloxacin (400 mg) intervention 3: IV Placebo (matching volume of placebo)

Protocol documents:
Clinical trial NCT01298518
Conditions: Type 2 Diabetes Patients
Keywords: multiple dose study in type 2 diabetes patients
Sponsor: Pfizer
Start date: 2011-02-01; Completion date: 2011-05-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The primary purpose of this trial is to evaluate the safety and tolerability, and pharmacodynamics, of multiple oral doses of PF-04620110 in T2DM patients.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: PF-04620110 intervention 2: PF-04620110 intervention 3: Placebo
Intervention descriptions: intervention 1: 5 mg of PF-04620110 given once daily intervention 2: 2.5 mg of PF-04620110 given twice daily intervention 3: Matching placebo giving for 4 weeks

Protocol documents:
Clinical trial NCT01301742
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2011-02-01; Completion date: 2011-05-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To investigate the relative bioavailability of BI 10773 following coadministration with 600 mg gemfibrozil bid dosed to steady-state in comparison to BI 10773 when given alone.

Detailed description:

Arms: arm 1: Subject to receive one single dose BI 10773 arm 2: Subject to receive one single dose BI 10773 plus 600 mg gemfibrozil bid for 5 days
Interventions: intervention 1: BI 10773 intervention 2: Gemfibrozil intervention 3: BI 10773
Intervention descriptions: intervention 1: 1 tablet single dose BI 10773 in the morning intervention 2: Gemfibrozil 600 mg bid for 5 days intervention 3: 1 tablet single dose BI 10773 in the morning

Protocol documents:
Clinical trial NCT01306162
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2011-02-01; Completion date: 2011-05-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of the study is to assess the relative bioavailability of a single dose of dabigatran after concomitant multiple oral administration of dronedarone with the aim to investigate whether and to what extent the P-gp inhibitor dronedarone affects pharmacokinetic parameters of dabigatran when administered to healthy subjects

Detailed description:

Arms: arm 1: Capsule, oral administration with 240 mL water arm 2: Capsule and Tablets, oral administration with 240 mL water arm 3: Capsule and Tablets, oral administration with 240 mL water arm 4: Capsule and Tablets, oral administration with 240 mL water arm 5: Capsule and Tablets, oral administration with 240 mL water
Interventions: intervention 1: Dabigatran etexilate plus dronedarone intervention 2: Dabigatran etexilate intervention 3: Dabigatran etexilate plus dronedarone intervention 4: Dabigatran etexilate plus dronedarone intervention 5: Dabigatran etexilate plus dronedarone
Intervention descriptions: intervention 1: dabigatran etexilate 150 mg plus dronedarone 400 mg as single dose intervention 2: 150 mg as single dose intervention 3: dabigatran etexilate 150 mg plus dronedarone 400 mg as single dose (staggered administration) intervention 4: dabigatran etexilate 150 mg single dose plus dronedarone 400 mg bid intervention 5: dabigatran etexilate 150 mg single dose plus dronedarone 400 mg bid (staggered administration)

Protocol documents:
Clinical trial NCT01310127
Conditions: Inflammation Pseudophakia
Keywords: NSAID Ocular Inflammation bromfenac
Sponsor: Toyos Clinic
Start date: 2010-11-01; Completion date: 2011-05-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a single-center, randomized, investigator-masked, parallel group, and active-comparator controlled study investigating the clinical outcomes for visual acuity and macular thickness after treatment with Bromday (bromfenac ophthalmic solution) 0.09% QD or Nevanac (nepafenac ophthalmic suspension) 0.1% TID in subjects who have undergone cataract extraction with posterior chamber intraocular lens implantation.

Detailed description:
Two topical NSAIDs currently approved for postoperative treatment of pain and inflammation in cataract surgery are bromfenac 0.09% and nepafenac 0.1%. Both purport to treat ocular inflammation by acting as a potent inhibitor of COX-1 and COX-2 enzymes. Clinical studies to date lack clarity on which topical NSAID may be the most efficacious.

Arms: arm 1: Patients receiving Bromday self-administered one drop of bromfenac 0.09% daily as a topical ophthalmic drop three days prior to cataract surgery, on the day of cataract surgery and 21 days post operatively. arm 2: Patients in this arm self-administered nepafenac topical ophthalmic drops three times daily beginning 3 days prior to cataract surgery, on the day of surgery and for 21 days postoperatively in addition to usual cataract procedure.
Interventions: intervention 1: Bromfenac intervention 2: Nepafenac
Intervention descriptions: intervention 1: bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery intervention 2: nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery

Protocol documents:
Clinical trial NCT01311505
Conditions: Tuberculosis
Keywords: bioequivalence; rifampicin
Sponsor: Pfizer
Start date: 2011-04-01; Completion date: 2011-05-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study is done to demonstrate bioequivalence of rifampicin component in Myrin© 2 Fixed-Dose Combination Tablet (each contains 75 mg isoniazid and 150 mg rifampicin, Pfizer Inc) with equivalent dose of the reference Rimactane® capsule (each contains 300 mg rifampicin, Novartis Sandoz) in healthy Filipino male subjects. This study also aims to determine the safety and tolerability of Myrin© 2 tablets and Rimactane® capsules in these subjects.

Detailed description:

Arms: arm 1: Test arm 2: Reference
Interventions: intervention 1: Myrin© 2 (Rifampicin + Isoniazid) intervention 2: Rimactane® (Rifampicin)
Intervention descriptions: intervention 1: Two (2) fixed-dose combination tablets each containing Rifampicin 150 mg and Isoniazid 75 mg intervention 2: One (1) capsule of Rifampicin 300 mg

Protocol documents: