ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02273141
Conditions: Colorectal Cancer Colorectal Carcinoma Colon Cleansing
Sponsor: Norgine
Start date: 2014-11-01; Completion date: 2015-08-01
Enrollment: 515 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluates the efficacy, safety and tolerability of NER1006 versus a sodium picosulfate and magnesium salt solution (SP + MS) in adult patients requiring bowel cleansing prior to any procedure that requires a clean bowel, using a Day Before Only Dosing regimen. Approximately 484 patients will be randomised with the aim of achieving a minimum of 220 patients in each of the 2 groups.

Detailed description:

Arms: arm 1: NER1006 1-Day Day Before-Only Split-Dosing Regimen (to commence on the evening of the day before colonoscopy). arm 2: SP+MS 1-Day Day Before-Only Split-Dosing Regimen (to commence on the morning of the day before colonoscopy).
Interventions: intervention 1: NER1006, Day Before-Only Dosing intervention 2: SP+MS, Day Before-Only Dosing
Intervention descriptions: intervention 1: The subject will self-administer both doses of NER1006 in the evening of Day 1 with 1-2 hours interval. Subject will take mandatory additional clear fluid after each dose. intervention 2: The subject will self-administer SP+MS in the morning of Day 1 and afternoon of Day 1. Subject will take mandatory additional clear fluid after each dose.

Protocol documents:
Clinical trial NCT02273167
Conditions: Colorectal Cancer Colorectal Carcinoma Colon Cleansing
Sponsor: Norgine
Start date: 2014-10-01; Completion date: 2015-08-01
Enrollment: 849 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluates the efficacy, safety and tolerability of NER1006 versus MOVIPREP in adult patients requiring bowel cleansing prior to any procedure that requires a clean bowel, using a 2-Day evening/morning Split-Dosing and 1-Day morning only Split-Dosing regimens. Approximately 810 patients will be randomised with the aim of achieving a minimum of 245 patients in each of the 3 groups.

Detailed description:

Arms: arm 1: NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy). arm 2: NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy). arm 3: MOVIPREP®: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
Interventions: intervention 1: NER1006, 2-Day Split-Dosing intervention 2: NER1006,1-Day Morning Split-Dosing intervention 3: MOVIPREP, 2-Day Split-Dosing
Intervention descriptions: intervention 1: The subject will self-administer the first dose of the assigned investigational product in the evening prior to the scheduled colonoscopy and take mandatory additional clear fluid. Subject will take the second dose together with mandatory additional clear fluids on the morning of the colonoscopy. intervention 2: The subject will self-administer the first dose of the investigational product on the morning of the colonoscopy and take mandatory additional clear fluid.

After a 1-2 hour break the subject will self-administer the second dose plus additional clear mandatory fluid. intervention 3: The subject will self-administer the first dose of the assigned investigational product in the evening prior to the scheduled colonoscopy and take recommended additional clear fluid. Subject will take the second dose together with recommended additional clear fluids on the morning of the colonoscopy.

Protocol documents:
Clinical trial NCT02288273
Conditions: Type 2 Diabetes
Sponsor: AstraZeneca
Start date: 2014-12-01; Completion date: 2015-08-01
Enrollment: 239 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A Randomized, Double-blind, Parallel-group Study to Evaluate the Effect of Bydureon Compared with Placebo on 24-hour Glucose Control in Metformin-treated Patients with Type 2 Diabetes.

Detailed description:
A Randomized, Double-blind, Parallel-group Study to Evaluate the Effect of Bydureon Compared with Placebo on 24-hour Glucose Control in 110 Metformin-treated Patients with Type 2 Diabetes

Arms: arm 1: Once weekly injected exenatide arm 2: Placebo comparator
Interventions: intervention 1: Bydureon intervention 2: Placebo
Intervention descriptions: intervention 1: Once weekly injection of 2mg bydureon (extended release exenatide) for 10 weeks. intervention 2: Placebo

Protocol documents:
Clinical trial NCT02288364
Conditions: Pain of Anesthesia at Breast Biopsy
Sponsor: Duke University
Start date: 2014-12-01; Completion date: 2015-08-01
Enrollment: 88 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the benefit, if any, of buffering lidocaine (adding sodium bicarbonate) when used for local anesthesia prior to percutaneous breast needle core biopsies. The medicine doctors use to reduce the pain of breast biopsies, lidocaine, can cause pain for approximately 15 seconds until the numbing effect begins. It is possible that this pain is caused because lidocaine is acidic. Some physicians believe that reducing the acidity of lidocaine by mixing it with sodium bicarbonate will reduce the initial pain of injecting the lidocaine. Both approaches - injecting 1% lidocaine alone and injecting 1% lidocaine mixed with sodium bicarbonate - are used as routine standard of care by radiologists today. The purpose of this study is to determine if either approach is more comfortable for patients having breast procedures.

Detailed description:

Arms: arm 1: 1% Lidocaine alone. arm 2: 1% Lidocaine plus 8.4% sodium bicarbonate
Interventions: intervention 1: 1% Lidocaine intervention 2: 1% Lidocaine plus sodium bicarbonate
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02291679
Conditions: Chronic Idiopathic Constipation
Sponsor: Ironwood Pharmaceuticals, Inc.
Start date: 2014-10-01; Completion date: 2015-08-01
Enrollment: 1223 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this trial was to determine the efficacy and safety of linaclotide 72 ug administered once daily to patients with chronic idiopathic constipation (CIC). The primary efficacy parameter is the percentage of participants in each dosing group that meet the protocol definition for complete spontaneous bowel movement (CSBM) Overall Responder.

Detailed description:
The trial also included a 145 ug linaclotide treatment arm (an FDA-approved dose for CIC) as an established positive control to validate the study design.

Arms: arm 1: 72 μg oral linaclotide, once daily for 12 weeks arm 2: 145 μg oral linaclotide, once daily for 12 weeks arm 3: matching placebo, once daily for 12 weeks
Interventions: intervention 1: Linaclotide intervention 2: Matching Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02305888
Conditions: Actinic Keratosis
Sponsor: LEO Pharma
Start date: 2015-03-01; Completion date: 2015-08-01
Enrollment: 189 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the trial is to investigate the Safety of LEO 43204 0.018%, 0.037% and 0.1% for actinic keratosis applied once daily for three consecutive days on face/chest, scalp and trunk/extremities, respectively.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: LEO 43204
Intervention descriptions: intervention 1: Treatment of actinic keratosis

Protocol documents:
Clinical trial NCT02312882
Conditions: Alopecia Areata Alopecia Totalis Alopecia Universalis
Sponsor: Stanford University
Start date: 2014-12-01; Completion date: 2015-08-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to investigate the ability of tofacitinib citrate, a Janus kinase inhibitor, to generate hair regrowth in patients with moderate to severe alopecia areata and its variants.

Detailed description:
This study is an open-label pilot study. Participants will be treated with oral tofacitinib for 3 months.

Arms: arm 1: Participants will receive tofacitinib for 3 months.
Interventions: intervention 1: Tofacitinib
Intervention descriptions: intervention 1: Tofacitinib 5 mg tablet taken by mouth twice a day.

Protocol documents:
Clinical trial NCT02322528
Conditions: Sjogren's Disease
Keywords: Non-invasive instruments Environment Wavefront Placido Disk Ellipsometer Thermal Imaging
Sponsor: University of Rochester
Start date: 2014-04-01; Completion date: 2015-08-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the effects of an anti-inflammatory drug (Lotemax®) on the surface of the eye and tear film (a film that coats the eye which is made up of oil and water).

Detailed description:

Arms: arm 1: An FDA approved drug (Lotemax) will be administered to both eyes to induce an inflammatory mediated response.
Interventions: intervention 1: Administration of Lotemax
Intervention descriptions: intervention 1: An FDA approved drug (Lotemax) will be administered to induce an inflammatory mediated response in both eyes.

Protocol documents:
Clinical trial NCT02322892
Conditions: Coronary Artery Bypass Cardiac Surgical Procedures
Keywords: Thiamine Vitamin B1 Coronary artery bypass grafting Cardiac surgery Lactate Pyruvate dehydrogenase
Sponsor: Beth Israel Deaconess Medical Center
Start date: 2015-01-01; Completion date: 2015-08-01
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this pilot study is to test the effects of thiamine (vitamin B1) administration before and after major cardiac surgery. Half of patients will receive thiamine and the other half will receive placebo.

The investigators' main hypothesis is that thiamine will improve cellular oxygen consumption and lead to decreased levels of post-operative lactate levels and ultimately improved patient outcomes.

Detailed description:
Over 230,000 patients in the United States undergo Coronary Artery Bypass Grafting (CABG) each year. While mortality is relatively low, morbidity remains substantial with a significant risk of prolonged time on mechanical ventilation, prolonged length of hospital and intensive care unit stay and many other complications. CABG causes a profound stress response and significant metabolic alterations occur, including a shift from aerobic to anaerobic metabolism, causing increased levels of pyruvate and lactate. Elevated lactate, a marker of anaerobic metabolism, is a common and significant finding in patients after CABG and is correlated with increased mortality and morbidity.

Aerobic metabolism occurs when pyruvate enters the mitochondria through pyruvate decarboxylation to acetyl-Coenzyme A, facilitated by the enzyme pyruvate dehydrogenase (PDH). Decreased PDH activity may cause a shift toward anaerobic metabolism and play a role in the changes seen in patients undergoing CABG. Thiamine (vitamin B1) is a key co-factor for PDH function and will increase activity even in non-deficient states. The investigators hypothesize that thiamine administration will increase PDH activity in patients undergoing CABG, leading to increased cellular oxygen consumption, as represented by decreased lactate levels after surgery, and ultimately improved clinical outcomes.

In order to test the investigators' hypothesis and to obtain data for a large-scale clinical trial evaluating relevant clinical endpoints, the investigators are conducting a randomized, double-blind, pilot trial of thiamine in high-risk patients undergoing CABG.

Arms: arm 1: 50 mL normal saline solution arm 2: 200 mg thiamine in 50 mL normal saline solution
Interventions: intervention 1: Thiamine intervention 2: Normal saline solution
Intervention descriptions: intervention 1: 200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit) intervention 2: 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)

Protocol documents:
Clinical trial NCT02330276
Conditions: Pre-diabetes
Sponsor: Veterans Medical Research Foundation
Start date: 2014-09-01; Completion date: 2015-08-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Early Phase Pre-Clinical and Initial Clinical Research on (+)- Epicatechin.

Detailed description:
This project is a double-blinded randomized Phase I study that will include dose-ranging one day PK and pharmacodynamic (PD) studies. Subjects will include healthy individuals and subjects who meet the American Diabetes Association (ADA) criteria for pre-diabetes, including IFG.

Arms: arm 1: 4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally arm 2: 4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally arm 3: 4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally
Interventions: intervention 1: (+)-Epicatechin
Intervention descriptions: intervention 1: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included.

Protocol documents:
Clinical trial NCT02335294
Conditions: Pain
Keywords: Pain abdominoplasty PCA
Sponsor: Trevena Inc.
Start date: 2014-12-01; Completion date: 2015-08-01
Enrollment: 200 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with placebo in patients with acute postoperative pain following abdominoplasty.

Detailed description:
The primary objective is to evaluate the analgesic efficacy of intravenous (IV) TRV130 administered via patient controlled analgesia device (PCA) compared with placebo administered via PCA in patients with moderate to severe, acute postoperative pain following abdominoplasty.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: TRV130 intervention 2: Morphine intervention 3: Placebo
Intervention descriptions: intervention 1: Rescue: Ibuprofen, oxycodone intervention 2: Rescue: Ibuprofen, oxycodone intervention 3: Rescue: Ibuprofen, oxycodone

Protocol documents:
Clinical trial NCT02343276
Conditions: Cardiac Catheterisation
Keywords: Radial Spasm
Sponsor: Instituto de Cardiologia de Santa Catarina
Start date: 2015-02-01; Completion date: 2015-08-01
Enrollment: 328 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Single-center study, randomized, double-blind, placebo controlled, with patients undergoing diagnostic or therapeutic catheterization via the transradial approach. Patients will be randomized into two groups: one group will receive the vasodilator nitroglycerin during the procedure (intervention group), and a second group will receive saline 0.9% in the same volume and time during the procedure (control group).

Will be evaluated: incidence of spasms of the radial artery, ability to perform the procedure without the need to change the access site, pain presented by the patient, time and total radiation of the procedure.

Detailed description:

Arms: arm 1: Placebo (saline solution 10 ml) in radial artery after sheath insertion arm 2: Nitroglycerin (200 micrograms) + saline solution 10 ml in radial artery after sheath insertion
Interventions: intervention 1: Nitroglycerin intervention 2: Placebo
Intervention descriptions: intervention 1: Nitroglycerin (200 micrograms) + saline solution 10 ml in radial artery after sheath insertion intervention 2: Placebo (saline solution 10 ml) in radial artery after sheath insertion

Protocol documents:
Clinical trial NCT02353871
Conditions: Moderate to Severe Glabellar Lines
Keywords: Moderate to Severe
Sponsor: Ipsen
Start date: 2015-01-01; Completion date: 2015-08-01
Enrollment: 185 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to demonstrate the safety and the efficacy of a single treatment of an injectable liquid form of Clostridium botulinum toxin type A haemagglutinin complex (BTX-A-HAC; hereafter referred to as BTX-A-HAC Next Generation (BTX-A-HAC NG)), used for the improvement in the appearance of moderate to severe glabellar lines (the lines between the eyebrows).

Detailed description:
At the Baseline Visit (Day 1), subjects were randomised in a ratio of 2:1 to receive either BTX-A-HAC NG solution (50 U) or placebo. Randomisation was stratified according to gender and severity of glabellar lines at maximum frown (moderate to severe) at Baseline. A single dose of BTX-A-HAC NG solution 50 U or placebo was injected on Day 1. Subjects were then monitored at the study centre for 30 minutes. On Day 4, subjects were contacted by telephone for adverse event monitoring and to record concomitant medications and treatments.

Subjects attended follow-up visits at the study centre on Days 8, 15, 29, 57, 85, 113, 148 and 183. The Day 183 follow-up visit was the end of study visit; all subjects who had completed the Day 183 Visit were considered to have completed the study.

Arms: arm 1: Clostridium Botulinum Toxin Type A (BTX-A-HAC NG) 50 Unit (U) solution, single dose (intramuscular injection). The total treatment volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region. A total of 50 U was injected. arm 2: Single dose (intramuscular injection). The total placebo volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region.
Interventions: intervention 1: Botulinum toxin type A intervention 2: Placebo
Intervention descriptions: intervention 1: A solution containing 50 U in 0.25 mL (200 U/mL). Each vial contained 0.625 mL of deliverable volume of solution. A volume of 0.25 mL, containing 50 U of BTX-A-HAC NG (i.e. 10 U/0.05 mL) was withdrawn from the vial into a syringe for administration. The total treatment volume (0.25 mL) was divided into five injections (0.05 mL per injection), each of which was to be administered into predefined sites across the glabellar region (two injections into each corrugator muscle and one injection into the procerus muscle). intervention 2: A solution containing only the excipients of BTX-A-HAC NG (identical in appearance to the active product). Each vial contained 0.625 mL of deliverable volume of solution. A volume of 0.25 mL was withdrawn from the vial into a syringe for administration. The total treatment volume (0.25 mL) was divided into five injections (0.05 mL per injection), each of which was to be administered into predefined sites across the glabellar region (two injections into each corrugator muscle and one injection into the procerus muscle).

Protocol documents:
Clinical trial NCT02356588
Conditions: Post-Operative Pain
Sponsor: Talphera, Inc
Start date: 2015-02-01; Completion date: 2015-08-01
Enrollment: 161 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy and safety of the sublingual Sufentanil Tablet (ST) 30 mcg to the sublingual Placebo Tablet (PT) for the short-term management of moderate-to-severe acute post-operative pain in patients after abdominal surgery.

Detailed description:

Arms: arm 1: A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. arm 2: A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.
Interventions: intervention 1: Sufentanil Tablet 30 mcg intervention 2: Placebo Tablet
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02387814
Conditions: Hepatic Insufficiency
Sponsor: Eli Lilly and Company
Start date: 2015-03-01; Completion date: 2015-08-01
Enrollment: 35 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The study involves a single dose of a study drug called abemaciclib taken by mouth. The purpose of this study will be to measure how much study drug gets into the blood stream and how long the body takes to get rid of it when given to participants with mild, moderate, or severe liver impairment compared to healthy participants. In addition, the tolerability of the study drug will be evaluated.

This study will last approximately 3 weeks for each participant, including check-in and follow-up.

Detailed description:

Arms: arm 1: Single dose of Abemaciclib administered orally on Day 1 to participants with normal hepatic function. arm 2: Single dose of Abemaciclib administered orally on Day 1 to participants with mild hepatic impairment. arm 3: Single dose of Abemaciclib administered orally on Day 1 to participants with moderate hepatic impairment. arm 4: Single dose of Abemaciclib administered orally on Day 1 to participants with severe hepatic impairment.
Interventions: intervention 1: Abemaciclib
Intervention descriptions: intervention 1: Administered Orally

Protocol documents:
Clinical trial NCT02399163
Conditions: Dental Caries
Sponsor: GlaxoSmithKline
Start date: 2015-04-01; Completion date: 2015-08-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The study will evaluate and compare the potential anti-caries efficacy of a test regimen: placebo (fluoride free) toothpaste (twice daily use) plus fluoride mouthwash (once daily use), in comparison with brushing with a placebo toothpaste alone (twice daily use), to remineralize previously demineralized enamel specimens, as measured by Surface MicroHardness Recovery (%SMHR).

This will be a single center, randomized, laboratory analyst blinded, placebo, four treatment, cross-over study in healthy participants. Participants will be assessed at baseline and at the beginning and end of each treatment visit to monitor clinical efficacy and safety.

Detailed description:

Arms: arm 1: Twice daily brushing with a non-fluoride (placebo) toothpaste followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride arm 2: Twice daily brushing with a non-fluoride (placebo) toothpaste arm 3: Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride arm 4: Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride, followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride.
Interventions: intervention 1: Fluoride free toothpaste intervention 2: Fluoride toothpaste intervention 3: Fluoride mouthwash
Intervention descriptions: intervention 1: Brushing with fluoride free toothpaste intervention 2: Brushing with fluoride containing toothpaste intervention 3: Fluoride mouth wash to be followed after brushing with fluoride free toothpaste in "Placebo dentifrice/Fluoride rinse" arm and in "Fluoride dentifrice/Fluoride rinse" arm

Protocol documents: