ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01657305
Conditions: Wounds
Keywords: Split-Thickness Skin Graft (STSG) donor site Split-thickness skin graft STSG Wound healing Skin grafting Superficial wound Partial-thickness wound Time to wound closure
Sponsor: Birken AG
Start date: 2012-08-01; Completion date: 2014-09-01
Enrollment: 107 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The main purpose of this phase III clinical trial was to compare intra-individually the efficacy, safety and tolerability of Oleogel-S10 and non-adhesive wound dressing versus non-adhesive wound dressing only in accelerating the wound healing of Split-Thickness Skin Graft (STSG) donor sites.

Detailed description:
Oleogel-S10 has shown efficacy and was well tolerated in previous clinical trials in participants with skin lesions. Especially the results in a previous study with STSG donor sites suggested that Oleogel-S10 should be efficacious and safe in the treatment of superficial wounds.

The present phase III clinical trial in STSG donor sites was initiated to demonstrate wound healing progress, i.e., the time to healing and the grade of epithelialization of the wound.

In this study, STSG donor sites were separated into 2 wound halves. Randomly assigned, 1 wound half was treated with Oleogel-S10 and non-adhesive wound dressing, the other wound half with non-adhesive wound dressing only (standard of care).

Wound healing progress was documented by photos which were assessed by expert reviewers blind to the treatment of the wound halves.

Arms: arm 1: A split-thickness skin graft (STSG) donor site wound \>15cm2 in size was divided in 2 halves. One half was randomized to Oleogel-S10 treatment and non-adhesive wound dressing (intra-individual comparison). Oleogel-S10 was administered (1 cm or 100 mg per cm2 wound area corresponding to thickness of about 1 mm or 0.04 inch) every 3 to 4 days until 95% epithelialization of the wound or end of treatment at Day 28. arm 2: A STSG donor site wound \>15cm2 in size was divided in 2 halves. One half was randomized to treatment with non-adhesive wound dressing only (intra-individual comparison). Non-adhesive wound dressings are standard of care (SOC) in the treatment of STSG donor sites. Wound dressings were changed every 3 to 4 days until 95% epithelialization of the wound or end of treatment at Day 28.
Interventions: intervention 1: Oleogel-S10, non-adhesive wound dressing intervention 2: Non-adhesive wound dressing only
Intervention descriptions: intervention 1: 1 cm or 100 mg Oleogel-S10 per cm2 wound area (corresponds to thickness of approximately 1 mm or 0.04 inch) every 3 to 4 days until 95% epithelialization of the wound or end of treatment at Day 28. intervention 2: Soft silicone faced polyurethane foam dressing such as Mepilex® only every 3 to 4 days until 95% epithelialization of the wound or end of treatment at Day 28.

Protocol documents:
Clinical trial NCT01677182
Conditions: Bipolar Disorder
Keywords: Drug therapy
Sponsor: Takeda
Start date: 2012-08-01; Completion date: 2014-09-01
Enrollment: 535 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy of ramelteon for treatment of acute depressive episodes associated with Bipolar 1 Disorder.

Detailed description:
The drug being tested in this study is called Ramelteon. Ramelteon is being tested to treat people who have Bipolar 1 Disorder. This study will look at the symptoms of depression in people who take Ramelteon as a sub-lingual formulation.

This study plans to enroll a minimum of 276 participants and a maximum of up to approximately 870 participants Participants will be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

* Ramelteon (Dose 1)
* Ramelteon (Dose 2)
* Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient All participants will be asked to take one tablet every night at bedtime throughout the study.

This study plans to conduct one unblinded interim analysis after the first 276 subjects have been enrolled and treated for the 6-week double-blind treatment period. Based on the interim analysis, the study plans to adapt limited aspects of the design including: 1) to make no changes to the study; 2) to reassess sample size based on the interim analysis results.

This multi-centre trial will be conducted in North America and Europe. The overall time to participate in this study is up to 14 weeks. Participants will make 8 visits to the clinic, and will be contacted by telephone 30 days after last dose of study drug for a follow-up assessment.

An independent Data Monitoring Committee (DMC) recently performed a planned interim analysis of efficacy and safety data from this study. Upon completion of their review, the DMC advised that the unblinded interim data met the predefined efficacy criteria for study termination. No safety concerns were identified.

Arms: arm 1: Ramelteon SL tablets, sublingual, once daily, at night time for up to 6 weeks. arm 2: Ramelteon SL tablets, sublingual, once daily, at night time for up to 6 weeks. arm 3: Ramelteon SL placebo-matching tablets, sublingual, once daily, at night time for up to 6 weeks.
Interventions: intervention 1: Ramelteon intervention 2: Placebo
Intervention descriptions: intervention 1: Ramelteon tablets for sublingual administration intervention 2: Ramelteon placebo-matching tablets for sublingual administration

Protocol documents:
Clinical trial NCT01686932
Conditions: Diabetes Mellitus Type 2
Keywords: vildagliptin sitagliptin continuous glucose monitoring (CGM) glycemic fluctuations MAGE impact of hypoglycemia on heart function (cardiac dysfuction measured via ECG) difference in glycemic profile of vildagliptin compared to sitagliptin
Sponsor: Novartis Pharmaceuticals
Start date: 2012-11-01; Completion date: 2014-09-01
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Vildagliptin and Sitagliptin both belong to the class of DPP-4 inhibitors, but differ in their pharmacokinetic profile as well as in their approved application (Vildagliptin, 2x 50 mg daily, Sitagliptin, 1x 100 mg daily). This leads to distinct results regarding postprandial blood-glucose normalization as well as protective properties regarding hypoglycemic episodes - especially during the night. Additionally, in type 1 diabetic patients a correlation has been described between hypoglycemia and abnormal heart function (QTc-elongation), which can have severe consequences for the patients. This study aims for the evaluation of the potency of both drugs to prevent and/or reduce hypoglycemic events in insulin-dependent type-2 diabetics and furthermore to evaluate the correlation of hypoglycemic episodes with changes in heart-function measured by Holter-ECG.

The hypothesis is tested, if vildagliptin leads to a more favourable glycemic profile than sitagliptin and is more potent in protecting from nocturnal abnormalities in heart-function caused by undetected hypoglycemic episodes.

Detailed description:

Arms: arm 1: Period 1: vildagliptin 50mg BID for 8 weeks; followed by Washout then Period 2: sitagliptin 100mg QD for 8 weeks arm 2: Period 1: sitagliptin 100mg QD for 8 weeks; followed by Washout then Period 2: vildagliptin 50mg BID for 8 weeks
Interventions: intervention 1: Vildagliptin intervention 2: Sitagliptin
Intervention descriptions: intervention 1: vildagliptin 50mg BID for 8 weeks intervention 2: sitagliptin 100mg QD for 8 weeks

Protocol documents:
Clinical trial NCT01698710
Conditions: Pancreatic Cysts
Keywords: Premalignant Malignant
Sponsor: Massachusetts General Hospital
Start date: 2012-11-01; Completion date: 2014-09-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This research study is a pilot study. In this pilot study we are testing the safety of a procedure. "Investigational" means that the Albumin bound paclitaxel (Abraxane) is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not approved Abraxane injection for your type of medical condition. Treatment of pancreatic cysts often requires follow-up imaging studies and surgical resection of the cysts. As part of standard medical care, you will be undergoing a diagnostic endoscopic ultrasound guided fine needle aspiration (EUS-FNA) in order to evaluate type of the cyst. During the EUS and just after the cyst fluid aspiration, you will undergo the injection of the drug into the cyst cavity if your cyst is thought to be cancerous or precancerous. Cyst fluid will be analyzed for further diagnosis.

Detailed description:
You will be asked to undergo some screening tests or procedures to find out if you can be in the research study. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out that you do not take part in the research study. If you have had some of these tests or procedures recently, they may or may not have to be repeated. Screening tests include the following: medical history, performance status, assessment of pancreatic cyst by CT, MRI or EUS, blood tests and a pregnancy test.

If these tests show that you are eligible to participate in the research study, you will begin the study treatment. If you do not meet the eligibility criteria you will not be able to participate in this research study.

As part of your medical care you will be undergoing an endoscopic procedure EUS-FNA (Endoscopic Ultrasound Fine Needle Aspiration) in order to evaluate and evacuate the cyst fluid. During the EUS-FNA and just after the cyst fluid aspiration, albumin bound paclitaxel will be injected into the cyst cavity.

The study procedure (injection of drug into cyst cavity) takes place over 5 minutes during the EUS-FNA. 2 days after the procedure you will receive a phone call from the research coordinator to check on how you are feeling. 3 months after study procedure participants will undergo a follow up CT to see what happened to the cyst. You will continue to have routine follow up for your medical problems.

Arms: arm 1: Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.
Interventions: intervention 1: Albumin bound paclitaxel
Intervention descriptions: intervention 1: Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.

Protocol documents:
Clinical trial NCT01703260
Conditions: Nonalcoholic Steatohapatitis
Keywords: Drug therapy
Sponsor: AstraZeneca
Start date: 2013-06-01; Completion date: 2014-09-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effect of roflumilast and pioglitazone therapy on serum transaminase (ALT) levels in adults with Nonalcoholic SteatoHepatitis.

Detailed description:
This proof of concept study will evaluate the effect of roflumilast and pioglitazone on transaminase levels and liver fat content.

Takeda has chosen not to continue this Study, however, randomized subjects were allowed to complete the study per protocol.

The decision to terminate the study is not related to any safety concerns with either of the study medications.

Arms: arm 1: Roflumilast dose and pioglitazone dose, orally for up to 4 months arm 2: Roflumilast dose and pioglitazone matching-placebo dose orally for up to 4 months. arm 3: Pioglitazone dose, orally and roflumilast matching-placebo dose, orally for up to 4 months
Interventions: intervention 1: Roflumilast intervention 2: Pioglitazone intervention 3: Placebo intervention 4: Placebo
Intervention descriptions: intervention 1: Roflumilast dose intervention 2: Pioglitazone dose intervention 3: Pioglitazone placebo-matching dose intervention 4: Roflumilast placebo-matching dose

Protocol documents:
Clinical trial NCT01704079
Conditions: Chronic Kidney Disease Hyperparathyroidism, Secondary Vitamin D Deficiency
Keywords: Parathyroid Diseases Renal Insufficiency Kidney Failure, Chronic Hyperparathyroidism, Secondary Vitamin D Hyperparathyroidism Kidney Diseases Kidney Failure Renal Insufficiency, Chronic
Sponsor: OPKO IP Holdings II, Inc.
Start date: 2012-11-01; Completion date: 2014-09-01
Enrollment: 216 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy of CTAP101 Capsules versus placebo in reducing intact parathyroid hormone (iPTH) by at least 30% from pretreatment baseline; safety and tolerability of CTAP101 will also be evaluated

Detailed description:
This is a phase 3, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of CTAP101 Capsules administered for 26 weeks to treat SHPT in subjects ≥18 years of age with stage 3 or 4 CKD and vitamin D insufficiency. The study will be conducted at approximately 40 sites within the United States (US). Approximately 550 subjects will be screened to randomize approximately 210 eligible subjects, stratified by CKD stage (approximately 105 subjects in each stage) in a 2:1 ratio to receive either CTAP101 Capsules or matching placebo. An Interactive Voice Response System (IVRS) will provide study treatment group assignments using the computer-generated randomization code provided by the IVRS vendor. Subjects will receive an initial daily dose of 1 capsule (CTAP101 Capsules, 30 µg, or matching placebo) for the first 12 weeks. After l2 weeks (visit 8) and per pre-defined criteria, the dose may be increased in a blinded fashion by the IVRS with oversight by an independent medical monitor.

Arms: arm 1: 1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26. arm 2: 1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.
Interventions: intervention 1: CTAP101 30 μg capsules intervention 2: Sugar pill to CTAP101 30 μg capsules
Intervention descriptions: intervention 1: CTAP101 30 μg capsule taken daily at bedtime intervention 2: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.

Protocol documents:
Clinical trial NCT01704755
Conditions: Chronic Hepatitis C Infection Compensated Cirrhosis
Keywords: Cirrhosis Hepatitis C Child Pugh A Compensated Cirrhosis Hepatitis C Genotype 1 Cirrhotic Chronic Hepatitis C Hepatitis C Virus ombitasvir paritaprevir dasabuvir Interferon-Free Viekira Pak
Sponsor: AbbVie (prior sponsor, Abbott)
Start date: 2012-10-01; Completion date: 2014-09-01
Enrollment: 381 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) coadministered with ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-infected adults with compensated cirrhosis.

Detailed description:
During the treatment period of the study, participants received treatment with ABT-450/ritonavir/ABT-267 and ABT-333 coadministered with RBV for either 12 or 24 weeks. Upon completing the treatment period or premature discontinuation of the treatment period, participants entered a 48-week post-treatment period.

Arms: arm 1: ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if \<75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks arm 2: ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if \<75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
Interventions: intervention 1: ABT-450/r/ABT-267, ABT-333 intervention 2: Ribavirin (RBV)
Intervention descriptions: intervention 1: Tablet; ABT-450 coformulated with ritonavir and ABT-267; ABT-333 tablet intervention 2: Capsule

Protocol documents:
Clinical trial NCT01712061
Conditions: Diabetic Nephropathy
Keywords: Diabetic nephropathy type 2 diabetes albuminuria chemokine antagonist
Sponsor: Pfizer
Start date: 2012-12-01; Completion date: 2014-09-01
Enrollment: 226 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study hypothesis under test is that administration of a CCR2/5 antagonist to subjects with type 2 diabetes and overt nephropathy will result in a reduction in urinary albumin, a surrogate for improved glomerular filtration.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: PF-04634817 intervention 2: Placebo
Intervention descriptions: intervention 1: Three or four tablets (50mg) daily for 12 weeks, depending on baseline renal function intervention 2: Three or four tablets (50mg) daily for 12 weeks, depending on baseline renal function

Protocol documents:
Clinical trial NCT01714609
Conditions: Clinically Significant Portal Hypertension
Keywords: portal hypertension sorafenib
Sponsor: Yale University
Start date: 2011-08-01; Completion date: 2014-09-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Sorafenib is approved by the US FDA for the treatment of unresectable (can not operate) liver cancer and for renal cell carcinoma. Sorafenib is a drug that inhibits the growth of cancer cells and prevents the formation of new blood vessels that would otherwise help the cancer spread.

Studies in experimental animals have shown that sorafenib may also lower portal vein pressure (the pressure of the blood passing from the intestine through the liver.) This study seeks to determine if sorafenib lowers the blood pressure in liver blood vessels (portal vein pressure) in patients with cirrhosis who have high portal vein pressure. The study will also obtain information whether sorafenib is safe in this patient population.

Half of the patients will be given sorafenib and half will be given a placebo (a pill without any medicine in it.) This allows a comparison of the reactions of people who take sorafenib to those who do not.

Detailed description:
This is a pilot proof-of-concept study that investigates the effect of sorafenib on portal pressure, as determined by the hepatic venous pressure gradient (HVPG), in patients with liver cirrhosis, portal hypertension and unresectable hepatocellular carcinoma (HCC) that has successfully responded to radiofrequency ablation and/or transarterial chemoembolization, and have obtained a complete response.

The primary end-point of the study is the change in HVPG observed from baseline to three months after starting treatment with sorafenib. Secondary end-point is safety of sorafenib.

The trial is structured as a randomized double blind placebo controlled study. After a three-month period of therapy with sorafenib or placebo (double-blind phase), patients will be given open-label sorafenib for an additional 3-month period (open-label phase). A total of 44 patients will be randomized (in the initial phase) on a 1:1 ratio to sorafenib or placebo. Patients will be followed monthly and HCC follow-up will be according to standards of care. The study will be sponsored by Onyx, who will also provide the treatment medication (sorafenib and placebo)

Arms: arm 1: Subjects randomized to placebo will take two tablets of placebo by mouth twice daily. arm 2: Subjects randomized to Sorafenib will take Sorafenib 400 mg by mouth twice daily.
Interventions: intervention 1: Placebo intervention 2: Sorafenib
Intervention descriptions: intervention 1: Placebo Comparator: Placebo intervention 2: Sorafenib, 400 mg twice daily

Protocol documents:
Clinical trial NCT01719653
Conditions: Bowel Preparation for Colonoscopy
Keywords: Colonoscopy Bowel Preparation MiraLAX Gatorade PEG-3350 MoviPrep SUPREP Chicago Bowel Preparation Scale Boston Bowel Preparation Scale
Sponsor: Gastroenterology Services, Ltd.
Start date: 2012-10-01; Completion date: 2014-09-01
Enrollment: 1079 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this investigation is to compare 3 versions of MiraLAX/Gatorade, MoviPrep and SUPREP to see which preparation cleanses the colon best and which preparation is best tolerated.

Detailed description:

Arms: arm 1: MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 51 g at 12 noon; Gatorade 64 oz mixed with Miralax 255 g from about 6 PM to 9 PM arm 2: MiraLAX 357 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 68 g at 12 noon; Gatorade 64 oz mixed with Miralax 289 g from about 6 PM to 9 PM. arm 3: MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed as a split-dose as follows: Gatorade 32oz mixed with Miralax 153 g from about 6 PM to 8 PM the day prior to the colonoscopy; Gatorade 32oz mixed with Miralax 153 g from about 2-4 hours prior to the colonoscopy. arm 4: MoviPrep consumed as a split-dose as follows: MoviPrep 1 liter consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 0.5 liter of clear liquids; MoviPrep 1 liter consumed from 3-4 hours prior to the colonoscopy followed by 0.5 liter of clear liquids. arm 5: SUPREP consumed as a split-dose as follows: SUPREP 16 oz consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 32 oz of clear liquids; SUPREP 16 oz consumed from 3-4 hours prior to the colonoscopy followed by 32 oz of clear liquids.
Interventions: intervention 1: MiraLAX intervention 2: Gatorade intervention 3: MoviPrep intervention 4: SUPREP
Intervention descriptions: intervention 1: MiraLAX consumed as described in each arm. intervention 2: Gatorade consumed as described in each arm. intervention 3: MoviPrep consumed as described in each arm. intervention 4: SUPREP consumed as described in each arm.

Protocol documents:
Clinical trial NCT01754714
Conditions: Non Alcoholic Fatty Liver Disease
Keywords: Steatohepatitis
Sponsor: Abbott
Start date: 2012-12-01; Completion date: 2014-09-01
Enrollment: 108 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Investigation the Effects of Different Doses of SAMe in Subjects with Nonalcoholic Fatty Liver Disease and non-treated matched healthy volunteers as control group

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: SAMe 1000 mg intervention 2: SAMe 1500 mg intervention 3: SAMe 2000 mg
Intervention descriptions: intervention 1: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner intervention 2: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner intervention 3: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner

Protocol documents: