ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01754493
Conditions: Major Depression Irritable Bowel Syndrome
Keywords: Major Depression Irritable Bowel Syndrome Somatization Cymbalta Duloxetine
Sponsor: New York State Psychiatric Institute
Start date: 2008-12-01; Completion date: 2014-12-01
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the efficacy of duloxetine in reducing depressive symptoms, abdominal pain, and other symptoms of Irritable Bowel Syndrome (IRS) in a population of outpatients with Major Depressive Disorder MDD and clinical symptoms of IBS.

Detailed description:
This study is a 12-week open trial to assess the efficacy of duloxetine (Cymbalta) for the treatment of Irritable Bowel Syndrome (IBS) symptoms and comorbid Major Depressive Disorder (MDD).

Participants will visit the clinic 8 times to meet with the psychiatrist. They will receive duloxetine to see if it helps their major depression and Irritable Bowel symptoms. Upon study completion at 12 weeks, they will receive an additional 3 months of free medication treatment at our clinic.

Arms: arm 1: Patients will receive open treatment with Duloxetine
Interventions: intervention 1: Duloxetine
Intervention descriptions: intervention 1: This study is a 12-week open trial to assess the efficacy of duloxetine (Cymbalta) for the treatment of Irritable Bowel Syndrome (IBS) symptoms and comorbid Major Depressive Disorder (MDD). Participants will visit the clinic 8 times to meet with the psychiatrist. They will receive duloxetine to see if it helps their major depression and Irritable Bowel symptoms.

Protocol documents:
Clinical trial NCT01756586
Conditions: Analgesia Duration
Keywords: popliteal block analgesia duration
Sponsor: University of Chicago
Start date: 2013-02-01; Completion date: 2014-12-01
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Dexamethasone has shown to prolong upper extremity blocks. No one ha studied its effect on lower extremity blocks. The study would evaluate that point.

Detailed description:

Arms: arm 1: Plain bupivacaine arm 2: Bupivacaine with Dexamethasone
Interventions: intervention 1: Dexamethasone intervention 2: Bupivacaine
Intervention descriptions: intervention 1: None intervention 2: Control

Protocol documents:
Clinical trial NCT01757275
Conditions: Bleeding Peptic Ulcer
Keywords: peptic ulcer bleeding prevention of rebleeding successful endoscopic haemostatic therapy
Sponsor: AstraZeneca
Start date: 2013-02-01; Completion date: 2014-12-01
Enrollment: 239 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To describe the rate of clinically significant rebleeding during 72 hours continuous i.v. infusion of high dose esomeprazole Na in patients in China with primary successful endoscopic haemostatic therapy of a bleeding peptic ulcer, with cimetidine i.v. in

Detailed description:
A multi-center, randomised, double-blind, parallel-group phase III study to assess high dose esomeprazole Na i.v. treatment (bolus infusion of 80 mg followed by a continuous infusion of 8 mg per hour administered for 72 hours) for prevention of rebleeding

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Esomeprazole Na intervention 2: Cimetidine intervention 3: Esomeprazole Mg
Intervention descriptions: intervention 1: Given as 80mg bolus infusion during 30 min and then 8mg/h constant infusion during 71.5 hous intervention 2: Given as 200mg bolus infusion during 30 min and then 60mg/h constant infusion during 71.5 hours intervention 3: 40 mg tablet once daily for 27 days

Protocol documents:
Clinical trial NCT01769378
Conditions: Type 2 Diabetes Mellitus
Sponsor: Eli Lilly and Company
Start date: 2013-01-01; Completion date: 2014-12-01
Enrollment: 300 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the efficacy and safety of once-weekly dulaglutide compared to placebo in participants with type 2 diabetes who have inadequate glycemic control with sulfonylurea monotherapy.

Detailed description:

Arms: arm 1: Placebo administered subcutaneously (SQ) once weekly for 24 weeks added to the participant's prescribed glimepiride dose. arm 2: Dulaglutide 1.5 milligram (mg) administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
Interventions: intervention 1: Placebo intervention 2: Dulaglutide intervention 3: Glimepiride
Intervention descriptions: intervention 1: Administered SQ intervention 2: Administered SQ intervention 3: Administered PO

Protocol documents:
Clinical trial NCT01774604
Conditions: Post-ERCP Acute Pancreatitis
Keywords: Post ERCP acute pancreatitis Post Fine Needle Aspiration (FNA) acute pancreatitis Indomethacin Rectal Non Steroidal Anti-Inflammatory Drugs (NSAIDs)
Sponsor: Dartmouth-Hitchcock Medical Center
Start date: 2013-01-01; Completion date: 2014-12-01
Enrollment: 449 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess whether peri-procedural administration of rectal indomethacin, compared to placebo, can reduce the incidence of post-ERCP pancreatitis.

Detailed description:

Arms: arm 1: Indomethacin 100 mg Per Rectum (PR) x 1 in peri-procedural period arm 2: Placebo suppositories (#2)
Interventions: intervention 1: Indomethacin intervention 2: Placebo
Intervention descriptions: intervention 1: 100 mg Indomethacin PR x 1 intervention 2: None

Protocol documents:
Clinical trial NCT01782742
Conditions: Alzheimer's Disease
Keywords: Mild to Moderate Alzheimer's Disease
Sponsor: The Cleveland Clinic
Start date: 2013-02-01; Completion date: 2014-12-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Retinoid X receptors (RXR) are nuclear receptors that have been linked to numerous metabolic pathways relevant to Alzheimer's disease (AD) and Aβ (harmful protein) production and removal. The study drug "bexarotene" is an FDA approved anti-cancer agent but is not approved for use in Alzheimer's disease. Bexarotene acts as an RXR agonist that has reduced Aβ (harmful protein) in the brain in experimental models of Alzheimer's disease.

This study aims to determine the safety and effect on abnormal proteins found in the brain (based on brain scans) of 300 mg of "bexarotene" administered for one month compared to placebo (inactive agent).

Detailed description:

Arms: arm 1: 75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.

Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks) arm 2: 1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.

Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)
Interventions: intervention 1: Bexarotene intervention 2: Placebo
Intervention descriptions: intervention 1: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo intervention 2: None

Protocol documents:
Clinical trial NCT01790685
Conditions: Retinal Vein Occlusion
Sponsor: Johns Hopkins University
Start date: 2013-02-01; Completion date: 2014-12-01
Enrollment: 40 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To measure the pro-permeability factors in the aqueous humor of patients with persistent/recurrent macular edema after an injection of Ozurdex.

Detailed description:
To measure various pro-permeability factors in the aqueous humor of patients with persistent/recurrent macular edema despite prior treatment with anti-VEGF agents at baseline and at 4 weeks after intraocular injection of OZURDEX.

Arms: arm 1: Central Retinal Vein Occlusion arm 2: Branch Retinal Vein Occlusion
Interventions: intervention 1: dexamethasone implant
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01791465
Conditions: Human Immunodeficiency Virus Infection Diabetes Mellitus
Keywords: HIV Diabetes
Sponsor: Vanderbilt University
Start date: 2013-03-01; Completion date: 2014-12-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This pilot study will evaluate the effects of the anti-diabetic drug Bydureon (exenatide extended-release formulation) on blood sugar levels and serum markers of inflammation in a cohort of 12 HIV-infected adults on combination antiretroviral therapy (cART) with untreated diabetes mellitus. Previous studies have shown that high levels of persistent systemic inflammation predict the development of cardiovascular and metabolic diseases in HIV-infected persons on cART (a group at very high risk of atherosclerosis and myocardial infarction). Bydureon has demonstrated potent anti-inflammatory effects in prior studies of non-HIV infected persons, which suggests that this agent may represent a unique and preferred medication for the treatment of insulin resistance in HIV-infected adults. The Investigators hypothesize that short-term (16 weeks) therapy with Bydureon will improve glucose tolerance and significantly reduce circulating plasma levels of interleukin-6 (IL-6) and highly-sensitive C-reactive protein (hsCRP), two biomarkers strongly implicated in the development of cardiovascular and metabolic diseases in diabetic, HIV-infected, cART-treated adults.

Detailed description:
No further information. This was a single-arm trial to add an additional anti-diabetic medication to patients already known to be diabetic. The primary endpoint assessed whether the intervention reduced inflammation. There was no control arm.

Arms: arm 1: Treatment for 16 weeks with extended-release Exenatide (Bydureon)
Interventions: intervention 1: extended-release exenatide
Intervention descriptions: intervention 1: Single arm study - 2mg Bydureon every 7 days x 16 weeks

Protocol documents:
Clinical trial NCT01807234
Conditions: Migraines
Sponsor: Johns Hopkins University
Start date: 2013-02-01; Completion date: 2014-12-01
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The investigators propose to test the efficacy of ketorolac nasal spray versus sumatriptan nasal spray versus placebo for acute abortive therapy of migraine head pain as well as for migraine associated symptoms including nausea and allodynia.

Detailed description:
Participants are randomized to Ketorolac NS 31.5 mg, Sumatriptan NS 20 mg or placebo to treat three moderate to severe migraine attacks and switched treatments with each attack so that they received each treatment only once.

For each treated attack (moderate to severe migraine attack), participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.

Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo

Arms: arm 1: Ketorolac 31.5 mg single dose nasal spray and Placebo arm 2: Sumatriptan 20 mg single dose nasal spray and placebo arm 3: single dose Ketorolac placebo, single dose Sumatriptan placebo
Interventions: intervention 1: Ketorolac intervention 2: Sumatriptan intervention 3: Placebo
Intervention descriptions: intervention 1: Single dose of Ketorolac (Sprix) nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack. intervention 2: Sumatriptan (Imitrex) 20 mg one single dose of nasal spray for an acute migraine attack. intervention 3: Placebo one spray in each nostril and placebo one nasal spray.

Protocol documents:
Clinical trial NCT01810380
Conditions: Schizophrenia
Sponsor: H. Lundbeck A/S
Start date: 2013-03-01; Completion date: 2014-12-01
Enrollment: 468 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine the efficacy and safety of brexpiprazole for the treatment of adults experiencing an acute episode of schizophrenia.

Detailed description:

Arms: arm 1: None arm 2: Patients randomised to brexpiprazole received 1mg/day on Day 1, 2mg/day on Day 2, 3mg/day on Day 3 (uptitration); the dose could be adjusted from Day 4 onwards to 2, 3, or 4mg/day to optimise the clinical effect and tolerability. arm 3: Active Reference. Patients randomised to quetiapine received 300mg/day on Day 1, 600mg/day on Days 2 and 3 (uptitration); the dose could be adjusted from Day 4 onwards to 400, 600, or 800mg/day to optimise the clinical effect and tolerability.
Interventions: intervention 1: Placebo intervention 2: Brexpiprazole intervention 3: Quetiapine extended release
Intervention descriptions: intervention 1: Once daily as tablets and capsules, orally intervention 2: 2-4 mg/day, once daily, tablets, orally intervention 3: 400-800 mg/day, once daily, encapsulated tablets, orally

Protocol documents:
Clinical trial NCT01812044
Conditions: Strabismus
Sponsor: Duke University
Start date: 2013-03-01; Completion date: 2014-12-01
Enrollment: 57 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if local anesthetic, either a subtenons injection (an injection just beneath the surface tissue of the eye) or a topical ophthalmic gel (applied directly on the surface of the eye) given at the end of strabismus surgery reduces postoperative pain. Some surgeons routinely use either the subtenon and/or topical anesthetic for pain at the end of strabismus surgery.

Detailed description:

Arms: arm 1: Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery arm 2: Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery arm 3: Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery
Interventions: intervention 1: subtenons anesthetic - preservative-free bupivacaine 0.75% intervention 2: topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel intervention 3: topical control - 0.5 cc of Hypromellose 0.3% gel intervention 4: subtenons control - 0.5 cc of Normal Saline
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT01824303
Conditions: Interstitial Cystitis
Sponsor: Allergan
Start date: 2013-03-01; Completion date: 2014-12-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purposes of the study is to determine if LiRIS®, an investigational drug-delivery system, is safe and tolerable in women with Interstitial Cystitis (IC), and to evaluate any change in IC symptoms following LiRIS administration.

Detailed description:
The study is conducted in 2 parts: a randomized, blinded part in which subjects are assigned randomly (by chance) to LiRIS 400 mg or LiRIS placebo; subjects who complete this part and are eligible to continue, may participate in the open-label part in which all subjects receive LiRIS 400 mg.

In both parts of the study (blinded and open-label), LiRIS is inserted into the bladder during cystoscopy, remains in the bladder for 14 days, and is removed during cystoscopy. In addition to the 14 day period with the LiRIS/LiRIS Placebo, there is a screening period of up to 2 weeks and a follow up period of 4 weeks.

Arms: arm 1: LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days. If eligible, participants could participate in the Open Label Extension where all participants were treated with LiRIS 400 mg. arm 2: LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days. If eligible, participants could participate in the Open Label Extension where all participants were treated with LiRIS 400 mg.
Interventions: intervention 1: LiRIS 400 mg intervention 2: LiRIS Placebo
Intervention descriptions: intervention 1: LiRIS 400 mg contains lidocaine which is gradually released into the bladder over 14 days. intervention 2: LiRIS Placebo contains lactose, inactive substance.

Protocol documents:
Clinical trial NCT01870297
Conditions: Type 2 Diabetes Mellitus
Sponsor: Eli Lilly and Company
Start date: 2013-06-01; Completion date: 2014-12-01
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to assess the safety and tolerability of LY3025876 given alone (Part A) and in combination with liraglutide (Part B) in participants with type 2 diabetes mellitus (T2DM).

Detailed description:
This study will also evaluate how much of the study drug enters the blood stream and how long it takes for the body to remove the study drug. Information about any side effects that may occur will also be collected. Participants will continue their usual diet and exercise program and may remain on their physician-prescribed dose of metformin.

Each part of the study is expected to last 10 to 12 weeks on average, not including screening. Participants may only enroll in one part.

Arms: arm 1: Part A: 0.5 milligram (mg), 1.5 mg, 5 mg, and 15 mg of LY3025876 administered as once daily (QD) subcutaneous (SQ) injections for up to 28 days. arm 2: Part B: Placebo matching LY3025876 administered as QD SQ injections for up to 28 days arm 3: Part B: 5.0 mg of LY3025876 and 1.8 mg liraglutide administered as separate QD SQ injections for up to 28 days, after titration of liraglutide over 2 weeks. arm 4: Part B: Placebo doses matching LY3025876 and 1.8 mg liraglutide administered as separate QD SQ injections for up to 28 days, after titration of liraglutide over 2 weeks.
Interventions: intervention 1: LY3025876 intervention 2: Placebo intervention 3: Liraglutide
Intervention descriptions: intervention 1: Administered SQ intervention 2: Administered SQ intervention 3: Administered SQ

Protocol documents:
Clinical trial NCT01881828
Conditions: Type 1 Diabetes
Sponsor: Jaeb Center for Health Research
Start date: 2013-09-01; Completion date: 2014-12-01
Enrollment: 164 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the proposed research is to evaluate the efficacy and safety of the use of metformin in addition to standard insulin therapy in overweight and obese children and adolescents, age 12-\<20 years, with type 1 diabetes for at least 1 year. Secondary objectives are to assess the effect of metformin on C-peptide levels, a measure of how much insulin is still being produced by the beta cells of the pancreas, and on vascular dysfunction. In addition, an ancillary study is planned to assess if metformin will improve tissue-specific insulin resistance in type 1 diabetes using a hyperinsulinemic euglycemic clamp.

Detailed description:

Arms: arm 1: Metformin 2000 mg per day arm 2: A central pharmacy will compound a placebo to match the metformin tablets.

The placebo product will contain the following components:

* Micosolle™, silica based excipient
* Silicified Micro Crystalline Cellulose, National Formulary
* Safflower Oil, United States Pharmacopeia
* K-30 Povidone Powder
* Magnesium Stearate, National Formulary (Vegetable source)
* Fumed Silica, National Formulary
Interventions: intervention 1: Metformin (glucophage) intervention 2: oral placebo
Intervention descriptions: intervention 1: The strength of each tablet will be 500 mg. Participants will build up to a daily dose over four weeks by taking one tablet per day for 7 days, one tablet twice daily for 7 days, one tablet in morning and 2 tablets at night for 7 days, and then 2 tablets in the morning and 2 tablets at night, daily throughout the remainder of the study treatment period. intervention 2: None

Protocol documents:
Clinical trial NCT01891305
Conditions: Tinea Pedis
Sponsor: Viamet
Start date: 2013-08-01; Completion date: 2014-12-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if the novel oral agent VT-1161 is safe and effective in treating patients with moderate - severe tinea pedis (also referred to as athletes foot). VT-1161 has been designed to inhibit CYP51, an enzyme essential for fungal growth. Inhibition of CYP51 results in the accumulation of chemicals know to be toxic to the fungus. CYP51 is the molecular target of the class of drugs referred to as 'azole antifungals'. All currently approved azole drugs have poor selectivity for CYP51 and this results in many of the side effects associated with the azole antifungals. The safety profile of the class similarly limits use in chronic treatment of non-life-threatening fungal infections. A safer antifungal drug would improve treatment options for infections seen in otherwise healthy individuals where significant side-effect risks are unacceptable.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: VT-1161 intervention 2: placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01891331
Conditions: Candidiasis, Vulvovaginal
Sponsor: Viamet
Start date: 2013-08-01; Completion date: 2014-12-01
Enrollment: 55 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if the novel oral agent VT-1161 is safe and effective in treating patients with acute vulvovaginal candidiasis (also referred to as yeast infection). VT-1161 has been designed to inhibit CYP51, an enzyme essential for fungal growth. Inhibition of CYP51 results in the accumulation of chemicals know to be toxic to the fungus. CYP51 is the molecular target of the class of drugs referred to as 'azole antifungals'. All currently approved azole drugs have poor selectivity for CYP51 and this results in many of the side effects associated with the azole antifungals. The safety profile of the class similarly limits use in chronic treatment of non-life-threatening fungal infections. VT-1161 has been design to be safer and more active against the fungal species typically responsible for vaginal yeast infections (i.e. vulvovaginal candidiasis).

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: VT-1161 intervention 2: Fluconazole
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents: