ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02232880
Conditions: Hypertension
Keywords: hypertension inflammation
Sponsor: Vanderbilt University Medical Center
Start date: 2014-08-01; Completion date: 2015-06-01
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test whether abatacept, a drug approved by the Food and Drug Administration to treat rheumatoid arthritis, may help blood pressure medications to work better. This will be studied in people with high blood pressure that is not well controlled on three or more blood pressure medications, the condition also known as resistant hypertension. We expect to show that adding abatacept therapy to standardized treatment of resistant hypertension will result in a greater decrease in blood pressure at 24 weeks compared to treatment with placebo and conventional blood pressure treatment.

Detailed description:

Arms: arm 1: Subjects randomized to abatacept weighing 60 to 100 kg will receive 750 mg, and those \>100 kg will receive 1000 mg abatacept by intravenous infusion at 0 \[randomization\], 2, and 4 weeks and then every 4 weeks thereafter for a total of 24 weeks.

All subjects will be treated with chlorthalidone 25 mg/day, lisinopril 20 mg/day \[Patients with a history of adverse reaction to lisinopril will be treated with losartan 50 mg/day\], amlodipine 5 mg/day and spironolactone 25 mg bid as standardized treatment of hypertension prior to randomization and throughout the active treatment phase. arm 2: Subjects randomized to placebo will receive 100 ml normal saline by intravenous infusion at 0 \[randomization\], 2, and 4 weeks and then every 4 weeks thereafter for a total of 24 weeks.

All subjects will be treated with chlorthalidone 25 mg/day, lisinopril 20 mg/day \[Patients with a history of adverse reaction to lisinopril will be treated with losartan 50 mg/day\], amlodipine 5 mg/day and spironolactone 25 mg bid as standardized treatment of hypertension prior to randomization and throughout the active treatment phase.
Interventions: intervention 1: Abatacept intervention 2: Placebo
Intervention descriptions: intervention 1: All subjects will be treated with chlorthalidone 25 mg/day, lisinopril 20 mg/day \[Patients with a history of adverse reaction to lisinopril will be treated with losartan 50 mg/day\], amlodipine 5 mg/day and spironolactone 25 mg bid as standardized treatment of hypertension prior to randomization and throughout the active treatment phase. intervention 2: All subjects will be treated with chlorthalidone 25 mg/day, lisinopril 20 mg/day \[Patients with a history of adverse reaction to lisinopril will be treated with losartan 50 mg/day\], amlodipine 5 mg/day and spironolactone 25 mg bid as standardized treatment of hypertension prior to randomization and throughout the active treatment phase.

Protocol documents:
Clinical trial NCT02239627
Conditions: Back Pain
Sponsor: West Virginia University
Start date: 2014-09-01; Completion date: 2015-06-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Low back pain is a common condition, affecting majority of the adults in the United States at some point in their lives. Fortunately, most resolve, even without treatment. However, some suffer from continued or recurrent pain.

For those suffering from continued or recurrent low back pain, numerous treatment options exist. One such option is an epidural injection, particularly when other non-surgical treatment options have failed. An epidural injection is the placement of a needle into the space around the spinal cord with the aid of a live X-Ray machine, followed by an injection of various medications. Typically, the medication that is injected is a steroid, commonly with the combination of local anesthetic medication. Epidural steroid injections, with or without local anesthetic is part of the established standard of care in the United States for those with continued or recurrent low back pain. The steroid is believed to reduce inflammation and edema of the injured or irritated nerves. However, despite the routine use of epidural steroids, the steroid itself is not without risks or side effects. Though rare, the steroids have been associated with complications including osteoporosis, steroid induced myopathy, cataracts and many others. In order to minimize the side effects associated with epidural steroids, limiting the dose and frequency have been outlined.

Clonidine is another medication, commonly used in numerous clinical settings. U. S. Food and Drug Administration approved the medication for epidural use for cancer pain but studies have shown effectiveness in non-cancer pain was well and is routinely used for various conditions. There is growing evidence on the use of epidural clonidine for treatment of pain, including low back pain.

This research will study and compare the effectiveness, if any, of clonidine compared to steroid in an epidural injection for low back pain.

Detailed description:

Arms: arm 1: Epidural steroid injection arm 2: Epidural clonidine injection
Interventions: intervention 1: Epidural steroid intervention 2: Clonidine
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02239692
Conditions: Bowel Cleansing
Sponsor: Ferring Pharmaceuticals
Start date: 2014-11-01; Completion date: 2015-06-01
Enrollment: 204 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a phase 3, randomised, assessor-blinded, multi-centre trial comparing the efficacy, safety and tolerability of a PICOPREP tailored dosing schedule to the PICOPREP day-before dosing schedule for colon cleansing in preparation for colonoscopy.

Detailed description:

Arms: arm 1: Both doses administered the day before colonoscopy. arm 2: First dose one day before colonoscopy or on the day of colonoscopy, dependent on the planned time for colonoscopy, and second dose on the day of colonoscopy.
Interventions: intervention 1: PICOPREP
Intervention descriptions: intervention 1: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution

Protocol documents:
Clinical trial NCT02243202
Conditions: Obesity
Keywords: Obesity Overweight Canagliflozin Phentermine INVOKANA®
Sponsor: Janssen Research & Development, LLC
Start date: 2014-09-01; Completion date: 2015-06-01
Enrollment: 335 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the effects of canagliflozin and phentermine to those of placebo to promote on a change in body weight over a 26 week period.

Detailed description:
This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), placebo-controlled (an inactive substance that is compared with a medication to test whether the medication has a real effect), parallel-group, multicenter study of the effects of canagliflozin and phentermine co-administration in non-diabetic overweight or obese participants. The study will be conducted for about 33 weeks, approximately 344 participants will be randomly assigned in a 1:1:1:1 ratio to one of the four treatment groups: co-administration of canagliflozin and phentermine, canagliflozin alone, phentermine alone, or placebo. All participants will be also provided with diet and exercise counseling for weight loss (standardized non-pharmacological therapy).

Arms: arm 1: 300 mg capsule of Canagliflozin along with 15 mg capsule of Phentermine, taken once daily, orally for 26 weeks. arm 2: 300 mg capsule of Canagliflozin along with matching placebo to Phentermine, taken once daily, orally for 26 weeks. arm 3: 15 mg capsule of Phentermine along with matching placebo to Canagliflozin, taken once daily, orally for 26 weeks. arm 4: Matching placebo to Canagliflozin and Phentermine, taken once daily, orally for 26 weeks.
Interventions: intervention 1: Canagliflozin intervention 2: Phentermine intervention 3: Matching Placebo to Canagliflozin intervention 4: Matching Placebo to Phentermine
Intervention descriptions: intervention 1: 300 mg capsule, taken once daily, orally for 26 weeks. intervention 2: 15 mg capsule, taken once daily, orally for 26 weeks. intervention 3: Placebo capsules look like canagliflozin but do not contain any active drug, taken once daily, orally for 26 weeks. intervention 4: Placebo capsules look like phentermine but do not contain any active drug, taken once daily, orally for 26 weeks.

Protocol documents:
Clinical trial NCT02248480
Conditions: Osteoarthritis of the Knee
Sponsor: Eli Lilly and Company
Start date: 2014-10-01; Completion date: 2015-06-01
Enrollment: 354 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to evaluate the efficacy of the study drug known as duloxetine in participants with chronic osteoarthritis (OA) and knee pain in Japan.

Detailed description:

Arms: arm 1: Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days. arm 2: Placebo administered orally once a day for 15 weeks.
Interventions: intervention 1: Duloxetine intervention 2: Placebo
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally

Protocol documents:
Clinical trial NCT02254486
Conditions: Colon Cancer Colorectal Carcinoma Colon Cleansing
Sponsor: Norgine
Start date: 2014-09-01; Completion date: 2015-06-01
Enrollment: 621 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluates the efficacy, safety and tolerability of NER1006 versus Trisulfate Solution (TS) in adult patients requiring bowel cleansing prior to any procedure that requires a clean bowel, using a 2-Day evening/morning Split-Dosing regimen. Approximately 540 patients will be randomised with the aim of achieving a minimum of 245 patients in each of the 2 groups.

Detailed description:

Arms: arm 1: NER1006:2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy) arm 2: Trisulfate Solution 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
Interventions: intervention 1: NER1006 intervention 2: Trisulfate solution
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 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.

Protocol documents:
Clinical trial NCT02284243
Conditions: Pain, Post-operative
Keywords: Bunion Bunionectomy Pain Analgesia dexmedetomidine intranasal
Sponsor: Baudax Bio
Start date: 2014-10-01; Completion date: 2015-06-01
Enrollment: 168 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the analgesic efficacy, on Post-Operative Day (POD) 1, of DEX-IN compared with placebo, using the summed pain intensity difference over the first 48 hours (SPID48) in subjects with acute moderate to severe pain following unilateral bunionectomy.

Detailed description:

Arms: arm 1: DEX-IN (Intranasal dexmedetomidine) 50mcg every 6 hours for 48 hours. arm 2: IN Placebo every 6 hours for 48 hours.
Interventions: intervention 1: Intranasal Dexmedetomidine intervention 2: Intranasal Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02336360
Conditions: Alzheimer's Disease
Sponsor: Avid Radiopharmaceuticals
Start date: 2015-01-01; Completion date: 2015-06-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will obtain data from urine in subjects administered flortaucipir in an Avid-sponsored study to augment the calculation of radiation dosimetry estimates.

Detailed description:

Arms: arm 1: Urine will be collected from subjects administered flortaucipir in an Avid-sponsored study to determine the amount of radioactivity excreted in urine.
Interventions: intervention 1: Flortaucipir F18
Intervention descriptions: intervention 1: No flortaucipir administered in this study. Subjects received flortaucipir in an Avid-sponsored study.

Protocol documents:
Clinical trial NCT02347085
Conditions: COPD
Sponsor: Pearl Therapeutics, Inc.
Start date: 2015-02-01; Completion date: 2015-06-01
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Randomized, Phase IIIb, Two-period, Two-treatment Double-blind, Multi-center, Crossover Study to Evaluate the 24-hour Lung Function Profile in Subjects with Moderate to Very Severe COPD after 4 Weeks of Treatment with PT003 and Placebo MDI

Detailed description:

Arms: arm 1: Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) arm 2: Placebo Metered Dose Inhaler (MDI) for Glycopyrronium and Formoterol Fumarate Inhalation Aerosol
Interventions: intervention 1: GFF MDI (PT003) intervention 2: Placebo MDI
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02371850
Conditions: Smoking
Keywords: Bioequivalence Therapeutic Equivalency
Sponsor: University of Maryland, Baltimore
Start date: 2014-10-01; Completion date: 2015-06-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a single-dose, Open-label, Non-Randomized, 2-way Crossover Bioequivalence Study to compare nicotine release after heating of a brand name (Nicoderm CQ) and generic (Aveva skin patch) nicotine skin patches in adult smokers.

Detailed description:
This research study is intended to determine the effect of heat on FDA-approved nicotine transdermal patches and whether the heat applied will result in more nicotine being absorbed through the skin than without applying heat. This is important given that little is known about how the release of nicotine is affected by heat, particularly for generic products that are also available over the counter. This study will use nicotine patches (brand name and generic patches) that have been approved by the Food and Drug Administration (FDA) and are already sold over the counter to customers in the United States, and will not include any placebos.

Arms: arm 1: Each subject gets two procedure days with heating applied for one hour at hours 4 and hour 8 after the application of the Nicoderm CQ nicotine patch, then followed by two procedure days with heating applied for one hour at hours 4 and hour 8, after the application of the Aveva nicotine patch (total of four Procedure days)
Interventions: intervention 1: Nicoderm patch first, then Aveva patch
Intervention descriptions: intervention 1: This is a single group assignment where each of 10 adult smokers completes 4 procedure days using a Nicoderm CQ nicotine patch (2 days) followed by the application of a generic Aveva patch (2 days). For each patch, heating is applied for one hour at hour 4 on the first procedure day and at hour 8 in the second procedure day (2 days per patch, or a total of 4 days per subject).

Protocol documents:
Clinical trial NCT02387580
Conditions: Malaria
Keywords: Malaria Bioavailability Formulation
Sponsor: Medicines for Malaria Venture
Start date: 2015-04-01; Completion date: 2015-06-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a single-centre, 2-part, randomised, single-dose parallel group study in healthy male subjects and female subjects of non-childbearing potential.

Detailed description:
Parts 1 and 2 will be randomised with 8 subjects receiving each regimen:

Part 1:

* Regimen A: Reference: 800 mg OZ439 + α-Tocopherol polyethylene glycol 1000 succinate (TPGS) granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
* Regimen B: Prototype 1: 800 mg OZ439 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
* Regimen C: Prototype 3: 800 mg OZ439 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets

There will be an interim decision after Part 1 to determine the formulation prototypes and the oral suspension volume to be administered in Part 2.

Part 2

* Regimen D: Reference: 800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
* Regimen E: Prototype 1 or 3: 800 mg OZ439 granules (oral suspension and rinse volume to be determined) and 960 mg (3 × 320 mg) PQP tablets
* Regimen F: Prototype 1 or 3: 800 mg OZ439 granules (oral suspension and rinse volume to be determined) and 960 mg (3 × 320 mg) PQP tablets

Arms: arm 1: 800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets arm 2: 800 mg OZ439 Prototype 1 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets arm 3: 800 mg OZ439 Prototype 3 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets arm 4: 800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets arm 5: 800 mg OZ439 Prototype 1 or 3 granules (oral suspension and rinse volume to be determined) and 960 mg (3 × 320 mg) PQP tablets arm 6: 800 mg OZ439 Prototype 1 or 3 granules (oral suspension and rinse volume to be determined) and 960 mg (3 × 320 mg) PQP tablets
Interventions: intervention 1: OZ439 + TPGS intervention 2: OZ439 Prototype 1 intervention 3: OZ439 Prototype 3 intervention 4: PQP
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT02423980
Conditions: Hypoglycemia
Sponsor: Xeris Pharmaceuticals
Start date: 2015-04-01; Completion date: 2015-06-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, exploratory pilot study in patients with T1D. The study will involve two daytime clinical research center visits 7-14 days apart. Subjects will receive a single injection of G-Pen™ (glucagon injection) at each visit.

Detailed description:
Following eligibility confirmation, each study participant will undergo two episodes of insulin-induced hypoglycemia with plasma glucose \< 50 mg/dL. Both episodes will be treated with a single subcutaneous injection of G-Pen™ glucagon. For the first treatment visit, all subjects will receive a 1 mg dose of G-Pen™ glucagon. The investigator will have discretion to repeat this same dose at the second treatment visit or give a 0.5 mg dose of G-Pen™ glucagon. A follow-up phone call will be conducted 3-7 days following administration of the final dose of study drug as a safety check.

Arms: arm 1: 1 mg G-Pen™ (glucagon injection) first, followed by 0.5 mg
Interventions: intervention 1: Glucagon
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02424565
Conditions: Pain
Sponsor: GlaxoSmithKline
Start date: 2015-05-01; Completion date: 2015-06-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The rationale of this study is to map out changes in temperature distribution brought about by topical application of our test product, and use this physiological phenomenon to visualize the onset of action involved in overall mechanism of action of the product.

Detailed description:

Arms: arm 1: 2 ± 0.2 g of product will be gently rubbed for 15 seconds on the affected knee joint. arm 2: 2 ± 0.2 g of product will be gently rubbed for 15 seconds on the affected knee joint.
Interventions: intervention 1: IODEX® balm intervention 2: Placebo balm
Intervention descriptions: intervention 1: 2 ± 0.2 g of test balm will be applied topically in a crossover fashion at a gap of 3 days between the two product applications. intervention 2: 2 ± 0.2 g of placebo balm will be applied topically in a crossover fashion at a gap of 3 days between the two product applications.

Protocol documents:
Clinical trial NCT02486328
Conditions: Gastrointestinal Dysfunction Alteration of Cognitive Function
Keywords: Cognitive dysfunction Colonoscopy Sedation
Sponsor: Ufuk University
Start date: 2015-05-01; Completion date: 2015-06-01
Enrollment: 103 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
There are different sedation regimes for lower gastrointestinal system endoscopy which can be administered by anesthesiologists and non-anesthesiologists. This study aims to compare the effects of propofol/remifentanil combination and midazolam/meperidine combination on early cognitive function following lower gastrointestinal system endoscopies.

Detailed description:
Sedation for lower gastrointestinal system endoscopies can be administered by anesthesiologists or endoscopists and cognitive dysfunction after this procedure has not been fully investigated. The aim of this study was to investigate the effect of different sedation regimes applied by anesthesiologists or endoscopists on early cognitive dysfunction. Following ethics committee approval and written informed consent, 100 patients were randomly divided into two groups. In Group MM where drug regime was solely determined by endoscopists, 2 mg midazolam and 20mg meperidine was given intravenously and additional 1-2mg midazolam and 20mg meperidine (wtih a maximum total of 5 mg midazolam and 50 mg meperidine) was given when facial pain scale (FPS) was greater than 3. In Group RP where drug regime was solely determined by anesthesiologists, 100 mcg/kg/min propofol infusion and 1 mcg/kg remifentanil bolus was administered and additional 0,5 mcg/kg remifentanil bolus was given when FPS was greater than 3. Bispectral index (BIS) and hemodynamic monitorization was carried out throughout the procedure and BIS 60-80 with FPS\<3 was targeted. The time to Observer Assessment of Alertness/Sedation Scale (OAAS) score to reach 3 was measured after the procedure and Trieger Dot Test (TDT) and Digit Symbol Substitution Test (DSST) was repeated at 5th, 15th and 30th minutes.

Arms: arm 1: 2 mg midazolam and 20mg meperidine given intravenously and additional 1-2mg midazolam and 20mg meperidine (wtih a maximum total of 5 mg midazolam and 50 mg meperidine) given when FPS greater than 3 arm 2: 100 mcg/kg/min propofol infusion and 1 mcg/kg remifentanil bolus administered and additional 0,5 mcg/kg remifentanil bolus given when FPS greater than 3
Interventions: intervention 1: Midazolam intervention 2: Meperidine intervention 3: Remifentanil intervention 4: Propofol
Intervention descriptions: intervention 1: Dosage adjustment intervention 2: Dosage adjustment intervention 3: Dosage adjustment intervention 4: Dosage adjustment

Protocol documents: