ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01854827
Conditions: Biliary Atresia
Keywords: Biliary atresia Hepatic portoenterostomy Intravenous immunoglobulin
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date: 2013-10-01; Completion date: 2016-07-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The Children Liver Disease Research and Education Network (ChiLDREN) is conducting a clinical trial to determine the feasibility, acceptability, tolerability and safety profile of IVIG treatment administered to infants after hepatic portoenterostomy (HPE) for biliary atresia, as well as investigate preliminary evidence of activity and explore mechanisms of action.

Detailed description:
In this multicenter prospective phase 1/2A open label trial, the feasibility, tolerability and safety of intravenous immunoglobulin (IVIG) therapy following hepatic portoenterostomy (HPE) will be assessed in 29 infants with biliary atresia (BA), efficacy will be estimated and exploratory mechanistic research studies will be performed. After written consent is obtained from the parent or guardian, the subject will be enrolled and will receive three intravenous doses of IVIG at designated intervals over the first 60 days following HPE and will be followed for 360 days after enrollment. Blood will also be obtained during this study to assess potential mechanisms by which the IVIG may alter or reduce bile duct inflammation and injury and improve bile flow. All infants in this trial will also be treated with standardized doses of other routine standard-of-care treatments for BA during this trial (ursodeoxycholic acid, trimethoprim-sulfamethoxasole, and fat-soluble vitamin supplements). This routine clinical care will not be modified by participation in this study. Subjects in this study will not receive corticosteroid therapy for treatment of biliary atresia, as this is of unproven benefit at the present time.

Arms: arm 1: Intravenous immunoglobulin (IVIG) 10% 1 gm/kg body weight/dose Day 3-5,30, 60 post HPE
Interventions: intervention 1: Intravenous immunoglobulin (IVIG)
Intervention descriptions: intervention 1: All participants will receive the same dose of IVIG at the same intervals in an open-label fashion as long as the subject does not have any increased risk for toxicity for any IVIG infusion. IVIG will be initiated on day 3 (up to day 5) after HPE surgery (HPE is day 0) at a dose of 1 gm/kg body weight by slow intravenous infusion over at least 4 hours. The same dose (1 gm/kg) and duration of infusion will be repeated on day 30 and day 60 after HPE.

Protocol documents:
Clinical trial NCT01856218
Conditions: Mucopolysaccharidosis Type 7
Keywords: Mucopolysaccharidosis type 7, MPS 7, Sly syndrome, enzyme replacement therapy, rare disease, lysosomal storage disease, metabolic disorder
Sponsor: Ultragenyx Pharmaceutical Inc
Start date: 2013-11-01; Completion date: 2016-07-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
UX003-CL201 is an open-label Phase 1/2 study to assess the safety, efficacy, and dose of UX003 in MPS 7 patients via intravenous (IV) administration every other week (QOW) for 36 weeks with up to an additional 36 weeks from the optional continuation period. Up to 5 participants, who are between 5 and 30 years of age inclusive, will be enrolled and treated with UX003.

The initial 12-week treatment period will be followed by a 24-week forced dose titration period to assess the optimal dose. Participants who complete both the initial treatment and forced dose titration periods will continue treatment in a 36- week continuation period.

Detailed description:

Arms: arm 1: During the initial 14-week treatment period of the study, participants receive 2 mg/kg UX003 every other week (QOW) for 12 weeks. At Week 14, participants continue on UX003 therapy and begin a forced dose titration period for an additional 24 weeks at the dose sequence of 1, 4, and 2 mg/kg UX003 QOW as follows: 1 mg/kg UX003 for 8 weeks beginning on Week 14; then 4 mg/kg UX003 for 8 weeks beginning on Week 22; then 2 mg/kg UX003 for 8 weeks beginning on Week 30. Following the 24 week forced dose titration period, participants who continue on treatment (continuation period) received 2 mg/kg UX003 QOW beginning at Week 38 for up to an additional 36 weeks.

After the first phase of the study, participants who elect to continue drug treatment are transitioned to the long-term extension phase, where they are treated with UX003 at 4 mg/kg beginning at Week 74, for up to an additional 168 weeks.
Interventions: intervention 1: UX003
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01931059
Conditions: Imaging of the Brain and Antipsychotics Neuronal Network Changes
Keywords: Imaging Risperidone Placebo antipsychotic
Sponsor: Northwell Health
Start date: 2013-07-01; Completion date: 2016-07-01
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To detect the effect of second-generation antipsychotic drug on the neural activity.

Detailed description:
To detect functional correlation changes in the brain with anti-psychotic drug administration as compared to placebo, and b.) to measure if these changes correlate with the plasma level of anti-psychotic, and c.) to evaluate if these changes correlate with drug induced symptoms and changes in cognitive function.

Arms: arm 1: This group will receive 2 mg (\>200lbs), 1.5mg (150-200lbs.) or 1 mg (\< 150lbs. of risperidone oral solution on the first day and a placebo on the second day. arm 2: This group will receive a placebo on the first day and 2mg (\> 200lbs.), 1.5mg (150-200lbs), or 1 mg (\<150lbs.) of risperidone oral solution on the second day
Interventions: intervention 1: Risperidone intervention 2: Placebo
Intervention descriptions: intervention 1: We gave oral liquid of risperidone one time 1-2 mg depending on subject's weight. intervention 2: We gave oral liquid without active risperidone (pt and provider were both double blinded)

Protocol documents:
Clinical trial NCT01938664
Conditions: Cocaine Dependence
Keywords: cocaine dependence pharmacotherapy
Sponsor: Baylor College of Medicine
Start date: 2013-01-01; Completion date: 2016-07-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to see if a drug called Candesartan will help to reduce use of cocaine.

Detailed description:
The noradrenergic system may play an important role in cocaine addiction in humans. Angiotensin II (Ang II) is known to enhance noradrenergic activity, which contributes to effects on blood pressure and sympathetic nervous system responses to stress. Inhibition of Ang II has been shown to reduce cravings for stimulants, including cocaine and methamphetamine.

This clinical trial among 75 cocaine-dependent subjects is designed to test the efficacy of the Angiotensin II receptor antagonist, Candesartan, for treatment of cocaine dependence. The results of this study will provide medical safety and efficacy data, and will guide future pharmacotherapy trials using this class of medications for cocaine addiction.

This 8-week trial includes a 1-week titration of the medication and 7-weeks of full dose medication (weeks 2-8), with all subjects receiving the active agent.

At the conclusion of the trial, subjects who wish to be referred to an appropriate treatment program or treatment research program will be assisted with a referral.

Arms: arm 1: Titration up to 8mg through week 1. Continue on 8mg thru wk 8. CBT optional thru study. arm 2: Sugar pill to mimic Candesartan for study duration. CBT optional thru study.
Interventions: intervention 1: Candesartan with CBT intervention 2: Placebo with CBT
Intervention descriptions: intervention 1: 8 mg, po (by mouth) intervention 2: None

Protocol documents:
Clinical trial NCT01965834
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma Fenofibrate
Sponsor: University of Miami
Start date: 2012-11-19; Completion date: 2016-07-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Multiple myeloma cells are dependent on calcium (Ca2+) for their function. Specifically, Ca2+ is required for the function of the endoplasmic reticulum in which proteins, including immunoglobulins, are folded prior to their release from the cell. Multiple myeloma cells secrete large concentrations of immunoglobulins continuously and as result depend on mitochondria activity to replenish the Ca2+ levels in the endoplasmic reticulum as was shown in vitro in our lab. Fenofibrate has been shown to inhibit mitochondrial function resulting in inhibition of protein folding in the endoplasmic reticulum of multiple myeloma (MM) cells that leads to the induction of a stress signal known as the unfolded protein response and subsequently apoptosis. The effective anti-myeloma concentrations for fenofibrate are attainable in the clinical setting as they are in the same range as the effective concentrations for anti-hyperlipidemic effect. The investigators propose to evaluate fenofibrate therapy in multiple myeloma patients.

Detailed description:

Arms: arm 1: Fenofibrate orally daily for each 28 day cycle, per study protocol.
Interventions: intervention 1: Fenofibrate
Intervention descriptions: intervention 1: Upon screening, registration and enrollment, all subjects will receive Fenofibrate 160 mg orally daily for at least 2 months and may continue receiving study medication for as long as in the opinion of the investigator there is clinical benefit in doing so. Patients with calculated creatinine clearance \< 50 mL/min will receive a reduced dose of 54 mg orally daily.

Protocol documents:
Clinical trial NCT01969084
Conditions: Type II Diabetes Mellitus
Keywords: Type II Diabetes Mellitus Diabetes Metabolism Linagliptin Tradjenta Glucose
Sponsor: Beth Israel Deaconess Medical Center
Start date: 2013-10-01; Completion date: 2016-07-01
Enrollment: 45 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Investigators propose to examine the effect of 12 weeks of Linagliptin, a diabetes drug, treatment on inflammation as well as vascular and mitochondrial function in diabetic patients. Investigators hypothesize that Linagliptin will reduce the proinflammatory state, improve endothelial function, increase the blood flow at the muscle microcirculation level and improve mitochondrial function. In this study, investigators will perform tests that evaluate the function of small and large blood vessels by employing ultrasound and laser doppler techniques. In addition MRI scans that evaluate the mitochondrial function of the lower extremity muscles at rest and during exercise will also be employed. Forty subjects with Type 2 diabetes will be studied for twelve weeks and half of them will be randomly assigned to receive linagliptin while the other half will receive placebo. All tests will be performed at the beginning and the end of the study.

Detailed description:

Arms: arm 1: Subjects given Linagliptin arm 2: Subjects given sugar pill/placebo
Interventions: intervention 1: Linagliptin intervention 2: Placebo intervention 3: Microcirculation testing intervention 4: Macrocirculation testing intervention 5: MRI Scans
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: The endothelial function of the micro-circulation will be assessed by measuring the hyperemic response of the vessels in the superficial skin of the forearm after the iontophoresis of acetylcholine. The endothelium independent vasodilation will be assessed by the iontophoresis of sodium nitroprusside. Laser Doppler perfusion imaging will be used to measure relative changes in flow velocity.Visible and NIR Medical Hyperspectral Imaging (MHSI) data will be collected with a HyperMed OxyView MHSI System (HyperMed, Inc., Watertown, MA). MHSI images will be obtained from same forearm area where the iontophoresis of acetylcholine and sodium nitroprusside will be performed, before and after the iontophoresis test. intervention 4: Use ultrasound to measure brachial artery flow mediated vasodilation (FMD, endothelium-dependent vasodilation) and nitroglycerin induced dilation (NID, endothelium-independent vasodilation). intervention 5: Phosphorus-31 MRI data will be obtained during an exercise protocol. Muscle oxygenation will be measured using the blood oxygenation level-dependent magnetic resonance imaging (BOLD MRI) technique after induced hyperemia.

Protocol documents:
Clinical trial NCT02011542
Conditions: Gulf War Illness
Keywords: Irritable Bowel Syndrome Gulf War Illness
Sponsor: University of Utah
Start date: 2013-09-01; Completion date: 2016-07-01
Enrollment: 29 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The overall objective is to determine whether VSL #3 will improve 1) intestinal symptoms of Irritable Bowel Syndrome (IBS) and 2) non-intestinal symptoms (fatigue, joint pain, insomnia, general stiffness and headache) associated with IBS. All of these symptoms are part of the Gulf War (GW) illness.

Detailed description:
Specific Aims:

Aim # 1: Determine the efficacy of VSL #3 on IBS symptoms in GW veterans.

Hypothesis: Treatment with VSL #3 compared to placebo will improve global and individual symptoms of IBS

Aim #2 Determine the efficacy VSL #3 in reducing non-intestinal symptoms of IBS (fatigue, joint pain, insomnia, general stiffness and headache).

Hypothesis: Treatment with VSL #3 compared to placebo will improve non-intestinal symptoms of IBS in GW veterans.

Aim #3 Determine whether changes in gut flora and plasma cytokines correlate with treatment response in GW veterans.

Arms: arm 1: Placebo (not an active drug/ Inactive component) is given to this group arm 2: VSL #3 (probiotic mixture) is given to this group
Interventions: intervention 1: VSL#3 intervention 2: Placebo
Intervention descriptions: intervention 1: This is a probiotic mixture intervention 2: This is a pill with inactive ingredients.

Protocol documents:
Clinical trial NCT02017327
Conditions: Primary Open Angle Glaucoma Ocular Hypertension
Sponsor: Laboratoires Thea
Start date: 2013-12-01; Completion date: 2016-07-01
Enrollment: 379 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary objective:

The primary objective is to demonstrate the superiority of Monoprost® versus Lumigan® 0.01% and Lumigan® 0.03% Unit Dose in term of safety with respect to the assessment of conjunctival hyperaemia in the worse eye at Day 84.

The conjunctival hyperaemia will be scored using the MacMonnies photographic scale (0 to 5).

Detailed description:

Arms: arm 1: 1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months. arm 2: 1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months. arm 3: 1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months.
Interventions: intervention 1: Monoprost intervention 2: Lumigan 0.01% intervention 3: Lumigan 0.03% Unit Dose
Intervention descriptions: intervention 1: Monoprost®: Latanoprost 0.005% ophthalmic preparation is a sterile unpreserved oil-based solution for topical ophthalmic use. It is supplied in 0.30 ml single use polyethylene containers. The batch numbers and reanalysis dates will be stated in the certificate of analysis. intervention 2: Lumigan® 0.01%: Bimatoprost eye drop solution is supplied in 3 ml multidose container. intervention 3: Lumigan® 0.03% Unit Dose: Bimatoprost eye drop solution is supplied in 0.4 ml single use low density polyethylene (LDPE) containers.

Protocol documents:
Clinical trial NCT02036476
Conditions: Merkel Cell Carcinoma Skin Cancer
Keywords: Merkel Cell Carcinoma Skin Cancer
Sponsor: Dana-Farber Cancer Institute
Start date: 2014-02-01; Completion date: 2016-07-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, non-randomized, phase 2 study to assess the feasibility of using cabozantinib in recurrent/metastatic Merkel Cell Carcinoma patients that progressed after platinum-based therapy.

Detailed description:
Cabozantinib (XL184) is an inhibitor of multiple receptor tyrosine kinases and was approved by the U.S. Food and Drug Administration (FDA) on 29 November 2012 for the treatment of patients with progressive, metastatic medullary thyroid cancer. It is commercially available as COMETRIQ™ in the United States.

During the Pre Treatment Period, participants are consented and qualified (screened) for the study. Treatment will be administered on an outpatient basis.

Each treatment cycle lasts 28 days, during which time the participant will be taking the study drug, cabozantinib, once daily. The participant will be given a study drug-dosing diary for each treatment cycle. The diary will also include special instructions for taking the study drug.

\- Participants will be followed for 8 weeks after removal from study or until death, whichever occurs first. Participants removed from study for unacceptable adverse events will be followed until resolution or stabilization of the adverse event.

Arms: arm 1: Cabozantinib 60 mg given orally daily for 28 days (4 weeks) each cycle. Participants were treated until disease progression, unacceptable toxicity or withdrawal for other reasons.
Interventions: intervention 1: Cabozantinib
Intervention descriptions: intervention 1: oral administration

Protocol documents:
Clinical trial NCT02040623
Conditions: Chronic Graft-versus-host Disease
Keywords: Chronic Graft versus Host Disease Keratoconjunctivitis Sicca
Sponsor: Rigel Pharmaceuticals
Start date: 2014-03-01; Completion date: 2016-07-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
* To assess the efficacy of R348 Ophthalmic Solutions administered for 12 weeks to subjects evaluated by objective and subjective measures.
* To investigate the safety and tolerability of R348 Ophthalmic Solutions administered for 12 weeks to subjects.

Detailed description:

Arms: arm 1: R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day arm 2: R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day arm 3: Placebo Ophthalmic Solution 2 drops per eye twice a day
Interventions: intervention 1: R348 Ophthalmic Solution, 0.2% intervention 2: R348 Ophthalmic Solution, 0.5% intervention 3: Placebo Ophthalmic Solution
Intervention descriptions: intervention 1: R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day intervention 2: R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day intervention 3: Placebo Ophthalmic Solution 2 drops per eye twice a day

Protocol documents:
Clinical trial NCT02063217
Conditions: Amyloid-beta
Sponsor: Washington University School of Medicine
Start date: 2013-12-01; Completion date: 2016-07-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to change the concentration of amyloid-beta in human cerebrospinal fluid (CSF) through modulation of the sleep-wake cycle.

Detailed description:
The purpose of this research study is to investigate whether or not increasing or decreasing duration of sleep over one night will change the concentration of amyloid-beta in cerebral spinal fluid (CSF).

Arms: arm 1: 7.5 grams of sodium oxybate arm 2: Sleep deprivation for up to 36 hours with no naps or other sleep periods arm 3: Participant will sleep as normal under the same controlled conditions in a clinical research unit
Interventions: intervention 1: Sodium Oxybate intervention 2: Sleep deprivation
Intervention descriptions: intervention 1: Sodium oxybate h.s. intervention 2: 36hr sleep deprivation

Protocol documents:
Clinical trial NCT02078193
Conditions: Kidney Transplantation
Sponsor: East Carolina University
Start date: 2013-11-01; Completion date: 2016-07-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to demonstrate that administration of belatacept in maintenance kidney transplant recipients may cause a reduction in Donor Specific HLA Antibody (DSA).

Detailed description:
The aim of this study is to evaluate patients converted to belatacept in combination with Mycophenolate Mofetil (MMF) with corticosteroids with respect to their DSA titer. Patients in this study will be converted from their calcineurin inhibitor (CNI) to belatacept from baseline in an attempt to down-modulate antibody production by B-cells. Dosing will be calculated per prescribing information for dosing maintenance phase (5mg per kg every 28 days.

Arms: arm 1: Participants will be converted from their current MMF to once a month infusions of Belatacept
Interventions: intervention 1: Belatacept
Intervention descriptions: intervention 1: Patients will be converted from their MMF to Belatacept

Protocol documents:
Clinical trial NCT02095197
Conditions: Radicular; Neuropathic, Cervical Neck Pain
Sponsor: Northwestern University
Start date: 2014-03-01; Completion date: 2016-07-01
Enrollment: 79 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Cervical radicular pain is a common, disabling problem, occurs in 83:100,000 individuals per year. Symptoms are most often caused by intervertebral disc herniation (21.9%) or central or foraminal stenosis from spondylosis (68.4%). Patients complain of pain in the head, neck, scapula or arm. The diagnosis of radicular pain is made clinically by history and physical examination, supported by imaging studies and electrodiagnostic tests. No study has compared the differences in pain, medication utilization, functional outcomes, or patient satisfaction between interlaminar and targeted epidural injections in the cervical spine. In theory, the technique of targeted epidural steroid delivery with a catheter has a lower risk of accidental vascular trespass or disc penetration during the procedure, and far less risk of dural penetration or spinal cord injury at rostral levels of the cervical spinal cord as compared with the interlaminar technique. The investigators hypothesize that this technique results in superior pain control, decreased medication use, improved function and fewer repeat injections. This data could improve patient safety and affect the evolving treatment guidelines for cervical epidural injections.

Detailed description:
Cervical radicular pain is a common, painful, disabling problem, often treated by epidural steroid injection (ESI). Two techniques of steroid delivery into the cervical epidural space include the transforaminal and interlaminar approaches. We aimed to determine if the CIESI with versus without a catheter is associated with superior clinical outcomes at follow-up. We hypothesized that the use of a targeted epidural catheter technique would result in superior pain control, function, decreased analgesic use, and lower surgical incidence as compared to standard CIESI at C7-T1.

Arms: arm 1: Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.

No Catheter Delivery will be used to deliver the medication. arm 2: Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.

Catheter targeted delivery will be used to deliver the medication.
Interventions: intervention 1: Triamcinolone 80mg
Intervention descriptions: intervention 1: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.

Protocol documents: