ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01536379
Conditions: Transplantation, Organ
Keywords: Infection Quality of Life
Sponsor: GlaxoSmithKline
Start date: 2013-09-01; Completion date: 2016-02-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Kidney transplantation is the best treatment for many patients with kidney failure. Sometimes a transplanted kidney is rejected by the patient's immune system. Many types of immune system cells, including B cells, are active in rejection. B cells produce antibodies against anything the body sees as non-self, like germs or a transplanted kidney. Most medicines that help prevent transplant rejection affect cells other than B cells. Belimumab is a medication used to treat a disease called lupus. Belimumab slows development of antibody-producing B cells. This study will test whether belimumab works on parts of the immune system that cause rejection. Twenty to thirty adults getting a kidney transplant will be in this study. Like flipping a coin, a computer will randomly assign half to be given belimumab and half to be given placebo (a fake medicine). Patients and doctors will not know which medicine was assigned until the study is over. A total of 7 doses of study medicine will be given through a vein. One dose will be given during transplant surgery, and the other 6 will be given 2, 4, 8, 12, 16 and 20 weeks after transplant surgery. Usual transplant medicines will also be given. After all of the doses have been given, patients will be watched and tested at 24, 36, and 52 weeks after the transplant surgery. Blood samples will be tested to see what study medicines do to the immune system in transplant patients. If patients get a kidney biopsy, the samples will be tested to see if belimumab had any effect. Patients will be asked many questions to see if they are having any side effects. The study will be done at Addenbrooke's Hospital in Cambridge and Guys \&St Thomas Hospital in London, United Kingdom. A pharmaceutical company, GlaxoSmithKline, is funding the study.

Detailed description:

Arms: arm 1: Subjects will receive belimumab 10 mg/ Kilogram (kg) infusion on Days 0, 14, 28 and every 4 weeks thereafter for a total of 7 infusions. The last dose of investigational product will be administered at the Week 20 visit; In addition to investigational product, all subjects will receive standard of care. arm 2: Subjects will receive placebo infusion on Days 0, 14, 28 and every 4 weeks thereafter for a total of 7 infusions. The last dose of investigational product will be administered at the Week 20 visit; In addition to investigational product, all subjects will receive standard of care
Interventions: intervention 1: Belimumab intervention 2: Placebo
Intervention descriptions: intervention 1: Belimumab (10 mg/kg) will be given as an intravenous solution over a 1 hour time period administered every 4 weeks for 24 weeks (with an additional dose at Week 2) intervention 2: Placebo will be given as an intravenous solution over a 1 hour time period administered every 4 weeks for 24 weeks (with an additional dose at Week 2)

Protocol documents:
Clinical trial NCT01574183
Conditions: Marijuana Dependence
Keywords: Marijuana Vilazodone Contingency management Motivational enhancement therapy
Sponsor: Medical University of South Carolina
Start date: 2012-08-01; Completion date: 2016-02-01
Enrollment: 76 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Marijuana is the most commonly used illicit drug, yet few clinical trials have evaluated pharmacotherapy treatments for marijuana dependence. This study will evaluate the efficacy of vilazodone for reducing marijuana use in marijuana-dependent adults. A contingency management intervention (CM)and motivational enhancement therapy (MET)will be incorporated to encourage study engagement and retention, and genomic DNA will be extracted to characterize subjects according to polymorphisms of genes potentially relevant to the activity of vilazodone. It is hypothesized that vilazodone combined with MET and CM will reduce the percent of marijuana-positive urine drug screen results in marijuana-dependent individuals as compared to a placebo treatment combined with MET and CM.

Detailed description:
The purpose of this study is to determine if the medication vilazodone is effective in helping frequent marijuana smokers cut down or stop using marijuana. Vilazodone is FDA approved for the treatment of depression- in this study, vilazodone's effect on marijuana dependence is being investigated.

Participation in the study takes 10 visits over a period of approximately two to three months. The first visit is a screening visit to determine if participants are eligible to participate. After the initial assessment visit, the weekly visits take about 30 minutes, with the exception of three therapy sessions which take approximately 60-90 minutes. The three therapy sessions will focus on participant's marijuana use and reasons they may have for stopping or cutting down on use. After completing an initial therapy session, participants will be randomly selected to receive the study medication, either vilazodone or placebo (a capsule that does not contain any active medication). Participants will have weekly study visits with a clinician. At each study visit, they will be asked to fill out forms and answer specific questions concerning their substance use, anxiety symptoms, and feelings in general. They will be providing urine samples to check for illegal drugs of abuse including marijuana and other drugs. They will also have blood samples drawn during to determine if you are taking the medication as directed.

Arms: arm 1: Flexible dose up to 40 mg capsule daily arm 2: Flexible dose up to 40 mg capsule daily
Interventions: intervention 1: Vilazodone intervention 2: Placebo
Intervention descriptions: intervention 1: up to 40 mg capsule daily intervention 2: up to 40 mg capsule daily

Protocol documents:
Clinical trial NCT01574248
Conditions: ACE Inhibitor-associated Angioedema
Keywords: ACE inhibitor Angioedema Bradykinin Swelling
Sponsor: Vanderbilt University Medical Center
Start date: 2011-08-01; Completion date: 2016-02-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Individuals with heart disease or high blood pressure are often prescribed angiotensin converting enzyme (ACE) inhibitors to treat their disease. However, the use of ACE inhibitors can be associated with angioedema, a rare but life-threatening condition that causes swelling of the face and other body parts. This study will evaluate the effectiveness of the drug HOE-140 at decreasing symptoms of angioedema in people taking ACE inhibitors who develop the condition.

Detailed description:
People who take ACE inhibitors may develop angioedema, a condition that causes itchy and painful swelling beneath the skin around the eyes, lips, tongue, throat, hands, or feet. In severe cases, the throat may swell, obstructing the airway and leading to breathing difficulty. ACE inhibitors prevent the breakdown of a natural chemical in the body called bradykinin. Increased levels of bradykinin, which can cause swelling, may contribute to the development of angioedema. Blocking bradykinin receptor cells prevents bradykinin from initiating swelling and may lead to a possible decrease in angioedema symptoms. The purpose of this study is to evaluate the effectiveness of HOE-140, a bradykinin receptor blocker, at reducing symptoms in people with ACE inhibitor-associated angioedema.

This study will enroll people admitted to the emergency room or hospital who have a severe case of ACE inhibitor-associated angioedema. Participants will be randomly assigned to receive an injection of either HOE-140 or placebo. Initially, participants will undergo an electrocardiogram to measure the electrical activity of the heart. Then blood pressure measurements, blood collection, a physical exam to determine the extent and duration of swelling, and photographs of the swelling will occur at 2, 4, 8, 16, and 24 hours following the start of treatment. Questionnaires will be completed by study staff and participants to assess changes in angioedema symptoms and the extent of swelling. Participants will remain in the hospital for 24 to 48 hours, depending on the severity of their symptoms. Blood will be collected at a follow-up visit that will occur 7 days after the resolution of angioedema symptoms.

Arms: arm 1: 30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization arm 2: Subcutaneous at time 0 and 6 hours
Interventions: intervention 1: icatibant intervention 2: Placebo
Intervention descriptions: intervention 1: Subcutaneous at time 0 and 6 hours intervention 2: Subcutaneous at time 0 and 6 hours

Protocol documents:
Clinical trial NCT01603355
Conditions: Juvenile Idiopathic Arthritis Associated Uveitis
Keywords: JIA
Sponsor: Eric B. Suhler
Start date: 2013-11-01; Completion date: 2016-02-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The investigators are doing this research study to see if tocilizumab (Actemra) is safe and effective when used for severe or refractory non-infectious uveitis. Uveitis is an inflammation of the eye that is caused by the body's immune system reacting against the eye tissues.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Tocilizumab
Intervention descriptions: intervention 1: Intravenous tocilizumab:

Patients less than 30 kg weight:10 mg per kg every 4 weeks Patients at or above 30 kg weight: 8 mg per kg every 4 weeks

Protocol documents:
Clinical trial NCT01612221
Conditions: Patients at Risk for Melanoma
Sponsor: University of Utah
Start date: 2012-09-01; Completion date: 2016-02-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase II intervention to propose a new melanoma chemoprevention agent. The investigators believe oxidative stress/damage in nevi is a probable indication for melanoma risk, and propose that reduced melanoma risk in humans can be inferred by protection of nevi from ultraviolet light (UV)-induced oxidative changes. The investigators will 1) evaluate whether administration of NAC around the time of UV exposure will reduce melanoma risk in high-risk patient populations with genetic susceptibility to UV-induced oxidative stress, and 2) examine key genetic variants that will identify which individuals are most likely to benefit from chemoprotection.

Detailed description:

Arms: arm 1: Patients receiving NAC (N-acetylcysteine) arm 2: Participants not receiving NAC (N-acetylcysteine)
Interventions: intervention 1: N-acetylcysteine intervention 2: Placebo arm
Intervention descriptions: intervention 1: N-acetylcysteine (NAC), 1200 mg Oral route 2 doses intervention 2: Sterile normal saline, diluted into 25 cc tomato juice, orally, x 1 dose. Then repeated 24 hours later.

Protocol documents:
Clinical trial NCT01622660
Conditions: Bladder Cancer
Keywords: URETER URINARY BLADDER renal pelvis GEMCITABINE GW786034 (PAZOPANIB) 11-191
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2012-06-01; Completion date: 2016-02-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Gemcitabine and Cisplatin are standard chemotherapy drugs used to treat advanced urothelial cancer. There is no standard chemotherapy for patients who cannot receive Cisplatin. However, most patients are treated with the chemotherapy drugs Gemcitabine and Carboplatin.

In this study, the researchers hope to learn what effects, good and/or bad, the combination of Gemcitabine and Pazopanib has on urothelial cancer. Gemcitabine is given intravenously (through the veins) and works by killing rapidly dividing cells in the body, including cancer cells. Pazopanib is an oral chemotherapy and works by decreasing the blood supply to tumors which limits the tumor's source of oxygen and nutrients.

The combination of Gemcitabine and Pazopanib is being tested in research studies such as this one. As of August 2011, more than 18 patients with various types of cancer have received treatment with Gemcitabine and Pazopanib. The main goal of this clinical research study is to learn if the study drugs Gemcitabine and Pazopanib can shrink or slow the growth of urothelial cancer. The safety of this drug will also be studied. The physical state, changes in the size of the tumor, and laboratory findings will help us decide if the combination of Gemcitabine and Pazopanib is safe and effective.

Detailed description:

Arms: arm 1: This is a phase II trial of gemcitabine and pazopanib in previously untreated patients with advanced/metastatic urothelial carcinoma (UC) who are ineligible for cisplatin-based chemotherapy.
Interventions: intervention 1: Gemcitabine intervention 2: Pazopanib
Intervention descriptions: intervention 1: Patients will receive gemcitabine 1200 mg/m2 intravenously on day 1 and day 8 and. Patients will receive 6 cycles of combination therapy (gemcitabine and pazopanib) unless disease progression or unacceptable toxicity occurs. Patients that achieve stable disease, a partial response, or a complete response after completion of 6 cycles, and who are not candidates for consolidation surgery, will be eligible to continue pazopanib monotherapy at the same dose and schedule until disease progression for a maximum of 18 additional cycles. intervention 2: pazopanib 800 mg orally daily day 1 through day 21 (1 cycle = 21 days) Patients will receive 6 cycles of combination therapy (gemcitabine and pazopanib) unless disease progression or unacceptable toxicity occurs. Patients that achieve stable disease, a partial response, or a complete response after completion of 6 cycles, and who are not candidates for consolidation surgery, will be eligible to continue pazopanib monotherapy at the same dose and schedule until disease progression for a maximum of 18 additional cycles.

Protocol documents:
Clinical trial NCT01644331
Conditions: Heart Failure Dyspnea
Sponsor: Duke University
Start date: 2012-10-01; Completion date: 2016-02-01
Enrollment: 257 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to compare the effects of oral Tolvaptan vs. placebo as an adjunct to fixed dose IV furosemide on dyspnea relief in patients with acute decompensated heart failure

The primary hypothesis is that the addition of oral Tolvaptan to fixed dose furosemide will be more effective at relieving dyspnea than fixed dose furosemide alone

Detailed description:
This study will be a randomized, double blind, placebo controlled, multi-center clinical trial of patients with signs and symptoms consistent with AHF within 24 hours of presentation at Emergency Department. A total of approximately 250 patients will be enrolled in the trial.

Patients will be randomized in a 1:1 ratio to either of 2 treatment regimens:

* Fixed-dose IV furosemide (1 x total daily oral dose given intravenously in divided doses Q12 hours OR 40 mg IV Q12 hours, whichever is greater) + oral Tolvaptan (given at 0, 24 and 48 hours)
* Fixed-dose IV furosemide (1 x total daily oral dose given intravenously in divided doses Q12 hours OR 40 mg IV Q12 hours, whichever is greater) + oral placebo (given at 0, 24 and 48 hours)

The study treatment regimen will be administered from randomization through 48 hours, at which point Tolvaptan/placebo will be discontinued and all diuretic treatment will be adjusted at the treating physician's discretion.

The primary endpoint will be the proportion of patients with at least moderate improvement in dyspnea by Likert scale at both 8 AND 24 hours AND without the need for escalation of therapy due to worsening heart failure (rescue therapy) or death within 24 hours.

Patients will be followed daily for the duration of hospitalization or for 7 days (whichever is shortest).

All patients will have Day 30 follow up phone contact for assessment of vital status and interval hospitalizations.

Arms: arm 1: Fixed-dose IV furosemide (1 x total daily oral dose given intravenously in divided doses Q12 hours OR 40 mg IV Q12 hours, whichever is greater) + oral Tolvaptan (given at 0, 24 and 48 hours) arm 2: Fixed-dose IV furosemide (1 x total daily oral dose given intravenously in divided doses Q12 hours OR 40 mg IV Q12 hours, whichever is greater) + oral placebo (given at 0, 24 and 48 hours)
Interventions: intervention 1: Tolvaptan intervention 2: Placebo
Intervention descriptions: intervention 1: IV furosemide plusTolvaptan (given at 0, 24 and 48 hours) intervention 2: IV furosemide plus oral placebo (given at 0, 24 and 48 hours)

Protocol documents:
Clinical trial NCT01655563
Conditions: Heart Transplantation Liver Transplantation Kidney Transplantation
Keywords: Transplant Pediatrics Tacrolimus Prograf
Sponsor: The Hospital for Sick Children
Start date: 2011-09-01; Completion date: 2016-02-01
Enrollment: 75 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Tacrolimus is a standard and widely used maintenance immunosuppressive agent after solid organ transplantation.The purpose of this trial is to determine if dosing of tacrolimus through genetics will help in early attainment and maintenance of the correct dosage level in the early post-transplant period. This pilot dose-finding trial will help to determine a dosing strategy guided by genotypes and age for solid organ transplant recipients that will be further validated through a multi-centre trial as an immediate next step. The study hypothesizes that dosage levels determined through age and genotype will be attained faster and more accurately than the standard dosing procedures in the 14-days after the transplant. Further, this study hypothesizes that a genotype and age dosing strategy will cause a faster recovery (tested through the kidneys' ability to clear creatine from the blood) and result in lower frequencies of adverse effects and rejection of the transplant.

Detailed description:

Arms: arm 1: Patients in the standard arm will receive standard starting dose of tacrolimus that is clinically used i.e. 0.1 mg/kg/dose twice a day. arm 2: Patients in the pharmacogenetic arm will receive a starting dose that is assigned based on age and CYP3A5 expressor status. Patients that are CYP3A5 expressors will receive the higher end of the dose range compared to non-expressors. All doses recommended represent clinically acceptable and safe dose ranges used at our institution.

CYP3A5 non-expressor starting dose:

Greater than 6 years of age - 0.075 mg/kg/dose q12 hours; Less than or equal to 6 years of age - 0.1 mg/kg/dose q12 hours

CYP3A5 expressor starting dose:

Greater than 6 years of age - 0.15 mg/kg/dose q12 hours; Less than or equal to 6 years of age - 0.2 mg/kg/dose q12 hours
Interventions: intervention 1: Tacrolimus
Intervention descriptions: intervention 1: Tacrolimus, a calcineurin inhibitor, is the commonest immunosuppressive agent used for maintenance immunosuppression after solid organ transplantation. The mechanism of action involves binding to an intracellular protein, FKBP-12. A complex of tacrolimus-FKBP-12, calcium, calmodulin and calcineurin is then formed and the phosphatase activity of calcineurin is inhibited. This prevents the generation of nuclear factor of activated T-cells, a nuclear component, resulting in inhibition of transcription of lymphokines (interleukin-2, γ-interferon). The net result is the inhibition of T-lymphocyte activation.Tacrolimus is metabolized primarily by the CYP3A enzymes in the liver particularly the CYP3A5.

Protocol documents:
Clinical trial NCT01680549
Conditions: Postoperative Pain
Sponsor: Texas Tech University Health Sciences Center
Start date: 2012-09-01; Completion date: 2016-02-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this project is to study the effects of gabapentin on pain control in the perioperative and post-operative period of total knee arthroplasty.

Detailed description:
Being able to understand and better control pain in patients undergoing total knee arthroplasty will help in many different areas of medicine. Gabapentin is one pain control modality that has been used by many different orthopaedic surgeons with excellent retrospective results. Gabapentin, however, has never been studied, to the investigators knowledge, in a prospective randomized fashion in the United States for total knee arthroplasty. This study will be the first of its kind to truly compare the effects of gabapentin, a drug that has been proven safe in many other areas of medicine, with placebo for total knee arthroplasty by analyzing post-operative narcotic usage, function and sleep quality.

Arms: arm 1: Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days. arm 2: Placebo 600 mg po preoperatively and continued postoperatively 300 mg po q8hours X 3 days
Interventions: intervention 1: Gabapentin
Intervention descriptions: intervention 1: Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.

Protocol documents:
Clinical trial NCT01691092
Conditions: Major Depressive Disorder Post-Traumatic Stress Disorder (PTSD)
Keywords: Depression Ketamine PET PTSD
Sponsor: Yale University
Start date: 2012-06-01; Completion date: 2016-02-01
Enrollment: 79 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is designed to look at that involvement of a process in the brain called the glutamate system in depression. Participants will undergo a screening session, up to two functional Magnetic Resonance Imaging (fMRI) scans, and up to three Positron Emission Tomography (PET) scans, as well as cognitive testing at each scan session. For one of the PET scans, a drug (either ketamine or n-acetyl cysteine) will be administered.

Hypothesis 1: The investigators hypothesize administration of ketamine or n-acetylcysteine (NAC) will lead to a decrease in mGluR5.

Hypothesis 2: The investigators hypothesize an improvement in memory and attentional skills after drug challenge.

Hypothesis 3: The investigators hypothesize an increase in mGluR5 availability and change in MRI measures post drug challenge as compared to baseline, signifying synaptogenesis.

Hypothesis 4: We expect there should not be a significant difference in reduction in mGluR5 availability due to differences in ABP688 radiotracer infusion.

Detailed description:
Aim 1: To determine the acute effect of medication-induced glutamate release on mGluR5 availability in human subjects. Hypothesis 1: We hypothesize administration of ketamine or n-acetylcysteine (NAC) will lead to a decrease in mGluR5 availability.

Aim 2: To determine if glutamate release via administration of ketamine or NAC has pro cognitive benefits.

Hypothesis 2: We hypothesize an improvement in memory and attentional skills after drug challenge.

Aim 3: To determine if there is synaptogenesis detectable by PET and MRI post ketamine or NAC within a week of drug challenge (at the time of greatest antidepressant response). Hypothesis 3: We hypothesize an increase in mGluR5 availability and change in MRI measures, post drug challenge as compared to baseline, signifying synaptogenesis.

Aim 4: To determine if there is a difference in reduction of mGluR5 availability after ketamine administration when radiotracer is administered bolus as compared to bolus to constant infusion in the same subjects (ABP688 radiotracer only).

Hypothesis 4: We expect there should not be a significant difference in reduction in mGluR5 availability due to differences in ABP688 radiotracer infusion.

Arms: arm 1: All subjects will receive ketamine
Interventions: intervention 1: Ketamine
Intervention descriptions: intervention 1: All subjects will receive ketamine to induce glutamate release in the brain

Protocol documents: