ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01661595
Conditions: Fatigue
Keywords: Fatigue Fatigability Surface Electromyography (sEMG) cyclic guanosine monophosphate (cGMP) Nitric Oxide (NO) NO-cGMP Phosphodiesterase (PDE) Sildenafil Tadalafil Isotope Infusion Anabolism Upregulation Accelerometer Placebo Nitrosylation
Sponsor: The University of Texas Medical Branch, Galveston
Start date: 2012-11-01; Completion date: 2015-06-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study is funded by the Moody Endowment. In this project, we will investigate the potential effect of skeletal muscle nitric oxide (NO) production on skeletal muscle anabolism, muscle strength, physical function, and body composition in older individuals. Further, we will determine whether augmentation of NO-mediated signaling reduces fatigue and fatigability.

Detailed description:
The Investigators hypothesize that upregulation of skeletal muscle NO-cGMP mediated responses through phosphodiesterase (PDE) inhibition by sildenafil or tadalafil causes an acute anabolic response of skeletal muscle protein synthesis. NO is well-known to elicit vasodilation through stimulation of cGMP signaling, and NO-mediated changes in muscle perfusion may influence both skeletal muscle anabolism and perceptual fatigue. To measure skeletal muscle protein synthesis, we will infuse a stable isotope tracer of phenylalanine and measure its incorporation into skeletal muscle proteins following a dose of sildenafil, tadalafil, or placebo. The Investigators will also determine whether differences exist between men and women in response to PDE inhibition. As skeletal muscle NO-cGMP signaling has been implicated in fatigue responses, we will assess the acute effect of sildenafil and tadalafil on fatigue. Fatigue can be manifested both as a performance deficit at a local level (e.g., a reduced ability of skeletal muscle to produce power or force) as well as a subjective experience of lacking physical or mental energy. Accordingly, we will use more than one means (skeletal muscle performance, fatigue questionnaires, accelerometers) to study fatigue. The Investigators hypothesize that sildenafil or tadalafil will acutely reduce exercise-associated fatigability and skeletal muscle fatigue development

Arms: arm 1: 50 mg/day Sildenafil: (Other Name: Viagra, Revatio) for weeks 0-4. Placebo for weeks 5-8. arm 2: 10 mg/day Tadalafil: (Other Name: Cialis, Adcirca) for weeks 0-4. Placebo for weeks 5-8. arm 3: Placebo for weeks 0-4. 50 mg/day Sildenafil: (Other Name: Viagra, Revatio) for weeks 5-8. arm 4: Placebo for weeks 0-4. 10 mg/day Tadalafil: (Other Name: Cialis, Adcirca) for weeks 5-8.
Interventions: intervention 1: Sildenafil intervention 2: tadalafil intervention 3: Placebo
Intervention descriptions: intervention 1: 50 mg/day for 4 weeks intervention 2: 10 mg/day for 4 weeks. intervention 3: Placebo 1 capsule per day for four weeks.

Protocol documents:
Clinical trial NCT01664598
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2012-05-01; Completion date: 2015-06-01
Enrollment: 49 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open-label, single arm, multicenter long-term extension study of WA19926 evaluated the safety and efficacy of tocilizumab (RoActemra/Actemra) in participants with moderate to severe rheumatoid arthritis who completed the 104-week WA19926 core study. Eligible patients received tocilizumab 8 mg/kg intravenously every 4 weeks for up to 104 weeks.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Tocilizumab
Intervention descriptions: intervention 1: 8 mg/kg administered intravenously (IV) every 4 weeks for 104 weeks

Protocol documents:
Clinical trial NCT01670721
Conditions: Colorectal Cancer Metastatic
Sponsor: Sanofi
Start date: 2012-08-01; Completion date: 2015-06-01
Enrollment: 175 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Primary Objective:

To evaluate the safety of aflibercept in participants with mCRC treated with irinotecan/5-Fluorouracil (5-FU) combination (FOLFIRI) after failure of an oxaliplatin-based regimen (participants similar to those evaluated in the VELOUR trial \[EFC10262, NCT00561470\]) according to side effects prevention and management guidelines.

Secondary Objective:

To document the Health-Related Quality of Life (HRQL) of aflibercept in this participant population.

Detailed description:
Each participant was treated until disease progression (DP), unacceptable toxicity, death, Investigator's decision or participant's refusal for further treatment (whichever come first). Participants were followed-up during treatment and for at least 30 days after its last study treatment (either Aflibercept or FOLFIRI) administration, up to a maximum of 6 months.

Arms: arm 1: Aflibercept 4 mg/kg intravenous (IV) infusion over 60 minutes followed by Irinotecan 180 mg/m\^2 IV infusion over 90 minutes and Leucovorin 400 mg/m\^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m\^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m\^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
Interventions: intervention 1: AFLIBERCEPT intervention 2: Irinotecan intervention 3: Fluorouracil intervention 4: Leucovorin
Intervention descriptions: intervention 1: Pharmaceutical form:Concentrate for solution for infusion; Route of administration: Intravenous intervention 2: Pharmaceutical form:Concentrate for solution for infusion; Route of administration: Intravenous intervention 3: Pharmaceutical form:Concentrate for solution for infusion; Route of administration: Intravenous intervention 4: Pharmaceutical form:Concentrate for solution for infusion; Route of administration: Intravenous

Protocol documents:
Clinical trial NCT01673594
Conditions: ADHD Stimulant-Induced Euphoria
Keywords: ADHD Naltrexone SODAS MPH Stimulant-Induced Euphoria Substance Abuse Adults
Sponsor: Massachusetts General Hospital
Start date: 2012-09-01; Completion date: 2015-06-01
Enrollment: 37 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to a) assess the efficacy of naltrexone in preventing stimulant-induced euphoria in adults with ADHD, b) assess whether naltrexone will interfere with the clinical efficacy of stimulants in treating adults with ADHD, c) assess whether naltrexone will interfere with the effects of stimulants on neurotransmitter activity. We predict that naltrexone will successfully prevent stimulant-induced euphoria without interfering with the ability of stimulants to effectively treat ADHD in adults. This study will be an 8 -week trial with young adults (18-24) with ADHD.

Detailed description:

Arms: arm 1: Arm 1: Naltrexone + SODAS MPH arm 2: Arm 2: Placebo + SODAS MPH
Interventions: intervention 1: SODAS MPH intervention 2: Naltrexone
Intervention descriptions: intervention 1: Adults with ADHD will receive open-label SODAS MPH intervention 2: Subjects randomized to the "active" double-blind group will receive Naltrexone HCl

Protocol documents:
Clinical trial NCT01702246
Conditions: Sickle Cell Disease
Keywords: sickle cell disease statins vaso-occlusive pain inflammation biomarkers
Sponsor: UCSF Benioff Children's Hospital Oakland
Start date: 2012-02-01; Completion date: 2015-06-01
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether simvastatin is effective in reducing the frequency and intensity of vaso-occlusive pain episodes in patients with sickle cell disease.

Detailed description:
Sickle cell disease (SCD) is characterized by recurrent vaso-occlusive episodes and a chronic inflammatory state leading to progressive multi-organ injury. The pathophysiology of SCD is related to endothelial dysfunction driven largely by impaired nitric oxide (NO) homeostasis and chronic inflammation. Through multiple mechanisms, including upregulation of NO, statins have been shown to confer protection from endothelial injury, independent of their cholesterol-lowering properties.

By inhibiting inflammation and several common pathways leading to vascular damage,simvastatin may help prevent the acute and chronic complications of SCD. The objective of this study is to determine whether our preliminary results showing simvastatin-associated reductions in plasma markers of vascular injury will translate into a reduction in vaso-occlusive pain episodes in patients with SCD. A web-based, smartphone-accessible electronic pain diary will be used to monitor frequency and intensity of vaso-occlusive pain in SCD patients treated with a single daily dose of simvastatin.

Arms: arm 1: Simvastatin (Zocor), 40mg tablet, 40mg orally once daily, for 3 months
Interventions: intervention 1: Simvastatin
Intervention descriptions: intervention 1: 40 mg, orally, once daily for 3 months

Protocol documents:
Clinical trial NCT01721460
Conditions: Parkinson's Disease Deep Brain Stimulation Surgery
Keywords: SubThalamic Nucleus Microelectrode recording Deep Brain Stimulation Electrode implantation
Sponsor: University of Wisconsin, Madison
Start date: 2012-11-01; Completion date: 2015-06-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to find out whether dexmedetomidine changes brain cell activity in the subthalamic nucleus (STN).

Detailed description:
In order to find whether dexmedetomidine is optimal for sedation during Deep brain stimulation surgery, we will measure the electrical activity in the STN during Deep brain stimulation surgery, and measure how this activity is changed during administration of Dexmedetomidine. We hypothesize that dexmedetomidine does not change the firing rate and pattern in the STN.

Arms: arm 1: The study is performed in patients undergoing DBS electrode implantation to their STN for the treatment of parkinson's disease. Microelectrode recording (MER) is performed as part of STN electrode implantation surgery, to increase the precision of the stimulating electrode placement. The study includes administration of dexmedetomidine while recording electrical activity at a single location to evaluate the effects of this drug on the MER.
Interventions: intervention 1: Dexmedetomidine
Intervention descriptions: intervention 1: Dexmedetomidine infusion will be started with a loading dose of 1 mcg/Kg over ten to 20 minutes followed by a maintenance infusion of 0.7 mcg/Kg/hr until stable sedation is achieved.

Protocol documents:
Clinical trial NCT01848756
Conditions: Cancer
Keywords: SNX-5422 HER2 positive cancer
Sponsor: Esanex Inc.
Start date: 2013-04-01; Completion date: 2015-06-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Hsp90 is a chemical in the body that is involved in the promotion of cancer. SNX-5422 is an experimental drug that blocks Hsp90

Detailed description:
Heat shock protein 90 (Hsp90) chaperone proteins stabilize well over 200 different known client proteins helping them to fold correctly as they take up their rightful positions in the cell. Hsp90 has a special fondness for oncoproteins whose structures shift according to functional state. Among Hsp90's clients, a surprising number are well recognized targets in oncology, including human epidermal growth factor receptor 2 (HER2). SNX-5422 is a pro-drug of SNX-2112, a potent, highly selective, small-molecule inhibitor of the molecular chaperone heat shock protein 90 (Hsp90). Treatment of HER2-positive cell lines such as BT-474 with the Hsp90 inhibitor SNX-2112 results in cellular degradation, decreased levels of phospho-AKT/cyclin D1, and increased apoptosis. Furthermore, treatment with SNX-5542 caused tumor regression, including remission in a HER2-overexpressing breast cancer xenograft model. SNX-5422 has demonstrated significant antitumor activity in mouse xenograft models of various human malignancies, including breast (BT474, MX-1), lung (H1975, H1650, EBC-1), colon (HT29), prostate (PC3), and melanoma (A375) with multiple oral dosing regimens.

Arms: arm 1: Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle. Subjects will continue treatment on a 28-day cycle at the discretion of the principal investigator based on safety.
Interventions: intervention 1: SNX-5422
Intervention descriptions: intervention 1: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle.

Protocol documents:
Clinical trial NCT01865708
Conditions: Complication of Urinary Catheter
Keywords: Ethanol Lock Alcohol lock Urinary catheter Safety
Sponsor: Children's Healthcare of Atlanta
Start date: 2013-07-01; Completion date: 2015-06-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Hypothesis 1: Blood alcohol concentration will be \<25 mg/100ml (equivalent to a blood alcohol concentration of \<0.025%) after a 1 hour urinary catheter ethanol lock.

Hypothesis 2: Daily urinary catheter ethanol locks will not result in increased hematuria or increased urinary white cells.

Detailed description:
This study involves a confirmatory/refuting approach to the above stated hypothesis. The investigators will test this hypothesis by addressing the following aims/objectives:

Specific Aim 1:

Quantify blood alcohol levels after a 1 hour 74% ethanol lock in urinary catheters utilized in the Pediatric Intensive Care Unit.

Specific Aim 2:

Compare cellular components in urinalyses after the introduction of the ethanol locks.

Potential study subjects will be recruited from the Children's Healthcare of Atlanta - Egleston Pediatric Intensive Care Unit. Children that are anticipated to have an indwelling urinary catheter for \>48 hours will be included. For this pilot study, the investigators will enroll 10 patients. Subject ages will range from 6 months to 17 years. Children who are on a service other than Critical Care Medicine will have clearance from the primary team prior to approaching for enrollment. The consent process will take place prior to or during the initial 24 hours of urinary catheter placement.

Arms: arm 1: Ethanol lock, utilizing 74% ethanol, will begin within 24 hours of urinary catheter placement. The lock will be done every 24 hours for 1 hour. The volume that will be instilled depends upon the fill volume of the catheter, which is imprinted by the manufacturer on each catheter. Once the alcohol is in the catheter, the proximal end of the catheter will be clamped for 1 hour. After the 1 hour dwell time, the clamp will be removed and the alcohol in the lumen of the catheter will be flushed out by the patient's own urine output.
Interventions: intervention 1: Ethanol Lock
Intervention descriptions: intervention 1: Ethanol lock, utilizing 74% ethanol, will begin within 24 hours of urinary catheter placement. The lock will be done every 24 hours for 1 hour. The volume that will be instilled depends upon the fill volume of the catheter, which is imprinted by the manufacturer on each catheter. Once the alcohol is in the catheter, the proximal end of the catheter will be clamped for 1 hour. After the 1 hour dwell time, the clamp will be removed and the alcohol in the lumen of the catheter will be flushed out by the patient's own urine output.

Protocol documents:
Clinical trial NCT01870739
Conditions: Hypertension
Keywords: LCZ696, Hypertension, Aortic stiffness, Central blood pressure, Cardiovascular MRI
Sponsor: Novartis Pharmaceuticals
Start date: 2013-10-01; Completion date: 2015-06-01
Enrollment: 115 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was the first evaluation of the effects of LCZ696 on local and regional measures of aortic stiffness in subjects with mild to moderate hypertension and widened pulse pressure. The results of this exploratory study will help to understand the mechanism of action of LCZ696 and used to inform the design of future clinical studies with LCZ696 in subjects with cardiovascular diseases.

Detailed description:

Arms: arm 1: Single drug treatment period: Patients received LCZ696 200mg once daily (q.d.) + placebo to 20 mg olmesartan q.d for 2 weeks. After 2 weeks, patients were dosed at the maintenance dose level (400 mg qd LCZ696 + placebo to 40 mg qd olmesartan) for 10 weeks.

Add-on Period: After 12 weeks on single-drug treatment, patients continued in the study on the blinded maintenance dose and if required, open label amlodipine (2.5 mg, 5 mg, or 10 mg qd) was added to the treatment regimen and titrated according to the investigator's discretion to achieve target blood pressure. arm 2: Single drug treatment period: Patients received 20 mg olmesartan q.d + placebo to LCZ696 200mg once daily (q.d.) for 2 weeks. After 2 weeks, patients were dosed at the maintenance dose level (40 mg olmesartan q.d + placebo to 400 mg qd LCZ696) for 10 weeks.

Add-on Period: After 12 weeks on single-drug treatment, patients continued in the study on the blinded maintenance dose and if required, open label amlodipine (2.5 mg, 5 mg, or 10 mg qd) was added to the treatment regimen and titrated according to the investigator's discretion to achieve target blood pressure.
Interventions: intervention 1: sacubitril/valsartan (LCZ696) intervention 2: olmesartan intervention 3: placebo to sacubitril/valsartan (LCZ696) intervention 4: placebo to olmesartan intervention 5: Amlodipine (Optional)
Intervention descriptions: intervention 1: 200 mg tablets intervention 2: None intervention 3: placebo intervention 4: placebo intervention 5: If required, open label amlodipine (2.5 mg, 5 mg, or 10 mg qd) was added to treatment regimen

Protocol documents:
Clinical trial NCT01882543
Conditions: Interstitial Cystitis Bladder Pain Syndrome
Keywords: Interstitial cystitis Bladder pain syndrome IC/BPS AQX-1125 SHIP1
Sponsor: Aquinox Pharmaceuticals (Canada) Inc.
Start date: 2013-06-01; Completion date: 2015-06-01
Enrollment: 69 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the effect of 6 weeks of treatment with once daily administration of AQX-1125 compared to placebo on average daily pain in subjects with interstitial cystitis/bladder pain syndrome (IC/BPS), during and after treatment, using a standardized 11-point numerical rating scale (NRS) pain score recorded by electronic diary

Detailed description:

Arms: arm 1: 1 x AQX-1125 Capsule daily arm 2: 1 x placebo capsule daily
Interventions: intervention 1: AQX-1125 intervention 2: Placebo
Intervention descriptions: intervention 1: Synthetic SHIP1 activator intervention 2: Double blind placebo capsule

Protocol documents:
Clinical trial NCT01906346
Conditions: Cocaine Dependence
Sponsor: Joshua A. Lile, Ph.D.
Start date: 2014-01-01; Completion date: 2015-06-01
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Cocaine-use disorders continue to be a significant public health concern, yet no effective medications have been identified. The goal of this study is to establish a research platform for the development of medications for treatment of cocaine abuse and dependence. This study will incorporate self-administration procedures and a non-drug alternative reinforcer, which is hypothesized to reduce the reinforcing effects of cocaine.

Detailed description:

Arms: arm 1: A low value reinforcer will be made available as an alternative to cocaine and placebo. arm 2: A medium value reinforcer will be made available as an alternative to cocaine and placebo. arm 3: A high value reinforcer will be made available as an alternative to cocaine and placebo.
Interventions: intervention 1: Cocaine intervention 2: Placebo
Intervention descriptions: intervention 1: Three active doses of cocaine will be made available for self-administration during experimental sessions. intervention 2: Placebo cocaine will be made available for self-administration during experimental sessions.

Protocol documents:
Clinical trial NCT01922115
Conditions: Mental Competency Urinary Bladder, Overactive Cognitive Function
Keywords: COGNITIVE FUNCTION OVERACTIVE BLADDER [C23.888.942.343.780]
Sponsor: University of North Carolina, Chapel Hill
Start date: 2013-06-01; Completion date: 2015-06-01
Enrollment: 59 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Anticholinergic medication is used to treat overactive bladder (OAB). A known side effect of this medication is cognitive dysfunction. OAB is more prevalent in the elderly population - a group that also has a higher baseline risk of cognitive dysfunction. Our objective is to evaluate the effect of an anticholinergic medication on cognitive function in elderly women.

Detailed description:
Subjects will be randomized to: 1) trospium chloride or 2) placebo.

There are three aims:

1. To evaluate changes in cognitive function in elderly women taking trospium versus placebo, using validated cognitive assessment tests
2. To develop a useful battery of cognitive screening tests for monitoring the cognitive safety of OAB management
3. To understand how the timing of cognitive changes relates to the timing of improvement in OAB symptoms. The investigators will recruit 60 women aged ≥ 50 with the diagnosis of OAB. Cognitive assessments will be performed at baseline and Week 1 and 4 after drug initiation using paper-based validated questionnaires. OAB improvement will be assessed with validated questionnaires.

Arms: arm 1: Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg). arm 2: Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride).
Interventions: intervention 1: Trospium Chloride intervention 2: Placebo
Intervention descriptions: intervention 1: Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit. intervention 2: None

Protocol documents: