ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02623816
Conditions: Heartburn
Sponsor: MetroHealth Medical Center
Start date: 2014-08-01; Completion date: 2015-12-01
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The overall aim of this study is to assess if patients with persistent gastroesophageal reflux disease (GERD) symptoms receiving sub-optimal omeprazole dosing experience improvement in GERD symptoms when prescribed an optimal dosing regimen. The optimal dosing regimen is defined as taking omeprazole 30 minutes prior to the first meal of the day.

Detailed description:
GERD remains a common gastrointestinal complaint, resulting in 6% of outpatient visits. The economic burden is significant with direct costs exceeding $12 billion/year and indirect cost as high as $75 billion/year. The primary aim of this study was determine whether a brief educational intervention optimizing proton pump inhibitor (PPI) dosing would reduce GERD symptoms using the gastroesophageal reflux disease symptom assessment scale (GSAS) questionnaire. Further, secondary analysis would utilize the results of the trial and combine them with costs related to uncontrolled GERD to estimated the potential economic impact.

Arms: arm 1: No change will be made to the sub-optimal dosing regimen of omeprazole 20 mg. Rescue antacid use is permitted. Total duration of 6 weeks. arm 2: Patients will be administered optimal dosing regimen of Omeprazole 20 mg for 4 weeks starting at week 2. Rescue antacid use is permitted. Total duration of 6 weeks.
Interventions: intervention 1: Optimal Dosing of Omeprazole
Intervention descriptions: intervention 1: Omeprazole 20 mg

Protocol documents:
Clinical trial NCT02631525
Conditions: Delayed Emergence From Anesthesia
Keywords: Airway extubation Anesthesia Recovery Period Desflurane Propofol Intravenous anesthesia Balanced Anesthesia
Sponsor: Federal University of Minas Gerais
Start date: 2014-08-01; Completion date: 2015-12-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Bispectral monitoring anesthesia with remifentanil-desflurane has a better post-operative recovery than remifentanil-propofol.

Detailed description:
It is a randomized, double blind study, involving 40 adult female patients submitted to general anesthesia. The patients were distributed into 2 groups: remifentanil-propofol-based anesthesia and remifentanil-desflurane-based anesthesia groups. Bispectral index (BIS) monitoring guided the anesthesia by setting target BIS range value between 40 and 60. Anesthetics were adjusted to reached that. Primary outcome was: extubation time (time from anesthetic discontinuation to endotracheal tube cuff). Secondary measured outcomes: intra-operative cardiovascular drug use; time to follow command before extubation; protective airway reflex recovery time after extubation. Protective airway reflex test recovery was performed at predetermined time intervals (2, 6, 14, 22 and 30 minutes) from the time to follow a standard command until the first demonstrated ability to swallow 20 ml of water in an upright position.Post-anesthesia care unit recovery data were also recorded: Ramsay sedation scale; vital signs, post-operative pain; morphine consumption.

Arms: arm 1: Total intravenous anesthesia with remifentanil and propofol, target controlled infusion based on Minto's and Marsh's pharmacokinetic models. arm 2: Balanced anesthesia with remifentanil target controlled infusion based on Minto's pharmacokinetic model and desflurane.
Interventions: intervention 1: Desflurane intervention 2: Propofol
Intervention descriptions: intervention 1: Balanced anesthesia with remifentanil and desflurane guided by bispectral monitoring intervention 2: Total intravenous anesthesia based on propofol

Protocol documents:
Clinical trial NCT02638051
Conditions: Peritoneal Neoplasms Ascites Yang Deficiency Yin Deficiency
Keywords: Peritoneal Carcinomatosis Malignant Ascites Modulated Electro-Hyperthermia Traditional Chinese Medicine
Sponsor: Galenic Research Institute Ltd
Start date: 2014-01-01; Completion date: 2015-12-01
Enrollment: 260 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial studies efficacy and safety of combination of modulated electro-hyperthermia (mEHT) with Traditional Chinese Medicine (TCM) in treatment of peritoneal carcinomatosis with malignant ascites versus standard chemoinfusion (CDDP+5FU).

Detailed description:
Conservative treatment of peritoneal carcinomatosis with malignant ascites (PCMA) is based on chemoinfusion with its inherent toxicity. There is a strong demand for a safe and non-toxic method of treatment of PCMA. The new technology of modulated electro-hyperthermia (mEHT) has proven efficacy in many advanced cancers with minimal side effects and synergy with Traditional Chinese Medicine (TCM). TCM has a long history of application at advanced cancer as a symptomatic treatment and enhancer of the general resistance of the organism. Shi Pi Decoction is supposed to be the optimum co-treatment of PCMA according to principles of TCM. Intraperitoneal chemoinfusion (IPCI) with cisplatin and fluorouracil is a widespread standard treatment of PCMA in China. This randomized II phase trial studies efficacy and safety of combination of mEHT with TCM in treatment of PCMA versus standard IPCI (CDDP+5FU).

Arms: arm 1: Modulated Electro-Hyperthermia (mEHT): 150 Watt x 60 min/session every 2nd day for 4 weeks (14 sessions); TCM Herbal Decoction: Shi Pi Decoction administered orally twice a day (200 mL x 2) 30 min after breakfast and supper, for 4 weeks. arm 2: IPCI: CDDP (30-60 mg) with 5FU (500-600 mg/sqm of body surface), both dissolved in 100 mL of normal saline, after abdominal paracentesis and catheterization with following closed drainage of the ascites up to small amount of remaining liquid. After IPCI, the catheter occluded. Administered biweekly during four weeks of the course, totally two times.
Interventions: intervention 1: Modulated Electro-Hyperthermia (mEHT) intervention 2: TCM Herbal Decoction (Shi Pi) intervention 3: IPCI (CDDP+5FU)
Intervention descriptions: intervention 1: MEHT is a descendant of hyperthermia initially based on nano-thermal but not temperature-dependent effects of electromagnetic fields and special fractal modulation, whose effect could 3-4 times exceed the effect of the overall heating (macroscopic temperature elevation). MEHT does not require hyperthermia-range temperatures and could be performed safely without invasive thermal control. EHY-2000 local machine is used for mEHT in the trial. intervention 2: Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang. intervention 3: Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm).

Protocol documents:
Clinical trial NCT02726113
Conditions: Prostate Cancer
Keywords: prostate cancer vitamin D
Sponsor: Medical University of South Carolina
Start date: 2011-10-01; Completion date: 2015-12-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study population will be 80 adult men who have been diagnosed with prostate cancer who are scheduled to have their prostate surgically removed at either the Medical University of South Carolina (MUSC) or the Ralph H. Johnson VAMC, both located in Charleston, SC. The men will be randomized into two groups: one group will take vitamin D3 supplementation and the other will take a placebo. Blood levels of vitamin D3 will be obtained at the beginning of the study and again after two months, just prior to the surgical procedure (prostatectomy). Prostate tissue will be obtained from the surgical procedure and studied for the effect of vitamin D on the prostate cancer cells.

Detailed description:
This study will enroll 80 (40 per study arm) subjects (\>18 years of age), recently diagnosed with prostate cancer (histologically documented adenocarcinoma of the prostate), who are scheduled to undergo prostatectomy.

Eligible subjects will be recruited in the Urology Clinic at MUSC or Ralph H. Johnson VAMC. All subjects will be refered to the study by their Urologist. At the baseline visit, consent will be obtained before any study procedures are initiated. A blood sample will be obtained for 25(OH)D3 analysis. Subjects will be randomized to either the intervention group (vitamin D3 4000 IU daily) or the placebo group and take the study medication for approximately two months before their scheduled prostatectomy. The final study visit is the day of surgery. A blood sample for 25(OH)D3 analysis will be obtained. Prostate tissue will be collected from the Pathologist for (a) genomics (RNA sequencing) analysis; (b) proteomics (proteins, glycons and lipids) analysis and (c) Vitamin D Receptor (VDR) by immunohistochemistry.

Arms: arm 1: vitamin D3 (cholecalciferol) supplementation at 4000 IU daily for approximately two months prior to surgery (prostatectomy). arm 2: softgel (containing no active ingredient) daily for approximately two months prior to surgery (prostatectomy).
Interventions: intervention 1: cholecalciferol intervention 2: placebo
Intervention descriptions: intervention 1: softgels 4000 IU daily for approximately two months prior to surgery (prostatectomy). intervention 2: softgel containing no active ingredient daily for approximately two months prior to surgery (prostatectomy).

Protocol documents:
Clinical trial NCT02733757
Conditions: Anesthesia
Keywords: Clonidine Sub-Tenon's and Peribulbar block IOP OPP OPA
Sponsor: Federal University of Minas Gerais
Start date: 2013-05-01; Completion date: 2015-12-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Regional anesthesia in orbit can reduce ocular blood flow, increase in intraocular pressure (IOP) or the pharmacological action of local anesthetics. This study was conduced to evaluate the effects of clonidine added to lidocaine in IOP, ocular perfusion pressure (PPO) and ocular pulse amplitude (OPA) in patients undergoing cataract surgery under sub-Tenon's and peribulbar anesthesia.

Detailed description:
In this prospective randomized and double blind clinical study, involving 80 patients with ages from 30 to 86 years old, ASA I and II, both genders. The patients were randomly divided into 4 groups of 20 patients, and then were administered in control sub-Tenon's group 5 mL of 2% lidocaine with 1 mL of 0.9% sodium chloride solution; in sub-Tenon's group clonidine, 5 mL of 2% lidocaine associated with 1 µg/kg of clonidine diluted in 1 mL 0.9% sodium chloride solution. In the peribulbar anesthesia, the control group with 6 mL of 2% lidocaine and 1 mL of 0.9% sodium chloride solution, and peribulbar group clonidine, 6 mL of 2% lidocaine associated with 1 µg/kg of clonidine diluted in 1 mL 0.9% sodium chloride solution. Were evaluated the systemic hemodynamic variables; IOP and OPA measurements according the dynamic contour tonometer (DCT) and calculation of OPP, prior to the blockade (M0), and one (M1), five (5) and ten minutes (M10) after the injection of the anesthetic solutions. Complications related to the sub-Tenon's and peribulbar anesthesia were recorded.

Arms: arm 1: 2% Lidocaine without epinephrine arm 2: 2% Lidocaine without epinephrine plus clonidine 1 µg/kg arm 3: 2% Lidocaine without epinephrine arm 4: 2% Lidocaine without epinephrine plus clonidine 1 µg/kg
Interventions: intervention 1: Clonidine
Intervention descriptions: intervention 1: Clonidine 1 µg/kg plus 2% lidocaine

Protocol documents:
Clinical trial NCT03687190
Conditions: Spinocerebellar Ataxias Tai Chi
Sponsor: Changhua Christian Hospital
Start date: 2013-05-13; Completion date: 2015-12-02
Enrollment: 21 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Spinocerebellar atrophy is the most common autosomal dominant inherited ataxia. There are over thirty subtypes, which characterize neurologic features differently. They all have obvious substantial cerebellar atrophies in image, and unstable gait、ataxia. In general a prevalence of about three cases per 100 000 people is assumed, but this may be an underestimate. Progressive neurologic degeneration, in about 10-20 years, will leads to disability or wheelchair-dependent. Accompanying with fatigue, downhill course of the disease often made patients depressive and hopeless. The recent review of researches concludes no effective therapy for the disease. The purpose of the investigator's study is to explore the Tai-chi exercise effect for spinocerebellar ataxia.

Detailed description:

Arms: arm 1: participants in this group accepted Tai chi exercise and conventional medicine. arm 2: participants were not received Tai chi exercise, but only routine conventional medicine
Interventions: intervention 1: Tai chi intervention 2: conventional medicine
Intervention descriptions: intervention 1: participants were required to receive hospital-based Tai chi training at least once a month, and home-based Tai chi exercise at least three times a week over the next 9 months intervention 2: participants without Tai chi training still received routine conventional medicine

Protocol documents:
Clinical trial NCT01263015
Conditions: Infection, Human Immunodeficiency Virus I
Keywords: GSK1349572 Abacavir/Lamivudine Treatment-naive HIV Infection Dolutegravir integrase inhibitor Atripla
Sponsor: ViiV Healthcare
Start date: 2011-02-01; Completion date: 2015-12-03
Enrollment: 844 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to assess the non-inferior antiviral activity of GSK1349572 50 mg plus Abacavir/Lamivudine once daily versus Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate (ATRIPLA® a trade mark of Bristol-Myers Squibb and Gilead Sciences LLC) over 48 weeks; non-inferiority will also be tested at Week 96. This study will be conducted in HIV-1 infected ART-naïve adult subjects. Long term antiviral activity, tolerability, safety, and development of viral resistance will be evaluated.

Detailed description:
ING114467 is a Phase 3 randomized, double-blind, double dummy, active-controlled, multicenter, study conducted in approximately 788 HIV-1 infected ART-naïve subjects. Subjects will be randomized 1:1 one of the following treatment arms:

GSK1349572 50 mg plus abacavir/lamivudine fixed-dose combination once daily (approximately 394 subjects)

OR

Atripla once daily (approximately 394 subjects)

Analyses will be conducted at 48 weeks and 96 weeks. Subjects randomized to receive GSK1349572 and who successfully complete 96 weeks of treatment will continue to have access to GSK1349572 plus abacavir/lamivudine fixed-dose combination through the study until it is locally available-as long as they continue to derive clinical benefit, until they meet a protocol-defined reason for discontinuation, or until development of the compound is terminated.

ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship

Arms: arm 1: Dolutegravir 50mg once daily + abacavir/lamivudine as the fixed-dose combination once daily + Atripla placebo once daily arm 2: Atripla once daily + Dolutegravir placebo once daily + abacavir/lamivudine as the fixed-dose combination placebo once daily
Interventions: intervention 1: Dolutegravir intervention 2: Atripla intervention 3: Abacavir/Lamivudine intervention 4: Abacavir/Lamivudine Placebo intervention 5: Dolutegravir placebo intervention 6: Atripla placebo
Intervention descriptions: intervention 1: Dolutegravir (also known as GSK1349572) 50 mg taken once daily intervention 2: Atripla once daily on an empty stomach intervention 3: taken once daily; also known as EPZICOM intervention 4: matching placebo taken once daily intervention 5: matching placebo taken once daily intervention 6: matching placebo taken once daily on an empty stomach

Protocol documents:
Clinical trial NCT02213094
Conditions: Pregnancy Induced Hypertension Superimposed Preeclampsia Hypertension
Keywords: preeclampsia pregnancy-induced hypertension nicotinamide
Sponsor: University of North Carolina, Chapel Hill
Start date: 2014-01-01; Completion date: 2015-12-03
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase I study of vitamin B3-amide (nicotinamide) dietary supplementation in pregnant women with early onset preeclampsia. The investigators will enroll 10 pregnant women at 24-32 weeks' gestation with the diagnosis of preeclampsia. If the woman is anticipated to remain undelivered for 48 hours after diagnosis she will receive vitamin B3-amide, 500 mg/day given in the morning (n=5) or 1000 mg given in the morning (n=5), continuing until delivery or for 14 days, whichever occurs first. Maternal blood will be collected at baseline and twice a day on days 1, 3, and 7 of nicotinamide administration to measure nicotinamide metabolites, The objectives of this Phase I study are to to test safety of nicotinamide.

Detailed description:

Arms: arm 1: Nicotinamide 500 mg by mouth each morning until delivery or 14 days, whichever occurs first. arm 2: Nicotinamide 1000 mg by mouth each morning until delivery or 14 days, whichever occurs first.
Interventions: intervention 1: Nicotinamide 500 mg intervention 2: Nicotinamide 1000 mg
Intervention descriptions: intervention 1: Nicotinamide 500 mg taken by mouth each morning intervention 2: Nicotinamide 1000 mg taken by mouth each morning

Protocol documents:
Clinical trial NCT02030600
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2014-01-06; Completion date: 2015-12-04
Enrollment: 721 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This trial is conducted in the United States of America (USA). The aim of the trial is to compare the safety and efficacy of insulin degludec (IDeg) and insulin glargine (IGlar) with or without OADs (oral anti-diabetic drugs) excluding SUs (sulfonylureas)/glinides in subjects with type 2 diabetes.

Detailed description:

Arms: arm 1: The trial includes two 32-week treatment periods in a cross-over design. Total trial duration for the individual subjects will be up to 67 weeks. arm 2: The trial includes two 32-week treatment periods in a cross-over design. Total trial duration for the individual subjects will be up to 67 weeks.
Interventions: intervention 1: insulin degludec intervention 2: insulin glargine
Intervention descriptions: intervention 1: Administered once daily injected s.c. / subcutaneously (under the skin). Dose is individually adjusted. intervention 2: Administered once daily injected s.c. / subcutaneously (under the skin). Dose is individually adjusted.

Protocol documents:
Clinical trial NCT02057874
Conditions: Adult Primary Hepatocellular Carcinoma Advanced Adult Primary Liver Cancer Localized Resectable Adult Primary Liver Cancer Localized Unresectable Adult Primary Liver Cancer Stage A Adult Primary Liver Cancer (BCLC) Stage B Adult Primary Liver Cancer (BCLC)
Sponsor: Vanderbilt-Ingram Cancer Center
Start date: 2014-02-01; Completion date: 2015-12-04
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This pilot clinical trial examines how well different imaging biomarkers acquired using 3-Telsa magnetic resonance imaging (MRI) methods perform in determining treatment response to transarterial chemoembolization (TACE) in patients with hepatocellular carcinoma. Compared to conventional imaging, multi-parametric 3-Tesla MRI offers the ability to quantitatively measure tissue structural, functional, cellular, and molecular properties, providing a more robust, clinically relevant method for assessing cancer response to therapy.

Detailed description:

Arms: arm 1: Patients undergo 3T MRI at baseline (=\< 2 weeks before TACE) and at 2-4 weeks, 4-8 weeks, and 12 weeks after TACE. Each 3T MRI session will utilize a sequence of the following modalities: CEST-MRI, MT-MRI, DW-MRI, and DCE-MRI.
Interventions: intervention 1: 3 Tesla Magnetic Resonance Imaging intervention 2: Magnevist® (Intravenous (IV) administration of MRI contrast agent)
Intervention descriptions: intervention 1: 3T MRI consists of a series of radiofrequency (RF) pulse sequences optimized for acquiring CEST-, MT-, DW-, and DCE-MRI data in one seamless imaging examination. For DCE, MR contrast agent will be intravenously administered. intervention 2: For the acquisition of DCE-MR data, the FDA-approved contrast agent Magnevist® (gadopentetate dimeglumine, 0.1 mmol/kg) will be delivered intravenously by the MR technologist at a rate of 2 mL/sec (followed by a saline flush) via a power injector after the acquisition of a set of baseline dynamic scans. The entire sequence lasts approximately 8 minutes.

Protocol documents:
Clinical trial NCT02418845
Conditions: Bacterial Vaginosis
Sponsor: Symbiomix Therapeutics
Start date: 2015-05-28; Completion date: 2015-12-05
Enrollment: 189 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this clinical trial is to test the safety and efficacy of the oral investigational new drug, SYM-1219 for the treatment of bacterial vaginosis.

Detailed description:

Arms: arm 1: Administered orally arm 2: Administered orally
Interventions: intervention 1: SYM-1219 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00357656
Conditions: Hemophilia A
Keywords: Hemophilia A (severe or moderately severe)
Sponsor: Baxalta now part of Shire
Start date: 2006-05-29; Completion date: 2015-12-09
Enrollment: 85 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the hemostatic efficacy and safety of continuous infusion versus intermittent bolus infusion in the peri- and post-operative setting, employing rAHF-PFM, a recombinant antihemophilic factor manufactured without added human or animal proteins, in previously treated patients with severe or moderately severe hemophilia A (baseline factor VIII level \<= 2% of normal) who are undergoing unilateral major orthopedic surgery that requires drain placement. The total study period per subject (from consent to study completion) will vary from approximately 9 to 26 weeks and will involve clinical and laboratory assessments.

Detailed description:

Arms: arm 1: Bolus infusion of rAHF-PFM arm 2: Continuous infusion of rAHF-PFM
Interventions: intervention 1: Recombinant Protein-Free Factor VIII (rAHF-PFM) intervention 2: Recombinant Protein-Free Factor VIII (rAHF-PFM)
Intervention descriptions: intervention 1: An initial loading dose will be administered intravenously over a period \<= 5 minutes (maximum of infusion rate of 10 mL/minute) within 60 minutes prior to surgery dose in order to maintain a minimum target FVIII level of at least 80% of normal.

CI will start prior to surgery as soon as the loading dose has been administered, at a rate calculated according to a formula provided by the sponsor.

All study product must be administered with a syringe pump running at an infusion rate according to the dosing regimen, but always \>= 0.4 mL/h. intervention 2: The treatment schedule for intermittent BI of rAHF-PFM will begin with the administration of the loading dose according to the dose recommendations provided by the sponsor. If required by the hemostatic challenge, additional boluses may be administered after a blood sample for FVIII determination has been drawn. All infusions of rAHF PFM will be given over a period \<= 5 minutes (maximum infusion rate, 10 mL/min).

Protocol documents: