ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01472835
Conditions: Sacroiliac Joint Pain Sympathetically Maintained Pain
Keywords: sedation sensitivity specificity validity diagnostic injection
Sponsor: Johns Hopkins University
Start date: 2011-03-01; Completion date: 2013-02-01
Enrollment: 73 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Interventional pain procedures have diagnostic, prognostic and therapeutic value. It is well-documented that the reference standard for identifying a pain generator is a low-volume block performed with local anesthetic, with or without steroid. Many factors may increase the false positive (FP) rate of diagnostic and prognostic nerve blocks; however, the use of sedation is the most controversial and remediable. Proponents of sedation argue that it has little effect on the rate of positive diagnostic blocks, and may even reduce the false-negative rate. The purpose of this study is to determine the effect of intravenous sedation on pain relief and the "false-positive rate" after diagnostic nerve blocks.

Detailed description:
Sixty-eight patients with sacroiliac (SI) joint or sympathetically-maintained pain will be randomized in a crossover fashion to receive diagnostic nerve blocks either with or without intravenous sedation. Among those who obtain some benefit and return for a 2nd block, this 2nd procedure will be done with sedation if the first was done without sedation, and vice versa. Midazolam and fentanyl will be used for intravenous sedation, titrated to anxiolysis and analgesia. Pain scores (0-10 numerical rating scale, or NRS) and an activity log will be recorded over the 8-hours following the blocks via a pain diary. The first follow-up visit will be 4 weeks after the procedure. Patients who obtain some benefit but continue to report significant pain or who might otherwise benefit from a repeat procedure will have this second procedure performed with sedation if no sedation was given for the first procedure, and without sedation if sedation was administered for the first procedure. The post-procedure pain data will be recorded in the same fashion as the initial nerve block. The second follow-up visit will be 4 weeks after the 2nd block.

Arms: arm 1: Pt will receive sedation with their procedure arm 2: Patient will not receive sedation during procedure
Interventions: intervention 1: Midazolam intervention 2: Fentanyl
Intervention descriptions: intervention 1: Used for anxiolysis intervention 2: Used for analgesia and as a sedative

Protocol documents:
Clinical trial NCT01473368
Conditions: Healthy Volunteers
Keywords: human Gut Microbiota gut microbiota gut microbiome probiotic antibiotic antibiotic-associated diarrhea intestinal bacterial overgrowth
Sponsor: Beth Israel Deaconess Medical Center
Start date: 2012-04-01; Completion date: 2013-02-01
Enrollment: 53 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare and contrast the effects of the probiotic Saccharomyces boulardii, the antibiotic amoxicillin/clavulanate and the combination on the gut microbiota of healthy volunteers.

Detailed description:

Arms: arm 1: 500 mg, 2 times daily for 14 days arm 2: 875/125 mg 2 times daily at least 1 hour before meals for 7 days arm 3: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily). arm 4: None
Interventions: intervention 1: Saccharomyces boulardii intervention 2: Amoxicillin Clavulanate
Intervention descriptions: intervention 1: 500 mg, 2 times daily for 14 days intervention 2: 875/125 mg 2 times daily at least 1 hour before meals for 7 days

Protocol documents:
Clinical trial NCT01475097
Conditions: Drug Safety
Keywords: AE - Adverse event Arteriography IA - Intra-arterial IOCM - Iso-Osmolar Contrast Medium LOCM - Low-Osmolar Contrast Medium Patient Comfort Body Image Disturbance Patient
Sponsor: GE Healthcare
Start date: 2011-10-01; Completion date: 2013-02-01
Enrollment: 255 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate and compare overall patient comfort profile between an Iso-osmolar contrast media (IOCM), iodixanol 320 mg I/mL, and a Low-osmolar contrast media (LOCM), iopamidol 370 mg I/mL in patients undergoing arteriography of peripheral arteries.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Iodixanol intervention 2: Iopamidol
Intervention descriptions: intervention 1: Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration. intervention 2: Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.

Protocol documents:
Clinical trial NCT01480089
Conditions: Pain
Keywords: Surgical Pain Management Robotic surgery Ropivacaine
Sponsor: Loyola University
Start date: 2011-11-01; Completion date: 2013-02-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to determine the effect of spraying a local anesthetic called Ropivacaine (numbing medicine) into the abdominal cavity prior to surgery. Ropivacaine is a local anesthetic used to block pain in the body. There are studies showing that Ropivacaine decreases the pain of surgery with minimally invasive (laparoscopic) appendix and gallbladder removal but has not been tried in robotic pelvic surgery.

Detailed description:
Practice guidelines from the American Society of Anesthesiologists peri-operative techniques for pain management have remained essentially unchanged over the last 10 years (3). Current acute pain-management strategies include 1.) Epidural or intrathecal opioids 2.) Patient-controlled devices delivering systemic opioids and 3.) Regional techniques such as peripheral nerve blocks and post-incisional infiltration with local anesthetics.

The use of epidural and systemic opioids results in significant side-effects such as post-operative nausea and ileus which often lead to increased hospital stay. The literature supporting the benefit of preincisional infiltration with anesthetics remains equivocal.

A recently published study describes the use of intraperitoneal Ropivacaine (2mh/kg) during laparoscopic appendectomy(4). The study was a randomized, double-blinded, placebo-controlled study using Ropivacaine (vs placebo) injected through the laparoscopic ports prior to the start of the appendectomy in 63 patients(4).

Patients treated with Ropivacaine had a significant decrease in visual analog pain scores post-operatively and had decreased narcotic use during their hospital stay compared to placebo. There were no side-effects found with the one-time use of the Ropivacaine.

The results of the above study and review of an additional 24 randomized controlled trials conducted from 1993-2003 are not felt to be generalizable to pelvic surgery where port placement and the operative procedures vary significantly. Hence this study was undertaken to investigate the role of intraperitoneal Ropivacaine as an adjuvant to muscle relaxants and narcotics at the time of pelvic surgery.

Arms: arm 1: Participants randomized to this arm will be given atomized intraperitoneal saline(AIS). arm 2: Participants randomized to this arm will receive atomized intraperitoneal ropivacaine (AIR).
Interventions: intervention 1: Intraperitoneal Ropivacaine (AIR) intervention 2: Atomized Intraperitoneal Saline (AIS)
Intervention descriptions: intervention 1: Ropivacaine 2 mg/kg per lean body mass up to no more than 200mg total dose will be atomized and delivered into the peritoneal cavity at the completion of surgery. intervention 2: Atomized saline will be administered to the peritoneal cavity at the completion of surgery.

Protocol documents:
Clinical trial NCT01484561
Conditions: Arthritis, Rheumatoid
Keywords: Phase 1
Sponsor: Pfizer
Start date: 2012-04-01; Completion date: 2013-02-01
Enrollment: 148 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of study is to explore the effect of CP-690,550 (Tofacitinib) on measures of kidney function in patients with active rheumatoid arthritis (RA).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: CP-690,550 or Placebo intervention 2: Placebo
Intervention descriptions: intervention 1: CP-690,550 10 mg twice a day (BID) orally or placebo BID orally, approximately 72 days intervention 2: Placebo BID orally, approximately 72 days

Protocol documents:
Clinical trial NCT01493427
Conditions: Open-Angle Glaucoma Ocular Hypertension
Keywords: Glaucoma OAG OHT
Sponsor: Alcon Research
Start date: 2011-12-01; Completion date: 2013-02-01
Enrollment: 202 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to assess the efficacy and tolerability of TRAVATAN® Solution without benzalkonium chloride (BAK) in patients previously on latanoprost 0.005% or bimatoprost 0.01% ophthalmic solution monotherapy.

Detailed description:

Arms: arm 1: Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks
Interventions: intervention 1: Travoprost 0.004%
Intervention descriptions: intervention 1: Travoprost 0.004% without benzalkonium chloride (BAK), containing Polyquad (PQ) preservative

Protocol documents:
Clinical trial NCT01495000
Conditions: Osteoporosis, Postmenopausal
Keywords: India dual energy x-ray absorptiometry bone mineral density denosumab
Sponsor: GlaxoSmithKline
Start date: 2012-01-01; Completion date: 2013-02-01
Enrollment: 250 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if denosumab is effective in increasing bone mineral density at the lumbar spine in Indian postmenopausal women with osteoporosis.

Detailed description:

Arms: arm 1: denosumab 60mg subcutaneous injection, single dose at the start of the 6-month double-blind treatment arm 2: placebo subcutaneous injection, single dose at the start of the 6-month double-blind treatment
Interventions: intervention 1: denosumab intervention 2: placebo
Intervention descriptions: intervention 1: 60mg subcutaneous injection, single dose intervention 2: placebo subcutaneous injection, single dose

Protocol documents:
Clinical trial NCT01497665
Conditions: Non-small Cell Lung Cancer (NSCLC) With Brain Metastases
Keywords: GRN1005 ANG1005 LRP-1 Targeted Therapy Brain Tumor Blood Brain Barrier Peptide-Drug Conjugate (PDC) Brain Metastases Paclitaxel Taxol NSCLC Non-Small Cell Lung Cancer
Sponsor: Angiochem Inc
Start date: 2011-11-01; Completion date: 2013-02-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the efficacy, safety, and tolerability of GRN1005 in patients with brain metastases from non-small cell lung cancer (NSCLC).

Detailed description:

Arms: arm 1: GRN1005 alone
Interventions: intervention 1: GRN1005
Intervention descriptions: intervention 1: 650 mg/m2 IV every 3 weeks

Protocol documents:
Clinical trial NCT01498653
Conditions: Asthma
Sponsor: GlaxoSmithKline
Start date: 2012-01-01; Completion date: 2013-02-01
Enrollment: 313 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A randomised, double-blind, double-dummy, parallel group study to evaluate the efficacy and safety of fluticasone furoate/vilanterol trifenatate (FF/VI) inhalation powder delivered once daily in the treatment of asthma in adolescent and adult subjects of Asian ancestry currently treated with high-strength inhaled corticosteroids or mid-strength ICS/LABA combination therapy

Detailed description:
This will be a randomized, double-blind, active-comparator, parallel group, multi-center study. At Visit 1 (Screening Visit) subjects who meet all of the inclusion criteria and none of the exclusion criteria will enter a two week Run-in period. Subjects will remain on their current ICS therapy throughout the Run-in period. At the end of the Run-in period (Visit 2) subjects meeting the randomization criteria will enter a 12 week treatment period and receive one of the two following treatments: 1) FF (200mcg)/VI (25mcg) administered once daily in the evening via a Novel Dry Powder Inhaler (NDPI) 2) Fluticasone propionate 500mcg administered twice daily via DISKUS™ Inhaler In addition, all subjects will be supplied with albuterol/salbutamol inhalation aerosol to be used as required to treat asthma symptoms.

Subjects who have not met the randomization criteria at Visit 2 will be withdrawn from the study.

Subjects meeting the randomization criteria will be randomized to one of the two treatment groups and will attend the clinic for 3 on-treatment visits at Week 4 (Visit 3), Week 8 (Visit 4) and Week 12 (Visit 5). Subjects will receive treatment for 12 weeks. A Follow-up Visit or Contact (Visit 6) will take place 1 week after completing study medication. All clinic visits will take place in the morning. Subjects will participate in the study for a maximum of 15 weeks (Screening to Follow-up inclusive). A subject is regarded to have completed the study if they complete all phase of the study (Screening, treatment, Follow-up).

Arms: arm 1: ICS/LABA arm 2: ICS
Interventions: intervention 1: GW685698/GW642444 intervention 2: CCI18781
Intervention descriptions: intervention 1: ICS/LABA intervention 2: ICS

Protocol documents:
Clinical trial NCT01498744
Conditions: Abscess Soft Tissue Methicillin-resistant Staphylococcus Aureus (MRSA) Infection Skin Abscess
Keywords: Skin and Soft Tissue Abscess Methicillin-resistant Staphylococcus aureus (MRSA) Incision and Drainage Clindamycin Trimethoprim-sulfamethoxazole Skin Infection
Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Start date: 2010-02-01; Completion date: 2013-02-01
Enrollment: 53 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to better understand why children develop methicillin-resistant Staphylococcus aureus (MRSA) skin infections that require surgical drainage and whether antibiotics are helpful after the infection is drained in the operating room.

Detailed description:
The emergence of community acquired methicillin-resistant Staphylococcus aureus (MRSA) as a pervasive cause of skin and soft tissue infections has increased the number of children requiring incision and drainage (I\&D) procedures and heightened concerns about the optimal treatment strategy. Data on patients with methicillin-sensitive Staphylococcus aureus (MSSA) abscesses, as well as emerging data on children with minor MRSA skin and soft tissue abscesses suggest that I\&D alone is sufficient therapy. However, given concerns about the pathogenicity of MRSA infections, many patients who require hospital admission and I\&D in the operating room receive postoperative antibiotics. The primary objective of this randomized controlled trial is to compare the effect of 5 days versus 1 day of postoperative antibiotics on the rate of treatment failure following I\&D of abscesses in children in the era of pervasive MRSA infection. Secondary outcomes to be measured include incidence of additional skin and soft tissue infections in other body sites and incidence of these infections in family members and household contacts. Prospective data will be collected from wound cultures, as well as from nasal, rectal and skin cultures sent at the time of initial I\&D to assess for MRSA carrier status. Finally, survey data will be used to assess epidemiologic risk factors.

Arms: arm 1: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole \[bactrim\] (5mg/kg trimethoprim up to 160 mg, every 12 hours). arm 2: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole \[bactrim\] (5mg/kg trimethoprim up to 160 mg, every 12 hours).
Interventions: intervention 1: Oral Clindamycin
Intervention descriptions: intervention 1: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole \[bactrim\] (5mg/kg trimethoprim up to 160 mg, every 12 hours).

Protocol documents:
Clinical trial NCT01516008
Conditions: Hallux Valgus
Keywords: Hallux Valgus Bunionectomy Bunion Acute pain Tapentadol Tapentadol IR
Sponsor: Janssen Research & Development, LLC
Start date: 2012-01-01; Completion date: 2013-02-01
Enrollment: 353 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to demonstrate the efficacy of at least 1 dose of tapentadol IR 50 mg and/or 75 mg versus placebo using the sum of pain intensity difference at 48 hours (SPID48) to measure analgesic effect in Korean patients with acute pain following bunionectomy.

Detailed description:
This is a randomized (study drug assigned by chance like flipping a coin), double-blind (neither physician nor patient knows the name of the assigned drug), placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of tapentadol immediate-release (IR) 50 mg and 75 mg in patients who are undergoing bunionectomy (a surgical procedure to remove a bunion). This study was designed to be a similar study to the pivotal global study of PAI-3003/KF32 in order to bridge the results from the global studies and to show similarity in effect of tapentadol between Korean and Caucasian population which will allow extrapolation of the foreign clinical data of tapentadol into Korea. The study will be divided into screening period, surgical period, qualification period, and a double-blind treatment period. The study length, including the screening period, will be up to a maximum duration of 32 days. Eligible patients will be randomly assigned to 1 of 3 treatment groups (tapentadol IR 50 mg, tapentadol IR 75 mg or placebo) in a 1:1:1 ratio. Efficacy and safety assessments will be performed during the study.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Tapentadol IR 50 mg intervention 2: Tapentadol IR 75 mg intervention 3: Placebo
Intervention descriptions: intervention 1: Type= exact number, unit= mg, number= 50, form= tablet, route= oral use. Tapentadol IR will be administered as a single oral dose once every 4 to 6 hours (patients may take their next dose as early as 4 hours, but no later than 6 hours, after the previous dose), for a period of 72 hours. intervention 2: Type= exact number, unit= mg, number= 75, form= tablet, route= oral use. Tapentadol IR will be administered as a single oral dose once every 4 to 6 hours (patients may take their next dose as early as 4 hours, but no later than 6 hours, after the previous dose), for a period of 72 hours. intervention 3: Form= tablet, route= oral use. Placebo tablets will be administered as a single oral dose every 4 to 6 hours, for a period of 72 hours.

Protocol documents:
Clinical trial NCT01516268
Conditions: Pain
Keywords: Cesarean Delivery TAP block sufentanyl Narcotic dosages
Sponsor: Tehran University of Medical Sciences
Start date: 2012-01-01; Completion date: 2013-02-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Adding sufentanyl to bupivacain in Transversus Abdominis Plane (TAP) block under ultrasound guide can reduce narcotic dosage, side effects and pain after cesarean delivery.

Detailed description:

Arms: arm 1: IN case group we add 1cc sufentanyl to 20 cc bupivacain in TAP block arm 2: In control group we add 1cc salin to 20cc bupivacain in TAP block
Interventions: intervention 1: Sufentanyl
Intervention descriptions: intervention 1: As intervention 1cc sufentanyl is added to bupivacain in case group for TAP block.

As comparator 1cc normal saline is added to bupivacain in control group for Tap block.

Protocol documents:
Clinical trial NCT01516424
Conditions: Schizophrenia
Keywords: Blonanserin
Sponsor: Sumitomo Pharma (Suzhou) Co., Ltd.
Start date: 2012-02-01; Completion date: 2013-02-01
Enrollment: 267 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Clinical trial to Investigate Blonanserin in Treatment of Schizophrenia when compared with Risperidone

Detailed description:
A Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Clinical trial to Investigate Blonanserin in Treatment of Schizophrenia when compared with Risperidone

Trial drugs:

* Blonanserin group: Blonanserin tablets+Risperidone mimetic tablets
* Risperidone group: Risperidone tablets+Blonanserin mimetic tablets

Objectives of Study :

To evaluate the efficacy and safety of Blonanserin in treating schizophrenia

Arms: arm 1: Antipsychotics arm 2: Antipsychotics
Interventions: intervention 1: Blonanserin intervention 2: Risperidone
Intervention descriptions: intervention 1: Blonanserin tablets: 8 - 24mg/day; twice daily after breakfast and dinner; in the meantime, the placebo and positive drug were taken in whole tablets. When the morning and evening doses could not be administered equally, the evening dose should be greater than the morning dose. The interval between 2 dose escalations should not be shorter than 3 days. intervention 2: Risperidone tablets: 2 - 6mg/day; twice daily after breakfast and dinner; in the meantime, the placebo and positive drug were taken in whole tablets. When the morning and evening doses could not be administered equally, the evening dose should be greater than the morning dose. The interval between 2 dose escalations should not be shorter than 3 days.

Protocol documents:
Clinical trial NCT01518244
Conditions: Glaucoma
Keywords: Primary open angle-glaucoma Ocular hypertension Pigment dispersion glaucoma
Sponsor: Alcon Research
Start date: 2011-12-01; Completion date: 2013-02-01
Enrollment: 50 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to assess the efficacy and tolerability of changing to AZARGA® from prior COMBIGAN® pharmacotherapy in participants with open-angle glaucoma or ocular hypertension.

Detailed description:

Arms: arm 1: Brinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks
Interventions: intervention 1: Brinzolamide/timolol maleate fixed combination
Intervention descriptions: intervention 1: None

Protocol documents: