ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01074229
Conditions: Postoperative Pain
Keywords: Pain Post Operative Opioids Laparoscopic Surgery Hysterectomy
Sponsor: Northwestern University
Start date: 2010-03-01; Completion date: 2010-10-01
Enrollment: 75 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The transversus abdominis plane (TAP) block involves the sensory nerve supply of the anterior -lateral abdominal wall where the T7-12 intercostal nerves, ilioinguinal, iliohypogastric and the lateral cutaneous branches of the dorsal rami of L1-3 are blocked with an injection of local anesthetic between the internal oblique abdominal muscle (IOAM) and the transverse abdominal muscle(TAM)This technique allows sensory blockade of the anterolateral abdominal wall via local anesthetic deposition superficial to the transversus abdominis muscle. It was first described by McDonnell et al. as a landmark technique to provide analgesia for lower abdominal surgery.

Hebbart et al. subsequently described an ultrasound guided technique for the TAP block which they named posterior TAP block. The ultrasound allows identification of the external oblique abdominal muscles (EOAM),IOAM and TAM. Previous studies about ultrasound -guided regional anesthetic techniques suggest improved block quality and safety, which is primarily due to direct visualization of the relevant anatomy, the tip of the needle, and the spread of the local anesthetics.

Clinical trials of the single shot posterior TAP block have shown a significant reduction in morphine consumption during the first 24-36 hours after surgery. More recently, El-dawlatly et al. demonstrated that ultrasound guided TAP block in patients undergoing laparoscopic cholecystectomy reduced perioperative opioid consumption by more than 50%.

This is the first study to evaluate the effect of TAP block in the quality of recovery in patients undergoing laparoscopic hysterectomy and may help the pathway to make this an outpatient procedure.

Detailed description:

Arms: arm 1: sterile normal saline as placebo arm 2: Instillation of 20 cc of 0.5% ropivacaine arm 3: Instillation of 20 cc of 0.25% ropivacaine
Interventions: intervention 1: Placebo intervention 2: Drug .5% Ropivacaine intervention 3: 20 cc of 0.25% ropivacaine
Intervention descriptions: intervention 1: placebo injection intervention 2: .5% ropivacaine 20 mls on each side of abdomen intervention 3: Will receive a bilateral TAP block using 20 cc of 0.25% ropivacaine

Protocol documents:
Clinical trial NCT01077973
Conditions: Pain
Keywords: Headache
Sponsor: Pfizer
Start date: 2010-03-01; Completion date: 2010-10-01
Enrollment: 200 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the ability of a single-dose of a novel ibuprofen formulation to relieve pain compared to placebo and standard ibuprofen in the treatment of episodic tension-type headache.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Novel Ibuprofen intervention 2: Standard Ibuprofen intervention 3: Placebo
Intervention descriptions: intervention 1: Single-dose of novel ibuprofen (equal to 400 mg ibuprofen) plus placebo intervention 2: Single-dose of standard ibuprofen (400mg) plus placebo intervention 3: Single-dose of placebo

Protocol documents:
Clinical trial NCT01080807
Conditions: Excessive Sleepiness
Sponsor: Cephalon
Start date: 2010-03-01; Completion date: 2010-10-01
Enrollment: 385 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to determine whether armodafinil treatment is more effective than placebo treatment in patients with excessive sleepiness associated with shift work disorder (SWD) by measuring improved clinical condition late in the shift, including the commute home.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Armodafinil intervention 2: Matching Placebo
Intervention descriptions: intervention 1: At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule. intervention 2: At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.

Protocol documents:
Clinical trial NCT01083979
Conditions: Interstitial Cystitis
Sponsor: Kenneth Peters, MD
Start date: 2010-08-01; Completion date: 2010-10-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective is to instill liposomes reconstituted with sterile water into the bladder as a compassionate use treatment in one patient with ulcerative interstitial cystitis (IC).

Detailed description:
A physician sponsored Investigation New Drug (IN) has been acquired from the FDA for compassionate use of this non-approved treatment in one patient from Dr. Peters' private practice. Since this treatment has not been used previously in the US, we propose to evaluate the safety and efficacy of the treatment in this one patient by comparing pre and post treatment symptom changes.

Prior to treatment (visit 1) baseline measures will be assessed: vital signs,pelvic/bladder pain on a visual analog scale (VAS; "0" being none and "10" being severe), concomitant medications, Serum pregnancy test and Antiphospholipid Antibody Panel, Urine cytology, urinalysis (dipstick), and culture.

At visits 2-5 (4 treatment visits) questionnaires will be completed and vital signs, pain VAS, post void residual (measured by bladder scan or catheter), unanticipated events, and voiding history (voiding diary) will also be assessed. Additionally, cystoscopy will be done prior to the first treatment to view the bladder lining. At each treatment visit, the patients will have a solution of liposomes instilled in the bladder with a catheter, retained for 30 minutes, and be carefully monitored for at least 1 hour after the liposomes are drained.

After treatment, visits 6 and 7 (follow up) will include vital signs with VAS pain assessment, post void residual (PVR), urinalysis (dipstick), unanticipated events assessment, questionnaire completion and review of voiding diary. Visit 8 (study exit) will include the same parameters measured at follow up visits 6 and 7 with the addition of cystoscopy and Antiphospholipid Antibody Panel testing.

Arms: arm 1: Intravesical instillation of Liposomes in sterile water totally 40 cc at four weekly treatments.
Interventions: intervention 1: Liposomes
Intervention descriptions: intervention 1: Intravesical instillation

Protocol documents:
Clinical trial NCT01090479
Conditions: Post-operative Surgical Site Infections
Keywords: Surgical site infections Chlorhexidine Shoulder surgery
Sponsor: Northwestern University
Start date: 2010-01-01; Completion date: 2010-10-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
We intend to determine how effective the use of a 2% Chlorhexidine Cloth is in terms of eliminating the bacterial load on patients undergoing shoulder surgery. We will be comparing the Chlorhexidine Cloths with a control group which will be performing an ordinary shower prior to surgery. At this time, it is standard of care to only take an ordinary shower the evening prior, and the morning of surgery.

Detailed description:
The use of home preoperative chlorhexidine wash has been used in various surgical fields for the prevention of perioperative infections. However, it's use in shoulder surgery has not been published up to this point. The shoulder has a unique microbial flora due to the prevalence of Propionibacterium acnes, a bacteria implicated in surgical site infections after shoulder surgery. This study is designed to examine the efficacy of using a preoperative Sage 2% chlorhexidine cloth in reducing bacterial load in the pre-operative area as well as in reducing post-operative surgical site infections after shoulder surgery. This study will compare the rate of post-operative infections and also the rate of positive skin cultures. The skin cultures will be obtained in the preoperative area from subjects who used the Sage 2% Chlorhexidine cloth protocol pre-operatively (n=50) versus those who used only soap and water (n=50).

Arms: arm 1: This group will perform an ordinary shower the night prior and the morning of their scheduled surgery date. arm 2: This group will use the 2% chlorhexidine wipes the night prior as well as the morning of their surgery date.
Interventions: intervention 1: 2% Chlorhexidine cloth
Intervention descriptions: intervention 1: The 2% Chlorhexidine cloth will be applied to the operative extremity the night prior and the the morning of their surgery.

Protocol documents:
Clinical trial NCT01093417
Conditions: Human Immunodeficiency Virus (HIV) Vitamin D Deficiency HIV Infections
Keywords: Vitamin D Human Immunodeficiency Virus (HIV) Complementary Therapies
Sponsor: University Hospitals Cleveland Medical Center
Start date: 2010-01-01; Completion date: 2010-10-01
Enrollment: 45 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate how Vitamin D affects endothelial function, inflammation, lipids, insulin resistance, vitamin D levels, and parathyroid hormone (PTH).

Detailed description:
Randomized placebo controlled trial of vitamin D supplementation in HIV infected subjects with vitamin D deficiency

Arms: arm 1: Participants that have been randomized into this arm will receive placebo pills. arm 2: Participants that have been randomized into this arm will receive Vitamin D 4000 IU (International Units) daily.
Interventions: intervention 1: Vitamin D intervention 2: Placebo
Intervention descriptions: intervention 1: Vitamin D 4000 IU will be administered to enrollees on the active comparator arm intervention 2: Placebo pills will be administered to enrollees in this arm

Protocol documents:
Clinical trial NCT01093690
Conditions: Cancer
Keywords: chemotherapy induced nausea and vomiting, metoclopramide
Sponsor: Mahidol University
Start date: 2009-04-01; Completion date: 2010-10-01
Enrollment: 162 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to assess the efficacy and tolerability of metoclopramide added to standard antiemetic regimen for prophylaxis of cisplatin-induced emesis.

Detailed description:
Ondansetron plus dexamethasone are standard emetic prophylactic agents for highly emetogenic chemotherapy. Metoclopramide is a dopamine antagonist, which may enhance efficacy of ondansetron and dexamethasone.

Arms: arm 1: ondansetron 8 mg orally twice a day on days 2-5 and dexamethasone 8 mg orally twice a day on days 2-4 plus metoclopramide 20 mg orally four times a day on day 2-5 arm 2: ondansetron 8 mg orally twice a day on days 2-5 and dexamethasone 8 mg orally twice a day on days 2-4 plus placebo 20 mg oral four times a day on day 2-5
Interventions: intervention 1: metoclopramide intervention 2: placebo
Intervention descriptions: intervention 1: ondansetron 8 mg orally twice a day on days 2-5 and dexamethasone 8 mg orally twice a day on days 2-4 plus metoclopramide 20 mg oral four times a day on day 2-5 intervention 2: ondansetron 8 mg orally twice a day on days 2-5 and dexamethasone 8 mg orally twice a day on days 2-4 plus placebo 20 mg oral four times a day on day 2-5

Protocol documents:
Clinical trial NCT01096875
Conditions: Coronary Artery Bypass Surgery Elective Surgical Procedure
Keywords: Endothelial progenitor cells Atorvastatin Coronary surgery
Sponsor: Ankara University
Start date: 2010-02-01; Completion date: 2010-10-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Experimental data have demonstrated favourable effects of statins on endothelial progenitor cell (EPC) mobilization from the bone marrow, and cardiac homing. The purpose of the present prospective randomized controlled trial is to determine the effects of aggressive atorvastatin treatment (40 mg daily 2-weeks prior to surgery) on the number of endothelial progenitor cells (EPCs) after cardiopulmonary bypass by comparing with placebo.

Detailed description:
Endothelial progenitor cells, a subgroup of hematopoietic stem cells have a significant role in vascular homeostasis. In animal models of ischemia, endothelial progenitor cells are rapidly incorporated into sites of neovascularization, have the potential to induce and augment vasculogenesis/ angiogenesis, prevent cardiomyocyte apoptosis in peri-infarct regions, and reduce adverse remodeling. Treatment with atorvastatin has been shown to increase endothelial progenitor cell count in patients with coronary artery disease. Therefore, we will investigate whether atorvastatin augments the number of endothelial progenitor cells after cardiopulmonary bypass in patients undergoing coronary artery bypass surgery (CABG). Thus, we conducted a randomized double-blind, placebo-controlled, 2-way parallel trial in 60 patients undergoing coronary artery bypass surgery. Patients will receive either 2-week treatment with atorvastatin or placebo prior to surgery. Endothelial progenitor cells will be quantitated by flow cytometric phenotyping obtained from peripheral blood samples. In addition, cardiac markers (CK-MB mass, cardiac troponin-I), biochemical profile, liver function tests, high sensitive C-reactive protein (hsCRP) and coagulation profile will be determined at 4 time points: 1) preoperatively (baseline); 2) 6 hours after the end of cardiopulmonary bypass; 3) 24 hours after surgery; 4) 5th days postoperatively. Clinical, operative characteristics, cardiac markers, high sensitive C-reactive protein and endothelial progenitor cell count will be compared between the groups. Adverse outcomes will also be noted and reported.

Arms: arm 1: Hydroxymethylglutaryl-CoA Reductase Inhibitors arm 2: Atorvastatin like pill
Interventions: intervention 1: Atorvastatin intervention 2: Placebo
Intervention descriptions: intervention 1: 40mg/day once daily for two weeks prior to surgery intervention 2: 1tb/day once daily for two weeks prior to surgery

Protocol documents:
Clinical trial NCT01111851
Conditions: Chemotherapy-Induced Nausea and Vomiting (CINV)
Keywords: NK1-receptor occupancy
Sponsor: Merck Sharp & Dohme LLC
Start date: 2010-04-01; Completion date: 2010-10-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate if the mean value of brain neurokinin 1 (NK1)-receptor occupancy of participants treated with aprepitant is similar to that of participants treated with fosaprepitant at certain timepoints.

Detailed description:
The third arm of the study (Aprepitant 250 mg) will only be conducted if the real-time assessment of the NK1-receptor occupancy data between fosaprepitant 150 mg \& aprepitant 165 mg reveals that the primary hypothesis will not be supported.

Arms: arm 1: Fosaprepitant 150 mg arm 2: Aprepitant 165 mg arm 3: Aprepitant 250 mg
Interventions: intervention 1: Fosaprepitant 150 mg intervention 2: Aprepitant 165 mg intervention 3: Aprepitant 250 mg intervention 4: Dexamethasone (12-8-16-16 mg) intervention 5: Dexamethasone (12-8-8-16 mg) intervention 6: Ondansetron intervention 7: MK0999
Intervention descriptions: intervention 1: a single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes on Day 1 15 minutes after consumption of a standard light breakfast meal intervention 2: a single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal intervention 3: a single oral 250 mg dose achieved by administering two 125 mg aprepitant capsules 15 minutes after consumption of a standard light breakfast meal intervention 4: Dexamethasone 12 mg will be administered orally 30 minutes after the start of fosaprepitant dimeglumine or 30 minutes after aprepitant on Day 1; Oral doses of dexamethasone will be administered on Day 2 (8 mg), Day 3 (8 mg twice daily), and Day 4 (8 mg twice daily) with or without a meal. intervention 5: Dexamethasone 12 mg will be administered orally 30 minutes after after aprepitant on Day 1; Oral doses of dexamethasone will be administered on Day 2 (8 mg), Day 3 (8 mg), and Day 4 (8 mg twice daily) with or without a meal. intervention 6: The intravenous (I.V.) infusion of ondansetron 32 mg will begin 30 minutes after the start of fosaprepitant dimeglumine or 30 minutes after aprepitant on Day 1 and will be administered as a 15-minute infusion intervention 7: I.V. infusion of MK0999 containing \~100 MBq (\~3 mCi) containing ≤ 5 ug of MK0999)

Protocol documents:
Clinical trial NCT01113931
Conditions: Urogential Chlamydia Trachomatis Infection
Keywords: Chlamydia
Sponsor: Warner Chilcott
Start date: 2010-04-01; Completion date: 2010-10-01
Enrollment: 495 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Evaluate the clinical efficacy and safety of WC2031 200 mg tablets taken orally once a day for 7 days versus Vibramycin (doxycycline) 100 mg capsules taken orally twice a day for 7 days, for the treatment of uncomplicated urogenital Chlamydia trachomatis infection. Primary efficacy endpoint is microbiological cure at Day 28. Safety assessments are adverse events, changes in vital signs and laboratory test results.

Detailed description:

Arms: arm 1: Once daily arm 2: Twice daily
Interventions: intervention 1: Doxycyline Hyclate tablet intervention 2: Vibramycin (doxycyline hyclate) capsule
Intervention descriptions: intervention 1: 200 mg tablet, once daily for 7 days intervention 2: 100 mg capsule, twice daily for 7 days, over-encapsulated

Protocol documents:
Clinical trial NCT01128569
Conditions: Asthma
Keywords: mild asthma allergen challenge early asthmatic response
Sponsor: GlaxoSmithKline
Start date: 2010-01-01; Completion date: 2010-10-01
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
We propose to use an inhaled allergen challenge model to explore the individual contributions of the components of a novel long-acting beta agonist (LABA)/ inhaled corticosteroid (ICS) combination product on protection from allergic triggers in asthma.

Detailed description:

Arms: arm 1: Placebo Inhaler arm 2: ICS/LABA inhaler arm 3: ICS inhaler
Interventions: intervention 1: Fluticasone Furoate intervention 2: FF/Vilanterol (VI; GW642444M) intervention 3: Placebo
Intervention descriptions: intervention 1: FF intervention 2: FF/VI intervention 3: Placebo Inhaler

Protocol documents:
Clinical trial NCT01133405
Conditions: Alzheimer's Disease
Sponsor: Eli Lilly and Company
Start date: 2010-06-01; Completion date: 2010-10-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a Phase 1 study in healthy subjects to evaluate the safety and tolerability of LY2886721 single doses, how the body handles the drug, and the drug's effect on the body.

Detailed description:
This is a Phase 1 study with 2 parts, both in healthy subjects. Part 1 is a subject- and investigator-blind, placebo-controlled, randomized, 3-period, crossover study. Part 1 will assess the safety and tolerability of LY2886721 single doses, how the body handles the drug, and the drug's effect on the body. Part 2 is a subject- and investigator-blind, placebo-controlled, randomized study to assess the safety and tolerability of an LY2886721 single dose, how the body handles the drug, and the drug's effect on the body including in cerebrospinal fluid.

Arms: arm 1: Single (7 milligram (mg), 15 mg, 25 mg, 35 mg) doses of LY2886721 administered orally in up to three of three study periods arm 2: Single dose in up to 1 period arm 3: Single 10 mg dose of LY2886721, dose determined by Part 1 arm 4: Single 35 mg dose of LY2886721, dose determined by Part 1 arm 5: Single dose
Interventions: intervention 1: LY2886721 intervention 2: Placebo
Intervention descriptions: intervention 1: Oral capsules intervention 2: Oral capsules

Protocol documents:
Clinical trial NCT01134705
Conditions: Rhinitis, Allergic, Perennial
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2010-05-01; Completion date: 2010-10-01
Enrollment: 474 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to assess the efficacy and safety of an investigational nasal aerosol compared with placebo nasal aerosol in the treatment of perennial allergic rhinitis.

Detailed description:

Arms: arm 1: During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily. arm 2: During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
Interventions: intervention 1: Beclomethasone dipropionate hydrofluoroalkane HFA Nasal Aerosol intervention 2: Placebo Nasal Aerosol
Intervention descriptions: intervention 1: Beclomethasone dipropionate (BDP) Hydrofluoroalkane (HFA) Nasal Aerosol intervention 2: HFA Vehicle Aerosol

Protocol documents: