louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04529798: Clinical Study Evaluating Outcomes of Reverse Shoulder Arthroplasty With SMR Stemless
Official title: A Monocentric Clinical Study Evaluating Clinical and Patient-reported Outcomes of Reverse Shoulder Arthroplasty With SMR Stemless
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rotator Cuff Tear Arthropathy
Osteo Arthritis Shoulders
Keywords: stemless reverse shoulder arthroplasty
Lead sponsor: Arthro Medics AG
Sponsor class: OTHER
First posted: 2020-08-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: There is a retrospective and prospective study population. All participants are older than 18 years old and approved the written informed consent. Additionally they are suffering from rotator-cuff arthropathy and/or osteoarthritis.

Brief summary: The objectives of this study are the assessment of the clinical, radiographical and patient-reported outcomes of SMR Stemless Reverse Shoulder Arthroplasty (LimaCorporate S.p.A.) used as standard of care over a period of at least 2 years of follow-up and the evaluation of the incidence of any complication.

Detailed description: The focus of this study is the evaluation on clinical, patient-reported and radiographical outcomes of SMR Stemless Reverse Shoulder Arthroplasty. There is a retrospective and prospective study population.

The follow up time-points are (as of standard of care and not different for this study):

* Baseline
* 6 weeks postop
* 6 months postop
* 12 months postop
* 24 months postop

Eligibility criteria: Inclusion Criteria:

* rotator-cuff arthropathy, osteoarthritis
* approving written informed consent

Exclusion Criteria:

* Female patients who are pregnant, nursing, or planning a pregnancy.
* All adult patients with any of the SMR Stemless contraindication for use for the reverse configuration as reported in the current local Instruction for use.
* not consenting in participating in this study

Primary outcomes:
measure: Subjective Shoulder Value score
timeFrame: 5 years
Secondary outcomes:
measure: ASES Shoulder Score
timeFrame: 5 years
measure: Quick-Dash score
timeFrame: 5 years
measure: VAS pain
timeFrame: 5 years
measure: UCLA shoulder score
timeFrame: 5 years
measure: Loosening, implant stability, radiolucent lines
timeFrame: 1 year
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Arthro Medics AG
state: Basel-Stadt
Study officials:
affiliation: Arthro Medics AG
name: Claudio Rosso, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00307398: Anecortave Acetate Risk-Reduction Trial (AART)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Dry AMD
Keywords: AMD
Dry AMD
Drusen
CNV
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2006-03-28
Enrollment: 2596
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A 48 month study of posterior juxtascleral administrations of Anecortave Acetate 15 or 30 mg or sham administration every 6 months.


Eligibility criteria: Inclusion Criteria:

* Dry AMD study eye, Wet AMD non-study eye.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Age
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Proportion of patients with sight-threatening choroidal neovascularization (ST-CNV) in the study eye at Month 48
timeFrame: Month 48
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Study Centers in the United States and Globally
state: Texas
Study officials:
affiliation: Study Manager
name: Patricia Zilliox
role: STUDY_DIRECTOR
References:
Clinical trial NCT03580798: Ridge Preservation Comparing Simultaneous vs. Delayed Grafting
Official title: Ridge Preservation Comparing the Traditional Approach vs. Early Implant Placement With Simultaneous Contour Augmentation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Tooth Loss
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2018-07-09
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of the clinical healing of simultaneous vs. delayed grafting for dental implant placement.

Detailed description: The primary aims of this study are to compare the clinical and histologic results of a traditional ridge preservation with implant placement at 16 weeks (control group) with early implant placement (8 weeks) with simultaneous contour augmentation as described by Buser (test group).

Eligibility criteria: Inclusion Criteria:

* Have one non-molar maxillary tooth requiring extraction that will be replaced by a dental implant. The site must be bordered by 2 teeth.
* Healthy persons at least 18 years old.
* Patients must sign an informed consent approved by the University of Louisville Human Studies Committee.

Exclusion Criteria:

* Patients with debilitating systemic disease, or diseases that have a clinically significant effect on the periodontium.
* Exclude any molar tooth.
* Presence of or history of osteonecrosis of jaws.
* Patients with current or previous history of IV bisphosphonates, irrespective of duration.
* Patients taking oral bisphosphonates for ≥ 3 years.
* Pregnant women.
* Allergy to any material or medication used in the study.
* Patients who need prophylactic antibiotics prior to dental procedures.
* Previous head and neck radiation therapy.
* Chemotherapy in the previous 12 months.

Primary outcomes:
measure: Final ridge width for simultaneous and delayed grafting treatment.
timeFrame: 16 to 20 weeks
Secondary outcomes:
measure: Soft tissue thickness
timeFrame: 16 to 20 weeks
measure: Histology
timeFrame: 16 weeks
measure: Implant dehiscence
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Graduate Periodontics, UofL School of Dentistry
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Henry Greenwell, DMD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04391998: Parasitic Infection in Anemic Pregnant Women
Official title: Parasitic Infection in Anemic Pregnant Women. Prevalence and Effects in Rural Area in Egypt.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Anemia of Pregnancy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-05-18
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Women included between 18 and 45 years old, pregnant during their second or third trimester of pregnancy (calculated by a sure menstrual date and confirmed by a 1st trimesteric ultrasound) with hemoglobin level below 10.5 mg /dL.

Detailed description: All patients in the study were subjected to:

1. Detailed history was recorded. A proper history concerning age, sex, residence, socioeconomic status, onset, progression, and previous treatment of anemia was taken. Participants' socio-demographic characteristics including gravida and parity were documented, level of education, occupation, Diet, and information useful to determine the socioeconomic level was recorded. Information on previous pregnancies and children and history of chronic diseases were also recorded.
2. General examination; patients were clinically examined and gestational age (assessed by measuring the fundal height), weight was calculated for each participant.
3. Diagnosis of anemia by Complete blood count (CBC), Hb level and measuring hematocrit concentration.
4. Diagnosis of parasitic infection by stool analysis using suitable techniques.
5. Imaging including obstetric ultrasound (U/S) to assess fetal development.
6. Women with helminthic infections will be divided into groups

Group (A): received iron + antiparasitic treatment as follows:

* Patients who have STH received alzental 200mg tab 2 tabs single oral dose.
* Patients who have Entamoeba or Giardia received flagyl 500mg tab twice daily for 5 days.
* (B): received iron only.

Eligibility criteria: Inclusion Criteria:

* pregnant during their second or third trimester of pregnancy (calculated by a sure menstrual date and confirmed by a 1st trimesteric ultrasound)
* hemoglobin level below 10.5 mg /dL

Exclusion Criteria:

* women with chronic diseases as diabetes, heart, renal, hepatic or endocrinological disorders
* women diagnosed with blood diseases as hemoglobinopathy or vascular diseases as vasculitis.
* Women with autoimmune diseases and those allergic to iron or antihelminsic treatment were also excluded

Primary outcomes:
measure: correction of naemia
timeFrame: 6 weeks after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy medical school
Study officials:
affiliation: Cairo University
name: Ahmed maged, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04468698: Intra-Abdominal Pressure Effect on Intra-Abdominal Volume and Airway Pressures During Laparoscopy
Official title: Intra-Abdominal Pressure Effect on Intra-Abdominal Volume and Airway Pressures During Pneumoperitoneum Insufflation - a Patient-Level Meta-Analysis of Three Randomized Clinical Trials
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Pneumoperitoneum
Intra Abdominal Pressure
Lead sponsor: Hospital Universitario La Fe
Sponsor class: OTHER
First posted: 2020-07-13
Enrollment: 204
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing pneumoperitoenum insufflation during general anesthesia and mechanical venitlation.

Brief summary: During pneumoperitoneum insufflation the insufflated gas increase intra-abdominal pressure. The generated pressure can lead to a different increase in volume depending on the abdominal cavity and patients' characteristics.

The primary objective is to determine the relationship between intraabdominal pressure (IAP) and intraabdominal volume (IAV) during pneumoperitoneum insufflation. The secondary objective is to determine the rate of abdominal-thoracic transmission (ATT) assessing the correlation between IAP and respiratory driving pressure (ΔPRS).


Eligibility criteria: Inclusion Criteria:

* Enrolled one of the three studies (IPPCollapse I, II or III).
* underwent an initial insufflation procedure with a stepwise change in intraabdominal pressure to record Intraabdominal volume
* data from insufflation at 5 cmH2O of PEEP

Primary outcomes:
measure: Intraabdominal volume
timeFrame: During pneumoperitoneum insufflation before surgery
Secondary outcomes:
measure: Driving pressure
timeFrame: During pneumoperitoneum insufflation before surgery
measure: Plateau pressure
timeFrame: During pneumoperitoneum insufflation before surgery
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital la Fe
Study officials:
References:
Clinical trial NCT01205698: Glycemic Index of Foods
Official title: Glycemic Index of Foods
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glycemic Response
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
First posted: 2010-09-20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: This clinical trial will determine the effect of varying types of carbohydrates contained in milk-based beverages on the glycemic response and GI values.


Eligibility criteria: Inclusion Criteria:

* male and non-pregnant females 18 - 75 years of age
* signed consent

Exclusion Criteria:

* Known history of chronic illnesses
* Current use of medication or any condition which could make participation dangerous or affect the results
* Unable to comply with experimental procedures
* Food allergies of any kind

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Glycemic Index Laboratories
state: Ontario
Study officials:
References:
Clinical trial NCT06322498: Inflammation Markers in Fluid Aspirate From a Scarred Uterine vs. a Normal Uterine Cavity
Official title: Inflammation Markers in Fluid Aspirate From a Scarred Uterine vs. a Normal Uterine Cavity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infertility Due to Nonimplantation
Infertility Secondary
Cesarean Section Complications
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2024-03-21
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: A prospective study that will take place in the hydrosonography clinic, comparing patients with an intact uterus to those who had a caesarean section. Eligible patients will preform a transvaginal ultrasound for evaluation of presence of a niche. After fixation of the transcervical catheter, we will flush 2 ml sterile NaCl 0.9% into the uterine cavity and aspirate the fluid. After collecting all samples, the samples will be snap frozen and stored at -80o C, until they undergo an immunological analysis.


Eligibility criteria: Inclusion Criteria:

- Patients suffering from infertility and assigned for a hydrosonography exam for assessment of the integrity of the uterus and fallopian tubes.

Exclusion Criteria:

1. Patients with hydrosalpinx/pyosalpinx/sactosalpinx
2. Patients who went through surgical correction of a niche
3. Hormonal treatment- estrogens or progestins.
4. Immunosuppressive/immunomodulating medication

Primary outcomes:
measure: Inflammatory cell population
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
References:
Clinical trial NCT02200198: Respiratory Muscle Training in Malnourished Patients Undergoing Abdominal Surgery
Official title: Effect of Respiratory Muscle Training in Malnourished Patients Undergoing Upper Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Undernutrition
Surgery
Keywords: undernutrition
abdominal surgery
respiratory muscles
muscles strength
pulmonary complication
perioperative care
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2014-07-25
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Malnutrition affects 50% of hospitalized patients around the world and causes changes in respiratory muscles predisposing the development of pulmonary complications probable, because of the ineffectiveness of cough. How the training of respiratory muscles can improve the effectiveness of cough, malnourished patients could benefit from this train however, the training of the muscles in malnourished patients has not been tested for safety or efficiency. So, the aim of this study is to assess the safety and efficiency of respiratory muscle training to improve the potency of cough in malnourished patients.


Eligibility criteria: Inclusion Criteria:

* hospitalized malnourished patients (BMI ≤ 20 Kg/m2, loss of body weight ≥ 10% unintentional, or serum albumin \<3.5 g/dL)
* candidate to elective abdominal surgery
* ability to perform all evaluations and training

Exclusion Criteria:

* previous respiratory disease
* necessity of over than 48h of mechanical ventilation
* reoperation

Primary outcomes:
measure: Expiratory peak flow in spirometry
timeFrame: on the 8th day of protocol (after 7 dyas of training)
Secondary outcomes:
measure: Maximum respiratory pressures
timeFrame: on the 8th day of protocol (after 7 days of training)
measure: Postoperative pulmonary complication
timeFrame: participants will be followed for the duration of hospital stay after surgery, an expected average of 10 days
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital of Clinics of Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: Celso RF Carvalho, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01271998: Pulmonary Disposition of TR-700 Following Once-Daily Oral 200 mg
Official title: Pulmonary Disposition of TR-700 Following Once-Daily Oral 200 mg TR-701 Free Acid in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bacterial Infection
Keywords: antibiotic
healthy subjects
pharmacokinetics
Lead sponsor: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Sponsor class: INDUSTRY
First posted: 2011-01-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The primary purpose of this study is to determine the steady-state plasma pharmacokinetics (PK) and properties of TR-700 into the pulmonary epithelial lining fluid (ELF) and alveolar macrophages (AM) of healthy volunteers.

Detailed description: No applicable.

Eligibility criteria: Inclusion Criteria:

* Healthy males and females, between 18 and 55 years of age, inclusive
* Females must be nonpregnant, nonlactating, and either postmenopausal or surgically sterile or practicing an effective method of birth control
* Males must be surgically sterile, abstinent, or practicing an effective method of birth control
* BMI between 20 and 34.9 kg/m2, inclusive

Exclusion Criteria:

* Allergy to lidocaine, midazolam, or other anesthetics/sedatives of similar classes
* Physician-diagnosed migraine headaches within 3 years
* Previous enrollment in a TR-701 or TR-701 FA trial

Primary outcomes:
measure: Pharmacokinetic parameters from plasma.
timeFrame: Day 3
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Trius Investigator Site 001
state: Connecticut
Study officials:
affiliation: Center for Anti-Infective Research and Development
name: David Nicolau, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Housman ST, Pope JS, Russomanno J, Salerno E, Shore E, Kuti JL, Nicolau DP. Pulmonary disposition of tedizolid following administration of once-daily oral 200-milligram tedizolid phosphate in healthy adult volunteers. Antimicrob Agents Chemother. 2012 May;56(5):2627-34. doi: 10.1128/AAC.05354-11. Epub 2012 Feb 13.
Clinical trial NCT06955598: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Injections of SHR-2173 in Patients With Systemic Lupus Erythematosus
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Injections of SHR-2173 in Patients With Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Systemic Lupus Erythematosus
Lead sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2025-05-02
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple subcutaneous injections of SHR-2173 in patients with systemic lupus erythematosus (SLE).


Eligibility criteria: Inclusion Criteria:

1. Age 18-65 years, regardless of gender;
2. Weight ≥45.0 kg at screening;
3. Confirmed SLE diagnosis for ≥12 weeks at screening.

Exclusion Criteria:

1. Pregnant or breastfeeding women, or those with a positive human chorionic gonadotropin (HCG) test.
2. History of alcohol abuse or illegal drug use within one year prior to screening.
3. Blood donation ≥450 mL within 8 weeks prior to screening or plans to donate blood during the study.
4. Current active infection or a history of active tuberculosis
5. Other inflammatory or autoimmune diseases beyond SLE and LN that may interfere with the interpretation of trial results or clinical assessment.

Primary outcomes:
measure: Adverse events
timeFrame: Week 0~16
Secondary outcomes:
measure: Cmax,
timeFrame: Week 0~16
measure: AUC0-t,
timeFrame: Week 0~16
measure: Anti- SHR -2173 antibody (ADA)
timeFrame: Week 0~16
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital affiliated to Shanghai Jiaotong
state: Shanghai
Study officials:
References:
Clinical trial NCT00815698: Effect of Suture for Mesh Fixation in Lichtenstein Hernia Repair
Official title: Effect of Suture for Mesh Fixation in Lichtenstein Hernia Repair, a Prospective Controlled Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia
Keywords: pain
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
Collaborators: name: Bispebjerg Hospital
name: University Hospital, Gentofte, Copenhagen
name: Frederikshavn Hospital
name: Nyborg Hospital
First posted: 2008-12-30
Enrollment: 334
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators want to evaluate the effect of suturing the mesh versus using a self-adhesive mesh for Lichtenstein hernia repair. Effect parameters include chronic pain.

Detailed description: Pain is a frequent problem after open inguinal hernia repair. The most frequent operative technique for inguinal hernia repair in adults is the Lichtenstein mesh repair, where a polypropylene mesh is sutured to the tissue in the inguinal region. We therefore want to evaluate the effect of suture for mesh fixation on the occurrence of chronic pain 12 months after operation.

Eligibility criteria: Inclusion Criteria:

* Healthy males 18-80 years
* Primary inguinal unilateral hernia

Exclusion Criteria:

* Recurrent hernia
* Bilateral, scrotal or femoral hernia
* BMI above 35

Primary outcomes:
measure: Pain, Numbness and Discomfort in the Groin
timeFrame: 12 months after surgery
Secondary outcomes:
measure: Recurrence
timeFrame: 12 months after surgery
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
state: Copenhaven
city: Gentofte
country: Denmark
facility: Gentofte Hospital
state: Hellerup
city: Nyborg
country: Denmark
facility: Nyborg Hospital
state: Svendborg
city: Frederikshavn
country: Denmark
facility: Frederikshavn Hospital
city: Randers
country: Denmark
facility: Randers Hospital
Study officials:
affiliation: Herlev Hospital
name: Jacob Rosenberg, MD, DSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jorgensen LN, Sommer T, Assaadzadeh S, Strand L, Dorfelt A, Hensler M, Rosenberg J; Danish Multicentre DANGRIP Study Group. Randomized clinical trial of self-gripping mesh versus sutured mesh for Lichtenstein hernia repair. Br J Surg. 2013 Mar;100(4):474-81. doi: 10.1002/bjs.9006. Epub 2012 Nov 30.
citation: Rosenberg J, Henriksen NA, Jorgensen LN. Multicenter data acquisition made easy. Trials. 2010 Apr 30;11:49. doi: 10.1186/1745-6215-11-49.