louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00549393: Study of Bathing With Chlorhexidine Impregnated Cloths on Nosocomial Infections in the Pediatric Intensive Care Unit
Official title: Impact of Daily Bathing With Chlorhexidine Impregnated Cloths on Nosocomial Infections in the Pediatric Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Nosocomial Infections
Keywords: intensive care unit
Healthcare associated infections (HAI)
pediatric
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Sage Products, Inc.
First posted: 2007-10-25
Enrollment: 5659
Sex: ALL
Minimum age (years): 2
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The investigators propose to conduct a large clinical study to determine if daily bathing with chlorhexidine impregnated cloths will reduce the incidence of healthcare-associated infections in the Pediatric Intensive Care Unit (PICU).


Eligibility criteria: Inclusion Criteria:

* Patients in pediatric intensive care unit

Exclusion Criteria:

* Patients with a history of an allergic reaction to chlorhexidine
* Patients less than 2 months of age
* Patients with severe skin disease or burn
* Patients with an indwelling epidural catheter or lumbar drain

Primary outcomes:
measure: Bacteremia
timeFrame: participants were followed for the duration of ICU stay, median stay 3 days
Secondary outcomes:
measure: Central Line Associated-bloodstream Infection (CLABSI)
timeFrame: participants were followed for the duration of ICU stay, median stay 3 days
Other outcomes:
measure: Bacteremia
timeFrame: duration of ICU stay, median 3 days
Locations:
city: Washington, D.C.
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Saint Louis
country: United States
facility: Saint Louis Children's Hospital
state: Missouri
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Johns Hopkins University
name: Trish M Perl, MD MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Aaron Milstone, MD MHS
role: STUDY_CHAIR
References:
citation: Milstone AM, Elward A, Song X, Zerr DM, Orscheln R, Speck K, Obeng D, Reich NG, Coffin SE, Perl TM; Pediatric SCRUB Trial Study Group. Daily chlorhexidine bathing to reduce bacteraemia in critically ill children: a multicentre, cluster-randomised, crossover trial. Lancet. 2013 Mar 30;381(9872):1099-106. doi: 10.1016/S0140-6736(12)61687-0. Epub 2013 Jan 28.
Clinical trial NCT02189993: Limited Long Term Survival in Patients After In-hospital Intestinal Failure Requiring Total Parenteral Nutrition
Official title: Limited Long Term Survival in Patients After In-hospital Intestinal Failure Requiring Total Parenteral Nutrition
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nutrition Disorders
Keywords: Mortality
Long term follow-up
Parenteral Nutrition, Total
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
First posted: 2014-07-15
Enrollment: 437
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients requiring total parenteral nutrition during in hospital admission.

Brief summary: The purpose of this study is to determine what the long term survival is after in hospital use of total parenteral nutrition due to intestinal failure.

Earlier studies only followed patients for a maximum of 6 months or included only very specific patients. We were interested in all patients in our hospital and followed them for up to 2 years.

Detailed description: Extensive description is not desired

Eligibility criteria: Inclusion Criteria:

* all consecutive patients on TPN

Exclusion Criteria:

* patients from the Pediatric and Haematological Departments

Primary outcomes:
measure: All cause mortality
timeFrame: Up to 1427 days
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Department of Gastroenterology and Hepatology, Small Bowel Unit, VU University Medical Center
Study officials:
affiliation: VUMC
name: Leendert Oterdoom, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oterdoom LH, Ten Dam SM, de Groot SD, Arjaans W, van Bodegraven AA. Limited long-term survival after in-hospital intestinal failure requiring total parenteral nutrition. Am J Clin Nutr. 2014 Oct;100(4):1102-7. doi: 10.3945/ajcn.114.087015. Epub 2014 Aug 13.
Clinical trial NCT01932411: Factors Affect Outcomes in Cardiovascular Surgery
Official title: Factors That Affect the Outcomes of Cardiothoracic and Vascular Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Valvular Diseases
Vascular Diseases
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2013-08-30
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing cardiovascular surgeries

Brief summary: Identify factors that contribute to perioperative morbidity and mortality in patients undergoing cardiac surgery that involves cardiopulmonary bypass.

Identify factors that affect perioperative morbidity and mortality in patients undergoing cardiac surgery.

Detailed description: Identify factors that affect perioperative morbidity and mortality in patients undergoing cardiac surgery.

Here are some examples, but may not limited the following factors:

1. demographic data
2. perioperative medications
3. comorbidity

Eligibility criteria: Inclusion Criteria:

Patients greater than or equal to 18 years old that underwent cardiovascular surgery at UC Davis Medical Center from 01/01/2001 to 07/15/2013.

Patients will only be included that underwent cardiovascular surgeries with or without cardiopulmonary bypass.

Exclusion Criteria:

Patients that did not undergo cardiovascular surgeries and age\< 18 years old will be excluded from the study.

Primary outcomes:
measure: all cause mortality
timeFrame: 12 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis Health System
state: California
Study officials:
affiliation: University of California, Davis, Department of Anesthesiology and Pain Medicine
name: Hong Liu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06559111: Cast or Functional Ankle Orthosis After Ankle Fracture Surgery
Official title: Postoperative Care After Operatively Treated Ankle Fractures With Cast or Functional Ankle Orthosis. A 2-year, Prospective, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Fracture
Postoperative Treatment
Lead sponsor: Töölö Hospital
Sponsor class: OTHER
Collaborators: name: Tampere University Hospital
First posted: 2024-08-19
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: The goal of this randomized clinical trial was to compare the effect of 6-week casting versus 2-week casting followed by 4-week ankle bracing in adult patients with surgically treated ankle fractures.

The primary outcome measures used were the functional results 3 months after surgery evaluated using two functional outcome measures (Olerud and Molander score and Kaikkonen score) and the patient return to work.

In the casting group, the traditional plaster was changed to a fiberglass one at 2 weeks and the cast treatment continued until 6 weeks. In the functional treatment group, the traditional plaster cast was changed to an reusable semi-rigid plastic orthosis (Aircast) at 2 weeks after surgery and its use was continued as an ankle support for up to 6 weeks. Follow-ups including subjective and objective evaluations were at 2, 6, 12 and 52 weeks and at 2 years postoperatively.


Eligibility criteria: Inclusion Criteria:

* Weber A or B type ankle fracture
* uni-, bi- or trimalleolar injury and/or fibular displacement of \>2 mm in any plane on the radiographs

Exclusion Criteria:

* Weber C injury necessitating syndesmotic fixation
* Pilon injury
* Inadequate co-operation
* Other severe concomitant injuries

Primary outcomes:
measure: Olerud-Molander score
timeFrame: 3 months and 24 months
Secondary outcomes:
measure: Olerud-Molander score
timeFrame: 6 weeks and 12 months
measure: Kaikkonen score
timeFrame: 6 weeks, 3, 12, and 24 months
measure: Visual Analog Scale for Pain
timeFrame: 6 weeks, 3, 12, and 24 months
measure: Swelling of the ankle
timeFrame: 6 weeks, 3, 12, and 24 months
measure: Atrophy of the calf muscles
timeFrame: 6 weeks, 3, 12, and 24 months
measure: Ankle active dorsiflexion
timeFrame: 6 weeks, 3, 12, and 24 months
measure: Ankle active plantarflexion
timeFrame: 6 weeks, 3, 12, and 24 months
measure: Return-to-work
timeFrame: Within 24 months
measure: Subjective symptoms and return to activities
timeFrame: 2 and 6 weeks; 3, 12, and 24 months
Other outcomes:
measure: Complications
timeFrame: 2 and 6 weeks; 3, 12, and 24 months
Locations:
Study officials:
affiliation: Helsinki University Central Hospital
name: Teppo Järvinen, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT02018211: Neuromuscular Electrical Stimulation Via the Peroneal Nerve Reduces Muscle Soreness Following Intermittent Exercise
Official title: Neuromuscular Electrical Stimulation Via the Peroneal Nerve Reduces Muscle Soreness Following Intermittent Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delayed Onset Muscle Soreness
Keywords: delayed onset muscle soreness
muscle damage
muscle function
inflammation
Lead sponsor: Firstkind Ltd
Sponsor class: INDUSTRY
Collaborators: name: Loughborough University
First posted: 2013-12-23
Enrollment: 21
Sex: MALE
Minimum age (years): 20
Maximum age (years): 22
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Numerous techniques are reported to enhance recovery following intense exercise, however there is equivocal support for such claims. A novel technique of neuromuscular electrical stimulation (NMES) via the peroneal nerve has been shown to augment limb blood flow which could enhance recovery following exercise. The present study examined the effects of NMES, compared to graduated compression socks on muscle soreness, strength, and markers of muscle damage and inflammation following intense intermittent exercise.


Eligibility criteria: Inclusion Criteria:

* healthy males
* currently playing intermittent sports (such as soccer, field hockey, rugby)
* currently representing their respective sports at either university, county, national or international levels

Exclusion Criteria:

* unhealthy males
* not currently playing intermittent sports (such as soccer, field hockey, rugby)
* not currently representing their respective sports at either university, county, national or international levels
* individuals indicating a history of cardiovascular, metabolic or haematological disorders
* participants reporting a sedentary lifestyle of less than three 30-min physical activity sessions per week

Primary outcomes:
measure: Perceived muscle soreness (PMS)
timeFrame: 72hrs
Secondary outcomes:
measure: muscle strength
timeFrame: 72hrs
Other outcomes:
measure: measurement of CK and LDH activity and IL-6, CRP and TBAR concentrations
timeFrame: 72 hrs
Locations:
city: Loughborough
country: United Kingdom
facility: School of Sport, Exercise and Health Sciences
state: Leicestershire
Study officials:
References:
citation: Ferguson RA, Dodd MJ, Paley VR. Neuromuscular electrical stimulation via the peroneal nerve is superior to graduated compression socks in reducing perceived muscle soreness following intense intermittent endurance exercise. Eur J Appl Physiol. 2014 Oct;114(10):2223-32. doi: 10.1007/s00421-014-2943-5. Epub 2014 Jul 11.
Clinical trial NCT01615211: Randomized Study of Letrozole and Trilostane for Medical Abortion
Official title: A Randomized Pilot Study of Two New Drug Combinations Fot the Termination fo Early Pregnancy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Medical Abortion, Complete or Unspecified, Without Complication
Keywords: Abortion
medical abortion
termination of pregnancy
Mifepristone
misoprostol
letrozole
trilostane
femara
Modrenal
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
name: The University of Hong Kong
First posted: 2012-06-08
Enrollment: 36
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: In menstruation an effective shedding of the endometrial lining occurs. Both progesterone and estrogen levels fall sharply at this time. During medical abortion the endometrial shedding is sometimes ineffective causing an incomplete abortion which may cause prolonged bleeding or require surgical intervention. In medical abortion a progesterone antagonist is used as treatment but the estrogen levels are not targeted. The investigators wish to explore whether addition of letrozole or trilostane which target estrogen levels can lead to a more effective shedding of the endometrial lining.


Eligibility criteria: Inclusion Criteria:

* Healthy women aged 18-45 without any contraindication for treatment of any of the drugs involved in teh study

Exclusion Criteria:

* Any ongoing medication or medical condition smoking \>20 cigarettes per day BMI \>30

Primary outcomes:
measure: efficacy
timeFrame: 4 weeks
Secondary outcomes:
measure: Acceptability
timeFrame: 1 week, 2 weeks and 4 weeks
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska Institutet
name: Kristina Gemzell Danielsson, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska Institutet
name: Helena Kopp Kallner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00294411: Vaginal Birth After Caesarean Section - Effect on Maternal Psychosocial Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaginal Birth After Cesarean
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2006-02-22
Sex: FEMALE
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The incidence of caesarean section has reached 15-20% in most developed countries. Encouraging vaginal birth after caesareans section (VBAC) has been considered a key component of a strategy to reduce the caesarean section rate. Most medical literature has focused on the efficacy of VBAC in reducing the caesarean section rate and the physical safety of successful VBAC. However, 30%-40% of these women fail to achieve a vaginal delivery. Little is known about how the uncertainty of labour outcome and a failed VBAC impact on the psychosocial function of these women. What we do know is that antenatal depression and unplanned caesarean section are major risk factors for postpartum depression, which in turn is the major cause of maternal mortality in many developed countries including Hong Kong. We propose to study a cohort of women with a prior caesarean section and presenting with a subsequent pregnancy for care. After consent and recruitment, these subjects will be randomly assigned to have a repeat caesarean section or VBAC. The medical outcomes, overall satisfaction of the subjects with the care they received, and the short-term psychosocial function of these subjects will be studied. The result of this study will provide important information that would be useful in assisting women to decide the mode of delivery after a prior caesarean section. The Hypothesis is that there is a significant difference in psychosocial function between these 2 groups of patients.


Eligibility criteria: Inclusion Criteria:

* women who agree for vaginal birth after prior cesarean section and who had no previous history of vaginal delivery

Exclusion Criteria:

* Inability or unwillingness to give informed consent. Multiple pregnancy, more than one previous caesarean section, and a previous classical caesarean section, presence of other contra-indications to vaginal birth

Primary outcomes:
measure: General Health Questionnaire (GHQ)
Secondary outcomes:
measure: State-Trait Anxiety Inventory
measure: Beck Depression Inventory
measure: Edinburgh Postnatal Depression Scale
measure: Client Satisfaction Questionnaire
measure: MRC Social Performance Schedule
measure: WHO Quality of Life questionnaire
Other outcomes:
Locations:
Study officials:
affiliation: Chinese University of Hong Kong
name: Tze Kin LAU, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00206011: Open Versus Endoscopic Surgery of Craniomaxillofacial (CMF) Condylar Neck Fractures
Official title: Open Versus Endoscopic Surgery of Condylar Neck Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Condylar Neck Fractures
Keywords: Condylar neck
fractures
endoscopic
Helkimo Dysfunction index
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a comparison of open surgery versus an endoscopic approach in condylar neck fractures; it will look at functional outcome, cosmetic outcome and patient satisfaction.

Detailed description: The primary outcome measure is functional outcome based on the Helkimo dysfunction index.

Eligibility criteria: Inclusion Criteria:

* Adult patient \> 18 years
* Unilateral or bilateral fracture of the condylar neck
* Inclination of the condyle \> 30%
* Severe dislocation
* Severe pain upon palpation/movement
* Eligible for open reduction and internal fixation of the fracture
* Amenable to endoscopic as well as open surgery

Exclusion Criteria:

* High or intracapsular condylar neck fracture
* Very low fractures that can be reduced intraorally
* CMF malfunctioning
* Drug or alcohol abuse
* General or local conditions that adversely affect bone physiology
* Physical or mental incapacity to sign informed consent

Primary outcomes:
measure: Functional outcome based on the Helkimo dysfunction index
timeFrame: 3 months
Secondary outcomes:
measure: Complication rate
timeFrame: 24 months
measure: Cost effectiveness
timeFrame: 24 months
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Universitaestklinik Freiburg, Klinik für Mund- Gesichts- und Kieferchirurgie
Study officials:
affiliation: Universitaet Freiburg
name: Rainer Schmlezeisen, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02920411: Effectiveness of a Combined Dermatological Treatment in Children With Atopic Dermatitis
Official title: Estudio Piloto Sobre la Efectividad de la acción Conjunta de Una Crema Corporal y un bálsamo Corporal en niños Con Dermatitis atópica
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis
Lead sponsor: Laboratorios Ordesa
Sponsor class: INDUSTRY
Collaborators: name: Clever Instruments S.L.
First posted: 2016-09-30
Enrollment: 43
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effectiveness of a combined dermatological treatment in children up to 5 years old with mild or moderated atopic dermatitis.

Detailed description: The intensive cream and body lotion of the PediATOPIC® products are two emollients expressly formulated to serve as adjuvants in the management of Atopic Dermatitis. Both products contain Dermosense complex®, a complex that includes 3 products: Bodyfensine peptide® (inductor of dephensine synthesis against microbial aggressions), Unimoist® (the mimetizing complex of the skin's natural hydration factor), and Ramnosoft® (polysaccharide that inhibits the adhesion of pro-inflammatory drugs and bacteria, while limiting the spread of inflammatory reactions in skin cells). They also contain Bisabolol, (plant extract with anti-inflammatory, anti-irritant and antimicrobial properties) and Panthenol (Pro vitamin B5 that accelerates the skin's natural regeneration process).

Eligibility criteria: Inclusion Criteria:

* Children from 1 month to 5 years old
* Patients with atopic dermatitis mild-moderate with an SCORAD=16-40

Exclusion Criteria:

* Other dermatological diseases that could interfere with the study results
* Corticoids use during 3 weeks prior to the study
* Antibiotics use to treat atopic dermatitis during 3 weeks prior to the study
* Use of topical immunomodulators
* Concurrent use of other emollients

Primary outcomes:
measure: Changes in Atopic Dermatitis severity according SCORAD test
timeFrame: At 15 days
Secondary outcomes:
measure: Number of atopic dermatitis outbreaks
timeFrame: At 5 months
measure: Duration of stable periods (between outbreaks)
timeFrame: At 5 months
measure: Patient satisfaction assessed by Visual Analog Scales
timeFrame: At 5 months
measure: Treatment compliance assessed by Morisky-Green test
timeFrame: At 5 months
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Centre Medic Digest
state: Barcelona
city: Barcelona
country: Spain
facility: Centro médico Quirón Teknon
Study officials:
affiliation: Centro Médico Quirón Teknon
name: Sapena Jordi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro Digest Pediatric Badalona
name: M.Carmen Gavilan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05386511: Real-world Study of UTD1 in Chinese Advanced Breast Cancer
Official title: An Observational, Real-world Study Study of UTD1 in Chinese Advanced Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2022-05-23
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with breast cancer (according to ICD-10) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage

Brief summary: To evaluate the efficacy and safety of UTD1 in patients with advanced breast cancer.


Eligibility criteria: Inclusion Criteria:

1. Patients aged over 18 years old.
2. Metastatic breast cancer included unresectable locally advanced breast cancer, de novo stage IV breast cancer, and recurrent metastatic breast cancer.
3. Plan to receive or has received UTD1 monotherapy or UTD1 based therapy
4. Available medical history.

Exclusion Criteria:

1.Incomplete medical history.

Primary outcomes:
measure: PFS
timeFrame: 6 weeks
Secondary outcomes:
measure: Adverse events
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References: