louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02897258: Thrombosis and Haemorrhage in Chronic Hemodialysis Patients
Official title: Thrombosis and Haemorrhage in Chronic Hemodialysis Patients - T2HD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Renal Failure
Keywords: Dialysis
Thrombosis
Haemorrhage
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2016-09-13
Enrollment: 600
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 treated for end-stage renal disease by chronic hemodialysis, in one of the 12 dialysis centers for adult Lorraine region (heavy or dialysis centers medicalized units).

Brief summary: The study T2HD "Thrombosis and Haemorrhage in chronic hemodialysis patients" is a study of pharmacoepidemiology observational, retrospective cohort, multicenter including 12 dialysis centers for adults Lorraine.

The main objective is to :

Describe the prescribing practices of drugs anticoagulants and antiplatelet agents in chronic hemodialysis patients in the Lorraine region.

The second objective is to :

Study the impact of these practices on the survival and the occurrence of major clinical events, thrombotic and hemorrhagic.

Detailed description: All adult patients aged 18 and over who started a new hemodialysis replacement therapy in Lorraine between 01/01/2009 and 31/12/2010 are identified from the registry REIN (Epidemiology and Information Network in nephrology). The latter are included in the study T2HD to the initiation of dialysis and followed until the date point 30/06/2013.

The outcome was survival without major clinical event. Are considered major clinical events: acute coronary syndrome, acute limb ischemia, deep venous thrombosis, arterial thrombosis, pulmonary embolism, thrombosis First, ischemic or hemorrhagic stroke, the digestive hemorrhage, and severe bleeding.

Statistical analysis will compare event-free survival of patients in 4 groups. Patients will be censored at the time of the occurrence of a kidney transplant, a dialysis method of change, a dialysis withdrawal, a move outside Lorraine, or date point if they are still alive . To minimize bias maximum indication, patients of different groups will be matched on propensity score (probability for a given patient to be treated by antiplatelet and / or anticoagulant).

Eligibility criteria: Inclusion Criteria:

* Male or female aged 18 and over,
* In end-stage renal disease,
* Initiating a first hemodialysis replacement therapy in Lorraine between 01/01/2009 and 31/12/2010.

Exclusion Criteria:

* Evolutionary Neoplasia at start of dialysis,
* Death within 45 days of the start of dialysis.

Primary outcomes:
measure: Survival without major clinical event
timeFrame: up to 54 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: n.thilly@chru-nancy.fr
name: Nathalie THILLY
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02413658: Phenytoin in the Healing of Clean Surgical Wounds
Official title: Phenytoin in the Healing of Clean Surgical Wounds
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Wound
Re-Epithelialization
Keywords: Phenytoin
Skin graft donor site
Clean surgical site
Wound model
Lead sponsor: Children's Surgical Center, Cambodia
Sponsor class: OTHER
First posted: 2015-04-10
Enrollment: 100
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the potential healing properties of phenytoin.

The investigators will use the donor site of a split skin thickness graft (SSTG) to model a basic wound in a randomized controlled trial of topical phenytoin against current best clinical practice. The investigators aim to demonstrate a dose dependent effect. The investigators hypothesis, based on previous clinical experience at our center and on current available literature, that phenytoin will reduce wound healing time.


Eligibility criteria: Inclusion Criteria:

* Undergoing split thickness skin graft during trial time period at Children's Surgical Centre

Exclusion Criteria:

Primary outcomes:
measure: Percentage rate of re-epithelialization
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 20 days
measure: Appearance of infection
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 20 days
Secondary outcomes:
Other outcomes:
Locations:
city: Phnom Penh
country: Cambodia
facility: Children's Surgical Centre
Study officials:
References:
Clinical trial NCT01792258: Procedures and Follow-up of Percutaneous Tracheostomy in Intensive Care Unit
Official title: Procedures, Complications and Follow-up of Percutaneous Tracheostomies in Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Respiratory Failure
Neurological Disease
Heart Failure
Keywords: Percutaneous tracheostomy
Intensive Care Unit
Ineffective Airway Clearance
Weaning failure
Lead sponsor: University of Genova
Sponsor class: OTHER
First posted: 2013-02-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Criticall ill patients requiring percutaneous tracheostomy in intensive care unit

Brief summary: Tracheostomy is worldwide performed in Intensive Care Unit (ICU). According to the current literature, indication for percutaneous tracheostomy (PDT) in ICU are: difficult prolonged weaning, prolonged mechanical ventilation, loss of airway reflex, copious secretions, upper airway obstruction. Many studies have focused on the comparison between different PDT techniques and complication. The aim of our study is to evaluate the procedural features, complications, ICU mortality, quality of life, post-discharge mortality of patients undergoing different PDT techniques performed in ICU.


Eligibility criteria: Inclusion Criteria:

* age \>18
* indication for tracheostomy

Exclusion Criteria:

* infectious disease of neck

Primary outcomes:
measure: Safety of percutaneous tracheostomy
timeFrame: at the beginning and at the end of the procedure
Secondary outcomes:
measure: Early complications
timeFrame: in the first 24 hours from the end of the procedure
measure: Late complications
timeFrame: from the 2nd day ofter the procedure until the ICU discharge (expected average of 2 weeks)
measure: Quality of life
timeFrame: at 3, 6 and 12 months after tracheostomy
measure: Evaluation of organ function
timeFrame: At 3, 6 , and 12 months after tracheostomy
measure: Quality of voice
timeFrame: At 3,6, 12 months after tracheostomy
measure: Mortality
timeFrame: at 3, 6 and 12 months from tracheostomy
Other outcomes:
Locations:
city: Genoa
country: Italy
facility: University of Genoa
Study officials:
affiliation: Universita degli Studi di Genova
name: Paolo Pelosi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03770858: Wearable Skin Sensors to Assess Nocturnal Scratch Behavior
Official title: A Single Arm, Prospective Clinical Study Using Novel Wearable Sensors to Assess the Improvement of Nocturnal Scratch Behavior and Sleep Quality in Children With Mild-to-moderate Atopic Dermatitis Treated With Topical Crisaborole
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atopic Dermatitis
Keywords: Wearables
Atopic Dermatitis
Scratch sensor
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2018-12-10
Enrollment: 23
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with mild to moderate atopic dermatitis

Brief summary: Pilot study of flexible and wearable sensor to monitor nocturnal scratching behavior

Detailed description: Present an advanced flexible, and wearable sensor intimately coupled to the skin that can measure the full spectrum of relevant physiological parameters associated with atopic dermatitis including scratch count, scratch duration, scratch intensity, heart rate, heart rate variability and respiratory rate.

Eligibility criteria: Inclusion Criteria:

* Participants with mild to moderate atopic dermatitis ages 2 years or older. This will be determined by clinical diagnosis of AD according to the Hanifin and Rajka criteria with a baseline Investigators Global Assessment score of mild (2) or moderate (3)
* Systemic therapy use (e.g. oral corticosteroid, cyclosporine, methotrexate, phototherapy) within 28 days of subject enrollment
* Topical corticosteroid use or topical calcineurin inhibitor use within 14 days of subject enrollment
* Willingness and ability to set up an infrared video camera nightly
* Willing to apply topical crisaborole twice daily to affected atopic dermatitis areas of the body

Exclusion Criteria:

* Active skin or systemic infection
* Inability to operate a smartphone or video camera
* Active atopic dermatitis on he dorsum of the hand or suprasternal notch

Primary outcomes:
measure: Percent agreement of scratching between the experimental sensor and the infrared camera
timeFrame: 3 weeks
Secondary outcomes:
measure: Improvement of sleep parameters (time asleep) measured by the experimental sensor during treatment
timeFrame: 3 weeks
measure: Improvement of sleep parameters (time until onset of sleep) measured by the experimental sensor
timeFrame: 3 weeks
measure: Improvement of sleep parameters (heart rate) measured by the experimental sensor
timeFrame: 3 weeks
measure: Improvement of sleep parameters (respiratory rate) measured by the experimental sensor
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Shuai Xu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01874158: DNA Clearance of Uncomplicated Trichomonas Vaginalis Infections in HIV Negative Women
Official title: DNA Clearance of Uncomplicated Trichomonas Vaginalis Infections in HIV Negative Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trichomonas Vaginitis
Keywords: Trichomonas vaginalis
Lead sponsor: Tulane University
Sponsor class: OTHER
Collaborators: name: Louisiana State University Health Sciences Center in New Orleans
First posted: 2013-06-10
Enrollment: 99
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: English speaking HIV- women over the age of 18 who are TV positive

Brief summary: The objective of this study is to screen treated Trichomonas vaginalis (TV) positive women weekly using culture and Polymerase Chain Reaction (PCR) to determine how long TV DNA is detectable post treatment and to examine potential confounders to clearance such as bacterial vaginosis.

Detailed description: Trichomonas vaginalis (TV), the most common sexually transmitted infection in the world, is associated with inflammation of the vagina, cervix, and urethra; low birth weight; preterm delivery; pelvic inflammatory disease; and may increase the risk of acquiring and transmitting genital herpes and HIV. Repeat infections are common, ranging from 5% - 31%, and have similar health outcomes as primary infections. Given the high prevalence of TV, the absence of a national screening program, the deleterious reproductive outcomes associated with TV and the potential for a TV infection to increase HIV transmission, reducing repeat TV infections is an important targeted public health approach. However, rescreening for TV should not happen until there is sufficient time for the parasites and DNA to clear from the vaginal cavity after treatment. HIV negative women who attend Delgado Personal Health Center will be asked to enroll in the screening component in order to test them for TV using InPouch culture along with the standard TV screening of wet preparation. The objective of this study is to screen treated TV positive women weekly using culture and Polymerase Chain Reaction to determine how long TV DNA is detectable post treatment and to examine potential confounders to clearance such as bacterial vaginosis. The outcome of interest will be a negative PCR result indicating that TV DNA has cleared.

Eligibility criteria: Inclusion Criteria:

* English speaking females
* \>18 years old
* HIV-negative
* a patient at the Delgado Personal Health Center

Exclusion Criteria:

* HIV+ women

Primary outcomes:
measure: TV negative by PCR, post treatment
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Delgado Personal Health Center
state: Louisiana
Study officials:
affiliation: Tulane University School of Public Health and Tropical Medicine
name: Patricia J Kissinger, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00383058: The Extract of Green Tea on Obese Women: a Randomized Double Blindness Clinical Trial
Official title: The Extract of Green Tea on Obese Women: a Randomized Double Blindness Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Keywords: obesity
green tea
Lead sponsor: Taipei City Hospital
Sponsor class: OTHER_GOV
Collaborators: name: National Science and Technology Council, Taiwan
name: Taipei Hospital, Taiwan
First posted: 2006-10-02
Enrollment: 100
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine whether the extract of the green tea is effective on obese women.

Detailed description: We conducted the pilot study in 2005. The initial findings showed the extract of green tea is benefit on obese women. The potential benefit include appetite lowing, lipid markers decreasing and regulating balance of obese related hormone peptides. So we designed this trial.

Eligibility criteria: Inclusion Criteria:

1. Age 16-60 years old female
2. BMI\>27㎞/m2
3. Signed informed consent

Exclusion Criteria:

1. Endocrine disease, e.g. thyroid disorder, pituitary disorder, and sex gland disorder.
2. Heart disease, e.g. arrhythmia, heart failure, myocardial infarction, and patient with pacemaker.
3. Allergy and Immunology disease.
4. High aminotransferases ( Alanine, Aspartate \>80 IU/L) or high serum Creatinine (\>2.5 mg/dL)
5. Pregnant or lactating women.
6. Childbirth within 6 months.
7. Stroke or otherwise unable to exercise
8. Management for weight control within 3 months.
9. Any other conditions deemed unsuitable for trial as evaluated by the physician-in-charge.

Primary outcomes:
measure: (Percent) reduction of body mass index and body weight
Secondary outcomes:
measure: (Percent) reduction of: Glucose, cholesterol,LDL, HDL and triglyceride
measure: leptin, adiponectin and ghrelin comparisons and analysis
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Hospital
Study officials:
affiliation: Chinese Medicine Dep, Taipei Hospital
name: Chung-Hua Hsu, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Hsu CH, Tsai TH, Kao YH, Hwang KC, Tseng TY, Chou P. Effect of green tea extract on obese women: a randomized, double-blind, placebo-controlled clinical trial. Clin Nutr. 2008 Jun;27(3):363-70. doi: 10.1016/j.clnu.2008.03.007. Epub 2008 May 12.
Clinical trial NCT01220258: A Four Week, Open-Label Study of Azithromycin Ophthalmic Solution, 1% (P08641)
Official title: A Single-Center, Open-Label Study to Characterize Eyelid Margin Erythema, Markers of Clinical Inflammation and Levels of Inflammatory Mediators in the Lid Margins and Conjunctivae of Untreated Healthy Volunteers and Subjects Diagnosed With Posterior Blepharoconjunctivitis Following Dosing With Azithromycin Ophthalmic Solution, 1% for Four Weeks
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Posterior Blepharoconjunctivitis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-10-13
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: One objective of this study is to determine the levels of markers of inflammation on the eyelid margin of subjects with blepharoconjunctivitis and compare them with those of healthy volunteers. Another objective is to determine in subjects with blepharoconjunctivitis the effect of azithromycin ophthalmic solution, 1 % on markers of inflammation of lid margins and conjunctivae and on signs and symptoms of blepharoconjunctivitis.


Eligibility criteria: Inclusion Criteria:

* Have a current diagnosis of posterior blepharoconjunctivitis in both eyes

(except for healthy volunteers)

* Have a Best Corrected Visual Acuity (BCVA), using corrective lenses if necessary, in both eyes of at least +0.7 LogMAR
* If female, are non-pregnant or non-lactating

Exclusion Criteria:

* Have anterior blepharitis
* Have lid structural abnormalities
* Have had penetrating intraocular surgery in the past 90 days or require

penetrating intraocular surgery during the study

* Unable to withhold the use of contact lenses within 3 days prior to Visit 1

during the study

* Have been diagnosed with ongoing glaucoma
* Have a serious medical condition which could confound study assessments

Primary outcomes:
measure: Change from baseline of investigator-rated scores for eyelid margin erythema
timeFrame: Week 4
Secondary outcomes:
measure: Change from baseline of investigator-rated scores of blepharoconjunctivitis signs
timeFrame: Weeks 2, 4, 6, 8
measure: Change from baseline of subject-rated scores of blepharoconjunctivitis symptoms
timeFrame: Weeks 2, 4, 6, 8
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor Eye Clinic, Alkek Eye Center of Baylor College of Medicine
state: Texas
Study officials:
affiliation: Medical Monitor
name: Reza Haque, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06127758: Effect of Virtual Reality Glasses Application on Surgical Fear and Anxiety
Official title: The Effect of Virtual Reality Glasses Application on Surgical Fear and Anxiety in Patients Planned for Open Heart Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Virtual Reality
Fear
Anxiety State
Surgery
Keywords: Heart surgery
surgical fear
anxiety
virtual reality
Lead sponsor: Uskudar University
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Purpose and Type of Research:This study will be conducted to examine the effect of virtual reality glasses on surgical fear and anxiety in patients scheduled for cardiovascular surgery. The study is a randomized controlled experimental research.

Method:The population of the research was approximately 2900 patients who underwent cardiovascular surgery in a year at Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Education Research Hospital. The sample size of the study was calculated using the G\*Power software program.The study will be completed with 60 people by taking 30 people into the experimental and control groups.Data will be collected with a personal information form, surgical fear scale and state anxiety scale.

Hypothesis of the Research:

H1: Application of virtual reality glasses reduces surgical fear in patients planned for cardiovascular surgery.

H2: Application of virtual reality glasses reduces anxiety in patients scheduled for cardiovascular surgery.


Eligibility criteria: Inclusion Criteria:

* 18 years and over,
* Those who will undergo open heart surgery,
* Those who have not had cardiovascular surgery before,
* No communication problems,
* Is conscious and able to answer questions and does not have any disorder/disease that affects decision-making ability (dementia, Alzheimer's, etc.),
* Does not have a psychiatric disease such as anxiety disorder, panic attack, depression,
* Individuals who do not receive psychiatric treatment such as antipsychotics/anxiolytics will be included in the study.

Exclusion Criteria:

* Being under the age of 18,
* Not having open heart surgery,
* Those who have previously undergone cardiovascular surgery,
* Having communication problems,
* Those who are unconscious and unable to answer questions Having any disorder/disease that affects decision-making ability (dementia, Alzheimer's, etc.),
* Having a psychiatric disease such as anxiety disorder, panic attack, depression,
* Individuals receiving psychiatric treatment such as antipsychotic/anxiolytic will not be included in the study.

Primary outcomes:
measure: Personal Information Form
timeFrame: for 1 day
measure: surgical fear scale
timeFrame: for 1 day
measure: state anxiety scale
timeFrame: for 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05544058: Retrospective Non-interventional Study of Stiripentol Use in Dravet Patients in the USA
Official title: Retrospective Non-interventional Study of Stiripentol Use in Dravet Patients in the USA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dravet Syndrome
Lead sponsor: Biocodex
Sponsor class: INDUSTRY
First posted: 2022-09-16
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with dravet syndrome and reated with stiripentol for a minimum of 3 months in routine practice

Brief summary: The present study aims to collect data regarding the history of the disease, previous and current treatments, and the clinical status of Dravet patients during the 3 months prior to stiripentol initiation, the first 3 months on stiripentol and the last 3 months on stiripentol (irrespective of stiripentol discontinuation).


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with Dravet syndrome
* Treated with stiripentol for a minimum of 3 months in routine practice

Exclusion Criteria:

* NA

Primary outcomes:
measure: management of the Dravet syndrome
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Better detection of the Dravet syndrome
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo clinic
state: Minnesota
Study officials:
References: