louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03626493: A Research on Hidden Blood Loss in Laparoendoscopic Single-site Radical Hysterectomy With Pelvic Lymphadenectomy
Official title: A Research on Hidden Blood Loss in Laparoendoscopic Single-site Radical Hysterectomy With Pelvic Lymphadenectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hidden Blood Loss
Single-site Laparoscopy
Radical Hysterectomy
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2018-08-13
Enrollment: 105
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The planned sample size was based on data from a previous study, in which the standard deviation was 5. We assumed an one-tailed α error of 0.05 and a sampling error of 1.0. we propose to enroll 105 participants and allow for a dropout rate of 10% for an effective sample size of 100.

Brief summary: The aim of this cross-sectional study is to evaluate the hidden blood loss in patients who undergo laparoendoscopic single-site radical hysterectomy with pelvic lymphadenectomy and identity its risk factors.

Detailed description: The electronic medical data of 105 patients who undergo laparoendoscopic single-site radical hysterectomy in the following year to treat cervical cancer will be analyzed retrospectively in this study. The amount of hidden blood loss will be calculated according to Gross's formula. And multiple linear regression analysis will be employed to identify its risk factors.

Eligibility criteria: Inclusion Criteria:

1. Volunteer to participate in the study with informed consent;
2. Females aged 20-80 who are confirmed with cervical cancer and are treated with laparoendoscopic single-site radical hysterectomy with pelvic lymphadenectomy.

Exclusion Criteria:

1. Pregnancy, lactation, postmenopause, or planned pregnancy within two years;
2. Suspected or identified as other tumors of genital tract;
3. History of hyperparathyroidism, infectious diseases (tuberculosis, AIDS), autoimmune diseases, or digestive system diseases (malabsorption, crohn disease and dysentery);
4. Other diseases or heavy injuries that will interfere with the results;
5. Simultaneous participation in another clinical study with investigational medicinal product(s) or researcher thinks the subjects are not suitable for this trial.

Primary outcomes:
measure: the volume of hidden blood loss (mL)
timeFrame: 10 months after the operation
Secondary outcomes:
measure: the risk factors of hidden blood loss
timeFrame: 10 months after the operation
measure: the volume of total blood loss (mL)
timeFrame: 10 months after surgery
measure: the volume of visible blood loss (mL)
timeFrame: 10 months after surgery
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: TING LI
state: Zhejiang
Study officials:
References:
Clinical trial NCT06543693: The Core Ultrasound Applications for Nurse Practitioners
Official title: The Development and Assessment of the Core Ultrasound Applications for Nurse Practitioners in Taiwan
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Immediate and 3-month Assessment of PoCUS Performance
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: nursing practitioners

Brief summary: This project aims to establish point-of-care ultrasound (PoCUS) training course for nurse practitioners in Taiwan, and standardized evaluation modules. The study subjects are nurse practitioners across different hospital levels.

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Detailed description: This project aims to establish point-of-care ultrasound (PoCUS) training course for nurse practitioners in Taiwan, and standardized evaluation modules. The study subjects are nurse practitioners across different hospital levels.

Eligibility criteria: Inclusion Criteria:

nursing practitioners who are interested in PoCUS.

Exclusion Criteria:

nursing practitioners who are not interested in PoCUS.

Primary outcomes:
measure: written test
timeFrame: 1day
measure: hands-on performance
timeFrame: 1 day
Secondary outcomes:
measure: written test at the 3-month assessment
timeFrame: 3 months
measure: hands-on performance at the 3-month assessment
timeFrame: 3 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Wan-Ching Lien
Study officials:
affiliation: NTUH
name: Wan-Ching Lien
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05342493: Specified Drug Use Survey on AJOVY Subcutaneous Injection for Long-term Use
Official title: AJOVY Subcutaneous Injection Long-term Specified Use-results Survey
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Migraine Disorders
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-04-22
Enrollment: 1000
Sex: ALL
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: Patients in Japan who are planned to be newly started on Ajovy syringe for SC injection 225 mg therapy for the suppression of migraine attacks

Brief summary: To evaluate the long-term safety of AJOVY in patients under actual use conditions and to specifically evaluate cardiovascular events. In addition, information on efficacy will be collected.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

* patients with a known hypersensitivity to components of AJOVY

Primary outcomes:
measure: Safety information (Adverse Event)
timeFrame: 2 years from the start date of treatment
measure: Number of Special Situations
timeFrame: 2 years from the start date of treatment
measure: Number of off-Label Use
timeFrame: 2 years from the start date of treatment
measure: Incidence of Serious Adverse Event (e.g. resulting in death or life-threatening)
timeFrame: 2 years from the start date of treatment
measure: Incidence of Non-serious Adverse Events (i.e. all Adverse Events that do not meet the definition of a serious Adverse Event)
timeFrame: 2 years from the start date of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Pharmacovigilance Department
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd.
name: Yasuhiko Fukuta, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01070693: Lichtenstein Patch or Prolene Hernia System (PHS) for Inguinal Hernia Repair
Official title: Randomized Clinical Trial of Lichtenstein Patch or Prolene Hernia System for Inguinal Hernia Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Inguinal hernia
Open mesh repair
Long term outcome
Recurrence
Discomfort
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2010-02-18
Enrollment: 300
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 randomised prospective study was designed to compare the convalescence and the long-term sequelae in inguinal hernia repair with either a bilayer mesh as devised by Gilbert (Prolene Hernia System®) or an onlay mesh applied according to Lichtenstein.


Eligibility criteria: Inclusion Criteria:

* Uni- or bilateral
* Primary or recurrent

Exclusion Criteria:

* body-mass index over 40kg/m2, severe co-morbidities

Primary outcomes:
measure: Long-term Sequelae
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Espoo
country: Finland
facility: Helsinki University Central Hospital
Study officials:
References:
Clinical trial NCT00772993: Efficacy of Retinal Nerve Fiber Layer (RNFL) / Retinal Thickness Ratio by Cirrus OCT Utilizing Spectral -Domain Technology as a Diagnostic Predictor of Glaucoma
Official title: Efficacy of RNFL / Retinal Thickness Ratio by Cirrus OCT Utilizing Spectral -Domain Technology as a Diagnostic Predictor of Glaucoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glaucoma
Myopia
Keywords: glaucoma
myopia
myopia with glaucoma
normal control
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2008-10-16
Enrollment: 400
Sex: ALL
Minimum age (years): 10
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: prospective consecutive recruitment from a tertialry glaucoma subspecialty practise

Brief summary: Glaucoma is presumed to be an axonal disease which starts at the lamina cribrosa. This assumption has led to the monitoring of the retinal nerve fiber layer thickness for the diagnosis and monitoring of progression of glaucoma. However, varying disc size, myopia and tilted discs affect the thickness of the retinal nerve fiber layer. This study aims to ascertain the ration of the retinal nerve fiber layer against full retina as a predictor of glaucoma diagnosis and progression.


Eligibility criteria: Inclusion Criteria:

* Primary open angle glaucoma
* Myopia
* Myopia with evidence of glaucoma
* Normal controls

Exclusion Criteria:

* Evidence of retinal disease
* BCVA \< 0.4
* Secondary glaucoma due to intraocular inflammation
* Lens induced glaucoma
* Tumor induced glaucoma
* Neovascular glaucoma

Primary outcomes:
measure: Ratio of RNFL / Full thickness retina
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Institute of Vision Research, Department of Ophthalmology, Severance Hospital, Yonsei University School of Medicine
Study officials:
References:
Clinical trial NCT00311493: Evaluation of Long-Term Immunogenicity in Subjects Boosted With a TBE Vaccine for Adults
Official title: A Phase IV, Randomized, Open-Label, Multi-Center Study in Adults: Evaluation of Long-Term Immunogenicity in Subjects Boosted With a New TBE Vaccine for Adults (Free of Protein-Derived Stabilizer) in Study V48P2E1, 5 Years After First Booster Immunization and Evaluation of Booster Kinetics in Subjects Boosted With a New TBE Vaccine for Adults (Free of Protein-Derived Stabilizer), 5 Years After First Booster Immunization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Encephalitis, Tick-Borne
Keywords: TBE
vaccine
adults
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Novartis Vaccines
First posted: 2006-04-06
Enrollment: 179
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The purpose of this study it is to evalutate the persistence of antibodies after a booster immunisation with a TBE vaccine for adults


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers of both sexes aged \>18 who participated in another study on TBE vaccination

Exclusion Criteria:

* Subjects with any condition, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.

Primary outcomes:
measure: Long-term antibody kinetics as measured both by ELISA and neutralisation test (NT) five years after first booster immunization.
Secondary outcomes:
measure: Booster response in a subset of subjects as measured by NT, ELISA and cellular immunity on Days 3, 5, 7 and 21 after 2nd booster immunization.
Other outcomes:
Locations:
city: Regensburg
country: Germany
Study officials:
affiliation: Chiron Corporation
name: Drug Information Services
role: STUDY_DIRECTOR
References:
Clinical trial NCT04013893: Evaluation of Enteral Nutrition in Critically Ill Children
Official title: Evaluation of Enteral Nutrition in Critically Ill Children Receiving Inotropic Support in Pediatric Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critical Illness
Enteral Feeding Intolerance
Keywords: Enteral feeding
vasopressor
lactate
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2019-07-10
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill children who have inotropic, vasopressor or inodilatory supplements without any problems and contraindications in gastrointestinal system functions

Brief summary: The aim of this study was to evaluate the effect of calorie and enteral feeding timing on survival in critically ill children receiving inotropic, vasopressor and inodilatory supplements.

Detailed description: The aim of this study was to evaluate the effect of calorie and enteral feeding timing on survival in critically ill children receiving inotropic, vasopressor and inodilatory supplements. Early enteral nutrition will be initiated within the first 24 hours of hospitalization in critically ill children who have inotropic vasopressor and inodilator support without any problems and contraindications in gastrointestinal system functions. The energy requirement of the intubated patients will be measured by indirect calorie meter method. Schofield method will be used to calculate the daily energy needs of extubated patients. 30% of the targeted energy in the first 48 hours of hospitalization and 80% of the targeted energy in the first week will be achieved by enteral nutrition.Nutritional solutions with a concentrated formula of 1 / 1.5 will be given to patients with cardiac pulmonary or renal disease requiring fluid restriction.Patients will be followed up for vomiting, diarrhea, abdominal distention, feeding intolerance, gastric residues and gastrointestinal bleeding. If these findings develop, the patient's nutrition will be interrupted according to the clinician's assessment and enteral nutrition will be re-fed as soon as possible.

Eligibility criteria: Inclusion Criteria:

* Children with normal gastrointestinal system function
* Children receiving inotropic, vasopressor or inodilatory support

Exclusion Criteria:

* Children with gastrointestinal system dysfunction
* Children with enteral nutrition contraindicated
* Children with metabolic disease with special nutrition

Primary outcomes:
measure: 28-d mortality
timeFrame: 28 days
Secondary outcomes:
measure: Lactate
timeFrame: During inotropic treatment
measure: Vasoactive inotrope score
timeFrame: During inotropic treatment
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University, Division of Pediatric Intensive Care Unit
Study officials:
affiliation: Cukurova University Medicine Faculty
name: Dincer Yildizdaş, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT06282393: FibriCheck Data Registry
Official title: The FibriCheck Data Registry
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiac Arrhythmia
Keywords: Photoplethysmography
Single-lead electrocardiography
Lead sponsor: Qompium NV
Sponsor class: INDUSTRY
First posted: 2024-02-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The goal of this interventional clinical trial is to establish a comprehensive, structured database that includes photoplethysmography (PPG) measurements with simultaneously recorded electrocardiography (ECG) data to evaluate the FibriCheck Algorithm in patients with heart rhythm disorders.


Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* Access to a smartphone to perform daily measurements
* Ability to understand Dutch
* Atrial Fibrillation diagnosis OR one of the following:

  * CHA2DS2-VASc score ≥2 (male) or ≥3 (female)
  * Underwent elective cardiac surgery
  * Known with:

    * Chronic obstructive pulmonary disease
    * Obstructive sleep apnea
    * Heart Failure
    * Hypertension
    * Previous stroke or transient ischaemic attack
  * Having palpitations and/or racing heart as symptoms
  * Other arrhythmia such as atrial flutter, premature atrial contractions (PAC), premature ventricular contractions (PVC)

Exclusion Criteria:

* Individuals which are currently in follow-up with their physician, using the FibriCheck application
* Individuals with unnaturally coloured fingers (i.e. tattoos, ink); this may weaken the signal and may interfere with the effectiveness of the device
* Persons with conditions causing tremors or the inability to hold their hand still for at least 60 seconds (e.g. Parkinson or dementia) as, in this case, the device may not be able to accurately process a measurement
* Persons with reduced blood flow in the fingertips (e.g. perniosis or severe callus formation) as the device may not be able to detect the intensity variations induced by the blood flow
* Persons that have a disability to perform the measurements according to the instructions for use
* Persons with cardiac pacemakers, implantable cardioverter-defibrillators, or other implanted electronic devices as these can control the natural heart rhythm

Primary outcomes:
measure: Alignment PPG measurement
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost Limburg
state: Limburg
Study officials:
affiliation: Ziekenhuis Oost-Limburg
name: Pieter Vandervoort, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05017493: Treatment of Covid-19 With a Herbal Compound, Xagrotin
Official title: Treatment of Early-Stage Covid-19 With a Herbal Compound, Xagrotin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Covid19
Lead sponsor: Biomad AS
Sponsor class: INDUSTRY
Collaborators: name: Directorate of Health of Sulaimani, Iraq
First posted: 2021-08-24
Enrollment: 661
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 is an interventional, multi-center, randomized study. Adults with confirmed covid-19 disease not more than 10 days before enrollment date were recruited (n=361). Patients in same condition who had treated with standard of care were randomly assigned to the control group (n=178). The investigators analyzed the effect of a herbal compound, Xagrotin, and also investigated impact of different characteristics for instance gender, age, duration of disease, smoking habits and concomitant diseases on the outcome.

Detailed description: This is an interventional, multi-center, randomized study that has been performed in an outpatient setting (n=361). Adults with confirmed covid-19 disease not more than 10 days before enrollment date were recruited. Patients in same condition who had treated with standard of care were randomly assigned to the control group (n=178). The investigators analyzed the effect of a herbal compound, Xagrotin, and also investigated impact of different characteristics for instance gender, age, duration of disease, smoking habits and concomitant diseases on the outcome. Adverse events were registered.

Eligibility criteria: Inclusion Criteria:

* Age 18 or higher
* Newly diagnosed (no longer than 10 days)
* PCR or clinically confirmed Covid-19

Exclusion Criteria:

* Severe pulmonary disease
* Severe cardiovascular disease
* Severe hepatic disease
* Severe renal disease
* Diabetes mellitus type one
* Metabolic acidosis
* Oxygen saturation \<70%
* Pregnancy
* Breast feeding
* Concomitant treatment with anticoagulation drugs
* Concomitant treatment with CYP3A4 medicines with narrow therapeutic window

Primary outcomes:
measure: Mortality
timeFrame: 30 days
Secondary outcomes:
measure: Duration of Disease From Beginning of Treatment
timeFrame: 30 days
measure: Hospitalization
timeFrame: 30 days
measure: Duration of Hospitalization When Occurred
timeFrame: 30 days
Other outcomes:
Locations:
city: Sulaymaniyah
country: Iraq
facility: Directorate of health of Sulaimani, Iraq -KRG
Study officials:
References:
Clinical trial NCT02776293: Prenatal Listening to Songs Composed for Pregnancy and Symptoms of Anxiety and Depression: a Pilot Study
Official title: Prenatal Listening to Songs Composed for Pregnancy and Symptoms of Anxiety and Depression: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prenatal Anxiety
Depression
Lead sponsor: Goldsmiths, University of London
Sponsor class: OTHER
First posted: 2016-05-18
Enrollment: 223
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prenatal anxiety and depression are distressing for the expectant mother and can have adverse effects on her fetus and child. This study aimed to determine whether listening to specially composed songs would be an effective intervention for reducing symptoms of prenatal anxiety and depression over a period of 12 weeks.

Detailed description: Prenatal anxiety and depression has negative implications for both the mother and the developing child, including developmental disorders, low birth weight, and altered immune function. It is therefore very important both to detect and to help ameliorate symptoms of anxiety and depression in pregnant women. Many women do not want pharmacological interventions at this time, and with less severe symptoms it may not be appropriate. Thus there is a need to find non-pharmacological methods of intervention. Psychological therapies such as cognitive behavioural therapy or interpersonal therapy can be effective. But these are often not available for the large numbers of women who could benefit. Though there has been evidence that music has the ability reduce anxiety, no study has quantitatively measured prenatal anxiety and depression over a long period of time. Proof of efficacy could justify investment into music as an inexpensive, and non-stigmatizing method to reduce prenatal anxiety and depression and therefore benefit both the mother and child.

Eligibility criteria: Inclusion Criteria:

* English speaking women
* At least 18 years of age.

Primary outcomes:
measure: State-Trait Anxiety Inventory
timeFrame: 12 weeks
measure: Edinburgh Postnatal Depression Scale
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Goldsmiths, University of London; Centre for Music in the Brain, Department of Clinical Medicine, Aarhus University & The Royal Academy of Music
name: Lauren Stewart, MSc. PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nwebube C, Glover V, Stewart L. Prenatal listening to songs composed for pregnancy and symptoms of anxiety and depression: a pilot study. BMC Complement Altern Med. 2017 May 8;17(1):256. doi: 10.1186/s12906-017-1759-3.