louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04119908: Videomicroscopy for the Prediction of Bleeding in Constitutional Haemorrhagic Diseases
Official title: Interest of Sublingual Videomicroscopy for the Prediction of Bleeding in Von Willebrand Disease and Other Constitutional Haemorrhagic Diseases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Von Willebrand Diseases
Glanzmann Thrombasthenia
Keywords: constitutional haemorrhagic diseases, Videomicroscopy, prediction, bleeding
Videomicroscopy
prediction
bleeding
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2019-10-09
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: In Willebrand disease, there is currently no test available to identify non-invasively patients with a high risk of bleeding from angiodysplasias The study propose to use a sublingual capillary bed analysis by video-microscopy, a sensitive, reproducible and non-invasive technique, to assess whether sublingual capillary density is predictive of hemorrhagic risk for patients with von Willebrand disease.


Eligibility criteria: Inclusion Criteria:

* Adult patient with a significant form of von Willebrand disease (according to the inclusion criteria of the Willebrand Disease French Reference Center), a Glanzmann Thrombasthenia, a moderate to severe Haemophilia A or a woman carrying the hemophilia gene
* Social insured patient

Exclusion Criteria:

* Minor patient
* Refusal of consent
* Person benefiting from a system of legal protection
* Pregnant patient

Primary outcomes:
measure: area under the ROC curve from Sublingual capillary density to inclusion for the event "existence of at least a clinically significant haemorrhage"
timeFrame: at 3 years
Secondary outcomes:
measure: Sublingual capillary density
timeFrame: At baseline
measure: qualitative abnormalities of sublingual capillaries (capillary haemorrhage, capillary dystrophy)
timeFrame: At baseline and at 3 years
measure: delta of Sublingual capillary density increase
timeFrame: between inclusion and end of study (at 3 years)
measure: ISTH-BAT haemorrhagic score (International Society on Thrombosis and Hemostasis - Bleeding Assessment Tool)
timeFrame: At baseline, at 3 years
measure: delta of increase of ISTH-BAT haemorrhagic score
timeFrame: between inclusion and end of study (at 3 years)
measure: plasma levels of proangiogenic markers
timeFrame: at inclusion and end-of-study visits(at 3 years)
measure: plasma levels of galectine
timeFrame: at inclusion and end-of-study visits(at 3 years)
measure: plasma levels of VEGF
timeFrame: at inclusion and end-of-study visits(at 3 years)
measure: delta of increase in plasma levels of all proangiogenic markers
timeFrame: At inclusion and end of study (at 3 years)
Other outcomes:
Locations:
city: Lille
country: France
facility: CHU de Lille
state: Nord
Study officials:
affiliation: University Hospital, Lille
name: Antoine Rauch, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01766908: Optimal Timing of Cord Clamping in Preterm Pregnancy Following Vaginal or Cesarean Delivery
Official title: Timing of Umbilical Cord Clamping After Vaginal or Cesarean Preterm Birth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Birth
Keywords: Timing of Umbilical Cord clamping
Cord Clamp 20 seconds
Cord Clamp 40 seconds
Cord Clamp 60 seconds
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
First posted: 2013-01-11
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This is an experimental research study for pregnant women between 23 and 37 weeks age of gestation who will be having a baby sooner than term. This study is to learn if waiting 20, 40, or 60 seconds to clamp the umbilical cord after baby delivers will improve his/her outcome and overall health. Benefit to the baby may come by increasing the amount of blood in the baby's body, reducing the need for possible transfusion later, and possible prevention of other complications caused by too little blood in the baby. Possible reduction of cerebral palsy may be realized by a longer interval for cord clamping.

Detailed description: Intention is to enroll every preterm delivery into this trial containing six groups of patients, vaginal or cesarean delivery with clamping of the cord at 20, 40 or 60 seconds. Expectation is 1500 deliveries over 2 year period of time. Randomization upon entry to L\&D unit. Removal from study if resuscitation deemed urgent by newborn staff. Strong effort to keep newborn warm using appropriate measures. Evaluation to determine if there are differences in transfusion, anemia, time to onset of spontaneous respiration, occurence of IVH or CP.

Eligibility criteria: Inclusion Criteria:

18 years old singleton gestation Between 23-37 weeks gestation Able to understand and sign informed consent

Exclusion Criteria:

multiple gestation/ known intrauterine fetal death unable to sign consent

Primary outcomes:
measure: Intraventricular Hemorrhage number and severity
timeFrame: 15 months
Secondary outcomes:
measure: Incidence and volume of red cell transfusion for newborns.
timeFrame: 15 months
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center, Winfred L. Wiser Hospital for Women and Infants
state: Mississippi
Study officials:
affiliation: University of Mississippi Medical Center
name: James Martin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00884208: Fall Risk Prediction and Reduction in Community Ambulators 65 Years of Age or Older
Official title: Fall Risk Prediction and Reduction in Community Ambulators 65 Years of Age or Older
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Accidental Falls
Elderly
Ambulatory
Lead sponsor: Guthrie Healthcare System
Sponsor class: OTHER
First posted: 2009-04-20
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults 65 years or older who are community ambulators.

Brief summary: The purpose of this study is to assess the diagnostic efficacy of the Tinetti Assessment, Timed up and Go test (TUG) and Gait Speed on predicting fall risk in adults 65 years of age or greater who are community ambulators.


Eligibility criteria: Inclusion Criteria:

* adults 65 years or older who are community ambulators.

Exclusion Criteria:

* known neurological disorder;limitation secondary to recent orthopedic condition; currently resides at skilled nursing facility

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sayre
country: United States
facility: Robert Packer Hospital
state: Pennsylvania
Study officials:
affiliation: Guthrie Healthcare System
name: Christy Tanton, DPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02296008: 3D High Resolution Anorectal Manometry in Children After Surgery for Anorectal Disorders
Official title: 3D High Resolution Anorectal Manometry in Children After Surgery for Anorectal Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Children
Anorectal Disorder
Anorectal Atresia
Hirschsprung Disease
Keywords: high resolution manometry
children
congenital anorectal disorder
surgery
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
Collaborators: name: Medtronic - MITG
First posted: 2014-11-20
Enrollment: 43
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 3D high resolution anorectal manometry (3DHRAM) is the most precise tool to assess function and 3D topographic picture of pressures along the anal canal.

Until now, it has been used only in adult population to evaluate defecatory disorders.

Congenital anorectal disorders are severe conditions and may present wide spectrum of symptoms from gastrointestinal tract.

The usefulness of the 3DHRAM hasn't been evaluated in children after surgery for anorectal disorders such as Hirschsprung's disease and anorectal malformations.

It may help for better understanding of pathophysiology of anorectal area and allow for planning improved procedures in these patients.

Moreover, the investigators study may elucidate the real usefulness of the procedure in management of disorders of gastrointestinal tract in pediatric population.


Eligibility criteria: Inclusion Criteria:

* age:1-18 yr
* after surgery for Hirschsprung's disease,
* after surgery for Anorectal malformations,
* after total procto/colectomy
* with parental agreement for the procedure

Exclusion Criteria:

* parental disagreement
* children \<12 months of age and \>18 years

Primary outcomes:
measure: Mean and maximum sphincters pressures during rest, voluntary squeeze and bear down maneuvers and asymmetry of the anal canal
timeFrame: 20 minutes
Secondary outcomes:
measure: Presence of rectoanal inhibitory reflex
timeFrame: 5 minutes
measure: Presence of sphincteric lesion in 3D picture of anal canal
timeFrame: 30 seconds
measure: Presence of ano-anal reflex
timeFrame: 10 seconds
measure: Presence of cough reflex
timeFrame: 10 seconds
measure: Presence of discomfort during procedure
timeFrame: 20 minutes
measure: Presence of dyssynergic defecation
timeFrame: 2 minutes
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Department of Pediatric Gastroenterology and Nutrition
Study officials:
affiliation: Department of Pediatric Gastroenterology and Nutrition Medical University of Warsaw, Poland
name: Marcin Banasiuk, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Banasiuk M, Dziekiewicz M, Dembinski L, Piotrowski D, Kaminski A, Banaszkiewicz A. Three-dimensional high-resolution anorectal manometry in children after surgery for anorectal disorders. Eur Rev Med Pharmacol Sci. 2021 Apr;25(7):2981-2993. doi: 10.26355/eurrev_202104_25551.
Clinical trial NCT03593408: Pharmacokinetics of Sedatives and Analgesics During Extracorporeal Membrane Oxygenation (ECMO) Support
Official title: Pharmacokinetics of Sedatives and Analgesics During Extracorporeal Membrane Oxygenation (ECMO) Support
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Drug Effect
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2018-07-20
Enrollment: 20
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All pediatric patients who present to Boston Children's Hospital (BCH) and supported on ECMO and receiving one or a combination of the following drugs dexmedetomidine, fentanyl, midazolam or morphine as part of the sedation management.

Brief summary: This study will measure plasma concentrations of dexmedetomidine, fentanyl, morphine and midazolam in pediatric patients supported with extracorporeal membrane oxygenation (ECMO) aiming to understand the pharmacokinetics of these drugs in this setting.


Eligibility criteria: Inclusion Criteria:

* supported on ECMO
* receiving one or a combination of the following drugs dexmedetomidine, fentanyl, midazolam or morphine as part of sedation management

Exclusion Criteria:

-none

Primary outcomes:
measure: Change in plasma concentrations of dexmedetomidine
timeFrame: Throughout the duration of sedation management with dexmedetomidine at baseline, 30, 60, 120 minutes and then at 4, 6, 12 hours after each bolus or change in infusion and then at 30,60, 90, 120, 240minutes and 4 hours after the drug is stopped
measure: change in plasma concentrations of fentanyl
timeFrame: Throughout the duration of sedation management with fentanyl at baseline, 30, 60, 120 minutes and then at 4, 6, 12 hours after each bolus or change in infusion and then at 30,60, 90, 120, 240minutes and 4 hours after the drug is stopped
measure: change in plasma concentrations of morphine
timeFrame: Throughout the duration of sedation management with morphine at baseline, 30, 60, 120 minutes and then at 4, 6, 12 hours after each bolus or change in infusion and then at 30,60, 90, 120, 240minutes and 4 hours after the drug is stopped
measure: change in plasma concentrations of midazolam
timeFrame: Throughout the duration of sedation management with midazolam at baseline, 30, 60, 120 minutes and then at 4, 6, 12 hours after each bolus or change in infusion and then at 30,60, 90, 120, 240minutes and 4 hours after the drug is stopped
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Viviane Nasr, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06357208: IMPACT OF BREATH CONTROL AND RETENTION ON PATIENT STRESS. E.S IN MEDICALLY ASSISTED REPRODUCTION
Official title: IMPACT OF BREATH CONTROL AND RETENTION ON PATIENT STRESS. E.S IN MEDICALLY ASSISTED REPRODUCTION BREATH HOLD TO BREATH BETTER PROGRAM IN MEDICALLY ASSISTED REPRODUCTION
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reproductive Disorder
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: the investigator propose for patient in the course of Medically Assisted Reproduction a study with to arm: one arm active "Breathing Control and Retention" and the other arm control

Detailed description: After signing the informed consent, the patient makes an appointment for an exchange with the psychologist at the Reproduction center.

During this exchange, the psychologist gives him the evaluation scales, explains to him when to complete them and re-explains the progress of the study.

Patients in the active "Breathing Control and Retention" group make 4 appointments, one week apart, with the Bluenery Academy. The participants self-assess 2 days before starting the breathing program (M0), 2 days after the end of the program, 1 month after starting the program (M1).

Patients in the "Usual follow-up" control group complete the self-assessments 2 days after the discussion with the psychologist (M0) and 1 month later (M1).

At the end of the 2 assessments, the patient was included. sends his assessment book to the psychologist.

An appointment will be made after the rating to communicate the results to them.

Eligibility criteria: Inclusion Criteria:

* Unmarried woman and couple of women with societal infertility,
* couple with medical infertility defined as absence of pregnancy after 12 months without contraception,
* age greater than 18 years,
* patient who has signed informed consent and affiliated to social security.
* Patient available at the proposed slots over 4 weeks

Exclusion Criteria:

* pregnant women before starting the program,
* heart failure
* Thrombocytopenia
* epilepsy

Primary outcomes:
measure: Rate of stressed patients
timeFrame: month 1
Secondary outcomes:
measure: STAI Y-A (anxiety state) scale
timeFrame: month 1
Other outcomes:
Locations:
city: Nice
country: France
facility: Chu de Nice
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Valérie BENOIT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01475708: Doxycycline in Therapy of Erythema Migrans
Official title: Doxycycline in Therapy of Erythema Migrans - do the Accompanying Symptoms Influence the Outcome?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lyme Borreliosis
Keywords: Lyme borreliosis
Erythema migrans
Doxycycline
Subjective symptoms
Outcome
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2011-11-21
Enrollment: 400
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with erythema migrans reffered to Lyme Borreliosis outpatient clinic of the University Medical Center Ljubljana, Slovenia, Department of Infectious Diseases.

Brief summary: The investigators will compare the outcome of three groups of erythema migrans patients treated with doxycycline: a group without any accompanying symptoms, with mild symptoms and with severe symptoms that require lumbar puncture.

Detailed description: Patients with erythema migrans treated with doxycycline for two weeks will be followed-up for one year (at 2 weeks, 2, 6 and 12 months) clinically and also by filling in the questionnaire to assess the presence of certain symptoms. Also the control group of their friends or relatives without a history of Lyme borreliosis will be included. The presence of their (unspecific) symptoms will also be recorded by the questionnaire at the time of enrollment and at 6 and 12 months.

Eligibility criteria: Inclusion Criteria:

* presence of erythema migrans
* \>15 years old
* informed consent

Exclusion Criteria:

* pregnancy
* lactation
* multiple erythema migrans
* already treated with antibiotic for this episode of Lyme borreliosis
* allergy to doxycycline
* treatment with drugs with known interactions with doxycycline
* cerebrospinal fluid pleocytosis

Primary outcomes:
measure: Comparing of objective sequelae and post-treatment subjective symptoms in three groups of erythema migrans patients treated with doxycycline: with no accompanying symptoms, with mild and with severe symptoms at the beginning.
timeFrame: 1 year follow-up
Secondary outcomes:
measure: Comparison of subjective symptoms between erythema migrans patients treated with doxycycline and control subjects without a history of Lyme borreliosis.
timeFrame: 1 year follow-up
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: UMC Ljubljana, Department of Infectious Diseases
Study officials:
affiliation: UMC Ljubljana
name: Franc Strle, MD PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04242108: Diagnostic Performance of Deep Learning for Angle Closure
Official title: Diagnostic Performance of Deep Convolutional Neural Networks for Angle Closure Glaucoma: an International Multicenter Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Angle Closure Glaucoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The training and primary validation datasets were collected from the databases of electronic medical and research records at Zhongshan Ophthalmic Center from September 1, 2016, to September 1, 2019. The external test dataset was obtained from the Singapore Eye Research Institute (SERI), Singapore during June 2008 to November 2019, and the Chulalongkorn University and King Chulalongkorn Memorial Hospital (KCMH, Bangkok, Thailand) from October, 2019 to April, 2020.

Brief summary: Primary angle closure diseases (PACD) are commonly seen in Asia. In clinical practice, gonioscopy is the gold standard for angle width classification in PACD patietns. However, gonioscopy is a contact examination and needs a long learning curve. Anterior segment optical coherence tomography (AS-OCT) is a non-contact test which can obtain three dimensional images of the anterior segment within seconds. Therefore, the investigators designed the study to verify if AS-OCT based deep learning algorithm is able to detect the PACD subjects diagnosed by gonioscopy.


Eligibility criteria: The inclusion criteria in the study were as follows: (1) All participants must be ≥ 18 years old; (2) Study subjects had a previous diagnosis of the ACA status (narrow or open, PAS or non-PAS) based on gonioscopy, SS-OCT scans and medical history records. Exclusion criteria of the data include: (1) poor compliance in receiving gonioscopy examination; (2) unclear AS-OCT scans due to blinking or out of focus; (3) recent use of miotics within a month; 4) secondary angle closure sue to subluxation or dislocation, uveitis, neovascular glaucoma, et al.; 5) history of ocular surgery or laser iridotomy; 6) patients who previously had an episode of primary angle closure (which was obtained on history by asking the patients).

Primary outcomes:
measure: Area under receiver operating curve (AUC)
timeFrame: Immediately after obtaining the AS-OCT images
Secondary outcomes:
measure: Sensitivity and specificity
timeFrame: Immediately after obtaining the AS-OCT images
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center
state: Guangdong
Study officials:
References:
Clinical trial NCT00730808: Effectiveness and Tolerability of an Oral Nutritional Supplement (PreOP Booster) Given Before Surgery
Official title: Efficacy and Tolerability of a Preoperative Oral Nutritional Supplement (PreOP Booster) vs. Placebo in Surgical Patients (Pilot Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Tumors
Keywords: Enteral nutritional regimen prior to surgery
Lead sponsor: Fresenius Kabi
Sponsor class: INDUSTRY
First posted: 2008-08-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this pilot study is to investigate effectiveness, tolerability and safety of an oral nutritional supplement (PreOP Booster), given to rectal tumour patients prior to low anterior resection.


Eligibility criteria: Inclusion Criteria:

* rectal tumour with indication for elective low anterior resection (open surgery, not laparoscopic surgery) or abdominoperineal resection (APR)
* preoperative radiotherapy (5x5 Gy) or chemoradiation
* loop ileostoma or colostoma;

Exclusion Criteria:

* severe malnutrition
* severe renal insufficiency
* diabetes mellitus I or II
* concomitant thyroid medication
* corticosteroids
* diuretic medication and antihypertensive medication
* known or suspected allergy to any component of the investigational product(s)

Primary outcomes:
measure: Immunoinflammatory parameters
timeFrame: on day -2, -1, 1, 2, 3, 5, and 7
measure: Antioxidant / oxidant parameters
timeFrame: on day -2, 1, 3, 5, and 7
measure: Ischemia / reperfusion injury parameters
timeFrame: on day -2, 1, 3, 5, and 7
Secondary outcomes:
measure: pre-and postoperative discomfort (well-being)
timeFrame: on day -1, and 0
measure: hand grip strength
timeFrame: on day -2, 1, 2, 3, 5, and 7
measure: GI tolerance
timeFrame: on day -1, 0, 1, 2, and 7
measure: Safety
timeFrame: on day -1, 0, 1, 2, 3, 5, and 7
Other outcomes:
Locations:
city: Alkmaar
country: Netherlands
facility: Medical Center Alkmaar
Study officials:
affiliation: University Hospital Amsterdam; The Netherlands
name: Paul A.M. van Leeuwen, Prof.
role: STUDY_CHAIR
References: