louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03843580: Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Could Decrease the Incidence of Oxygen Desaturation During Suspension Laryngoscopy: a Randomized Controlled Trial (Optilaryngo)
Official title: Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Could Decrease the Incidence of Oxygen Desaturation During Suspension Laryngoscopy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Apnea, Postanesthetic
Desaturation of Blood
Apnea
Anesthesia
Larynx Disease
Pharynx; Anomaly
Keywords: Time of apnea
Optiflow
Thrive
Apnea oxygenation
Suspension laryngoscopy
General Anesthesia
Oxygenation apnea
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
Collaborators: name: Centre Francois Baclesse
First posted: 2019-02-18
Enrollment: 80
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: Suspension laryngoscopy is realised during apnea. In effect, surgeons are in the mouth of the patient and we can't have access at the aiways.

So investigators like to use a Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) to increase time of apnea and decrease the impact of oxygen desaturation.


Eligibility criteria: Inclusion Criteria:

* suspension laryngoscopy

Exclusion Criteria:

* THRIVE contraindication:
* epistaxis
* undrained pneumothorax
* Recent gastroesophageal surgery (1months)
* Skull Fractures

Primary outcomes:
measure: desaturation defined as the number of patient who presented at least one desaturation during suspension laryngoscopy
timeFrame: Two hours
Secondary outcomes:
measure: hypoxemia (decrease the number of Hypoxemia event define like SpO2<90%)
timeFrame: 2 hours
measure: side effect
timeFrame: 2 hours
Other outcomes:
measure: time of apnea
timeFrame: 2 hours
Locations:
city: Caen
country: France
facility: CaenUH
state: Normandie
city: Caen
country: France
facility: Centre François Baclesse
Study officials:
affiliation: Centre Francois Baclesse
name: Eleonore Mulac-Vauclair
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Caen
name: Pierre-Emmanuel Marsan
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Caen
name: Kamga Herve
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Caen
name: Boutros Mariam
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05905380: Covid-19 Convalescent Plasma and Monoclonal Antibodies Treatment of Immunocompromised Patients
Official title: Analysis of the Efficacy and Tolerance of Covid-19 Convalescent Plasma and Monoclonal Antibodies in the Treatment of SARS-Cov2 Infections in Immunocompromised Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19 Convalescent Plasma Treatment
Keywords: Covid-19
SARS-Cov2
Immunosuppression
Cytokine
Convalescent Plasma
Monoclonal
Antibodies
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patient immunocompromised patient hospitalized between 25/02/2020 and 15/01/2023

Brief summary: Data on the use of convalescent plasma in the treatment of covid-19 are scarce: the results of randomized studies involving mainly immunocompetent patients are disappointing, while case series or retrospective data on more selected patients , in particular immunocompromised patients suggest a benefit in these patients whose clinical manifestation seems essentially related to the uncontrolled infection and not the cytokine storm.


Eligibility criteria: Inclusion criteria:

* Adult patient
* Immunocompromised patient (solid neoplasia, malignant hemopathy, solid organ transplantation, primary immune deficiency, systemic disease, chronic inflammatory disease, etc.)
* Hospitalized between 25/02/2020 and 15/01/2023 at HUS, ICANS, CH Colmar and CH Mulhouse
* Having received curative monoclonal antibody treatment or convalescent plasma treatment for SARS-Cov2 infection
* Patient who has not expressed, after being informed, his opposition to the reuse of his data for scientific research purposes.

Exclusion criteria:

* Subject who expressed their opposition to participating in the study
* Subject under guardianship, curatorship or safeguard of justice

Primary outcomes:
measure: Retrospective analysis of the tolerance of Covid-19 convalescent plasma and monoclonal antibodies in the treatment of SARS-Cov2 infections in immunocompromised patients
timeFrame: Files analysed retrospectively from February 25, 2020 to January 15, 2023 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service des Maladies Infectieuses et Tropicales - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT05547880: CNS Correlates of Extended Sleep Restriction
Official title: CNS Correlates of Extended Sleep Restriction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Restriction
Keywords: Sleep Restriction
Alertness
Performance
Neuroinflammation
Biomarker
Lead sponsor: Walter Reed Army Institute of Research (WRAIR)
Sponsor class: FED
Collaborators: name: National Institute of Mental Health (NIMH)
name: National Intrepid Center of Excellence
First posted: 2022-09-21
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

Brief summary: Chronic sleep restriction is ubiquitous in both the general population and the military. The deleterious effects of sleep loss on human alertness and cognitive performance have been documented in numerous studies dating back to the nineteenth century. Over the past decade, evidence has emerged indicating that chronic sleep restriction may also precipitate deleterious, long lasting neuropathological changes in the brain. The purpose of this study is to determine neuropathological effects of sleep restriction and identify physiological mechanisms that correlate with sleep loss-induced performance impairment.


Eligibility criteria: * Ages 18 to 39 (inclusive)
* A body mass index (BMI) below 30.
* Weigh at least 140 lbs
* Females must not be pregnant or nursing, and must be on some form of birth control, if sexually active (e.g., oral contraceptive, condom, intrauterine device, etc.)
* No history of sleeping problems such as insomnia or sleep apnea.
* Test negative for alcohol, nicotine, illegal drugs, and not take certain medications.
* Must not excessively consume alcohol or caffeine.
* Active duty and Federal employees must be on leave during participation.
* No history of heart disease (high blood pressure), neurologic disorder (such as seizures of epilepsy), liver disease, kidney disease, or metabolic disorder or diabetes.
* No history of underlying acute or chronic pulmonary disease requiring daily inhaler use.

Primary outcomes:
measure: Positron Emission Tomography (PET) based measurement of neuroinflammation
timeFrame: 3 Days
Secondary outcomes:
measure: Psychomotor Vigilance Task (PVT)
timeFrame: 55 Days
measure: Actigraphy
timeFrame: 55 Days
measure: Polysomnographic measurements of sleep and wakefulness
timeFrame: 19 Days
Other outcomes:
Locations:
city: Silver Spring
country: United States
facility: Walter Reed Army Institute of Research
state: Maryland
Study officials:
References:
citation: Belenky G, Wesensten NJ, Thorne DR, Thomas ML, Sing HC, Redmond DP, Russo MB, Balkin TJ. Patterns of performance degradation and restoration during sleep restriction and subsequent recovery: a sleep dose-response study. J Sleep Res. 2003 Mar;12(1):1-12. doi: 10.1046/j.1365-2869.2003.00337.x.
Clinical trial NCT01016080: Role of Oral Glutathione in Skin Whitening
Official title: Glutathione as an Oral Whitening Agent: a Randomized, Double-blind, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Skin Whitening
Keywords: glutathione
melanin
whitening
UV spots
skin pigment
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2009-11-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Oral and intravenous glutathione have been used widely to whiten the skin. The investigators tested this hypothesis by giving oral glutathione for 4 weeks to medical students.


Eligibility criteria: Inclusion Criteria:

* Healthy medical students

Exclusion Criteria:

* history of skin cancer, especially melanoma
* consumption of any preparations containing glutathione within 1 month of enrollment
* pigmentary disorders or any dermatoses

Primary outcomes:
measure: Skin melanin index
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
Study officials:
References:
Clinical trial NCT00148980: Creation of Bone Marrow Microenvironment for Treatment of Myelodysplastic Syndrome (MDS) in Conjunction With Allogeneic Stem Cell Transplantation
Official title: Creation of Bone Marrow Microenvironment for Treatment of MDS in Conjunction With Allogeneic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Myelodysplastic Syndromes
Myelofibrosis
Keywords: Myelodysplastic syndrome (MDS)
Allogeneic stem cell transplantation
Demineralized bone matrix (DBM)
Bone marrow microenvironment
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2005-09-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Normal bone marrow function depends on the coexistence of normal hematopoietic stem cells and a microenvironment mostly located in the medullary part of the bones. Stem cells cannot function properly in the absence of an adequate microenvironment. Whereas in malignant and non-malignant hematologic diseases caused by a deficiency or abnormal stem cells, stem cell transplantation is the treatment of choice that results in a cure, in diseases such as MDS, myelofibrosis, and other conditions associated with an abnormal microenvironment, pancytopenia may occur despite the presence of apparently normal hematopoietic cells with no recognizable cytogenetic abnormality.

We, the investigators at Hadassah Medical Organization, proved in experimental studies that the entire osteohematopoietic complex consisting of trabecular bone, hematopoietic microenvironment (of stromal origin) and hematopoietic tissue has been successfully transferred directly into ablated bone marrow cavity in a one-step transplantation procedure.

The goal of this study is to enhance hematopoiesis in patients with myelofibrosis syndrome by intraosseous inoculation of demineralized bone matrix (DBM) together with allogeneic bone marrow cells (BMC).


Eligibility criteria: Inclusion Criteria:

* Patients with impaired marrow stem cells by cytogenetic analysis or morphology (blasts), considered normal candidates for allogeneic BMT. Such patients will also be entitled to allogeneic bone marrow transplantation with intraosseous DBM.
* Patients with documented myelofibrosis will be entitled to allogeneic bone marrow transplantation with intraosseous DBM.

Exclusion Criteria:

* Patients with anticipated life expectancy of \< 4 weeks.
* Pregnant or lactating women.
* Patients with an unrelated disease or relevant clinical problem that may not permit evaluation of the results of the study.
* Patients under 18 years old.

Primary outcomes:
measure: Enhancement of hematopoiesis in patients with myelofibrosis MDS by intraosseous demineralized bone matrix together with allogeneic bone marrow transplantation (BMT)
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Olga Gurevitch, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06258980: Use of Recombinant Factor VII as a Prophylactic Therapy for Adolescent Females With Heavy Menstrual Bleeding
Official title: Professor and Consultant of Pediatric Hematology Faculty of Medicine, Minia University, Al Minya, Egypt.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Assessing the Bleeding Profile and the Quality of Life of the Enrolled Patients Before and 1 Year After Drug Intervention
Lead sponsor: Minia University Hospital
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 3
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adolescent females known Glanzmanns Thrombaesthenia with heavy menstrual bleeding

Brief summary: the study is conducted on adolescent females proved to be Glanzmanns Thrombaesthenia with heavy menstrual bleeding by the use of 3 doses of recombinant factor VII in the first day of their cycles. bleeding profile and quality of life were assessed before and 1year after this regular recombinant factor VII administration.


Eligibility criteria: Inclusion Criteria:

* adolescent females proved to be Glanzmanns Thrombaesthenia heavy menstrual bleeding no improvment by platelet transfusion or antifibrinolytic therapy

Exclusion Criteria:

chronic systemic disease previous allergic reaction to recombinant FVII

-

Primary outcomes:
measure: regular accepted menstrual cycles less than 6 days
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Al Minyā
country: Egypt
facility: Gehan Lotfy Abdel Hakeem
Study officials:
References:
Clinical trial NCT03873480: Trigger Thumb Randomized Controlled Trial
Official title: Administration of Local Anesthetic in Trigger Thumb Surgery: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trigger Thumb
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2019-03-13
Enrollment: 31
Sex: ALL
Minimum age (years): 0
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We are conducting this study to determine if administration of local anesthetic to the thumb prior to surgery can reduce the amount of anesthetic gas given during the course of surgery.


Eligibility criteria: Inclusion Criteria:

1. Males or females, age 0-4 years, presenting to the Children's Hospital of Philadelphia (CHOP) Department of Orthopaedics with unilateral trigger thumb that requires surgical treatment.
2. American Society of Anaesthesiologists (ASA) Classification of 1 or 2.
3. Parental/guardian permission (informed consent).

Exclusion Criteria:

1. Males or females over the age of 4.
2. ASA Classification higher than 2.
3. Patients presenting with systemic diseases or significant comorbidities.
4. Patients that received treatment for trigger thumb at an outside institution.

Primary outcomes:
measure: Difference in administered anesthesia
timeFrame: 3 years
Secondary outcomes:
measure: Difference in observed pain score
timeFrame: 3 years
measure: Difference in operative time
timeFrame: 3 years
measure: Difference in length of stay
timeFrame: 3 years
measure: Difference in complication rates
timeFrame: 3 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Apurva S Shah, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01554280: Fully Coated, Removable, Self-expanding Oesophageal Stents for Preventing Strictures Following Complete Barretts Excision.
Official title: Fully, Coated, Removable, Self-expanding Oesophageal Stents for the Prevention of Oesophageal Stricture Following Endoscopic Mucosal Resection of Short Segment Barrett's With High Grade Dysplasia and Early Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constriction, Pathological
Keywords: Stricture
Dysphagia
Lead sponsor: Western Sydney Local Health District
Sponsor class: OTHER
First posted: 2012-03-14
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate whether preventative placement of a removable oesophageal stent reduces the rate of scar tissue, or stricture formation after removing the precancerous or early cancerous Barrett's mucosa by Endoscopic Mucosal Resection (EMR). The stent will be placed 10-14 days after initial EMR. The stent will then be removed 8 weeks later by repeat Endoscopy. Patients will be followed up weekly following insertion of the oesophageal stent.


Eligibility criteria: Inclusion Criteria:

* Patients with short segment Barrett's Oesophagus with high grade dysplasia or early cancer, having circumferential EMR to achieve complete Barrett's excision.
* Aged 18-75 years old
* Biopsy proven to be Barretts with HGD or EAC
* The absence or lymph node involvement
* Short segment \<3cm of Barretts Oesophagus.

Exclusion Criteria:

* Women who are pregnant and the human foetus
* Children and/or young people \<18 years
* People with an intellectual or mental impairment.

Primary outcomes:
measure: Improvement in Stricture Formation
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
Study officials:
affiliation: WSLHD
name: Michael Bourke, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Holt BA, Jayasekeran V, Williams SJ, Lee EY, Bahin FF, Sonson R, Lord RV, Bourke MJ. Early metal stent insertion fails to prevent stricturing after single-stage complete Barrett's excision for high-grade dysplasia and early cancer. Gastrointest Endosc. 2015 Apr;81(4):857-64. doi: 10.1016/j.gie.2014.08.022. Epub 2014 Oct 16.
Clinical trial NCT01334580: Cognitive-Behavioral Therapy for Pain and Opioid Dependence in Methadone Maintenance Treatment
Official title: Comparison of Cognitive-Behavioral Therapy and Methadone Drug Counseling for Methadone-Maintained Patients With Co-occurring Chronic Pain and Opioid Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Pain
Opiate Dependence
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2011-04-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This study involves the comparison of two treatment approaches for patients with chronic pain who are entering methadone maintenance treatment (MMT) for opioid addiction: (a) an integrated counseling that addresses both chronic pain and opioid dependence(POD)and (b) a counseling intervention that addresses opioid dependence only.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* prescription opioid or heroin addiction
* moderate to severe chronic pain
* enrolled in methadone maintenance at the APT Foundation for opioid addiction
* understand English

Exclusion Criteria:

* current suicide or homicide risk
* life-threatening or unstable medical problem

Primary outcomes:
measure: Pain reduction
timeFrame: 16 weeks
measure: Reduce illicit opioid use
timeFrame: 16 weeks
Secondary outcomes:
measure: Finalization of treatment manuals
timeFrame: 16 weeks
measure: Development and modification of therapy training and process rating measures
timeFrame: 16 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Methadone Research Unit
state: Connecticut
Study officials:
affiliation: Yale University
name: Declan Barry, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05438680: Bovine Colostrum in Prevention of Sepsis and Retinopathy of Prematurity
Official title: Evaluation of the Effect of Bovine Colostrum in Prevention of Late Onset Sepsis and Retinopathy of Prematurity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm
Keywords: Premature infants
colostrum
ROP
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-06-30
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Masking controlled clinical trial will be used to assess the effect of prophylactic bovine colostrum in preventing retinopathy of prematurity.
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate efficacy of bovine colostrum administration as a prophylaxis to decrease the incidence and the occurrence of retinopathy of prematurity in preterm neonates of gestational age less than 32 weeks during their hospital stay.

Detailed description: This study will include a randomized controlled trial carried out on preterm neonates who will fulfill the eligibility criteria delivered at Alexandria University Children's Hospital. Evaluation of the outcome will be done only for those who admitted to the neonatal intensive care unit (NICU) at Alexandria University Children's Hospital.

The study will be carried out in 4 phases:

1. First phase: Enrollment and selection phase.
2. Second phase: Intervention phase ( enteral bovine colostrum administration) .
3. Third phase: Evaluation phase.
4. Fourth phase: collected data analysis and results.

Eligibility criteria: Inclusion Criteria:

* Preterm infants ≤ 32 weeks gestational age, weight ≤ 1500 gm. Start feeding in the first 72 hours of life

Exclusion Criteria:

* Exclusion criteria

Patients with any of the following will be excluded:

1. Obvious major congenital abnormalities.
2. Infants expected to be \>72 hours of age at the time of randomization.
3. Parental consent lacking/refusal

Primary outcomes:
measure: Fundus examination to detect retinopathy of prematurity
timeFrame: 28 days
Secondary outcomes:
measure: prematurity related complications
timeFrame: 28 days
measure: Assessment of weight
timeFrame: 28 days
measure: -Assessment of Head circumference
timeFrame: 28 days
measure: -Assessment of length
timeFrame: 28 days
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria university, Elshattbi hospital
city: Alexandria
country: Egypt
facility: Marwa Mohamed Farag
Study officials:
affiliation: Faculty of medicine, Alexandria University, Egypt
name: Mohamed Alaaaldin Thabet, PhD
role: STUDY_DIRECTOR
affiliation: Faculty of medicine, Alexandria University, Egypt
name: Islam Shereen Hamdy, PhD
role: STUDY_DIRECTOR
affiliation: Faculty of medicine, Alexandria University, Egypt
name: Eman Shabban Mohamed, MBBCh
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of medicine, Alexandria University, Egypt
name: Marwa Mohamed Farag, PhD
role: STUDY_CHAIR
References: