louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06792565: Compare the Impact of Hemofilters and Hemodialyzers on Cytokine Removal During Cardiopulmonary Bypass in Pediatric Cardiac Surgery
Official title: Hemofilters vs. Hemodialyzers: Impacts on Cytokine Removal During Cardiopulmonary Bypass in Pediatric Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardio-pulmonary Bypass
Cytokine
Lead sponsor: Alnas Hospital
Sponsor class: OTHER
First posted: 2025-01-24
Enrollment: 40
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: compare impact of hemofilters and hemodialyzers on cytokine removal during cardiopulmonary bypass in pediatric cardiac surgery.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Cardiopulmonary bypass (CPB) allowed the correction of several congenital heart diseases such as intracardiac malformations, but it is well known that this is not a harmless procedure because it can lead to a systemic inflammatory response syndrome (SIRS), with activation of complement, cytokines, coagulation, and fibrinolysis pathways.

Due to economic causes, hemofilters became less available in low-resource countries, which forced perfusionists to use hemodialyzers instead during CPB. Preliminary data showed the potential safety of using hemodialyzers instead of hemofilters in Zero-balanced ultrafiltration.

The Objectives of the study This study aims to compare impact of hemofilters and hemodialyzers on cytokine removal during cardiopulmonary bypass in pediatric cardiac surgery.


Eligibility criteria: Inclusion Criteria:

1. Pediatric patients who are undergoing elective cardiothoracic surgery which cardiopulmonary bypass will be conducted.
2. Age of patients from 1 year to 15 years.
3. CPB duration more than 60 minutes.

Exclusion Criteria:

1. Pediatric patients with known signs of sepsis.
2. Pediatric patients having had previous cardiothoracic surgery.
3. Preoperative renal failure.
4. Preoperative cardiogenic shock requiring the use of inotropes.
5. Preoperative lactate concentration \&gt; 2 mmol/L.

Primary outcomes:
measure: IL6 level as a proinflammatory cytokine
timeFrame: preoperatively after induction of anesthesia (T1), after removal of aorta cross clamp and before starting zero-balanced ultrafiltration (T2) and after coming off CPB (T3).
Secondary outcomes:
measure: Other proinflammatory cytokine
timeFrame: preoperatively after induction of anesthesia (T1), after removal of aorta cross clamp and before starting zero-balanced ultrafiltration (T2) and after coming off CPB (T3).
Other outcomes:
Locations:
city: Shubra El Kheima
country: Egypt
facility: Alnas Hospital
Study officials:
affiliation: Alnas Hospital
name: Amal F Rizk, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05636865: Descriptive Study of the Incidence and Outcome of PAS in Two Large Referral Hospitals in Egypt
Official title: Descriptive Study of the Incidence and Outcome of PAS in Two Large Referral Hospitals in Egypt , Kasr Alainy Hospital , Cairo University , and Banisuef Specialized Hospital in Last 6 Years
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Placenta Accreta
Keywords: PAS
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-12-05
Enrollment: 10000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant woman above 28 weeks

Brief summary: placenta accreta spectrum incidence and outcome

Detailed description: placenta accreta spectrum ( PAS ) one of the most serious condition in obstetrics nowadays so the investigators measure the incidence by this study

Eligibility criteria: Inclusion Criteria:

* gestational age above 28 weeks

Exclusion Criteria:

* age less than 18

Primary outcomes:
measure: number of diagnosed pregnant women with placenta accreta spectrum
timeFrame: in last 6 years
Secondary outcomes:
measure: incidence of hystrectomy
timeFrame: in last 6 years
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy , Cairo University
Study officials:
affiliation: kasr alainy
name: rihab hagag, resident
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00507065: Safety and Efficacy of ADDERALL XR in the Treatment of Adolescents Aged 13-17 With Attention Deficit Hyperactivity Disorder (ADHD)
Official title: A Phase III, Randomized, Multicenter, Double-blind, Parallel-Group, Placebo-Controlled Safety and Efficacy Study of ADDERALL XR With an Open Label Extension, in the Treatment of Adolescents Aged 13-17 With ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: ADHD
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2007-07-25
Enrollment: 329
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Assess the safety and efficacy of ADDERALL XR compared to placebo in the treatment of adolescents (aged 13-17) with ADHD. Subjects were assigned to one of two cohorts based on weight (\<= 75 kg or \> 75 kg).


Eligibility criteria: Inclusion Criteria:

* Males/females 13-17 years of age meeting DSM-IV criteria for a primary diagnosis of ADHD

Exclusion Criteria:

* Controlled or uncontrolled comorbid psychiatric diagnosis (except ODD) with significant symptoms such as PTSD, psychosis, bipolar disease, severe OCD
* Known non-responder to stimulant medication
* Documented allergy or intolerance to ADDERALL, ADDERALL XR or amphetamines
* Conduct Disorder, hypertension, history of seizure
* Tic disorder or Tourette's disorder

Primary outcomes:
measure: Change from baseline to final visit of the double-blind phase of the study in the ADHD-RS-IV score in the cohort weighing less than or equal to 75 kg.
timeFrame: approximately 4 weeks
Secondary outcomes:
measure: Change from baseline to final visit of double-blind phase of the study in ADHD-RS-IV score in the cohort weighing >75 kg and the CGI for ADHD in both cohorts.
timeFrame: Approximately 4 weeks
measure: Adverse events, labs, physical exam, ECG
timeFrame: approximately 4 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University - Child Study Center
state: New York
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Spencer TJ, Wilens TE, Biederman J, Weisler RH, Read SC, Pratt R. Efficacy and safety of mixed amphetamine salts extended release (Adderall XR) in the management of attention-deficit/hyperactivity disorder in adolescent patients: a 4-week, randomized, double-blind, placebo-controlled, parallel-group study. Clin Ther. 2006 Feb;28(2):266-79. doi: 10.1016/j.clinthera.2006.02.011.
Clinical trial NCT02089165: Bioavailability of Fatty Acids From Krill Oil and Krill Meal and Fatty Acids From Fish Oil in Healthy Subjects.
Official title: Randomized, Single-center, Open-label, Blinded Endpoint Assessment Study (Cross-over Study With 3 Study Products) on Bioavailability of Fatty Acids (Plasma Lipid Fractions) From Krill Oil and Krill Meal and Fatty Acids From Fish Oil in Healthy Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy
Lead sponsor: Olympic Seafood AS
Sponsor class: INDUSTRY
Collaborators: name: Oy Foodfiles Ltd
First posted: 2014-03-17
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare the acute bioavailability of two different krill oil products called krill oil and krill meal in comparison to fish oil product.


Eligibility criteria: Inclusion Criteria:

* Healthy female and male
* Age 18 - 65 years
* Body mass index 18.5 - 30
* Informed consent, signed

Exclusion Criteria:

* Medication potential to affect the bioavailability of fatty acids (e.g. lipid-lowering drugs)
* Familial hypercholesterolemia, marked combined hyperlipidemia, condition that would impair, fat absorption (e.g. chronic pancreatitis, pancreatic lipase deficiency syndrome)
* Any untreated medical condition affecting absorption of fat
* Type 1 and 2 diabetes
* Cancer or other malignant disease within past five years
* Periodical hormone replacement therapy
* High intake of oily fish (once a week or more) (i.e. salmon, herring, sardines, mackerel, vendace)
* Smoking
* Alcohol consumption \> 15 doses per week
* Females who are pregnant, breast-feeding or intend to become pregnant
* Hypersensitivity to any of the components of the test product
* Regular use of n-3 supplements 4 weeks before randomization
* Lack of suitability for participation in the trial, for any medical reason, as judged by the principal investigator

Primary outcomes:
measure: Incremental 0-72 h area under the curve of EPA + DHA proportion in plasma phospholipids.
timeFrame: 0-72 h
Secondary outcomes:
measure: Incremental 0-72 h area under the curve of EPA + DHA proportion in plasma triglyceride.
timeFrame: 0-72 h
Other outcomes:
measure: Mean proportions of fatty acids in plasma phospholipids and triglycerides.
timeFrame: 0-72 h
Locations:
city: Kuopio
country: Finland
facility: Oy Foodfiles Ltd, memeber of Foodfiles group
Study officials:
affiliation: Oy Foodfiles Ltd, member of Foodfiles group
name: Essi S Sarkkinen, Ph.D
role: STUDY_DIRECTOR
affiliation: Oy Foodfiles Ltd, memeber of Foodfiles group
name: Sakari A Nieminen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kohler A, Sarkkinen E, Tapola N, Niskanen T, Bruheim I. Bioavailability of fatty acids from krill oil, krill meal and fish oil in healthy subjects--a randomized, single-dose, cross-over trial. Lipids Health Dis. 2015 Mar 15;14:19. doi: 10.1186/s12944-015-0015-4.
Clinical trial NCT06795165: STUDY of the SAFETY and EFFICACY of MOXIDECTIN TABLETS for the REDUCTION of DEMODEX EYELASH INFESTATION
Official title: A SINGLE-CENTER, INVESTIGATOR- MASKED, RANDOMIZED, PLACEBO- CONTROLLED, INVESTIGATOR INITIATED STUDY of the SAFETY and EFFICACY of MOXIDECTIN TABLETS for the REDUCTION of DEMODEX EYELASH INFESTATION
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Blepharitis
Keywords: blepharitis
demodex
Lead sponsor: Eye Research Foundation, Inc.
Sponsor class: INDUSTRY
First posted: 2025-01-27
Enrollment: 24
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: A Single-Center, Investigator-Masked, Randomized, Placebo-Controlled, Investigator Initiated Study of the Safety and Efficacy of Moxidectin Tablets for the Reduction of Demodex Eyelash Infestation


Eligibility criteria: Inclusion Criteria: Active blepharitis with collarettes -

Exclusion Criteria:Other clinically significant eye disease

-

Primary outcomes:
measure: Collarette count
timeFrame: 6 weels
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Eye Research Foundation, Inc.
state: California
Study officials:
References:
Clinical trial NCT04386265: Compassionate Use of Hyperbaric Oxygen Therapy
Official title: The Compassionate Use of Hyperbaric Oxygen Therapy in the Treatment of COVID-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Keywords: COVID-19
Mechanical Ventilation
Hyperbaric Oxygen Therapy
Patient Registry
Lead sponsor: SerenaGroup, Inc.
Sponsor class: NETWORK
Collaborators: name: SerenaGroup Research Foundation
First posted: 2020-05-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with COVID-19.

Brief summary: This is an observational patient registry of COVID-19 patients treated with HBOT.

Detailed description: The retrospective analysis will focus on the reduction in need for mechanical ventilation in COVID-19 patients. The information will be gathered prospectively. Data will be collected from the patients' medical record, including medical notes and data recorded into the study database.

Eligibility criteria: Inclusion Criteria:

* Adult patients with COVID-19.
* The clinical decision to use HBOT is independent of the decision to participate in registry.
* A signed and dated informed consent form for the off-label use of Hyperbaric Oxygen Therapy specific to the institution where treatment is rendered.
* Subject is willing and able to comply with instructions and scheduled visits.

Exclusion Criteria:

* The Subject has other concurrent conditions that in the opinion of the Investigator may compromise patient safety.
* The patient has an untreated pneumothorax.

Primary outcomes:
measure: Gather information on patients treated with hyperbaric oxygen therapy
timeFrame: 24 months
Secondary outcomes:
measure: Gather information on adverse events
timeFrame: 24 months
Other outcomes:
Locations:
city: Batesville
country: United States
facility: White River Wound Healing Center
state: Arkansas
city: Monterey
country: United States
facility: Community Hospital
state: California
city: Tampa
country: United States
facility: Innovative Healing Systems
state: Florida
city: Decatur
country: United States
facility: Decatur Memorial Hospital
state: Indiana
city: Kansas City
country: United States
facility: Providence Medical Wound Care Center
state: Kansas
city: Marrero
country: United States
facility: West Jefferson Medical Center
state: Louisiana
city: Opelousas
country: United States
facility: The Wound Treatment Center
state: Louisiana
city: Shreveport
country: United States
facility: Christus Shreveport Bossier Hyperbaric & Wound Care Center
state: Louisiana
city: Rochester
country: United States
facility: Ascension Providence Rochester Hospital Wound Care Center
state: Michigan
city: Chattanooga
country: United States
facility: CHI
state: Tennessee
city: Poznan
country: Poland
facility: Klinika Baromedical
state: Wielkopolskie
Study officials:
affiliation: SerenaGroup, Inc.
name: Thomas E Serena, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03396965: Mini-C-Arm for Distal Radius Fractures in Adults
Official title: The Efficacy of Mini-c-arm Fluoroscopy for the Closed Reduction of Distal Radius Fractures in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distal Radius Fracture
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2018-01-11
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Patients randomized to fluoroscopically-aided reduction of fracture, versus no fluoroscopic guidance
Primary purpose: TREATMENT

Brief summary: Determine efficacy of the use of mini-c-arm fluoroscopy for the closed reduction of isolated distal radius fractures in adult patients in the emergency department setting.


Eligibility criteria: Inclusion Criteria:

* Closed distal radius fracture requiring reduction

Exclusion Criteria:

* Open, other ipsilateral upper extremity fractures, pregnant, incarcerated, less than 18 yo

Primary outcomes:
measure: Reduction quality
timeFrame: Immediately post reduction
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02688465: Effect of an Apomorphine Pump on the Quality of Sleep in Parkinson's Disease Patients (POMPRENELLE).
Official title: Effect of an Apomorphine Pump on the Quality of Sleep in Parkinson's Disease Patients (POMPRENELLE).
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Parkinson's Disease
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-02-23
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Parkinson's disease is not only a pathology of movements. There are many non-motor symptoms that complicate and impair patients' quality of life. Among those disorders are sleep disorders.

Insomnia is the most frequent symptom. Most patients report 2-5 awakenings per night and long periods of awakening which occupy 30 to 40% of their night.

Apomorphine is a dopamine agonist that may be administered with a pump . The objective of the study is to assess changes in the quality of sleep in Parkinson's disease patients treated with an apomorphine pump.


Eligibility criteria: Inclusion Criteria:

* Parkinson's disease patients for whom a treatment with an apomorphine pump is indicated

Exclusion Criteria:

* atypical parkinsonian syndrome
* cognitive impairment
* pregnancy
* breast feeding
* patient under a legal protection procedure
* patient denying to participate to the study
* lack of affiliation to a social security system

Primary outcomes:
measure: Difference between the Parkinson's disease sleeping disorders (PDSD-2) score before treatment with an apomorphine pump and 3 months after the beginning of the treatment
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation ophtalmique Adolphe de Rothschild
Study officials:
References:
Clinical trial NCT03157765: Trial of Endometrial Scratch Prior to Frozen Embryo Transfer in Patients With Recurrent Implantation Failure
Official title: A Randomized Study on the Value of an Endometrial Scratch Prior to a Frozen Embryo Transfer Cycle in the Treatment of Recurrent Implantation Failure
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Recurrent Implantation Failure in Setting of Artifically Prepared Endometrium
Keywords: recurrent implantation failure
frozen embryo transfer
IVF
endometrial scratch
endometrial injury
Lead sponsor: Brown Fertility
Sponsor class: OTHER
First posted: 2017-05-17
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with a history of recurrent implantation failure who are planning a frozen embryo transfer (FET) are enrolled into the program. Patients are randomized to an endometrial biopsy prior to starting estrogen to prepare for the transfer of warmed vitrified embryos or to routine care.

Detailed description: Patients who failed to achieve a clinical pregnancy after embryo transfer of at least three high quality embryos in at least two IVF or FET cycles and for whom their last failed cycle was a frozen embryo transfer are offered the opportunity to enroll in this study. All patients will follow our routine FET protocol.

On a randomized basis, selected patients will undergo an endometrial biopsy using a Pipelle disposable device in the week prior to starting estrogen to prepare her endometrium.

Eligibility criteria: Inclusion Criteria:

* At least two prior consecutive failed IVF or FET cycles with transfer of at least 3 high quality embryos and with last cycle a FET cycle

Exclusion Criteria:

* Alternate explanation for implantation failure (e.g., intrauterine pathology)

Primary outcomes:
measure: Implantation rate
timeFrame: within 6 months after recruitment
measure: clinical pregnancy rate
timeFrame: within 6 months after recruitment
Secondary outcomes:
measure: ongoing pregnancy rate
timeFrame: within 18 months of recruitment
measure: biochemical pregnancy rate
timeFrame: within 6 months after recruitment
measure: miscarriage rate
timeFrame: within 18 months after recruitment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03957265: Prospective Observational Study of SynCone® Concept
Official title: Prospective Observational Study of SynCone® Concept: Patient-related Outcomes, Clinical, Radiographic, Immunoinflammatory Mediators and Microbiological Analysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Jaw, Edentulous
Lead sponsor: Paulista University
Sponsor class: OTHER
Collaborators: name: Dentsply Sirona Implants and Consumables
First posted: 2019-05-21
Enrollment: 15
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this prospective observational study will be to evaluate patient-related outcomes, clinical, microbiological and peri-implant immunoinflammatory mediators in completely edentulous patients rehabilitated with delayed loaded overdentures prostheses. The investigators hypothetize that this system could restore edentulous patients with healthier mucosal concerning clinical, microbiological and immunoinflammatory parameters, besides to promote improvement in patient satisfaction and quality of life.

Detailed description: This prospective observational study will include fifteen edentulous patients rehabilitated with conventional dentures. Patients will receive four to six maxillary implants loaded three months after surgery. Clinical, microbiological and immunoinflammatory parameters will be evaluated at baseline, three, and six months following overdenture prosthesis. Patient-centered/reported outcomes concerning general satisfaction with the prostheses as well as comfort, ability to speak, stability, esthetics, ease of cleaning and occlusion, will be evaluated at baseline (conventional denture evaluation) and after 6 months (overdenture evaluation).

Eligibility criteria: Inclusion Criteria:

* subject has total edentulous maxilla.
* subject whose dental extractions occurred at least 6 months before treatment.

Exclusion Criteria:

* pregnancy, lactation, smoking or ex-smokers, systemic conditions that could affect bone metabolism (e.g., immunologic disorders, diabetes), use of anti-inflammatory, biphosphonate, and immunosuppressive medications, subjects that required bone grafts before/during implant surgery.

Primary outcomes:
measure: Modified Gingival Index
timeFrame: 6 months
Secondary outcomes:
measure: Modified Plaque Index
timeFrame: 6 months
measure: Oral Healthy Impact Profile-14 (OHIP-14)
timeFrame: 6 months
measure: Microbiological assays
timeFrame: 6 months
measure: Concentration of osteoimmuneinflammatory mediators
timeFrame: 6 months
measure: Crestal bone level
timeFrame: 6 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: School of dentistry - Paulista University UNIP
state: SP
Study officials:
References: