louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06058221: Hybrid Intubation Technique for Difficult Airway Children
Official title: Fiberoptic Intubation With Simultaneous Video-laryngoscopy Versus Through a Supraglottic Airway in Children With a Difficult Airway: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Failed or Difficult Intubation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 116
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To compare two hybrid techniques, flexible bronchoscopy-guided intubation with a video laryngoscope and flexible bronchoscopy-guided intubation with a laryngeal mask, that have recently shown promise as a way to increase first-attempt success rates and reduce complications in children with anticipated difficult intubation.


Eligibility criteria: Inclusion Criteria:

* Children from 1 month of age to less than 12 years of age who are expected to have a difficult intubation when undergoing routine surgery under general anesthesia.

Exclusion Criteria:

* When there is limited mouth opening, making it difficult to insert supraglottic airway ② The patient or their parents do not agree to participate in the study. ③ Other cases deemed unsuitable by the researcher

Primary outcomes:
measure: first attempt intubation success rate
timeFrame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
Secondary outcomes:
measure: total intubation time (seconds)
timeFrame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
measure: Number of intubation attempts
timeFrame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
measure: successful tracheal intubation with the allocated method
timeFrame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
measure: successful tracheal intubation (Yes or No)
timeFrame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
measure: Nadir oxygen saturation during intubation (SpO2 value, %)
timeFrame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
measure: Oxygen reserve index during intubation (ORi™, Rainbow Signal Extraction Technology)
timeFrame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
measure: intubation-related complication
timeFrame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
measure: The degree of vocal cord exposure assessed with a flexible bronchoscope. (Modified Cormack-Lehane grade, I/II/III/IV)
timeFrame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul national university hospital
Study officials:
References:
Clinical trial NCT03060421: Evaluation of the Safety of Intraarticular Aquamid Reconstruction Injection for Knee Osteoarthritis in Humans
Official title: Evaluation of the Safety of Intraarticular Aquamid Reconstruction Injection for Knee Osteoarthritis in Humans
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis, Knee
Lead sponsor: Frederiksberg University Hospital
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 91
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 161 participants the total number of patients treated for Knee OA with Aquamid Reconstruction.

Brief summary: As the use of Aquamid Reconstruction as an intraarticular device on humans is a relatively novel treatment, it is relevant to assess the safety profile of the device in a safety study to evaluate the safety of the device.

This is a retrospective single center cohort study of patients with osteoarthritis of the knee(s) that have been treated for knee OA referred to a clinical evaluation at our department.

The study consists of one clinical visit, at which the patients medical history will be taken and upon informed consent adverse events data is collected from medical records.

The study is retrospective.


Eligibility criteria: Inclusion Criteria:

* Previously treated with intra-articular Aquamid Reconstruction in the knee for knee osteoarthritis and referred to our clinic for evaluatino of possible adverse device events.

Exclusion Criteria:

- There are no exclusion criteria

Primary outcomes:
measure: Adverse Device Events
timeFrame: Day 1 (at the clinical examination)
Secondary outcomes:
Other outcomes:
measure: Western Ontario and McMaster Universities Arthritis Index (WOMAC)
timeFrame: Day 1 (at the clinical examination)
measure: Knee joint range of motion
timeFrame: Day 1 (at the clinical examination)
measure: Global perceived effect of treatment
timeFrame: Day 1 (at the clinical examination)
Locations:
city: Copenhagen
country: Denmark
facility: The Parker Institute
Study officials:
References:
Clinical trial NCT04901221: The Use of Statically Determinate Force System in Closure of Anterior Open Bite in Adults.
Official title: Dentoalveolar and Skeletal Changes Associated With a Statically Determinate Force System in the Closure of Anterior Open Bite in Adults: A Single-arm Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Openbite
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-05-25
Enrollment: 23
Sex: ALL
Minimum age (years): 17
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the current study was to evaluate and quantify the cephalometric changes produced by maxillary and mandibular extrusion arches in closure of anterior open bite in non-growing patients.


Eligibility criteria: Inclusion Criteria:

* Adult patients with anterior open bites more than 1 mm, permanent dentition except for the third molars which were extracted if erupted

Exclusion Criteria:

* Frankfort to mandibular plane angle \> 40
* congenital craniofacial malformations or temporomandibular joint disorders,
* patients with severe gum show during smiling or increased incisal show at rest.

Primary outcomes:
measure: angular and vertical linear effects on incisors
timeFrame: up to 6 months
measure: angular and vertical linear effects on first molars
timeFrame: up to 6 months
Secondary outcomes:
measure: change in the SN' to Mandibular plane angle
timeFrame: up to 6 months
measure: change in the palatal to Mandibular plane angle
timeFrame: up to 6 months
measure: change in the Anterior facial height
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria faculty of Dentistry
Study officials:
affiliation: Alexandria University
name: Tasneem Y Hammad, BDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University
name: Hanan Ismail, PHD
role: STUDY_DIRECTOR
affiliation: Alexandria University
name: Wessam Marzouk, PHD
role: STUDY_CHAIR
affiliation: Alexandria University
name: Hassan Moussa, PHD
role: STUDY_CHAIR
References:
Clinical trial NCT00977821: Embryo Developmental Capacity After Egg Banking in an Ovum Donation Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
Lead sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
Sponsor class: OTHER
First posted: 2009-09-16
Enrollment: 625
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: For an efficient "egg banking" system, an equally efficient cryopreservation strategy that ensures the viability of the oocytes is required. Very recently, improved and new methods are yielding satisfactory results. In particular, vitrification is providing excellent results for both survival and clinical outcomes. However, to evaluate the over all out come there are other parameters to be considered. In this sense, capacity development of embryos generated after oocyte vitrification is a major factor when assessing the viability of vitrified oocytes. Accordingly, the evaluation of the capacity of vitrified oocytes to reach the blastocyst stage will be highly valuable to fully assess the effectiveness of the "egg banking" and its contribution to ovum donation programs.

The aim of this study is to evaluate the developmental capacity of vitrified oocytes by their ability to reach the blastocyst stage. The study includes oocyte donation cycles conducted with vitrified versus fresh oocytes.


Eligibility criteria: Inclusion Criteria:

* 18-35 year old
* Normal response (8-15 follicles) to long protocol of ovarian stimulation with hCG
* Donors with normal menstrual cycles (21-35 day duration)
* Donors with BMI between 18-25 Kg/m2

Exclusion Criteria:

* Donors with two or more previous miscarriages
* Polycystic ovary syndrome
* Donors with antecedents of poor embrionary quality not attributed to masculine factor
* Donors with drop of estradiol of more than 10% or estradiol plateau.
* Donors with a high response\>20 oocytes and or levels above 3000pg/ml of estradiol the day of the administration of chorionic gonadotrophin (hCG)

Primary outcomes:
measure: Mean outcome measures will be survival, fertilization and blastocyst rates and clinical outcome.
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: IVI Valencia
Study officials:
References:
Clinical trial NCT03178721: Regulatory BCells in Systemic Lupus Erythematosus
Official title: Regulatory BCells in Systemic Lupus Erythematosus and Its Relation to Atherosclerosis and Disease Activity
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Systemic Lupus Erythematosus
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-06-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: adult patients with systemic lupus erythematosus

Brief summary: Systemic lupus erythematosus , the archetypal multisystem autoimmune disease, presents many diagnostic and management challenges. One such challenge is the excess cardiovascular disease observed in patients with Systemic lupus erythematosus . Coronary heart disease and other manifestations of atherosclerosis continue to be a major cause of death in patients with Systemic lupus erythematosus.Regulatory B-cells have been identified as a negative regulator of the immune system that inhibit pathological immune response by suppressing both uncontrolled protective immune response and damaging autoimmune responses

Detailed description: Regulatory B cells have been identified as an IL10 producing B cells subsets that are characterized by the expression of CD19 CD24hiCD38hi . Breg cells can inhibit inflammatory responses in autoimmune disease, like Systemic lupus erythematosus, via the production of IL-10 (an antiatherogenic cytokine) which will suppress TNF- α production by monocytes leading to inhibition of T cell-mediated inflammation. Regulatory B have a vital role in immune tolerance and their deficiency resulted in exacerbation of autoimmunity . Evidence suggests Breg in autoimmune disease may be dysfunctional .

In this proposal, We suggest IL-10 production by Breg confers an atheroprotective role. In Systemic lupus erythematosus, Regulatory B ability to control atherosclerosis is reduced therefore, we will test the hypothesis that Regulatory B play an important role in both autoimmunity and accelerated atherosclerosis and dysfunction in Regulatory B from autoimmune disease may or may not result in a reduced ability to control atherosclerosis .

Eligibility criteria: Inclusion Criteria:

* Clinical and laboratory Diagnosis of Systemic Lupus disease.
* Must be adult.

Exclusion Criteria:

* Patients with clinical atherosclerotic vascular disease
* pregnancy.

Primary outcomes:
measure: Coronary calcium scoring
timeFrame: 1year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00903721: Nasonex® Nasal Suspension 50 μg Long-term Designated Drug Use Investigation (Study P05876)
Official title: Nasonex® Nasal Suspension 50 μg Long-term Designated Drug Use Investigation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergic Rhinitis
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2009-05-18
Enrollment: 3806
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Japanese patients with perennial allergic rhinitis and/or seasonal allergic rhinitis

Brief summary: The investigation will be conducted to define safety and efficacy under the conditions of post-marketing use of this drug in subjects with allergic rhinitis.

Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.


Eligibility criteria: Inclusion Criteria:

* Patients who are treated with Nasonex for perennial or seasonal allergic rhinitis.

Exclusion Criteria:

* Patients with an infection for which there is no effective antimicrobial drug or systemic fungal infection \[symptoms may exacerbate\]
* Patients with a history of hypersensitivity to any ingredient of this drug

Primary outcomes:
measure: Estimate the incidence of Adverse Drug Reactions (ADRs)
timeFrame: After 6 months of observation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02478021: Effects of Hydrocortisone on Social Cognition and Memory
Official title: Effekte Von Hydrocortison Auf Soziale Kognition Und Gedächtnis Unter Berücksichtigung Von Geschlechtereffekten
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Individuality
Keywords: effects of cortisol on cognition
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2015-06-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The effects of hydrocortisone on cognition will be investigated.

Detailed description: 80 healthy young individuals (40 females and 40 male) will be recruited an randomized to either placebo or 10 mg hydrocortisone before testing. Tasks will on emotion recognition, memory and cognitive flexibilty will be conducted.

Eligibility criteria: Inclusion Criteria:

* age 18 - 30
* medication free

Exclusion Criteria:

* any medication
* severe ilness

Primary outcomes:
measure: social cognition
timeFrame: 25 min
Secondary outcomes:
measure: memory
timeFrame: 25 min
measure: cognitive flexibilty
timeFrame: 10 min
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite University
Study officials:
affiliation: Charite University
name: Katja Wingenfeld
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01005121: Colchicine for Diabetic Nephropathy
Official title: Colchicine for Diabetic Nephropathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Diabetic Nephropathy
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-10-30
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with diabetic nephropathy and proteinuria, despite maximal anti- hypertensive and anti-glucose treatment, will receive colchicine for six months, 2 mg a day, during which their 24 hour urine protein and renal function tests will be monitored. The investigators' hypothesis is that colchicine will diminish proteinuria and might also help slow down the development of end stage renal failure in the long run.


Eligibility criteria: Inclusion Criteria:

1. Patients with DM aging 18+, able to sign an informed consent.
2. 24 hour protein collection between 0.5-6 mg during the last 6 months prior enrollment.
3. Hemoglobin A1c in the range of 6-9%, stable for the last year (0.5±)
4. Creatinine lower than 1.5 mg/dL.
5. Blood pressure lower than 150/90 mmHg on stable anti-hypertensive treatment for at least 3 months.
6. Treated with ACE \& ARB, unless contraindicated

Exclusion criteria:

1. Malignancy or significant heart, lung or liver disease.
2. Any GI disease, IBD, malnutrition ( BMI under 18 )
3. Psychiatric disease
4. Any muscle disease, history of rhabdomyelysis, myopathy or myositis.
5. Any disease causing renal injury/proteinuria apart from DM
6. Any inflammatory or autoimmune disease
7. Any infection during the last month.
8. Use of potentially nephrotoxic drugs.
9. Woman in child bearing age that do not use at least one contraceptive device.
10. Pregnant or lactating woman.
11. Participation in another study during the last 3 months.
12. Alcohol or drug abusers
13. Anyone whom the investigators conclude are not appropriate
14. Any patient receiving steroids.
15. Any patient with Colchicine allergy, or treated with the drug during the last two weeks.

Primary outcomes:
measure: 24 hr urine protein collection
timeFrame: every 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat gan
country: Israel
facility: Sheba medical center, Tel hashomer
Study officials:
References:
Clinical trial NCT06539221: Sphingolipids in Asthma Pathogenesis
Official title: Sphingomyelin in Asthma Pathogenesis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Asthma
Keywords: asthma
Th17
T-cell senescence
Sphingolipids
ceramide
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with asthma who visited or were hospitalized in the Department of Respiratory and Critical Care Medicine of Peking University Third Hospital, who met the asthma diagnostic criteria proposed in the Bronchial Asthma Prevention and Treatment Guidelines and healthy controls without history or symptoms of chronic respiratory disease, allergic status or other conditions that could affect the outcome.

Brief summary: The study aims to investigate the relationship between the small molecule metabolite sphingolipids and asthma clinical features and explore its involvement in asthma pathogenesis.


Eligibility criteria: Inclusion Criteria:

* 1. clinical diagnosis of asthma

Exclusion Criteria:

* 1. Combined with chronic obstructive pulmonary disease, bronchiectasis, pneumonia, obstructive sleep apnea hypopnea syndrome, malignant tumor 2. Combined with acute and chronic respiratory failure 3. Combined with severe cardiovascular disease 4. Pregnant woman.

Primary outcomes:
measure: lipidomics
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking university third hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Chun Chang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01037621: Herpes Simplex Type 2 Co-infection in Veterans With Chronic Hepatitis C
Official title: The Interaction of HSV-2 Co-infection in Veterans With Chronic Hepatitis C: the Effect of Valacyclovir on HCV Viral Load
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Hepatitis C Virus Infection
Infection
Herpesvirus 2, Human
Keywords: Herpes simplex type 2
Hepatitis C virus
Valacyclovir
Herpes Simplex virus type 2 infection
Lead sponsor: G.V. (Sonny) Montgomery VA Medical Center
Sponsor class: FED
First posted: 2009-12-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is to determine the safety of valacyclovir in persons with chronic hepatitis C and herpes simplex type 2 infection. Participants will be randomized to valacyclovir or matching placebo. After receiving the initial therapy for eight weeks, the participants will cross over to the alternate therapy for an additional eight weeks. Each treatment period will be separated by a two-week period of daily placebo. The hypothesis is that treatment with valacyclovir will result in a significant reduction in serum levels of hepatitis C virus ribonucleic acid.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of hepatitis C infection
* Clinical diagnosis of herpes simplex type 2 infection

Exclusion Criteria:

* HIV infection
* Other forms of chronic liver disease
* Chronic medical conditions
* On immunosuppressive medications

Primary outcomes:
measure: The number of study participants who experience adverse events while receiving valacyclovir.
timeFrame: 18 weeks
Secondary outcomes:
measure: The effect of valacyclovir compared with placebo to serum levels of HCV RNA
timeFrame: 18
Other outcomes:
Locations:
city: Jackson
country: United States
facility: G.V. Sonny Montgomery VA Medical Center
state: Mississippi
Study officials:
affiliation: G.V. (Sonny) Montgomery VA Medical Center
name: Mary Jane Burton, M.D.
role: PRINCIPAL_INVESTIGATOR
References: