louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01928901: Trial With Bronchipret and Sinupret to Evaluate Acceleration of Mucociliary Clearance (MCC)
Official title: Randomized, Placebo-controlled, Double-blind, Cross-over Trial With Bronchipret and Sinupret to Evaluate Acceleration of Mucociliary Clearance (MCC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Current Smokers
Lead sponsor: Bionorica SE
Sponsor class: INDUSTRY
First posted: 2013-08-27
Enrollment: 56
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Proof of concept: Superiority of Bronchipret or Sinupret to placebo in respect to mucociliary clearance


Eligibility criteria: Inclusion Criteria:

1. Volunteers who have given their signed declaration of consent and have signed the data protection declaration
2. Male or female volunteers 25 - 40 years
3. Current smokers (5-20 cigarettes per day since 5 years at least)
4. Ability to taste sweetness of saccharin
5. Perception of sweetness within 30 minutes after placement of saccharin behind nasal valve

Exclusion Criteria:

1. Ciliary dyskinesia
2. Cystic fibrosis
3. COPD/emphysema
4. Asthma
5. Chronic rhinosinusitis
6. Acute respiratory tract infection within the last 6 weeks prior to enrolment
7. Septal or sinus surgery
8. Symptomatic allergic rhinitis
9. Known allergic rhinitis
10. Treatment with not-permitted previous or concomitant therapy
11. History of snuff consumption for longer than 1 month or intranasal consumption of recreational drugs such as cocaine or heroin for longer than 1 month
12. Any disease or condition that might affect the safety of the subject during the trial, according to the investigator's judgement

Primary outcomes:
measure: Time to perception of sweetness
timeFrame: after 7 days of treatment
Secondary outcomes:
measure: Perception of Sweetness of Saccharin
timeFrame: 4 - 7 weeks
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Claus Bachert, Prof.Dr.Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT05849701: Shock Wave Versus Vacuum Assisted Closure on Chronic Diabetic Foot Ulcer
Official title: Shock Wave Versus Vacuum-assisted Closure on Chronic Diabetic Foot Ulcer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Diabetic Foot Ulcer
Keywords: Shock wave therapy
vacuum-assisted closure
Chronic diabetic foot ulcer
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Kafrelsheikh University
First posted: 2023-05-09
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: This study will be a randomized, open-label, pretest post-test with two study groups.

Detailed description: The randomization procedure will be performed by a simple drawing of lots (A or B) which determined whether participants would receive Shock wave therapy ( group A) or vacuum-assisted closure therapy (group B). Patients in both groups will receive the same medical treatment and nursing care.

Eligibility criteria: Inclusion Criteria:

All patients had chronic diabetic foot ulcers that did not heal within six weeks of the incidence.

Exclusion Criteria:

Patients with acute cellulitis, osteomyelitis, or gangrene anywhere in the affected extremity.

Patients with renal, hepatic, neurological, or malignant diseases.

Patients with severe protein malnutrition (serum albumin \< 2.0 g/dl) or severe anemia (Hgb \< 7.0 g/dl).

Patients with an ankle-brachial index \< 0.7, absence of the dorsalis pedis or posterior tibial artery pulse.

Patients who had debridement; pregnancy.

Patients who refused to join the study, or to sign the written consent.

Primary outcomes:
measure: Wound surface area
timeFrame: change from baseline and after six weeks of intervention.
measure: Wound volume
timeFrame: change from baseline and after six weeks of intervention.
Secondary outcomes:
measure: Wound surface area
timeFrame: change from baseline and after two weeks of intervention.
measure: Wound surface area
timeFrame: change from baseline and after four weeks of intervention.
measure: Wound volume
timeFrame: change from baseline and after two weeks of intervention.
measure: Wound volume
timeFrame: change from baseline and after four weeks of intervention.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Shaimaa Mohamed Ahmed El Sayeh
Study officials:
affiliation: Lecturer at Faculty of Physical Therapy, Cairo University
name: Shaimaa MA El Sayeh, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistant Professor at Faculty of Physical Therapy, Cairo University
name: Nesrein A Abdel Rashed, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistant Professor at Faculty of Physical Therapy, Cairo University
name: Hamada A Hamada, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06358001: EchoTip AcuCore Post-Market Clinical Study
Official title: EchoTip AcuCore Post-Market Clinical Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Adenocarcinoma
Neuroendocrine Tumors
Hepatocellular Carcinoma
Cholangiocarcinoma
Malignant Lymphoma
Metastasis
Chronic Pancreatitis
Autoimmune Pancreatitis
Keywords: Fine needle biopsy (FNB)
Core biopsy
Endoscopic ultrasonography-guided fine-needle biopsy (EUS-FNB)
Tissue Diagnosis
Histology
Endoscopic ultrasound
Interventional EUS
Pancreas
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2024-04-10
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients referred for a EUS-FNB procedure will be considered for enrollment

Brief summary: The purpose of collecting this data is to continue to learn more about the EchoTip AcuCore and the device's ability to produce the desired favorable effect and if there are any undesired outcomes that may be related to the EchoTip AcuCore.


Eligibility criteria: Inclusion Criteria:

* Patient has been referred for an endoscopic ultrasound (EUS) fine needle biopsy procedure
* The EchoTip AcuCore device is the first EUS biopsy needle used in the procedure.

Exclusion Criteria:

* Patient's age is less than 18 years
* Patient is unable or unwilling to sign and date the informed consent. If IRB approves a waiver of consent, this exclusion criterion is not applicable.
* Patient is simultaneously participating in another pre-market investigational drug or pre-market investigational device study involving an EUS fine needle biopsy procedure and for which the patient has not completed the follow-up phase for the primary endpoint at least 30 days prior to enrollment in this study.
* Inaccessible or unsuitable lesion (lesion not visualized or a large vessel, duct or primary mass interposition)

Primary outcomes:
measure: Technical Success
timeFrame: Duration of the procedure (approx. 1 hr)
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California, Irvine
state: California
city: Denver
country: United States
facility: Advent Health, Porter
state: Colorado
city: Gainesville
country: United States
facility: Shands Hospital-University of Florida
state: Florida
city: Gainesville
country: United States
facility: University of Florida Shands Hospital
state: Florida
city: Orlando
country: United States
facility: Advent Health Medical Group, Orlando
state: Florida
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Houston
country: United States
facility: University of Texas Memorial Hermann Hospital
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
References:
Clinical trial NCT03975101: Very Small Embryonic-like Stem Cells for Knee Osteoarthritis
Official title: Autologous Very Small Embryonic-like Stem Cells(VSELs) for Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Stem Cell Transplant Complications
Knee Osteoarthritis
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
Collaborators: name: Guangzhou Four-Leaf Clover HealthTech Co., Ltd.
First posted: 2019-06-05
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three experimental groups were injected with different doses of VSEL, and the control group was injected with platelet-containing serum that dissolved VSEL.
Primary purpose: TREATMENT

Brief summary: The aim of this study is the safety and efficacy of autologous very small embryonic-like stem cells(VSELs) to knee osteoarthritis.

Detailed description: VSELs come from the patient's peripheral blood, and will be injected in the most painful knee, or the worse knee on physical examination. Then follow-up the knee pain and imaging changes at 6 months and 1 year after treatment.

Eligibility criteria: Inclusion Criteria:

* Patients had moderate to severe osteoarthritis of both knees.
* Those had mechanical pain of knee joints, which was aggravated by walking or stair climbing.
* Those complained of gelling pain of knee joint.
* Those have crepitus and limitation of the joint range of motion with joint bony hypertrophy on physical examination, X-rays showed narrowing of joint space and osteophyte formation

Exclusion Criteria:

* Diabetic foot and patients with obvious edema in the legs caused by various causes
* Blood disease patients, thrombocytopenia or dysfunction, hypofibrinemia or anticoagulant therapy, long-term use of aspirin

Primary outcomes:
measure: Change of knee pain score
timeFrame: 2-4 weeks after injection
Secondary outcomes:
measure: Change of knee pain score
timeFrame: 6 months after injection
measure: Imaging changes in the knee joint
timeFrame: 6 months after injection
measure: Change of knee pain score
timeFrame: 12 months after injection
measure: Imaging changes in the knee joint
timeFrame: 12 months after injection
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Biological treatment center in Fuda cancer hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT05125601: PEACH Questionnaire Study
Official title: Hearing Quality of Life of Children With Hearing Aids: Study Based on the PEACH Questionnaire
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deafness
Keywords: Deafness in children
The Parents' Evaluation of Aural/Oral Performance of Children (PEACH) in french
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-11-18
Enrollment: 130
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients followed by the Pediatric ENT department of Necker-Enfants Malades hospital.

Brief summary: There are few or no questionnaires in French on the hearing quality of life of children with hearing aids.

The objectives of the study are to measure the hearing quality of life of children with hearing aid and / or cochlear implants and to compare the hearing quality of life according to the type of hearing aid (hearing aid and / or cochlear implant).

Detailed description: There are few or no questionnaires in French on the hearing quality of life of children with hearing aids.

The study will allow an evaluation of the quality of life benefit of hearing rehabilitation at different ages and with varying levels of deafness.

The translated questionnaire for the study will be given to the parents of the child after a sure diagnosis of the child's degree of deafness and at least 1 month of hearing aids. The translated is proposed by Necker Hospital Pediatric ENT department.

The objectives of the study are to measure the hearing quality of life of children with hearing aid and / or cochlear implants and to compare the hearing quality of life according to the type of hearing aid (hearing aid and / or cochlear implant).

Eligibility criteria: Inclusion Criteria:

* Minors aged 2 to 10 years (inclusive)
* Patients followed in consultation at Necker Hospital in the Pediatric ENT department
* With a slight to deep bilateral deafness
* Auditory experience with hearing aid and / or cochlear implant bilateral for more than 1 month
* holders of parental authority not opposed to participation in the study

Exclusion Criteria:

* Non-wearing of hearing aid and / or implant over the last month
* malfunction of hearing aids and / or implant
* Non-understanding of the French language by parents

Primary outcomes:
measure: Hearing quality of life
timeFrame: Day 0
Secondary outcomes:
measure: Difference of score to the Peach questionnaire according to the type of hearing aids
timeFrame: Day 0
measure: Difference of score to the Peach questionnaire according to the type of deafness
timeFrame: Day 0
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Natalie LOUNDON, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Tabatha DERAY, Hearing Care Professional
role: STUDY_DIRECTOR
References:
Clinical trial NCT06918301: Comparison of Cardiac Index and Stroke-volume-index Measured by Pulmonary Artery Catheter, FloTrac® and Argos® in Cardiac Surgery Patients.
Official title: Comparison of Cardiac Index and Stroke-volume-index Measured by Pulmonary Artery Catheter, FloTrac® and Argos® in Cardiac Surgery Patients.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Failure Acute
Hemodynamic Monitoring
Lead sponsor: Karlsburg Hospital
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients after cardiac surgery requirering a pulmonary artery catheter

Brief summary: A comparison of cardiac performance determined by stroke-volume-index measured by different mechanisms in patients during and after cardiac surgery:

1. Pulmonary artery catheter
2. Flo Trac
3. Argos Monitor Investigations will be done in theater and on ICU in ventilated and spontaneously breathing patients.


Eligibility criteria: Inclusion Criteria:

* Patient after cardiac surgery with pulmonary artery catheter

Exclusion Criteria:

* Hemodynamic instability, no consent

Primary outcomes:
measure: stroke volume index
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Karlsburg
country: Germany
facility: Klinik für Anästhesiologie und Intensivmedizin, Klinikum Karlsburg
Study officials:
affiliation: Head of Department of Anesthesiology and intensive care, Karlsburg Hospital
name: Matthias Heringlake
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05479201: Prevalence of Obstructive Sleep Apnoea (OSA) Among 4-8 Years Old Children in the General Population
Official title: Prevalence of Obstructive Sleep Apnoea (OSA) Among 4-8 Years Old Children in the General Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea (OSA)
Lead sponsor: Akureyri Hospital
Sponsor class: OTHER_GOV
Collaborators: name: MyCardio
First posted: 2022-07-29
Enrollment: 386
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All children in a pre-specified geographical area 4-8 years of age

Brief summary: The purpose of this study is to estimated prevalence of obstructive sleep apnea (OSA) in 4-8 year old children. To date, most studies estimating prevalence of sleep apnea in young children are based on utilizing subjective questionnaires. The few studies that have utilized objective sleep measures have tested only those children suspected of sleep apnea based on subjective questionnaires, finding prevalence in the range of 1-13%. Untreated OSA is associated with significant morbidities in children, affecting their behavior, cognitive development, cardiovascular-and cardio metabolic health, endocrine and immune function. Better understanding of prevalence of sleep apnea in young children should be beneficial. This study will help to understand the prevalence of sleep apnea in each age-group of children 4-8 years of age and whether certain groups, such as children with obesity or asthma have higher prevalence and/or more severe disease.

The primary objective of this study is to get better understanding of prevalence and severity of sleep apnea in young children using objective sleep measures for all participants.

Detailed description: The study is a population-based, observational study of 4-8 year old children located in Akureyri, Iceland. All parents in this geographical area will be invited for their child/children to participate in the study.

Parents of all participating children will be asked to answer questionnaires to assess general health, sleep habits, behavior and quality of life and then measure their sleep for five consecutive nights with a home based sleep test.

Eligibility criteria: Inclusion Criteria:

* Children 4-8-years old

Exclusion Criteria:

* Children with atrial fibrillation or ventricular trigemini

Primary outcomes:
measure: Prevalence of OSA in 4-8 year old children
timeFrame: Baseline
Secondary outcomes:
measure: Prevalence of OSA defined by a specific age range (4-5-year-old/5-6-year-old/6-7-year-old/7-8-year-old)
timeFrame: Baseline
Other outcomes:
measure: Intra-night variability in OSA
timeFrame: Baseline
Locations:
city: Akureyri
country: Iceland
facility: Sjukrahusid a Akureyri
Study officials:
affiliation: University of Iceland
name: Hannes Pedersen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01512901: Efficacy and Safety of Betamethasone Microsphere in Patients With Macular Edema Following Branch Retinal Vein Occlusion (HIKARI)
Official title: A Randomized, Sham Controlled, Multicenter, Double-Masked, Phase 2/3 Study Assessing Efficacy and Safety of Betamethasone Microsphere in Patients With Macular Edema Following Branch Retinal Vein Occlusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Macular Edema Following Branch Retinal Vein Occlusion
Lead sponsor: Santen Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-01-19
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This study will evaluate the efficacy and safety of Betamethasone Microsphere (DE-102) for macular edema following branch retinal vein occlusion


Eligibility criteria: Inclusion Criteria:

* 20 years of age or older
* Diagnosis of macular edema following branch retinal vein occlusion

Exclusion Criteria:

* BCVA ETDRS letter score in non-study eye \< 35
* Known steroid-responder

Primary outcomes:
measure: Change from baseline of Best Corrected Visual Acuity(BCVA) in ETDRS letter score
Secondary outcomes:
measure: Change in retinal thickness from baseline
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Santen study sites
city: Seoul
country: Korea, Republic of
facility: Santen study sites
Study officials:
References:
Clinical trial NCT01421901: Antibiotics Versus Surgery in Acute Appendicitis
Official title: Antibiotics vs.Surgery in Acute Appendicitis;an Intention to Treat Prospective Randomised Study. The ASAA-study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Appendicitis Without Peritonitis
Keywords: Acute appendicitis
Surgery
Antibiotics
comparison surgery and antibiotics
resolutions of symptoms
Lead sponsor: A.O. Ospedale Papa Giovanni XXIII
Sponsor class: OTHER
First posted: 2011-08-23
Enrollment: 218
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: TREATMENT

Brief summary: The acute appendicitis (AA) is a very common disease with a life time risk 7-8% and the highest incidence in the second decades . The aetiology of AA is still poor understood: the commonest hypothesis refers to appendix obstruction followed by impairment of wall appendix barrier and thus wall perforation and/or abscess formation1. However some studies suggest that no-complicate and complicate appendicitis are different entities allowing a different treatment. The study aims to test the no inferiority in terms of efficacy of antibiotic treatment compared to surgery in a population with high probability to suffer of 1st episode of AA.The study aims to test the no inferiority in terms of efficacy of antibiotic treatment compared to surgery in a population with high probability to suffer of 1st episode of AA.


Eligibility criteria: Inclusion Criteria:

* patients between 18 and 65 years old
* first episode of suspected AA diagnosed by Andersson's score or combination with abdominal ultrasound

Exclusion Criteria:

* patients with any potential immunodeficiency status
* assumption of antibiotics for different infectious disease or surgery in the last 30 days
* allergy to antibiotics established in the study protocol
* no acceptance of study protocol
* pregnancy or delivery in the last 6 months
* ASA IV or V, no Italian or English fluently speakers.

Primary outcomes:
measure: the rate of patients free of symptoms into 2 weeks (from operation in the surgery group or from the third Ertapenem administration in the antibiotics group) with no pain, no fever, WBC ≤ 10000, CRP ≤ 1
timeFrame: 2 weeks
Secondary outcomes:
measure: Secondary outcomes will be considered major complications occurring after 2 weeks and into 1 year. Phone consultation will be performed at 1 year
timeFrame: 2 weeks- One year
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: 1St General Surgery Unit Papa Giovanni XXIII Hospital Bergamo
Study officials:
affiliation: Papa Giovanni XXIII Hospital Bergamo
name: Luca Ansaloni
role: STUDY_DIRECTOR
affiliation: Papa Giovanni XXIII Hospital Bergamo
name: Michele Pisano
role: PRINCIPAL_INVESTIGATOR
References: