louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05925543: Outcome of Kasai Portoenterostomy in Biliary Atresia in Upper Egypt
Official title: Outcome of Kasai Portoenterostomy in Biliary Atresia in Upper Egypt
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Biliary Atresia
Keywords: Cholestasis
Neonate jaundice
Cholangitis
Short-term outcome
Survival with the native liver
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2023-06-29
Enrollment: 45
Sex: ALL
Minimum age (years): 4
Maximum age (years): 19
Standard ages: CHILD
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all neonates diagnosed with biliary atresia in the previous period (2019) and managed by Kasai portoenterostomy.

Brief summary: Kasai portoenterostomy is the key standard operation for biliary atresia. The aim of the study is to evaluate the short-term outcome of Kasai portoenterostomy for biliary atresia infants in Upper Egypt.

Detailed description: It is a cross-sectional retrospective multicenter study from Upper Egypt. The data will collected from the medical records of three university hospitals in Upper Egypt from January 2019 to December 2019.

Inclusion and exclusion criteria

Inclusion criteria included all neonates diagnosed with biliary atresia in the previous period and managed by Kasai portoenterostomy.

Exclusion criteria were neonates without a confirmed diagnosis of biliary atresia.

Eligibility criteria: Inclusion Criteria:

* all neonates diagnosed with biliary atresia in the previous period and managed by Kasai portoenterostomy.

Exclusion Criteria:

* Exclusion criteria were neonates without a confirmed diagnosis of biliary atresia.

Primary outcomes:
measure: the rate of jaundice clearance
timeFrame: from 3 months up to one year
Secondary outcomes:
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan university Hospital
state: Aswan Governorate
Study officials:
affiliation: Aswan University Hospital
name: Sarah Abdelmohsen, Md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02228343: A Prospective Trial of Ayurveda for Coronary Artery Disease
Official title: A Prospective Trial of Ayurveda for Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2014-08-29
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Can Ayurvedic therapy improve markers of cardiovascular health and cardiovascular risk factors in patients with coronary artery disease.

Detailed description: Patients with established coronary artery disease will be treated with 90 days of Ayurvedic therapy to include yoga, meditation, breathing exercises,and herbs. Arterial stiffness, weight, BMI, BP, medications, cholesterol, LDL, HDL, triglyceride, HS-CRP will be measured at baseline and after 90 days of therapy.

Eligibility criteria: Inclusion Criteria:

* stable coronary artery disease (prior mi, coronary angioplasty or stent, coronary bypass surgery)

Exclusion Criteria:

* age \< 18 years
* life expectancy \< 6 months
* pregnancy or breast feeding
* unwilling or unable to complete 90 days of therapy
* already receiving/taking Ayurvedic therapy
* unable to converse in or understand English language

Primary outcomes:
measure: Participants With Arterial Stiffness Were Measured as Pulse Wave Velocity Meters/Second
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico Medical Group McMahon Cardiology
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Robert J DuBroff, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02435043: A Trial of Nature-based Post-stroke Fatigue Rehabilitation (NASTRU)
Official title: A Randomized Controlled Trial of Nature-based Post-stroke Fatigue Rehabilitation (NASTRU)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Lund University
name: Swedish University of Agricultural Sciences
name: Epidemiology and Register Centre South
First posted: 2015-05-06
Enrollment: 101
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of NASTRU was to examine whether ten weeks of nature-based rehabilitation, as add-on to standard management, could influence post-stroke fatigue (primary outcome), depression, work ability or functional outcome (secondary outcomes), compared to controls.

Detailed description: Patients randomized to the intervention undergo a rehabilitation program in groups up to 8 patients in an especially designed garden at the Swedish University of Agricultural Sciences, Alnarp. The intervention is grounded in environmental psychology and occupational therapy, supported by a multimodal rehabilitation team that utilizes the garden/nature for sensory stimulation, body awareness, meaningful occupations and nature experiences.

The enrollment of 101 patients (51 intervention; 50 control) was completed on August 2014. Follow-up is on-going, with assessments by examiner blinded to treatment group, at end of intervention period, 8 months, and 14 months after randomization. A parallel study with qualitative in-depth interviews in a subset of patients, who were randomized to the intervention group, as well as the staff, is also ongoing.

Eligibility criteria: Inclusion Criteria:

* Ischemic or haemorrhagic stroke
* First ever or recurrence, about 3 months (group 1) or more than one year prior to screening (group 2)
* Age: 55-80 years

Exclusion criteria:

* Dementia
* Severe communication disorder that made it difficult to participate and/or serious illnesses besides stroke (for example, serious cancer disease)

Primary outcomes:
measure: Post stroke fatigue
timeFrame: 8 months after inclusion
measure: Occupational value of everyday occupation
timeFrame: 8 months after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Skåne university hospital
Study officials:
affiliation: Skane University Hospital
name: Hélène Pessah-Rasmussen, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03901443: Survey on Itch in Outpatients of a University Clinic
Official title: Survey on Itch in Outpatients of a University Clinic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Itch
Keywords: itchy skin diseases
itch treatments
pruriception
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2019-04-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All outpatients of the dermatologic university clinic suffering from itch are eligible to participate in the study (from December 2015 until the end of April 2016).

Brief summary: This study is to investigate the pruriception (i.e. the perception of the character and intensity of itch), the impact of itch on quality of life, the response to itch and the subjective efficacy and preferences of the different treatment options among patients with different skin diseases. Better insights into these aspects might help to optimize itch treatment in clinical Settings.


Eligibility criteria: Inclusion Criteria:

* outpatients suffering from itch

Exclusion Criteria:

* outpatients (suffering from itch) not willing or able to participate

Primary outcomes:
measure: itch intensity
timeFrame: single time point assessment at baseline
measure: itch perception
timeFrame: single time point assessment at baseline
measure: impact of itch on quality of life
timeFrame: single time point assessment at baseline
measure: quality of sleep
timeFrame: single time point assessment at baseline
measure: days missing at work
timeFrame: single time point assessment at baseline
measure: helpfulness of common itch therapies
timeFrame: single time point assessment at baseline
measure: preferred treatment options
timeFrame: single time point assessment at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Dermatology, University Hospital Basel
Study officials:
affiliation: Department of Dermatology, University Hospital Basel
name: Simon Müller, Dr. med
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05068843: Arthroscopic Partial Meniscectomy Versus Exercise Therapy for Meniscal Injuries in Older Patients, a 5 Year Follow up.
Official title: Arthroscopic Partial Meniscectomy Versus Physical Therapy for Patients Over 45 Years With a Meniscal Tears: 5-year Follow-up of the ESCAPE Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meniscus Tear, Tibial
Osteoarthritis, Knee
Lead sponsor: Onze Lieve Vrouwe Gasthuis
Sponsor class: OTHER
First posted: 2021-10-06
Enrollment: 321
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Arthroscopic partial meniscectomie (APM) offers little short-term to medium-term benefit above sham surgery or non-surgical management for knee function in most patients with a symptomatic degenerative meniscus tear. It is suggested that APM is associated with increased risk of accelerated progression of knee osteoarthritis in middle-aged to older patients.

With the 5 year follow-up of the ESCAPE trial we will investigate the longterm results of APM and physical therapy in patients with a meniscal tear over 45 years old.


Eligibility criteria: Inclusion Criteria:

* 45 to 70 years old MRI confirmed, non-obstructive and symptomatic meniscal tear

Exclusion Criteria:

* Knee locking or trauma leading to acute surgery;

  ▸ Associated injuries on the index knee consisting of:
* Symptomatic partial or total tear of the anterior cruciate ligament (ACL),
* Posterior cruciate ligament tear,
* OA of the knee, grade 4 on the Kellgren and Lawrence Grading Scale,
* An injury to the lateral or posterolateral ligament complex with significant laxity;

  * Previous knee surgery on the index knee (with the exception of diagnostic arthroscopy);
  * Tumour that is suspected of malignancy, detectable on MRI;
  * Obesity with a body mass index \>35;
  * American Society of Anesthesiologists (ASA) class 4 or 5 patients;
  * General disease that effects physical function or systemic medication/abuse of steroids;
  * Any other medical condition or treatment interfering with the completion or assessment of the trial, for example, contraindications to MRI or surgery;
  * Drugs or alcohol abuse;
  * Patients unable to fill out the Dutch questionnaires.

Primary outcomes:
measure: Knee Documentation Committee Subjective Knee Form (IKDC) questionnaire
timeFrame: 60 months
Secondary outcomes:
measure: Radiographic Knee osteoarthritis
timeFrame: 60 months
measure: Symptomatic knee osteoarthritis (OA)
timeFrame: 60 months
measure: Patient reported knee pain during weight bearing
timeFrame: 60 months
measure: Patient reported quality of life
timeFrame: 60 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03265743: HPV Vaccination in Women With Cystic Fibrosis
Official title: HPV (Papilloma Human Virus) Vaccination in Young Women With Cystic Fibrosis and Followed in the Auvergne Rhône-Alpes Region
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Papillomavirus Infection
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-08-29
Enrollment: 74
Sex: FEMALE
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study is intended for girls with Cystic Fibrosis, followed in a pediatric or mixed Cystic Fibrosis center of the region Auvergne Rhône Alpes (AuRA), aged 11 years or older.

Brief summary: The main risk factor for the development of cervical lesions is human papillomavirus (HPV) infection. Vaccination against human papillomavirus, which is offered to all girls aged 11 to 14, and catching up to girls aged 15 to 19, is an effective method of preventing cervical pathology. Despite this, human papillomavirus vaccination coverage remains low in France.

Some women with cystic fibrosis might need a transplantation, which is a factor associated with increased risk of human papillomavirus carriage and cervical pathology. An over-risk of cervical pathology would also be present in non-transplanted women with cystic fibrosis. Particular attention should therefore be paid to vaccination in this population.

The objective is to estimate the frequency of human papillomavirus vaccination in young patients with cystic fibrosis, and to evaluate the reasons for non-vaccination.


Eligibility criteria: Inclusion Criteria:

* girls with Cystic Fibrosis
* followed in a pediatric or mixed Cystic Fibrosis center of the region Auvergne Rhône Alpes (AuRA)
* aged 11 years or older

Exclusion Criteria:

- Refusal to respond to the questionnaire

Primary outcomes:
measure: Realization of human papillomavirus vaccination
timeFrame: 15 minutes
Secondary outcomes:
measure: Type of vaccine used
timeFrame: 15 minutes
measure: Respect for the vaccinal plan
timeFrame: 15 minutes
measure: Reasons for non-vaccination
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Nouvel Hôpital d'Estaing CRCM Mixte
city: Grenoble
country: France
facility: CHU Grenoble
city: Pierre-Bénite
country: France
facility: Cystic Fibrosis Reference Center, Hospices Civils de Lyon
Study officials:
References:
Clinical trial NCT05857943: Efficacy and Safety of AEYE-DS Software Device for Automated Detection of Diabetic Retinopathy From Digital Funduscopic Images
Official title: Prospective Clinical Trial to Demonstrate the Efficacy and Safety if AEYE-DS Software Device for Automated Detection of Diabetic Retinopathy From Digital Funduscopic Images Obtained With a Funduscopic Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Diabetic Retinopathy
Lead sponsor: AEYE Health Inc
Sponsor class: INDUSTRY
First posted: 2023-05-15
Enrollment: 363
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: AEYE-DS is a software device developed to increase compliance with diabetic retinopathy screening by automatically detecting more-than-mild diabetic retinopathy from digital funduscopic images using AI-based software. This study has been designed to validate the safety and efficacy of the device at primary care and other point of care sites.


Eligibility criteria: Inclusion Criteria:

1. Age ≥22
2. Male or female
3. Documented diagnosis of diabetes mellitus, meeting the criteria established by the American Diabetes Association (ADA) and World Health Organization (WHO):
4. Understand the study and volunteer to sign the informed consent

Exclusion Criteria:

1. Uncorrectable vision loss (e.g., with the use of eyeglasses), blurred vision, or floaters.
2. Diagnosed with macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion.
3. Previously diagnosed with Diabetic Retinopathy.
4. History of laser treatment of the retina or injections into either eye, or any history of retinal surgery.
5. Currently participating in another investigational eye study and actively receiving investigational product for DR or DME.
6. Participant has a condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure or glycemic control, microphthalmia or previous enucleation).
7. Participant is contraindicated for imaging by fundus imaging systems used in the study:

   1. Participant is hypersensitive to light
   2. Participant recently underwent photodynamic therapy (PDT)
   3. Participant is taking medication that causes photosensitivity
   4. Participant has a history of angle-closure glaucoma or narrow anterior chamber angles
8. Subject is pregnant.

Primary outcomes:
measure: Sensitivity and Specificity
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Karas Health Care
state: Arkansas
city: Orlando
country: United States
facility: Lake Nona Research
state: Florida
city: Jackson
country: United States
facility: The Jackson Clinic
state: Tennessee
Study officials:
References:
Clinical trial NCT02084043: In Vitro Assessment of a Breath-synchronized Vibrating Mesh Nebulizer During Non Invasive Ventilation
Official title: In Vitro Comparison of Continuous and Breath-synchronized Vibrating Mesh Nebulizer During Non Invasive Ventilation: Analysis of Inhaled and Lost Doses.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Diseases
Lung Diseases
Cystic Fibrosis
COPD
Asthma
Keywords: aerosol delivery
vibrating mesh nebulizer
breath-actuated nebulizer
non invasive ventilation
bilevel ventilator
single limb circuit ventilator
Amikacin
Lead sponsor: University Hospital St Luc, Brussels
Sponsor class: OTHER
Collaborators: name: Université Catholique de Louvain
name: University of Applied Sciences of Western Switzerland
name: School of Gestion and Engineering Vaud, Switzerland
First posted: 2014-03-11
Enrollment: 3
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Using an adult lung bench model of non invasive ventilation, the aim of the study is to compare an experimental system of breath-synchronized vibrating mesh nebulizer to a conventional vibrating mesh nebulizer during non invasive ventilation in terms of inhaled and lost doses.


Eligibility criteria: Inclusion Criteria:

* Not applicable (in vitro study)

Exclusion Criteria:

* hypersensitivity (allergic) reactions to aminoglycosides

Primary outcomes:
measure: Inhaled dose
timeFrame: after 24 hours
Secondary outcomes:
measure: Expiratory wasted dose
timeFrame: after 24 hours
Other outcomes:
measure: Estimated lost dose
timeFrame: after 24 hours
Locations:
city: Brussels
country: Belgium
facility: University Hospital St Luc
Study officials:
affiliation: University of Health Sciences (HESAV)
name: Jean-Bernard Michotte, PhD student
role: PRINCIPAL_INVESTIGATOR
affiliation: Cliniques universitaires Saint-Luc, service des soins intensifs
name: Jonathan Dugernier, PhD student
role: PRINCIPAL_INVESTIGATOR
affiliation: School of Gestion and Engineering Vaud (HEIG-VD)
name: Enrico Staderini, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: School of Gestion and Engineering Vaud (HEIG-VD)
name: Rares Rusu, MSc
role: STUDY_CHAIR
affiliation: Cliniques universitaires Saint-Luc, service des soins intensifs
name: Jean Roeseler, PhD
role: STUDY_CHAIR
affiliation: Cliniques universitaires Saint-Luc, service de pneumologie
name: Giuseppe Liistro, MD PhD
role: STUDY_CHAIR
affiliation: Cliniques universitaires Saint-Luc, service de pneumologie
name: Gregory Reychler, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05743543: A Pilot Study of SPG Block for PTSD
Official title: A Feasibility Study of a Sphenopalatine Ganglion (SPG) Block for Post Traumatic Stress Disorder (PTSD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Post Traumatic Stress Disorder
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2023-02-24
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Some patients with Post Traumatic Stress Disorder (PTSD) respond only partially to medication. This study is a pilot study investigating whether blocking the SPG helps reduce the symptoms of PTSD. This study does not involve treatment with medications. It is a proof of principal study.

Detailed description: The sphenopalatine ganglion (SPG) is a collection of neurons involved in autonomic regulation (which refers to bodily processes that are automatic like heart rate and blood pressure). Blocking the SPG is used to treat disorders, such as migraines or cluster headaches (short, severe headaches that occur together). The procedure will be performed by a doctor who specializes in ear, nose throat surgery. The block consists of the injection of a numbing agent (similar to the type used by dentists) to the SPG. After the SPG block, we will follow patients for 8 weeks to see how they feel.

Eligibility criteria: Inclusion Criteria:

* Participants with a principal diagnosis of PTSD on stable dose of psychiatric medication or in stable psychotherapy for at least 3 months, who experience residual symptoms.
* Participants who understand all study procedures and can undergo informed consent

Exclusion Criteria:

* Participants with a medical disorder, for whom study participation could be deleterious (neurologic, cardiac, renal or infectious disease)
* Pregnant or breast feeding participants
* Participants who are on an anticoagulant, such as warfarin, or otherwise have a medical condition that increases bleeding risk

Primary outcomes:
measure: feasibility: number of participants completing the 8-week study
timeFrame: 8 weeks
measure: tolerability: number of adverse events
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYSPI
state: New York
Study officials:
References: