louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04484688: Prestilol(Perindopril+Bisoprolol) in Therapy of Patients With Atrial Fibrilation
Official title: Perindopril+Bisoprolol in Therapy of Patients With Atrial Fibrilation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patient Participation
Lead sponsor: Aversi Clinic
Sponsor class: OTHER
First posted: 2020-07-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with AF and normal EF

Brief summary: The study aims to evaluate the effectiveness and safety of oral fixed-dose combination of bisoprolol/perindopril in patients with permanent atrial fibrillation


Eligibility criteria: Inclusion Criteria:permanent atrial fibrillation with normal EF -

Exclusion Criteria:AF with decreased EF

-

Primary outcomes:
measure: 12-ecg and echocardiography evaluation after 1 month treatment
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Tbilisi
country: Georgia
facility: Aversi Clinic
city: Tbilisi
country: Georgia
facility: Aversi Clinic
Study officials:
References:
Clinical trial NCT01200888: Controlled Ventilation CT in CF Infants
Official title: Differentiating Outcome Measures in Infants/Young Children With Cystic Fibrosis Utilizing Controlled Ventilation Infant/Young Child Chest CT Scanning and Lung Function Testing
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cystic Fibrosis
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2010-09-14
Enrollment: 1
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young children with cystic fibrosis at Packard Children's Hospital.

Brief summary: The objective of the study is to implement a new method of performing chest CT imaging in young children with cystic fibrosis at Packard Children's Hospital. This technique will be used to evaluate early lung disease comparing quantitative chest CT air trapping and airway measurements with lung function measurements in infants, toddlers, and young children with chronic lung disease.


Eligibility criteria: Inclusion Criteria:

1. Infants and young children (age \~ 2/3 months to \< 5 years)
2. Diagnosed with cystic fibrosis with either 2 identified CFTR gene mutations, or a positive sweat chloride
3. Informed consent by parent or legal guardian.
4. Ability to comply with study visit procedures as judged by the investigator.

Exclusion Criteria:

1. Acute wheezing and/or respiratory distress at either study visit.
2. Acute intercurrent respiratory infection, defined as an increase in cough, wheezing, or respiratory rate with onset in 1 week preceding Study visit.
3. Oxygen saturation \< 90% on room air at study visit.
4. Any medical condition that in the opinion of the investigator precludes subject participation.

Primary outcomes:
measure: Quantitative Air Trapping, A2 & A3
timeFrame: Baseline & F/U
measure: Quantitative CT Airway Measurements (AWT/TAD, LD/TAD, Wall Area %, Lumen Area %
timeFrame: Baseline & F/U
Secondary outcomes:
measure: FEV 0.5 sec
timeFrame: Baseline & F/U
measure: FEF 85%
timeFrame: Baseline & F/U
measure: FEF25-75%
timeFrame: Baseline & F/U
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Terry Earl Robinson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06298188: Risankizumab in Children With Crohn's Disease (RisaKids)
Official title: Risankizumab in Children With Crohn's Disease (RisaKids): A Multi-center PORTO Group Prospective Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Crohn Disease
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2024-03-07
Enrollment: 90
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this observational study is to to prospectively explore the real life short (12 weeks) and longer term (54 weeks) clinical, biochemical and endoscopic outcomes of risankizumab in pediatric CD.

This is a 1-year prospective multi-center cohort study of children commencing on risankizumab for pediatric CD with 2 years extension for long-term follow-up. The investigators will record clinical manifestations, blood markers and fecal calprotectin, with monitoring for safety signals including infusion and injection site reactions, pyrexia and infections at various intervals as outlined below. The investigators will also include calprotectin monitoring and fecal sample collection for microbiome and serum samples for drug levels. According to available budget, the investigators will also collect fecal and serum samples for metabolome. Samples collection is optional, thus failure of bio-samples collection will not exclude patients from the study.


Eligibility criteria: Inclusion Criteria:

* Children under the age of 18 years,
* Patients diagnosed with CD.
* Patients commenced on risankizumab by treating physician (at least one dose), either alone or in combination with any other CD medications, at any stage of the disease.

Exclusion Criteria:

\* There will be no exclusion criteria to this study.

Primary outcomes:
measure: Co-primary outcomes: Complete remission at end of remission (weeks 12 and week 54)
timeFrame: Through study completion, approximately 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
Study officials:
References:
Clinical trial NCT02430688: Irreversible Electroporation(IRE) For Unresectable Extremities Neoplasms
Official title: Irreversible Electroporation(IRE) For Unresectable Extremities Neoplasms: Phase I and Phase II Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Extremities Neoplasms
Keywords: irreversible electroporation
Unresectable Extremities
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
First posted: 2015-04-30
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Extremities Neoplasms.

Detailed description: By enrolling patients with unresectable Extremites Neoplasms adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous IRE for unresectable Extremities Neoplasms.

Eligibility criteria: Inclusion Criteria:

* Extremities Neoplasms diagnosed by positive biopsy or non-invasive criteria,
* Not suitable for surgical resection,
* Eastern Cooperative Oncology Group (ECOG) score of 0-1,
* A prothrombin time ratio \> 50%,
* Platelet count \> 80x10\^9/L,
* Ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure,
* Able to comprehend and willing to sign the written informed consent form (ICF),
* Have a life expectancy of at least 3 months.

Exclusion Criteria:

* Cardiac insufficiency, ongoing coronary artery disease or arrhythmia,
* Any active implanted device (eg Pacemaker),
* Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
* Have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System,
* Are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.

Primary outcomes:
measure: Number of participants with Adverse events
timeFrame: 6 month
Secondary outcomes:
measure: Percentage of lesions that show no sign of recurrence 12 months after IRE
timeFrame: 12 months
measure: A minimum and maximum range of voltage for safe and effective IRE
timeFrame: 3 months
measure: Progress free disease (PFS)
timeFrame: 12 months
measure: Overall survival (OS)
timeFrame: 36 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Biological treatment center in Fuda cancer hospital
state: Guangdong
Study officials:
affiliation: Fuda Cancer Hospital
name: Lizhi Niu, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02880488: Validation of a Questionnaire Assessing Quality of Life in Children With Amblyopia and Strabismus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amblyopia
Strabismus
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-08-26
Enrollment: 294
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients of pediatric ophthalmology will be included in the study. 50 patients will be included in each class of age: 3-4 years old; 5-7 years old; 8-17 years old.

For each class of age, 50 children with strabismus or amblyopa will be included, half of which treated by eye occlusion ; and 50 children with no strabismus nor amblyopia, half of which wearing glasses.

Brief summary: The validation of a French questionnaire is very important to assess rigorously and objectively the impact of the treatments of strabismus and amblyopia on children quality of life.


Eligibility criteria: Inclusion Criteria:

* children with a status of strabismus or not strabismus made by a specialized ophthalmologist
* children with a status of amblyopia or not amblyopia made by a specialized ophthalmologist
* signed consent of parents

Exclusion Criteria:

* ocular pathology (except for isolated ametropia)
* evolutive paralytic strabismus
* antecedent of surgery for strabismus
* strabismus surgery in the past 6 months
* disease with possible impact on the child's answers, such as severe neurologic troubles)
* poor knowledge of French language

Primary outcomes:
measure: validation of the questionnaire
timeFrame: immediate
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild
Study officials:
References:
Clinical trial NCT06441188: Sonography of the Nipple Areolar Complex
Official title: Sonography of the Nipple Areolar Complex (SONAC) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Nipple ultrasound imaging
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The purpose of this study is to determine ultrasound scanning techniques of the nipple areolar complex (NAC) that provide optimal diagnostic imaging features.


Eligibility criteria: Inclusion Criteria:

Female, Age of 18 or older; no breast cancer; no breast symptom.

Exclusion Criteria:

Subjects lacking capacity to consent; vulnerable subjects such as prisoners.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Primary outcomes:
measure: Image quality satisfaction
timeFrame: Baseline
Secondary outcomes:
measure: Ultrasound exam length of time
timeFrame: Baseline
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Christine Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Shigao Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04448288: Time-based Effects of Stretching on Hamstrings Muscle Strength
Official title: Time-based Effects of Stretching on Hamstrings Muscle Strength
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stretch
Keywords: Stretching
Muscle strength
Hamstring Muscles
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2020-06-25
Enrollment: 14
Sex: ALL
Minimum age (years): 24
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Stretching is reported to have detrimental effects on strength and thus avoided prior to strength training session. Do stretching indeed decreases muscle strength? To examine the time course (immediate, 10- and 20-min post stretching) for the effects of 2, 4, and 8 min long duration of static-stretching (SS) on isometric maximum voluntary contraction (MVC) force of hamstring muscles.

Detailed description: OBJECTIVE: To examine the time course (immediate, 10- and 20-min post stretching) for the effects of 2, 4, and 8 min long duration of static-stretching (SS) on isometric maximum voluntary contraction (MVC) force of hamstring muscles.

METHODS: Pretest-posttest experimental design. Total of 14 subjects with mean age 25 years participated in three experimental trials on three different days. On day-I for static-stretching for 2 minutes (SS2), day-II for 4 minutes (SS4), and day-III for 8 minutes (SS8). Testing was conducted before (pre), immediately after (post), and at 10 and 20 min post stretching. MVCF was measured using strain gauze as the main outcome measure.

Eligibility criteria: Inclusion Criteria:

* Subjects used to engage in 1 to 5 hours of physical activity per week. They were not doing stretching exercises regularly.

Exclusion Criteria:

* Subjects having any current injury specific to lower limb joints or current neuromuscular disease were excluded from the study.

Primary outcomes:
measure: Change in Maximum voluntary contraction force (MVCF) before and after stretching
timeFrame: MVCF was measured on 3 different days with each day separated by 3-4 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Saud University
Study officials:
affiliation: Rehabilitation research chair
name: Masood Khan, MPTh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04264988: Major Pelvic Hemorrhage in Complex Surgery
Official title: Management and Outcomes of Major Pelvic Hemorrhage in Patients Undergoing Complex Abdomino-Pelvic Surgery: A Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Bleeding
Lead sponsor: Acibadem University
Sponsor class: OTHER
Collaborators: name: Bursa Medicana Hospital
name: Dokuz Eylul University
name: Cukurova University
name: Pamukkale University
name: Ankara University
name: TOBB University
name: Gazi University
name: Baskent University
name: Ege University
name: Medipol University
name: Gulhane Training and Research Hospital
First posted: 2020-02-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient operated for complex abdominopelvic surgery including radical oncologic operations for the primary advanced or recurrent carcinoma of pelvic organs, pelvic cytoreduction, revisional/redo operations for failed ileal/colonic pouches, repair of the entero-enteral, entero-cutaneous, entero-vesical and entero-vaginal fistulas who had presacral bleeding in centers which had over 225 colorectal cases per year were included. Major pelvic bleeding is defined as symptomatic bleeding originating from pelvis, bleeding leading to transfusion of ≥2 units of whole blood or packed red cells; surgical site bleeding that requires a second intervention; or surgical site bleeding that is unexpected and prolonged and/or sufficiently large to cause hemodynamic instability with an associated decrease in hemoglobin ≥20 g/L.

Brief summary: Hemorrhage is a challenging complication of pelvic surgery. In this study, the investigators aimed to analyze the causes, management, and outcomes of major pelvic hemorrhage in patients undergoing complex abdomino-pelvic surgery. Participants who had a major intraoperative pelvic hemorrhage during complex abdomino-pelvic surgery at 11 tertiary referral centers were included. Participant characteristics, causes of hemorrhage, management strategies, and outcomes including morbidity and mortality analyses were evaluated.


Eligibility criteria: Inclusion Criteria:

* Patients who had major pelvic bleeding during complex abdominopelvic surgery
* Patients operated in hospitals where over 225 colorectal cases were performed every year

Exclusion Criteria:

* Patients operated for palliative intent

Primary outcomes:
measure: Peri-operative outcomes
timeFrame: Within postoperative day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acibadem Maslak Hospital
Study officials:
References:
Clinical trial NCT02077088: Effect of Galactooligosaccharides on Incidence of Atopic Manifestations in Infants
Official title: Double Blind, Randomised Study on the Effect of Prebiotics on Incidence of Atopic Manifestations in Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis
Keywords: interventional
doubleblind
randomised
pediatric
prebiotic
atopic
dermatitis
infant
Lead sponsor: Humana Co.Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Vitkovice Hospital
First posted: 2014-03-04
Enrollment: 120
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Addition of prebiotic galactooligosaccharides to hypoallergenic starter formula would lead to decreased allergic (atopic) symptoms in nonbreastfed infants with a positive history of allergy in family


Eligibility criteria: Inclusion Criteria:

* nonbreastfed eutrophic infants of corresponding gestational age
* presence of a positive family allergic anamnesis in parents or siblings (atopic eczema, allergic rhinitis or bronchial asthma)

Exclusion Criteria:

* children with serious disease,
* breastfed children
* children fed another formula then the ones used

Primary outcomes:
measure: SCORAD (SCORing Atopic Dermatitis score) assessment of atopy
timeFrame: at 6 months of age
Secondary outcomes:
measure: anthropometric parameters (height, weight)
timeFrame: at 6 months of age
Other outcomes:
measure: incidence of febrile episodes
timeFrame: at 6 months
Locations:
city: Ostrava-Vitkovice
country: Czech Republic
facility: Vitkovice Hospital
Study officials:
affiliation: Vitkovice Hospital, Ostrava, Czech Republic
name: Jan Bozensky, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bozensky J, Hill M, Zelenka R, Skyba T. Prebiotics Do Not Influence the Severity of Atopic Dermatitis in Infants: A Randomised Controlled Trial. PLoS One. 2015 Nov 16;10(11):e0142897. doi: 10.1371/journal.pone.0142897. eCollection 2015.
Clinical trial NCT03358888: Prolonged Multimodal Analgesia for Post-Discharge Pain Control After Primary Total Hip Arthroplasty
Official title: Prolonged Multimodal Analgesia for Post-Discharge Pain Control After Primary Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Hip
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2017-12-02
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a prospective, three-arm, comparative study with a provider-crossover design. The first arm will comprise the standard of care pain regimen after discharge, which comprises PRN oxycodone, tramadol, and acetaminophen. The second arm will comprise a multimodal pain regimen; however, patients will still be routinely provided PRN oxycodone and tramadol to use on an as needed basis. The third arm will comprise a multimodal pain management protocol, which does not routinely allow for opioid consumption. However, patients will be provided a one week supply of oxycodone and tramadol for emergency pain relief only.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing unilateral, primary cementless THA with underlying diagnosis of osteoarthritis.
* ASA I - III
* Spinal anesthesia
* Male and Female over 18 who are willing and able to provide informed consent

Exclusion Criteria:

* Opioid use within 3 months prior to surgery
* General anesthesia
* Non-english speaking
* ASA IV or greater
* Allergy/contraindications to protocol medications
* Renal insufficiency with Cr \> 2.0 or hepatic failure
* Sensory/motor disorder involving the operative limb
* Planned or unplanned discharge to rehab
* Length of stay \>3 days
* Revision or conversion THA
* Cigarette smokers

Primary outcomes:
measure: total opioid consumption
timeFrame: total consumption calcuated from surgery date through 30 days post-op
measure: Pain
timeFrame: 30 days post-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Institute
state: Pennsylvania
Study officials:
References:
citation: Fleischman AN, Tarabichi M, Foltz C, Makar G, Hozack WJ, Austin MS, Chen AF; Opioid Prescription in Orthopedic Surgery after Discharge Research Group. Cluster-Randomized Trial of Opiate-Sparing Analgesia after Discharge from Elective Hip Surgery. J Am Coll Surg. 2019 Oct;229(4):335-345.e5. doi: 10.1016/j.jamcollsurg.2019.05.026. Epub 2019 Jun 5.