louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01524120: Endoscopy and Endomicroscopy for Assessment of Mucosal Healing in Inflammatory Bowel Disease (IBD)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Inflammatory Bowel Disease
Crohn's Disease
Ulcerative Colitis
Keywords: Mucosal healing
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2012-02-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Crohn´s disease and ulcerative colitis. Only patients with mucosal healing are included.

Brief summary: Inflammatory bowel disease (IBD) encompasses two major forms of chronic intestinal disorders, Crohn's disease and ulcerative colitis (UC). Diagnosis is based on several macroscopic and histologic features including patterns of inflammation, crypt abscesses and granulomas. Confocal laser endomicroscopy (CLE) is rapidly emerging as a valuable tool for gastrointestinal endoscopic imaging, enabling the endoscopist to obtain an "optical biopsy" of the gastrointestinal mucosa during the endoscopic procedure.

The main objective of this study is to determine endoscopic and endomicroscopic features of mucosal healing in patients with IBD.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Age 18-85 years
* Ability of subjects to understand character and individual consequences of clinical trial
* Subjects undergoing colonoscopy

Exclusion Criteria:

* Inability to provide written informed consent
* Severe Coagulopathy (Prothrombin time \< 50% of control, Partial thromboplastin time \> 50 s)
* Pregnancy or breast feeding
* Active gastrointestinal bleeding
* Residing in institutions (e.g. prison)
* Known allergy against fluorescein

Primary outcomes:
measure: Mucosal healing
timeFrame: 3 years
Secondary outcomes:
measure: Histologic correlation
timeFrame: 3 years
measure: Therapeutic effect
timeFrame: 3 years
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: University of Erlangen-Nuremberg
Study officials:
affiliation: University of Erlangen-Nürnberg
name: Markus F. Neurath, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Erlangen-Nürnberg
name: Helmut Neumann, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03739320: A Study on the Effect of Mepolizumab Therapy on Daily Physical Activity of Patients With Severe Eosinophilic Asthma
Official title: A Prospective Observational Study on the Effect of Mepolizumab add-on Therapy on Daily Physical Activity in Patients With Severe Eosinophilic Asthma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Severe Eosinophilic Asthma
Keywords: severe asthma
biologic therapy
physical activity monitoring
Lead sponsor: Sotiria General Hospital
Sponsor class: OTHER
First posted: 2018-11-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with severe asthma, already on maximal and optimised treatment who fulfil the criteria for mepolizumab add-on therapy.

Brief summary: Daily physical activity in adult patients with asthma remains overlooked. Limited evidence demonstrates reduced levels of daily physical activity in asthma populations but studies examining the potential effect of available therapies are missing. This study aims to investigate the overall levels of daily physical activity in patients with severe eosinophilic asthma and whether anti-interleukin-5 therapy with mepolizumab, on top of existing, maximal, and optimised asthma treatment, may improve patient's daily physical activity.

Detailed description: A multi-centre, prospective, observational study of continuous patients who fulfil the definition of severe asthma and the criteria for mepolizumab (nucala; GSK) therapy. Patients have their daily physical activity recorded using triaxial accelerometry (DynaPort MoveMonitor; McRoberts) prior to treatment, and at 6 and 12 months of mepolizumab therapy (100 mg subcutaneously once every 4 weeks).

Eligibility criteria: Inclusion Criteria:

1. Severe asthma
2. Criteria for mepolizumab therapy: blood eosinophils ≥150 cells/μL at screening or ≥300 cells/μL in the past 12 months.

Exclusion Criteria: Comorbidities limiting physical activity

Primary outcomes:
measure: Change in daily moving time
timeFrame: 7 days
measure: Change in daily movement intensity
timeFrame: 7 days
measure: Change in daily time in moderate-to-vigorous-intensity activity
timeFrame: 7 days
measure: Change in daily steps
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Sotiria General Hospital
Study officials:
affiliation: Sotiria General Hospital
name: Marios Panagiotou, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05624320: Using AGN-190584 in Subjects Utilizing Single -Use Daily, Contact Lenses
Official title: Improved Near Vision and Intermediate Without Loss of Binocular Distance Vision Using AGN-190584 in Subjects Utilizing Single -Use Daily, Contact Lenses for Distance Vision Correction in Both Eyes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Presbyopia
Keywords: presbyopia
Lead sponsor: Gordon Schanzlin New Vision
Sponsor class: OTHER
Collaborators: name: AbbVie
First posted: 2022-11-22
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: AGN-190584 has gone through many clinical trials showing its safety and effectiveness in individuals from 40-55 years of age. There has been no published data on the use of this product in individuals corrected with contact lenses for distance vision. There are many other applications AGN-190584 could be used for and further studies will show the effectiveness for each.

Detailed description: The study is a single center open label, single arm study with no control and no randomization. Investigators will enroll 30 presbyopic patients between the ages of 40-55 years old who have undergone successful contact lens fitting in single-use, daily, contact lenses between the spectacle lens powers of -4.00 -to +1.00, in both eyes for best distance correction by the primary investigator. Investigators will measure change in letters read at near and intermediate vision from baseline. Subjects will be required to apply AGN-190584 drops once daily OU. Subjects will be applying the drops on their own every day including the day of visits. During treatment investigators will measure changes in letters read from baseline in intermediate and near vision at the days 7, 14 and 21. These visits will be conducted between 2 and 4 hours after instillation of AGN-190584, with 3 hours being the target time.

Eligibility criteria: Inclusion Criteria:

* Subjects from age 40-55
* Prescription range: -4.00 - +1.00
* Correctable to 20/25 or better for distance
* Adapted single use contact lens patients
* Subjects able to understand the consent agreement and willing to participate

Exclusion Criteria:

* Non-contact lens wearer
* Previous use of AGN-190584
* Out of age range
* Out of prescription range
* Any corneal abnormality
* Any eye pathology
* Iritis
* Know allergy to pilocarpine

Primary outcomes:
measure: The primary endpoint will be changes from baseline in letters read at near without loss of distance acuity (defined as loss of 5 or more letters)
timeFrame: 30 days
Secondary outcomes:
measure: secondary endpoint will be changes in intermediate letters read from baseline
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01533220: Efficacy of Nasal Naphazoline Hydrocloride + Pheniramine Maleate + Panthenol Compared With Naphazoline Hydrocloride in the Symptomatic Control of Nasal Congestion and Nasopharyngeal
Official title: A Randomized, Double-blind, Prospective, Multicentric, Superior Efficacy and Safety of Naphazoline Hydrocloride + Pheniramine Maleate + Panthenol Compared With Naphazoline Hydrocloride in the Symptomatic Control of Nasal Congestion and Nasopharyngeal Due to Colds or Other Upper Respiratory Allergies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Flu
Cold
Allergic Disorder of Respiratory System
Keywords: nasal and nasopharyngeal congestion
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2012-02-15
Enrollment: 132
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: The common cold is a major cause of nasal obstruction and reaches children and adults two or more times a year. At the moment, there is no cure for the common cold, and therefore the reduction of symptoms is the focus of the treatment.

The study has parallel distribution design, with two equal groups, in which one group will be treated by a combination of naphazoline hydrocloride + pheniramine maleate + panthenol and the other will receive treatment with naphazoline hydrocloride.

Detailed description: STUDY DESIGN

* randomized,double blind, prospective, multicentric, parallel group, intent to treat trial
* Experiment duration: 3 days
* 2 visits (days 0 and 2)
* Evaluation of symptoms reduction
* Adverse events evaluation

Eligibility criteria: Inclusion Criteria:

1. Patients must be able to understand the study procedures, agree to participate and give written consent.
2. Patients aged over 18 years of both sexes;
3. Patients with clinical signs of flu and colds or other upper respiratory allergies;
4. Patients with early signs and symptoms with time of evolution not more than 72 hours.

Exclusion Criteria:

1. Patients treated with antibiotics
2. Current treatment with immunosuppressants (eg.cyclosporine or methotrexate);
3. Use of intranasal cromalin the week before inclusion;
4. Use of decongestants or anti-histaminic (intranasal or systemic);
5. Presence of any disease or anatomical abnormality that may difficult the data analysis ;
6. Uncontrolled hypertension;
7. Presence of respiratory symptoms for more than 14 days;
8. History of abuse of drugs and alcohol;
9. Presence of other concomitant pulmonary diseases;
10. Hypersensitivity to any compound of investigational product

Primary outcomes:
measure: Efficacy of treatment in nasal congestion reduction based on Peak Flow Nasal Inspiratory (PFNI) assay
timeFrame: 3 days
Secondary outcomes:
measure: Safety will be evaluated by the Adverse events occurence
timeFrame: 3 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04089020: Walking to School Supports
Official title: Psychosocial Supports for Walking to School Paired With a Walking School Bus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
Collaborators: name: University of Kansas Medical Center
name: University of Kansas
First posted: 2019-09-13
Enrollment: 32
Sex: ALL
Minimum age (years): 5
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This pilot study will test the feasibility and acceptability of an enhanced individual-level intervention delivered to 4th-6th graders to increase rates of walking to/from school. Up to 8 youth who do not already walk to school will be enrolled into the intervention. The theoretically-based intervention content will be delivered over 6 weeks through family-based telephone coaching sessions, ongoing short message service (SMS) text messaging, and activities and content on the study website.


Eligibility criteria: Inclusion Criteria:

* Parents of children enrolled at Benjamin Banneker school
* Parents/child dyads who completed the Phase 1 survey OR respond to recruitment attempts and express interest in walking to school. Included parent/child dyads will be:

Those who do not participate in LINC program both before and after school 4+ days per week (child); Those who live within the school boundary and south of Meyer Blvd (i.e., close enough to an existing walking school bus route) or are willing to drop off and/or pick up the child at a place along an existing walking school bus route (i.e., remote drop off).

Exclusion Criteria:

* Children not enrolled at Benjamin Banneker school
* Those who participate in LINC program both before and after school 4+ days per week (child); Those who do not live within the school boundary and south of Meyer Blvd (i.e., close enough to an existing walking school bus route) or are not willing to drop off and/or pick up the child at a place along an existing walking school bus route (i.e., remote drop off).
* We will exclude each of the following special populations:

Adults unable to consent Prisoners Wards of the state Pregnant women may be included, but only in such capacity as parents of other children enrolled at Benjamin Banneker school

Primary outcomes:
measure: Acceptability of Intervention: "Satisfaction Questionnaire"
timeFrame: at 6 weeks, immediately after completion of the intervention
Secondary outcomes:
measure: Frequency of Walking to School
timeFrame: up to 6 weeks
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital Kansas City
name: Jordan Carlson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06222320: Kinesiotaping Method for Rib Fractures
Official title: Can Kinesiotaping Reduce Pain in Rib Fractures?: Randomized Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Rib Fractures
Pain, Chest
Lead sponsor: Kastamonu University
Sponsor class: OTHER
First posted: 2024-01-24
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Kinesiotaping is used as a physiotherapy method to reduce muscle pain. In this technique, kinesiotaping tapes are attached to the relevant parts of the body. Patients experience serious pain in rib fractures. Kinesiotaping technique can potentially reduce pain by contributing to external stabilization of the ribs. In this study, patients with isolated rib fractures will be divided into two groups. The first group will be treated with kinesiotaping technique and routine painkillers. The second group will receive routine painkiller treatment. Pain scores between both groups will be compared.


Eligibility criteria: Inclusion Criteria:

* Isolated thoracic injury within the last 24 hours
* Patients aged 18-100 years

Exclusion Criteria:

* Hemothorax and pneumothorax requiring intervention
* Injury severity index\>16
* Asthma and COPD
* Tape allergy
* Loss of consciousness (GCS \<15)
* Incapacitated patients
* Fracture of rib number 1-3

Primary outcomes:
measure: Day 4 Visual Analogue Scale Pain Score
timeFrame: 4 days
Secondary outcomes:
Other outcomes:
Locations:
city: Kastamonu
country: Turkey
facility: Kastamonu University
Study officials:
References:
Clinical trial NCT04558320: COVID-19 and Lactating Mothers
Official title: COVID-19 and Lactating Mothers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus Infection
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: New York University
First posted: 2020-09-22
Enrollment: 76
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will include 50 adult lactating parents with COVID-19, and their infants (total sample size = 100). Participants can be residing anywhere in the continental United States.

Brief summary: The purpose of this study is to determine if there may be COVID-19 virus in various samples collected from mothers and infants.


Eligibility criteria: Inclusion Criteria:

* Currently lactating mother:

  * English-speaking
  * greater than or equal to 18 years of age
  * Assigned female at birth (AFAB)
  * Having a positive COVID-19 test within 14 days
* Child:

  * Infants younger than or equal to 6 months of age, exclusively or partially human milk fed, sourced from mother. Infants who are fed both directly at the breast and exclusively fed mother's milk via bottle will be included

Exclusion Criteria:

* Non-English speaking

Primary outcomes:
measure: mean change in SARS-Cov-2 viral load in breast milk
timeFrame: baseline, days 3, 10, 19, 28 and 90
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
References:
Clinical trial NCT03449420: Predictability of Thromboelastography Parameters in Severe Post Partum Hemorrhage
Official title: Predictability of Thromboelastography Parameters in Severe Post Partum Hemorrhage : a Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post Partum Hemorrhage
Keywords: thromboelastography
Lead sponsor: Hôpital Armand Trousseau
Sponsor class: OTHER
First posted: 2018-02-28
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women presenting with a post partum hemorrhage

Brief summary: The aim of the study is to determine if thromboelastography parameters can be predictive of severe post partum hemorrhage.


Eligibility criteria: Inclusion Criteria:

* Women presenting with a post partum hemorrhage
* needing sulprostone infusion
* during third trimester of pregnancy

Exclusion Criteria:

* known coagulation disorders

Primary outcomes:
measure: Calculated blood loss
timeFrame: during the 24 hours after delivery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hôpital Armand Trousseau
name: Agnes Rigouzzo, MD
role: STUDY_DIRECTOR
References:
citation: Rigouzzo A, Louvet N, Favier R, Ore MV, Piana F, Girault L, Farrugia M, Sabourdin N, Constant I. Assessment of Coagulation by Thromboelastography During Ongoing Postpartum Hemorrhage: A Retrospective Cohort Analysis. Anesth Analg. 2020 Feb;130(2):416-425. doi: 10.1213/ANE.0000000000004422.
Clinical trial NCT01996020: Measurement of Cerebral Flow Using Transfontanellar Doppler in Infants Under Cardiopulmonary Bypass
Official title: Intraoperative Trans-fontanel Cerebral Ultrasonography in Infants During Pediatric Cardiac Surgery Under Cardiopulmonary Bypass
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiopulmonary Arrest
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-11-27
Enrollment: 43
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pediatric patients with congenital heart disease scheduled to recieve cardiac surgery under CPB

Brief summary: Transfontanellar Doppler can measure the velocity at both the carotid artery and the anterior cerebral artery during cardiopulmonary bypass in congenital heart disease patients. This study can provide reference value of appropriate cerebral blood flow velocity during pediatric cardiac surgery.


Eligibility criteria: Inclusion Criteria:

1. the patients less than 1 year of age undergo congenital heart surgery with cardiopulmonary bypass
2. written informed consent is obtained from their guardians in accordance with the requirements of the local ethics committee

Exclusion Criteria:

1. synostosis
2. skull abnormality or fracture
3. epidural hematoma, scalp hematoma

Primary outcomes:
measure: cerebral blood flow velocity
timeFrame: 6hour
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
citation: Park YH, Song IK, Lee JH, Kim HS, Kim CS, Kim JT. Intraoperative trans-fontanellar cerebral ultrasonography in infants during cardiac surgery under cardiopulmonary bypass: an observational study. J Clin Monit Comput. 2017 Feb;31(1):159-165. doi: 10.1007/s10877-015-9815-3. Epub 2015 Dec 21.
Clinical trial NCT04138420: Evaluation of Retinal and Vascular Features in Macular Degeneration After Intravitreal Injections of Bevacizumab
Official title: Study of Retinal and Vascular Features by Optical Coherence Tomography and Optical Coherence Tomography Angiography After Intravitreal Injections of Bevacizumab in Exudative Age-related Macular Degeneration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Exudative Age-related Macular Degeneration
Keywords: optical coherence tomography angiography
optical coherence tomography angiography angiography
bevacizumab
vascular endothelial growth factor antagonists
intravitreal injection
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2019-10-24
Enrollment: 38
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participans were older than 50 years with diagnosis of exudative age-relative macular degeneration. They did not present other ophthalmological disease and did not receive previous treatment before Bevacizumab.

Brief summary: This study evaluates the retinal and vascular features in patients with macular degeneration under the effects of Bevacizumab intravitreal injections using optical coherence tomography and optical coherence tomography angiography.

Detailed description: Bevacizumab is a vascular endothelial growth factor antagonist represent an efficacy treatment for exudative age-related macular degeneration acting on vascular hyperpermeability.

The optical coherence tomography and optical coherence tomography angiography represent novel and non-invasive diagnostic techniques that allow a detailed and quantitative analysis of retinal and vascular features.

The study evaluates the changes in optical coherence tomography and optical coherence tomography angiography parameters at baseline and after three monthly injections of Bevacizumab in exudative AMD.

Eligibility criteria: Inclusion Criteria:

* age older than 50 years, diagnosis of exudative age-related macular degeneration, treatment-naïve with Bevacizumab for exudative age-related macular degeneration.

Exclusion Criteria:

* age younger than 50 years, diagnosis of exudative macular degeneration due to other causes, previous treatments before Bevacizumab for exudative age-related macular degeneration.

Primary outcomes:
measure: Study of retinal structural features in exudative age-related macular degeneration after intravitreal injections of Bevacizumab
timeFrame: three months
measure: Study of retinal vascular features in exudative age-related macular degeneration after intravitreal injections of Bevacizumab
timeFrame: three months
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University of Naples "Federico II"
Study officials:
affiliation: Federico II University
name: Gilda Cennamo, MD
role: PRINCIPAL_INVESTIGATOR
References: