louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01218230: Intravitreal Pegaptanib in Treatment of Choroidal Neovascularisation Secondary to Pathologic Myopia
Official title: A Clinical Trial to Study the Efficacy and Safety of Intravitreal Pegaptanib in Treatment of Choroidal Neovascularisation Secondary to Pathologic Myopia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Myopic Choroidal Neovascular Membrane
Keywords: Pegaptanib, myopic CNVM, intravitreal anti-VEGF
Lead sponsor: L.V. Prasad Eye Institute
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2010-10-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Intravitreal pegaptanib for treatment of choroidal neovascularisation secondary to pathologic myopia

Detailed description: This is a Prospective Interventional, non-comparative study in 20 consecutive patients who will be selected from the outpatient services. After taking an informed consent, the patients will be given intravitreal Pegaptanib 0.3 mg every 6 weeks for 3 procedure of injection. Thereafter, patients will continue to be examined every 6 weeks (± 2 weeks) and of may receive additional injections as needed based on the presence of one or more re-treatment criteria (please see below). Final assessment will be done at 54 weeks and all the baseline investigations will be performed.

Eligibility criteria: Inclusion Criteria:

1. Should be willing to participate in the trial.
2. Age less than 55 years.
3. Best corrected visual acuity (BCVA) score of at least 5 letters (20/200), as assessed by ETDRS chart.
4. Myopia of ≥ 6 Diopters.
5. Fluorescein angiographic documentation of CNV.

Exclusion Criteria:

1. Ocular causes, or other ocular disorders leading to vision loss.
2. Maculopathy not related to pathologic myopia.
3. Pregnancy, lactation.
4. Not willing to provide an informed consent.
5. History of previous macular laser including PDT.
6. Other forms of therapy including intravitreal injections.
7. History of intraocular surgery in the past 3 months.
8. Anticipated cataract surgery in the next 6 months.
9. Any active infection or inflammation in the eye.
10. Cases where good quality imaging is not possible, either due to hazy media or extremely high myopia.
11. Patients with uncontrolled glaucoma, with IOP \> 21mm Hg on 2 or more medications.
12. Patients with subfoveal scar or significant subretinal haemorrhage occupying more than 50% of lesion size.
13. Eyes with previous retinal detachment.

Primary outcomes:
measure: Visual Acuity
timeFrame: 12 months
Secondary outcomes:
measure: Mean change in macular thickness on OCT from baseline to 54 weeks
timeFrame: 12 months
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: LV Prasad Eye Institute
state: AP
Study officials:
affiliation: LV Prasad Eye Institute
name: Raja Narayanan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01480648: Single Rising Dose Study of BI 144807 Powder in Bottle in Healthy Male Volunteers
Official title: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Rising Oral Doses of BI 144807 Powder in Bottle (1 to 1200 mg) in Healthy Male Volunteers in a Randomised, Single-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2011-11-29
Enrollment: 74
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This first-in-man trial forms the basis for potential clinical development of BI 144807 in the indications of asthma and allergic rhinitis. The safety, tolerability, pharmacokinetics, and pharmacodynamics of single rising doses of BI 144807 will be assessed in healthy male volunteers.


Eligibility criteria: Inclusion criteria:

1. healthy male subjects

Exclusion criteria:

1. any relevant deviation from healthy conditions

Primary outcomes:
measure: All adverse events
timeFrame: up to 14 days postdose
measure: Number of participants with clinically significant changes in vital signs
timeFrame: up to 14 days postdose
measure: Number of participants with clinically significant changes in ECG
timeFrame: up to 14 days postdose
measure: Number of participants with clinically significant changes in laboratory tests
timeFrame: up to 14 days postdose
measure: Number of participants with clinically significant changes in physical examination
timeFrame: up to 14 days postdose
measure: Number of participants tolerating BI 144807
timeFrame: up to 14 days postdose
Secondary outcomes:
measure: Cmax (maximum measured concentration of the analyte in plasma)
timeFrame: up to 72h postdose
measure: tmax (time from dosing to maximum measured concentration)
timeFrame: up to 72h postdose
measure: AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
timeFrame: up to 72h postdose
measure: AUC(0-tz) (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
timeFrame: up to 72h postdose
measure: t1/2 (terminal half-life of the analyte in plasma)
timeFrame: up to 72h postdose
Other outcomes:
Locations:
city: Biberach
country: Germany
facility: 1313.1.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT02726048: Simplus and Eson Non-Invasive Ventilation (NIV) Evaluation - Germany
Official title: Simplus and Eson Non-Invasive Ventilation (NIV) Evaluation - Germany
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity Hypoventilation Syndrome
Obstructive Sleep Apnea
Chronic Obstructive Pulmonary Disease
Neuromuscular Disease
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
First posted: 2016-04-01
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This investigation is designed to evaluate the performance, comfort and ease of use of the Simplus and Eson masks amongst NIV patients who are currently on Bi-level therapy

Detailed description: Up to 40 NIV patients who currently use a full face mask or a nasal mask will be recruited. They will be issued a Simplus (if they are existing full face users) or Eson (if they are existing nasal users) to use in-home for 2 weeks. This will consists of male and female participants who have been prescribed with NIV therapy for at least 3 months.

Eligibility criteria: Inclusion Criteria:

* Aged 18+
* Existing full face mask user or a nasal mask user
* Prescribed NIV therapy for at least 3 months

Exclusion Criteria:

* Inability to give informed consent
* Pregnant or think they may be pregnant
* Anatomical or physiological conditions making NIVtherapy inappropriate
* Patients who are in a coma or decreased level of consciousness
* Existing Simplus and Eson users

Primary outcomes:
measure: Objective Leak data
timeFrame: 2 weeks
Secondary outcomes:
measure: Subjective measurement of Leak
timeFrame: 2 weeks
measure: Subjective measurement of Comfort
timeFrame: 2 weeks
measure: Subjective measurement of Ease of Use
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Ingo Fietze, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00781248: Safety and Efficacy Study of the NG Shield, a Device Intended to Reduce Pain and Discomfort Level Related to Nasogasstric Tube Usage
Official title: Evaluation of Safety and Efficacy of the NasoGastric Shield (NG Shield) in Healthy Subjects With Indwelling Nasogastric Tube
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Intubation, Nasogastric
Keywords: enteral feeding
Subject who requires nasogastric tube
Lead sponsor: Nanovibronix
Sponsor class: INDUSTRY
First posted: 2008-10-28
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study i to demonstrate the safety and efficacy of a device that intends to reduce pain/discomfort related to nasogfastric tube usage by reducing the friction between the tube and internal orifice (nose and pharynx)using micro vibrations


Eligibility criteria: Inclusion Criteria:

1. Subject is in good health and able to undergoes the NG tube insertion procedure, according to the PI decision
2. Subject is able to understand and answer the pain and discomfort questionnaires
3. Subject has been fasting for at least 12h prior to the insertion phase
4. Subject underwent a physical examination by the PI
5. Subject able, agrees and signs the Inform Consent Form (ICF)

Exclusion Criteria:

1. Subject has any history of dysphagia or esophageal disease
2. Subject used anti pain medications during the last week prior to the study date
3. Subject used Antibiotics during the last week prior to the study date
4. Subject with Asthma
5. Subject with chronic or acute nasal or throat disorder
6. Subject who suffered from upper respiratory infection at least 7 days prior to the insertion procedure
7. Any pain from other source prior to the initiation of the study procedure according to the PI judgment and decision
8. Subject has any condition, which precludes compliance with study and/or device instruction for use
9. Subject is currently participating in another clinical study

Primary outcomes:
measure: Pain/discomfort levelusing flicker scale (1-10 scale)during indwelling phase
timeFrame: every 30 minutes for 6 hours
measure: safety of device usage
timeFrame: 6 hours
Secondary outcomes:
measure: pain/Dicomfort during insertion and removal of the nasogastric tube
timeFrame: at t=0h and t=6h
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: "Bikur Cholim" Hospital
Study officials:
affiliation: "Bikur Cholim" Hospital, Jerusalem ISRAEL
name: Shmuel Adler, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04760548: Segmentation of Structural Abnormalities in Chronic Lung Diseases
Official title: Segmentation of Structural Abnormalities in Chronic Lung Diseases
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cystic Fibrosis
Asthma
COPD
Interstitial Lung Disease
Lead sponsor: Hôpital Haut-Lévêque
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
name: Collaborative NOVAA study group
First posted: 2021-02-18
Enrollment: 800
Sex: ALL
Minimum age (years): 3
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic lung disease and a Clinical examination, pulmonary function test, and CT acquired during an annual routine follow-up

Brief summary: Lung structural abnormalities are complex, time-consuming, and may lack reproducibility to evaluate visually on CT scans. The study's aim is to perform automated recognition of structural abnormalities in CT scans of patients with chronic lung diseases by using dedicated software.

Detailed description: Three chronic lung diseases will constitute the target of the study, by using retrospective data from each lung disease:

* Cystic fibrosis
* Asthma and COPD
* Interstitial lung diseases

Dedicated algorithms will be developped for each disease condition.

Eligibility criteria: Inclusion Criteria:

* Patients with chronic lung disease and clinical examination, pulmonary function test, and CT acquired during a routine follow-up

Primary outcomes:
measure: Validity of automated measurement
timeFrame: From date of inclusion until the date of final quantification, assessed up to 12 months
Secondary outcomes:
measure: Correlation with pulmonary function test
timeFrame: From date of inclusion until the date of final quantification, assessed up to 12 months
measure: Longitudinal variation over time
timeFrame: From date of inclusion until the date of final quantification, assessed up to 12 months
measure: Reproducibility
timeFrame: From date of inclusion until the date of final quantification, assessed up to 12 months
Other outcomes:
Locations:
city: Pessac
country: France
facility: Hopital Haut Leveque
Study officials:
affiliation: Hopital Haut Leveque
name: Patrick Berger, Pr
role: STUDY_CHAIR
References:
citation: Dournes G, Hall CS, Willmering MM, Brody AS, Macey J, Bui S, Denis de Senneville B, Berger P, Laurent F, Benlala I, Woods JC. Artificial intelligence in computed tomography for quantifying lung changes in the era of CFTR modulators. Eur Respir J. 2022 Mar 3;59(3):2100844. doi: 10.1183/13993003.00844-2021. Print 2022 Mar.
Clinical trial NCT06766448: Effectiveness of Instrumental Rehabilitation in Patients With Adhesive Capsulitis
Official title: Robotic Training in the Management of Adhesive Capsulitis: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adhesive Capsulitis of the Shoulder
Keywords: adhesive capsulitis
rehabilitation
robotic training
Lead sponsor: Mohammed V Souissi University
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 70
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 aim of this study is to evaluate the effectiveness of robotic training compared to conventional rehabilitation in patients with AC.

Detailed description: Nowadays, rehabilitation focuses on functional work during physiotherapy sessions to improve the patient's autonomy.

In the era of new technologies, robotics and virtual reality have shown great interest in functional rehabilitation and cortical reorganization.

Eligibility criteria: Inclusion Criteria:

* Patients \>18 years of age
* Shoulder pain and/or movement limitation
* Idiopathic AC or associated with confirmed systemic disease (e.g., diabetes or dyslipidemia)

Exclusion Criteria:

* Cognitive impairment
* History of surgery
* Fracture or dislocation of the shoulder
* History of shoulder tendinopathy
* History of inflammatory or degenerative disease
* Infection
* Neurological disease (Parkinson's disease, stroke, multiple sclerosis, neurological
* Manipulation under anesthesia, hydro dilation, platelet rich plasma or hyaluronic acid infiltration within the last 6 months

Primary outcomes:
measure: shoulder fonction using Shoulder Pain and Disability Index (SPADI)
timeFrame: at 3 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months
Secondary outcomes:
measure: pain using a visual analogue scale
timeFrame: at 3 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months
measure: Active and passive range of motion
timeFrame: at 3 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months
Other outcomes:
Locations:
city: Rabat
country: Morocco
facility: Faculty of medecine and pharmacy of rabat
Study officials:
affiliation: Mohammed V Souissi University
name: samia karkouri, professor
role: STUDY_CHAIR
References:
Clinical trial NCT04864730: Modal Anatomy of the Ethmoid Bone
Official title: Constitution d'un modèle 3D d'Anatomie Modale de L'Ethmoide Par intégration de Multiples Instances d'Acquisition
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anatomic Abnormality
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-04-29
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who had a sinus CT-scan during the 2016-2019 period.

Brief summary: The creation of a 3D model of modal anatomy of the ethmoid could, like other parts of the body, improve anatomical, radiological and perhaps even surgical learning. Anatomical variations might constitute a "background noise" of the modal anatomy, which can be attenuated by multiplying the instances of acquisitions. The objective of this work is to establish modal anatomy of the ethmoid by the analysis of a large number of CT-scan acquisitions carried out in individuals with no acquired sinus pathology.

Detailed description: Non-interventional descriptive research.

Sinus CTscans (period 2016-2019) will be reviewed from the PACS database of the CHRU of Nancy and selected in individuals without sinus pathology. All CT-scans will be fully anonymized. 26 landmarks will be pointed out to enable :

1. prior images alignment (centering on the median line, realignment rotations then resizing)
2. a mean and median calculation, allowing to establish a mean and median ethmoid model
3. calculation of standard deviations for each voxel The structures obtained in this way (bone, tissue or aerial) will be described anatomically.

Eligibility criteria: Retrospective analysis of sinus CT scans images from individuals (period 2016-2019)

Inclusion Criteria:

All individuals (\>18 years all) with a sinus CT scan available in the CHRU database

Exclusion Criteria:

inflammatory sinus disease (eg. nasal polyposis, aspergilloma, ...) evolutive sinus tumor anatomical abnormality (e.g. post traumatic, prior sinus surgery, embryologic abnormality...)

Primary outcomes:
measure: Descriptive study of the anatomy of the final 3D model
timeFrame: Through completion of the study: 1 month (The model will be available only at the end of the study, after implementation of all CT-scans)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01526330: Safety, Tolerability and Efficacy of YH14618 in Patients With Degenerative Disc Disease
Official title: A Double-blind, Randomized, Parallel, Placebo Controlled, Phase I/II Clinical Trial to Investigate the Safety, Tolerability and Efficacy of YH14618 Following Single Intradiscal Injection in Patients With Degenerative Disc Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Degenerative Disc Disease
Keywords: Degenerative disc disease
YH14618
Penial 2000
Penial 2K
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2012-02-03
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to assess the safety and tolerability of YH14618 during 24 weeks of follow-up period after single administration in patients with degenerative disc disease.


Eligibility criteria: Inclusion Criteria:

* Have signed a written informed consent voluntarily, prior to the any procedure
* Degenerative disc disease patients of aged over 20 years
* Have one or more of the symptomatic lumbar level(L1\~S1) as confirmed using radiology(X-ray, MRI and/or discogram/CT)
* Have been diagnosed 2\~3 degree of MRI index by modified thompson classification
* Oswestry diability index(ODI) of 30 or greater
* Visual analog scale(VAS) of 4 or greater

Exclusion Criteria:

* Subjects unable to have radiological examination
* Have history of neurological disease, herniated lumbar disc, compression fractures and lumbar spinal surgery
* Sacroiliac joint dysfunction
* Have been treated with any drugs for pain control within 7 days prior to the first administration
* Hypersensitivity to drugs
* Pregnant women, nursing mothers or subjects who do not agree to assigned contraception in the study
* Participated in any other clinical trials within 30 days prior to the first administration

Primary outcomes:
measure: Evaulate the safety and tolerability after single intradiscal administation
timeFrame: 12 weeks of observational period
Secondary outcomes:
measure: Change from baseline in disc height index at 12 week
timeFrame: Baseline, Week 12
measure: Change from baseline in magnetic resonance imaging(MRI) index
timeFrame: Baseline, Week 12
measure: Change from oswestry diability index(ODI) at week 12
timeFrame: Baseline, Week 12
measure: Change from baseline in visual analogue scale(VAS) at week 12
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Medical Center
Study officials:
affiliation: Kangbuk Samsung Hospital
name: Young-joon Kwon, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04024930: Endoscopic Ultrasound Guided Choledocoduodenostomy With the Lumen Apposing Metal Stent [Axios® Stent]
Official title: Endoscopic Ultrasound Guided Choledocoduodenostomy With the Lumen Apposing Metal Stent [Axios® Stent]
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: EUS Guided Biliary Drainage
Keywords: EUS guided biliairy drainage
EUS Choledoco-duodenostomy
Axios stent
Lumen Apposing Metal Stent
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2019-07-18
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with tumoral obstruction of the distal biliary tract that have been treated by an EUS-CDS with a electrocautery enhanced LAMS

Brief summary: Endoscopic Ultrasound (EUS) guided biliary drainage is indicated in case of impossibility or failure of classic biliary drainage by endoscopic retrograde cholangio-pancreatography (ERCP). Recently the investigators reported a good efficiency of EUS guided choledocoduodenostomy using the HOT-AXIOS device (Electrocautery enhanced lumen apposing metal stent) in a retrospective multicentric study. Utilization of the recommended technique (direct punction with the HOT AXIOS using a pure cut current + using a 6 mm Stent) was the only predicting factor of clinical success. The investigators reevaluate this procedure one year after in the same centers.


Eligibility criteria: Inclusion Criteria:

* patients with tumoral obstruction of the distal biliary tract that have been treated by an EUS-CDS with a electrocautery enhanced LAMS

Exclusion Criteria:

* \< 18 years old
* refusal to participate

Primary outcomes:
measure: technical success rate
timeFrame: Day 1
Secondary outcomes:
measure: Clinical success
timeFrame: Day 28
measure: Periprocedural adverse events: adverse events that occur during the procedure
timeFrame: Day 1
measure: short-term adverse events
timeFrame: Day 7
measure: Long-term biliary adverse events: biliary adverse events that occur after discharge from hospital.
timeFrame: Year 1
measure: Six month stent patency rate
timeFrame: Month 6
Other outcomes:
Locations:
city: Brest
country: France
facility: Hospital University
city: Limoges
country: France
facility: University Hospital
city: Lyon
country: France
facility: Hospital Private Jean MERMOZ
city: Marseille
country: France
facility: APHM Hospital La Timone
city: Montpellier
country: France
facility: University Hospital
city: Paris
country: France
facility: APHP Hospital Saint-Antoine
city: Quimper
country: France
facility: Hospital Cournouaille
city: Vichy
country: France
facility: Hospital Jacques Lacarin
Study officials:
References: