louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02959801: Outcome of Percutaneous Mechanical Thrombectomy to Treat Acute Deep Venous Thrombosis
Official title: Outcome of Percutaneous Mechanical Thrombectomy to Treat Acute Deep Venous Thrombosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Deep Venous Thrombosis
Keywords: Deep Venous Thrombosis
Percutaneous Mechanical Thrombectomy
Lead sponsor: Beijing Tsinghua Chang Gung Hospital
Sponsor class: OTHER
First posted: 2016-11-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to compare the efficacy of Percutaneous mechanical thrombectomy (PMT) followed by standard anticoagulant therapy, with anticoagulation therapy alone, for the treatment of acute proximal lower extremity deep vein thrombosis.

Detailed description: The conventional treatment of acute deep vein thrombosis (DVT) is anticoagulation therapy, as recommended in the international guidelines. Anticoagulation prevents recurrent venous thrombosis, pulmonary embolism, and death. Early thrombus removal is now considered as the standard of medical care for deep vein thrombosis (DVT). Early thrombus removal can offer the potential for early restoration of venous patency and preservation of valve function. Percutaneous mechanical thrombectomy (PMT) uses a number of catheter-based mechanical devices to deliver the thrombolytic agent as well as to produce some combination of thrombus fragmentation, distribution of thrombolytic drugs throughout the thrombus, and/or thrombus aspiration. The purpose of this study was to compare the efficacy of Percutaneous mechanical thrombectomy (PMT) followed by standard anticoagulant therapy, with anticoagulation therapy alone, for the treatment of acute proximal lower extremity deep vein thrombosis.

Eligibility criteria: Inclusion Criteria:

* proven acute deep venous thrombosis, less than 21 days and who were referred to the interventional radiology department.

Exclusion Criteria:

* presence of subacute or chronic DVT more than 21 days in duration, inability to lie in the prone position required for intervention, terminal systemic disease requiring palliative treatment, active bleeding (from a gastric/duodenal ulcer or the cerebrovascular system), a haemorrhagic stroke within the previous year, an impaired bleeding-clotting profile, and any haemophilic disorder, or pregnancy.

Primary outcomes:
measure: post-thrombotic syndrome
timeFrame: one year
Secondary outcomes:
measure: complication
timeFrame: one year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tsinghua Chang Gung Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT06385301: Exercise Performance on Ambient Air vs. Low-Flow Oxygen Therapy With Chronic Lung Diseases
Official title: Exercise Performance on Ambient Air vs. Commonly Prescribed Nasal Low Oxygen Therapy - a Non-Inferiority Trial in Patients With Exercise Induced Desaturation Due to Chronic Lung Diseases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Disease Chronic
Lung Diseases, Interstitial
Lung Diseases, Obstructive
Keywords: Supplemental Oxygen Therapy
6 Minute Walking Distance
Chronic lung diseases
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2024-04-26
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each participant is its own control
Primary purpose: OTHER

Brief summary: The investigators aim to study the effect of SOT in subjects with chronic lung disease in submaximal exercise.

Detailed description: Participants with lung disease who live in Switzerland will have 6-minute walk distance (6MWD) test with and without SOT at approximately 3l/min via nasal cannula according to a randomized cross-over design.

The trial aims to test that the 6MWD with SOT is non-inferior to a 6MWD in the same participant under ambient air.

Our effect size was estimated with a difference of less or equal to 35m compared under SOT compared to ambient air.

Eligibility criteria: Inclusion Criteria:

* Minimum 18 years of age
* Written informed consent
* Patients with diagnosed chronic lung disease
* Former desaturation under exercise defined as Spo2-decrease \>3%- Page 3 of 4
* Treated with a stable drug therapy (with no changes for at least 14 days prior to screening)

Exclusion Criteria:

* Severe hypoxemia needing supplemental oxygen therapy defined as (partial pressure of Oxygen (PaO2) \< 6.9 KiloPascal (kPa)
* Pregnancy
* Unability or contraindications to undergo the investigated intervention
* Unability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.

Primary outcomes:
measure: 6-minute walk distance (6MWD) with supplemental oxygen therapy (SOT) vs. ambient air
timeFrame: after 6 minutes
Secondary outcomes:
measure: SpO2 at rest and peak 6MWD with SOT vs. ambient air
timeFrame: after 6 minutes
measure: Heart rate at rest and peak 6MWD with SOT vs. ambient air
timeFrame: after 6 minutes
measure: Borg dyspnea scale at rest and peak 6MWD with SOT vs. ambient air
timeFrame: 6 minutes
measure: Borg leg fatigue scale at rest and peak 6MWD with SOT vs. ambient air
timeFrame: after 6 minutes
measure: Blood pressure at rest and peak 6MWD with SOT vs. ambient air
timeFrame: after 6 minutes
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zürich
Study officials:
affiliation: University Hospital Zurich, Department of Pulmonology
name: Silvia Ulrich, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05264701: Investigation of the Effects of the Technology-based Cardiac Rehabilitation Program in Coronary Artery Patients
Official title: Investigation of the Effects of Artificial Intelligence-supported and Technology-based Cardiac Rehabilitation Programs on Participation and Exercise Capacity in Coronary Artery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Physical Inactivity
Keywords: Cardiac Rehabilitation
Exercise Training
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2022-03-03
Enrollment: 52
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was planned to investigate the effectiveness of technology-based and traditional cardiac rehabilitation programs in individuals with coronary artery disease.

Detailed description: Cardiovascular diseases constitute one of the most critical health problems of today's society due to the loss of workforce, morbidity, mortality, and high hospital expenses.

This study was planned to investigate the effectiveness of technology-based and traditional cardiac rehabilitation programs in individuals with coronary artery disease.

Eligibility criteria: Inclusion Criteria:

* Patients with coronary artery disease
* Access to the online program
* Volunteering to participate in the research
* Having an iOS or Android operating system compatible phone

Exclusion Criteria:

* Having a musculoskeletal problem
* Having uncontrolled hypertension
* Having chronic heart failure (NYHA III-IV)
* A history of acute coronary syndrome or surgical revascularization less than 12 months ago
* More than 50% occlusion on the main coronary artery
* Having arrhythmia

Primary outcomes:
measure: Exercise Capacity
timeFrame: Baseline, after 12 weeks, after 24 weeks
measure: Participation
timeFrame: after 12 weeks
Secondary outcomes:
measure: Maximal Effort Capacity
timeFrame: Baseline
measure: Peripheral muscle strength
timeFrame: Baseline, after 12 weeks, after 24 weeks
measure: Endothelial function
timeFrame: Baseline, after 12 weeks, after 24 weeks
measure: Healthy Living Habit Evaluation
timeFrame: Baseline, after 12 weeks, after 24 weeks
measure: Health-Related Quality of Life
timeFrame: Baseline, after 12 weeks, after 24 weeks
measure: QoL
timeFrame: Baseline, after 12 weeks, after 24 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Naciye Vardar-Yagli, PhD
role: STUDY_DIRECTOR
affiliation: Hacettepe University
name: Hikmet Yorgun, PhD
role: STUDY_DIRECTOR
affiliation: Hacettepe University
name: Ahmet Hakan Ates, PhD
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Deniz Yuce, PhD
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Dilara Saklica, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04562701: Relationship Between Hamstring Length and Gluteus Maximums in Mechanical Low Back Pain
Official title: Relationship Between Hamstring Length and Gluteus Maximums Strength With and Without Normalization in Mechanical Low Back Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mechanical Low Back Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Prof.Dr Nadia Abdelazim fayaz
name: Walaa Mohsen Mohamed
name: Nagy Sabet
name: Hamada Ahmad Hamada
First posted: 2020-09-24
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: * Male and female patients
* Age ranged from 18-40 years
* Body mass index ranged from 25-30 kg/m2

Brief summary: The aim of this study was to determine the correlation between hamstring length and gluteus maximus strength with and without normalization in patients with mechanical low back pain

Detailed description: seventy-three patients diagnosed as mechanical low back pain. Firstly, gluteus maximus (GM) strength was measured isometrically as a force (kg) and then converted to torque (Nm). GM strength was normalized for body weight and height using the following formula: % (body weight × h) = torque (N × m) ×100 / body weight (N) × h (m), then assessment of hamstring length flexibility using the active knee extension method.

Data was collected and the correlation was determined.

Eligibility criteria: Inclusion criteria:

* Patients diagnosed as mechanical low back pain (MLBP) with very high grade mechanical inflammatory low back pain (MIL) index.
* Age ranged from 18 to 40 years.
* Body mass index ranged from 25 to 30 kg/m2

Exclusion Criteria:

* History of previous fractures, surgeries, malignancies, trauma, rheumatoid arthritis, spondylosis, and spondylolisthesis.
* History of lower limb injuries in the last six months before the study.
* Inability to correctly produce maximal Gluteus Maximus contraction in a pain-free ROM.

Primary outcomes:
measure: Gluteus muscle torque
timeFrame: 20 minutes
measure: Hamstring length
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo university
Study officials:
References:
Clinical trial NCT04393701: A Pilot Study for Systematic Neonatal Screening for Lysosomal Storage Diseases Using Tandem Mass Spectrometry
Official title: A Pilot Study for Systematic Neonatal Screening for Lysosomal Storage Diseases Using Tandem Mass Spectrometry
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neonatal Screening
Lysosomal Storage Diseases
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
Collaborators: name: University Hospital, Caen
First posted: 2020-05-19
Enrollment: 100000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The study will include all newborns in Normandie region for 3 years (about 105,000 births) for whom signed consent by one (or two) parents will be collected. Based on our previous pilot study (2011) assessing MCAD and PKU using tandem mass spectrometry-based method in Normandie region in which informed consents have been signed for all newborns (43,000) but we are expecting a great willingness to participate to this project. Thus, we are aiming to include 100,000 newborns, and the study will be continued until we reach at least this target.

The primary objective is to evaluate the epidemiology of MPS1 and Pompe disease using dried blood samples in the first cohort of neonates tested in France (Normandie region).


Eligibility criteria: Inclusion Criteria:

* Newborn in a Normandy maternity hospital
* Newborn participating in the National Neonatal Screening Program
* Holder(s) of parental authority having read and understood the information letter and signed the informed consent form

Exclusion Criteria:

There are no criteria for non-inclusion in this study. Participation in the study, such as participation in the National Neonatal Screening Program, is not mandatory.

Primary outcomes:
measure: Number of newborns in relation to the number of cases of blotting paper collected
timeFrame: From day 2 to day 4
Secondary outcomes:
measure: Number of newborns with positive sample for Mucopolysaccharidosis type I
timeFrame: From day 2 to day 4
measure: Number of newborns with positive sample for Pompe disease
timeFrame: From day 2 to day 4
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Soumeya BEKRI, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06382701: Effect of Aromatherapy on Pain, Anxiety and Satisfaction in Cannulation
Official title: The Effect of Local Aromatherapy Applied to Hemodialysis Patients Before Arterio-venous Fistula Cannulation on Pain, Anxiety and Satisfaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis Patients
Keywords: clove oil
arteriovenous fistula
pain
anxiety
satisfaction
hemodialysis
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was designed as a randomized controlled and double-blind study to evaluate the effect of clove oil applied to arterio-venous fistula on pain and anxiety caused by cannulation and to determine the effect of the application on satisfaction.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The most active members of the healthcare professionals responsible for hemodialysis units are nurses, and they have a key role in pain, anxiety and satisfaction management as they are responsible for cannulation. Therefore, complementary and integrated practices need to be implemented based on evidence to strengthen the independent role of nurses in managing pain and anxiety.


Eligibility criteria: Inclusion Criteria:

* Those who are over 18 years of age,
* Able to answer questions and communicate,
* No hearing, vision or speech impairments,
* Regularly undergoing hemodialysis three times a week,
* Having arterio-venous fistula for at least 3 months,
* Having pain during needle cannulation and scoring at least two or more points on the Visual Analogue Scale (VAS),
* Having been on hemodialysis for at least three months,
* Agreeing to participate in the study with their own consent,
* Patients who are not allergic to clove oil will be included in the study.

Exclusion Criteria:

* Having neuropathic pain,
* Patients with arterio-venous fistula and loss of sensation of more than 50% in the extremity,
* Patients with infection in the arterio-venous fistula line,
* Patients with aneurysm or pseudoaneurysm in arterio-venous fistula,
* Patients who have used analgesic medication/s in the last 6 hours,
* Patients who have used sedative agent(s) in the last 6 hours,
* Patients who used local anesthetic agents before needle intervention will not be included in the study.

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: before and after the intervention, for 1 month, 12 times
Secondary outcomes:
measure: State and Trait Anxiety Inventory (STAI)
timeFrame: before and after the study, for 1 month, 2 times
Other outcomes:
Locations:
city: Melikgazi
country: Turkey
facility: Erciyes University
state: Kayseri
Study officials:
References:
Clinical trial NCT03235401: The PAH Disability and Bothersomeness Questionnaire
Official title: "Validation of a Questionnaire Assessing Disability and Bothersomeness in Pulmonary Arterial Hypertension (PAH): The PAH Disability and Bothersomeness Questionnaire"
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Arterial Hypertension (PAH)
Keywords: Questionnaire
Disability assessment
Bothersomeness
Pulmonary Arterial Hypertension
patient-reported outcome measure
New York Heart Association (NYHA) functional class
Lead sponsor: Association de Recherche en Physiopathologie Respiratoire
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
name: Soladis
name: Interlis
First posted: 2017-08-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * 120 patients with idiopathic and heritable PAH (40 of which will be selected for a test-retest procedure)
* Patients with PAH associated with other diseases will be excluded in order to clearly circumscribe the results to PAH

Brief summary: To develop a patient-reported questionnaire to investigate the impact of PAH (pulmonary arterial hypertension) on patients' daily lives in terms of bothersomeness and disability.

Detailed description: A 3-steps study protocol was initiated in 2011 to develop a patient reported outcome measure (PROM) in PAH.The first two steps have been completed (qualitative study and Delphi consensus study) leading to the development of a provisional 37-items questionnaire. A reduction of items in this provisional questionnaire and the validation of the final questionnaire are the goals of the current study.

Eligibility criteria: Inclusion Criteria:

* patients with idiopathic and heritable PAH;
* patients over 18;
* male and female;
* NYHA Functional Class I, II, III \& IV;
* Written consent signed
* Patients with a good understanding of the French - language
* Patient affiliated with a social security scheme

Exclusion Criteria:

* Patients under 18 years of age
* Patients with other pathologies associated with PAH (Group 1)
* Patients with other forms of pulmonary hypertension (groups 2, 3, 4 and 5)
* Non-consenting patients
* Patients who do not have a good understanding of the French language

Primary outcomes:
measure: Cronbach's alpha≥ 0.7
timeFrame: at the end of the study (an average of 6 months)
Secondary outcomes:
measure: Low rate of answers (≤95%)
timeFrame: at the end of the study (an average of 6 months)
Other outcomes:
Locations:
city: Le Kremlin-Bicêtre
country: France
facility: Centre de Référence de l'Hypertension Pulmonaire Sévère, Service de Pneumologie et Soins Intensifs, Hôpital de Bicêtre,
state: Val De Marne
Study officials:
affiliation: Service de Pneumologie et Soins Intensifs, Hôpital de Bicêtre, Université Paris-Sud France
name: Olivier SITBON, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06172101: Free Fat Flap In Recurrent Neurogenic Thoracic Outlet Syndrome Surgical Treatment
Official title: Prospective Evaluation of Improvement in Pain and Quality of Life After Free Fat Flap for Treatment of Recurrent Neurological Thoracobrachial Outlet Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neurogenic Thoracic Outlet Syndrome
Keywords: Recurrent neurogenic thoracic outlet syndrome
Free fat flap
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2023-12-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients operated on for brachial plexus neurolysis and free fat flap coverage in the setting of recurrent neurological thoracic brachial outlet syndrome.

Brief summary: The Thoraco-Brachial Outlet Syndrome (T-BOS) corresponds to the entirety of clinical manifestations related to the compression of the branches of the brachial plexus and/or the subclavian vessels during their passage through the cervico-thoracic region.

Following surgery, a recurrence of symptoms occurs in 5% to 30% of operated patients. The treatment of these recurrences primarily relies on conservative therapies, and in case of failure, surgical intervention, particularly neurolysis of the brachial plexus.

In order to prevent a new recurrence, it is desirable to cover the neurolyzed brachial plexus with a flap, providing better local vascularization. However, fatty perforating flaps, by avoiding muscle harvesting, reduce donor site sequelae. We aim to investigate, through validated and recommended questionnaires, the impact of covering the neurolyzed brachial plexus with a free fatty flap after neurolysis in the context of recurrent neurological Thoraco-Brachial Outlet Syndrome.


Eligibility criteria: Inclusion Criteria:

* Patients underwent brachial plexus neurolysis and free fat flap coverage in the context of recurrence of neurological thoraco-brachial outlet syndrome

Exclusion Criteria:

* Patients were unable to express their non-opposition to participating in the study.
* patients under guardianship or trusteeship.
* patients whose mother tongue is not French.
* patients who cannot read and/or write.

Primary outcomes:
measure: Evaluating the impact on pain of covering the brachial plexus with a free fat flap
timeFrame: pre-op and six months post-op
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: Dr Lancien
Study officials:
References:
Clinical trial NCT03460301: Observational of PNH Type Cells in Korean Patients With Bone Marrow Failure Syndrome and Having Hemolytic PNH
Official title: Observational of GPI-anchored Protein-deficient (PNH-Type) Cells in Korean Patients With Bone Marrow Failure Syndrome and Having Hemolytic Paroxymal Nocturnal Hemoglobinuria (OPENK)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PNH
Lead sponsor: Handok Inc.
Sponsor class: INDUSTRY
First posted: 2018-03-09
Enrollment: 233
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Idiopatic AA/MDS/Patients who had PNH clone size \<10%

Brief summary: Patients who are positive of PNH-type cells are followed up for the percentage of PNH-type cells regularly for examining how it change.


Eligibility criteria: Inclusion Criteria:

* Patients with Commbs' test - negative
* Any patients meeting any of Idiopathic AA/MDS/Patients who had PNH clone size \<10%

Exclusion Criteria:

Primary outcomes:
measure: Time-course changes in the percentage of PNH-type cells in patients who are positive of PNH-type cells during period
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: