louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06204731: The Impact of Physical Training Under Normobaric Hypoxia on Oxidative Stress Level, Inflammatory State, Intestinal Damage, and Mitochondrial Metabolism in Young Males
Official title: The Influence of Physical Training in Normobaric Hypoxia on Prooxidant-Antioxidant Imbalance, Inflammatory Marker Levels, Intestinal Damage Degree, and Mitochondrial Energy Release Rate in Young Non-trained Males
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypoxia, Altitude
Keywords: inflammation
oxidative stress
intestinal damage
muscle damage
mitochondrial metabolism
normobaric hypoxia
training
Lead sponsor: University School of Physical Education, Krakow, Poland
Sponsor class: OTHER
Collaborators: name: Ministry of Education and Science,Poland
First posted: 2024-01-12
Enrollment: 50
Sex: MALE
Minimum age (years): 19
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: * Cognitive assessment of the influence of a 4-week proprietary training program under normobaric hypoxia conditions on the levels of inflammatory markers, disturbances in prooxidant-antioxidant balance, degree of intestinal damage, and mitochondrial energy production rate in young sedentary males.
* Applied objective: Development of practical training guidelines utilizing training in normobaric hypoxia conditions to enhance mechanisms related to oxygen transport, adaptive changes within the immune system, body's antioxidant capacity, gut permeability, substrate utilization efficiency, and mitochondrial function for coaches and athletes.


Eligibility criteria: Inclusion Criteria:

* no known metabolic diseases, no contraindications to physical exercise and no history of high altitude sickness stated in interview. A medical examination (including ECG, blood and urine tests) is required.

Exclusion Criteria:

* changes in diet during the experiment, smoking and abuse of alcohol and/or other stimulants.

Primary outcomes:
measure: Measurement of aerobic capacity (endurance)
timeFrame: 7 days before training and 7-10 days after the training. Training will last 4 weeks.
measure: Measurement of anaerobic capacity
timeFrame: 7 days before training and 7-10 days after the training. Training will last 4 weeks
measure: Blood analysis
timeFrame: 7 days before training and 7- 10 days after the training. The training will last 4 weeks and will consist of 12 workouts.
measure: Somatic indices
timeFrame: 7 days before training and 7-10 days after the training. Training will last 4 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: University School of Physical Education in Cracow
Study officials:
References:
Clinical trial NCT05228431: Modified Sandwich Therapeutic Regimen for Locally Advanced Rectal Cancer
Official title: Single Arm and Phase II Clinical Trial of a Sandwich Regimen as XELOX Regimen and Capecitabine Alternate Administration Combined With Preoperative Intensity Modulated Radiation Therapy for pMMR Locally Advanced Rectal Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Advanced Rectal Cancer
Keywords: Rectal cancer
neoadjuvant chemoradiotherapy
optimization
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In the treatment of locally advanced rectal cancer, the short-term and long-term efficacy of the traditional sandwich regimen has not reached satisfactory efficacy. For this reason, the concept of reducing the dose of postoperative chemotherapy or directly moving forward the full amount of postoperative chemotherapy was proposed, which is called total neoadjuvant therapy (TNT). However, TNT also includes the high toxicity of oxaliplatin in the whole process and the long time interval between the end of radiotherapy and the operation, which leads to fibrosis of the surrounding tissue, which increases the difficulty of surgical resection and makes it difficult to ensure good surgical specimen quality. In addition to this, there are issues that may increase the risk of potential disease progression in patients with poor treatment withdrawal. Therefore, appropriately reducing the intensity of chemotherapy and controlling the total duration of preoperative neoadjuvant therapy during radiotherapy is expected to alleviate the side effects of neoadjuvant therapy. Here, the investigators synthesized the characteristics of TNT and sandwich regimens and proposed a XELOX regimen and capecitabine alternate administration combined with preoperative intensity modulated radiation therapy.


Eligibility criteria: Inclusion Criteria:

Pathological confirmed rectal adenocarcinoma.

Clinical stage T3-4 or T any N1.With or without MRF positivity, with or without EMVI positivity, R0 resection is estimated.

No metastasis

No signs of intestinal obstruction; or intestinal obstruction has been relieved after proximal colostomy surgery.

Age ranged from 18 to 75

No previous radiotherapy，surgery and chemotherapy.

Exclusion Criteria:

Multiple primary tumor

Cachexy

Primary outcomes:
measure: Rate of pCR
timeFrame: One week after surgery
Secondary outcomes:
measure: DFS
timeFrame: 3 years
measure: OS
timeFrame: 5 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhenhai Lu
state: Guangdong
Study officials:
References:
Clinical trial NCT02646631: Behavioral and Educational Tools to Improve Epilepsy Care
Official title: Behavioral and Educational Tools to Improve Epilepsy Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: UCB Pharma
First posted: 2016-01-05
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The long-term goal of this research is to improve seizure control among patients with epilepsy, which has the potential to improve quality of life for thousands of people living with epilepsy and reduce health care utilization, social and economic costs, and epilepsy-related mortalities. Participants who are suffering from epilepsy will be randomized to receive usual care (UC), a smartphone-based self-management intervention called Management of Risks in Epilepsy (MORE), or MORE + telephone-based motivational interviewing (MI). Participants will be followed for 3 months.


Eligibility criteria: Inclusion Criteria:

1. At least 18 years of age
2. English- or Spanish-speaking
3. Partial (focal) or generalized epilepsy (as confirmed with epileptiform activity on an electroencephalogram)
4. Poor medication adherence
5. Willing and able to use a smartphone (provided by the study) to manage disease.

Exclusion Criteria:

1. Known or suspected psychogenic nonepileptic seizures as sole seizure type
2. Active psychotic disorder

Primary outcomes:
measure: Percent adherence to anti-epileptic drug schedule (pill counts)
timeFrame: 3 months
Secondary outcomes:
measure: Number of patients who complete the study
timeFrame: 3 months
measure: Percentage of MI sessions completed
timeFrame: 3 months
measure: Percentage of diary entries completed
timeFrame: 3 months
measure: Adherence to anti-epileptic drug schedule (self-reported) as measured by the Morisky Medication Adherence Scale
timeFrame: 3 months
measure: Seizure frequency
timeFrame: 3 months
measure: Quality of life as measured by the Quality of Life in Epilepsy questionnaire score
timeFrame: 3 months
measure: Quality of life as measured by the PROMIS-10 questionnaire score
timeFrame: 3 months
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Tanya Spruill
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05437731: Titanium Mesh Coated With Natural Hydroxyapatite Nanocrystals in Orbital Reconstruction
Official title: Evaluation of Titanium Mesh Coated With Natural Hydroxyapatite Nanocrystals in Orbital Reconstruction (Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Orbital Deformity
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-06-29
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Reconstruction of maxillofacial continuity defects has always been a challenging task for scientists and surgeons over the years. The main goal of the reconstruction of the maxillofacial region is to restore facial form, function, and full rehabilitation of occlusion and articulation. A refinement in surgical technique and methods of reconstruction has improved patients' quality of life. Aim of this study: Evaluation of titanium mesh coated with natural hydroxyapatite in orbital reconstruction.

Detailed description: Twelve patients having orbital defects will be selected. Six defects will be reconstructed using titanium mesh coated with natural hydroxyapatite nanocrystals (study group) and the other six will be treated with uncoated titanium mesh (control group). Patients will be evaluated clinically, then a radiographic follow-up will be performed immediately postoperatively and after three months to evaluate the bone density at the defect. Also, the coated and uncoated titanium mesh will be mechanically evaluated to compare the tensile strength of the two groups.

Eligibility criteria: Inclusion Criteria:

* All patients requiring reconstruction of acquired orbital defects using titanium mesh.
* Both genders with age group ranging from 18-60 years old.
* Limited size defects according to Cordeiro and Santamaria.
* Isolated unilateral or bilateral orbital fractures or combined with other facial fractures.
* Orbital reconstruction after removal of benign pathological lesions.

Exclusion Criteria:

* Infected fracture sites.
* Chronic systemic diseases such as uncontrolled diabetes, rheumatoid arthritis, metabolic bone disease, immunocompromised status etc.
* Defects requiring soft tissue reconstruction.
* Patients suffering from burns.
* Patients suffering from carcinomas and sarcomas in the oral cavity.

Primary outcomes:
measure: Change in wound healing criteria
timeFrame: after 24-hours, one week, four weeks, and six weeks
measure: Change in bone density
timeFrame: at baseline and 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University
Study officials:
References:
Clinical trial NCT05494931: Effect of Superficial Keratotomy on Reducing Postoperative Pain Fallowing Conjuctival Flap
Official title: Effect of Superficial Keratotomy on Reducing Postoperative Pain Fallowing Conjuctival Flap
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reduced Corneal Sensation
Keywords: keratotomy.conjuctival flap.radial corneal nerve
Lead sponsor: Iran University of Medical Sciences
Sponsor class: OTHER
First posted: 2022-08-10
Enrollment: 9
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: During conjunctival flap surgery the corneal epithelium is removed and a conjunctival flap is placed on the cornea and after a few weeks the conjunctiva covers the surface of the eye.

Complications of this operation are flap retraction, conjunctival inclusion cysts, bleeding, infection and pain. Pain is one of the main complications of conjunctival flap surgery. Two sources are conceivable for pain: 1) conjunctival pain 2) corneal pain, the second of which is the main part of the pain.

Numerous methods for controlling corneal pain have been reported in various articles. Eye patches are often recommended for the treatment of corneal abrasions despite the lack of evidence. Recommended analgesics to control corneal scratch pain include nonsteroidal anti-inflammatory drugs (NSAIDs), local anesthetics, and topical cycloplegias.

In this article, we are going to review and evaluate a new method called corneal neuorotomy, i.e., corneal nerve endings that inserted radially can be cut to reduce postoperative pain.

Detailed description: The main idea of this randomized clinical trial is to test the extent of pain relief after incision of radial corneal nerve endings.

Patients are divided into two groups. In the first group, the same classic method of conjunctival flap surgery was used and in the second group, conjunctival flap surgery was performed adjuncted by cutting the radial superficial nerves of the cornea. The postoperative pain scores of these two groups will be measured using visual analogue scale, after 6 hours, 24 hours and 48 hours, and finally the average pain of the two groups will be compared.

Eligibility criteria: Inclusion Criteria:

* VLE (vision loss eye)Patients who are candidates for prosthesis implantation

Exclusion Criteria:

* 1 painful vision loss eye
* 2 Patients who are candidates for conjunctival flap with indications other than implant placement (such as pain due to corneal ulcers, etc.)

Primary outcomes:
measure: postoperative pain 6 hours after conjunctival flap
timeFrame: 6 hours after surgery
measure: postoperative pain 24 hours after conjunctival flap
timeFrame: 24 hours after surgery
measure: postoperative pain 48 hours after conjunctival flap
timeFrame: 48 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Eye Research Center
state: Tehrani
Study officials:
References:
Clinical trial NCT03775031: Chemical Peels and Fractional Laser on IGF-1 Levels in Skin
Official title: Impact of Chemical Peels and Fractional Laser on IGF-1 Levels in Skin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Skin Cancer
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2018-12-13
Enrollment: 20
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Randomized-Controlled (Subjects will serve as their own control)
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the impact of fractional laser versus chemical peels on IGF-1 levels in skin.

Detailed description: This study is designed to assess the feasibility of using a fractional non ablative laser and chemical peels to wound skin, and thereby elicit a change in IGF-1. Our hypothesis is that fractional non ablative laser and a TCA chemical peel can induce similar effects as the fractional ablative laser at three months. In other words, our theory is that these approaches can stimulate the production of IGF-1 in older skin and restore UV damage repair and response mechanisms.

Eligibility criteria: Inclusion Criteria:

* Male and female subjects \>55 years old
* Fitzpatrick type I-II
* Able to provide informed consent.
* Cutaneous photodamage of 3 or above on the Larnier photodamage scale (see Appendix).

Exclusion Criteria:

* Prior laser or peel treatment in the area evaluated in the current study in the past year.
* Currently taking immunosuppressant medications known to interfere wound healing or anti-inflammatory medications (such as NSAIDs, or steroids).
* Subjects who have underlying diseases that could alter wound healing response (such as Diabetes).
* Currently taking insulin.
* History of substance abuse, mental dysfunction, or other factors limiting ability to cooperate with study.
* History of abnormal scarring such as Keloids.
* History of vitiligo.
* Allergy or sensitivity or allergy to topical anesthesia
* Inability to use sunscreen.
* History of smoking in the last 10 years
* Scar or prior surgery in the area of treatment.
* Use of isotretinoin in the prior 6 months
* Subjects who have bleeding disorders or who are taking anticoagulants

Primary outcomes:
measure: IGF-1 Levels
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Clinical Unit for Research Trials and Outcomes in Skin
state: Massachusetts
Study officials:
References:
Clinical trial NCT04153331: Burden of Influenza at Emergency Department Level : BIED
Official title: Burden of Influenza at Emergency Department Level : BIED
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emergencies
Flu
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-11-06
Enrollment: 2487
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Seasonal influenza surveillance in France relies on several sources to detect the onset of the epidemic early, as well as to estimate the severity of epidemics and their impact on the health system. However, the data collected do not fully measure the impact of epidemics on the hospital system.

Increasing the investigator's knowledge of the impact of influenza on the hospital system, particularly on emergencies, which are the most affected service, is essential to better adapt the resources put in place to care for patients.

The study will allow a better understanding of the influenza burden, by systematically documenting the severe events (i.e. requiring consultations to the Emergency Rooms) that are triggered by influenza but not necessarily reported/recorded as influenza.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Consultation for a medical cause

Exclusion Criteria:

* Consultation for a non-medical cause (trauma...)
* Pregnant, parturient and lactating women
* Persons deprived of their liberty
* Persons of full age who are subject to a legal protection measure
* Persons not affiliated to a social security system

Primary outcomes:
measure: Proportion of laboratory confirmed influenza among patients admitted to Emergency Room during the influenza season
timeFrame: 1 day (at admission)
Secondary outcomes:
measure: Proportion of patients with co-morbidities
timeFrame: 1 day (at admission)
measure: Proportion of patients with laboratory confirmed influenza and related outcomes
timeFrame: 1 day (at admission)
measure: Proportion of patients who consult for other causes than influenza
timeFrame: 1 day (at admission)
measure: Proportion of asymptomatic influenza cases among patients with laboratory confirmed influenza
timeFrame: 1 day (at admission)
Other outcomes:
Locations:
city: Lyon
country: France
facility: Service Hygiène, Epidémiologie et Prévention
Study officials:
affiliation: Service Hygiène, Epidémiologie et Prévention
name: Philppe VANHEMS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06460831: A Comparative Study Evaluating the Vein of MArshall Ethanol Infusion Ablation Using an Over-the-wire (OTW) Balloon Versus a microcatHeter in Patients With Atrial Fibrillation
Official title: A Comparative Study Evaluating the Vein of MArshall Ethanol Infusion Ablation Using an Over-the-wire (OTW) Balloon Versus a microcatHeter in Patients With Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Atrial Flutter
Keywords: marshall vein
mitral valve isthmus line
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to compare OTW balloon with microcatheter in the Marshall vein alcohol ablation study. The main questions it aims to answer are: • Is there a difference in the effectiveness and safety of OTW balloon and microcatheter in Marshall vein alcohol ablation? Participants will be asked to:

Undergo treatment with OTW balloon Undergo treatment with microcatheter If there is a comparison group: Researchers will compare the OTW balloon group and the microcatheter group to see different effects.


Eligibility criteria: Inclusion Criteria:

1. Age range: 18-80 years.
2. Persistent atrial fibrillation or atrial flutter dependent on the mitral isthmus.
3. Inadequate response to antiarrhythmic drug therapy, or intolerance to antiarrhythmic drugs.
4. New York Heart Association functional class ≤ IV,with left ventricular ejection fraction (LVEF) ≥ 35%

Exclusion Criteria:

1. Patients with known allergies to alcohol.
2. Participants with a history of serious cardiovascular events such as myocardial infarction or stroke within the past three months will be excluded from the study

Primary outcomes:
measure: Acute rate of mitral isthmus block
timeFrame: During catheter ablation procedures
measure: Procedural complications
timeFrame: During catheter ablation procedures
measure: Recovery rate of the mitral isthmus line
timeFrame: beyond 3 months after the ablation procedure.
Secondary outcomes:
measure: Procedural characteristics
timeFrame: Periprocedural period
measure: Hospitalization costs
timeFrame: Periprocedural period
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong University of Traditional Chinese Medicine
state: Shandong
city: Shanghai
country: China
facility: Ren Ji Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
city: Taizhou
country: China
facility: Yuhuan Second People's Hospital
state: Zhejiang
city: Changshu
country: China
facility: Changshu Hospital of Traditional Chinese Medical
Study officials:
References:
Clinical trial NCT03401931: Artificial Intelligence Use for the Detection of Atrial Fibrillation Drivers
Official title: Artificial Intelligence Use for the Detection of Atrial Fibrillation Drivers
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Fibrillation, Atrial
To Evaluate the Intraoperative Efficiency of the AIFIB Software in the Detection of Atrial Fibrillation Driver During an Ablation Procedure
Lead sponsor: Hospital St. Joseph, Marseille, France
Sponsor class: OTHER
First posted: 2018-01-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: major patient with an indication of AF or AT ablation

Brief summary: pilot clinical study, multicenter, prospective, open, nonrandomized

Detailed description: The hypothesis is that ablation targeting PVI alone for the treatment of persistent AF is less efficient that ablation targeting electrophysiologic areas with spatio-temporal-dispersion with or without PVI

Eligibility criteria: Inclusion Criteria: major patient with an indication of AF or AT ablation -

Exclusion Criteria:

-

Primary outcomes:
measure: AF termination
timeFrame: during the ablation procedure
Secondary outcomes:
measure: AT termination
timeFrame: during the ablation procedure
Other outcomes:
Locations:
city: Aix-en-Provence
country: France
facility: Hopital d'Aix en Provence
city: Nice
country: France
facility: CHU Nice
city: Zwolle
country: Netherlands
facility: Isala Hospital
state: Netherland
Study officials:
affiliation: Hopital saint Joseph
name: Julien SEITZ, MD
role: PRINCIPAL_INVESTIGATOR
References: