louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01903655: Study of the Telomere-telomerase System and the Expression of Candidate Genes in the Leukocytes of Patients With Depressive Disorder: Search for Peripheral Markers of Somatic Stress
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depressive Disorder
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2013-07-19
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The mechanisms of oxidative stress and inflammation involved in mood disorders are factors of chronicity and severity. These mechanisms induce a phenomenon of accelerated cellular senescence and are reflected by alterations in systemic gene expression detectable in leukocytes in peripheral blood. The genetic markers of these mechanisms are clinically significant markers. The identification of new genetic markers will make it possible to improve evaluations of the severity and somatic consequences of depressive syndromes.


Eligibility criteria: Inclusion Criteria:

* Persons who have given their written informed consent
* absence of a diagnosis of major depressive disorder throughout the study and no history of psychiatric disorders
* diagnosis of a first episode of a major depressive disorder
* diagnosis of a recurrent major depressive disorder (at least three episodes) with or without resistance to therapy

Remarks:

* the diagnosis of major depressive disorder with characteristics of melancholy must be clearly mentioned in the case report form but is not a reason for not being included in the study
* the presence of a recent or older attempted suicide must lead to a careful clinical assessment of the diagnosis of depressive disorder and must be clearly mentioned in the case report form.

Exclusion Criteria:

* Persons not covered by the national Health Insurance Agency
* Psychotic or bipolar disorders
* Severe personality disorders
* cardiovascular disease, proven inflammatory disease and cancer
* persons unable to give their consent personally,
* persons in emergency situations,
* pregnant women,
* breast-feeding women

Primary outcomes:
measure: Telomere length
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 6 months
Secondary outcomes:
measure: level of oxidative stress.
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 6 months
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU de Dijon
Study officials:
References:
Clinical trial NCT03823755: Evaluation of the Mobility of the Digital Flexor Tendons
Official title: Evaluation of the Mobility of the Digital Flexor Tendons Operated by Dynamic MRI: a Pilot Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Flexor Digitorum Longus on the Right
Flexor Digitorum Longus on the Left
Tendon Rupture
Tendon Injury - Hand
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2019-01-30
Enrollment: 15
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: Adult patient with flexor tendon injury in zone 2 and insufficient functional after surgery with MRI requested for exploration

Brief summary: To study flexor tendon excursion in the hand after surgery by dynamic MRI

Detailed description: The study of the movement of the digital flexor tendon operated on MRI could lead to a better understanding of the biomechanics of this tendon after surgery, to objectively assess the repair of the tendon and the recovery of its mobility. The visualization of the aspect and the movement of this operated tendon would make it possible to adapt the rehabilitation for each patient and to prevent the occurrence of complications which limit functional recovery and source of handicap.

The analysis of the imaging in patients evolving would establish useful criteria the surgeon to judge the evolution of the operated tendon.

The first step consists in evaluating the feasibility of the acquisition of dynamic sequences in MRI and the possibility of observing the movement of the flexor tendon operated during the mobilization of the finger, and comparing the biomechanical data obtained with those of the nonoperated tendons and experimental models.

Eligibility criteria: Inclusion Criteria:

* flexor tendon injury in zone 2
* treatment by surgery
* insufficient functional outcome after surgery
* MRI requested by surgeon

Exclusion Criteria:

* pregnancy
* MRI contraindications
* previous surgery on the hand
* rheumatic disorder

Primary outcomes:
measure: Flexor tendon excursion
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
city: Brest
country: France
facility: Clinique Keraudren
city: Brest
country: France
facility: HIA
Study officials:
References:
Clinical trial NCT04360655: Bronchoscopic Microwave Intervention Treatment in Advanced Central NSCLC
Official title: A Randomized, Prospective Study of the Efficacy and Safety of the 1st Treatment in Advanced Central NSCLC by PD-1/PD-L1 Inhibitor and Chemotherapy With/Without Bronchoscopic Microwave Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Effect Increased
Safety Issues
Keywords: anti-PD-1 / PD-L1 monoclonal antibody
chemotherapy
bronchoscopic microwave intervention
advanced central non-small cell lung cancer patients
Lead sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized, prospective study of the efficacy and safety of the first-line treatment in advanced central non-small cell lung cancer patients by anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy versus anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy combined with bronchoscopic microwave intervention

Detailed description: This study is a randomized, prospective study, which will analyze the efficacy and safety of the first-line treatment in advanced central non-small cell lung cancer patients by anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy versus anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy combined with bronchoscopic microwave intervention. The efficacy will include objective response rate, disease control rate, progression-free survival, and overall survival. The safety will include adverse events and quality of life.

Eligibility criteria: Inclusion Criteria:

* advanced central non-small cell lung cancer patients, untreated, tolerating bronchoscopy

Exclusion Criteria:

* contraindications to tracheoscopy, chemotherapy, and immunotherapy

Primary outcomes:
measure: objective response rate
timeFrame: 6 weeks
measure: progression-free survival
timeFrame: 1 years
Secondary outcomes:
measure: disease control rate
timeFrame: 6 weeks
measure: overall survival
timeFrame: 2 years
measure: adverse events
timeFrame: 3 weeks
measure: quality of life score
timeFrame: World Health Organization Quality of Life Scale-Brief (WHOQOL-BREF)score 0-100，higher scores mean a better outcome.
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai Pulmonary Hospital, Shanghai, China
name: Caicun Zhou, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01010555: In-vivo Wettability Grading and Assessment Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
Collaborators: name: University of Waterloo
First posted: 2009-11-10
Enrollment: 25
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the front surface wettability of soft contact lenses while on eye.


Eligibility criteria: Inclusion Criteria:

* is at least 17 years of age
* has read and signed an information consent letter
* is a current daily wear contact lens wearer
* has acceptable fit with the study lenses
* has had an ocular exam in the last two years
* other protocol-defined inclusion criteria may apply

Exclusion Criteria:

* has any ocular disease
* has undergone corneal refractive surgery or is aphakic
* has any systemic disease affecting ocular health
* is pregnant or lactating
* other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: On-eye Wettability
timeFrame: 4 weeks of wear
Secondary outcomes:
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: Centre for Contact Lens Research: University of Waterloo
state: Ontario
Study officials:
References:
Clinical trial NCT06211855: Cerebroplacental Ratio and Perinatal Outcomes in Mild and Moderate Idiopathic Polyhydramios Cases
Official title: Cerebroplacental Ratio and Perinatal Outcomes in Mild and Moderate Idiopathic Polyhydramios Cases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Polyhydramios Cases
Keywords: polyhidramnios,cerebroplacental ratio
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women diagnosed with mild-moderate IP and randomly selected low-risk singleton pregnancies without polyhydramnios were included in the study one-on-one by matching their gestational ages.

Brief summary: This study aims to evaluate the predictability of fetal Doppler parameters in terms of perinatal adverse outcomes in singleton pregnancies with mild and moderate idiopathic polyhydramnios

Detailed description: Pregnant women diagnosed with mild-moderate IP and randomly selected low-risk singleton pregnancies without polyhydramnios were included in the study one-on-one by matching their gestational ages. The diagnosis of polyhydramnios was made if the AFI was 24 cm and above.

Eligibility criteria: Inclusion Criteria:

* Pregnant women diagnosed with mild-moderate IP ,selected low-risk singleton pregnancies without polyhydramnios

Exclusion Criteria:

* Women who had chromosomal or anatomical abnormalities, multiple pregnancies, oligohydramnios (AFI 5 cm), severe polyhydramnios, fetal growth restriction, elective cesarean section (CS), pre-existing conditions (hypertension, diabetes, thrombophilia), or obstetric complications (gestational hypertension, preeclampsia, gestational diabetes) were excluded

Primary outcomes:
measure: perinatal outcome
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Meram
country: Turkey
facility: Necmettin Erbakan University
state: Konya
Study officials:
affiliation: NECMETTİN ERBAKAN UNIVERCITY
name: şükran doğru
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03337555: A Comparison of McGrath MAC®, Pentax-AWS® and Macintosh Direct Laryngoscopes for Nasotracheal Intubation
Official title: A Comparison of McGrath MAC®, Pentax-AWS® and Macintosh Direct Laryngoscopes for Nasotracheal Intubation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation;Difficult
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2017-11-09
Enrollment: 123
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: A comparison of intubation time, difficulty of intubation in nasotracheal intubation using McGrath MAC®, Pentax-AWS® and Macintosh direct laryngoscopes

Detailed description: This trial is prospective randomized trial. The Objects are adult patients who need nasotracheal intubation for surgery. Using computed randomized table, participants are assigned to three groups, McGrath MAC®, Pentax-AWS® and Macintosh direct laryngoscopes.

The intubation will be done by One expert anesthesiologist who have more than 10 years experience.

Investigators compare intubation time, success rate and difficulty between three groups.

Eligibility criteria: Inclusion Criteria:

* Age \> 19 years old
* ASA I or II
* Patients who need nasotracheal intubation for surgery

Exclusion Criteria:

* Anatomical deformity in head and neck
* Modified Mallampati score IV
* Bleeding tendency in preoperative evaluation

Primary outcomes:
measure: Intubation time
timeFrame: within 5 minutes
Secondary outcomes:
measure: Success rate
timeFrame: within 5 minutes
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou university schoole of medicine
state: Gyeonggi-do
Study officials:
affiliation: Ajou University School of Medicine
name: Yun Jeong Chae, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01746355: Assessment and Treatment Patients With Atypical Facial Pain Trough Repetitive Transcranial Magnetic Stimulation
Official title: Assessment and Treatment Patients With Atypical Facial Pain Trough Repetitive Transcranial Magnetic Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atypical Facial Pain or Atypical Odontalgia
Keywords: atypical facial pain
atypical odontalgia
repetitive transcranial magnetic stimulation
neuropathic pain
chronic pain
assessment
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2012-12-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Atypical Facial Pain is a chronic condition and presents controversies during diagnostic and treatment, between specialist not have consensus about the pathophysiology. It is possible consider this entitie a potential neuropathic cause without pathological signs. It knows the repetitive transcranial magnetic presents good results in the treatment of chronic pain coditions. The aim this study is evaluated the thresholds and excitability cortical in patients with AFP and verify the patterns of improvement in pain for patients undergoing rTMS compared to controls, as well as the therapeutic response to neuromodulation procedures. This enroll 20 patients with DAF and 20 controls treated with rTMS (5 sessions) and evaluated through questionnaires (EDOF clinical record, McGill Pain Questionnaire, Visual Analogue Scale, Inventory of symptoms of neuropathic pain, neuropathic pain DN4 questionnaire, SF -36, brief pain inventory). At the end of the data will be statistically analyzed and expressed as mean and standard deviation, and analyzed by Student's t test, analysis of variance (ANOVA), Tukey-Kramer and Pearson correlation. The level of significance is 5%. The results will be published in journals indexed in the area both nationally and internationally and presented at conferences and scientific meetings.


Eligibility criteria: Inclusion Criteria:

* Fulfill criteria of Atypical Facial Pain by International Headache Society
* Signed Term of Informed Consent

Exclusion Criteria:

* Trauma of Skull, epilepsy don't treated,
* Use of medications decrease the seizure threshold
* Patients in use of drugs, how cocaine and alcohol
* neurosurgical clips, pacemakers, increased intracranial pressure (risk of sequelae after seizure)
* Pregnant or lacting women

Primary outcomes:
measure: Change in Baselin of Pain
timeFrame: base line (moment of inclusion) and end of each session rTMS (4X in three months)
Secondary outcomes:
measure: Excitability cortical
timeFrame: baseline (in the moment of inclusion) and end of each session of rTMS (4X in three months)
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC/FMUSP)
state: SP
Study officials:
References:
Clinical trial NCT01379755: Comparison of Stability and Outcomes in Single-radius Femoral Component for Total Knee Arthroplasty
Official title: Study of Compare Mid-flexion Stability and Clinical Outcomes in Single-radius Femoral Design or Multi-radius Femoral Design.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoarthritis
Keywords: stability
single-radius
multi-radius
total knee arthroplasty
Lead sponsor: Chonnam National University Hospital
Sponsor class: OTHER
First posted: 2011-06-23
Enrollment: 213
Sex: ALL
Minimum age (years): 48
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 56 total knee arthroplasties(TKAs) with a single-radius femoral design (Scorpio NRG) (single-radius(SR) group) and 59 total knee arthroplasties(TKAs) with multiradius femoral design (NexGen CR) (multi-radius(MR) group)

Brief summary: This is a comparison of the functional results and Varus-Valgus Stability in Single-radius versus Multi-radius Femoral Component for Total Knee Arthroplasty.

Detailed description: Recently, femoral designs based on a sagittal single radius were designed to allow better mid-flexion stability and extensor function after total knee arthroplasty. The purpose of this study was to compare mid-flexion stability and clinical outcomes in patients that received TKA using either a single-radius femoral design or multi-radius femoral design.

Eligibility criteria: Inclusion Criteria:

* followed for a minimum of two years.

Exclusion Criteria:

* Not followed for a minimum of two years.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hwasun-Gun
country: Korea, Republic of
facility: Center for Joint Disease, Chonnam National University Hwasun Hospital
state: Jeonnam
Study officials:
affiliation: Center for Joint Disease, Chonnam National University Hwasun Hospital, Jeonnam, Korea
name: Jong Keun Seon, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05157555: Quality of Life in Patients After Pharyngolaryngectomy
Official title: Quality of Life in Patients After Pharyngolaryngectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Laryngectomy; Status
Keywords: Laryngeal cancer - laryngectomy - quality of life
Lead sponsor: Université de Reims Champagne-Ardenne
Sponsor class: OTHER
First posted: 2021-12-15
Enrollment: 60
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: patients with laryngectomy

Brief summary: Laryngeal cancer is an indication for a laryngectomy (separation of the airways and digestive tract). Laryngectomy causes a permanent disruption of self-perception. Communication, social interactions, diet andaesthetic appearance are altered. Its modifications disrupt the quality of life of patients and must be taken into account as soon as possible in patient cares.

Detailed description: The aim of the study is to describe quality of life in patients with laryngectomy.

Eligibility criteria: Inclusion Criteria:

* male or female
* with laryngectomy
* agreeing to participate in the study

Exclusion Criteria:

- less than 18 years old

Primary outcomes:
measure: EORTC QLQ-C30
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
References:
Clinical trial NCT00750555: Maintenance of Tarceva (Erlotinib) in Patients With Locally Advanced Head and Neck Cancer
Official title: Phase II Study of Maintenance of Tarceva (Erlotinib) in Patients With Locally Advanced Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Head and Neck Cancer
Keywords: squamous cell cancer of head and neck
SCCHN
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2008-09-10
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: Phase II Study of Maintenance Tarceva (Erlotinib) in patients with locally advanced Head and Neck Cancer after treatment with curative intent


Eligibility criteria: Inclusion Criteria:

* Stage III, IV SCCHN
* Completed curative treatment

Exclusion Criteria:

* Prior chemotherapy or radiotherapy
* Recurrent disease

Primary outcomes:
measure: One Year Disease Free
timeFrame: 1 year
Secondary outcomes:
measure: Overall Survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Danville
country: United States
facility: Geisinger Health System
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: Amy Law, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00979355: Study to Compare a Fast Gama Camera for Nuclear Imaging to Conventional Camera
Official title: Evaluation of Multi Purpose D-spect Camera for General Nuclear Scans
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Detect Pathalogical Lesions
Keywords: Whole body
SPECT
Lead sponsor: Spectrum Dynamics
Sponsor class: INDUSTRY
First posted: 2009-09-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A feasibility trial to evaluate the usefulness of a high efficiency camera (D-SPECT) as an imaging modality for general nuclear medicine applications such as oncology.


Eligibility criteria: Inclusion Criteria:

1. Patient is referred to nuclear medicine department for a SPECT scan.
2. Written informed consent is obtained by a study investigator.

Exclusion Criteria:

1. Patient pregnancy (known or suspected).
2. Lack of written informed consent
3. Prisoner status
4. Patient under age 18 or over 80 years old.

Primary outcomes:
measure: A comparison of high efficiency camera images (D-SPECT) to a conventional camera (A-SPECT) with respect to the ability to detect pathological lesions.
timeFrame: 12 month
Secondary outcomes:
measure: A comparison of high efficiency camera images (D-SPECT) to a conventional camera (A-SPECT) with respect to image quality/resolution
timeFrame: 12 month
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
Study officials:
affiliation: Bnai Zion Medical Center
name: MIGUEL GORENBERG, MD
role: PRINCIPAL_INVESTIGATOR
References: