louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03107260: The Association Between Variation in Oxygen Saturation (ScO2) and Incidence of Postoperative Cognitive Dysfunction (POCD) in a Population of Elderly Patients Admitted for Emergency Surgery.
Official title: The Association Between Variation in Oxygen Saturation (ScO2) and Incidence of Postoperative Cognitive Dysfunction (POCD) in a Population of Elderly Patients Admitted for Emergency Surgery.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Saturation
Cognitive Impairment
Emergencies
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2017-04-11
Enrollment: 300
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: There is no study of the association between ScO2 and POCD in non-cardiac, thoracic or vascular surgery. The few studies found in cardiac, thoracic and vascular surgery show an incidence up to 50% with a variation of the ScO2 threshold which varies between 15 and 25% according to the studies.

Age is the main risk of OCDD. The management of this pathology should be early to avoid loss of autonomy of the patient. Finding a relationship, if it exists, would therefore significantly improve the mortality and morbidity of the said patient.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 65 years
* Non-cardiac, thoracic and vascular emergency surgery
* Surgery under general anesthesia
* ASA I, II or III
* Simple information without consent
* Patient affiliated to social security

Exclusion Criteria:

* Inability to understand
* Patient under tutelage, or curatorship or deprived of public right
* ASA IV
* History of severe dementia MMSE \<20
* Personal or familial history of malignant hyperthermia
* History of allergy or hypersensitivity to anesthetic products used
* Contra-indication to Cisatracurium®: myasthenia gravis
* Contra-indication to Sevoflurane®
* Contra-indication to local anesthetics
* Indication of use of a Ketamine®-type hypnotic (modification of the BIS)
* Indication of use of nitrous oxide
* History of cranial trauma
* Neuromuscular pathology
* Spinal anesthesia
* Cardiac, thoracic or vascular surgery
* Surgery not performed in emergency
* Neurochirugia in the context of cranial trauma
* Any surgery that does not allow the use of the NIRS (impossibility of positioning of the electrodes by the location of the surgical field).

Primary outcomes:
measure: Occurrence of POCD
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
state: Picardie
Study officials:
References:
Clinical trial NCT02375360: OIT Effect on FAQLQ
Official title: Quality of Life in Food Allergic Patients Before, During and After Oral Immunotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Food Allergy
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2015-03-02
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children, teenagers and their parents and adults with food allergy

Brief summary: Patients with food allergy and their parents will answer a food allergy quality of life questionnaire that will be translated to Hebrew and validated. Questionnaires will be filled also by patients undergoing oral immunotherapy (OIT).

Detailed description: The food allergy quality of life questionnaires (FAQLQ) for children 8-12 y/o, teenagers 13-17 y/o and adults \> 18 y/o and parents to children 0-12 y/o and to teenagers will be translated to Hebrew. Questionnaires will be given to patients with food allergy followed at Asaf Harofeh Medical Center. Questionnaires will be examined for internal consistency. The Food Allergy Independent Measure (FAIM) questionnaire for the same age groups will also be translated to Hebrew. The FAQLQ will be validated by correlation with the FAIM.

The questionnaires will then be administered to patients and families undergoing food oral immunotherpy, before during and following treatment.

Eligibility criteria: Inclusion Criteria:

* Patients with suspected food allergy

Exclusion Criteria:

* none

Primary outcomes:
measure: Quality of life
timeFrame: 1 - 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Asaf Harofeh Medical Center
Study officials:
References:
Clinical trial NCT06639360: Effects of Transcranial Magnetic Stimulation After Endovascular Treatment for Acute Ischemic Stroke
Official title: Effects of Transcranial Magnetic Stimulation After Endovascular Treatment for Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ischemic Stroke, Acute
Endovascular Thrombectomy
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicenter, randomized, double-blind, sham-controlled trial, to determine the efficacy and safety of cTBS in treating patients with acute ischemic stroke after endovascular treatment.


Eligibility criteria: Inclusion Criteria:

1. Patients with acute anterior circulation ischemic stroke aged between 18 and 80 years old.
2. Imaging suggests that the infarction is caused by occlusion of the terminal portion of the internal carotid artery or the M1 segment of the middle cerebral artery.
3. DWI shows an infarct volume less than one-third of the MCA territory, with onset of symptoms ≤6 hours, or a head CT within 24 hours of onset indicating an ASPECT score ≥6.
4. Symptom onset time is ≤6 hours or between 6-24 hours with multimodal imaging (assessment) confirming eligibility for thrombectomy.
5. Pre-stroke mRS score is ≤1.
6. NIHSS score before thrombectomy is between 6 and 25.
7. With vascular recanalization of mTICI \> 2b/3.

6. Informed consent form signed.

Exclusion Criteria:

1. Patients with contraindications to TMS treatment, such as those with metallic foreign objects in the head, pacemakers, implantable drug pumps, cochlear implants, etc.;
2. Patients with epilepsy, increased intracranial pressure, tumors, acute cerebral hemorrhage, or other severe neurological diseases, and those with severe functional impairment of organs such as the heart, liver, and kidneys;
3. Head CT/MRI indicates midline shift or significant mass effect, or patients planned for surgical intervention;
4. Head CT/MRI suggests acute cerebral infarction in both sides;
5. Patients with a history of congenital or acquired bleeding disorders, coagulation factor deficiencies, or thrombocytopenia;
6. Patients with blood pressure more than 180/110 mmHg after antihypertensive treatment;
7. Patients who are pregnant or breastfeeding;
8. Patients with severe mental disorders or dementia who cannot cooperate with follow-up;

6. Patients with other severe diseases resulting in an expected survival of less than 90 days; 7. Patients who are participating in other interventional clinical studies within 30 days before the start of this study or after the onset of this condition; 8. Patients who cannot cooperate with informed consent.

Primary outcomes:
measure: Changes of infarct volumes from baseline to Day 5
timeFrame: 5 days after enrollment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00595660: Best Needle Size for FNA of Palpable Breast Mass:Randomised Controlled Study
Official title: Best Needle Size for FNA of Palpable Breast Mass:Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Palpable Breast Mass
Keywords: Palpable Breast Mass
FNA
Cytology
Fine needle aspiration
Specimen Adequacy
Lead sponsor: Kashani Social Security Hospital
Sponsor class: OTHER
First posted: 2008-01-16
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Needle size from22 to 25 were used for fine needle aspiration of palpable breast lumps. In this study we choose one, randomly, and fallow the result of cytologic evaluation regarding specimen adequacy.

Detailed description: Patient assigned randomly to FNA of palpable breast mass with different needle size:21-22-23-24

Eligibility criteria: Inclusion Criteria:

* Any Woman with palpable Breast Mass

Exclusion Criteria:

* Previous open Biopsy or Surgery
* Active infection
* Breast cysts
* Patient refusal to do FNA

Primary outcomes:
measure: specimen adequacy
timeFrame: 2 years
Secondary outcomes:
measure: complication
timeFrame: 1 year
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Kashani Social Security Hospital
Study officials:
affiliation: Kashani Social Security Hospital
name: Bijan Mohammadhosseini, General Surgeon,MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04213560: The Effects of Weighted Waist-Hooping
Official title: The Effects of Weighted Waist-Hooping on Balance, Proprioception, and Body Awareness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Weighted waist-hooping
Balance
Proprioception
Neurocom
Lead sponsor: VA Puget Sound Health Care System
Sponsor class: FED
First posted: 2019-12-30
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Purposes: 1) To determine the effects of weighted waist-hooping on balance in healthy individuals and 2) to observe whether these effects are attributed to neuromuscular conditioning or core strength gains.

Methods: 27 females (ages 20-45) were included, 15 in the intervention group, and 12 in the control. The intervention consisted of six weeks of weighted waist-hooping four times a week for 10 minutes each session. Balance was assessed pre and post intervention using the BESS, SEBT, and Neurocom SOT. Core strength was assessed using hold duration of a bilateral and unilateral plank.


Eligibility criteria: Inclusion Criteria:

* healthy women age 18-45.

Exclusion Criteria:

* pregnancy and vertigo

Primary outcomes:
measure: Balance Error Scoring System (BESS)
timeFrame: baseline
measure: Balance Error Scoring System (BESS)
timeFrame: 6 - weeks
measure: Star Excursion Balance Test (SEBT)
timeFrame: baseline
measure: Star Excursion Balance Test (SEBT)
timeFrame: 6 - weeks
measure: equilibrium scores (EQ scores) of the Sensory Organization Test (SOT) on the NeuroCom
timeFrame: baseline
measure: equilibrium scores (EQ scores) of the Sensory Organization Test (SOT) on the NeuroCom
timeFrame: 6 - weeks
measure: Core Strength position 1
timeFrame: baseline
measure: Core Strength position 1
timeFrame: 6 - weeks
measure: Core Strength position 2
timeFrame: baseline
measure: Core Strength position 2
timeFrame: 6 - weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00918060: Clinical Effects of Locally-delivered Gel Containing Camella Sinensis Extracts as an Adjunct in Peridontitis Treatment
Official title: Clinical Effects of Locally-delivered Gel Containing Camella Sinensis Extracts
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Periodontitis
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2009-06-11
Enrollment: 48
Sex: ALL
Minimum age (years): 34
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate clinical result including plaque index, gingival inflammation, bleeding score, pocket depth reduction and clinical attachment level gain after used locally-delivered gel containing Camella sinensis extracts as an adjunctive treatment in periodontal therapy


Eligibility criteria: Inclusion Criteria:

* subjects have sound tooth with pocket depth = or \> 5 mm. without caries, restoration, mobility and furcation involvement
* no systemic complicated factors
* no allergy to green tea or product of green tea
* signing in informed consent form

Exclusion Criteria:

* smoking
* pregnancy or lactation
* antibiotic premedication or antibiotic intake in previous 3 month

Primary outcomes:
measure: pocket depth reduction, clinical attachment level gain, gingival index, bleeding score
timeFrame: baseline, 1, 3 and 6 month after gel had loaded
Secondary outcomes:
measure: plaque index
timeFrame: baseline, 1, 3, and 6 month after gel had loaded
Other outcomes:
Locations:
Study officials:
affiliation: Department of Oral Medicine, Mahidol University
name: Kanyawat Rattanasuwan
role: STUDY_DIRECTOR
affiliation: Maha Chakri Sirindhorn Dental Hospital
name: Kanyawat Rattanasuwan
role: STUDY_CHAIR
References:
citation: Rattanasuwan K, Rassameemasmaung S, Sangalungkarn V, Komoltri C. Clinical effect of locally delivered gel containing green tea extract as an adjunct to non-surgical periodontal treatment. Odontology. 2016 Jan;104(1):89-97. doi: 10.1007/s10266-014-0190-1. Epub 2014 Dec 19.
Clinical trial NCT03211260: Effects of Proprioceptive Focal Stimulation (EQUISTASI) on Freezing of Gait in Parkinson's Disease
Official title: Effects of Proprioceptive Focal Stimulation (EQUISTASI) on Freezing of Gait in Parkinson's Disease: a Open, Single-arm Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Freezing of Gait
Parkinson Disease
Keywords: Parkinson Disease
Freezing of gait
Equistasi
Lead sponsor: ASST Gaetano Pini-CTO
Sponsor class: OTHER
Collaborators: name: Grisons Foundation for Parkinson's Disease
name: Fondazione IRCCS Policlinico San Matteo di Pavia
First posted: 2017-07-07
Enrollment: 42
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Freezing of gait (FOG) is a common disabling condition in Parkinson's disease (PD), causes falls, and impairs quality of life. Therapeutic options for this symptom are limited and of limited efficacy. Besides, the pathophysiology has been not clarified yet. Proprioceptive sensitivity is likely to play a role and recent studies have reported that high-frequency microfocal vibratory stimulation exert a modulatory effect of proprioceptive reflex circuits and could be considered a valuable treatment strategy. However, evidence is not available. The present study was designed to collect preliminary evidence of efficacy of a vibrotactile device (Equistasi) for the treatment of FOG.


Eligibility criteria: Inclusion Criteria:

* Patient with Parkinson's Disease
* Stable drug therapy response without any change in the 3 months before the study.
* written informed consent

Exclusion Criteria:

* Hoehn-Yahr stage ≥ 4
* Cognitive decline (Mini Mental State Examination \<26)
* Systemic illness involving the nervous system
* Diabetes
* Presence of cardiac pacemaker
* Presence of deep brain stimulation
* Presence of severe dysautonomia with marked hypotension
* History or active neoplasia
* Pregnancy

Primary outcomes:
measure: Freezing of gait questionnaire severity
timeFrame: 4 weeks
Secondary outcomes:
measure: Gait and Falls Questionnaire (GFQ) score
timeFrame: 4 weeks
measure: 39-item Parkinson's Disease Questionnaire
timeFrame: 4 weeks
measure: Falls
timeFrame: 4 weeks
measure: Treatment continuation
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Centro Parkinson, ASST Gaetano Pini-CTO
Study officials:
affiliation: Centro Parkinson, ASST Gaetano Pini-CTO di Milano
name: Gianni Pezzoli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04383860: Sutures in Orbital Implants in Retinoblastoma Patients
Official title: Choice of Sutures in Orbital Implants in Retinoblastoma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery--Complications
Retinoblastoma Bilateral
Keywords: Retinoblastoma
suture
complications
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 132
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate different sutures for orbital implants in retinoblastoma patients.

Detailed description: To evaluate the effectiveness and complications of 4-0 and 5-0 sutures for orbital implants in retinoblastoma patients.

Eligibility criteria: Inclusion Criteria:

* diagnosed as retinoblastoma
* enucleation and orbital implantation in the same surgery

Exclusion Criteria:

* death during follow-up

Primary outcomes:
measure: Rate of participants with complications
timeFrame: 2 year after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sun Yat-sen University
name: Huijing Ye
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03265860: Intravoxel Incoherent Motion Prognostic Value in the Initial Evaluation of Patients With Acute Ischemic Strokes Using 3 Tesla Magnetic Resonance Imaging
Official title: Intravoxel Incoherent Motion Prognostic Value in the Initial Evaluation of Patients With Acute Ischemic Strokes Using 3 Tesla Magnetic Resonance Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Magnetic Resonance Imaging
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2017-08-29
Enrollment: 274
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with an acute ischemic stroke

Brief summary: Ischemic strokes are the first cause of handicap in adult people, the second cause of dementia and the third cause of death in France. Brain Magnetic Resonance (MR) initial assessment is mandatory to get the right diagnosis, to exclude hemorrhagic lesions and to determine the best treatment.

The conventional diffusion weighted imaging sequence is used to establish the diagnosis and to estimate the volume of ischemic lesions. The perfusion weighted imaging sequences are also used to assess the diffusion-perfusion mismatch which is supposed to be the ischemic penumbra corresponding to territories that could be saved with appropriate treatments.

IntraVoxel Incoherent Motion (IVIM) is a multi-b diffusion sequence which allows to extract four quantitative variables (D, D\*, f, ADC) related to the true molecular diffusion and correlated to the microvascular perfusion.

It's a quick sequence with no need of contrast injection and allowing a perfect coregistration with the true diffusion. It has been validated in many pathologies but not in acute strokes.

The feasibility of this sequence in acute ischemic strokes has already been assessed with interesting results.

The study aims to assess the correlation between the quantitative values of IVIM at initial MR exam and the modified Rankin Scale (mRS) score 3 months after an acute ischemic stroke.


Eligibility criteria: Inclusion Criteria:

* Adult patients
* Admitted for an acute ischemic stroke
* Affiliated to a Social Security scheme

Exclusion Criteria:

* Absolute contraindications to MRI
* Pregnant or breastfeeding woman

Primary outcomes:
measure: Correlation between quantitative values of IntraVoxel Incoherent Motion at initial Magnetic Resonance Imaging (MRI) and the modified Rankin Scale (mRS) at 3 months after an acute ischemic stroke.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique A. de Rothschild
Study officials:
affiliation: Fondation Ophtalmologique A. de Rothschild
name: Augustin Lecler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00832260: IES-ACap: Influence of Atrial Pulse Width in the Behaviour of ACap™ Confirm Algorithm.
Official title: Influence of Atrial Pulse Width in the Behaviour of ACap™ Confirm Algorithm.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sinus Bradycardia
Sinus Node Disease
Atrio-ventricular Block
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2009-01-30
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients whit a Zephyr™ pacemaker implanted, models 5826 and 5820.

Brief summary: The purpose of this observational study is to collect data regarding the population of patients with a pacemaker implanted.

Detailed description: The purpose of this observational study is to collect data regarding the population of patients whit a Zephyr™ pacemaker implanted, models 5826 and 5820, and active or passive fixation leads , when the Algorithms Acap Confirm, which automatically regulates the Atrial Pulse Width, is enabled.

Eligibility criteria: Inclusion Criteria:

* Patient has an indication for implantation of a dual-chamber pacemaker;
* Patient is older than 18 years of age
* Patient has signed the study specific Informed consent document.
* Primo implant.

Exclusion Criteria:

* Patient is pregnant or nursing
* Patient is less than 18 years of age
* Patient is in New York Heart Association (NYHA) class III and IV.
* Patient has a pacemaker replacement;
* Patient is unable to attend the follow-up visits;

Primary outcomes:
measure: Percentage of Patients in Whom ACap™ Confirm Algorithm is Programmed Safely to ON During the First 12 Months.
timeFrame: 12 months
Secondary outcomes:
measure: Percentage of Patients in Whom ACap™ Confirm Algorithm is Recommended at a Pulse Width of 0.4 Milliseconds (ms) During All Follow-ups (Implant, Staples Removal, 3, 6, 9 and 12 Months).
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Universitario La Fe
name: José Olagüe de Ros, PhD.
role: PRINCIPAL_INVESTIGATOR
References: