louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00813345: Ambulatory Anesthesia and Light Therapy
Official title: A Role for Light Therapy at Immediate Recovery From Short Duration Ambulatory Anesthesia to Prevent Dysregulation of Circadian Rest-Activity Rhythm in Patients Submitted to Colonoscopy.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia
Colonoscopy
Keywords: anesthesia propofol ambulatory rhythm
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2008-12-23
Enrollment: 360
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: We previously evidenced in both animal models and patients that a short duration ambulatory anesthesia impacts the circadian rest-activity biological rhythm, at least during the first 3 days. The light is the main, natural synchronisateur, of the biological cerebral clock, and is used as therapeutics in chronic disturbances of the circadian rest activity rhythm and of the sleep (Alzheimer disease for example). We would like to test for a simple and safe strategy to prevent such a long-lasting effect of anesthesia on biological clock:the increase of the light intensity at a still physiological level during the initial phase of recovery from anesthesia by using a particular artificial light of color spectrum similar to natural sun daylight.


Eligibility criteria: Inclusion Criteria:

* ASA I \& II
* ambulatory anesthesia for colonoscopy on Monday or Tuesday
* social security

Exclusion Criteria:

* treatment for cancer
* hypnotics, beta-bloquers
* pregnancy
* legal supervision
* trans 5 meridian travel in the last two months

Primary outcomes:
measure: Modification of on parametric analysis of circadian rhythm of rest-activity post anesthesia as compared to reference period (within factor) ; between factor : light intensity group
timeFrame: Within the first 5 days after anesthesia
Secondary outcomes:
measure: Influence of gene period 3 phenotype on the effect of anesthesia
timeFrame: Blood sample taken the day of the anesthesia
Other outcomes:
Locations:
city: Clichy
country: France
facility: Service d'Anestésie et Réanimation - Hôpital Beaujon
city: Colmar
country: France
facility: Service d'Anesthésie et Réanimation - Hôpital Pasteur
city: Metz
country: France
facility: Service d'Anesthésie et Réanimation, Hôpital d'Instruction des Armées Legouest
city: Strasbourg
country: France
facility: Centre Ambulatoire des Diaconesses
city: Strasbourg
country: France
facility: Centre Ambulatoire-Clinique Saint-Odile
city: Strasbourg
country: France
facility: Service d'Anesthésie et Réanimation - Hôpital de Hautepierre
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Laure PAIN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06142305: Supracondylar Femur Fracture After DDH
Official title: Ipsilateral Supracondylar Femoral Insufficiency Fractures After Cast Removal of Developmental Dysplasia of the Hip Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: DDH
Keywords: DDH
insufficiency fractures
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-11-21
Enrollment: 300
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: incidence of ipsilateral Supracondylar femoral fractures after cast removal for Developmental dysplasia of the hip (DDH) surgery
Primary purpose: TREATMENT

Brief summary: incidence of ipsilateral Supracondylar femoral fractures after cast removal for Developmental dysplasia of the hip (DDH) surgery


Eligibility criteria: Inclusion Criteria:

* Age 1-7 years old
* Primary DDH

Exclusion Criteria:

* • Paralytic hip DX in cases of (Cerebral palsy,Meningomyelocele,Neuropathy or Myopathy)

  * Recurrent cases of DDH
  * Past history of ipsilateral distal femoral fractures

Primary outcomes:
measure: Number of patients with supracondylar femoral fracture
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Clinical practice guideline: early detection of developmental dysplasia of the hip. Committee on Quality Improvement, Subcommittee on Developmental Dysplasia of the Hip. American Academy of Pediatrics. Pediatrics. 2000 Apr;105(4 Pt 1):896-905. doi: 10.1542/peds.105.4.896.
Clinical trial NCT03252405: Effect of Induction Method in Post Operative Agitation
Official title: the Effect of Two Different Method; Mask Ventilation or Intravenous Canulation on Emergence Agitation and Recovery Conditions on Pediatric Adenotonsillectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emergence Agitation
Lead sponsor: Ahi Evran University Education and Research Hospital
Sponsor class: OTHER
First posted: 2017-08-17
Enrollment: 67
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To compare the effect of two different induction method; mask ventilation and intravenous cannulation on emergence agitation on pediatric adenotonsillectomy

Detailed description: Many things cause emergence agitation after operations on pediatric population. This research aims determine which method, mask ventilation or intravenous cannulatin is more effective on emergence agitation

Eligibility criteria: Inclusion Criteria:

* pediatric adenotonsillectomy

Exclusion Criteria:

* patients with neurological, hepatic, renal disorders and using any drugs

Primary outcomes:
measure: assess changing in pediatric agitation/ emergence delirium scale(PAED) scores
timeFrame: postoperative first hour
Secondary outcomes:
measure: FLACC (face, legs,activity, cry, consolobility)
timeFrame: postoperative first hour
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Dışkapı Yıldırım Beyazıt Education and research hospital
city: Kırşehir
country: Turkey
facility: Ahi evran university education and research hospital
Study officials:
affiliation: Ahi Evran University Education and Research Hospital
name: kevser peker
role: PRINCIPAL_INVESTIGATOR
References:
citation: Peker K, Polat R. Effects of intravenous and mask induction on post-operative emergence delirium in pediatric patients undergoing tonsillectomy with or without adenoidectomy. Ir J Med Sci. 2020 Aug;189(3):1061-1068. doi: 10.1007/s11845-020-02197-4. Epub 2020 Feb 11.
Clinical trial NCT04551105: Evaluation of TaiHao Breast Ultrasound Diagnosis Software
Official title: Evaluation of TaiHao Breast Ultrasound Diagnosis Software
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Breast Diseases
Lead sponsor: TaiHao Medical Inc.
Sponsor class: INDUSTRY
Collaborators: name: Columbia University
name: Taipei Veterans General Hospital, Taiwan
name: Virginia Polytechnic Institute and State University
First posted: 2020-09-16
Enrollment: 16
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The BR-USCAD DS Module is a computer-assisted detection and diagnosis software based on a deep learning algorithm. This retrospective, fully-crossed, multi-reader, multi-case (MRMC) study aims to compare the performances of readers without and with the aid of the Breast Ultrasound Image Reviewed with Assistance of Computer-Assisted Detection and Diagnosis System (BR-USCAD DS) in interpreting breast ultrasound images of lesions.


Eligibility criteria: Inclusion Criteria:

* B-mode breast ultrasound image
* Female, age 21 or older
* Breast lesion images acquired before a biopsy or surgery - these images were retrospectively collected with histology report.
* Non-biopsied benign lesions with negative follow-up for a minimum of 24 months
* At least two orthogonal views of a lesion

Exclusion Criteria:

* Breast lesion images acquired after biopsy or surgery.
* Any breast surgeries or interventional procedures in the 12 months prior to ultrasound imaging
* Case demonstrating administrative or technical errors
* Multiple lesions in one 2-D ultrasound image
* Breast ultrasound images with Doppler, elastography, or other overlays present
* Case with less than 2-year follow-up and without biopsy confirmation

Primary outcomes:
measure: Comparing the Area Under the LROC Curve
timeFrame: 10 weeks
Secondary outcomes:
measure: The Reading Time Was Computed and Compared for Aim 1 (Baseline) and Arm 2 (With BU-CAD Assistance) Studies.
timeFrame: 10 weeks
measure: The Sensitivity, Specificity, PPV, and NPV Were Computed and Compared for Aim 1 (Baseline) and Arm 2 (With BU-CAD Assistance) Studies.
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Arlington
country: United States
facility: Arlington Innovation Center: Health Research - Virginia Tech
state: Virginia
Study officials:
affiliation: Arlington Innovation Center: Health Research - Virginia Tech
name: Shih Chung Lo, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01305005: Effect of Phacoemulsification on Ocular Blood Flow in Human
Official title: To Investigate Ocular Haemodynamics After Phacoemulsification Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Hypertension
Diabetes
Keywords: blood flow
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2011-02-28
Enrollment: 58
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients who underwent phacoemulsification surgery in Eye Hospital of Wenzhou Medical College

Brief summary: * To investigate ocular haemodynamics after phacoemulsification surgery
* To evaluate the influence in people with different autoregulation of ocular blood flow


Eligibility criteria: Inclusion Criteria:

* age-related cataract
* no complications during surgery

Exclusion Criteria:

* complications during surgery
* have other complications

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Eye Hospital of Wenzhou Medical College
state: Zhejiang
Study officials:
affiliation: Wenzhou Medical University
name: qu jia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhao Y, Wang D, Nie L, Yu Y, Zou R, Li Z, Xu M, Zhao Y. Early changes in retinal microcirculation after uncomplicated cataract surgery using an active-fluidics system. Int Ophthalmol. 2021 May;41(5):1605-1612. doi: 10.1007/s10792-021-01694-4. Epub 2021 Feb 6.
Clinical trial NCT01340105: Effectiveness of Microwave Ablation of Hepatocellular Carcinoma as Compared to Radiofrequency Ablation
Official title: Microwave Versus Radiofrequency Ablation for Hepatocellular Carcinoma: a Prospective Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: Microwave ablation
Radiofrequency ablation
Randomised controlled trial
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2011-04-22
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare microwave ablation using the Acculis Microwave Tissue Ablation (MTA) System with conventional radiofrequency ablation (RFA) using Covidien cool-tip radiofrequency needle in patients with localized unresectabe hepatocelluar carcinoma (HCC).

The investigators hypothesize that microwave ablation can achieve a better complete ablation rate as compared to radiofrerquency ablation.

A randomized comparative study is performed by randomly assigned participants to microwave ablation arm or radiofrequency ablation arm. The efficacy of treatment outcome is assessed by the complete tumor ablation rate at 1 month, recurrence rate and survival time of participants. Safety of the procedures is also compared between the 2 treatment arms.


Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Unresectable hepatocellular carcinoma (HCC) and tumor amendable for local ablation
* Resectable HCC but patient opts for local ablation
* Maximum diameter of tumor ≤6cm
* Maximum number of tumor nodules ≤3
* Absence of radiology evidence of major vascular or bile duct invasion
* Child's A or B liver function
* Karnofsky performance status ≥70%

Exclusion Criteria:

* Informed consent not available
* Pregnant female patients
* Tumors unfavourable for local ablation (e.g. tumor close to porta hepatis)
* HCC with history of rupture
* Concomitant hepatectomy
* Patients with chronic renal failure

Primary outcomes:
measure: Complete ablation rate
timeFrame: 1 month
Secondary outcomes:
measure: Treatment related mortality
timeFrame: 30-day
measure: Recurrent disease
timeFrame: 3 year
measure: Survival
timeFrame: 3 year
measure: Long-term liver function
timeFrame: 3 year
measure: Treatment related morbidity
timeFrame: 30-day
measure: Hospital stay
timeFrame: 30-day
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Prince of Wales Hospital
Study officials:
affiliation: Department of Surgery, The Chinese University of Hong Kong
name: Kit-fai Lee, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00974805: An Investigation of the Mechanism of Action of Seretide in Chronic Obstructive Pulmonary Disease
Official title: An Investigation Into the Mechanisms of Action of a Combined Long Acting Beta Agonist/Inhaled Corticosteroid (Seretide 500 Accuhaler) on the Bacterial Colonisation, Immunology and Inflammation of Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Emphysema
Bronchitis
Lead sponsor: University of Southampton
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2009-09-10
Enrollment: 48
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study is investigating the possible mechanisms of action of an inhaled treatment (Seretide), currently used worldwide in millions of patients with COPD (Chronic Obstructive Pulmonary Disease) and how it improves the symptoms of these patients. Previous research has failed to identify the mechanisms at play other than dilation of the airways. The research community has long thought the mechanism to be immune based or anti inflammatory but despite intensive research this has not yet been identified.

Detailed description: We aim to recruit equal numbers of healthy smokers, mild, moderate and severe COPD patients (12 patients to be recruited from each group). These patients will never have been prescribed the components present in Seretide (Salmeterol and Flixotide or similar compounds).

The patients will have spirometry at the beginning of the study to confirm the presence of COPD. Healthy smokers will defined as ex or current smokers who match the study population but have normal lung function.

Patients with a history of asthma, bronchiectasis, carcinoma of the bronchus, or other significant respiratory disease will be excluded.

The patients will have a total of four study visits, 2 off treatment and 2 while on treatment, over a 56 day study period. At each study visit induced sputum will be performed and blood extracted. The cells fom both of these samples will be analysed for cells type and activation. Sputum and serum will be stored for cytokine analysis at a later date.

The Sputum will be induced using standardised protocols using nebulised saline solution.

Eligibility criteria: Inclusion Criteria:

* \>35yrs.
* \>10 Pack Years COPD as defined as an FEV1\<70% and an FEV1/FVC ratio of \<70%

Exclusion Criteria:

* Asthma
* Lung cancer
* Bronchiectasis

Primary outcomes:
measure: The primary outcome measures are change in cell type and activation status
timeFrame: 56 days
Secondary outcomes:
measure: Change in sputum and serum cytokines Change in bacterial colonization
timeFrame: 56 days
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
state: Hampshire
Study officials:
References:
Clinical trial NCT00106405: An Evaluation of the Safety and Efficacy of Memantine in Patients With Acute Mania Associated With Bipolar I Disorder
Official title: A Pilot Evaluation of the Safety and Efficacy of Memantine in Patients With Acute Mania Associated With Bipolar I Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bipolar Disorder
Keywords: Bipolar I Disorder
Mania
Memantine HCl
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2005-03-25
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: Bipolar disorder affects 2.4 million adults in the USA between the ages of 18-65 and has considerable economic impact on our society. Bipolar mania accounts for 1 in 7 psychiatric emergencies and is associated with significant morbidity and mortality. The purpose of the study is to evaluate the safety and efficacy of open-label memantine in the acute management of adults with bipolar I disorder hospitalized for mania.


Eligibility criteria: Inclusion Criteria:

* Patients must have a documented clinical diagnosis of bipolar I disorder and must be currently experiencing a manic or mixed episode.
* Patients must be voluntarily hospitalized with a primary diagnosis of mania.

Exclusion Criteria:

* Rapid cycling bipolar disorder.
* Suicidal risk.
* First manic episode.
* ECT, clozapine or a depot neuroleptic in the past 3 months.
* Substance dependence.
* Known HIV infection.
* Co-morbid serious, uncontrolled systemic illness.

Primary outcomes:
measure: Young Mania Rating Scale (YMRS)
measure: Mania Rating Scale
measure: Clinical Global Impression
measure: Montgomery Asberg Depression Rating Scale
measure: Positive and Negative Syndrome Scale (PANSS)
measure: PANSS - Excited Component
Secondary outcomes:
Other outcomes:
Locations:
city: National City
country: United States
facility: Synergy Clinical Research Center
state: California
city: Baltimore
country: United States
facility: Sheppard Pratt Health System
state: Maryland
city: St. Charles
country: United States
facility: St. Charles Psychiatric Associates
state: Missouri
city: Cincinatti
country: United States
facility: Psychiatric Professional Services, Inc.
state: Ohio
city: Galveston
country: United States
facility: Rebecca Sealy Hospital
state: Texas
city: Irving
country: United States
facility: University Hills Clinical Research
state: Texas
Study officials:
References:
Clinical trial NCT01474005: Establishment of an Artificial Larynx After Total Laryngectomy
Official title: Establishment of an Artificial Larynx After Total Laryngectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carcinomatous Disease
Keywords: laryngectomy
artificial larynx
breathing
swallowing
upper airway
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2011-11-17
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the effectiveness of an artificial larynx on the restoration of laryngeal functions, mainly breathing and swallowing.


Eligibility criteria: Inclusion Criteria:

* Anyone over 18 years, male or female, with a carcinomatous disease of the upper airways requiring a total laryngectomy

Exclusion Criteria:

* Less than 18 years
* Contraindications to general anesthesia
* Any situation considered by the physician operator as an exclusion
* Pregnant women
* Lactating women
* Subglottic or basi-lingual tumor extension more than 1 cm
* Prior radiotherapy
* Severe coagulation disorders

Primary outcomes:
measure: Evaluation of the restoration of respiratory functions
timeFrame: one year
measure: Evaluation of the restoration of the ability to swallow by nasofibroscopy
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'ORL et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre, 1 avenue Molière
Study officials:
References:
Clinical trial NCT00973505: CYP19 Genetic Polymorphism & Aromatase Inhibitor(AI)
Official title: Significance of CYP19 Genetic Polymorphism on Musculoskeletal Symptom & Complication of Aromatase Inhibitor(AI)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Neoplasms
Arthralgia
Arthritis
Genetic Polymorphism
Keywords: Breast neoplasms
Aromatase inhibitors
Genetic polymorphisms
Arthralgia
Arthritis
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
Collaborators: name: Korea University
First posted: 2009-09-09
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast cancer patients taking the medication of AI (aromatase inhibitor) in post menopause status.

Brief summary: The purpose of this study is to investigate the relationship between the side effects(especially arthralgia and arthritis) which appear in the patients who are prescribed aromatase inhibitor(AI) and the CYP19 genetic polymorphisms.


Eligibility criteria: Inclusion Criteria:

1. The patient must sign the informed consent.
2. The patient must sign the informed consent of genetic screening test.
3. The patient must be between 18 years old and 80 years old who can make a decision independently.
4. The patient must be post-menopause status.
5. The patient should be the stage 1,2 or 3 of the breast cancer.
6. The test result of the estrogen receptor or progesterone receptor is positive, so the patient should be taking the medication of AI (Aromatase Inhibitor).

Exclusion Criteria:

1. The patient is pre-menopause status.
2. The test result of serum FSH level is below 30mU/ml.
3. The test result of the hormone receptor(ER \& PR) is negative or unknown.
4. Patient's breast cancer stage is 4 which has systemic metastatics.

Primary outcomes:
measure: Change of SNPs (PCR & sequencing), Estrogen, Inflammatory Cytokine level
timeFrame: 6, 12 months
Secondary outcomes:
measure: EORTC (European Organization for Research and Treatment of Cancer)- QOL(Quality of Life)- C30, BR23 & Skeletal pain information, BMI
timeFrame: 3,6,12 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hopital
Study officials:
affiliation: Korea University Anam Hospital
name: Eun Sook Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: