louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00459966: Preoperative Prevention and Early Rehabilitation for Patients Undergoing Elective Spine Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spine Surgery
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2007-04-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Aim: The aim is to evaluate the outcome after spine surgery when using an integrated program that combined preoperative prevention and early postoperative rehabilitation compared to the routine procedures.

Outcome measurements: Postoperative hospital stay, complications, function, pain, and patient satisfaction.

Method: 60 patients scheduled for surgery for degenerative lumbar disease. The control group followed the routines in the department. The intervention group followed the integrated program consisting of preoperative prevention.

Detailed description: Introduction: An increasing number of patients undergo surgery for degenerative spine disease, which is, however, related to a significant development of postoperative complications. Evidence has been gathered for other surgical procedures about improved outcome after early rehabilitation programs (fast track surgery), preoperative smoking and alcohol cessation programs, respectively. Hitherto, no studies have been published concerning a combined program of the preoperative prevention programs and fast track surgery.

Aim: The aim is to evaluate the outcome after spine surgery when using an integrated program that combined preoperative prevention and early postoperative rehabilitation compared to the routine procedures.

Outcome measurements: Postoperative hospital stay, complications, function, pain, and patient satisfaction.

Method: 60 patients scheduled for surgery for degenerative lumbar disease were computer-randomized to intervention. The control group followed the routines in the department. The intervention group followed the integrated program consisting of preoperative prevention, which began 2 months prior to the operation: an exercise program designed to strengthen the muscles of the spine, and optimization of the analgetic treatment. Smokers and harmful drinkers were offered cessation intervention. The day before surgery all had enteral protein supplement.

Early postoperative rehabilitation included balanced pain therapy, including self-administered epidural analgesia, intensified mobilization immediately after surgery and enteral protein supplement.

Eligibility criteria: Inclusion Criteria:

* Degenerative lumbar disease

Primary outcomes:
measure: hospital discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Head-Ortho-Centre, Anesthesiology Department, Rigshospitalet,
Study officials:
affiliation: uaffiliatation
name: Per Rotboell Nielsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06494566: Omega-3 Supplementation After Surgical Treatment of Obesity
Official title: Diet Supplementation of Omega-3 Fatty Acids After Surgical Treatment of Obesity: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Obesity
Keywords: Sarcopenia
Lipid profile
Bariatric surgery
Metabolic surgery
Lead sponsor: Instituto de Cardiologia do Rio Grande do Sul
Sponsor class: OTHER
First posted: 2024-07-10
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Double-blind, Placebo-controlled, Multicenter, CONSORT oriented study
Primary purpose: PREVENTION

Brief summary: The study evaluates diet supplementation of Omega-3 fatty acids after surgical treatment of obesity in adults. Half participants will receive diet supplementation of Omega-3 fatty acids, while the other half will receive placebo.

Detailed description: Omega-3 fatty acids has been related to immunomodulation and antioxidant action. Diet supplementation of Omega-3 fatty acids after surgical treatment of obesity may help stabilize protein catabolism, reduce peroxidative damage, and improve lipid profile.

Eligibility criteria: Inclusion Criteria:

* BMI \> 30kg/m2
* Candidate to bariatric and metabolic surgery

Exclusion Criteria:

* Use of Omega-3
* Contraindication to bioimpedance analysis
* Uso of steroids, non steroidal inflammatory drugs, immunomodulators or antibiotics
* Refusal to participate

Primary outcomes:
measure: Weight
timeFrame: Assessment points: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery.
measure: Height
timeFrame: Points of evaluation: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery.
Secondary outcomes:
measure: Manual Grip Strength
timeFrame: Assessment points: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery.
measure: 6-Minute Walk Test
timeFrame: Points of evaluation: first and last preoperative nutritional assessment, fifteen days and three months and medium after surgery.
measure: Electrical Bioimpedance - Percentage of muscle mass
timeFrame: Assessment points: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery.
measure: Electrical Bioimpedance - Body fat percentage
timeFrame: Assessment points: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery.
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Irmandade Santa Casa de Misericórdia de Porto Alegre
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Instituto de Cardiologia
state: Rio Grande Do Sul
Study officials:
References:
Clinical trial NCT02939066: Endoscopic Ultrasound-guided Needle-based Confocal Laser Endomicroscopy for Evaluation of Malignant Lymph Nodes - a Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Malignancy or Benign of Enlarged Lymph Nodes
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2016-10-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients undergoing EUS for staging of malignancy or assessment of enlarged lymph nodes will be recruited in this study at Qilu Hospital, Shandong University.

Brief summary: Current modalities for lymph node staging in cancer can be limited. Needle-based confocal laser endomicroscopy (nCLE) is a novel endoscopic technique, which is compatible with the 19-gauge FNA needle. Under endoscopic ultrasonography (EUS) guidance, nCLE enables real-time in vivo imaging of lesion tissues at cellular and subcellular levels.This study aimed to evaluate the feasibility of needle-based confocal laser endomicroscopy (nCLE) at the time of endoscopic ultrasound (EUS) and to describe the nCLE features that distinguish between benign and malignant lymph nodes.


Eligibility criteria: Inclusion Criteria:

* patients undergoing EUS for staging of malignancy or assessment of enlarged lymph nodes

Exclusion Criteria:

* Patients aged \<18 years or \>80 years
* Known allergy to fluorescein dye
* Previous EUS-FNA performed within the past 3 months, and usualcontraindications to EUS-FNA
* Pregnancy or breastfeeding
* Inability to provide informed consent

Primary outcomes:
measure: The nCLE interpretation criteria for the characterization of malignant lymph nodes
timeFrame: 20 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Department of Gastroenterology, Qilu Hospital, Shandong University
name: Yanqing Li, PhD. MD.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04788966: Evaluation of an Innovative Speech-enabled Translator in Emergency Settings
Official title: Evaluation of an Innovative Speech-enabled Translator in Emergency Settings
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diagnoses Disease
Keywords: Translation tool
Anamnesis
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: University of Geneva, Switzerland
First posted: 2021-03-09
Enrollment: 42
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 30 patients were recruited with an average age of M=38.2 (SD=16.49) of which 53.33% were males. The distribution between the different languages was the following: Spanish (11), Arabic (4), Farsi (7), Tigrinya (7) and Albanian (1).

Brief summary: Survey-based satisfaction, performance and technical features evaluation of a speech-enabled fixed-phrase translation tool (BabelDR) in an emergency department.


Eligibility criteria: Inclusion Criteria:

* As per inclusion criteria, patients were required to have no understanding of French, thus making a diagnostic interview by the doctors impossible.

Exclusion Criteria:

* Exclusion criteria concerned patients who shared a common language with the doctor and/or were not able to read in their native language.

Primary outcomes:
measure: Satisfaction evaluation through a 4-point scale survey
timeFrame: During the consultation
measure: Efficacy evaluation through a 2-point scale survey
timeFrame: During the consultation
measure: Technical features evaluation through a 4-point scale survey
timeFrame: During the consultation
Secondary outcomes:
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University Hospitals of Geneva (HUG)
Study officials:
References:
Clinical trial NCT04726566: Chronic Ankle Instability Return to Sport
Official title: Return to Sport and Functional Assessment After Surgery for Chronic Lateral Ankle Instability
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Ankle Instability
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
Collaborators: name: Euraxi Pharma
First posted: 2021-01-27
Enrollment: 190
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated in rehabilitation at the European Sports Rehabilitation Center after anatomical surgery for chronic lateral ankle instability.

Brief summary: Real-life, observational, monocentric, prospective, longitudinal study, carried out at the European Center for Sports Rehabilitation (CERS), France.

Detailed description: The data will be collected through an electronic Case Report Form completed by the physician, and some auto-questionnaire completed by the patient.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 15 years;
* Patient treated at the European Sports Rehabilitation Center after a first arthroscopic surgery on the external lateral ligament of the ankle for chronic instability by anatomical reconstruction:

  * With tendon graft;
  * By suture with biological reinforcement;
* Non-opposition of the patient and his/her parents (if minor) to the collection of his/her personal data.

Exclusion Criteria:

- Minor patient (age \<18 years) not accompanied by one of his/her parents or legal representative during the inclusion visit;

* History of surgery on the same ankle;
* Associated complex osteochondral or internal ligament damage, syndesmosis, fracture;
* Non-anatomical reconstruction;
* Inability of the patient to understand the study protocol;
* Vulnerable person whose inclusion is not justified by the purposes of the research: pregnant woman, person undergoing psychiatric care, or adult person subject to legal protection.

Primary outcomes:
measure: Rate of return to main sport at the expected level in both groups
timeFrame: 10 months
Secondary outcomes:
measure: Factors associated with the lack of resumption of sport at the level before the injury
timeFrame: 10 months
measure: Time taken to resume sport after arthroscopic stabilization
timeFrame: 10 months
measure: Functional state of the ankle
timeFrame: 10 months
Other outcomes:
Locations:
city: Capbreton
country: France
facility: European sports rehabilitation center
Study officials:
References:
Clinical trial NCT02916966: Environmental Exposure and Neurological Diseases Questionnaire
Official title: Case-control and Population Questionnaire Studying Environmental Risk Factors and Neurological Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amyotrophic Lateral Sclerosis
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: The Cleveland Clinic
First posted: 2016-09-28
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1. ALS patients in case-control at CCF
2. Non-neurodegenerative patients in case control at CCF
3. Non-neurodegenerative general population in Ohio
4. ALS patient registry in Ohio

Brief summary: The proposed research is particularly relevant to the National ALS Registry and public environmental health issues because it addresses the potential environmental causes of sporadic ALS. The research will develop an ALS surveillance program in Ohio that can be compared with the national and State-Metro Surveillance Programs of the National ALS Registry, and novel methodologies to determine the role of the cyanobacterial toxin, BMAA (beta-methylamino-L-alanine), and other environmental toxins/toxicants as risk factors for ALS. This work will advance the mission of the Centers for Disease Control Agency for Toxic Substances and Disease Registry (CDC ATSDR) National ALS Registry by offering data on ALS cases in Ohio that address public health concerns over the effects of chronic exposure to cyanobacterial blooms in Lake Erie.


Eligibility criteria: Inclusion Criteria:

* ALS
* Non-neurodegenerative controls
* Can willingly give consent
* Over 18 years of age

Exclusion Criteria:

* Cannot give consent
* Under 18 years of age

Primary outcomes:
measure: Questionnaire for Environmental Exposures, Toxins, and Neurological Disease
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
References:
Clinical trial NCT00735566: Antiangiogenic Factors in Gastric Cancer
Official title: The Role of Endogenous Antiangiogenic Factors in Gastric Cancer Progression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Keywords: gastric cancer
antiangiogenic factors
TNM stage
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2008-08-15
Enrollment: 240
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible patients will undergo subtotal or total gastrectomy with D2 lymph node dissection

Brief summary: Endogenous antiangiogenic factors are related with gastric cancer progression.

Detailed description: Gastric cancers have been known to secrete the proangiogenic cytokine VEGF in vitro and in vivo. Tumor VEGF expression is correlated with the severity of disease in patients with gastric cancer and some authors have suggested using circulating VEGF as a prognostic factor or tumor marker.In addition to producing proangiogenic cytokines, recent data demonstrate that tumors can produce antiangiogenic cytokine as well. It has been suggested that, in humans, the generation of antiangiogenic compounds in the presence of a primary tumor suppresses the growth of distant metastases. This phenomenon has been demonstrated in mice and in patients with clear cell renal cancer, breast cancer, and colorectal cancer. However, the presence of endogenous antiangiogenic cytokines in patients with gastric cancer has not been reported.

Eligibility criteria: Inclusion Criteria:

* Histologic diagnosis of gastric adenocarcinoma
* No other forms of cancer therapy, such as chemotherapy or radiotherapy for at least 3 weeks before the enrollment in study
* Performance status of 0, 1, 2 on the ECOG criteria
* ASA class I, II
* Patient compliance that allow adequate follow up
* Informed consent from patient or patient's relative.

Exclusion Criteria:

* Second primary malignancy
* EMR (Endoscopic mucosal resection) indication
* Laparoscopic gastrectomy
* Radiologic or clinical evidence of metastasis

Primary outcomes:
measure: Relationship between antiangiogenic factor and tumor, node, metastasis
timeFrame: One year
Secondary outcomes:
measure: Overall survival, treatment failure
timeFrame: 5 years
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Geonggi-do
Study officials:
affiliation: Gastric Cancer Branch, National Cancer Center
name: Jun Ho Lee, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04006626: 18F-FES PET/CT's Additional Clinical Value in ER+ BC
Official title: 18F-FES PET/CT Influences the Staging and Management of Newly Diagnosed Oestrogen Receptor-Positive Breast Cancer Patients: A Retrospective Comparative Study With 18F-FDG PET/CT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with breast cancer (according to ICD-10) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage

Brief summary: To figure out whethetr 18F-FES PET/CT could influence the staging and management of newly diagnosed Oestrogen Receptor-positive Breast Cancer Patients.


Eligibility criteria: Inclusion Criteria:

* Patients with newly diagnosed immunohistochemical confirmed oestrogen receptor (ER)-positive breast cancer
* Patients underwent both 18F-FES PET/CT and 18F-FDG PET/CT in Fudan University Shanghai Cancer Center within 1 week after diagnosis
* Patients with available medical history

Exclusion Criteria:

* Patients with incomplete medical history

Primary outcomes:
measure: Staging of breast cancer
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Biyun Wang, MD
state: Shanghai
Study officials:
affiliation: Fudan University
name: Biyun Wang, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05028426: Safety of Total Knee Replacement Surgery Before and After the Implementation of Enhanced Recovery Program
Official title: Single-center Retrospective Study on Safety of Total Knee Replacement Surgery Before and After the Implementation of Enhanced Recovery Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthroplasty Complications
Lead sponsor: Groupe Hospitalier de la Rochelle Ré Aunis
Sponsor class: OTHER
First posted: 2021-08-31
Enrollment: 455
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients were classified into three groups according to the type of care management they received: traditional method of care, some elements of a fast-track program during a transition period, and full enhanced recovery program.

Brief summary: The objectives are to describe the transition from traditional care to an enhanced recovery program for the management of total knee arthroplasty, and to evaluate the effect on patient outcomes.

Detailed description: Enhanced recovery programs are an organizational evolution in surgical patient management, in which the patient becomes an actor of his or her own recovery. This multimodal approach aims at optimizing patient physiological and psychological states across preoperative, intraoperative and postoperative domains of care.

At la Rochelle hospital, the decision to take the step happened at the end of 2016. It was proposed by a young surgeon that have been trained on this new approach during his studies and who convinced the head of the surgery department of the benefits for the patients, the healthcare workers, and the institution. The transition took place in two stages, first operative and postoperative techniques were modified, and then preoperative education and counselling were added.

Eligibility criteria: Inclusion Criteria:

* Patients operated on for posterior-stabilized total knee arthroplasty between January 2015 and December 2018
* unilateral arthroplasty
* a known address for mailing the study information letter

Exclusion Criteria:

* revision arthroplasty
* patients who refused to the use of their data

Primary outcomes:
measure: Number of Patients With Early Complication
timeFrame: 3 months after surgery
Secondary outcomes:
measure: Number of Patients With Late Complication
timeFrame: up to 28 months after surgery
measure: Length of Hospital Stay
timeFrame: up to 1 month after surgery
measure: Preoperative Knee Extension
timeFrame: up to 1 month before surgery
measure: Postoperative Knee Extension
timeFrame: At 3 months after surgery
measure: Preoperative Knee Flexion
timeFrame: up to 1 month before surgery
measure: Postoperative Knee Flexion
timeFrame: At 3 months after surgery
Other outcomes:
Locations:
city: La Rochelle
country: France
facility: Groupe Hospitalier la Rochelle Ré Aunis
Study officials:
affiliation: Groupe Hospitalier La Rochelle Ré Aunis
name: Vivien Fontaine, MD
role: STUDY_DIRECTOR
References: