louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02258672: Preoperative Rehabilitation for Patients Undergoing Surgery for Lumbar Spinal Stenosis
Official title: Effects of a Preoperative Rehabilitation Program on the Recovery of Patients Undergoing Surgery for Lumbar Spinal Stenosis: a Feasibility Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Spinal Stenosis
Keywords: Preoperative rehabilitation
Minimally invasive surgery
Functional capacity
Lead sponsor: Université du Québec à Trois-Rivières
Sponsor class: OTHER
Collaborators: name: Fonds de soutien au démarrage de projets en collaboration (CSSSTR)
name: Fonds pour la Recherche Clinique de l'UQTR
First posted: 2014-10-07
Enrollment: 68
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 the present study is to evaluate the effectiveness of a prehabilitation program on the recovery of patients undergoing a minimally invasive surgery for degenerative lumbar spinal stenosis. To do so, 40 participants will be recruited and randomized into two groups; intervention or control group. Participants in the intervention group will take part in a physical training program, three times a week for six weeks before undergoing surgery. The exercise program will be supervised and will aim at improving core muscles strength and endurance as well as spine stability. It is hypothesized that the prehabilitation program will significantly improve disability and pain intensity reported by patients after surgery. Ultimately, this study aims to improve health care of patients awaiting lumbar surgery but its results may also impact the management of patients awaiting spine surgery for various conditions.


Eligibility criteria: Inclusion Criteria:

To be affected by degenerative lumbar spinal stenosis and to be awaiting minimally invasive surgery for the lumbar spinal stenosis

Exclusion Criteria:

Non-degenerative spinal stenosis, arthritic conditions (except for facet arthrosis), impaired cognitive function, spinal instability and disagreement from the treating neurosurgeon for the patient to take part in the preadaptation programme.

Primary outcomes:
measure: Change from Baseline in disability
timeFrame: baseline, week 6, week 10, week 18, week 30
Secondary outcomes:
measure: Change from Baseline in pain intensity
timeFrame: baseline, week 6, week 10, week 18, week 30
Other outcomes:
Locations:
city: Trois-Rivières
country: Canada
facility: Université du Québec à Trois-Rivières
state: Quebec
Study officials:
affiliation: Université du Québec à Trois-Rivières
name: Martin Descarreaux, DC, PhD
role: STUDY_DIRECTOR
References:
citation: Marchand AA, Suitner M, O'Shaughnessy J, Chatillon CE, Cantin V, Descarreaux M. Effects of a prehabilitation program on patients' recovery following spinal stenosis surgery: study protocol for a randomized controlled trial. Trials. 2015 Oct 27;16:483. doi: 10.1186/s13063-015-1009-2.
Clinical trial NCT04745572: Development of an Adaptive Treatment for Weight Loss in People With Prediabetes
Official title: Development of an Adaptive Treatment Strategy for Weight Loss in People With Prediabetes Using a Sequential Multiple Assignment Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PreDiabetes
Obesity
Keywords: weight loss
reduced carbohydrate diet
exercise training
time restricted eating
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: General Mills
First posted: 2021-02-09
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: This 16-week study will use an experimental approach called the Sequential Multiple Assignment Randomized Trial to help determine which combination and sequence of weight loss program features are most effective in people who are at risk for type 2 diabetes. Participants in the study will be initially randomized to consume either a high or reduced carbohydrate diet. After 4 weeks, participants will be identified as Responders (greater than or equal to 2.5% weight loss) or Non-Responders (less than 2.5% weight loss). Responders will continue with their initial randomized group for the remainder of the trial. Non-responders will be re-randomized to 2nd stage interventions of either including additional exercise counseling and training or beginning a time restricted eating protocol for the remainder of the trial.


Eligibility criteria: Inclusion Criteria:

* 18-75 years of age
* BMI of 27 kg/m2 or greater
* at risk for developing type 2 diabetes (prediabetes)

Exclusion Criteria:

* Pregnant, planning to become pregnant, or breastfeeding
* uncontrolled hypo or hyperthyroidism

Primary outcomes:
measure: Changes in body weight
timeFrame: week 16 visit
Secondary outcomes:
measure: Change in glucose
timeFrame: week 16 visit
measure: Change in hemoglobin A1c
timeFrame: week 16 visit
measure: Change in insulin
timeFrame: week 16 visit
measure: Changes in QUICKI index
timeFrame: week 16 visit
Other outcomes:
measure: Changes in fat mass
timeFrame: week 16 visit
measure: Changes in lipids
timeFrame: week 16 visit
measure: Change in Blood Pressure
timeFrame: week 16 visit
measure: Changes in body weight
timeFrame: week 4 visit
measure: Changes in aerobic fitness
timeFrame: week 16 visit
measure: Changes in overall strength
timeFrame: week 16 visit
measure: Diet Intake and Physical Activity Monitoring
timeFrame: week 16 visit
measure: Diet Intake and Physical Activity Monitoring
timeFrame: week 4 visit
Locations:
city: Birmingham
country: United States
facility: UAB Highlands Family and Community Medicine Clinic
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Holly Wyatt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00006272: Study of Energy Expenditure in Infants With Ventricular Septal Defects
Official title: Study of Energy Expenditure in Infants With Ventricular Septal Defects
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Septal Defects, Ventricular
Keywords: cardiovascular and respiratory diseases
heart defects
rare disease
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: Indiana University School of Medicine
First posted: 2000-09-12
Enrollment: 20
Sex: ALL
Minimum age (years): 3
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: NATURAL_HISTORY

Brief summary: OBJECTIVES:

I. Compare the total daily energy expenditure in infants with ventricular septal defects vs healthy control infants.

Detailed description: PROTOCOL OUTLINE:

Height, weight, and vital signs (including oxygen saturation by pulse oximetry) are measured on Day 1. Resting energy expenditure, oxygen consumption (VO2), carbon dioxide production (VCO2), and resting respiratory exchange quotient (RQ) are measured using open circuit respiratory calorimetry on Day 1. Patients undergo assessment of total daily energy expenditure using the doubly labeled water method comprised of oral deuterium and oral oxygen O 18 with the next scheduled feeding on Day 1. Urine samples are collected prior to isotope administration, then serially for approximately 12 hours after isotope administration on Day 1, and then daily on Days 2-7. These samples are analyzed by mass spectrometry. On Day 1, patients also undergo echocardiogram to confirm size of defect and measure the degree of pulmonary/systemic blood flow ratio and pulmonary artery pressures.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Infants with moderate to large ventricular septal defect (VSD) by most recent echocardiogram who meet the following conditions: no other concurrent heart or lung disease; no chromosomal defects or congenital anomalies

OR

Healthy control infants without VSD who meet the following conditions: clinically well; no heart disease; no chromosomal defects or congenital anomalies

--Prior/Concurrent Therapy--

Surgery: VSD infants -- No prior cardiac surgery or palliative procedures; VSD and control infants -- Greater than 6 weeks since other prior surgery

Other: VSD and control infants: Greater than 6 weeks since prior hospitalization

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Indiana University
name: Catherine A. Leitch
role: STUDY_CHAIR
References:
Clinical trial NCT00199472: Comparison of Dynamic Contrast Enhanced CT and Diuretic Renogram in The Evaluation of UPJO
Official title: Comparison of Dynamic Contrast Enhanced CT and Diuretic Renogram in The Evaluation of Ureteropelvic Junction Obstruction
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Ureteral Obstruction
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: St. Joseph's Health Care London
name: General Electric
First posted: 2005-09-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: Renal blood flow is inversely related to obstruction. We propose that this imaging will be as effective as the diuretic renogram in the functional diagnosis of obstruction. Furthermore, dynamic contrast CT scanning may also add anatomic information necessary for the surgical treatment.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older;
* Subjects suspected to have UPJO.

Exclusion Criteria:

* Pregnancy;
* Renal failure (Creatinine \>150);
* Allergy to contrast material;
* Ureteral stent;
* Nephrostomy tube;
* Renal pelvis calculi.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: Urology Clinic, St. Joseph's Hospital, St. Joseph's Health Care London
state: Ontario
Study officials:
affiliation: Urology, St. Joseph's Hospital, University of Western Ontario
name: John D Denstedt, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04098172: Evaluate the Performance and Safety of Comet Pressure Guidewire in the Measurement of FFR
Official title: A Prospective, Multicenter Study to Evaluate the Performance and Safety of CometTM Pressure Guidewire in the Measurement of FFR in Chinese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2019-09-23
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A prospective, open-label, multi-center study designed to validate the agreement of CometTM Pressure Guidewire and Pressure Wire Certus® in FFR measurements

Detailed description: The COMET China study is a prospective, open-label, multi-center study designed to validate the agreement of CometTM Pressure Guidewire and Pressure Wire Certus® in FFR measurements. Patient with stable angina or any form of non-ST elevation acute coronary syndrome, who are scheduled for diagnostic angiography and pressure wire assessment, and signed the informed consent, will be screened for enrollment in this study.

Eligibility criteria: General Inclusion Criteria:

1. Patient must be at least 18 years old and less than or equal to 75 years of age
2. Patient or his/her legally-authorized representative agrees to sign the EC-approved ICF prior to the procedure
3. Patient with stable angina or any form of non-ST elevation acute coronary syndrome and is clinically indicated of intra-coronary diagnostic angiography and FFR assessment

Angiographic Inclusion Criteria:

Moderate stenosis (30% to 70% diameter stenosis by visual estimation) is detected at diagnostic angiography

General Exclusion Criteria:

1. Patients unable to provide informed consent
2. Patients in pregnant state
3. Known renal insufficiency or failure (serum creatinine level of \> 2.5 mg/dL, or on dialysis)
4. Allergy to the contrast
5. Significant arrhythmia, such as II degree or above of atrioventricular block, Sick sinus syndrome, ventricular tachycardia
6. Spastic bronchial asthma
7. ST elevation coronary syndrome
8. Hemodynamic instability
9. Contraindication to nitroglycerin or ATP
10. Current participation in another investigational drug or device clinical study that may affect the FFR measurements

Angiographic Exclusion Criteria:

CTO lesion Severe vessel tortuosity at the stenotic segments Culprit vessel of non-ST-segment elevation acute myocardial infarction

Primary outcomes:
measure: Fractional Flow Reserve (FFR)
timeFrame: during procedure, 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The First Affilited Hospital of Xi,an Jiaotong University
state: Shaanxi
city: Tianjin
country: China
facility: The General Hospital of Tianjin Medical University
state: Tianjin
Study officials:
affiliation: The First Afflilited Hospital of Xi,an Jiaotong University
name: Ning Guo, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05369572: Connection Between Tongue Signs and Bile Reflux Analysed With Artificial Intelligence
Official title: Analysing the Link Between Tongue Signs and Bile Reflux by Artificial Intelligence
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Artificial Intelligence
Tongue
Bile Reflux
Keywords: artificial intelligence
tongue
bile reflux
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2022-05-11
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
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 aged 18-80 years who will undergo gastroscopy and who fulfil the inclusion criteria and do not fulfil the exclusion criteria.

Brief summary: By introducing artificial intelligence into Chinese medicine tongue diagnosis, we collated and collected tongue images, anxiety and depression scales and gastroscopy reports, mined and analysed the correlation between tongue images and bile reflux and anxiety and depression and constructed a prediction model to analyse the possibility of predicting bile reflux and anxiety and depression in patients based on tongue images.

Detailed description: Firstly, after the patient signs the informed consent form, the researcher will collect pictures of the patient's tongue and obtain basic information about the patient.

Second, the patients are scored on the Anxiety and Depression Scale.

Thirdly, after the patient undergoes gastroscopy, the patient's gastroscopy report is obtained.

Finally, the patient's tongue image, information and gastroscopy report are matched to construct an artificial intelligence model of tongue image and bile reflux and anxiety and depression, and the quality of the model is assessed.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 to 80 years who wish to undergo gastroscopy.
* Patients have given their informed consent and signed the informed consent form.

Exclusion Criteria:

* Serious heart, liver, kidney or other underlying illness, or mental illness.
* Patients taking anti-anxiety or depression medication within 3 months.
* Current H. pylori infection.
* History of surgery on the digestive or biliary tract.
* Peptic ulcer, malignant tumour of the digestive tract, etc.
* Patients taking bismuth or other staining medications.
* Pregnant or lactating women.

Primary outcomes:
measure: Sensitivity
timeFrame: 3 years
measure: Specificity
timeFrame: 3 years
measure: Positive predictive values(PPV)
timeFrame: 3 years
measure: Negative predictive values (NPV)
timeFrame: 3 years
measure: AUC (95% CI)
timeFrame: 3 years
measure: Accuracy
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu hosipital
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Xiuli Zuo, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03268772: PLD and IFO As First-line Treatment for Patients With Advanced or Metastatic STS
Official title: Pegylated-liposome Doxorubicin Combined With Ifosfamide As First-line Treatment for Patients With Advanced or Metastatic Soft Tissue Sarcoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Soft Tissue Sarcoma
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2017-08-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate the efficacy and safety of pegylated liposomal doxorubicin (PLD) combined with ifosfamide (IFO) for the first-line treatment of patients with advanced or metastatic soft tissue sarcoma (STS).

Detailed description: This phase II study is designed to evaluate the efficacy and safety of pegylated liposomal doxorubicin (PLD) combined with ifosfamide (IFO) for the first-line treatment of patients with advanced or metastatic soft tissue sarcoma (STS).

Eligibility criteria: Inclusion Criteria:

* aged 18-70 years with histologically confirmed advanced or metastatic STS
* Eastern Cooperative Oncology Group performance status of 0 to 2
* life expectancy of ≥ 3 months
* have not received chemotherapy before
* at least one measurable lesion
* LVEF≥50%
* have adequate bone marrow, hepatic, and renal function

Exclusion Criteria:

* osteosarcoma, Ewing's sarcoma/PNET (primitive neurotodermal tumour),GIST(Gastrointestinal Stromal Tumors), rhabdomyosarcoma, dermatofibrosarcoma protuberans
* patients with symptomatic brain metastases
* active clinical severe infection

Primary outcomes:
measure: progression free survival
timeFrame: 6 months
Secondary outcomes:
measure: overall response rate
timeFrame: 2 months
measure: overall survival
timeFrame: 12 months
measure: Adverse Events
timeFrame: 2 months
measure: biomarker analysis
timeFrame: 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References:
citation: Liu X, Jiang S, Wang H, Wu X, Yan W, Chen Y, Xu Y, Wang C, Yao W, Wang J, Yu L, Miao J, Chen H, Xia J, Huang M, Zhang X, Luo Z. Pegylated Liposomal Doxorubicin Combined with Ifosfamide for Treating Advanced or Metastatic Soft-tissue Sarcoma: A Prospective, Single-arm Phase II Study. Clin Cancer Res. 2022 Dec 15;28(24):5280-5289. doi: 10.1158/1078-0432.CCR-22-1785.
Clinical trial NCT00202072: Mucin in Sputum of CF During Pulmonary Exacerbation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cystic Fibrosis
Keywords: lung
airway
pulmonary exacerbation
mucus
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: RETROSPECTIVE

Brief summary: The purpose of this study is to determine whether mucin is increased during pulmonay exacerbations in adult patients with cystic fibrosis (CF).

Detailed description: CF is typically associated with mucus hypersecretion in the airways. In health, mucin is the major macromolecular component and is responsible for the protective and clearance properties of the mucus gel. In a recent study we found that mucins are decreased in the sputum of adult CF patients.

In this study we want to investigate the differences on the mucin and DNA quantity and quality of airway secretions in during pulmoanry exacerbation.We hypothesize that during an exacerbation the mucin and DNA amount is increasing.

The aim of this study is to evaluate the molecular (mucins) and structure properties (mucin-DNA-network) of the airway secretions in CF related to the severity of the disease.

We characterize sputum composition of patients with pulmonary exacerbations. Using gel electrophoresis and dot-blot with specific antibodies we will analyze MUC5AC and MUC5B mucins. DNA amount will be measured by microfluorimetry. With the laser scanning confocal microscopy the mucin-DNA-network will be evaluated.

The significance of these studies is that they will give us novel information about the pathogenesis of chronic inflammatory airway diseases, provide tools for assessing the progression of lung disease, and most critically, will identify novel opportunities and targets for therapeutic intervention.

Eligibility criteria: Inclusion Criteria:

* cystic fibrosis
* chronic pseudomonas aeruginosa inflammation
* pulmonary exacerbation

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Giessen
country: Germany
facility: Pediatric department, CF center, University Giessen
city: Marburg
country: Germany
facility: Pediatric department, CF center, University Marburg
Study officials:
affiliation: Philipps University Marburg
name: Markus O Henke, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Henke MO, Renner A, Huber RM, Seeds MC, Rubin BK. MUC5AC and MUC5B Mucins Are Decreased in Cystic Fibrosis Airway Secretions. Am J Respir Cell Mol Biol. 2004 Jul;31(1):86-91. doi: 10.1165/rcmb.2003-0345OC. Epub 2004 Feb 26.
Clinical trial NCT03349372: Impact of Pulmonary Follow-up After Stem Cell Graft
Official title: Impact of Systematic Pulmonary Follow-up After Hematopoietic Stem Cell Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematologic Neoplasms
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-11-21
Enrollment: 227
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients from Hospices Civils de Lyon, Lyon, France with blood cancer undergoing a hematopoietic stem cell transplantation between January 2013 and July 2016

Brief summary: Allogeneic hematopoietic stem cell transplantation is the only possible treatment for many malignant and non-malignant hemopathies. The graft-versus-host immunological reaction (GvH) is a frequent and sometimes serious complication. The objective is to study whether a systematic and early follow-up by a lung specialist of allografted patients would allow an earlier diagnosis of GvH with pulmonary complications.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* patients with a hematopoietic stem cell transplantation

Exclusion Criteria:

* Death within 100 days post-surgery

Primary outcomes:
measure: Medical complications
timeFrame: Medical complications, especially Graft-versus-Host reaction with pulmonary complications occurring within 100 days post-surgery are studied
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Croix-Rousse Hospital, Hospices Civils de Lyon
Study officials:
References: