louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04199481: Univation XM France
Official title: A Prospective, Observational, Monocentre 5-year Follow-up Clinical Trial on a Historical Consecutive Cohort of Unicompartmental Knee Arthroplasty Patients Treated With the Mobile Bearing Unicondylar Knee Prosthesis Univation XM
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Osteoarthritis, Knee
Osteoarthrosis of Knee
Arthritis Knee
Unicompartmental Knee Arthroplasty
Keywords: unicompartmental knee arthroplasty
retrospective study
Knee Society Score
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
Collaborators: name: B. Braun Medical SA
First posted: 2019-12-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients

Brief summary: The study is set up due to regulatory purposes and to collect routine clinical data of the mobile-bearing implant univation XM. The study is designed as a prospective follow-up study with a historic patient cohort who have been treated with the product under investigation two years ago. This design is selected to quicker realize follow-up data as patients have already been treated in the past.

As the mobile version of the implant is not widely used, the study will be set up as a monocentric study in France. The clinical hypothesis of the study is that patients who are treated with the product under investigation have a similar outcome and survival rate in comparison to other established unicondylar knee systems on the market. Comparison for the later evaluation will be taken out of recent orthopaedic registries.


Eligibility criteria: Inclusion Criteria:

* Patient has received a primary mobile bearing UKA at the study site between January 2017 and December 2018 using the product under investigation
* Patient's written consent and willingness to participate at the clinical study and the follow-up examinations

Exclusion Criteria:

* Pregnancy
* Patient Age \<18 years at the time of the surgery

Primary outcomes:
measure: Survival Rate of the Implant
timeFrame: 5 years after surgery
Secondary outcomes:
measure: Development of Knee joint function
timeFrame: in the postoperative course, up to 5 years after surgery
measure: Development of Oxford Knee Score
timeFrame: in the postoperative course, up to 5 years after surgery
measure: Intraoperative/surgery Data
timeFrame: intraoperative
measure: Radiographic evaluation
timeFrame: in the postoperative course, up to 5 years after surgery
measure: Rate of Serious Adverse Events
timeFrame: in the postoperative course, up to 5 years after surgery
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: CHU Hopital Hautepierre
Study officials:
References:
Clinical trial NCT03271281: PET/CT Imaging of Angiogenesis in Patients With Neuroendocrine Tumors Using 68Ga-NODAGA-E[c(RGDyK)]2
Official title: PET/CT Imaging of Angiogenesis in Patients With Neuroendocrine Tumors Using 68Ga-NODAGA-E[c(RGDyK)]2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neuroendocrine Tumors
Keywords: 68Ga-NODAGA-E[c(RGDyK)]2
Angiogenesis PET/CT
Neuroendocrine tumors
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2017-09-05
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this non-randomised, prospective study is to investigate the applicability and prognostic value of angiogenesis PET/CT with the radioligand 68Ga-NODAGA- E\[c(RGDyK)\]2 in patients with neuroendocrine tumors (NETs).

Detailed description: The radioligand 68Ga-NODAGA- E\[c(RGDyK)\]2 targets the Arg-Gly-Asp (RGD) sequence known to bind with the αvβ3 integrin that is expressed on the surface of angiogenic blood vessels or tumor cells. The radioligand can be used to visualize tumor angiogenesis using PET/CT.

A total of 120 NET patients will be subjected to an angiogenesis-PET/CT scan. Follow-up will be performed (from the time of the angiogenesis PET/CT) at 6 months for disease specific survival (DSS) and a 1 year follow-up for PFS and OS. The uptake of 68Ga-NODAGA-E\[c(RGDyK)\]2 (Standardized Uptake Values, SUVmax) in tumor lesions will be quantified as Standardized Uptake Values (SUVmax/SUVmean) and compared with PFS, DSS and OS (dichotomized above/below median SUVmax and analyzed by Kaplan-Meier).

Eligibility criteria: Inclusion Criteria:

* Diagnosed with gastro-entero-pancreatic Neuroendocrine Tumors (GEP-NET; grade: G1-G3) or broncho-pulmonary NET.
* WHO performance status 0-2
* Must be able to read and understand the patient information in Danish and to give informed consent

Exclusion Criteria:

* Pregnancy
* Breast-feeding
* Weight more than the maximum weight limit for the PET/CT bed of the scanner (140 kg)
* History of allergic reaction attributable to compounds of similar chemical or biologic composition to 68Ga-NODAGA-E\[c(RGDyK)\]2
* In case of broncho-pulmonary NET, the subtype must not be small cell lung cancer (SCLC)

Primary outcomes:
measure: Angiogenesis PET/CT imaging of patients with neuroendocrine tumors
timeFrame: 1 hour
Secondary outcomes:
measure: Angiogenesis PET/CT progonostic factor for progression free survival
timeFrame: 12 months
measure: Angiogenesis PET/CT prognostic factor for overall and disease specific survival
timeFrame: 12 months
measure: Target validation of angiogenesis PET/CT
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Esben Carlsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04584281: Artificial Intelligence (AI) in Cardiotocography (CTG) Interpretation
Official title: Introduction of Artificial Intelligence (AI) and Machine Learning in Cardiotocography (CTG) Interpretation to Improve Clinical Use
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: To Introduce Artificial Intelligence (AI) and Machine Learning in Cardiotocography (CTG) Interpretation to Improve Clinical Use
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement
First posted: 2020-10-12
Enrollment: 15000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with singleton pregnancies and CTG-registrations during labour from 01.01.2006 to 31.12.2019

Brief summary: The project leaders plan to create a clinical decision support (CDS) system by programming a self-learning software to analyze the cardiotocography (CTG) traces in the - already existing - database from the maternity department of the Inselspital Berne. The project leaders will process and analyze all clinical outcomes of the estimated 10000-15000 eligible patient records. CSEM will design, develop, and validate several AI architectures with the intend to create the CDS system. The AI would learn to assist on this task by training machine learning (ML) algorithms. The main purpose of the AI-CDS will be to determine the best fetal extraction moment during labor, based on a self-learning approach, as a "superhuman" support tool for obstetricians in decision making during labor.


Eligibility criteria: Inclusion Criteria:

* CTG-registrations of patients with singleton pregnancies during labour from 01.01.2006 to 31.12.2019
* Gestational age ≥ 24+0 weeks
* Age ≥ 18 years
* Written informed consent

Exclusion Criteria:

* Documented refusal
* Multiple pregnancies
* CTG-registrations of planned caesarean sections

Primary outcomes:
measure: Superior prediction of fetal morbidity through the self-learning CDS system than if performed by obstetricians alone, especially in regards to specificity.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Frauenklinik Inselspital Bern
Study officials:
References:
Clinical trial NCT00186381: Autologous Bone Marrow Transplantation in Acute Non-Lymphoblastic Leukemia During First or Subsequent Remission
Official title: Autologous Bone Marrow Transplantation for Acute Non-Lymphoblastic Leukemia During First or Subsequent Remission
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leukemia, Myelocytic, Acute
Leukemia
Blood and Marrow Transplant (BMT)
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Maximum age (years): 69
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluate the role of high dose chemotherapy with autologous hematopoietic cell transplantation for AML.

Detailed description: To use high dose chemotherapy with autologous stem cell rescue to try to increase the chance of long term control and cure of the disease.

Eligibility criteria: Inclusion Criteria:- must be in remission

* adequate organ function Exclusion Criteria:- prior MDS
* active infection
* liver disease

Primary outcomes:
measure: Disease free survival (DFS)
Secondary outcomes:
measure: Transplant related mortality (TRM)
measure: Toxicity
measure: Adequacy of cell collections
measure: Engraftment kinetics
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Laura Johnston
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02257281: The Effect of Therapeutic Ultrasound on Soft Tissue: An Experimentally-induced Skin Model
Official title: Chung Shan Medical University Hospital Institutional Review Board
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Keywords: Sodium lauryl sulfate
Skin irritants
inflammation
therapeutic ultrasound
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2014-10-06
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purposes of study are to investigate the effect of therapeutic ultrasound for the inflammatory skin repair and whether the tissue repair under ultrasound treament is depend on different inflammatory level.

Detailed description: Therapeutic ultrasound for soft tissue repair has been used in clinical during the past decades. In some recent systematic review, the evidence of clinical trials were insufficiency. We assumed the reaserch biasin clinical trials may be due to the different inflammatory level of soft tissue under the similar ultrasound intensity. Our purpose of study is to investigate the effect of therapeutic ultrasound for the inflammatory skin repair and whether the tissue repair under ultrasound treament is depend on different inflammatory level.

Eligibility criteria: Inclusion Criteria:

1. asia healthy subjects
2. aged 20-45 years

Exclusion Criteria:

1. disadvantaged groups
2. systemic disease, such as DM, cancer, autoimmune disorder
3. hyperhidrosis or hypothyroidism
4. a past history of dermatitis
5. active infective or inflammatory cutaneous disease
6. smoking or drinking
7. take medicine, over sun exposure, exercise or menstruation during experimental period
8. contraindication of therapeutic ultrasound

Primary outcomes:
measure: skin blood flow
timeFrame: 2 weeks
Secondary outcomes:
measure: skin temperature
timeFrame: 2 weeks
measure: skin water content
timeFrame: 2 weeks
measure: Tactile pain threshold
timeFrame: 2 weeks
measure: erythema index
timeFrame: 2 weeks
measure: skin thickness
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Department of rehabilitation
name: Peir Renn Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00328081: State of Obesity Care in Canada Evaluation Registry
Official title: State of Obesity Care in Canada Evaluation Registry An Observational Study of Clinical Care of Patients With Obesity
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Obesity
Morbid Obesity
Keywords: Obesity
Weight gain
Anti-obesity medication
Anti-obesity management strategies
Body Weight
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2006-05-19
Enrollment: 1906
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: The purpose of this study is to see whether care gap(s) exist in the management of obesity and its related conditions in obese patients seen by primary care physicians and specialists. The study will also look at whether there is a compliance and adherence gap that exists in patients prescribed medication for obesity management.

Detailed description: Obesity currently affects over 15% of the adult population in Canada. The economic burden associated with obesity is estimated at $4.3 billion or 2.2% of the total health care costs in Canada. Despite increasing recognition as a public health problem, clinical management of obese patients in Canada has received little attention. This study will collect information on the current status, characteristics and management of subjects with obesity. The design of the study will mirror real-life management of these subjects.There are three goals in this study: the primary goal is to document appropriate obesity management strategies aimed at reducing and maintaining a healthy body weight by participating primary care physicians and specialists. The second goal is to explore factors that determine patients compliance and adherence to anti-obesity medication when prescribed. Obesity management is currently not a priority in tertiary care centres in Canada. An exception being the Bariatric Clinic located at McMaster University, which is one of the few academic centers dedicated to obesity management in Canada. The primary goal of the Bariatric Clinic Substudy is to evaluate the management, compliance and adherence of patients seen at a tertiary care obesity clinic compared to those of primary care physicians and specialists.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older and is able to provide informed consent
* Has not been enrolled in this study at an earlier office visit; and
* Provides signed informed consent
* BMI \> = 27 kg/m

Exclusion Criteria:

* Participation in a clinical trial
* Hospitalized patient
* Subject expected to have difficulties to come back at follow-up visits
* Pregnant or nursing

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences - Cardiovascular Obesity Research and Management
state: Ontario
Study officials:
affiliation: McMaster University
name: Arya M Sharma, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04996381: Feasibility of AI-based Heart Function Prediction Model Using CXR
Official title: Feasibility of Artificial Intelligence-based Heart Function Prediction Model Using Chest Radiography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chest X-ray for Clinical Evaluation
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2021-08-09
Enrollment: 505
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing a transthoracic echocardiogram will be enrolled.

Brief summary: The investigators will develop an artificial intelligence model to predict left ventricular ejection fraction using chest radiographic images and transthoracic echocardiography data.

Detailed description: Echocardiography should be considered at an early stage in patients who have first developed heart failure or who do not have information about heart function, but the examination may be delayed due to lack of time and manpower in the actual medical field.

Primary Objective: Use chest radiographs to predict the left ventricular ejection fraction

Eligibility criteria: Inclusion Criteria:

* Adults who are 20 years and older
* Patient who visited the emergency room or outpatient clinic due to dyspnea and chest pain

Exclusion Criteria:

* Patient refusal
* Uncertain radiographs or transthoracic echocardiography
* Uncertain tests results

Primary outcomes:
measure: Left Ventricular Ejection Fraction < 40%
timeFrame: Within two weeks of chest X-ray
Secondary outcomes:
Other outcomes:
Locations:
city: Yongin
country: Korea, Republic of
facility: Yongin Severance Hospital
state: Giheung-gu
Study officials:
affiliation: Yongin Severance Hospital, Yonsei University College of Medicine
name: In Hyun Jung, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02124681: Rediscovering Hydroxychloroquine as a Novel Insulin Sensitizer
Official title: Rediscovering Hydroxychloroquine as a Novel Insulin Sensitizer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Insulin Resistance
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2014-04-28
Enrollment: 34
Sex: ALL
Minimum age (years): 21
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Current options to treat insulin resistance in diabetes are fairly limited. For this reason, novel treatments would represent a major progress. The generic drug hydroxychloroquine (HCQ) has poorly understood effects on blood sugar metabolism. In this study, the investigators will examine the mechanisms by which this drug affects glucose metabolism and which cells are affected. Findings emanating from this project will help establish whether HCQ may be a viable treatment for disorders of glucose metabolism.


Eligibility criteria: Inclusion Criteria:

* Age 21-69 years-old;
* BMI 28-40;
* Presence of at least one of the following markers of insulin resistance: a) fasting hyperinsulinemia (\>7 uU/ml by ultrasensitive insulin assay); impaired fasting glucose (100-125 mg/dl); prior history of impaired glucose tolerance provided by the participant; history of previous gestational diabetes; history of PCOS; waist circumference \>40" (men) or \>35" (women) (cut-offs from ATP-III criteria for metabolic syndrome).

Exclusion Criteria:

* Pregnancy, or unable/unwilling to avoid pregnancy during the study;
* Unstable cardiopulmonary disease, hepatitis, liver dysfunction, renal insufficiency, or any other medical condition affecting glucose metabolism or safety during the study;
* Diabetes;
* Medications that affect glucose metabolism: (e.g. systemic glucocorticoids, antipsychotics);
* History of hypersensitivity to local lidocaine, similar anesthetics, or HCQ;
* History of G6PDH deficiency;
* History of retinopathy;
* Weight instability (\>3Kg of weight change in the past three months);
* Bariatric surgery in the last two years, intention to lose weight or engage in exercise regimen during study;
* Alcohol intake \>1 drink/day (averaged);
* Hemoglobin \<10g%

Primary outcomes:
measure: Insulin sensitivity in muscle and liver
timeFrame: 13±1 weeks
Secondary outcomes:
measure: biomarkers of inflammation
timeFrame: 13±1 weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Montefiore Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Frederico Toledo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05910281: Rebound Pain and Related Factors in Postoperative Patients With Total Knee Arthroplasty
Official title: Rebound Pain and Related Factors in Patients Who Underwent Femoral Nerve Block for Postoperative Pain Control in Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Postoperative Pain
Postoperative Complications
Postoperative Nausea and Vomiting
Lead sponsor: Gulhane Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2023-06-18
Enrollment: 150
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: - 18-80 years older age who underwent total knee arthroplasty

Brief summary: The aim of this prospective observational study is to detect rebound pain and related factors in postoperative patients with total knee arthroplasty.

Detailed description: Total knee arthroplasty is an effective treatment method for knee osteoarthritis and because it is an invasive method, more than 50% of patients experience postoperative pain. Peripheral nerve blocks are widely used for optimal pain control. The femoral block is a frequently preferred peripheral nerve block method for postoperative analgesia in total knee arthroplasty surgery. However, after peripheral nerve block, a condition called rebound pain (rebound pain), which is described as very severe pain, lasting about 2 hours, usually of the burning type, occurs. The aim of this prospective observational study is to detect rebound pain and related factors in postoperative patients with total knee arthroplasty.

Eligibility criteria: Inclusion Criteria:

* 18-80 years older age who underwent total knee arthroplasty

Exclusion Criteria:

* ASA score 4 or \>4
* Active infection
* End stage organ failure
* Pregnancy
* Established diagnosis neuropsychiatric disease ( epilepsy, neuropathy, neuromuscular disease, cerebrovascular disease...)
* Uses of oral corticosteroids

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: postoperative 3-5 days fellow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
state: None Selected
Study officials:
References: