louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01033838: Randomized Trial Comparing Laparoscopic-assisted Rectosigmoid Resection Versus Laparoscopic Rectosigmoid Resection With Transrectal Specimen Retrieval
Official title: Conventional Laparoscopic-assisted Rectosigmoid Resection Versus Laparoscopic Rectosigmoid Resection With Intracorporeal Anastomosis and Transrectal Specimen Retrieval
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Symptomatic Recurrent Diverticular Disease
Benign Adenomatous Sigmoidal Polyp, Requiring Surgery
Early Non-transmural Sigmoidtumor
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2009-12-17
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Laparoscopic anterior resection is a standardized procedure requiring a small muscle split incision to retrieve the specimen and to fashion the proximal part of the double stapled anastomosis. Most patients can be included within a standardized perioperative care program called Enhanced Recovery After Surgery (ERAS). A new evolution as a primary step towards a complete Natural Orifice Translumenal Endoscopic Surgery (NOTES)-procedure is a hybrid approach (transrectal and laparoscopic). The dissection is performed laparoscopically but the specimen is retrieved within an endobag through the rectum. The anastomosis is created intracorporeally using a triple stapled technique. There are no trials available in the literature concerning these 2 techniques. Therefore this study will be undertaken to establish the role of the 2 surgical procedures and to compare them after short-term follow-up.


Eligibility criteria: Inclusion Criteria:

* Age 18-90
* Symptomatic recurrent diverticular disease
* Benign adenomatous polyp, requiring surgery
* Early non-transmural sigmoidtumor
* Signed written informed consent, approved by ethical committee

Exclusion Criteria:

* Patients unsuitable for laparoscopy
* Pregnancy
* ASA \>III
* Coagulation disorders
* Anti-coagulants

Primary outcomes:
measure: Reduction in analgetic need
Secondary outcomes:
measure: reduction in hospital stay within an ERAS-program
measure: effect on the inflammatory response
measure: effect on anal continence
measure: procedural cost assessment (incorporating operative time)
measure: overall cost assessment
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
References:
citation: Wolthuis AM, Fieuws S, Van Den Bosch A, de Buck van Overstraeten A, D'Hoore A. Randomized clinical trial of laparoscopic colectomy with or without natural-orifice specimen extraction. Br J Surg. 2015 May;102(6):630-7. doi: 10.1002/bjs.9757. Epub 2015 Mar 12.
Clinical trial NCT02393638: ERCP Mechanical Simulator (EMS) Practice for Training Endoscopic Sphincterotomy
Official title: ERCP Mechanical Simulator (EMS) Practice for Training Endoscopic Sphincterotomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endoscopic Sphincterotomy
Keywords: Endoscopic Sphincterotomy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2015-03-19
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This randomized-controlled study aims to evaluate the effectiveness of using ERCP mechanical simulator for training endoscopic sphincterotomy.

Detailed description: Usual clinical ERCP training is supervised hands-on practice and the number of procedures is used as a surrogate for trainees' experience. At least 180 cases are required to achieve ERCP competence. A major limitation is lack of suitable patients. Alternative supplemental training includes simulator practice using computer simulators, live animal models, and ex-vivo porcine organ. Our previous study has showed that the mechanical simulator training improves trainees' clinical performance in terms of success of deep CBD cannulation. In this study, we aim to evaluate the usefulness of ERCP mechanical simulator for training endoscopic sphincterotomy.

Eligibility criteria: Inclusion Criteria:

* GI trainees who met the minimum endoscopy training experience

Exclusion Criteria:

* GI trainees with no endoscopy experience

Primary outcomes:
measure: proportion of endoscopic sphincterotomy successfully performed by trainees
timeFrame: 1year
Secondary outcomes:
measure: Improvement in overall performance as measured by sphincterotomy score
timeFrame: 1 year
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Gastroenterology, National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: W C Liao, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liao WC, Leung JW, Wang HP, Chang WH, Chu CH, Lin JT, Wilson RE, Lim BS, Leung FW. Coached practice using ERCP mechanical simulator improves trainees' ERCP performance: a randomized controlled trial. Endoscopy. 2013 Oct;45(10):799-805. doi: 10.1055/s-0033-1344224. Epub 2013 Jul 29.
Clinical trial NCT02528838: An Observational Study to Assess Safety and Outcome of the Various Medication Usage Patterns in Clinical Routine Practice in Patients Receiving Lenalidomide.
Official title: A Non-interventional Observational Post Authorization Study to Assess Safety and Outcome of the Various Medication Usage Patterns in Clinical Routine Practice in Patients Receiving Lenalidomide (REVIEW)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Keywords: Myeloma
Non-interventional
Observational
Lenalidomide
REVIEW
Post-authorization
Netherlands
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2015-08-19
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients already successfully, i.e. with currently stable disease or meeting the criteria for complete response, very good partial response or partial response, on-treatment for maximally up to 6 cycles with lenalidomide at each site will be enrolled into the study. In all cases, the decision to treat the patient with lenalidomide was already made prior to the decision to enter the subject into the study.

Brief summary: The study is designed as a prospective, non-interventional, observational single arm study. Hundred-fifty patients over 18 with stable disease or at least partial response while on treatment with lenalidomide will be recruited from approximately 20 haematology/oncology sites in the Netherlands. Recruitment will continue until 150 patients have started the study. When this target is reached, all patients on lenalidomide will continue to be followed until the last patient has been followed for 36 months.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age who understand and voluntarily sign an informed consent form.
* Patients with multiple myeloma who are currently receiving lenalidomide treatment and who have taken lenalidomide for \> 2 cycles and \< 6 cycles.
* Patients with currently stable disease or meeting the criteria for complete response, very good partial response or partial response while on lenalidomide treatment.

Exclusion Criteria:

* Refusal to participate in the study.
* Women who are pregnant or breast-feeding.
* Women of childbearing potential unless all of the conditions of the Pregnancy Prevention Programme are met.
* Hypersensitivity to the active substance or to any of the excipients.

Primary outcomes:
measure: Adverse Event (AE)
timeFrame: Up to approximatly 4 years
Secondary outcomes:
measure: Quality of Life
timeFrame: Up to approximatly 24 months
measure: Lenalidomide usage patterns
timeFrame: Up to approximatly 4 years
measure: Lenalodomide dose modifications
timeFrame: Up to approximatly 4 years
measure: Reasons for discontinuation of lenalidomide
timeFrame: Up to approximatly 4 years
measure: Clinical outcome
timeFrame: Up to approximately 4 years
Other outcomes:
Locations:
Study officials:
affiliation: Celgene BV
name: Jeroen Stevens, MSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT02532738: The Efficiency of MSC in Refractory Crohn's Disease
Official title: A Stage II Clinical Trial Comparing the Efficiacy of Routine Treatment Combined With or Without MSC Therapy in Refractory Crohn's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Crohn's Disease
Keywords: efficacy of MSC
refractory
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Third Affiliated Hospital, Sun Yat-Sen University
name: Nanfang Hospital, Southern Medical University
First posted: 2015-08-26
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators' preliminary study indicates that MSC is effective therapy in treating IBD. But the standard treatment is still lacking and the effect is not stable in IBD patients. This study is to explore the efficacy and standard strategy when using MSC in refractory IBD.


Eligibility criteria: Inclusion Criteria:

* Failure or intolerance to GC, immune inhibitors and biological agents treatment
* CDAI between 250-450
* Weight between 40-150 kg
* Normal renal function
* endoscopic or imaging diagnosis of CD in the small intestine, colon ileocolon
* Signed informed consent

Exclusion Criteria:

* HIV or active hepatitis patients;
* Allergic to CT contrast agents, cattle or pig products;
* Stricture or perforation type CD;
* Recieved permanent colostomy;
* Used biological preparation in 3 months
* Used prednisone \> 20 mg/day within 1 month ;
* Patients with short bowel syndrome;
* Need total parenteral nutrition;
* Liver meritorious service is abnormal;
* Suffering from malignant tumor during the last 5 years;
* Combined bacterial or viral enteritis;
* Suffering from intestinal typicality thickening of the living
* Patients with tuberculosis.

Primary outcomes:
measure: Clinical Response of CD patients 12 weeks after receiving treatment (Reduction of CDAI score at less 100)
timeFrame: 12 weeks after receiving treatment
Secondary outcomes:
measure: Clinical Response of CD patients 6 weeks after receiving treatment (CDAI score less than 150)
timeFrame: 6 weeks after receiving treatment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05230238: Pituitary Gland Stimulation for Cancer Pain Relief
Official title: Pituitary Gland Stimulation for Cancer Pain Relief
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oncology Pain
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients will undergo an implantation of an extradural pituitary surface electrode in the pituitary fossa. The electrode will be attached to a neurostimulator via which the patient will receive up to 8 (patient requested) stimulations per day.


Eligibility criteria: Inclusion Criteria:

* Adult patient
* In palliative phase of metastatic disease, without options for further systemic treatment or radiotherapy
* Inadequately controlled pain with standard care
* Most prominent part of experienced pain is nociceptive
* Karnofsky Performance Score ≥30

Exclusion Criteria:

* Not fit for general anesthesia
* Pregnancy
* Unfavorable local anatomy for PGS, due to a disease process, or anatomical configuration
* Clinical signs of posterior pituitary gland disfunction
* Recent history of alcohol or drug abuse
* Severe immunodeficiency
* Need for anticoagulation therapy that cannot be abrogated for surgery
* Need for subsequent MRI-imaging
* Cognitive impairments prohibiting full understanding of study and ability to provide informed consent
* Not able to adequately communicate in Dutch or English

Primary outcomes:
measure: Perceived pain
timeFrame: 4 months
measure: Pain Medication
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
Study officials:
affiliation: Leiden University Medical Center
name: Wouter van Furth, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00173238: The Study of Human Atherosclerosis by Polarization-Sensitive Optical Coherence Tomography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pathological Conditions, Anatomical
Keywords: atherosclerosis
optical coherence tomography
polarization
phase retardation
birefringence
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 5
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER

Brief summary: Atherosclerosis is unquestionably the leading cause of morbidity and mortality in developed countries, and the world-wide importance of acute vascular syndromes is increasing. Rupture of atherosclerotic plaque has been identified as the proximate event in the majority of cases of acute ischemic syndromes. Therefore, modalities capable of characterizing the atherosclerotic lesion may be helpful in understanding its natural history and detecting lesions with high risk for acute events.

Optical coherence tomography (OCT) is a powerful tool capable of tomographic imaging based on low coherence interferometry. It is analogous to ultrasound imaging except that it uses infrared light instead of sound. Polarization-sensitive optical coherence tomography (PS-OCT) combines the advantages of OCT with additional image contrast of the sample. The added contrast is based on the ability of PS-OCT to detect the birefringent properties of a sample (phase retardation and fast-axis orientation) simultaneously.

The goals of this project are: 1) to examine whether PS-OCT is an acceptable tool for the characterization of typical plaque constituents; and 2) to explain the correlation between birefringence and forming or rupture of a plaque; and 3) to establish a quantitative PS-OCT image criteria for atherosclerotic plaque characterization in vitro.

Detailed description: Optical Coherence Tomography (OCT) is a promising new class of diagnostic medical imaging technology that utilizes advanced photonics and fiber optics to obtain images and tissue characterization on a scale never before possible within the human body. OCT combines the principles of ultrasound with the imaging performance of a microscope and a form factor that is familiar to clinicians. Whereas ultrasound produces images from backscattered sound "echoes," OCT uses infrared light waves that reflect off the internal microstructure within the biological tissues.

Eligibility criteria: Inclusion Criteria:

* Heart transplantation, atherosclerosis

Exclusion Criteria:

* Infection

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital,Taipei.Taiwan
name: Nai-Kuan Chou, MD.,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03225638: Performance Evaluation by Magnetic Resonance Imaging (MRI) of Intramuscular Thigh Injections With 3 Configurations of Needle-free Injector (ZENEO®)
Official title: Performance Evaluation by Magnetic Resonance Imaging (MRI) of Intramuscular Thigh Injections With 3 Configurations of Needle-free Injector (ZENEO®)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: No Condition
Lead sponsor: Crossject
Sponsor class: INDUSTRY
First posted: 2017-07-21
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study is to evaluate the intramuscular nominal thigh injection performance and the low threshold strength thigh injection (by evaluating 2 low threshold : upper limit and lower limit). All participants will receive an intramuscular nominal thigh injection, and half of the participants will receive an intramuscular low threshold (upper limit) strength thigh injection, while the other half will receive an intramuscular low threshold (lower limit) strength thigh injection.


Eligibility criteria: Inclusion Criteria:

* Male or female healthy volunteers aged between 18 and 60 years
* Affiliated to or covered by the French social security system
* BMI between ≥ 18 and \< 30 kg/m²
* Patients without chronic medical or surgical illness
* Patients with normal clinical examination at the screening visit
* Patients with normal blood pressure at the screening visit: systolic BP \< 140 mmHg and diastolic BP \< 90 mmHg, determined with the patient seated and resting for at least 5 minutes
* Patient within normal range values for the following laboratory tests (appendix I) unless the investigator considers an abnormality to be clinically irrelevant (to be documented and agreed with the sponsor before inclusion) within 1 month prior to the start of the study.
* Absence of cannabis, opiate, cocaine, amphetamine history
* Written Informed consent

Exclusion Criteria:

* History of drug abuse
* History of hypersensitivity (disease or drug)
* Treatment with platelet inhibiting drugs within one week before inclusion
* Treatment with anticoagulant within four weeks before inclusion
* Subject likely to take any medication during the study
* Contra-indication to MRI: metallic intra-corporeal devices, claustrophobia
* Prior participation to other interventional clinical research within 3 months
* In custody due to administrative or legal decision or under tutelage or being admitted in a sanitary or social institution
* pregnant or breastfeeding woman

Primary outcomes:
measure: Depth of the injection
timeFrame: 5 minutes after the injection
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01032538: Time-dependent Improvement of Functional Outcome Following Oxford Medial Unicondylar Knee Replacement
Official title: Time-dependent Improvement of Functional Outcome Following Oxford Medial Unicondylar Knee Replacement - A Prospective Longitudinal Study With Repetitive Measures of KOOS in 100 Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Keywords: Unicondylar Knee Replacement
Lead sponsor: Martina Hansen's Hospital
Sponsor class: OTHER
Collaborators: name: South-Eastern Norway Regional Health Authority
First posted: 2009-12-15
Enrollment: 99
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients operated with total knee arthroplasty at Martina Hansens Hospital, Akershus University Hospital and Baerum hospital

Brief summary: The objective of this prospective study is to determine (1) the time course of patient-relevant functional outcome evaluated by the Knee injury and Osteoarthritis Outcome Score (KOOS) and (2) the time course of range of motion (ROM) the first six years following Oxford Medial Unicondylar Knee prosthesis. Improvement of patient self-reported pain and daily function during the study period, are of particular interest.

Detailed description: The objective of this prospective study is to determine (1) the time course of patient-relevant functional outcome evaluated by the Knee injury and Osteoarthritis Outcome Score (KOOS) and (2) the time course of range of motion (ROM) the first six years following Oxford Medial Unicondylar Knee prosthesis. Improvement of patient self-reported pain and daily function during the study period, are of particular interest. Thats it!

Eligibility criteria: Inclusion Criteria:

* patients with medial knee osteoarthritis
* admitted for unicondylar knee replacement
* age 50-80 years

Exclusion criteria

* rheumatoid arthritis
* previous knee infection

Primary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score
timeFrame: Preoperative until 2 years postoperatively
Secondary outcomes:
measure: Range of Motion
timeFrame: Preoperative until 2 years postoperatively
measure: Oxford Knee Score
timeFrame: Preoperative until 2 years postoperatively
measure: UCLA Score
timeFrame: Preoperative until 2 years postoperatively
measure: Knee Injury and Osteoarthritis Outcome Score
timeFrame: 10 years postoperatively
measure: Oxford Knee Score
timeFrame: 10 years postoperatively
Other outcomes:
Locations:
city: Bærum
country: Norway
facility: Bærum Sykehus
state: Akershus
city: Lørenskog
country: Norway
facility: Akershus University Hospital
state: Akershus
city: Bærum
country: Norway
facility: Martina Hansens Hospital
Study officials:
affiliation: Martina Hansens Hospital
name: Tor Kjetil Nerhus, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06753838: Choice of Anticoagulant for Primary Hemostasis Studies with PFA200® (Platelet Function Analyser)
Official title: Choice of Anticoagulant for Primary Hemostasis Studies with PFA200® (Platelet Function Analyser)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hemostasis
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2024-12-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients requiring a PFA test

Brief summary: The PFA (platelet function analysis) test is prescribed for the exploration of primary hemostasis and the study of platelet-willebrand factor interaction. It is performed using citrated blood, with technical difficulties and frequent alarms that may be linked to the choice of anticoagulant (citrate). It is proposed to compare the results obtained with a conventional citrate tube and a BAPA tube, which is an anticoagulant used in clinical research and which blocks coagulation by another mechanism that would have less impact on blood platelets.


Eligibility criteria: Inclusion Criteria:

* Person having given their non-opposition
* Person of legal age
* Person receiving a haemostasis consultation at the haemophilia and haemorrhagic diseases treatment center followed by a blood sample with a PFA test prescribed by the doctor (the test is not added for the study).

Exclusion Criteria:

* persons under legal protection (curatorship, guardianship)
* persons subject to a court protection order
* pregnant, parturient or breast-feeding women
* adult incapable or unable to give consent
* minor

Primary outcomes:
measure: Occlusion time measurement
timeFrame: at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References: