louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01105351: Effect of Folic Acid on Primary Folate Forms in Relation to MTHFR
Official title: Effect of Mild Increase in Folic Acid Intake on the Distribution of Folate Forms in Relation to a Common Polymorphism in One Folate Catabolising Enzyme
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: the Effect of MTHFR C677T on Folate Metabolism
Keywords: Folate
MTHFR
Homocysteine
Lead sponsor: Universität des Saarlandes
Sponsor class: OTHER
First posted: 2010-04-16
Enrollment: 75
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The common polymorphism in MTHFR gene (C677T) has a significant effect on (6S)-5-CH3-H4folate after folic acid supplementation. For example, post supplementation differences in (6S)-5-CH3-H4folate between CC and TT are above 30%.

Detailed description: The investigators aim to test the effect of low doses of folic acid with or without B6 and B12 on folate forms in relation to polymorphisms in folate catabolising enzymes in elderly people. Our hypothesis is that differences in folate forms after folic acid supplementation might be due to polymorphisms in folate catabolising enzymes. Therefore, folic acid might be retained by people with certain genotypes.

Eligibility criteria: Inclusion Criteria:

* Males and females
* Age \> 65 years.

Exclusion Criteria:

* Renal dysfunction
* Recent stroke, or coronary event (within the last 3 months)
* Current cancer treatment
* Antifolate (e.g. methotrexate) treatment
* Ileum resection
* Current B-vitamin supplement
* Epilepsy medications
* Megaloblastic anemia or other indications for treatment with high doses of folate or vitamin B12.

Primary outcomes:
measure: blood metabolic markers
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Homburg
country: Germany
facility: University of Saarland
state: Saarland
Study officials:
affiliation: Department of Clinical Chemistry, University of Saarland
name: Rima Obeid, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Obeid R, Kirsch SH, Dilmann S, Klein C, Eckert R, Geisel J, Herrmann W. Folic acid causes higher prevalence of detectable unmetabolized folic acid in serum than B-complex: a randomized trial. Eur J Nutr. 2016 Apr;55(3):1021-8. doi: 10.1007/s00394-015-0916-z. Epub 2015 May 6.
Clinical trial NCT04936451: Electrotherapy in the Management of Myofascial Syndrome
Official title: Contribution of an Electrotherapy Technique Such as TENS ECOMODYN® vs Electrotherapy Only Type TENS in the Management of Myofascial Syndrome After Breast Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer
Surgery
Myofascial syndrome
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
First posted: 2021-06-23
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Monocentric, randomized in cross over in two arms, open
Primary purpose: SUPPORTIVE_CARE

Brief summary: Myofascial syndrome is defined as "musculoskeletal pain characterized by local and referred pain perceived to be deep and constant, and by the presence of myofascial trigger points in any part of the body" Post-breast surgery myofascial syndrome affects up to 44.7% of operated women, mainly on the muscles of the greater shoulder girdle. The repercussions are significant, functional, somatic, psychological and socio-professional affecting the quality of life. The treatments offered may or may not be medicinal. Transcutaneous electrical nerve stimulation (TENS) is a therapy that uses low voltage electrical current to provide pain relief. A TENS unit consists of a battery-powered device that delivers electrical impulses through electrodes placed on the surface of your skin. The electrodes are placed at or near nerves where the pain is located or at trigger points.


Eligibility criteria: Inclusion Criteria:

* Male or female who had first breast cancer surgery, regardless of the type of surgery
* Age ≥ 18 years
* Patients with refractory pain with myofascial syndrome, with a numerical scale ≥ 4
* Topical treatment for refractory pain completed more than 30 days ago
* Healthy, non-irritated skin on painful areas to treat
* Patient with a third party who can attend visits M0 and M2.5
* Obtaining the signed written consent of the patient
* Major patient affiliated to a social security scheme

Exclusion Criteria:

* Patient who has used TENS before on the muscles affected by the myofascial syndrome
* Post-surgery management of the affected area by a physiotherapist
* Person with venous thrombosis
* Contraindications specific to the treatments studied

Primary outcomes:
measure: The main objective is to evaluate the effectiveness of TENS and TENS ECOMODYN® on the management of chronic breast pain after surgery.
timeFrame: 16,5 months
Secondary outcomes:
measure: Evaluate the changes made by the treatment felt by the patient
timeFrame: 16.5 months
Other outcomes:
Locations:
city: Saint-Herblain
country: France
facility: Institut de Cancerologie de l'Ouest
Study officials:
affiliation: Institut de Cancérologie de l'Ouest
name: EVA KERROUAULT, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04021251: Performance Characteristics of Non-invasive Glucose Monitoring Device Prototypes
Official title: Performance Characteristics of Non-invasive Glucose Monitoring Device Prototypes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes
Lead sponsor: RSP Systems A/S
Sponsor class: INDUSTRY
First posted: 2019-07-16
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This clinical study has been launched to collect spectral raman data paired with validated glucose reference values in private homes of subjects

Detailed description: Subjects will collect either 8 or 44 daily optical raman readings paired with either 8 capillary Blood Glucose comparator or 8 capillary Blood Glucose comparator plus 44 readings using a flash glucose monitoring system in own home with maintaining usual routines. Subjects will either collect data for 5 days during a 10 days period or collect data for 90 days during a 40 days period or collect data for 90 days during 6 months period.

Eligibility criteria: Inclusion Criteria:

* Male and female subjects 18 years of age or older
* Diabetic patients (all types)
* Skin phototype 1-4

Exclusion Criteria:

* For female participants: Pregnancy or subject is attempting to conceive or not willing and able to practice birth control during the study duration
* For female participants: Breastfeeding
* Subjects not able to understand and read Danish
* In Investigator's opinion, subject is not able to follow instructions as specified in the protocol
* Participants not able to hold hand/arm steadily (including tremors and Parkinson's Disease)
* Diagnosed with reduced circulation
* Extensive skin changes, tattoos or diseases on probe application site
* Known allergy to medical grade alcohol
* Known allergy to adhesives, applicable to subjects in RSP-16-01
* Systemic or topical administration of glucocorticoids for the past 7 days and under investigation
* Participants undergoing dialysis treatment
* Medical history or any condition that may, in the opinion of the Investigator, compromise the subject's ability to participate
* Concomitant medical condition which could present a risk to the safety or welfare of the subject or study staff.
* Participants currently enrolled in another study

Primary outcomes:
measure: Generation of predictive algorithms for determining blood glucose levels
timeFrame: 3 years
measure: Validation of predictive algorithms for determining blood glucose levels
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Department of Endocrinology M
Study officials:
affiliation: Odense University Hospital, Dpt. of Endocrinology M
name: Jan Erik Henriksen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05096351: Immunological Reaction of the Recipient After Cold-stored Saphenous Venous Allograft (Bioprotec)
Official title: Immunological Reaction of the Recipient After Cold-stored Saphenous Venous Allograft (Bioprotec)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Allograft
Cold Temperature
Saphenous Vein
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2021-10-27
Enrollment: 50
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 receiving a scheduled venous allograft within the CHU of Nîmes for an arterial bypass in the lower limb or an arteriovenous bypass in the upper limb within the framework of the creation of arteriovenous fistulas in dialysis patients, in the absence of available autologous venous material.

Brief summary: The study investigators propose to perform a blood test before and after allograft placement in all patients receiving a cold-stored venous allografts at the University Hospital of Nîmes to study the occurrence of FVFA-related ASD in these patients.

The aim of this work is to characterize a possible immune reaction generated by the implantation of venous allografts prepared according to the BIOPROTEC method. In case of a proven immune reaction, the study will allow a modification of our current attitude and to exclude patients potentially eligible for renal transplantation at the time of venous allograft placement, or to perform in these patients an allo-compatibility test with the venous allograft preoperatively and thus protect these patients from an increased risk of subsequent organ transplant rejection.


Eligibility criteria: Inclusion Criteria:

* The patient must be a member or beneficiary of a health insurance plan
* Patients receiving a scheduled venous allograft within the CHU of Nîmes for an arterial bypass in the lower limb or an arteriovenous bypass in the upper limb within the framework of the creation of arteriovenous fistulas in dialysis patients, in the absence of available autologous venous material.

Exclusion Criteria:

* The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
* The subject has already been included in the study
* The subject refuses to participate
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* Patient previously having received a venous allograft or organ transplant
* Pregnant, parturient or breastfeeding patients

Primary outcomes:
measure: Presence of donor specific antibodies after venous allograft
timeFrame: 1 month
Secondary outcomes:
measure: Allograft anomalies linked to allograft rejection
timeFrame: 1 month
measure: Allograft anomalies linked to allograft rejection
timeFrame: 6 month
Other outcomes:
Locations:
city: Nimes
country: France
facility: CHU de Nîmes
Study officials:
affiliation: CHU Nimes
name: Elsa Faure
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00269451: Assessing PTSD After Earthquake in Turkey
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Post-Traumatic Stress Disorder
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2005-12-23
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Assessing the prevalence and natural course of PTSD after the 1999 Turkish earthquake


Eligibility criteria: Inclusion Criteria:

* People were in the earthquake area while it occured

Exclusion Criteria:

* People were not in the earthquake area while it occured

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tel Aviv University
name: Joseph Zohar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03477851: Tramadol Simultaneously With Sciatic Nerve Block for Calcaneus Fracture Osteosynthesis
Official title: Evaluation of the Influence of Tramadol Injection Simultaneous With Sciatic Nerve Block on the Duration of Efficient Sensory Blockade in Patients Operated on for Calcaneus Fracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Foot Fracture
Pain, Acute
Keywords: sciatic nerve block
tramadol
foot fracture
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2018-03-26
Enrollment: 40
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 blinded two-arm parallel assignment
Primary purpose: TREATMENT

Brief summary: Comparison of duration of efficient analgesia after painful surgical repair od foot fractures between groups treated with sciatic nerve block alone and sciatic nerve block simultaneously with i.m. tramadol

Detailed description: A randomized, double-blinded study in patients scheduled for surgical repair of foot fractures in spinal anaesthesia where two pain treatment modalities would be compared. One group receives sciatic nerve block with standardized dosis od bupivacaine under ultrasound visualisation, while the other group receives the same block but with simultaneous i.m. injection of tramadol (also standardized). Both the patient and the anaesthesist are blinded, i.e. the control group receives simultaneously with the block a 0,9% sodium hydrochloride injected. Drug or control syringes do not differ, and would be prepared directly before in a randomised, blinded manner by trained co-investigator. Both group receive also the same standardised systemic analgetics with no further use of tramadol.

Eligibility criteria: Inclusion Criteria:

* Patients with foot fracture scheduled for surgical repair in spinal anesthesia
* Informed consent

Exclusion Criteria:

* No consent
* Spinal anesthesia or sciatic nerve block contraindicated
* Known intolerance to tramadol or other contraindications for the drug

Primary outcomes:
measure: Overall analgesic in 24h
timeFrame: 24hour
Secondary outcomes:
measure: Time to block resolution
timeFrame: 24hour
measure: Time to first analgesic
timeFrame: 24hour
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Dept.of Anesthesia and Intensive Care, Warsaw Medical University
state: Mazowieckie
Study officials:
affiliation: Medical University of Warsaw
name: Janusz Trzebicki, Dr hab.
role: STUDY_CHAIR
References:
Clinical trial NCT01643551: Neuron Specific Enolase in Ventricular Assist Device Recipients
Official title: Neuron Specific Enolase in Ventricular Assist Device Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Heart Failure
Left Ventrucular Assist Device
Keywords: Heart Failure
Left Ventricular Assist Device
Reperfusion Injury
Neuron Specific Enolase
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2012-07-18
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cardiovascular Surgical candidates from outpatient cardiology clinic or inpatient service.

Brief summary: An observational study of neuron specific enolase, as a marker of reperfusion injury, in LVAD recipients before and following VAD implantation.

Detailed description: Patients eligible for left ventricular assist device (LVAD) typically have severe heart failure, which is characterized by poor cardiac output. The relatively abrupt increase in cardiac output that follows implant of a LVAD may cause reperfusion injury. Furthermore, selected patients may have particularly severe consequences of such injury, including refractory acidosis and vasoplegia. Neuron specific enolase (NSE) has been established as a biomarker of reperfusion injury. We hypothesize that changes in NSE following LVAD will be greater than the changes in NSE noted in a control population of patients undergoing non-VAD cardiac surgery.

Eligibility criteria: Inclusion Criteria:

Group 1 - Pre-VAD implantation patients

* 18 years and older
* lanning to undergo VAD implantation Group 2 Cardiac Surgery Comparison Group
* 18 years or older
* Planning to undergo valve or coronary bypass surgery

Exclusion Criteria:

* Acute cerebrovascular infarction

Primary outcomes:
measure: Neuron-Specific Enolase
timeFrame: Pre and post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center-Fairview
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Peter M Eckman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Demitri Yannopoulos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03908151: Five and Ten Year Results of the CMK21 Hip System
Official title: Five and Ten Year Results of the CMK21 Hip System
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Osteoarthritis
Keywords: hip prosthesis
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2019-04-09
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of all patients who received a CMK21 hip stem as part of a primary total hip arthroplasty between 2005 and 2007. This includes all diagnoses, all ages, male and female.

Brief summary: Five and ten year results of the CMK21 Hip system

Detailed description: This study is being conducted to collect long term retrospective and prospective clinical and radiological data to evaluate the safety of revision rate and adverse events, and efficacy of clinical and patient assessment of the CMK21 hip stem in primary total hip arthroplasty.

Eligibility criteria: Inclusion:

* The patients enrolled in the study were already operated at the time of the screening.
* All the patients with osteoarthritis of the hip who received CMK21 hip stem between 2005 and 2007.
* Skeletally mature patients requiring primary total hip arthroplasty due to non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, avascular necrosis, or traumatic arthritis.

Primary outcomes:
measure: Implant revision rate
timeFrame: 5 years
measure: Implant revision rate
timeFrame: 10 years
measure: Device related adverse events
timeFrame: 10 years
measure: Device related adverse events
timeFrame: 5 and 10 years
measure: Radiographic assessment
timeFrame: 5 and 10 Years
measure: Radiographic assessment
timeFrame: 5 and 10 Years
measure: Radiographic assessment
timeFrame: 5 and 10 Years
measure: Radiographic assessment
timeFrame: 5 and 10 Years
measure: Radiographic assessment
timeFrame: 5 and 10 Years
measure: Radiographic assessment
timeFrame: 5 and 10 Years
Secondary outcomes:
measure: Harris Hip Score (HHS)
timeFrame: 5 and 10 years
measure: EuroQoL Five Dimensions Questionnaire (EQ-5D)
timeFrame: 5 and 10 years
Other outcomes:
Locations:
city: Asse
country: Belgium
facility: Novellas Healthcare
city: Hasselt
country: Belgium
facility: Associatie Orthopedie Hasselt
Study officials:
affiliation: Vice President, Global Clinical Strategy
name: Beate Hanson, VP, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03718351: Endoscopic Submucosal Dissection Versus Transanal Endoscopic Microsurgery For Early Rectal Neoplasms And Large Rectal Adenomas: Сomparison Of Treatment Efficacy And Safety.
Official title: Randomized Controlled Trial of Endoscopic Submucosal Dissection Versus Transanal Endoscopic Microsurgery For Early Rectal Neoplasms And Large Rectal Adenomas: Сomparison Of Treatment Efficacy And Safety.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Early Rectal Cancer
Large Rectal Adenomas
Keywords: Transanal endoscopic microsurgery
Endoscopic submucosal dissection
Minimally invasive surgery
Lead sponsor: State Scientific Centre of Coloproctology, Russian Federation
Sponsor class: OTHER_GOV
First posted: 2018-10-24
Enrollment: 236
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: Transanal endoscopic microsurgery is the main treatment option for rectal tumors such as large adenoma, early cancer because of lower complications and mortality rates and shorter hospital stays rather than conventional surgery. Particularly, However, transanal endoscopic microsurgerymust be performed under either general or spinal anesthesia, and expensive surgical instruments are required. Colorectal endoscopic submucosal dissection is a novel endoscopic procedure that enables en bloc resection of benign colorectal lesions and early colorectal cancer. Endoscopic submucosal dissectioncan be performed under conscious sedation without anesthesia, and there are fewer hospital days than those for transanal endoscopic microsurgery. In the present study, we compared the treatment efficacy and safety between endoscopic submucosal dissectionand transanal endoscopic microsurgery for the treatment of early rectal neoplasms and large rectal adenomas.


Eligibility criteria: Inclusion Criteria:

* The lower and upper borders of the adenoma or early rectal cancer are located at ≥2 cm and ≤15 cm from the anal verge, respectively.
* Have signed approved informed consent form for the study
* preoperative stage uT0 and/or uT1, mrT0 and/or mrT1

Exclusion Criteria:

* non-epithelial tumors
* tumors \</= 3 cm in size
* recurrent tumors
* suspicion of lymph node metastasis (N + disease)
* preoperative stage uT2 and/or mrT2
* mucous or low-grade adenocarcinoma
* preoperative stage rM1 and/or uM1

Primary outcomes:
measure: R0 resection rate
timeFrame: 14 day
measure: En-block resesction rate
timeFrame: 14 day
Secondary outcomes:
measure: Incidence of locoregional recurrence
timeFrame: 12 months
measure: Morbidity defined by the Clavien-Dindo classification
timeFrame: 30 day
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: State Scientific Centre of Coloproctology
Study officials:
References: