louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05160662: The Important Project of Obese Pregnant Women
Official title: "Important Project," a Prospective Cohort Study on Pregnant Women With BMI>=35
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overweight and Obesity
Keywords: BMI, obesity
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2021-12-16
Enrollment: 600
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: A prospective cohort study involving all women with a BMI \>35 who give birth at the women's clinic, between 2019-2023. New guidelines for this group are being developed using NICE guidelines (UK) as a model and will be tested in clinical practice

The material will be grouped into:

Women with BMI\>=35 delivered at the hospital 2019-2020 (control group) Women with BMI\>=35 delivered at the hospital 2021-2023 (where new guidelines have been used)
Primary purpose: OTHER

Brief summary: Obesity is a globally growing public health problem. In 1993, about 25% of women in Sweden were overweight (BMI over 25) or obese (BMI over 30) on the first visit to maternal health care. Twenty years later, in 2013, the corresponding proportion was 38%. Being fat increases the risk of several severe complications during pregnancy and childbirth, such as miscarriage, premature birth, congenital disabilities, intrauterine fetal death, thromboembolism, gestational diabetes, pregnancy-induced hypertension.

Purpose of the project: To assess whether the introduction of new guidelines for overweight pregnant women (BMI\>35) affects the outcome of pregnancy and childbirth, such as the frequency of cesarean sections or labor inductions.

Detailed description: A prospective cohort study involving all women with a BMI \>35 who give birth at the women's clinic, Soder Hospital, Stockholm, between 2019-2023. New guidelines for this group are being developed using NICEguidelines (UK) as a model and will be tested in clinical practice.

Information from births will be collected from medical files. The information will be handled on a group basis.

Internationally, there are guidelines for how pregnancy should be handled when a woman has a high BMI. This is currently lacking in Swedish maternity care. These international guidelines have now been translated and adapted to Swedish conditions and will be tested for a 2 year period at the women's clinic.

Eligibility criteria: Inclusion Criteria:

* : Pregnancy where the woman has a BMI\>=35 when enrolling to prenatale care

Exclusion Criteria:

* Pregnant women with BMI\<35

Primary outcomes:
measure: Change in unnecessary interventions
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Eva Wiberg-Itzel
Study officials:
affiliation: Karolinska Institute Sodersjukhuset Sweden
name: Eva wiberg-itzel
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02600962: Impact of Initial Diagnosis on Mortality for Patients Hospitalised With Acute Myocardial Infarction
Official title: Impact of Initial Diagnosis on Mortality for Patients Hospitalised With Acute Myocardial Infarction: A National Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ST-elevation Myocardial Infarction
Non ST-elevation Myocardial Infarction
Lead sponsor: University of Leeds
Sponsor class: OTHER
Collaborators: name: University College, London
First posted: 2015-11-09
Enrollment: 564412
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population comprises 725,860 patients hospitalised for acute myocardial infarction and entered into the Myocardial Ischaemia National Audit Project (MINAP) database between April 2004 and March 2013.

Brief summary: The aim of the study is to investigate the impact of an initial non-specific / non-cardiac diagnosis on mortality among patients hospitalised with acute myocardial infarction.


Eligibility criteria: Inclusion Criteria:

* patients aged between 18 and 100 years
* patients discharged alive with STEMI or NSTEMI

Exclusion Criteria:

* patients who die in hospital
* patients not discharged with STEMI or NSTEMI

Primary outcomes:
measure: Mortality
timeFrame: Mortality censored 1 year after discharged from hospital
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Leeds
name: Christopher P Gale, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02467062: Implementation of Non-size Markers Derived From 4D Flow MRI of Patients With Aortic Disease.
Official title: Implementation of Non-size Markers Derived From 4D Flow MRI of Patients With Aortic Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Disease
Aortic Aneurysm
Keywords: 4D flow
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2015-06-09
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the investigator is to implement 4D FLOW MRI technique into a clinical setting and evaluate the blood flow pattern and wall sheer stress in patients with aortic and/or aortic valve diseases.

Detailed description: Currently, the timing of the replacement of the ascending aorta is solely based on the aortic diameter and concomitant valvular dysfunction and the most recent ESC guideline proposes surgical intervention of ascending aortic aneurysm in patients who have a maximal aortic diameter ≥ 55mm, regardless of etiology. On the contrary, a recent publication by Rylski et al showed that most of the dissections occur at diameters smaller than 55 mm. Several publictions have shown that the flow profile and wall sheer stress derived from 4D flow MRI are significantly different between the valve morphology, the type of the aneurysm (tubular or diffuse enlargement) and pre and postoperative patients. Clinical implementation of 4D flow may enable us to stratify the patients with aortic and/or aortic valve diseases, especially in regard to the risk of ruptures. The patients with aortic/aortic valve disease will be referred to 4D flow MRI and contrast-enhanced angiografie from the aorta clinic. Phase 1: 6 healty adult volunteers will be scanned prior to the scan of the patients and settings would be optimised for 4D flow MRI and the contrast will not be given.

Phase 2: 30 patients either scheduled for surgical treatment of their aortic disease, post-operative patients and patients under surveillance for known aortic root and/or aortic valve disease will be imaged. Only patients having a clinical indication for an MRI of the aorta/aortic valve will be included.

Eligibility criteria: Inclusion Criteria:

- Patients with aortic aneurysm and/or aortic valve disease older than 18 years.

Exclusion Criteria:

* Patients \<18 years
* Pregnancy.
* Patients who have known contraindiction of MRI (ex claustrophobia, ICD, insulin pump etc)

Primary outcomes:
measure: the bloodflow pattern
timeFrame: 1 day
Secondary outcomes:
measure: wall sheer stress
timeFrame: 1 day
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel
state: Vlaams Brabant
Study officials:
affiliation: Department of Radiology, Universitair Ziekenhuis Brussel
name: Kaoru Tanaka, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brussels Center for Aortic and Cardiovascular Connective Tissue Disease
name: Jan Nijs, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03583762: Time to Appropriate Antibiotic Between Using Microarray Assay and Mass Spectrometry Technique
Official title: Comparison of Time to Appropriate Antibiotic Between Using Microarray Assay and Mass Spectrometry Technique for Identification of Positive Blood Cultures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Septicemia
Keywords: Microarray Assay Technique
Mass Spectrometry Technique
Time to appropriate antibiotic
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2018-07-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is an experimental study of participants who had positive blood culture to compare time to appropriate antibiotic between using Microarray Assay and Mass Spectrometry to bacterial Identification.

Detailed description: Between June to Dec 2018, 200 participants those met the eligibility criteria were enrolled in this study that is a quasi experimental study. All participants were empirical antibiotic therapy by infectious physician. 100 patients in Pre-intervention group had bacterial identification by Mass spectrometry technique from bacterial colony and 100 patients in Post-intervention group had bacterial identification by Microarray assay from blood culture. Antibiotic adjustment were considered after bacterial identification and result of antibiotic susceptibility testing. Then all participants were re-evaluated outcome after treatment. Finally, the results were ready to analysis in January 2019.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 year old with positive hemoculture between June 2018 and Dec 2018
* Internal medicine wards patients at Maharaj Nakorn Chiang Mai Hospital
* Ability to provide informed consent

Exclusion Criteria:

* Suspected contaminated positive blood culture
* Bacteremia cause by more than two species of bacteria, as suspected from the gram staining examinations
* Terminally ill patients

Primary outcomes:
measure: To compare the time to appropriate antibiotic therapy in patients with positive blood cultures between using Microarray assays versus Mass Spectrometry technique for Identification of Positive Blood Cultures
timeFrame: 4 days from positive hemoculture
Secondary outcomes:
measure: Mortality rate at 2 weeks
timeFrame: 14 days from positive hemoculture
measure: Length of hospital stays
timeFrame: 30 days
measure: Cost of antibiotic therapy
timeFrame: 14 days
measure: Percentage of De-escalation or escalation antibiotic
timeFrame: 14 days
Other outcomes:
Locations:
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University
Study officials:
affiliation: Chiang Mai University
name: Parichart Sakulkonkij, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04859062: Lidocaine Gel 2% and Muscle Traction Pain During Squint Surgery in Pediatrics
Official title: The Effect of Applying Xylocaine Gel 2% to the Eye Preoperatively in Pediatrics Undergoing Squint Surgeries on Oculocardiac Reflex Intraoperatively and Postoperative Pain and Agitation: Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Squint
Keywords: squint
muscle traction
pain
Lead sponsor: Research Institute of Ophthalmology, Egypt
Sponsor class: OTHER
First posted: 2021-04-26
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 group control and xylocaine gel 2% group
Primary purpose: PREVENTION

Brief summary: Assessing the efficacy of lidocaine gel 2% application 10 minutes before surgery on post operative pain and the use of analgesics postoperatively

Detailed description: After inhalational induction of anesthesia and applying the pulse oximeter to the patient's finger but and before cannulating or managing the patient's airway lidocaine gel 2% is efficiently applied to the surgical eye (to give more time for the gel to act without delaying the surgery) then cannulation and laryngeal mask inserted to maintain ventilation properly.

Applying lidocaine gel 2% should be filling the upper and lower 10 minute fornices before disinfecting the eye and starting the surgery

The primary outcome is assessing postoperative pain and need for postoperative systemic analgesia The secondary outcome is to monitor the oculocardiac reflex intraoperatively and the need for intraoperative atropine.

Eligibility criteria: Inclusion Criteria:

* age 3 to 12 years
* squint surgery

Exclusion Criteria:

* below 2 years or more than 13

Primary outcomes:
measure: Postoperative pain after recovery in PACU using FLACC score (Face, Leg, Activity, Cry, Condolence)
timeFrame: during surgery
Secondary outcomes:
measure: oculocardiac reflex occurrence during muscle traction intraoperative
timeFrame: during surgery
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Research Institute of Ophthamology
Study officials:
affiliation: research institute of ophthalmology
name: abeer salem, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06586762: Sagittal Knee Kinematics of Transtibial Amputee with Running Blade
Official title: Symmetry in Sagittal Knee Kinematics of Transtibial Amputee: Daily-Use Prosthesis Vs Running-Specific Prosthesis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amputation
Prosthesis User
Keywords: amputee
symmetry
knee
running
running-specific prosthesis
Lead sponsor: Baskent University
Sponsor class: OTHER
Collaborators: name: Gulhane School of Medicine
First posted: 2024-09-19
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Unilateral transtibial amputee at K4 functional level

Brief summary: Introduction: People with transtibial amputation often suffer musculoskeletal deformities in the form of knee osteoarthritis or osteophytosis due to asymmetric movement patterns and often complain of associated symptoms. Therefore, this study aims to evaluate the sagittal kinematics of the intact and residual knee in the use of Running-Specific Prostheses (RSP), which are increasing in popularity and use among amputees.

Materials and Methods: Participants will be video recorded in the sagittal plane to convert knee flexion motion into angles for the amputee and intact knee and to make measurements using the software's virtual goniometer. Recordings will be taken under the following two conditions: 1) walking at a self-selected walking speed with a Daily Use Prosthesis (DUP); 2) Slow running with RSP. The peak flexion during the swing phase and the initial flexion during the first contact of the stance phase will be recorded as angles in both conditions.


Eligibility criteria: Inclusion Criteria:

* body mass index below 30 kg/m2,
* Having unilateral transtibial amputation,
* Being at K4 functional level,
* Having an existing running blade,
* Being able to use RSP integrating it into their DUP,
* Having no self-reported problems with the residual limb or prosthesis, pain or skin lesions,
* Being active recreational runners (at least once a week) for at least 1 and up to 3 months without injury.

Exclusion Criteria:

* Having a history of knee surgery or contracture in the intact/amputee knee.

Primary outcomes:
measure: Sagital Knee Kinematics of intact and residual knee with Daily-Use Prosthesis (DUP)
timeFrame: Baseline
measure: Sagital Knee Kinematics of intact and residual knee with Running-Specific Prosthesis (RSP)
timeFrame: Same day as baseline; 10 minutes after RSP integrated to prosthesis.
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: University of Health Sciences
state: Etlik Keçiören
Study officials:
References:
Clinical trial NCT06562062: Radiological Outcomes of Modified Extra-articular LCL
Official title: Radiological Outcomes of Modified Extra-articular Lateral Column Lengthening Procedure for Correction of Adult Acquired Flexible Flatfoot Deformity
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adult Acquired Flexible Flatfoot Deformity After Failure of Conservative Treatment
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-08-20
Enrollment: 1
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult flexible acquired flatfoot deformity which doesn\&amp;#39;t include genetic or spasmodic flatfoot deformity in children

Brief summary: To assess radiological and functional outcomes of modified extra-articular lateral column lengthening procedure for correction of adult acquired flexible flatfoot deformity

Detailed description: Measurement of

1. Calcencal pitch : This angle is formed on a weight-bearing lateral foot radiograph between the calcaneal Inclination axis and the supporting horizontal surface(10), normal ranges of between 10-25° and 20-30 have Been proposed(11)
2. Meary's angle: It is the angle between a line drawn along the longitudinal axis of the talus (mid-talar axis) and the first metatarsal (first metatarsal axis) , typically', Meary's angle is 0°, with abnormal values considered angle \>4° convex upward: pes cavus , angle \<-4 convex downward: pes planus, It can be used to classify the severity of deformity
3. lateral talocalceneal angle : the angle between the calcaneal inclination axis and the mid-talar axis , The lateral talocalcaneal angle should normally measure between 25 and 40°, \>40° diagnoses flatfoot deformity(12)
4. Talonavicular coverage angle: it is the medial angle between ( talar head articular surface and Proximal navicular articular surface) ,Interpreting the talonavicular coverage angle (13)Normal: \<7,Adult Acquired flatfoot disease: \>7°

Eligibility criteria: Inclusion Criteria:

- 1) Age : adult ( age above 16 years old and below 65 years old

2) symptomatic flexible flat foot after failure of Conservative treatment

Exclusion Criteria:

* 1- Age: (\&amp;lt;16,\&amp;gt;65) years old 2 -Previous foot surgery 3- autoimmune disease
* 4 Uncontrolled blood sugar 5- Osteoprotic patient 6- Infection

Primary outcomes:
measure: Radiological outcome & by standard erect plain x ray after 3 months
timeFrame: 3 months after the surgery
Secondary outcomes:
measure: clinical outcome by American orthopedic foot and ankle score (hindfoot
timeFrame: 6 months after the surgery when the patient restore his life activities maximally
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of medicine assiut university
state: Assiuu
Study officials:
References:
Clinical trial NCT01169662: Effects of Dietary Nitrate From Vegetable/Fruit Juice on Cerebral Blood Flow Parameters
Official title: Effects of Dietary Nitrate From Vegetable/Fruit Juice on Cerebral Blood Flow Parameters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cerebrovascular Circulation
Cognitive Impairment
Lead sponsor: Northumbria University
Sponsor class: OTHER
First posted: 2010-07-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Nitrate provides the body with an alternative source of Nitric Oxide which plays a large role in promoting blood flow and reducing blood pressure. Nitrate supplementation with vegetable/fruit juice has recently been shown to reduce blood pressure and reduce energy expenditure during low intensity exercise. Such findings combined with the previously known biological effects of nitric oxide would suggest that nitrate supplementation would also impact on blood flow. The aim of this study is to examine the effects of dietary nitrate supplementation via vegetable/fruit juice drink on cerebral (brain) blood flow (using Near Infrared Spectroscopy).


Eligibility criteria: Inclusion Criteria:

* healthy young (18-35 years) male and female adults, not vulnerable.

Exclusion Criteria:

* smoke or consume any tobacco products (even occasionally)
* not proficient in English
* pregnant (or are seeking to become)
* currently taking recreational, over the counter/prescription medication (excluding the contraceptive pill), and/or dietary/herbal supplements.
* any food allergies or sensitivities that are relevant to the study
* history of/current head trauma, learning difficulties, ADHD, dyslexia, migraines or any gastric problems.

Primary outcomes:
measure: Change from baseline cerebral blood flow
timeFrame: From baseline to 2.5 hours post-dose
measure: Change from baseline cognitive function
timeFrame: 90 minutes post-dose
measure: Change from baseline mood
timeFrame: 2.5 hours post-dose
Secondary outcomes:
measure: Change from baseline blood pressure, heart rate and venous nitrate and nitrite levels
timeFrame: 2.5 hours post-dose
Other outcomes:
Locations:
city: Newcastle upon Tyne
country: United Kingdom
facility: Northumbria University
state: Tyne & Wear
Study officials:
affiliation: Northumbria University
name: David Kennedy
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wightman EL, Haskell-Ramsay CF, Thompson KG, Blackwell JR, Winyard PG, Forster J, Jones AM, Kennedy DO. Dietary nitrate modulates cerebral blood flow parameters and cognitive performance in humans: A double-blind, placebo-controlled, crossover investigation. Physiol Behav. 2015 Oct 1;149:149-58. doi: 10.1016/j.physbeh.2015.05.035. Epub 2015 May 31.