louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04151914: Prevalence of Auditory Dysfunction and ICU-acquired Delirium Following Cardiac Surgery With Cardiopulmonary Bypass: a Prospective Observational Study
Official title: Prevalence of Auditory Dysfunction and ICU-acquired Delirium Following Cardiac Surgery With Cardiopulmonary Bypass: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hearing Loss
Cardiac Surgery
Cardiopulmonary Bypass
Postoperative Cognitive Dysfunction
Delirium
Lead sponsor: European Georges Pompidou Hospital
Sponsor class: OTHER
First posted: 2019-11-05
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: Over 18 years old undergoing non urgent cardiac surgery with cardiopulmonary bypass.

Brief summary: AUDICS-ICU is a prospective observational aiming to evaluate the prevalence of auditive dysfunction following cardiac surgery. Participants will undergo audiometric testings before and 3 months after cardiac surgery with cardiopulmonary bypass. Furthermore, the study evaluates hearing loss-associated ICU-acquired delirium after cardiac surgery with cardiopulmonary bypass.


Eligibility criteria: Inclusion Criteria:

* Over 18 years old
* Undergoing non urgent cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

* Pregnant
* History of ear surgery
* Ear disease
* Inadequate understanding of the protocol

Primary outcomes:
measure: Prevalence of auditive dysfunction following cardiac surgery with cardiopulmonary bypass
timeFrame: 3 months
Secondary outcomes:
measure: ICU-acquired delirium
timeFrame: 7 days
measure: Cerebral perfusion
timeFrame: 7 days
measure: Patient's quality of life after cardiac surgery: Survey
timeFrame: 3 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Georges Pompidou European Hospital
Study officials:
affiliation: European George Pompidou Hospital
name: Matthieu Daniel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: European George Pompidou Hospital
name: Bernard Cholley, PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04003714: REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION FOR FAILED BACK SURGERY SYNDROME
Official title: EFFECTIVENESS OF REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION IN PATIENTS WITH FAILED BACK SURGERY SYNDROME A DOUBLE-BLINDED, RANDOMISED, PLACEBO CONTROLLED TRIAL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Failed Back Surgery Syndrome
Keywords: repetitive transcranial magnetic stimulation
back pain
failed back surgery syndrome
Lead sponsor: Fatih Sultan Mehmet Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-07-01
Enrollment: 20
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: Failed back surgery syndrome (FBSS) is the term of persistent back and/or leg pain after surgery for lumbar disk herniation (LDH). Repetitive transcranial magnetic stimulation (r-TMS) is a technique that allows non-invasive and relatively painless stimulation of cerebral cortex. It can reduce the experience of chronic pain by using magnetic field to produce small electrical currents in the cortex.The aim of this study is to determine the effectiveness of r-TMS treatment on patients with FBSS.

Detailed description: Methods: In this double-blinded, randomized, placebo-controlled trial, 20 patients (aged 34-65 years) clinically diagnosed as FBSS, who had a history of surgery for LDH with persistent back and leg pain. Patients in r-TMS group received 5 Hz of r-TMS, as a 20-min (1000 pulses) daily session, 5 days per weeks, for a total of 10 sessions. R-TMS applied with MagVenture device (MagPro X100, Denmark, 2009) and figure eight coil (MMC 140 parabolic, MagVenture). Control group received sham r-TMS with the same protocol. Patients were assessed at baseline,after 5th and 10th sessions and 1 and 3 months after treatment. Visual Analogue Scale (VAS), DN-4 (Douleur Neuropathique-4 Questionnaire), Oswestry Disability Index (ODI), Beck Depression Inventory (BDI), Pittsburgh Sleep Quality Index (PSQI) were used for evaluation.

Eligibility criteria: Inclusion Criteria:

* Aged 34-65 years
* Clinically diagnosed as FBSS
* History of surgery for LDH with persistent back and leg pain
* Patients with no root compression in postoperative magnetic resonance imaging of lumbar spine

Exclusion Criteria:

* Epilepsy
* Stroke
* Head trauma
* History of intracranial operation
* Cardiac pacemaker
* Pregnancy
* Postoperative lumbar root compression
* Neurologic deficits
* Prior physiotherapy for low back pain last 6 month

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: 4 months
measure: Oswestry Disability Index
timeFrame: 4 months
measure: DN-4 Interview Questionnaire
timeFrame: 4 months
Secondary outcomes:
measure: The Pittsburgh Sleep Quality Index
timeFrame: 4 months
measure: Beck Depression Inventory
timeFrame: 4 months
Other outcomes:
Locations:
Study officials:
affiliation: Fatih Sultan Mehmet Training and Research Hospital
name: Meryem Yılmaz Kaysın, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06079814: Virtual Reality Application for Pain and Anxiety Reduction During Cystoscopy
Official title: Virtual Reality Application for Pain and Anxiety Reduction During Cystoscopy: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain
Anxiety
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2023-10-12
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this research is to conduct a two-group randomized controlled intervention study to determine the effect of virtual reality applications on pain and anxiety during cystoscopy. The study population will consist of patients who have applied to the urology outpatient clinic of a University Hospital for cystoscopy. The study sample will be composed of patients who volunteer to participate in the study and meet the criteria during the planned dates of the research. Data will be collected using a 'Personal Information Form' created by the researcher through a literature review, the 'Visual Analog Scale' (VAS) for assessing pain, and the 'State Anxiety Inventory' (SAI) for assessing anxiety.


Eligibility criteria: Inclusion Criteria:

* Being literate,
* Being conscious,
* Ability to understand and speak Turkish and not have hearing or visual impairment,
* Agreeing to participate in the research.

Exclusion Criteria:

* Having a diagnosed psychiatric and mental illness,
* Patients diagnosed with epilepsy (due to the risk of virtual reality glasses triggering epileptic seizures),
* Patients who do not want to continue the study

Primary outcomes:
measure: The effect of virtual reality applications on pain during cystoscopy
timeFrame: 30 minutes after the procedure
measure: The effect of virtual reality applications on anxiety during cystoscopy
timeFrame: 30 minutes after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University
Study officials:
References:
Clinical trial NCT02671214: The Effect of Selected Fibres and Flours in Flat Bread on Post-prandial Blood Glucose Responses
Official title: The Effect of Selected Fibres and Flours in Flat Bread on Post-prandial Blood Glucose Responses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: guar gum
konjac mannan
blood glucose
legume flour
Lead sponsor: Unilever R&D
Sponsor class: INDUSTRY
First posted: 2016-02-02
Enrollment: 42
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Identify one or more flat bread mixes that produce a reduction in positive incremental area under the curve (iAUC) of post-prandial glucose relative to the control product.

Detailed description: This study was a double-blind, randomised, balanced incomplete block design exploratory study of efficacy, with 11 active treatments compared to a control product in 42 healthy subjects to see if a mix of active ingredients (viscous fibres and flours) lowered the post-prandial glucose (PPG) response in capillary blood (finger prick) over a two and three hours period, relative to the control product. Every subject received the control and 4 out of the 11 treatments on five separate test days.

Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) ≥ 20 and ≤ 25.0 kg/m2.
* Apparently healthy: no medical conditions which might affect study measurements (as judged by the study physician).
* A fasting blood glucose value between 3.5 - 5.6 mmol/litre at screening (measured by finger prick).

Exclusion Criteria:

* Use of medication which interferes with study measurements (as judged by the study physician).
* Reported dietary habits: medically prescribed diet, slimming diet, not used to eat 3 meals a day, vegetarian.
* Reported weight loss/gain (\>10%) in the last six month before the study

Primary outcomes:
measure: Positive incremental area under the curve (iAUC)
timeFrame: 120 minutes
Secondary outcomes:
measure: Positive incremental area under the curve (iAUC)
timeFrame: 180 minutes
Other outcomes:
Locations:
city: Leatherhead
country: United Kingdom
facility: Leatherhead Food Research UK
state: Randalls Road, Surrey
Study officials:
affiliation: Leatherhead Food Research UK
name: Sarah Hull
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boers HM, MacAulay K, Murray P, Seijen Ten Hoorn J, Hoogenraad AR, Peters HPF, Vente-Spreeuwenberg MAM, Mela DJ. Efficacy of different fibres and flour mixes in South-Asian flatbreads for reducing post-prandial glucose responses in healthy adults. Eur J Nutr. 2017 Sep;56(6):2049-2060. doi: 10.1007/s00394-016-1242-9. Epub 2016 Jun 21.
Clinical trial NCT04752514: Prevalence of Dynamic Instability Among Football Players in the UAE: A Cross-sectional Study
Official title: Prevalence of Dynamic Instability Among Football Players in the UAE: A Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Football Players
Lead sponsor: Delta University for Science and Technology
Sponsor class: OTHER
First posted: 2021-02-12
Enrollment: 200
Sex: MALE
Minimum age (years): 16
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 200 male football players aged from 16 to 24 years old were recruited to be a potential participants in this study

Brief summary: the purpose of this study is to determine dynamic instability prevalence in United Arab Emirates football players.


Eligibility criteria: Inclusion Criteria:

* male
* 16-24 years .

Exclusion Criteria:

* previous injury in lower extremities

Primary outcomes:
measure: overall stability index
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gamasa
country: Egypt
facility: Delta University For Science and Technology
Study officials:
References:
Clinical trial NCT01848314: The Effect of Renal Denervation on Renal Flow in Humans
Official title: The Effect of Renal Denervation on Renal Flow in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2013-05-07
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Many studies have studied the effect and safety of renal denervation. However, it remains unknown what the exact mechanism behind renal denervation is. It can be hypothesized that a difference in renal blood flow occurs after treatment. In the light of this ignorance, current study will investigate whether renal denervation leads to a difference in renal blood flow after treatment with renal denervation.


Eligibility criteria: Inclusion Criteria:

* Individual is scheduled to undergo renal denervation as standard patient care for resistant hypertension.
* Individual is diagnosed with resistant hypertension. Secondary causes and a white coat hypertension are actively excluded.
* Individual is ≥18 years of age.
* Individual agrees to have all study procedures performed, and is competent and willing to provide written informed consent to participate in this clinical study.

Exclusion Criteria:

* Individual is excluded from treatment with pRDN .
* Individual has an estimated glomerular filtration rate (eGFR) of \<30mL/min/1.73m2, using the MDRD calculation.
* Individual has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 6 months of the screening visit, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques.
* Individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, haemophilia or significant anaemia).
* Individual is pregnant, nursing or planning to be pregnant.
* Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.

Primary outcomes:
measure: Change in microvascular resistance
timeFrame: Within 30 minutes after renal denervation
Secondary outcomes:
measure: change in average flow velocity
timeFrame: within 30 minutes after renal denervation
Other outcomes:
measure: safety of measurement
timeFrame: within 24 hour after renal denervation
Locations:
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
affiliation: UMC Utrecht
name: Michiel Voskuil, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05567614: Platelets Indices and Its Role to Predict Liver Fibrosis in Patients With Chronic Hepatitis B Infection
Official title: Platelets Indices and Its Role to Predict Liver Fibrosis in Patients With Chronic Hepatitis B Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fibrosis, Liver
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-10-05
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients at Age from 18 to 70 years with chronic hepatits B infection will do liver fibroscan and correlate between platelets indicies and degree of liver fibrosis

-

Brief summary: Platelets indices and its role to predict liver Fibrosis in patients with chronic hepatitis B infection

Detailed description: Patients with chronic Hepatitis B infection will be collected and will do liver fibroscan to predict the degree of liver Fibrosis and correlate between the role of platelets count and degree of liver Fibrosis in patients with Chronic hepatitis B virus

Eligibility criteria: Inclusion Criteria:

* Age from 18 to 70 years
* without a history of clinical illness

Exclusion Criteria:

* with other hepatitis virus infection; (b) with alcoholic liver disease; (c) with any disease related to fibrosis (such as connective tissue diseases, chronic obstructive pulmonary disease, kidney failure, tumors, and so on); (d) have received any anti-fibrosis therapy; and (e) pregnancy

Primary outcomes:
measure: Platelets indices and its role to predict liver Fibrosis in patients with chronic hepatitis B infection
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: AssiutU
Study officials:
affiliation: Assiut University
name: Ahmed AB Maghraby, Professor
role: STUDY_DIRECTOR
References:
citation: Zhong LK, Zhang G, Luo SY, Yin W, Song HY. The value of platelet count in evaluating the degree of liver fibrosis in patients with chronic hepatitis B. J Clin Lab Anal. 2020 Jul;34(7):e23270. doi: 10.1002/jcla.23270. Epub 2020 May 4.
citation: Tan YW, Zhou XB, Ye Y, He C, Ge GH. Diagnostic value of FIB-4, aspartate aminotransferase-to-platelet ratio index and liver stiffness measurement in hepatitis B virus-infected patients with persistently normal alanine aminotransferase. World J Gastroenterol. 2017 Aug 21;23(31):5746-5754. doi: 10.3748/wjg.v23.i31.5746.
Clinical trial NCT05106114: Intensive Gait Training Rehabilitation Protocol After Surgery in Cerebral Palsy
Official title: Intensive Gait Training Rehabilitation Protocol to Enhance Functional Parameters of Walking After Single-event Multi-level Surgery in Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Fondation Ellen Poidatz
Sponsor class: OTHER
First posted: 2021-11-03
Enrollment: 24
Sex: ALL
Minimum age (years): 10
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In the context of cerebral palsy, rehabilitation post Single-Event Multi-Level Surgery (SEMLS) is a long process. One year after surgery and rehabilitation, the functional benefits are usually less improved than the gait pattern. This may be caused by a lack of intensity in the final rehabilitation steps. Thus we created an intensive gait training rehabilitation protocole. This protocole associates 4 weeks of intensive rehabilitation in a healthcare center followed by 2 weeks of intensive rehabilitation at home. The objective of this study is to evaluate the efficiency of this protocol to improve walking speed and endurance, gross motor function et muscular strength.


Eligibility criteria: Inclusion Criteria:

* Cerebral palsy
* Age between 10 and 20 years
* Single-Event multi-level surgery more than one year ago
* GMFCS I to III
* Capacity to understand simple instructions
* Volontary consent

Exclusion Criteria:

* injuries or pain in lower limbs
* toxines or surgery less than one year before the study

Primary outcomes:
measure: 6-minutes walking test
timeFrame: 15 minutes
Secondary outcomes:
measure: Gross Motor Function Measure (GMFM)
timeFrame: 30 minutes
measure: 10 meters walking test
timeFrame: 5 minutes
measure: Shuttle Run test-I and II
timeFrame: 10 minutes
measure: Muscle strength via a Dynamometer
timeFrame: 15 minutes
measure: Spatio-temporal gait parameters
timeFrame: 45 minutes
measure: Number of steps per day
timeFrame: one week wearing an accelerometer
measure: Pediatric Quality of Life Inventory (PedSQL)
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Saint-Fargeau-Ponthierry
country: France
facility: Fondation Ellen Poidatz
Study officials:
affiliation: Medical Doctor
name: Michel Bams, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Director of research
name: Eric Desailly, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01020214: Fasting Study of Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg and Benicar HCT® Tablets 40 mg/25 mg
Official title: Single-Dose Fasting Bioequivalence Study of Olmesartan Medoxomil and Hydrochlorothiazide Tablets (40 mg/25 mg; Mylan) to Benicar HCT® Tablets (40 mg/25 mg; Sankyo) in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
First posted: 2009-11-25
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The objective of this study was to investigate the bioequivalence of Mylan's olmesartan medoxomil and hydrochlorothiazide 40 mg/25 mg tablets to Sankyo's Benicar HCT® 40 mg/25 mg tablets following a single, oral 40 mg/25 mg (1 x 40 mg/25 mg) dose administered under fasting conditions.


Eligibility criteria: Inclusion Criteria:

* healthy, adult subjects, 18 years and older
* able to swallow medication

Exclusion Criteria:

* institutionalized subjects
* history of any significant disease
* use of any prescription or OTC medications within 14 days of start of study
* received any investigational products within 30 days prior to start of study

Primary outcomes:
measure: The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data.
timeFrame: blood collections through 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Fargo
country: United States
facility: PRACS Institute Ltd.
state: North Dakota
Study officials:
affiliation: PRACS Institute Ltd.
name: Alan K Copa, Pharm. D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03886714: Screening for Fabry Disease in Renal Transplantation
Official title: Screening for Fabry Disease in Renal Transplantation
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Fabry Disease
Nephropathy
Keywords: Fabry disease
Renal transplantation
Diabetic nephropathy
Focal Segmental Hyalinosis (FSH)
Undetermined nephropathy
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-03-22
Enrollment: 592
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients identified from a database, who have undergone renal transplantation for nephropathy of indeterminate cause, vascular nephropathy, diabetic nephropathy or secondary focal segmental hyalinosis with no established cause, and still followed at the Montpellier University Hospital.

Brief summary: Single centre, prospective pilot study examining the relevance to screen for Fabry disease in a cohort of patients who have undergone renal transplantation for nephropathy of indeterminate cause, vascular nephropathy, diabetic nephropathy or secondary focal segmental hyalinosis with no established cause.

Detailed description: Exploration whether Fabry disease cases can be identified among patients who are followed at the Montpellier University Hospital after renal transplantation, with indeterminate cause of renal failure or diabetic nephropathy (due to its high frequency) or secondary focal segmental hyalinosis (FSH).

At the population level, the identification of cases at the Montpellier centre could then justify to expand this screening to other French centres. The goal is to contribute to adapt current guidelines of renal failure assessment, by systematically including Fabry among the diagnostic tests. Whether all patients with renal failure are concerned, or only those with indeterminate cause, is an important question this study will address.

Eligibility criteria: Inclusion Criteria:

* Nephropathy of indeterminate cause, or secondary FSH or diabetic nephropathy
* Patients with kidney transplanted
* Patients still followed at the Montpellier University Hospital
* Obtaining written informed consent
* Age \> 18 years old, no upper age limit

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Number of Patients with Positive screen result
timeFrame: Inclusion visit
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uh Montpellier
Study officials:
References: