louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT07006376: Thoracolumbar Fascia Thickness in Patients With Parkinson's Disease
Official title: Investigation of Thoracolumbar Fascia Thickness, Trunk Flexibility and Manual Dexterity in Parkinson's Disease Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson Disease
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 100
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Parkinson's Disease

Brief summary: The aim of this study is to examine thoracolumbar fascia thickness, trunk flexibility, trunk control and upper extremity skills in Parkinson's disease patients. Patients between the ages of 55-80 who have been diagnosed with Parkinson's disease by a neurologist and healthy individuals with similar demographic characteristics will be included in the study as a control group. Demographic information of the individuals will be recorded and clinical evaluations will be made. Staging of Parkinson's patients will be done with the Modified Hoehn and Yahr Scale (MHRS), and disease severity will be done with the Unified Parkinson's Disease Rating Scale (UPDRS). Thoracolumbar fascia thickness of individuals in both groups will be evaluated with ultrasonography, trunk flexibility with the Active Trunk Range of Motion Assessment and Sit-Reach test, trunk functions with the Trunk Impairment Scale, and manual skills with the Purdue Pegboard Test.


Eligibility criteria: Inclusion Criteria:

* Age between 50 and 80
* Mini Mental State Examination (MMSE) score between 24 and 30
* Diagnosed with Parkinson's by a neurologist
* MH\&Y stage 2-3

Exclusion Criteria:

* Inability to communicate verbally
* Use of walking aids
* Elderly people with severe visual impairment, neurological disorders and/or congestive heart failure
* Older adults in whom exercise is not recommended.

Primary outcomes:
measure: Ultrasonography Measurement
timeFrame: Baseline
measure: Range of Motion Assessment
timeFrame: Baseline
measure: Sit and Reach Test
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Atılım University
Study officials:
affiliation: Hacettepe University
name: Ayla Fil Balkan, Assoc Prof
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Gül Yalçın Çakmaklı, Assoc Prof
role: STUDY_CHAIR
References:
citation: De Coninck K, Hambly K, Dickinson JW, Passfield L. Measuring the morphological characteristics of thoracolumbar fascia in ultrasound images: an inter-rater reliability study. BMC Musculoskelet Disord. 2018 Jun 1;19(1):180. doi: 10.1186/s12891-018-2088-5.
citation: Yerli S, Yinanc SB, Yagci G, Erbahceci F, Ozcakar L. Thoracolumbar fascia and chronic low back pain in idiopathic lumbar scoliosis: an ultrasonographic study. Eur Spine J. 2024 Jun;33(6):2469-2475. doi: 10.1007/s00586-024-08266-x. Epub 2024 Apr 23.
Clinical trial NCT05551676: Transforaminal and Parasagittal Approach in Lumbar Epidural Steroid Injection
Official title: Comparison of Lateral Parasagittal Approach and Transforaminal Epidural Approach in Lumbar Epidural Steroid Injection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lumbar Radiculopathy
Keywords: epidural steroid injection
transforaminal steroid injection
radicular pain
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
First posted: 2022-09-23
Enrollment: 60
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: Lumbar epidural injection is used in the treatment of lumbar radicular pain. There are three different application methods: lateral parasagittal, midline interlaminar and transforaminal epidural injection. Investigator aimed to compare lateral parasagittal and transforaminal epidural injection methods. The purpose of the study is to determine which method is more efficient.

Detailed description: It was planned to recruit 60 participants in the study. Interlaminar epidural steroid injection will be applied to 30 patients with midline and 30 patients with lateral parasagittal approach. All patients will receive Oswestry disability index before and 2-4-12 weeks after the procedure. All patients will receive Somatization Amplification Scale (SSAS) before the treatment. The results of the patients will be compared. It will be investigated which method is more effective.

Eligibility criteria: Inclusion Criteria:

* Unilateral low back pain, radiculopathy

Exclusion Criteria:

* malignancy
* past back surgery

Primary outcomes:
measure: Oswestry disability index
timeFrame: baseline, week 4, week 12
Secondary outcomes:
Other outcomes:
measure: The SomatoSensory Amplification Scale
timeFrame: Baseline
Locations:
city: Ankara
country: Turkey
facility: Diskapi Yildirim Beyazıt Teaching and Research Hospital
Study officials:
affiliation: Diskapi TRH
name: Ömer Taylan AKKAYA
role: STUDY_DIRECTOR
affiliation: Diskapi TRH
name: Hüseyin Alp Alptekin
role: STUDY_CHAIR
affiliation: Diskapi TRH
name: Ezgi Can
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01542476: The Impact of Initiating/Switching to Insulin Detemir on Emotional Well-being and Treatment Satisfaction
Official title: An Observational Study in Dutch Type 1 and Type 2 Diabetes Patients: The Impact of Initiation of/Switching to Levemir® on Emotional Well-being, Insulin Perceptions and Treatment Satisfaction - CONFIDENCE (Clinical ObservatioNs oF Levemir® In Dutch ExperieNCE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-03-02
Enrollment: 299
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any subject with type 1 or type 2 diabetes not optimally controlled in whom at the discretion of the participating physicians it was decide to either initiate or switch to a treatment with a long-acting insulin analogue

Brief summary: This study is conducted in Europe. The aim of this study is to assess the well-being of patients following treatment with insulin detemir (Levemir®) in subjects with type 1 or type 2 diabetes in whom either initiation of or a switch to insulin treatment with a long-acting basal insulin analogue is needed.


Eligibility criteria: Inclusion Criteria:

* Any subject with type 1 or type 2 diabetes not optimally controlled (HbA1c above 7.5%) in whom at the discretion of the participating physicians it was decide to either initiate or switch to a treatment with a long-acting insulin analogue
* Subjects with type 1 diabetes should have been treated with insulin for at least 12 months
* Potential pre-study treatment with insulin detemir (Levemir®) should have started no more than two months before baseline

Primary outcomes:
measure: Change in Patient-Reported Outcomes (PRO) using World Health Organization 5 (WHO-5) item Well-being Index: Insulin Treatment Appraisal Scale (ITAS)
timeFrame: Baseline, month 6
Secondary outcomes:
measure: Change in Patient-Reported Outcomes (PRO) using Insulin Treatment (ITSQ)
timeFrame: Baseline, month 6
measure: Change in HbA1c (glycosylated haemoglobin)
timeFrame: Baseline, month 6
measure: Change in Fasting blood glucose (FBG)
timeFrame: Baseline, month 6
measure: Change in body weight
timeFrame: Baseline, month 6
measure: Hypoglycaemic episodes
timeFrame: Month 6
measure: Adverse events
timeFrame: Month 6
Other outcomes:
Locations:
city: Alphen a/d Rijn
country: Netherlands
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06027476: Preoperative Inflammatory Status and Postoperative Acute Kidney Injury
Official title: Prognostic Significance of Preoperative Inflammatory Status for Postoperative Acute Kidney Injury in Elderly Patients Undergoing Non-cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Acute Kidney Injury
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2023-09-07
Enrollment: 8472
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly patients (aged ≥ 65 years) who underwent a non-cardiac surgery at Tongji Hospital between July 2018 and December 2021 were included in our study.

Brief summary: Acute kidney injury (AKI) is a common complication during the early postoperative period after noncardiac surgery. Patients with AKI are at an increased risk of developing chronic kidney disease, prolonging hospitalization, and experiencing higher rates of morbidity and mortality. Identifying preoperative risk factors for postoperative AKI can significantly contribute to the development of preventive strategies and improved perioperative care in this vulnerable patient population.

The goal of this retrospective study is to investigate the predictive value of preoperative inflammatory status, as measured by complete blood count-derived inflammatory markers, such as the neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), monocyte-to-lymphocyte ratio (MLR), derived neutrophil-to-lymphocyte ratio (dNLR), neutrophil-to-lymphocyte\*platelet ratio (NLPR), systemic immune-inflammatory index (SII), systemic inflammatory response index (SIRI), and aggregate index of systemic inflammation (AISI), on postoperative AKI in elderly patients undergoing non-cardiac surgery.


Eligibility criteria: Inclusion Criteria:

1. aged ≥ 65 years.
2. general, gynaecological, neurosurgery, orthopaedic, or thoracic surgery.
3. surgery duration lasting longer than one hour.

Exclusion Criteria:

1. patients with an American Society of Anesthesiologists (ASA) physical status V.
2. those with concurrent cardiac, vascular, transplant or urological surgeries.
3. those with end-stage renal disease (i.e. a glomerular filtration rate of 15 mL/min/1.73 m2 or receiving haemodialysis) or a history of kidney transplantation..
4. those did not have sufficient data required for calculation for inflammatory markers or AKI evaluation.

Primary outcomes:
measure: Number of participants with acute kidney injury after surgery
timeFrame: Within 7 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Rao Sun
Study officials:
References:
Clinical trial NCT01387776: Detecting Early Onset Pre-eclampsia and Use of Placental Growth Factor (PlGF) for Marker of Trisomy 21
Official title: Study for the Evaluation of the Benefits of 1 st Trimester Risk Markers in Detecting Early Onset Pre-eclampsia and the Use of the Placental Growth Factor (PlGF) as a Potential Marker for Trisomy 21 and Other Aneuploidies
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pregnancy
Lead sponsor: Clinique Ovo
Sponsor class: INDUSTRY
First posted: 2011-07-06
Enrollment: 370
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women in 1st trimester of pregnancy coming to clinique OVO for prenatal screening

Brief summary: This is a study for the evaluation of the benefits of 1 st Trimester risk markers in detecting Early Onset Pre-eclampsia and the use of the Placental Growth factor(PIGF) as a potential marker for Trisomy 21 and other aneuploidies.

Aim of this prospective nonprofit study is to analyze the benefits of early onset pre eclampsia risk assessment in the 1st trimester (measuring biochemical markers \[PIGF\], blood pressure and Doppler ultrasound), and how the results can permit to modify or influence the course of the preeclampsia during the pregnancy. The investigators will also evaluate the potential use of the PIGF as a marker to improve the prenatal screening with the currently used nuchal translucency, serum Pregnancy-associated plasma protein A (PAPP-A) and free beta subunit of human chorionic gonadotropin (fBhCG) parameters.


Eligibility criteria: Inclusion Criteria:

* Singleton pregnancy
* Nulliparous pregnancy
* Gestation age between 6.0-13.6 weeks by last menstrual period verified by ultrasound
* Blood sample provided at gestational age 6.0-13.6 weeks
* Informed Consent

Exclusion Criteria:

* Multi-fetal pregnancy
* Primiparous or multiparous pregnancy
* Mental retardation or other mental disorders that impose doubts regarding the true patient's willingness to participate in the study
* Gestation age below 6.0 or above 13.6 weeks by last menstrual period verified by ultrasound.
* Lack of blood sample at the specified enrollment period
* Known major fetal anomaly or fetal demise
* Lack of demographic data

Primary outcomes:
measure: levels of Placental Protein 13 (PP13) , PIGF, PAPP-A, PIBF
timeFrame: 6-13.6 wks gestation
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: OVO Prénatal
state: Quebec
Study officials:
affiliation: Clinique Ovo
name: Robert Hemmings, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinique Ovo
name: Bernard Couturier, MD
role: STUDY_DIRECTOR
affiliation: Clinique Ovo
name: Dominique Berube, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06592976: Effects of a Multi-strain Oral Probiotic on the Vaginal Microbiota Composition in Healthy Women and Women with Endometriosis
Official title: Effects of Gut Microflora on Cervico-vaginal Microenvironment in Women with Endometriosis (Original Version: Effetti Della Flora Intestinale Sul Microambiente Cervico-vaginale in Donne Con Endometriosi)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Endometriosis
Bacterial Vaginosis
Healthy Volunteer
Keywords: Gut microbiota
Vaginal microbiota
Probiotic
endometriosis
bacterial vaginosis
16s metagenomic
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 123
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Endometriosis is a chronic inflammatory disease affecting approximately 10-15% of reproductive age women, and, in recent years, an association between this pathology and dysbiosis, either involving the gut or the genital microbiota, has been hypothesized.

Therefore, the aim of the study is to investigate the etiopathogenetic role of cervico-vaginal microbiota, and its relationship to the gut microbiota, in women with endometriosis. Furthermore, the effects of a multi-strain oral probiotic formulation will be evaluated on the composition of the genital microbiota in healthy women and patients with endometriosis.


Eligibility criteria: Inclusion Criteria:

* age between 20 and 40 years old;
* clinical diagnosis of endometriosis via gynecological examination and transvaginal ultrasound (TVUS);
* genital healthy condition as confirmed via gynecological examination.

Exclusion Criteria:

* pre-menarche or menopause status;
* diabetes, neoplastic diseases, urinary or genital infections in the past 6 months
* bowel and/or liver disorders;
* current treatment with oral contraceptive or progestins, prokinetics, antacids or proton pump in-hibitors;
* sexual activity in the week before sampling;
* recent or current antibiotic treatment (oral or topical);
* the use of probiotics and/or prebiotics for three months before the enrolment.

Primary outcomes:
measure: Comparison in the mean microbial diversity of the vaginal and gut microbiota between women with endometriosis and healthy volunteers, as assessed by Shannon Diversity Index (alpha-measure) and UniFrac analysis (beta measure), calculated in qiime2.
timeFrame: At the time of enrollment
Secondary outcomes:
measure: Changes in the mean microbial diversity (Shannon Diversity Index and UniFrac analysis) of the vaginal microbiota at two month supplementation, from baseline, of the probiotic product in either healthy women or women with endometriosis.
timeFrame: At the time of enrollment and after 2 months of probiotic supplementation
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Umberto I Hospital, University of Rome &#34;Sapienza&#34;
state: Lazio
Study officials:
References:
Clinical trial NCT03471676: Study of the Correlation Between Muscle Oxygenation and Motor Function in Children With Neuromuscular Disease.
Official title: Study of the Correlation Between Muscle Oxygenation and Motor Function in Children With Neuromuscular Disease.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuromuscular Diseases in Infants
Neuromuscular Diseases in Children
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2018-03-20
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 6-17 years old patients suffering from neuromuscular disorder and able to walk

Brief summary: Preliminary data underline the fact that muscular deoxygenation during training happens earlier in adult patients suffering from neuromuscular disorders in comparison to controls. Up to date, pediatric data are lacking.

The study aims at demonstrating if a correlation exists between the motor deficiency and the muscular deoxygenation in children suffering from neuromuscular disorders.

Detailed description: Preliminary data underline the fact that muscular deoxygenation during training happens earlier in adult patients suffering from neuromuscular disorders in comparison to controls, as it was demonstrated in Becker muscular dystrophy patients and fascioscapulo humeral muscular dystrophy. Moreover, the deoxygenation kinetics was positively correlated to the functional status and the muscular deficiency severity. However, no pediatric study has been conducted on this topic up to date.

The aim of the study is to determine if a correlation exists in children suffering from neuromuscular diseases:

* between muscular oxygenation and the percentage of the 6 minutes walking test performed in the routine medical care
* between muscular oxygenation and the total and D1 motor function measure value

Eligibility criteria: Inclusion Criteria:

* Children from 6 to 18 years-old suffering from a neuromuscular disorder
* Able to walk, with or without help

Exclusion Criteria:

* Hypoxia secondary to heart or lung disease
* Visual impairment (\<5/10)
* Parents refusal concerning data storage

Primary outcomes:
measure: Muscular oxygenation
timeFrame: 6 minutes
Secondary outcomes:
measure: 6 minutes walking distance
timeFrame: 6 minutes
measure: Motor function
timeFrame: 25 minutes
Other outcomes:
Locations:
city: Tours
country: France
facility: University Hospital, Tours
Study officials:
affiliation: University Hospital, Tours
name: Emmanuelle LAGRUE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02904876: Evaluation of Early Changes Visible to the Diffusion MRI in Response to Two Years of Treatment With Tysabri in Patients With Multiple Sclerosis
Official title: Evaluation of Early Changes Visible to the Diffusion MRI in Response to Two Years of Treatment With Tysabri in Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Multiple Sclerosis
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2016-09-19
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Through this phase IV study, multicenter prospective exploratory, uncontrolled, the investigators propose to identify MRI predictive factors of treatment response, using diffusion MRI sequences, in addition to conventional sequences.

The primary objective is to study the links between changes on MRI diffusion and response to treatment with Tysabri to 2 years.

The secondary objective is to compare the evolution of diffusion MRI data with the volumetric MRI data.


Eligibility criteria: Inclusion Criteria:

* Major Patient
* Patient with relapsing remitting multiple sclerosis and eligible for treatment with Tysabri
* Patient affiliated to a social security scheme
* Patient who signed informed consent
* Patient who have been informed of the results of the prior medical examination

Exclusion Criteria:

* Patient not currently eligible for treatment with Tysabri
* Contraindication to MRI scanning
* Unability to provide informed consent (subject in an emergency situation, difficulties in understanding , ...)
* Patient under judicial protection
* Patient under guardianship or curatorship
* Pregnancy (women of childbearing age in the absence of effective contraception)
* Breastfeeding

Primary outcomes:
measure: Comparaison of diffusion Magnetic Resonance Imaging before and after the initiation of treatment with Tysabri using fractional anisotropy (FA).
timeFrame: 24 months
Secondary outcomes:
measure: Comparison of different Magnetic Resonance Imaging criteria before and after treatment
timeFrame: 24 months
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Neurologie Hôpital de Hautepierre
state: Alsace
Study officials:
affiliation: Service de Neurologie HUS hautepierre
name: Jérôme DE SEZE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04330976: Preventing Excessive Gestational Weight Gain Via Short Mobile Messages in WIC
Official title: Preventing Excessive Gestational Weight Gain Via Short Mobile Messages in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Weight Gain
Lead sponsor: University of Hawaii
Sponsor class: OTHER
First posted: 2020-04-02
Enrollment: 83
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this trial was to investigate the effect of educational short message service (SMS), or text messages, on gestational weight gain (GWG) in a low-income population.


Eligibility criteria: Inclusion Criteria:

* 15-20 weeks gestational age and 18 years of age or older at time of recruitment
* body mass index (BMI) of 25-45 kg/m2 in the first trimester
* possession of a cellular phone with the ability to receive text messages without a charge

Exclusion Criteria:

* conditions requiring a special diet
* multiparous pregnancies
* unable to consent to participate
* unwilling to be randomized

Primary outcomes:
measure: Change between pre-pregnancy weight and last weight taken before delivery
timeFrame: From date of randomization until delivery of child (e.g. up to 25 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: University of Hawaii
state: Hawaii
Study officials:
References: