louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05742139: Impact on the Quality of Life and Persistent Symptoms of Patients Away From Diagnosed and Treated Neuroborreliosis
Official title: Impact Sur la qualité de Vie et symptômes Persistants Des Patients à Distance d'Une neuroborréliose diagnostiquée et traitée
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuroborreliosis, Lyme
Quality of Life
Lead sponsor: Hopital Nord Franche-Comte
Sponsor class: OTHER
First posted: 2023-02-23
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A online questionnaire is completed by the patient concerning socio-demographic date, patient history, quality of life scale, persistent neurological symptoms

Brief summary: The link between Lyme neuroborreliosis (NBL) and persistent symptoms is debated in the medical world. Some report a frequency of post NBL symptoms similar to the general population, and others define a specific entity, the PTLDS (Post Treatment Lyme Disease Symptoms).

In France, few studies have evaluated the persistent symptoms and the impact on the quality of life of patients after treatment for NBL.


Eligibility criteria: Inclusion Criteria:

* Have been hospitalized or consulted for neuroborreliosis between 2010 and 2021;
* Have a diagnosis of probable neuroborreliosis (compatible clinical signs + lumbar puncture with positive intrathecal synthesis of immunoglobulins) or certain (compatible clinical signs + lumbar puncture with pleocytosis and positive intrathecal synthesis of immunoglobulins);
* Have received adequate treatment according to the recommendations (1st intention DOXYCYCLINE 100mgx2/day or 2nd intention CEFTRIAXONE IV 2g/day for 14 to 21

Exclusion Criteria:

* Be part of the entourage of the cases;
* Do not have ATCD of Lyme borreliosis (especially erythema migrans);
* Not having been bitten by a tick in the last 5 years;

Primary outcomes:
measure: Assess the quality of life of patients compared to a healthy control population using the SF-36 questionnaire and the Fatigue Scale Severity
timeFrame: At inclusion
measure: Identification of symptoms recognized by the patient as persistent after neuroboreliosis from a list of referenced symptoms
timeFrame: At inclusion
Secondary outcomes:
measure: Imputability according to the patient of his pain in relation to the initial infection
timeFrame: At inclusion
measure: Comparison of symptoms and/or quality of life between patients with definite versus probable neuroborreliosis using the SF-36 questionnaire
timeFrame: At inclusion
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU Besançon
city: Trévenans
country: France
facility: Hôpital Nord Franche-Comté
Study officials:
References:
Clinical trial NCT01909739: The Effects of Statin on Postoperative Renal Function in Valvular Heart Surgery: a Randomized, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Kidney Injury
Keywords: AKI, atrovastatin, Valvular heart surgery
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-07-26
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to examine the association between preoperative statin treatment and the incidence of postoperative acute kidney injury(AKI) in patients undergoing valvular heart surgery.


Eligibility criteria: Inclusion Criteria:

- patients over the age of 20 scheduled for valvular heart surgery

Exclusion Criteria:

1. Current statin use
2. Left ventricular ejection fraction \< 30%
3. Preexisting congestive heart failure
4. Severe coronary artery disease
5. Hemodynamically unstable arrhythmia
6. Cardiogenic shock during perioperative period
7. Ventricular assist device
8. Severe renal dysfunction (eGFR \< 15 ml/min per 1.73 m2)
9. History of liver disease or elevated serum transaminases
10. History of rhabdomyolysis or elevated creatinine kinase

Primary outcomes:
measure: Comparison of postoperative renal function with or without statin in patients undergoing valvular heart surgery
timeFrame: renal function change from 24-hour after surgery to 120-hour after surery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Study officials:
References:
citation: Park JH, Shim JK, Song JW, Soh S, Kwak YL. Effect of atorvastatin on the incidence of acute kidney injury following valvular heart surgery: a randomized, placebo-controlled trial. Intensive Care Med. 2016 Sep;42(9):1398-407. doi: 10.1007/s00134-016-4358-8. Epub 2016 Apr 27.
Clinical trial NCT06056739: Alio WEAR Study: Long-term Wear of the Alio Platform
Official title: Alio WEAR Study: Long-term Wear of the Alio Platform
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: End Stage Kidney Disease
Lead sponsor: Alio, Inc.
Sponsor class: INDUSTRY
First posted: 2023-09-28
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The WEAR study is long-term interventional study designed to evaluate patient and clinician use of the Alio platform, per its FDA cleared indications.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age.
* Receiving hemodialysis via an AVF or AVG in an arm location at the time of study start.
* Able to wear the SmartPatch effectively at the specified location on the arm.
* Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures.
* Willing and able to wear the SmartPatch as instructed and comply with all interviews, surveys and questionnaires, and schedule of evaluations.

Exclusion Criteria:

* Skin near the proximity of the AV access that is chronically swollen, infected, inflamed, open wounds, lesions, or has skin eruptions.
* Participation in any other clinical trials involving investigational or marketed products that in the opinion of the investigator could affect the quality of the data.
* Other conditions that in the opinion of the Principal Investigator may increase risk to the subject and/or compromise the quality of the clinical trial.

Primary outcomes:
measure: Assessing usage of the Alio platform by the test subject
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Huntley
country: United States
facility: Site 1
state: Illinois
Study officials:
affiliation: Alio
name: David Whittaker, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05778539: Lateral Retinacular Release in Total Knee Arthroplasty With Patellar Replacement
Official title: Systematic Lateral Retinacular Release Does Not Reduce Post-Operative Anterior Knee Pain After Primary Total Knee Arthroplasty With Patellar Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Knee Pain Syndrome
Keywords: Total knee arthroplasty
Patellar resurfacing
Lateral retinacular release
Anterior knee pain
Lead sponsor: Hospital del Mar
Sponsor class: OTHER
First posted: 2023-03-21
Enrollment: 220
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to assess the effect of systematic lateral retinacular release on anterior knee pain, as well as its impact on the functional and radiological outcomes after total knee arthroplasty with patellar resurfacing.

Detailed description: Anterior knee pain is an important cause of persistent pain after total knee arthroplasty. Lateral retinacular release has been proposed as a procedure to prevent anterior knee pain syndrome, based on the reduction of lateral tension and improving patellar tracking.

However, its effect on anterior knee pain after total knee arthroplasty is not clear when it is not strictly needed to correct maltracking.

The purpose of this trial is to evaluate the effect of systematic lateral retinaculare release on anterior knee pain, peformed during a total knee arthroplasty with patellar resurfacing.

Eligibility criteria: Inclusion Criteria:

* diagnosis of knee osteoarthritis

Exclusion Criteria:

* prior major surgery on the same knee (high tibial or distal femoral osteotomy, patellar realignment)
* important preoperative malalignment (varus or valgus \>15º or flexion deformity \>15º)
* inability to sign informed consent

Primary outcomes:
measure: Change from baseline in Anterior Knee Pain at one year after surgery
timeFrame: At the preoperative visit and at the 1-year follow up
measure: Change from baseline in Knee Pain measured by Visual Analogue Scale at one year after surgery
timeFrame: At the preoperative visit and at the 1-year follow up
Secondary outcomes:
measure: Change from baseline in patellar pain and function at one year after surgery
timeFrame: At the preoperative visit and at the 1-year follow up
measure: Change from baseline in knee fuction, measured by the Knee Society Score, at one year after surgery
timeFrame: At the preoperative visit and at the 1-year follow up
Other outcomes:
measure: Change from baseline in Patelar Height at one year after surgery
timeFrame: At the preoperative visit and at the 1-year follow up
measure: Change from baseline in Patellar Tilt at one year after surgery
timeFrame: At the preoperative visit and at the 1-year follow up
Locations:
city: Barcelona
country: Spain
facility: Parc de Salut Mar
Study officials:
References:
Clinical trial NCT00839839: Egg Freezing Pilot Study
Official title: Oocyte Cryopreservation in Assisted Reproduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Egg Freezing
Keywords: infertility
egg freezing
fertility preservation
Lead sponsor: University Reproductive Associates
Sponsor class: OTHER
First posted: 2009-02-10
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: University Reproductive Associates is conducting a pilot study to study the technique of egg freezing. Your participation in this study will provide us with important information to allow us to offer this technology for women wishing to freeze their eggs before cancer treatments. Your participation will include a standard IVF cycle with your eggs being frozen for a brief period of time and then transferred back to you as usual. You will receive a significant reduction in your IVF cycle cost.


Eligibility criteria: Inclusion Criteria:

1. 10 women between the ages of 18-35 inclusive at time of signing Informed Consent Form.
2. In good general health off of current medications which may confound response to study medications.
3. Desire to seek pregnancy actively during the study period by IVF-ICSI.
4. A normal uterine cavity must have been confirmed by either hydrosonogram or hysteroscopy within two years of entering the study.
5. Ability to use the required medications.
6. Day 3 FSH level \< 12 IU/ml

Exclusion Criteria:

1. Current pregnancy
2. Patients with significant anemia (Hemoglobin \< 10 mg/dL).
3. Patients enrolled simultaneously into other investigative studies that would interfere with this research study.

Primary outcomes:
measure: Incidence of Biochemical Pregnancy
timeFrame: 1 year
Secondary outcomes:
measure: Recovery of viable oocytes
timeFrame: 1 year
measure: incidence of fertilization
timeFrame: one year
measure: embryo development (how many fertilized eggs undergo development to a more advanced stage)
timeFrame: 1 year
measure: clinical pregnancy (fetal pole visible on transvaginal ultrasound) per cycle
timeFrame: 1 year
Other outcomes:
Locations:
city: Hasbrouck Heights
country: United States
facility: University Reproductive Associates
state: New Jersey
Study officials:
affiliation: UMDNJ-NJMS
name: Peter G. McGovern, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03052686: Retrospective Study of 110 Cases of Uterine Rupture to Determine Obstetric and Neonatal Complications
Official title: Retrospective Study of 110 Cases of Uterine Rupture to Determine Obstetric and Neonatal Complications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anomaly Uterus
Keywords: Uterine rupture
Lead sponsor: Hôpital NOVO
Sponsor class: OTHER
First posted: 2017-02-14
Enrollment: 110
Sex: FEMALE
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: Women with rupture uterine at the childbirth.

Brief summary: This study has for objective to collect medical data from patients with uterine rupture at the childbirth.

Detailed description: This is a retrospective study, gathering data of five maternity in the department of Val d'Oise in France, during 13 years (between 01/01/2000 an 31/12/2013).

The incidence of uterine rupture increases with increasing cesarean rates. It occurs at a rate of 0.08% across all childbirths in France, and 0.5 to 1% of the childbirths on cicatricial uterus in France.

Although the risk factors are known, it is usually unexpected. This is a serious complication for the mother (mortality \<1%, severe morbidity at 15% ) and for the child (mortality for 3 to 6 % for childbirth at term, neonatal asphyxia for 6 to 15%) that can occur during pregnancy or during labor.

Eligibility criteria: Inclusion Criteria:

* Childbirth with uterine rupture

Exclusion Criteria:

* Childbirth in a maternity which do not participate to the study

Primary outcomes:
measure: Identify maternal and foetal risk factors associated to an uterine rupture ; by the report of events during pregnancy, pathology, lifestyle, Concomitant pathology...
timeFrame: 1 day
Secondary outcomes:
measure: Number of maternal and foetal adverse events associated to an uterine rupture at the childbirth.
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: CH Rene Dubos, Pontoise
name: MARKOU Georges, PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07000786: EUmetriosis: Insights Into the Pathogenesis of Endometriosis
Official title: EUmetriosis: Insights Into the Pathogenesis of Endometriosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endometriosis
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2025-06-03
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 56
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study investigates epigenetic changes in menstrual effluent and plasma from women with endometriosis to identify potential non-invasive diagnostic biomarkers for the disease.


Eligibility criteria: Inclusion Criteria:

* Premenopausal
* In spontaneous menstrual cycle (no hormonal treatments for the last 3 months)
* Healthy or with a clear diagnosis of endometriosis via ultrasound, MRI or laparoscopy

Exclusion Criteria:

* HIV or Hepatitis positive
* Pregnancy

Primary outcomes:
measure: Epigenetic analysis
timeFrame: Throughout the entire study, approximately during 3,5 years
measure: Epigenetic analysis
timeFrame: Throughout the entire study, approximately during 3,5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
Study officials:
References:
Clinical trial NCT05505786: The Effects of Increased vs. Traditional Squat Stance Width on Performance Indices in Elite Rugby League Players
Official title: The Effects of Increased vs. Traditional Squat Stance Width on Performance Indices in Elite Rugby League Players; an 8-week Pre-season Randomized Control Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sports Performance
Lead sponsor: University of Central Lancashire
Sponsor class: OTHER
First posted: 2022-08-18
Enrollment: 26
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Stratified to include similar number of forward and backs in each arm.
Primary purpose: BASIC_SCIENCE

Brief summary: The back squat is a commonly utilized resistance training exercise for the promotion of both performance and musculoskeletal health. There are a range of manipulations that can be made to the setup of this resistance exercise, with once such adaptation being the stance width when performing the exercise. This intervention aims to explore the effects of increasing the stance with on performance indices in elite rugby league players.


Eligibility criteria: Inclusion Criteria:

* Rugby league player contracted to a professional Super League team
* 5-years minimum of back squat experience
* Male
* Injury free for 6-months

Exclusion Criteria:

* Female
* Any injury at baseline
* Any international matches played during the between season break

Primary outcomes:
measure: 505 agility test
timeFrame: Baseline
measure: 505 agility test
timeFrame: 8-weeks
Secondary outcomes:
measure: Body mass
timeFrame: Baseline
measure: Body mass
timeFrame: 8-weeks
measure: Sum of skinfold thickness
timeFrame: Baseline
measure: Sum of skinfold thickness
timeFrame: 8-weeks
measure: Three repetition maximum squat strength
timeFrame: Baseline
measure: Three repetition maximum squat strength
timeFrame: 8-weeks
measure: Counter movement jump height
timeFrame: Baseline
measure: Counter movement jump height
timeFrame: 8-weeks
Other outcomes:
Locations:
city: Preston
country: United Kingdom
facility: University of Central Lancashire
state: Lancashire
Study officials:
References:
Clinical trial NCT06024486: Fibrinogen to Albumin Ratio and C-reactive Protein to Albumin Ratio in Juvenile Idiopathic Arthritis
Official title: Correlation of Fibrinogen to Albumin Ratio and C-reactive Protein to Albumin Ratio With Disease Activity in Juvenile Idiopathic Arthritis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Juvenile Idiopathic Arthritis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-09-06
Enrollment: 50
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All juvenile idiopathic arthritis fulfilling the criteria of International League of Associations for Rheumatology (ILAR) and age and sex matched healthy subjects.

Brief summary: The fibrinogen to albumin ratio (FAR) and C-reactive protein to albumin ratio (CAR) have emerged as useful biomarkers to predict systemic inflammation. The aim here is to investigate the relation between FAR/CAR and Juvenile arthritis disease activity score (JASDAS27) in Juvenile idiopathic arthritis (JIA)

Detailed description: The JADAS27 includes a selected count of the following joints: cervical spine, elbows, wrists, metacarpophalangeal joints (from first to third), proximal interphalangeal joints, hips, knees and ankles.

Eligibility criteria: Inclusion Criteria:

* All juvenile idiopathic arthritis fulfilling the criteria of International League of Associations for Rheumatology (ILAR) and age and sex matched healthy subjects

Exclusion Criteria:

* Other systemic inflammatory or autoimmune disorders.
* History of corticosteroid medication in the last 6 months.
* Liver diseases.
* Malignancy.

Primary outcomes:
measure: The fibrinogen to albumin ratio
timeFrame: 3 months
measure: The CRP to albumin ratio
timeFrame: 3 MONTHS
measure: Correlation of fibrinogen to albumin and CRP to albumin ratios on one side with disease activity on the other side
timeFrame: 3 MONTHS
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06657586: Investigation of the Effectiveness of Neuromuscular Exercise Program Accompanied With Degenerative Meniscal Tear
Official title: Investigation of the Effectiveness of Neuromuscular Exercise Program Accompanied by a Physiotherapist in Individuals With Degenerative Meniscal Tear
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meniscus Tear
Knee Injuries
Keywords: knee
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2024-10-24
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study was to investigate the effect of exercise program added to the treatment on physical function, postural balance, muscle strength, pain and gait in individuals with meniscal damage.


Eligibility criteria: Inclusion Criteria:

* Age between 20-65 years.
* Having a meniscus tear.
* Volunteering to participate in the study.

Exclusion Criteria:

* Being diagnosed with a psychiatric illness.
* Having a neurological disease that may interfere with treatment.
* Having undergone meniscal surgery before.
* Having received physical therapy in the knee area in the last 6 months.
* Benefiting from any other treatment during the study.

Primary outcomes:
measure: Vertical jump
timeFrame: 6 weeks
measure: Star Balance Test
timeFrame: 6 weeks
measure: Tegner Activity Level Scale
timeFrame: 6 weeks
measure: KOOS-PS (Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form)
timeFrame: 6 weeks
measure: WOMET (Western Ontario Meniscal Evaluation Tool)
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bahçehir University
Study officials:
References: