louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06701409: Epidemiology and Risk Factors for Injuries in Beach Tennis Players
Official title: Epidemiology and Risk Factors for Injuries in Beach Tennis Players: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Sport Injury
Keywords: Beach tennis
Injuries
National prospective cohort
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2024-11-22
Enrollment: 440
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Beach tennis players on the national territory

Brief summary: Beach tennis, a fast-growing sport since its creation in Italy in the 1970s, has rapidly gained in popularity, particularly in La Réunion sisland since 2000. However, despite its development, studies on beach tennis-specific injuries are rare, based on cross-sectional studies and therefore limited by temporal or memory bias. The need for prospective research is crucial if we are to gain a better understanding of the epidemiology of injuries and improve prevention and medical management.

The aim will be to determine the risk of injury among beach tennis players within a one-year national prospective cohort.


Eligibility criteria: Inclusion Criteria:

* Player declaring that they train regularly in beach tennis (at least once a week)
* At least 18 years old at the time of inclusion
* Male or female
* Able to read and understand French
* Whether or not registered within a club
* Not opposed to the research

Exclusion Criteria:

* Protected adults (guardianship or curatorship) or those under court protection

Primary outcomes:
measure: Risk of injury
timeFrame: 1 year
Secondary outcomes:
measure: Type of injury
timeFrame: 1 year
measure: Main risk factors
timeFrame: 1 year
measure: Injury epidemiology
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: CHU de la Réunion
name: Nicolas Bouscaren, MD
role: PRINCIPAL_INVESTIGATOR
name: Julien Sebon, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02263209: Investigation to Determine Safety of Taperloc Stems With BioGuard Coating When Used in Cementless Total Hip Arthroplasty
Official title: Prospective Clinical Investigation to Determine the Safety of Taperloc Stems With BioGuard Coating and Exceed ABT Taperfit Acetabular Cups With BioGuard Coating When Used in Cementless Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Osteoarthritis of Hip
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2014-10-13
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective clinical investigation to determine the safety of Taperloc stems with BioGuard coating and Exceed ABT Taperfit acetabular cups with BioGuard coating when used in cementless total hip arthroplasty

Detailed description: Bioguard Safety Study: Prospective clinical investigation to determine the safety of Taperloc stems with BioGuard coating and Exceed ABT Taperfit acetabular cups with BioGuard coating when used in cementless total hip arthroplasty

Eligibility criteria: Inclusion Criteria:

* Eligible for cementless primary total hip arthroplasty according to the Surgical Technique brochure (Appendix 10): "The Taperloc Porous Primary Hip and Exceed ABT Taperfit Prostheses are marketed for non-cemented use in skeletally mature patients undergoing primary hip replacement surgery of non inflammatory degenerative joint disease."
* Under 80 and over 40 years of age
* A pre-operative level of pain and function the same as for conventional joint replacement.
* A likelihood of obtaining relief of pain and improved function
* Full skeletal maturity
* Ability to follow instructions
* Good general health for age
* Willing to return for follow-up evaluations

Exclusion Criteria:

* Patients aged over 80 and under 40 years
* Known allergy to any antibiotics
* Active infection
* Revision arthroplasty
* Marked bone loss which could preclude or compromise adequate fixation of the device
* Uncooperative subjects
* Parkinson's Disease
* Vascular insufficiency of the affected limb, which could compromise bony ingrowth/implant fixation, i.e., diabetes.
* Severe instability or deformity of the ligaments and/or surrounding soft tissue which may preclude stability of the device
* Pregnancy
* BMI \> 40
* Use of immunosuppressive drugs
* Women of child bearing potential

Primary outcomes:
measure: Change in normalised peri-implant BMD as measured by DXA
timeFrame: 6 months post operative
Secondary outcomes:
Other outcomes:
Locations:
city: Oswestry
country: United Kingdom
facility: RJAH
Study officials:
affiliation: RJAH, Oswestry
name: Sudheer Karlakki, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04978909: PVI for TVC Response
Official title: The Effectiveness of Tidal Volume Challenge Incorporating Plethysmographic Variability Index in Predicting Fluid Responsiveness
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Validation of PVI in Tidal Volume Challenge Test
Keywords: tidal volume challenge,Plethysmography variability index,Fluid responsiveness
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-07-27
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing elective major surgery (estimated \> 2-hr) with general anesthesia and mechanical ventilation in supine position

Brief summary: Determine the ability of changes in Plethysmographic Variability Index during tidal volume challenge to predict fluid responsiveness

Detailed description: The change of Plethysmographic Variability Index after tidal volume challenge as a predictor of fluid responsiveness, confirmed with the change of SVV using Flotrac advance cardiac output monitor.

To determine whether the patient is fluid responder, Fluid challenge will be performed afterwards to confirm the patient's fluid responsiveness.

We also aim to calculate the least significant change for Plethysmographic Variability Index and Philips PPV system.

Eligibility criteria: Inclusion:

Patients undergoing elective major surgery (estimated \> 2-hr) with general anesthesia and mechanical ventilation in supine position

Exclusion:

1. BMI \< 18.5 or \>30 kg/m2
2. Pregnant patient
3. Allergy to starch solution
4. estimated glomerular filtration rate\< 60

Primary outcomes:
measure: The predictive ability of change in Plethysmographic Variability Index after Tidal volume challenge to predict fluid responsiveness
timeFrame: 20 minutes
Secondary outcomes:
measure: Least significant change for Massimo PVI and Philips PPV
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chun-Yu Wu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01268709: Effect of Doxepin and Nortriptyline on Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Irritable Bowel Syndrome
Lead sponsor: Qom University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Young Researchers Club
First posted: 2010-12-31
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Primary purpose: TREATMENT

Brief summary: The objective of this randomized triple blind controlled trial is to compare the effects of Doxepin and Nortriptyline on diarrhea predominant irritable bowel syndrome. In this stuy, 75 patients with IBS are randomly assigned to receive Doxepin , Nortriptyline or placebo, a tablet per day, orally, for two months. Abdominal pain, mucus in the stool, incomplete evacuation, and bloating are measured and compared between groups at the baseline and one and two month after the intervention.


Eligibility criteria: Inclusion Criteria:

* Presence of diarrhea predominant irritable bowel syndrome according to ROME criteria

Exclusion Criteria:

* Gastrointestinal bleeding
* More than 5% weight loss in the last 6 months
* Presence of any finding in favor of organic disorders in the lab tests or organic disorder in colonoscopy of high risk patients

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Qom
country: Iran, Islamic Republic of
facility: Gastrointestinal Research center,Beheshti Hospital
Study officials:
References:
Clinical trial NCT02346409: Cerebello-thalamo-cortical Coupling in Essential Tremor
Official title: Cerebello-thalamo-cortical Coupling in Essential Tremor: Effects of High Frequency tACS of the Cerebellum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Essential Tremor
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2015-01-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Essential tremor (ET) is a frequent and disabling disorder with progressive worsening of postural tremor of the upper limbs that impairs most of the manual activities of every day life (feeding, drinking, etc.). Although the pathophysiology of essential tremor (ET) is not fully elucidated, tremor is associated with abnormal activity within different brain regions, in particular the thalamus and the cerebellum. Deep brain stimulation (DBS) of the ventral intermediate nucleus of the thalamus (VIM-Thal) reverses the symptoms of tremor but is an invasive procedure. Transcranial stimulation of the cerebellum may represent a non-invasive therapeutic option for ET patients. Here, the investigators propose to test the efficacy of cerebellar stimulation in 15 ET patients previously operated for DBS of the thalamus. To further understand how this treatment provokes tremor reduction, the investigators will analyse the brain neuronal activity in 13 others ET patients candidate to thalamic DBS by using combined electrophysiological recordings of the thalamus (with the electrodes implanted), the cerebellum and the cortex with magnetoencephalography.


Eligibility criteria: Inclusion Criteria:

* age below 75 years
* diagnosis of essential tremor according to the criteria of the Tremor Investigation Group and the Consensus statement of the Movement Disorder Society Group (ref)
* health insurance
* signed informed written consent

Exclusion Criteria:

* other neurological disorders
* medications that interact with or influence brain excitability
* significant brain lesions detected in MRI

Primary outcomes:
measure: The neuronal activity in the cerebello-thalamo-cortical pathway
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: ICM
Study officials:
References:
Clinical trial NCT04643509: Validity of Cardiac Output Measurement Using Niccomo Device After Cardiac Surgery
Official title: Cardiac Output Analysis by Cardiographic Impedance: a Validation Study of the Niccomo Non-invasive Monitor in Post-operative Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Shock, Cardiogenic
Surgery
Output, Low Cardiac
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2020-11-25
Enrollment: 100
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: All patients bénéfiting from cardiac surgery and pulmonary arterial catheter at the discretion of the physician

Brief summary: Cardiac surgery is at high risk of low cardiac output syndrome after procedure. Monitoring cardiac function, and especially cardiac output, is important to identify cardiovascular dysfunction and to introduce and adjust optimal therapies. Invasive monitor such as pulmonary arterial catheter or transpulmonary thermodilution provide precise measurements but need an invasive access to arterial and central venous route, with possible complications.

Cardiographic bioimpedencemetry (Niccomo device, Imedex Corp) allows a non invasive measurement of cardiac output and some other parameters of cardiovascular function. Nevertheless, the reliability of this device has been little studied after cardiac surgery.


Eligibility criteria: Inclusion Criteria:

* age \> 18 y/o
* Patients benefiting from cardiac surgery AND pulmonary arterial catheter monitoring

Exclusion Criteria:

* Aortic regurgitation grade 3-4
* Uncontrolled Hypertension (MAP \> 130 mmHg)
* Circulatory or cardiac assistance
* Active pacemaker

Primary outcomes:
measure: agreement between cardiac outputs measured by Pulmonary Arterial Catheter (PAC) and Niccomo
timeFrame: 48 hours
Secondary outcomes:
measure: Systolic Time Ratio
timeFrame: 48 hours
measure: Pre-ejection Period
timeFrame: 48 hours
measure: Velocity Index
timeFrame: 48 hours
measure: Left Ventricular Ratio
timeFrame: 48 hours
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
References:
Clinical trial NCT06774209: Multimodal PET Imaging in the Diagnosis and Treatment of Pelvic Tumors
Official title: Multimodal PET Imaging in the Diagnosis and Treatment of Pelvic Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endometrial Cancer
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2025-01-14
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is a prospective exploratory study to explore the application value of gallium 68 labeled-fibroblast activation protein inhibitor-04 Positron Emission Tomography（68Ga-FAPI-04 PET）imaging in patients with endometrial cancer and compare it with the imaging agent with better imaging effects to study its advantages. After patient enrollment, 68Ga-FAPI-04 Positron Emission Tomography/Computed Tomography（PET/CT） and Positron Emission Tomography/Magnetic Resonance Imaging（PET/MRI） examinations are performed, with the imaging agent administered intravenously at a dose of 0.02 to 0.04 mCi/Kg×patient weight (Kg), and a whole-body scan is performed 30-60 minutes later, with images processed as usual. Within 1 week before and after the examination, Fluorine18 labeled-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography（18F-FDG PET/CT） is completed, along with medical history collection and necessary laboratory tests. Subsequently, patients undergo surgical resection of the lesion and suspicious metastatic lymph nodes shown by FAPI PET/CT to obtain the corresponding pathological results. Finally, the diagnostic value of all patients in 68Ga-FAPI-04 PET/CT and PET/MR is analyzed and compared with 18F-FDG PET/CT to study the differences in diagnostic efficacy between the two.


Eligibility criteria: Inclusion Criteria:

* 18-70 years old
* Obtaining written informed consent
* Being able to accept follow-up
* Feasible surgery or biopsy to obtain the final result

Exclusion Criteria:

* Pregnant and lactating female patients
* Patients who are difficult to receive further diagnosis and treatment due to their severe condition
* Any patients with contraindications to magnetic resonance imaging

Primary outcomes:
measure: tumor size and SUVmax
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Lymph Node Metastasis FAPI Uptake (SUVmax) and Distant Metastasis FAPI Uptake (SUVmax)
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT01180309: Lingual Frenum and Articulation of Phonemes
Official title: Lingual Frenum and Possible Alterations in the Articulation of Phonemes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Speech Disorders
Keywords: Tongue frenum
Lingual frenum
Audio Phonology
Speech disorders
Lead sponsor: Fortaleza University
Sponsor class: OTHER
Collaborators: name: Izabella Santos Nogueira de Andrade
First posted: 2010-08-12
Enrollment: 16
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The total study population consisted of subjects with complete phonological system, ie more than seven years of chronological age, both male and female, accompanied in the field of Dentistry, University of Fortaleza - UNIFOR.

Brief summary: Purpose To investigate the relationship between lingual frenum and possible alterations in the articulation of phonemes.

Methods This is a quantitative observational study, the individual operative kind with transversal time reference. The population sample consisted of 16 individuals, each one with their phonological system complete. The data were captured through an application form that contained relevant aspects as to the qualitative-classification of the lingual frenum, quantitative-relation of mouth opening, with and without the tongue in the papillae, tongue mobility and ERT - 78 phonologically balanced words.

Detailed description: The data were captured through an application form that contained relevant aspects as to the qualitative-classification of the lingual frenum, quantitative-relation of mouth opening, with and without the tongue in the papillae, tongue mobility and ERT - 78 phonologically balanced words.

Eligibility criteria: Inclusion Criteria:

* patients with the frenulum of the tongue - the presence of the central incisors and upper and lower side

Exclusion Criteria:

* patients in speech therapy aimed at enabling oral motor or speech - without integrity orofacial motor - patients using grid palate - with changes in the temporomandibular joint - anterior open bite

Primary outcomes:
measure: Relation between lingual frenulum altered and articulation phonetics
Secondary outcomes:
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: Dentistry, University of Fortaleza
state: Ceará
Study officials:
References:
Clinical trial NCT02475109: Study of Topical Ocular PAN-90806 in PDR
Official title: A Phase 1 Open-Label, Single-Center Study to Evaluate the Safety and Tolerability of Topical Ocular PAN-90806 in Patients With Proliferative Diabetic Retinopathy (PDR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetic Retinopathy
Keywords: Proliferative Diabetic Retinopathy
Lead sponsor: PanOptica, Inc.
Sponsor class: INDUSTRY
First posted: 2015-06-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to assess the safety and tolerability of topical ocular PAN-90806 in patients with proliferative diabetic retinopathy.


Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older with type 1 or type 2 diabetes
* Proliferative diabetic retinopathy (PDR) in study eye retina with or without diabetic macular edema (DME) involving the center of the macula
* Demonstrate the ability, or have a family member who is willing and able, to instill topical ocular drops in the study eye

Exclusion Criteria:

* Current or recent use (within the last 3 months) of anti-vascular endothelial growth factors (anti-VEGF) in either eye;
* Uncontrolled hypertension despite use of antihypertensive medications
* Unwillingness to refrain from wearing contact lenses for the duration of the study.
* Participation in any investigational drug or device study, systemic or ocular, within past 3 months
* Women who are pregnant or nursing
* Known serious allergies or hypersensitivity to the fluorescein dye used in angiography or to the components of the PAN-90806 formulation

Primary outcomes:
measure: Number of Patients with Adverse Events
timeFrame: 2 months
Secondary outcomes:
measure: The mean change in best-corrected visual acuity from baseline
timeFrame: Week 8
measure: Change in preretinal neovascularization
timeFrame: Week 4 and Week 8
measure: The mean number of rescue treatments during the study
timeFrame: Week 8
measure: Time to first rescue treatment
timeFrame: up to Week 8
Other outcomes:
Locations:
city: Harlingen
country: United States
facility: Valley Retina Institute
state: Texas
city: McAllen
country: United States
facility: Valley Retina Institute
state: Texas
Study officials:
affiliation: Valley Retina Institute
name: Victor H Gonzalez, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04156009: Lavender Aromatherapy Spine Procedure Study
Official title: Aromatherapy for Procedural Anxiety in Pain Management and Interventional Spine Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spine Injuries and Disorders
Pain, Back
Keywords: aromatherapy
lavender
anxiety
spine intervention
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2019-11-07
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patient anxiety prior to invasive procedures poses a significant barrier to successful treatment if not well-managed. The purpose of this study is to evaluate lavender aromatherapy, a non-sedating alternative, to reduce anxiety prior to interventional spinal procedures.


Eligibility criteria: Inclusion Criteria:

1. Males and females between 18-85 years old
2. Scheduled for one of the following procedures on the day of consent:

   1. Epidural steroid injection (ESI)
   2. Medial branch block (MBB)
   3. Radiofrequency ablation (RFA)
3. Able to provide informed consent

Exclusion Criteria:

1. History of anxiety disorder
2. Currently on anxiolytic therapy
3. Poor sense of smell
4. Allergy/aversion to aromatherapy
5. Non-English speaking

Primary outcomes:
measure: Change in Subjects' Anxiety State as measured by the State Trait Anxiety Inventory (STAI-6)
timeFrame: Administered within 30 minutes before and 30 minutes after intervention
Secondary outcomes:
measure: Number of Vasovagal Events during Standard of Care Spine Procedure
timeFrame: Assessed within 30 minutes following the standard of care spine procedure
measure: Number of Aborted Standard of Care Spine Procedures
timeFrame: Assessed within 30 minutes following standard of care spine procedure completion or abortion
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Jaspal R Singh, MD
role: PRINCIPAL_INVESTIGATOR
References: