louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05261737: Steroid Injection in De Quervain Tenosynovitis
Official title: Effectiveness of Steroid Injection in Treating Pain in De Quervain Tenosynovitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: De Quervain Disease
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants of the study will be selected by attending physician in Hand and Reconstructive Microsurgery outpatient clinic.

Estimated sample size is 50 patients.Statistical power calculation (error type II) is 0.8The Kaplan-Meier product-limit method will be used to estimate the rates of freedom from recurrence of symptoms. Confidence intervals for Kaplan-Meier survivorship functions will be based on Greenwood's variance estimated. A multivariable Cox proportional hazards regression model is planned to identify independent predictors of outcome.

Brief summary: This study is carried out to find out the degree of pain relief achieved with standard treatment as steroid injection as well as its time to onset. It will recruit 50 subjects over a period of 18 months.

Detailed description: The aim of the study is determine how effective these injections are and when will the patient start feeling relief of his/her symptoms.The aim of the study is not to change the current practice, but provide hand surgeons enough data to clarify their patients the expected outcomes and onset timing of the treatment performed.

Eligibility criteria: Inclusion Criteria:

* \>21 years old

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: Determine efficacy of steroid injection
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: National University Hospital, Singapore
name: Renita Sirisena
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06014437: Study on Regeneration of Skin Defects in Diabetic Ulcers Treated With New Electrospun Material PLCL/Fg
Official title: Study on Regeneration of Skin Defects in Diabetic Ulcers Treated With New Electrospun Material Poly (L-lactide-co-caprolactone) and Formulated Porcine Fibrinogen
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Diabetic Foot
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2023-08-28
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective cohort studies through clinical trials. Obtained a large amount of real-world data to explore the efficacy of PLCL/Fg dressings for specific clinical applications.

Published 1 relevant SCIE paper. Provide a large amount of data support for the application of PLCL/Fg dressing in diabetic foot ulcer wound repair through basic experimental and clinical experimental studies. It can provide a practical and effective biomaterial for the treatment of clinical skin wound structure and function reconstruction, make the patient's wound healing as soon as possible, benefit the general public, reduce medical expenditure, reduce the burden on the society, lay the foundation for the industrialization and marketization of national innovative medical devices, and help to improve the international status and value of the application.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 90 years; type 1 or type 2 diabetes mellitus; history of ulceration for more than 4 weeks at enrollment; wound area between 1 and 25 square centimeters; wound depth of Wagner grades 1 and 2; and an ABI of 0.7 to 1.3 on the affected lower extremity or a transcutaneous oxygen pressure of greater than or equal to 30 mmHg.

Exclusion Criteria:

* Wound healing percentage greater than 30% during wound preparation (7 days); any infection, osteomyelitis, or other condition that may affect wound healing, such as deep vein thrombosis, rheumatoid arthritis, systemic lupus erythematosus, or any other systemic inflammatory disease.

Primary outcomes:
measure: Incidence of complete wound closure during treatment and follow-up (12 weeks). (Outpatient follow-up 2-3 times per week, standardized photographs and measurement of wound size)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Vascular Surgery, Jinshan Hospital, Fudan University
Study officials:
affiliation: Department of Vascular Surgery, Jinshan Hospital, Fudan University
name: zhihui dong
role: STUDY_CHAIR
References:
Clinical trial NCT00456937: Escitalopram in Schizophrenia in OCD- Open Label Study
Official title: Escitalopram in the Treatment of Patient Suffering From Scizophrenia and Obsessive Compulsive Disorder- an Open Label Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Lead sponsor: BeerYaakov Mental Health Center
Sponsor class: OTHER_GOV
Collaborators: name: Lundbeck Israel
First posted: 2007-04-05
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: SSRI's has been demonstrated to be partially effective in schizophrenia and OCD. We therefore suggest that Escitalopram up to 20 mg /d in those patients could be effective in reducing obsessive compulsive symptomatology


Eligibility criteria: Inclusion Criteria:

* Patients who suffer from schizophrenia and OCD

Exclusion Criteria:

* Substance abuse,
* Serious medical condintions,
* Being on SSRI treatment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Beer Yaakov
country: Israel
facility: Beer Yaakov MHC
Study officials:
affiliation: Beer Yaakov Mental Health Center
name: Rafael Octavio Stryjer, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04875637: Middle-ear Reflex Testing Using Wideband Acoustic Immittance
Official title: Middle-ear Reflex Testing Using Wideband Acoustic Immittance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hearing Disorders
Keywords: middle ear muscle reflex
wideband acoustic immittance
Lead sponsor: Mimosa Acoustics
Sponsor class: INDUSTRY
Collaborators: name: Vanderbilt University Medical Center
First posted: 2021-05-06
Enrollment: 326
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This project will assess the middle-ear muscle reflex using wideband acoustic immittance which is a valuable method for evaluating infants, children, and adults. The developments will facilitate clinical applications that include hearing screening and diagnostic evaluation of persons of all ages with normal hearing and with hearing loss.

Detailed description: Measurement of middle-ear muscle reflexes (MEMR) constitutes an important component of the standard of care in auditory function assessment and diagnostic audiology. An important component of the middle-ear test battery involves characterizing neural function through the eighth nerve-brainstem pathway which is accomplished through measurement of the MEMR. The evaluation component of this project will involve testing of human subjects using wideband acoustic immittance in the evaluation of middle-ear muscle reflexes. Subjects in this project will be infants, children and adults with normal hearing as well as with conductive, sensory, and neural hearing loss. All subjects will receive wideband acoustic immittance (WAI) and middle-ear muscle reflex (MEMR) testing. Baseline testing includes pure tone audiometry and otoacoustic emissions.

Eligibility criteria: Inclusion Criteria:

* Normal hearing or hearing loss

Exclusion Criteria:

* None

Primary outcomes:
measure: WAI-MEMR
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References:
Clinical trial NCT01192737: "COhort Study on A/H1N1 FLU During PREGnancy"
Official title: Cohort Study to Evaluate Clinical Expression and Maternofetal Consequences of A/H1N1 Influenza in Pregnant Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza
Pregnancy
Keywords: pandemic
A/H1N1
pregnancy
cohort
vaccine
Influenza and Pregnancy
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2010-09-01
Enrollment: 919
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women

Brief summary: The purpose of this study is to measure the incidence of A/H1N1 Influenza infection in the mother and her child and to identify the determinants in pregnant women during pandemic period in three public maternities in Paris, France.


Eligibility criteria: Inclusion Criteria:

* \> 18 years
* Pregnancy between 12 and 35 weeks of gestation, going in one of the following maternity cares: Port Royal, Necker, Saint Vincent de Paul
* Provides written informed consent
* Speaks and understands French
* Covered by French Social Security

Exclusion Criteria:

* Not covered by French Social Security
* Previous H1N1 influenza (virologically documented)

Primary outcomes:
measure: Frequency of A/H1N1 Influenza virus infection in pregnant women and impact of Flu on pregnancy outcome.
timeFrame: 1 year
Secondary outcomes:
measure: Safety of Flu vaccine
timeFrame: 1 year
Other outcomes:
Locations:
city: Paris
country: France
facility: Maternité Necker-Brune
city: Paris
country: France
facility: Maternité Port Royal
city: Paris
country: France
facility: Maternité Saint Vincent de Paul
Study officials:
affiliation: CIC de Vaccinologie Cochin Pasteur
name: Odile Launay, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03683537: Association Between Changes of GFAP After Surgery and Postoperative Delayed Cognitive Recovery
Official title: Association Between Changes of GFAP After Surgery and Postoperative Delayed Cognitive Recovery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Astrogliosis
Postoperative Cognitive Dysfunction
Postoperative Delirium
Lead sponsor: Moscow Clinical Scientific Center
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who undergo surgery in Moscow Clinical Scientific Center

Brief summary: Assessment of serum level of glial fibrillary acidic protein (GFAP) before surgery (on the day of surgery), 24 hours after surgery and on 3 or 4 postoperative day. Neuropsychological testing before surgery and on 3 or 4 day after surgery. Investigation of relationship between changes of GFAP and scores of neuropsychological tests.


Eligibility criteria: Inclusion Criteria:

* Patients with different diseases, who require prolonged laparoscopy or open surgery
* Age more than 60
* ASA I-III
* Informed consent to participate in the study

Exclusion Criteria:

* ASA IV-V
* Severe neurodegenerative or psychological diseases

Primary outcomes:
measure: Changes in serum GFAP
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Moscow Clinical Scientific Center
Study officials:
affiliation: Moscow Clinical Scintific Center
name: Valery Subbotin, Ph.D., M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT04960137: Shoulder Dislocations Treated With Button Plates and Non-absorbable Suture Anchor
Official title: Non-randomized Controlled Study of Shoulder Dislocations Treated With Button Plates and Non-absorbable Suture Anchor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Dislocation
Keywords: button
non-absorbable suture anchor
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Hunan People's Hospital
name: The First Hispital of Jilin University
First posted: 2021-07-13
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to conduct a comparative study through clinical trials to verify the safety and efficacy of the products in the experimental group for clinical use.

Detailed description: The product of this clinical validation is the fixed button plate system, which is used for the reconstruction of the coracoclavicular ligament in the treatment of recurrent shoulder dislocation. The clinical trial was conducted to verify the rationality of its structural design, the convenience of its operation, and the effectiveness and safety of its clinical use. This trial was conducted in a parallel controlled trial design, the patients were divided into test and control groups to evaluate the safety and efficacy of the product.

Eligibility criteria: Inclusion Criteria:

1. a glenoid defect ≥10%
2. contact sport athletes with a glenoid defect \< 10%
3. failure after Bankart repair.

Exclusion Criteria:

1. epilepsy
2. multidirectional shoulder instability
3. concomitant other lesions including rotator cuff tear, symptomatic acromioclavicular joint pathology or pathological involvement of the long head of the biceps
4. Follow-up was less than 2 years or incomplete follow-up data.

Primary outcomes:
measure: Rowe score
timeFrame: before surgery
measure: Rowe score
timeFrame: 3 months after surgery
measure: Rowe score
timeFrame: 6 months after surgery
Secondary outcomes:
measure: ASES score
timeFrame: before surgery
measure: ASES score
timeFrame: 3 months after surgery
measure: ASES score
timeFrame: 6 months after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: PekingUTH
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Guoqing Cui
role: STUDY_CHAIR
References:
Clinical trial NCT00420537: Shift to Everolimus (RAD) Kidney Sparing Study
Official title: Safety and Efficacy of Low-dose Cyclosporine in Association With Everolimus to Minimize Renal Dysfunction in Heart Transplant Recipients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Kidney Dysfunction
Heart Transplantation
Keywords: Kidney
Heart Transplantation
Creatinine
Glomerular Filtration Rate
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2007-01-11
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to verify if the combination of Everolimus with a very low dose of cyclosporine is more effective than the combination of mycophenolate mofetil with low-dose of cyclosporine in reducing the progression of kidney dysfunction in patients with heart transplantation.


Eligibility criteria: Inclusion Criteria:

* Heart Transplant with 1 to 4 years of follow-up
* GFR between 20 and 60 ml/min (calculated with Colkoroft-Gault formula)

Exclusion Criteria:

* Acute rejection in the previous 6 months
* Contraindications to statin therapy
* Ongoing infection
* Ongoing heart failure
* Myocardial infarction or myocardial revascularization after transplant
* Malignancy

Primary outcomes:
measure: Calculated GFR
timeFrame: One year after randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Policlinico S.Orsola-Malpighi
Study officials:
affiliation: Alma Mater Studiorum University of Bologna
name: Angelo Branzi, MD
role: STUDY_CHAIR
References:
citation: Lehmkuhl H, Ross H, Eisen H, Valantine H. Everolimus (certican) in heart transplantation: optimizing renal function through minimizing cyclosporine exposure. Transplant Proc. 2005 Dec;37(10):4145-9. doi: 10.1016/j.transproceed.2005.10.005.
citation: Eisen HJ, Tuzcu EM, Dorent R, Kobashigawa J, Mancini D, Valantine-von Kaeppler HA, Starling RC, Sorensen K, Hummel M, Lind JM, Abeywickrama KH, Bernhardt P; RAD B253 Study Group. Everolimus for the prevention of allograft rejection and vasculopathy in cardiac-transplant recipients. N Engl J Med. 2003 Aug 28;349(9):847-58. doi: 10.1056/NEJMoa022171.
Clinical trial NCT04112537: Dermatologic Patterns of Tuberous Sclerosis Patients and Somatic Mutation Relationship
Official title: Dermatologic Clinical Patterns Study of Tuberous Sclerosis Complex Patients Related With Their Somatic Mutation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tuberous Sclerosis Complex
Keywords: Tuberous Sclerosis Complex
MTOR associated protein
Neurocutaneous Syndromes
High-Throughput Nucleotide Sequencing
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-10-02
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients followed in Centre Hospitalier Universtaire of Montpellier for Tuberous Sclerosis

Brief summary: Tuberous Sclerosis is a rare genetic disorder that affects about one in 15,000 individuals. It is part of the phacomatoses: a germline mutation of the gene Tuberous Sclerosis Complex 1 (TSC1) or TSC2 causes a protein dysfunction, hamartin and tuberin respectively, leading to mTOR signaling pathway activation, thus tumors rise on the skin but also brain, eyes, kidneys, heart.

Thanks to the advent of sequencing techniques of the human genome, genes involved were found twenty years ago. Most commonly, these are de novo private mutations and autosomal dominant Mendelian transmission. About 15% of patients have a phenotype corresponding to the disease but no mutation is found.

Although the initial clinical description was in 1880, publications regularly describe new signs in Tuberous Sclerosis, especially for skin.

Cutaneous manifestations are important in the diagnostic criteria of the disease and often even the first sign of appeal. However, no data is available on the relationship between genotype and dermatological phenotype.

Therefore the investigator intend to review all cutaneous finding in Tuberous Sclerosis patient and try to link with their mutation.


Eligibility criteria: Inclusion criteria:

- Diagnosis of Tuberous Sclerosis Complex established of confirmed by a geneticin, with a genetic study done or processing, patients accepting to be exanimated

Exclusion criteria:

- None

Primary outcomes:
measure: Phenotype
timeFrame: 1 day
Secondary outcomes:
measure: Genotype
timeFrame: 1day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uh Montpellier
Study officials:
affiliation: University Hospitals of Montpellier
name: Didier BESSIS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03929237: When do School-aged Patients Return to School After ACL Surgery?
Official title: When do School-aged Patients Return to School After ACL Surgery?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ACL Reconstruction
Lead sponsor: St. Louis University
Sponsor class: OTHER
Collaborators: name: University of Michigan
name: University of Pittsburgh
First posted: 2019-04-26
Enrollment: 58
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: School aged patients who undergo ACL reconstruction surgery during the school year

Brief summary: We intend to survey school aged patients following ACL surgery on when they return to school. We will analyze independent variables to determine if any relationship exists that may influence the amount of time missed.

Detailed description: All patients undergoing ACL surgery who are enrolled in middle or high school will be recruited for study participation. Patients undergoing concomitant additional ligament surgery will be excluded. The only procedure will be to answer a short written questionnaire asking when they returned to school and what accommodations, if any, the school made available for them. This will occur at the patient's 2 week post-operative clinic visit. This clinic visit is a standard of care visit. Independent variables will be collected from the medical record and are all standard of care information routinely collected from this patient populations (age, sex, race, date of surgery, surgeon, sport played, grade, ACL surgery graft type, associated meniscal or chondral surgery, length of post-operative narcotic use, regional nerve block at the time of surgery, SANE score, IKDC score, brace used).

Eligibility criteria: Inclusion Criteria:

* ACL reconstruction surgery
* currently enrolled in middle or high school (grades 6-12)
* Surgery occurs during the school year
* No concomitant additional ligament surgery (ie. PCL, MCL, LCL or MPFL)

Exclusion Criteria:

* patient is home schooled or in non-traditional school setting (ie. school for special needs)
* concomitant additional ligament surgery
* surgery occurs outside of the school year or on a scheduled break from school

Primary outcomes:
measure: When return to school after surgery
timeFrame: 1-2 weeks post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Saint Louis
country: United States
facility: SSM Health Saint Louis University Hospital
state: Missouri
Study officials:
References: