louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02923440: Creation of a French South-Eastern Database and DNA-bank of Congenital Heart Disease to Explore the Genetic Pathways
Official title: Creation of a French South-Eastern Database and DNA-bank of Congenital Heart Disease to Explore the Genetic Pathways
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Congenital Heart Defects
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-10-04
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Congenital heart defects are seen in 0,8% of life births. In France this means more than 5000 newborns per year. The south-east region of France is particularly affected as a result of a higher birth rate and consanguinity, when compared to other regions. The majority of congenital heart diseases remain unexplained. Genetic causes are indisputable but remain poorly understood. Genetic research needs the availability of a large-scale DNA collection, guided by a robust phenotypic classification. Such a DNA-bank has been created in Paris (CARREG DNA bank, created by the M3C reference centre for congenital heart diseases). Such a bank is currently unavailable in south-east France. To transport biological specimens from Marseille to Paris would be very expensive. In addition, the whole infrastructure required for correct diagnosis and classification of the congenital heart diseases, for sampling, for storage of the samples and genetic analysis, does exist in our AP-HM hospital and in our AMU research unit. For those reasons it is highly preferable to elaborate such a database and DNA-bank locally. The acronym SEA-HD (South-EAst-Heart-Diseases) would be used to name this DNA-bank


Eligibility criteria: Inclusion Criteria:

* Echocardiographic diagnosis of congenital heart defect falling within the classification Houyel and Bonnet
* Necessity of making a blood test regardless of study
* Medical care in the AP-HM Timone Hospital children, medical-surgical unit of pediatric and congenital cardiology, Marseille - These Parent Child

Exclusion Criteria:

* Pregnant women
* Patients or parent / legal guardian (if minor) in physical or mental incapacity to understand or sign the consent
* People in Emergencies
* Persons deprived of freedom
* Persons not beneficiaries of a social security scheme
* Persons in health or social institution

Primary outcomes:
measure: number of patient with Congenital Heart Defects
timeFrame: 3years
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: ASSISTANCE PUBLIQUE HÔPITAUX DE MARSEILLE
name: catherine GEINDRE
role: STUDY_DIRECTOR
References:
Clinical trial NCT01395940: A Randomized Open Label Study of KLH-2109 in Patients With Endometriosis(1)
Official title: A Multicenter, Randomized, Open Label Phase II Study of KLH-2109 in Patients With Endometriosis(1)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endometriosis
Keywords: Gonadotropin-Releasing Hormone (GnRH) antagonist
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-07-18
Enrollment: 20
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of KLH-2109 in patients with endometriosis.


Eligibility criteria: Inclusion Criteria:

* Female patients with endometriosis

Exclusion Criteria:

* Patients with clinically significant hepatic, renal, or cardiovascular dysfunction

Primary outcomes:
measure: The severity score of the pelvic pain
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo and Other Japanese City
country: Japan
facility: Japan
Study officials:
affiliation: Kissei Pharmaceutical Co., Ltd.
name: Katsumi Hontani
role: STUDY_DIRECTOR
References:
Clinical trial NCT00261040: Minimally Invasive Surgery of the Hip Versus Standard Approach
Official title: Minimally Invasive Surgery of the Hip: A Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Arthroplasty
Osteoarthritis
Keywords: Osteoarthritis
Total Hip Arthroplasty
Minimally Invasive Surgery
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Zimmer Biomet
First posted: 2005-12-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine if there is a difference in terms of length of hospital stay and post-operative outcomes between patients whose total hip replacement surgery is performed with a minimally invasive versus standard surgical approach.

Detailed description: Traditional techniques for total hip arthroplasty (THA) require complete visualization of the acetabulum and proximal femur since anatomic landmarks are crucial for correct orientation of the prosthetic components. All surgeons are taught that a wide surgical exposure is one of the most important factors in performing successful THA. Traditionally, it was impossible to achieve accurate fixation and orientation of the components without complete visualization of bony landmarks. These extensile exposures facilitate accurate implant alignment, but at the expense of more extensive soft tissue dissection. Little clinical research has been undertaken to relate the surgical approach to postoperative complications or patient function. Furthermore, despite the good overall results of THA, the recovery time to improved function can be lengthy. Blood loss is expected to be directly related to the extent of the surgical exposure and to influence patients outcomes. Based upon these facts, an important principle of arthroplasty surgery is to minimize the amount of soft tissue trauma while being able to achieve the surgical goal of reconstructing the arthritic hip joint. By definition, minimally invasive surgical (MIS) procedures result in less soft tissue disruption, which in turn should reduce pain, expedite healing, decrease recovery time, and potentially reduce the number of associated complications.

Eligibility criteria: Inclusion Criteria:

BMI \> 30 kg/m2 No prior ipsilateral hip surgery Osteoarthritis

Exclusion Criteria:

Patients with grossly distorted bony anatomy whereby standard implants are contraindicated; i.e. congenital dysplasia of the hip, proximal femoral abnormalities, etc

Rheumatoid Arthritis

Primary outcomes:
measure: Clinical Outcomes
timeFrame: 24 months
Secondary outcomes:
measure: Harris Hip Score
timeFrame: 24 months
measure: Change in Timed Get-up-and-Go Test (TUG)
timeFrame: 3 months
measure: Operating Time Duration
timeFrame: Day of Surgery
measure: Estimated Blood Loss
timeFrame: Day of surgery
Other outcomes:
Locations:
Study officials:
affiliation: OHRI
name: Paul Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05509140: Clinical Analysis of Juvenile Dermatomyositis Patients
Official title: Clinical Analysis of 12 Cases of Juvenile Dermatomyositis Treated With Methylprednisolone Repeated Intermittent Pulse Combined With Mycophenolate Mofetil
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Juvenile Dermatomyositis
Keywords: intravenous methylprednisolone repeated intermittent pulse
mycophenolate mofetil
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2022-08-19
Enrollment: 12
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who meet the inclusion and exclusion criteria

Brief summary: This study aimed to investigate the clinical effectivity of intravenous methylprednisolone repeated intermittent pulse combined with mycophenolate mofetil in the treatment of newly diagnosed juvenile dermatomyositis.

Detailed description: Reviewed the clinical data of 12 juvenile dermatomyositis patients, from January 2014 to January 2017, hospitalized and treated with intravenous methylprednisolone repeated intermittent pulse combined with mycophenolate mofetil

Eligibility criteria: Inclusion Criteria:

1. patients with age of JDM onset \<16 years
2. newly treated cases
3. no contraindications to corticosteroids
4. provide signed informed consent form
5. regular follow-up for more than 30 months.

Exclusion Criteria:

1. patients with serious complications of heart, liver and kidney
2. patients with a history of contraindications and/or allergies to GC
3. patients who underwent treatment before admission
4. patients who failed to regularly follow-up
5. patients with positive anti-melanoma differentiation-associated gene 5 (MDA5) antibodies

Primary outcomes:
measure: Change from baseline in CMAS score
timeFrame: 1, 3, 6, 12, 18, 24 and 36 months
Secondary outcomes:
measure: Changes from baseline of the patient's height percentile in the same age and sex crowd.
timeFrame: 1, 3, 6, 12, 18, 24 and 36months
measure: Changes from baseline of the patient's weight percentile in the same age and sex crowd.
timeFrame: 1, 3, 6, 12, 18, 24 and 36months
measure: intraocular pressure
timeFrame: 1, 3, 6, 12, 18, 24 and 36months
measure: triglycerides
timeFrame: 1, 3, 6, 12, 18, 24 and 36months
Other outcomes:
Locations:
Study officials:
affiliation: The First Hospital of Jilin University
name: Sirui Yang, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004801: Phase I/II Study of Monoclonal Factor IX Concentrate for Factor IX Deficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hemophilia B
Factor IX Deficiency
Keywords: hematologic disorders
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: University of North Carolina
First posted: 2000-02-25
Enrollment: 3
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

Assess the safety and long-term efficacy of monoclonal factor IX concentrate in patients with factor IX deficiency.

Detailed description: PROTOCOL OUTLINE:

Patients receive monoclonal factor IX replacement therapy as inpatients. Patients with a satisfactory response receive further therapy as needed for bleeding for up to 36 months at home.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

Patients with factor IX deficiency.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of North Carolina
name: Gilbert C. White
role: STUDY_CHAIR
References:
Clinical trial NCT01808001: Simulation Team Training and Critical Event Checklist Use for Optimizing the Management of Critical Perioperative Events in an Ambulatory Surgical Facility
Official title: Critical Event Checklist Use for Management of Critical Events in Ambulatory Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Simulation Team Training in Ambulatory Surgery
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
First posted: 2013-03-08
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Health care professionals

Brief summary: This study will determine if operating room teams manage a simulated event more effectively using a critical event checklist. Performance will be evaluated using a score based on how closely they follow a protocol for critical event management; a 'team' score and a score based on clinical recovery of the simulated patient. All teams will receive a debriefing session after managing 4 scenarios. Teams will return and manage 4 further scenarios after a period of 6-9 months.

The investigators will be testing the hypothesis that both clinical and behavioral team performance will improve with the use of Critical Event Checklists. The investigators also expect that health professional (participant) could attain knowledge related to the importance of non-technical skills and the use of CECs in the management of critical events.


Eligibility criteria: Inclusion Criteria:

* Eligibility Criteria for Participation:

  1. RN in active practice
  2. Anesthesiologist in active practice
  3. Surgeon in active practice

     Exclusion Criteria:

Primary outcomes:
measure: professional health care teams' behavioural performance is measured using a previously validated non-technical skills (NTS) tool (TEAM)and key process checklists
timeFrame: 1.5 years
Secondary outcomes:
measure: questionnaires in participants' opinion of the educational intervention, willingness to participate in annual simulated scenario training, effect on subsequent clinical performance and opinion re: best sites for CEC placement
timeFrame: 1.5 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Women's College Hospital
state: Ontario
Study officials:
References:
Clinical trial NCT04948801: SOF/VEL±RBV: Efficacy and Safety in GT 3 and 6 HCV Patients
Official title: SOF/VEL±RBV: Real-World Efficacy and Safety in GT 3 and 6 HCV Patients in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis C
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2021-07-02
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The groups or cohorts will be selected from people who was diagnosed with hepatitis c at the hospital.

Brief summary: 150 GT3 or GT6 CHC patients with or without compensated cirrhosis will be recruited from five centers in China including G3a 50, G3b 50, G6 50 respectively. GT3a and GT6 CHC with or without compensated patients will be administered one pill of Epclusa each day for 12 weeks, and GT3b patients will be administered Epclusa each plus Ribavirin for 12 weeks.

Detailed description: This is a Prospective, observational, multi-center, real-world study to investigate real world effectiveness and safety of SOF/VEL±RBV in Chinese patients infected by HCV GT-3 and 6. 150 GT3 or GT6 CHC patients with or without compensated cirrhosis will be recruited from five centers in China including G3a 50, G3b 50, G6 50 respectively. GT3a and GT6 CHC with or without compensated cirrhosis will be administered one pill of Epclusa each day for 12 weeks, and GT3b patients will be administered one pill of Epclusa each plus Ribavirin for 12 weeks.Demographic, clinical, adverse event and virological data were be collected throughout treatment and post-treatment follow-up.

Eligibility criteria: Inclusion Criteria:

* HCV RNA ≥ 15 IU/Ml at Screening
* HCV genotype 3a ,3b and 6
* Hepatitis C without decompensated cirrhosis of the liver

Exclusion Criteria:

* Patients failed to previous NS5A-containing DAAs therapy
* Decompensated cirrhosis
* HCC
* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).

Primary outcomes:
measure: SVR12
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Deparment of Infectious Diseases, the Second Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT02755467: Clinical Evaluation of the Treatment of Spider Angioma
Official title: A Clinical Evaluation of the Treatment of Spider Angioma Using a Dual Wavelength Laser Emitting 532 nm Laser Energy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spider Angioma
Lead sponsor: Cutera Inc.
Sponsor class: INDUSTRY
First posted: 2016-04-29
Enrollment: 22
Sex: ALL
Minimum age (years): 5
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and effectiveness of the laser treatment for the treatment of spider angiomas.

Detailed description: The purpose of this study is to evaluate the safety and efficacy of the 532 nm KTP laser within the Cutera Excel V system for the treatment of spider angiomas.

Eligibility criteria: Inclusion Criteria:

1. Males or females, 5 to 65 years of age (inclusive).
2. Fitzpatrick Skin Types I-IV
3. Subject must be able to read, understand and sign the Informed Consent Form.
4. If subject is a minor (\<18 years old in Illinois), Assent must be obtained from the subject and a Parental Consent Form must be signed by the parents or legal guardian.
5. Subject must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
6. Willing to have limited sun exposure for the duration of the study, including the follow-up period.
7. Willingness to have digital photographs taken of their spider angioma(s) and agree to use of photographs for presentation, educational or marketing purposes
8. Agree not to undergo any other procedure for the treatment of spider angioma during the study.

Exclusion Criteria:

1. Pregnant.
2. History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
3. Having a known anti-coagulative condition or taking anticoagulation medications, including aspirin.
4. History of seizure disorders due to light.
5. Systemic use of isotretinoin (Accutane®) within 6 months of study participation.
6. Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
7. Participation in a study of another device or drug within 3 months prior to enrollment or during the study.
8. In the opinion of the investigator, any physical or mental condition which might make it unsafe for the subject to participate in this study or which requires systemic therapy that could interfere with this research study.

Primary outcomes:
measure: Physician's Global Assessment Scale for Improvement of Spider Angioma
timeFrame: Four weeks post laser treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Naperville
country: United States
facility: DuPage Medical Group
state: Illinois
Study officials:
affiliation: DuPage Medical Group
name: Kelly Stankiewicz, MD FAAD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06164067: The Role of Cervical Consistency Index and Uterocervical Angles in Medical Termination
Official title: The Role of Cervical Consistency Index and Uterocervical Angles in Predicting Second Trimester Medical Termination
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Second Trimester Abortion
Uterocervical Angle
Cervical Consistency Index
Keywords: medical termination
uterocervical angle
abortion
second trimester
Lead sponsor: Sanliurfa Mehmet Akif Inan Education and Research Hospital
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 136
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: PROBABILITY_SAMPLE
Study population: white people same demographics no socio- cultural difference

Brief summary: The main aim of the investigator study is the success of predictivity cervical consistency index (CCI), anterior uterocervical angle (aUCA) and posterior uterocervical angle (pUCA) in second trimester terminations.

Detailed description: This prospective clinical study includes 136 pregnant women with a diagnosis of in utero ex fetus who were hospitalized for medical termination in the gynecology service of Health Sciences University Bursa High Specialization Training and Research Hospital Gynecology and Obstetrics Clinic as a single center. The participants were divided into 2 groups as those whose treatment was completed in the first 24 hours (who were completely aborted and removed the fetal material and its attachments ) and those who aborted within 24-48 hours when additional cycles were needed. Furthermore who applied to additional treatment methods were recorded (cervical balloon, hysterotomy ) during these periods. In all pregnant women; characteristic features, abortion times, doses of misoprostol used, anterior- posterior uterocervical angle, cervical length, cervical consistency indexes and gestational weeks were saved.

Eligibility criteria: Inclusion Criteria:

* women who had a termination indication in the second trimester and had abortion or abortion in our hospital
* women who have had a miscarriage or abortion with a normal vaginal route or hysterotomy

Exclusion Criteria:

* multiple pregnancies
* pregnant women with misoprostol-related allergies
* scar pregnancies or heterotopic pregnancies
* patients with a history of previous conization or cervical surgery,
* patients with placental invasion anomaly

Primary outcomes:
measure: success of predictivity cervical consistency index, anterior uterocervical angle and posterior uterocervical angle
timeFrame: 6 months
Secondary outcomes:
measure: compare the measured ultrasonographic values
timeFrame: 6 months
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Nefise Nazlı YENIGUL
Study officials:
References:
Clinical trial NCT05651867: EPIONE Guided Lung Evaluation
Official title: Prospective Clinical Investigation on the Evaluation of Performance and Safety of the EPIONE Assisted CT-guided Percutaneous Procedures in the Lungs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: percutaneous
CT-guided
Ablation
Biopsy
Abcess Drainage
Fiducial placement
Lung
Robotics
Lead sponsor: Quantum Surgical
Sponsor class: INDUSTRY
First posted: 2022-12-15
Enrollment: 25
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: Interventional clinical study to obtain performance and safety data of the EPIONE® device when used for percutaneous procedures in the lung.

Detailed description: The objectives are:

* to evaluate the technical success of the device
* to evaluate performance parameters (accuracy measures, adjustements, post-intervention ablation success, local tumor recurrence)
* to evaluate the safety of the device

  25 subjectsare planned and will undergo an intervention, during which the clinician will use the EPIONE device

Eligibility criteria: Inclusion Criteria:

* Patient ≥18 years old,
* Patient for whom a percutaneous CT-guided intervention in lung has been prescribed and agreed by a multidisciplinary team of radiologists, surgeons and clinicians,
* Patient with a signed informed consent form.
* Patient covered by a social security system.

Exclusion Criteria:

* Patient unable to undergo general anesthesia,
* Pregnant or nursing female, confirmed before the intervention
* Patient already participating in another clinical study

Primary outcomes:
measure: Feasibility of the device
timeFrame: an average of 7 months
Secondary outcomes:
measure: Needle placement accuracy
timeFrame: an average of 7 months
measure: Number and grade of needle adjustments
timeFrame: an average of 7 months
measure: Post-intervention ablation success
timeFrame: through study completion, an average of 1 year
measure: Long-term efficacy of ablation
timeFrame: through study completion, an average of 1 year
measure: Adverse event
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Gustave Roussy Institut
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Baptiste BONNET, MD
role: PRINCIPAL_INVESTIGATOR
References: