louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05189574: Endo-Vac-Therapy for Post-Sleeve Gastrectomy Leaks
Official title: Endoscopic Negative Pressure Therapy for Post-sleeve Gastrectomy Proximal Staple Line Leaks
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anastomotic Leak
Keywords: staple line leak
endoscopic vacuum therapy
endoscopic negative pressure therapy
laparoscopic sleeve gastrectomy
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients older 18 years who underwent laparoscopic sleeve gastrectomy for morbid obesity and developed a proximal staple line leak within 30 days.

Brief summary: Endoscopic negative pressure therapy (ENPT) is a safe technique, showing promising results in the treatment of leakages of the upper and lower gastrointestinal tract. The purpose of this study is to determine the safety and efficacy of ENPT in the management of proximal staple line leak after sleeve gastrectomy.

Detailed description: Clinical data of 40 cases of post-SG proximal staple line leak treated with ENPT are analysed. Success is defined as resolution of the fistula with no further need for intervention (surgical or endoscopic).

Eligibility criteria: Inclusion Criteria:

* Staple line leak detected by endoscopy and/or CT within 30 days after surgery.
* Age 18 years or older.
* Written informed consent.

Exclusion Criteria:

* Declined informed consent.
* Leaks detected later than 30 days after surgery.

Primary outcomes:
measure: Number of patients with closure of staple line leak
timeFrame: up to 16 weeks
Secondary outcomes:
measure: Number of endoscopic interventions
timeFrame: up to 16 weeks
measure: Hospital stay
timeFrame: up to 24 weeks
measure: Mortality
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Recklinghausen
country: Germany
facility: Klinikum Vest GmbH
state: NRW
Study officials:
affiliation: Chief Dept. Medicine and Gastroenterology
name: Markus Reiser, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01715974: Use of GM-CSF Treatment in Recurrent Implantation Failure
Official title: Administration of GM-CSF in Women With Recurrent Implantation Failure in IVF Cycles and Egg Donation Cycles
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Women With Recurrent Implantation Failure in IVF
Keywords: GM-CSF, IVF failure,pregnancy
Lead sponsor: Centre for Endocrinology and Reproductive Medicine, Italy
Sponsor class: NETWORK
First posted: 2012-10-29
Enrollment: 140
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether in Assisted Reproductive Technologies the treatment with GM-CSF, a growth factor working on stem cells, may improve the pregnancy rate and pregnancy outcome in patients experiencing recurrent implantation failure in IVF cycles.

Detailed description: The GM-CSF is a cytokine promoting leukocyte growth, but also trophoblast development. In this randomized sudy investigators will test this cytokine as a treatment for recurrent implantation failure after IVF, at leat three failed previous IVF attempts.

The study will be conducted in 100 women with recurrent implantation failure of egg donation cycles. The inclusion criteria will be, at least three previous failed Egg Donation attempts where at least 4 good blastocysts were transferred, women less than 50 years old, absence of systemic diseases. These women will undergo egg donation cycle and they will randomly divided in two groups: one (50 women) will be treated with subcutaneous GM-CSF 60 micrograms/day from the day of transfer to the day of β-hCG test, and if it will be positive the treatment will be continued for other 40 days; the group of control will be treated with subcutaneous saline solution infusion in the same way of the study group. Primary outcomes will be considered: pregnancy rate and live birth rate, the of β-hCG levels at 14/21/28 and 35 days after embryo transfer.

Eligibility criteria: Inclusion Criteria:

* women 50 years old or less with three or more previous egg donation cycles failed,
* with a total of at least 4 blastocysts replaced in uterus

Exclusion Criteria:

* chromosomal defects in the patients,
* metabolic diseases (diabetes etc.)
* genetic diseases (thalassemia, cystic fibrosis, etc.)

Primary outcomes:
measure: pregnancy outcome
timeFrame: 12 months
Secondary outcomes:
measure: implantation rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Cerm-Hungaria
Study officials:
affiliation: Centre for Endocrinology and Reproductive Medicine, Italy
name: Marco Sbracia, MD
role: STUDY_CHAIR
References:
citation: Scarpellini F, Sbracia M. Use of granulocyte colony-stimulating factor for the treatment of unexplained recurrent miscarriage: a randomised controlled trial. Hum Reprod. 2009 Nov;24(11):2703-8. doi: 10.1093/humrep/dep240. Epub 2009 Jul 17.
Clinical trial NCT07006974: SMCs With LVH Compared to HCM
Official title: Patients With Left Ventricular Hypertrophy in Syndromic and Metabolic Cardiomyopathy Compared to Hypertrophic Cardiomyopathy: an Age-sex Matched Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Syndromic and Metabolic Cardiomyopathy
Hypertrophic Cardiomyopathy (HCM)
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2025-06-05
Enrollment: 165
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We identified patients with SMCs by screening the electronic database. Gene testing and muscle biopsy were used to confirm the diagnosis of SMCs. (Part two) Patients with HCMs were included as the controls of SMCs who had LVH and available CMR data in our study. The diagnose of HCM was according to the 2024 ESC Guidelines of HCM but without evidence of SMCs. Controls were matched 1:2 to each case based on sex, age (matched within ± 5 years), and admission year (matched within ± 12 months).

Brief summary: The goal of this cohort study is to investigate the clinical characteristics of SMCs and to explore the difference in cardiovascular outcomes in comparison to age-, sex-, and admission year-matched HCM patients. The main question it aims to answer is:

* Do patients with SMCs have higher rates of cardiac outcomes?
* What risk factors do SMCs patients experience a poor prognosis?


Eligibility criteria: Inclusion Criteria:

* patients who were diagnosed SMCs or HCM. Gene testing and muscle biopsy were used to confirm the diagnosis of SMCs. The diagnose of HCM was according to the 2024 ESC Guidelines of HCM but without evidence of SMCs.
* complete baseline data
* accessible follow-up data

Exclusion Criteria:

* incomplete baseine data

Primary outcomes:
measure: primary outcome
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital, Chinese Academy of Medical Sciences
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Liang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01622374: Effects of "Music for the Mind" on Pre-operative Anxiety in Dentistry
Official title: a Randomized Controlled Clinical Trial on the Effects of "Music for the Mind" on Pre-operative Anxiety in Dentistry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Dental Anxiety
Keywords: Music
dental anxiety
"music for the mind"
mozart
iranian traditional music
Lead sponsor: Azad University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-06-19
Enrollment: 120
Sex: ALL
Minimum age (years): 17
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To examine the pre-operative effect of music for the mind compared to some other styles of music in patients undergoing dental procedures.

Detailed description: 120 patients were sequentially assigned to four groups of 30 subjects. the music groups received Music for the mind, Iranian traditional music and Mozart music through headphone for ten minutes prior to dental procedures, and the control group received silence through headphone. anxiety score and pulse rate and blood pressure were measured before and after receiving music

Eligibility criteria: Inclusion Criteria:

* need for dental treatments

Exclusion Criteria:

* usage of anxiety drugs
* usage of psychoactive drugs
* emergency cases

Primary outcomes:
measure: STAI Inventory
timeFrame: 5 minutes
Secondary outcomes:
measure: Heart rate
timeFrame: 30 seconds
measure: Systolic blood pressure
timeFrame: 30 seconds
measure: Diastolic blood pressure
timeFrame: 30 seconds
Other outcomes:
Locations:
Study officials:
affiliation: Azad university of medical science
name: Aminpasha Samadian, DDS
role: STUDY_CHAIR
References:
Clinical trial NCT05394974: Joint Consultation Between a Neurologist and a Clinical Psychologist
Official title: Evaluation of a Joint Consultation Between a Neurologist and a Clinical Psychologist, Dedicated to Neurodegenerative and/or Neurogenetic Disorders
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neurodegenerative Disorders
Keywords: Joint neurologist
psychologist consultation
neurodegenerative and/or neurogenetic disease
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-05-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patient with a neurodegenerative and/or neurogenetic disease

Brief summary: Joint consultations appeared a few years ago in routine medical practice, but they are still not widely used and rarely evaluated.

The primary purpose of the study is to evaluate the impact for the patient of the presence of a clinical psychologist during the joint consultation.

The secondary purpose is to evaluate the impact for the patient and for the neurologist of the presence of a clinical psychologist during the joint consultation


Eligibility criteria: Inclusion Criteria:

* patient with a neurodegenerative and/or neurogenetic disease
* adult patient

Exclusion Criteria:

* dementia
* age \<18 years

Primary outcomes:
measure: Patient satisfaction after the consultation assessed by 3 questions on a Likert scale
timeFrame: After consultation et 1 to 3 months later
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Neurologie - CHU de Strasbourg - France
Study officials:
affiliation: Service de Neurologie - CHU de Strasbourg - France
name: Mathieu ANHEIM, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02086474: Daily Activity and Gait Analysis After Viscosupplement Injection Among Hip Osteoarthritis Patients
Official title: Daily Activity Quantification and Gait Pattern Analysis Before and After Intra-articular Injection of Viscosupplement Among Hip Osteoarthritis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hip Osteoarthritis
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2014-03-13
Enrollment: 38
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to assess the changes in daily physical activity and gait pattern, following a viscosupplement injection among a population who is suffering from hip osteoarthritis. A kinetic and kinematic gait analysis, an Actigraph activity monitor, a functional Timed-Stair-Test and two questionnaires (Medical Outcome Study Short-Form36 (MOS-SF36), Hip disability and Osteoarthritis Outcome Score (HOOS)) about how the pathology affects the quality of life, will be use.


Eligibility criteria: Inclusion Criteria:

* From 45 years old to 65 years old
* Clinically symptomatic moderate or severe hip osteoarthritis (Tönnis Grade II to III)
* Capacity to keep steady upright position and walking during 15 minutes
* Body mass index \< 40kg/m2

Exclusion Criteria:

* Bilateral hip osteoarthritis
* No broken hip or leg during the last 12 months
* Bone necrosis
* Rheumatoid arthritis, articular chondrocalcinosis, metabolic bone disease, psoriasis, gout, active infection
* Per os corticosteroid treatment
* Corticosteroid injection \< 3 months
* Viscosupplement injection \< 6 months
* Hypersensitivity to hyaluronic acid products
* Planed surgery during study duration
* Physical or mental disability to fill in questionnaires and/or to participate to follow-up

Primary outcomes:
measure: Change in hip flexion-extension range of motion
timeFrame: Change from Baseline at 6 months
measure: Change in daily physical activity
timeFrame: Change from Baseline at 6 months
Secondary outcomes:
measure: Change in hip pain
timeFrame: change from Baseline at 6 months
measure: Change in quality of life
timeFrame: Change from Baseline at 6 months
measure: Change in walking cadence
timeFrame: Change from Baseline at 6 months
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Pavillon de l'Éducation Physique et des Sports - Université Laval
Study officials:
affiliation: Laval University
name: Antoine Cantin-Warren, B.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Laval University
name: Étienne L. Belzile, MD
role: STUDY_DIRECTOR
affiliation: Laval University
name: Philippe Corbeil, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02518074: Hearing and Vestibular Interactions in the Collection of Own Body and Sense of Self
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: volunteers
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2015-08-07
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators objective is twofold. Investigators propose to study how the vestibular and auditory information interact in the construction of coherence between the staff and extrapersonal space.

Furthermore, investigators want to investigate whether, even in the absence of gravity, the auditory spatial information allocentric provide a framework for spatial reference.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers (men or women)
* Aged between 18-65 years
* Affiliates to a social security system or, for non-residents in France, holder of a European Health Insurance Card European (EHIC European Health Insurance Card)
* Who are willing to take part in the study,
* Who gave written informed consent,
* Declared fit after a similar visit to a medical aeronautical medical fitness for the non-professional cabin crew in civil aviation. There will be no other aptitude tests for the selection of subjects.

Exclusion Criteria:

* People who took part in a biomedical research protocol for which the exclusion period is complete,
* People with psychotic disorders and / or depression,
* People receiving psychotropic medication,
* People with alcohol dependence or illicit substances,
* People with visual acuity less than 8 / 10ths corrected by lenses or glasses,
* People with a significant decrease in hearing,
* pregnant women.

Primary outcomes:
measure: Responses to the questionnaire "Botvinick Cohen" on the sensations of the body out experiments
timeFrame: baseline
measure: Answers on the location of auditory stimuli
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Caen CEDEX
country: France
facility: Umr Ucbn/Inserm U1075 Comete
state: Basse-Normandie
Study officials:
References:
Clinical trial NCT03494374: The Effect of Orthosis and Exercise in Pes Planus
Official title: The Effect of Orthosis and Exercise in Pes Planus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pes Planus
Keywords: pes planus
UCBL
exercise
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-04-11
Enrollment: 200
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Annual evaluation after applying UCBL and exercise treatment. Cohort study.
Primary purpose: TREATMENT

Brief summary: There is no definite evidence for the conservative treatment of pes planus. We want to verify the combination efficacy of orthosis and toe walking exercise for the treatment of pes planus.

Detailed description: Observation cohort study

We prescribe UCBL orthosis and teach toe walking exercise. And we will check standing foot radiography (AP/Lateral) annually. And we will compare the changes of talometatarsal angle and calcaneal pitch angle.

Eligibility criteria: Inclusion Criteria:

* Clinically diagnosed with pes planus
* Calcaneal pitch angle \< 15 degree

Exclusion Criteria:

* peripheral neuropathy
* infection
* rheumatoid arthritis
* operation history

Primary outcomes:
measure: TM angle
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: CP angle
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul national university bundang hospital
state: Bundang-gu
Study officials:
References:
Clinical trial NCT06741774: Efficacy and Safety of Trabecular Meshwork Microstent Drainage System ( MicroCOGO )
Official title: Efficacy and Safety of Trabecular Meshwork Microstent Drainage System in Reducing Intraocular Pressure in Adult Patients with Mild to Moderate Open-angle Glaucoma Combined with Cataract: a Prospective, Multicenter, Randomized, Open Label, Parallel Controlled, Superiority Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Open-angle Glaucoma
Cataract
Keywords: cataract
IOP reduction
open-angle glaucoma
trabecular meshwork
micro stent
Lead sponsor: Healthguard Biomed
Sponsor class: INDUSTRY
First posted: 2024-12-19
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is a prospective, multicenter, randomized, open label, parallel controlled, superiority clinical trial that evaluate efficacy and safety of Trabecular Meshwork Microstent Drainage System in Reducing Intraocular Pressure in Adult Patients With Mild to Moderate Open-angle Glaucoma Combined With Cataract.

Detailed description: The trial is a prospective, multicenter, randomized, open label, parallel controlled, superiority study. Eligible subjects will be randomly assigned to either test group or control group for treatment. The trial is divided into four research stages, with each subject expected to participate for maximum 14 months. The entire research phase includes:

Screening visit (V1, -60\~-1 day). Baseline visit (V2). Randomization and surgery (V3): The subjects will be randomly assigned in 2:1 ratio to either test group (phacoemulsification with implantation of IOL combined with implantation of trabecular meshwork microstent drainage system) or control group (phacoemulsification with implantation of IOL only).

Follow-up visits (V4 \~ V10): different time points after surgery.

Eligibility criteria: Inclusion Criteria:

* Male of female, age 18 years or older
* Mild to moderate open-angle glaucoma
* Cataract
* Average of IOP is less than or equal to 24mmHg with 1-3 drugs in the screening period
* All 3 diurnal IOPs after drug-eluting are greater than 21mmHg and less than or equal to 35mmHg, average of diurnal IOPs is at least 3.0mmHg higher than the pre drug-eluting IOP
* Cup to disc ratio (C/D) less than or equal to 0.8, or VFI greater than 75%
* Gonioscope shows that anterior chamber angle is open

Exclusion Criteria:

* Traumatic, uveitic, neovascular, angle-closure glaucoma or glaucoma associated with vascular disorders
* Active corneal inflammation or edema
* Retinal disorders not associated with glaucoma

Primary outcomes:
measure: Percentage of subjects with reduction of IOP greater than or equal to 20% compared to baseline in 12th month after surgery
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Suzhou
country: China
facility: Healthguard Biomed
state: Jiangsu
Study officials:
affiliation: EENT hospital of Fudan University
name: Xinghuai Sun, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06915974: Comparison Between Interleukin 6 and Procalcitonin in Detecting Sepsis and Incidence of Mortality in Burn ICU Patients
Official title: Comparison Between Interleukin 6 and Procalcitonin in Detecting Sepsis and Incidence of Mortality in Burn ICU Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Burns
Sepsis
Septic Shock
Death
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-04-08
Enrollment: 70
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The investigators will compare the efficacy of Interleukin-6 (IL-6) as a better indicator than procalcitonin in burn patients with sepsis or septic shock regarding success of treatment and early ICU discharge.

Detailed description: Interleukin 6 and procalcitonin will be sampled for all patients on days 1, 3, 7, and 10.

Treatment plan will be initiated to all patients according to the burn ICU protocol.

According to the lab results, interleukin 6 and procalcitonin will guide the investigators to take decisions regarding clinical improvement and ICU stay.

Eligibility criteria: Inclusion Criteria:

* Patients with acute burn admitted to burn ICU within 24 hours from the burn incidence.
* patients with burn percentage of 25% to 50% of total body surface area
* patients with second to third degree burns
* ASA 1 and ASA 2 patients

Exclusion Criteria:

* Burn percentage more than 50% or less than 25% of total body surface area
* Having autoimmune diseases
* Cancer patients
* ASA 3 and ASA 4 patients

Primary outcomes:
measure: Occurrence of sepsis and septic shock
timeFrame: From day 1 to day 10 in burn ICU
Secondary outcomes:
measure: Length of ICU stay
timeFrame: One month after ICU admission
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: Anaesthesia, intensive care, and pain management resident Ain Shams University
name: Ahmed H Elsayed, M.B.B.CH
role: PRINCIPAL_INVESTIGATOR
References: