louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05271890: Rheumatoid Arthritis and Treatment of Periodontitis: a Randomized Clinical Trial.
Official title: Rheumatoid Arthritis and Treatment of Periodontitis: a Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Arthritis, Rheumatoid
Keywords: Periodontitis
Rheumatoid arthritis
Treatment of periodontitis
Lead sponsor: University of Pisa
Sponsor class: OTHER
First posted: 2022-03-09
Enrollment: 30
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: Periodontitis is an infectious disease defined by bacteria-mediated inflammation of the supporting tissues of the teeth that if left untreated may ultimately lead to the destruction of the attachment apparatus, culminating in tooth loss. Rheumatoid arthritis is a chronic destructive inflammatory disease characterized by autoantibodies and the accumulation and persistence of an inflammatory infiltrate in the synovial membrane that leads to synovitis and the destruction of the joint architecture. The objective of this study was to evaluate the possible beneficial additional value of non-surgical periodontal therapy on systemic markers of inflammation and clinical and serological parameters of rheumatoid arthritis.


Eligibility criteria: Inclusion Criteria:

* Subjects affected by rheumatoid arthritis with a stable therapeutic regimen for at least 3 months preceding the study participation
* Subjects with at least 15 teeth
* Subjects affected by severe generalized periodontitis that had undergone no periodontal treatment in the 6 months preceding the study participation

Exclusion Criteria:

* Age younger than 18 years
* Pregnancy or breastfeeding
* Edentulism
* Diagnosis of other autoimmune pathologies, liver disease, diabetes, early/juvenile arthritis or syndromes associated with RA

Primary outcomes:
measure: Disease Activity Score 28 (DAS-28)
timeFrame: 90 days
Secondary outcomes:
measure: Erythrocyte Sedimentation Rate (ESR)
timeFrame: 90 days
measure: C-Reactive Protein (CRP)
timeFrame: 90 days
measure: Interleuchin-6 concentration (IL-6)
timeFrame: 90 days
measure: Oral Health Related Quality of Life (OHRQoL)
timeFrame: 90 days
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: University of Pisa
Study officials:
References:
Clinical trial NCT03683290: Modulation Contrast Microscopy Imaging for Oocyte Quality Assessment
Official title: Efficiency of Modulation Contrast Microscopy Image Analysis as a Predictive Tool for Human Oocyte Quality
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oocyte Competence
Keywords: Oocyte
Embryo
Development
Pregnancy
Competence
Lead sponsor: Center for Reproductive an Genetic Health
Sponsor class: INDUSTRY
Collaborators: name: University College, London
First posted: 2018-09-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Registered patients at The Centre for Reproductive and Genetic Health

Brief summary: The present study aims to describe novel non-invasive parameters related to the competence of female reproductive cells (oocytes). In a fertility unit, human reproductive cells and embryos are subjected to different imaging technologies. Images can easily be obtained without disturbing the microenvironment during different standard procedures. Turning images into quantifiable data might provide a further understanding on oocyte behavior and performance in the laboratory.


Eligibility criteria: Inclusion Criteria:

* Intracytoplasmic sperm injection
* Embryo culture with subsequent fresh embryo transfer

Exclusion Criteria:

- Conventional IVF

Primary outcomes:
measure: Implantation
timeFrame: 6 weeks gestation
Secondary outcomes:
measure: Live Birth
timeFrame: 40 weeks gestation
measure: Fertilisation
timeFrame: 17 ± 1 hours post insemination
measure: Embryo quality clevage
timeFrame: 68 ± 1 hours post insemination
measure: Embryo quality Blastocyst
timeFrame: 116 ±2 hours post insemination
measure: Euploidy
timeFrame: 2-3 weeks post insemination
measure: Nuclear maturity
timeFrame: 36-41 post hCG
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Centre for Reproductive and Genetics Health
Study officials:
affiliation: Institute for Women's Health (UCL)
name: Sioban SenGupta
role: STUDY_CHAIR
References:
Clinical trial NCT05591690: Use of MiniMed 780G System in Children and Adolescents
Official title: Use of MiniMed 780G System in Children and Adolescents, a French Real Life Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Keywords: Advanced hybrid closed loop
pediatrics
real-world
time in range
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2022-10-24
Enrollment: 32
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetic minors treated with closed-loop insulin pumps

Brief summary: Hybrid closed-loop technology have shown that it improves glycemic control parameters, but the investigators do not have sufficient data at more than 6 months of follow-up, allowing us to describe the effectiveness of these systems in the long term.

All MiniMed 780G system users from November 2020 to March 2022 were included (n=32) For every time points, there was a significant difference in Time In Range between the pre-AHCL and post-AHCL. Noted difference were +14.5% and, +10.8% at respectively 3 months and 1 year. No more hypoglycemia were identified.

This "real-life" analysis shows that the algorithm is effective in improvement of metabolic control for T1 diabetic children and adolescents, at one year of follow-up.

However, an effect of breathlessness is observed which underlined the need for a solid therapeutic education program.


Eligibility criteria: Inclusion criteria:

All children with type 1 diabetes in whom a Medtronic G780 closed-loop pump was placed between November 2020 and March 2022 in our center were included.

Exclusion criteria:

Participant opposition

Primary outcomes:
measure: Glycated hemoglobin
timeFrame: 1 year
measure: Time spent in range Level with glucose levels within the norm
timeFrame: 1 year
measure: Time spent with glucose levels below range
timeFrame: 1 year
measure: Time spent with glucose levels above range
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Fabienne Dalla Vale, PH
role: STUDY_DIRECTOR
References:
Clinical trial NCT04864990: Dyspnea and Idiopathic Pulmonary Fibrosis
Official title: Dyspnea in Idiopathic Pulmonary Fibrosis (IPF): Multidimensional Assessment and Correlations With Lung Function
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Fibrosis
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Santelys Association
First posted: 2021-04-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 50 patients with a diagnosis of idiopathic pulmonary fibrosis (IPF) and reporting dyspnea

Brief summary: Longitudinal prospective exploratory study on the evolution of dyspnea, in its sensory and affective dimensions, in patients followed for idiopathic pulmonary fibrosis (IPF), between inclusion and a 6-month evaluation

Detailed description: Dyspnea is a multidimensional experience involving a sensory component and an affective component. To better understand this symptom in IPF, this study will describe the different component of dyspnea and their evolution between inclusion and a 6-month evaluation in IPF patients.

There is no strong correlation between the intensity of dyspnea and respiratory function impairments. Innovative techniques demonstrated abnormalities in ventilation variability and pulmonary compliance in patients with interstitial lung disease. These abnormalities could be more relevant to explain dyspnea. The objective of this work is also to assess the link between the different dimensions of dyspnea and respiratory functional parameters, ventilation variability and ventilatory mechanics measured by impulse oscillometry technique.

Eligibility criteria: Inclusion Criteria:

* diagnosis of IPF according to ATS/ERS guidelines
* dyspnea at rest (VAS ≥ 1) or on exertion (mMRC ≥ 1)

Exclusion Criteria:

* diffuse interstitial lung disease other than IPF
* other significant chronic pathology that may cause dyspnea: chronic obstructive pulmonary disease, asthma, heart failure, anemia, obesity (non-exhaustive list), except for pulmonary hypertension

Primary outcomes:
measure: Evolution of the sensory and affective components of dyspnea
timeFrame: baseline, 6 months
Secondary outcomes:
measure: Evolution of dyspnea during activities of daily living
timeFrame: baseline, 6 months
measure: Association between the sensory and affective components of dyspnea and quality of life, anxiety symptoms, lung volumes, gas exchanges, ventilation variability, pulmonary compliance, pulmonary hypertension
timeFrame: baseline, 6 months
measure: Assess the prevalence of refractory dyspnea
timeFrame: baseline, 6 months
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Calmette Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: Cécile Chenivesse, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06640790: Effect of Endodontic Case Difficulty on Endodontic Mishaps: Clinical Study
Official title: Effect of Endodontic Case Difficulty on Endodontic Mishaps: Clinical Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Effect of Endodontic Case Difficulty on Endodontic Mishaps
Root Canal Treatment
Keywords: Case Difficulty, Endodontic Mishaps, Postgraduate Dental Education, Root Canal Treatment
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who refer to our clinic for routine endodontic treatment

Brief summary: The aim of this study investigate the influence of endodontic case difficulty, as categorized by the American Association of Endodontists (AAE) assessment form (low, moderate, high), on the incidence of endodontic mishaps and treatment visit requirements in postgraduate dental students.


Eligibility criteria: Inclusion Criteria:

* Primary root canal treatment
* Retreatment

Exclusion Criteria:

* Patients who do not accept to participate to study

Primary outcomes:
measure: Case difficulty category
timeFrame: Radiographic images were taken at the final treatment appointment. Case difficulty classification of cases was performed according to AEE case difficulty form data, and all radiographs were evaluated in terms of endodontic mishaps within 24 hours.
measure: Endodontic mishaps
timeFrame: Radiographic images were taken at the final treatment appointment. Case difficulty classification of cases was performed according to AEE case difficulty form data, and all radiographs were evaluated in terms of endodontic mishaps within 24 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Kutahya
country: Turkey
facility: Kutahya Health Sciences University
city: Kütahya
country: Turkey
facility: Kutahya Health Sciences University
Study officials:
References:
Clinical trial NCT00485290: Effect of Meal on Portal and Esophagus Variceal Pressure
Official title: Effect of Meal on Portal and Esophagus Variceal Pressure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cirrhosis
Esophageal Varices
Keywords: cirrhosis, Portal Hypertension, Esophageal Varices, Meal
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2007-06-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The reason why esophagus varices suddenly rupture and start to bleed is unclear. Food intake increase the hepatic blood flow and the portal pressure, but it is yet unknown if there is also an increase in variceal pressure. The aim of this study is to evaluate the efficacy of a meal on variceal pressure with a non invasive endoscopic measurement device, and compare it with portal pressure.


Eligibility criteria: Inclusion Criteria:

* Large Esophageal varices

Exclusion Criteria:

* Treatment with beta-blocking agents
* Respiratory diseases that contradict endoscopy
* Gastric-retention
* Former gastric resection
* Resent sclerotherapy or former banding

Primary outcomes:
measure: effect of meal on variceal pressure
timeFrame: 30 minutes after the meal
Secondary outcomes:
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
Study officials:
affiliation: Hvidovre University Hospital
name: Flemming Bendtsen, MD, DMsc.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01000090: Surgical Versus Medical Treatment of Acromegaly
Official title: Surgical Versus Medical Treatment of Acromegaly: Effects on Biochemical Markers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acromegaly
Keywords: Acromegaly
Somatostatin analogues
Treatment
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2009-10-22
Enrollment: 63
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acromegalic patients followed in the outpatient clinic at Århus University Hospital, Medical Department M

Brief summary: Evaluate biochemical differences in acromegalic patients treated with surgery versus somatostatin analogues (SMS) (after surgery or alone).

Hypothesis: Treatment modality exhibit different biochemical responses in acromegaly.


Eligibility criteria: Inclusion Criteria:

* Acromegaly diagnosis
* treated with Somatostatin analogues or surgery
* in treatment control

Exclusion Criteria:

* treatment with GH-antagonist
* never treated
* not in treatment control

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Århus
country: Denmark
facility: Århus University Hospital, Medical department M
Study officials:
affiliation: Medical department M, Århus University Hospital
name: Kristine Z Rubeck, stud. med.
role: STUDY_DIRECTOR
affiliation: Medical department M, Århus University Hospital
name: Jens Otto L Jørgensen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical department M, Århus University Hospital
name: Michael Madsen, MD
role: STUDY_DIRECTOR
affiliation: Medical department M, Århus University Hospital
name: Sanne Fisker, MD
role: STUDY_DIRECTOR
affiliation: Medical department M, Århus University Hospital
name: Caroline Adreasen, MD
role: STUDY_DIRECTOR
affiliation: Medical department M, Århus University Hospital
name: Jan Frystyk, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05405790: Antibiotic Prophylaxis for TEVAR
Official title: Antibiotic Prophylaxis for Thoracic EndoVascular Aortic Repair
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Dissection
Aortic Diseases
Aortic Aneurysm, Thoracic
Coarctation of Aorta
Hematoma; Aorta
Keywords: Antibiotic prophylaxis
TEVAR
Fever
MAGIC classification
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2022-06-06
Enrollment: 457
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were diagnosed with thoracic aortic dissection, thoracic aortic aneurysm, thoracic aortic intramural hematoma, or other thoracic aortic diseases and underwent TEVAR during hospitalization

Brief summary: The infection rate of thoracic endovascular aortic repair (TEVAR) is unknown due to a lack of epidemiological data. The rate currently available comes from researches conducted decades ago, when open surgery was the standard of care. Because of the potentially fatal consequences of a stent graft infection in the thoracic aorta, the investigators tend to prescribe antibiotic prophylaxis for at least three days. In this study, the investigators are going to collect data on patients receiving TEVAR in the past five years and provide the following information: a. the infection rate (MAGIC classification), b. the rate of fever, c. the results of the lab tests, such as the WBC count and C-reaction protein. d. risk factors associated with infection and fever.


Eligibility criteria: Inclusion Criteria:

1. Diagnosed with thoracic aortic diseases
2. Received TEVAR

Exclusion Criteria:

1. Suspected infectious aortic disease, such as a mycotic aneurysm.
2. TEVAR combined with open surgery
3. Antibiotics have been used more than 24 hours before the operation
4. Combined with immune deficiency disease or using hormone or immunosuppressant；
5. The treatment is for the complications of TEVAR, such as endoleak
6. Endovascular aortic repair for abdominal aortic disease
7. History of open aortic surgery or heart surgery.
8. Revascularization of visceral arteries during the TEVAR

Primary outcomes:
measure: Infection rate after TEVAR
timeFrame: during hospitalization (up to post-operation day 14)
measure: Infection rate at one month after TEVAR
timeFrame: One month after TEVAR
measure: Infection rate at six months after TEVAR
timeFrame: Six months after TEVAR
measure: Infection rate at one year after TEVAR
timeFrame: One year after TEVAR
Secondary outcomes:
measure: Fever
timeFrame: one day, two days, three days, one month, six months, one year after TEVAR
measure: WBC count
timeFrame: one day, two days, three days after TEVAR
measure: C-reaction protein
timeFrame: one day after TEVAR
Other outcomes:
Locations:
city: Hanzhou
country: China
facility: The First Affiliated Hospital, College of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT05602090: Growth Hormone For Poor Ovarian Reserve Patients in ICSI Trials
Official title: Effect of Growth Hormone Adjuvant Therapy on ICSI Trials For Poor Ovarian Reserve Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Poor Ovarian Reserve
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2022-11-01
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Effect of Growth Hormone Adjuvant Therapy on ICSI Trials For Poor ovarian Reserve Patients

Detailed description: To study the effect of growth hormone as adjuvant treatment on the outcomes of ICSI trials in poor ovarian reserve patients.

Eligibility criteria: Inclusion Criteria:

According to Bologna criteria (((at least two )))of the following features must be present:

1. Advanced maternal age (40years).
2. A previous poor ovarian response with 3 oocytes retrieved after conventional stimulation
3. An abnormal ovarian reserve test (ORT)

   * antral follicle count (AFC)\<7 or
   * anti-Müllerian hormone (AMH)\<1.1ng/ml.

Exclusion Criteria:

1. Any known contraindications to the approved fertility drugs.
2. Any contraindications to growth hormone, pregnancy (to be ruled out and documented before GH treatment)

4- Hydrosalpinx 5- Uterine malformations or abnormal uterine cavity. 6- Basal FSH more than 17 IU. 7- Abnormal karyotyping 8- Partner with severe male factor 9- Uncontrolled endocrinopathies: DM, hyperthyroidism, hypothyroidism.

Primary outcomes:
measure: pregnancy rate
timeFrame: ICSI trial (1month)
Secondary outcomes:
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Beni-suef university
state: Beni Suef
Study officials:
affiliation: Faculty of Medicine Beni-Suef University
name: Beni-Suef University
role: STUDY_CHAIR
References:
Clinical trial NCT05442190: Topical SGX302 for Mild-to-Moderate Psoriasis
Official title: Phase 2 Study Evaluating SGX302 (Synthetic Hypericin) in the Treatment of Mild-to-Moderate Psoriasis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Psoriasis
Plaque Psoriasis
Psoriasis Vulgaris
Keywords: Hypericin
Lead sponsor: Soligenix
Sponsor class: INDUSTRY
First posted: 2022-07-01
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: This is a 2 part study. All protocol procedures, timing for schedule of events and assessments are identical for Parts A and B. In Part A, 10-15 patients will be assigned open-label SGX302 (ointment or gel). Once the tolerability and response to SGX302 has been established, Part B of the protocol will commence. In Part B, approximately 32 patients will be randomized to double-blind treatment groups at a ratio 1:1 of active drug to a placebo.
Primary purpose: TREATMENT

Brief summary: To evaluate SGX302 (topical hypericin ointment and gel) with visible light in an initial 18-week treatment course for improving lesions in patients with mild-to-moderate psoriasis.


Eligibility criteria: Inclusion Criteria:

* Have a clinical diagnosis of plaque psoriasis (psoriasis vulgaris) of at least 6-months duration that involves the body (trunk and/or limbs) that is amenable to topical treatment and opaque coverage after application.
* Have a static Investigator Global Assessment (IGA)/Psoriasis Area and Severity Index (PASI) of disease severity of mild or moderate on the body (trunk and/or limbs).
* Have lesions involving 2-30% of the body (trunk and/or limbs). For subjects with scalp psoriasis included in the treatment area, the total treatment area on body and scalp must not exceed 30%.

Exclusion Criteria:

* Use of topical anti psoriatic therapy within one week prior to the beginning of the study and willing to not use other psoriasis treatments for 4 weeks following completion of the treatment portion of the study.
* Received systemic biologic therapy to treat psoriasis within 12 weeks prior to the beginning of the study.
* Received systemic psoriasis therapy within 4 weeks prior to the beginning of the study.
* Received phototherapy (including laser) or photodynamic (light activated drug) therapy within 4 weeks prior to the beginning of the study.

Primary outcomes:
measure: Number of patients that achieve a 0 or 1 score using the 5-point Investigator's Global Assessment scale
timeFrame: 18 weeks
Secondary outcomes:
measure: Number of patients achieving a ≥75% improvement in Psoriasis Area and Severity Index
timeFrame: 18 weeks
measure: Number of patients achieving a ≥90% improvement in Psoriasis Area and Severity Index
timeFrame: 18 weeks
measure: Number of patients achieving a 100% improvement in Psoriasis Area and Severity Index
timeFrame: 18 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
Study officials:
References: