louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06939790: Digital Cognitive-behavioral Therapy for Insomnia: a Randomized Controlled Trial
Official title: Digital Cognitive-behavioral Therapy for Insomnia: a Randomized Controlled Trial to Improve Cost-effectiveness and Treatment Outcomes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Insomnia
Keywords: Sleep
Insomnia
Cognitive-Behavioral Therapy for Insomnia
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2025-04-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study investigates whether online Cognitive-Behavioral Therapy for insomnia is as effective as the standard in-person group treatment, using clinical and sleep-related outcomes in adult patients.

Detailed description: This study aims to evaluate the effectiveness of digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) in Italian, comparing it to the traditional face-to-face group-based CBT-I. Sixty adults with chronic insomnia will be randomized to one of the two interventions, with assessments conducted pre- and post-treatment through validated questionnaires and objective sleep monitoring.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of chronic insomnia Individuals aged 18 to 75 years Signed informed consent form (ICF) prior to study participation

Exclusion Criteria:

* Diagnosis of comorbid sleep disorder (e.g. obstructive sleep apnea) Diagnosis of mental disorder in comorbidity Physical problems that may alter and dysregulate sleep Pregnancy and breastfeeding

Primary outcomes:
measure: To assess whether the benefits of dCBT-I are comparable with CBT-I treatment in standard group mode
timeFrame: Change from baseline to post-treatment (2 months)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06287190: Assessment of Self-Confidence of Dental Interns Regarding Provision of Different Pediatric Dentistry Procedures
Official title: Assessment of Self-Confidence of Dental Interns Regarding Provision of Different Pediatric Dentistry Procedures: A Before and After Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Self Confidence
Keywords: dental interns
pediatric dentistry
assessment
treatment
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-03-01
Enrollment: 85
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Dental interns who are taking their internship at the Cairo university

Brief summary: This study mainly about dental interns testing their knowledge before and after entering the pediatric rotation

Detailed description: A convenient sample will be selected from the dental interns attending the Pediatric Dentistry Department, Cairo University training period. The study will include all the dental interns submitted for training over 12 successive months.

Eligibility criteria: Inclusion Criteria:

* Dental interns who got their bachelor's degree from Egyptian governmental and private universities.
* Dental interns who passed the internship period in the pediatric dentistry department.

Exclusion Criteria:

* Dental interns who got their bachelor's degrees from abroad universities.

Primary outcomes:
measure: Self-confidence regarding treatment
timeFrame: during first month
Secondary outcomes:
measure: difficulties in dental practice through this period
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Professor in Pediatric Dentistry and Public Health Department Faculty of Dentistry, Cairo University
name: Sherine E Eldin, Prof
role: STUDY_CHAIR
References:
citation: Yiu CK, McGrath C, Bridges S, Corbet EF, Botelho MG, Dyson JE, Chan LK. Self-perceived preparedness for dental practice amongst graduates of The University of Hong Kong's integrated PBL dental curriculum. Eur J Dent Educ. 2012 Feb;16(1):e96-e105. doi: 10.1111/j.1600-0579.2011.00681.x. Epub 2011 Feb 17.
citation: Togoo R, Nasim V, Zakirulla M, Yaseen S. Knowledge and Practice of Pulp Therapy in Deciduous Teeth among General Dental Practitioners in Saudi Arabia. Ann Med Health Sci Res. 2012 Jul;2(2):119-23. doi: 10.4103/2141-9248.105657.
citation: Shelton A, Yepes JF, Vinson LA, Jones JE, Tang Q, Eckert GJ, Downey T, Maupome G. Utilization of Stainless Steel Crowns by Pediatric and General Dentists. Pediatr Dent. 2019 Mar 15;41(2):127-131.
citation: Rodd HD, Farman M, Albadri S, Mackie IC. Undergraduate experience and self-assessed confidence in paediatric dentistry: comparison of three UK dental schools. Br Dent J. 2010 Mar 13;208(5):221-5. doi: 10.1038/sj.bdj.2010.207.
citation: SWY, Wong & XQ, Wong & Vaithilingam, Rathna & Rajan, Sadna. (2015). Dental Undergraduates' Self-Assessed Confidence in Paediatric Dentistry. Annals of Dentistry. 22. 9. 10.22452/adum.vol22no2.4
Clinical trial NCT06794190: Characterization of Hepatopathy in Turner Syndrome: Analysis of Determinants
Official title: Characterization of Hepatopathy in Turner Syndrome: Analysis of Determinants in an Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Turner Syndrome
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be enrolled from the cohort of adult TS patients under longitudinal monitoring at the U.O.C. of Endocrinology and Diabetes Prevention and Care IRCCS Policlinico S. Orsola.

Brief summary: The present study is therefore aimed at investigating the prevalence of hepatic alterations (laboratory and imaging) in adult patients with TS and generating hypothesissto the possible etiopathogenetic factors most involved, as well as evaluating the correlation between biochemical and structural abnormalities.

Thus, the study could provide relevant etiopathogenetic and prognostic results on the development of hepatopathy in TS patients.

Detailed description: The study is an observational retrospective cohort type; patients with TS in longitudinal monitoring at the U.O.C. of Endocrinology and Diabetes Prevention and Care, DIMEC, of IRCCS Policlinico S. Orsola of Bologna will be enrolled. The diagnosis of TS was made for most patients by the Pediatrics unit of Policlinico S. Orsola; in rare cases it was performed in adulthood by our operating unit or at another center; in all cases, the diagnosis was made by karyotype analysis on peripheral blood.

The patients, as per clinical practice, underwent clinical evaluation with measurement of anthropometric parameters; an evaluation of the patients' medical history will be performed, paying attention to possible diagnosis of metabolic comorbidities and autoimmune diseases. Complete information regarding the history of menstrual cycles and replacement therapies used will also be collected. Finally, laboratory investigations are planned.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Turner syndrome made by karyotype analysis on peripheral blood.
* Age 18 years or older
* Written informed consent obtained

Exclusion Criteria:

* TS patients on therapy with drugs responsible for significant liver enzyme alterations (liver function alteration, LFA).

Primary outcomes:
measure: Factors associated with hepatopathy
timeFrame: Baseline
Secondary outcomes:
measure: Comparison of liver morpho-functional parameters with results obtained by fibroscan.
timeFrame: Baseline
measure: Comparison of liver morpho-functional parameters with results obtained by fibroscan.
timeFrame: Baseline
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Alessandra Gambineri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00361790: Aripiprazole and Lexapro Drug Interaction Study
Official title: Effects on Aripiprazole on the Steady-State Pharmacokinetics of Escitalopram in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy Subjects
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2006-08-09
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this clinical research study is to learn whether aripiprazole has effect on the steady-state pharmacokinetics of escitalopram in healthy subjects. The safety and tolerability of aripiprazole and escitalopram co-administration will also be studied.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female subjects, ages 18 to 45. (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study in such a manner that the risk of pregnancy in minimized.
* Body Mass Index (BMI) of 18 to 33 kg/m2 inclusive.

Exclusion Criteria:

* Subjects with a decrease in SBP of \>=20 mm Hg and increase in HR of \>=20 bpm after 2 minutes standing vs. 2 minutes supine at screening or with frank orthostatic hypotension at screening.
* Supine BP of 90/50 mm Hg or lower at screening.

Primary outcomes:
measure: Multiple dose PK parameters for Lexapro when administered alone and coadministered with aripiprazole will be derived. Cmin for aripiprazole,dehydro-aripiprazole will be measured
Secondary outcomes:
measure: Safety will be based on review of AEs, VS, ECGs, physical exam, clinical labs
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: Local Institution
state: Kansas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Boulton DW, Balch AH, Royzman K, Patel CG, Berman RM, Mallikaarjun S, Reeves RA. The pharmacokinetics of standard antidepressants with aripiprazole as adjunctive therapy: studies in healthy subjects and in patients with major depressive disorder. J Psychopharmacol. 2010 Apr;24(4):537-46. doi: 10.1177/0269881108096522. Epub 2008 Oct 2.
Clinical trial NCT01585090: Effect of Ankle Position and Pelvic Floor Muscle Force With Relaxation of Pelvic Floor Muscles Syndrome
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Pelvic Floor Muscle Syndrome
Keywords: Ankle positions
pelvic floor muscles strength
relaxation of pelvic floor muscles syndrome
doing strengthening exercises of pelvic floor muscles
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-04-25
Enrollment: 0
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Strengthening exercises of Pelvic Floor Muscles (PFM) is the first line treatment for female pelvic floor dysfunction. Actually the best position to facilitate PFM force is controversial in different studies. The aim of this study is to assess the effect of ankle positions on pelvic ﬂoor muscle force during PFM exercises.

This clinical trial study was carried out on 58 women aged 25-55 years with relaxation of pelvic floor muscles who referred to women's clinic of educational hospitals of Mashhad University of Medical Sciences in 1389. After clinical examination and confirmation of pelvic floor muscle relaxation, women were randomize divided into 3 groups, doing strengthening exercises of PFM in standing position with passive ankle dorsi ﬂexion (on wooden surface with 15 degree angle)(n=20), active ankle plantar ﬂexion with arm up (standing on toe)(n=20) and horizontal standing position (n=19) for 8 weeks. PFM exercises were instructed to women by using a pamphlet and face to face education. They were followed up every two week by telephone call and were asked to refer to women's clinic after 4 \& 8 weeks. Pelvic floor muscles strength was assessed with brink score before and after intervention. Data analyzed by using analytic-descriptive statistics.


Eligibility criteria: Inclusion Criteria:

* age 25-55
* bma 20-30
* women with relaxation of pelvic floor muscles syndrome in ph.ex and inspection

Exclusion Criteria:

* severe deformity in knee joint and ankle
* regular exercise or yoga
* severe or moderate vaginal atrophy

Primary outcomes:
measure: pelvic floor muscles force
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03743090: Influence of Extracorporeal Circulation on the Development of OSA (Obstructive Sleep Apnea)
Official title: Influence of Extracorporeal Circulation on the Development of OSA (Obstructive Sleep Apnea)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Coronary Artery Disease
Keywords: coronary artery disease
obstructive sleep apnea
Lead sponsor: Astes
Sponsor class: OTHER
First posted: 2018-11-15
Enrollment: 0
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: All of the patients scheduled for an elective CABG at the Clinique Saint-Luc of Bouge (Namur, Belgium).

Brief summary: * 1. Coronary artery bypass grafting (CABG) could be performed with or without extracorporeal circulation (ECC).
* 2. OSA (Obstructive Sleep Apnea) could be influenced by in intravenous perfusion.
* 3. ECC could influence the amount of intravenous perfusion administered to the patient.

The aim of this study was to examine the influence of ECC on the development of OSA.

Detailed description: * 1. Coronary artery bypass grafting (CABG) could be performed with or without extracorporeal circulation (ECC).
* 2. OSA (Obstructive Sleep Apnea) could be influenced by in intravenous perfusion.
* 3. ECC could influence the amount of intravenous perfusion administered to the patient.

The aim of this study was to examine the influence of ECC on the development of OSA. The AHI (Apnea Hypopnea Index) will be used to assess this potential influence.

Eligibility criteria: Inclusion Criteria:

* All of the patients scheduled for an elective CABG

Exclusion Criteria:

* Patient's refusal

Primary outcomes:
measure: Change in the AHI
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Astes
name: Eric DEFLANDRE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05706090: Effect of Neurostimulator Usage on Block Success
Official title: Effect of Neurostimulator Usage on Block Success in Costoclavicular Block: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PATIENTS WITH UPPER EXTREMITY SURGERY
Keywords: Brachial Plexus Block; Nerve Block; Ultrasonography
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2023-01-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The need of a neurostimulator for a successful nerve block was questioned in different block types after ultrasound has become standard. The aim of this clinical study was to determine the effect of neurostimulator use on block success in costoclavicular block


Eligibility criteria: Inclusion Criteria:

* Class I, II and III of American Society of Anesthesiologists (ASA) classification
* being between 18 and 80 years of age,
* body mass index (BMI) between 18 and 35 kg/m2

Exclusion Criteria:

* Patients who did not give consent,
* were above ASA III,
* pregnant,
* had a neuromuscular disease,
* bleeding diathesis,
* a local anesthetic allergy,
* an infection in the area where nerve block would be applied, and
* had previously operated from the infraclavicular fossa were not included in the study

Primary outcomes:
measure: The block success rate (ratio of successful blocks to all blocks)
timeFrame: during procedure
Secondary outcomes:
measure: Block application time
timeFrame: 30 minutes
measure: time to readiness for surgery
timeFrame: 30 minutes
measure: number of needle passes
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gazoosmanpasa Education and Research Hospital
Study officials:
References:
Clinical trial NCT05820464: Diastolic Deceleration Area in Early-onset FGR
Official title: Diastolic Deceleration Area in Severe Early-onset Growth Restriction of the Fetus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypoxia
Anemia
Lead sponsor: Orthogyn Medical Center, Bulgaria
Sponsor class: OTHER
First posted: 2023-04-19
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: No specific criteria, apart from the listed inclusion/exclusion ones

Brief summary: DDA is a new Doppler parameter aiming to assess fetal well-being in-utero. Early-onset SGR is a specific subgroup of fetuses where the clinical application of this Doppler modality could play an important role in the detection of hypoxia, anemia, and brain-sparing.


Eligibility criteria: Inclusion Criteria:

* absence of fetal abnormalities and/or genetic conditions;
* single pregnancy;
* fetal growth restriction (FGR) \< 10%, according to the INTERGROWTH 21st nomograms, appearing before 32nd week of gestation

Exclusion Criteria:

* documented fetal abnormalities and/or genetic conditions in the course of the pregnancy;
* multiple pregnancy;
* absence of fetal growth restriction (FGR) \< 10%, according to the INTERGROWTH 21st nomograms before 32nd week of gestation

Primary outcomes:
measure: Hypoxia in the newborn
timeFrame: immediately after delivery
measure: Anemia in the newborn
timeFrame: immediately after delivery
measure: Occurence of hypoxic-ischemic encephalopathy
timeFrame: first 72 hours after delivery
Secondary outcomes:
measure: Apgar score at 1st minute
timeFrame: 1 minute after delivery
measure: Apgar score at 5th minute
timeFrame: 5 minutes after delivery
measure: Apgar score at 10th minute
timeFrame: 10 minutes after delivery
measure: Admissions to a NICU
timeFrame: first 72 hours after delivery
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Orthogyn Medical and Dental Center
Study officials:
affiliation: Orthogyn Medical Center
name: Petar N Ignatov, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00975364: Folate Gene Polymorphisms and Cellular Folate Speciation Pilot Study
Official title: Pilot Study to Investigate Relationship Between Common Folate Gene Polymorphisms, Folate Status and Cellular Folate Speciation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Single Nucleotide Polymorphism
Keywords: Folate
Methylenetetrahydrofolate reductase
Speciation
Nutrient status
Bioavailability
Polymorphism, single nucleotide
Lead sponsor: Quadram Institute Bioscience
Sponsor class: OTHER
First posted: 2009-09-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adults (male and female) aged 18-65

Brief summary: This pilot study is designed to investigate differences in folate-related genes (single nucleotide polymorphisms) and their relationship to the species of folate present on red blood cells.

Detailed description: The main questions to be addressed in this pilot study are:

1. what is the type of folate in red blood cells in individuals with different methylterahydrofolate reductase (MTHFR) genotypes
2. what is the relationship between other folate metabolism-related gene single nucleotide polymorphisms and type (species) of folate found in red blood cells
3. what is the relationship between folate and other B vitamin status, genotype and folate species
4. is there a relationship between serum ferritin status and folate metabolism

Whole blood will be taken from apparently healthy male and female volunteers, aged 18-65, which will be used to determine genotype for various folate metabolism-related genes. Furthermore, the type of folate present on the red blood cells will be assessed, and folate, vitamin B12, riboflavin and serum ferritin status determined.

Eligibility criteria: Inclusion Criteria:

* Aged 18-65
* Males and females
* Body Mass Index greater than 19.5 and less than 40
* Smokers and non-smokers

Exclusion Criteria:

* Pregnancy or been pregnant in last 12 months
* Diabetes
* Parallel participation in another research project if total amount of blood from combined studies is greater than 470ml
* Participation in another research project where blood samples were taken within the past 4 months, unless total blood volume does not exceed 470ml
* Any person related to or living with a member of the study team
* Has donated or intends to donate blood within 16 weeks (prior to or after) the study

Primary outcomes:
measure: Relationship between MTHFR TT, CT and CC genotype and red cell folate species
timeFrame: July 2010
Secondary outcomes:
measure: Relationship between other folate metabolism related genes and red cell folate species
timeFrame: July 2010
measure: Relationship between folate, B12, riboflavin and ferritin status and red cell folate species
timeFrame: December 2010
Other outcomes:
Locations:
city: Norwich
country: United Kingdom
facility: Institute of Food Research
state: Norfolk
Study officials:
affiliation: Quadram Institute Bioscience
name: Paul Finglas
role: PRINCIPAL_INVESTIGATOR
References: