louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00989378: Individual Differences in Diabetes Risk: Role of Slow WaveSleep
Official title: Ancillary Studies to Major Ongoing NIDDK Clinical Research Studies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep
Diabetes
Keywords: sleep
insulin
diabetes
determine association between sleep characteristics and diabetes risk
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2009-10-05
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 20
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: normal healthy men and women

Brief summary: This study will examine the relationship between the amount of slow wave sleep (deep sleep) and the ability of the body to bring the blood sugar level to a normal range after receiving glucose.


Eligibility criteria: Inclusion Criteria:

* healthy volunteers age 18-20 with a BMI \< 27kg/m2 in women and \< 28 kg/m2 in men with normal findings on clinical examination, routine laboratory tests and EKG
* only subjects who have regular life styles (no shift work, no travel across time zone during the previous 4 weeks)
* habitual bedtimes between 7.0-8.5 hours/night
* do not take medications will be recruited

Exclusion Criteria:

* women taking hormonal contraceptive therapy and pregnant women will be excluded
* individuals with a history of psychiatric, endocrine, cardiac or sleep disorders will be excluded
* other exclusion criteria will be: tobacco use, habitual alcohol use of more than 1 drink per day, excessive caffeine intake of more than 300 mg per day

Primary outcomes:
measure: Amount of Slow Wave Activity determines insulin sensitivity.
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Eve Van Cauter, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04022278: Cross-sectional Study on a Given Day Within the Paris Saint-Joseph Hospital Group
Official title: Evaluation of the Population Likely to Benefit From Sleep Exploration: Cross-sectional Study on a Given Day Within the Paris Saint-Joseph Hospital Group
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Sleep Apnea
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2019-07-17
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: NON_PROBABILITY_SAMPLE
Study population: Any patient hospitalized on the day of the survey in any of the services of the cardio-neurovascular division of the Paris Saint-Joseph Hospital Group, whatever the history of comorbidities, the reason for hospitalization

Brief summary: Sleep apnea syndrome has an estimated incidence of 2 to 4% in the adult population and more so in men and with aging. It is an independent risk factor for mortality. Cardiovascular pathologies, diabetes, and stroke are known comorbidities with a high rate of association. There is no recommendation to screen these patients although the interest is assumed and sleep apnea syndrome is largely underdiagnosed. Interrogation and clinical examination guide but they are neither sensitive nor specific. The use of scores improves screening. In the general population, the Berlin score has a high false negative rate. The STOP-BANG score is sensitive but with a poor positive predictive value. Combined, these scores can be used to detect Sleep Apnea Syndrome. The interest of a management was especially shown for the very symptomatic syndromes because it is a pledge of observance of the treatment, itself necessary for the effectiveness in the prevention of the cardiovascular complications.


Eligibility criteria: Inclusion Criteria:

* Patient whose age is\> 18 years
* Any patient hospitalized on the day of the survey in any of the services of the cardio-neurovascular division of the Paris Saint-Joseph Hospital Group, whatever the history of comorbidities, the reason for hospitalization
* Francophone patient

Exclusion Criteria:

* Patient under tutorship or curatorship
* Patient deprived of liberty
* Patient at the end of life
* Patient opposing his participation in the research protocol

Primary outcomes:
measure: Patients with severe co-morbidities whose clinical presentation suggests sleep apnea syndrome sufficiently severe and symptomatic to benefit from sleep exploration
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: Claire P GAZANIOL, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01012778: Implementation of Climb Up Program for Children With Attention Deficit Hyperactivity Disorder (ADHD) and Dyslexia in a School in India
Official title: Implementation of a Multimodal Program Including Yoga and Meditation as Well as Play Therapy for ADHD and Dyslexia in a Public School in Najibabad, India
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Attention Deficit Hyperactivity Disorder
Dyslexia
Keywords: Performance impairment
Yoga
Meditation
Peer mediated
Lead sponsor: Climb Up Kids
Sponsor class: OTHER
First posted: 2009-11-13
Enrollment: 76
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A multimodal intervention was rolled out at a large public school in Najibabad, Uttar Pradesh (UP). The program identified elementary school children with ADHD and Dyslexia using standard screening of all children who had performance impairment in at least one domain of the Vanderbilt questionnaire. The program consisted of play therapy, physical exercise, yoga and meditation. The program was established by High school volunteers from The US and UK over 6 weeks. Once implemented during the morning of school, high school volunteers from the school were trained to continue the program. Vanderbilt questionnaires were completed at intervals to allow follow up.


Eligibility criteria: Inclusion Criteria:

* All children between 6 and 11 years attending MDKV public school in Najibabad, UP who had assessment performed for ADHD or Dyslexia

Exclusion Criteria:

* Children who were not enrolled by the parents

Primary outcomes:
measure: Changes in ADHD scores using Vanderbilt
timeFrame: Intervals of 6 months
Secondary outcomes:
measure: Improvement in self-care as assessed by improvement in dental Decayed, Missing and Filled Teeth (DMFT) scores
timeFrame: 6 to 12 month interval changes
measure: Improvement in speed and accuracy of reading samples for children with Dyslexia
timeFrame: 6 to 12 monthly
Other outcomes:
Locations:
city: Najibabad
country: India
facility: MDKV Schools
state: UP
Study officials:
affiliation: Arnold Palmer Hospital for Children
name: Devendra Mehta, MBBS MSC MRCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00903578: Impact of Fibroblast Growth Factor 23 (FGF-23) and Serum Phosphate on Allograft Function and Mortality in Kidney Allograft Recipients
Official title: Impact of FGF-23 and Serum Phosphate on Allograft Function and Mortality in Kidney Allograft Recipients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Kidney Transplantation
Keywords: FGF-23
vitamin D
phosphate
allograft dysfunction
mortality
Lead sponsor: Ramathibodi Hospital
Sponsor class: OTHER
First posted: 2009-05-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Kidney transplant recipients

Brief summary: The present study will examine whether serum FGF-23 and serum phosphate at baseline of kidney transplant recipients can predict progression of allograft dysfunction at 3 years and all-cause mortality at 5 years.


Eligibility criteria: Inclusion Criteria:

* at least one year post-transplantation
* no more than 10% increase in serum creatinine for the past 3 months

Exclusion Criteria:

* refuse to participate in the study
* any acute illnesses

Primary outcomes:
measure: Progression of allograft dysfunction and all-cause Mortality
timeFrame: 3 and 5 years
Secondary outcomes:
measure: Relationship of FGF-23 and 25-OH-D, 1-25-OH-D, PTH, calcium, phosphate, urine phosphate and eGFR
timeFrame: 1 year
Other outcomes:
Locations:
city: Phayathai
country: Thailand
facility: Ramathibodi Hospital, Mahidol University
state: Bangkok
Study officials:
affiliation: Ramathibodi Hospital, Mahidol University
name: Sinee Disthabanchong, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06363578: Different Doses of Dexmedetomidine in External Oblique Intercostal Plane Block in Splenectomy
Official title: Comparing the Analgesic Effects of Different Doses of Dexmedetomidine as an Adjuvant in External Oblique Intercostal Plane Block in Splenectomy: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dexmedetomidine
External Oblique Intercostal Plane Block
Splenectomy
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-04-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to compare the analgesic effects of different doses of dexmedetomidine as an adjuvant in external oblique intercostal plane block (EOIPB) in splenectomy.

Detailed description: External oblique intercostal plane block (EOIPB) was reported by Elsharkawy et al . It is a novel block, which has been described as an important modification of the fascial plane blocks that can consistently involve the upper lateral abdominal walls. In comparison to quadratus lumborum block (QLB) and erector spinae plane block (ESPB) , EOIPB has the benefit of being performed when the patient is supine. It also has an advantage over serratus intercostal plane block (SIPB) in that it produces greater analgesia throughout the midline of the abdomen.

Dexmedetomidine is used for sedation in patients admitted to the intensive care unit (ICU). Dexmedetomidine is a selective alpha 2- adrenoceptor agonist possessing sedative, anxiolytic, and analgesic properties without the development of respiratory depression . Several studies have shown that dexmedetomidine has an anesthetic sparing effect, which has led to its use as a general adjuvant for prolonging peripheral nerve block duration.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* Both sexes.
* American Society of Anesthesiology (ASA) physical status II-III.
* Scheduled for splenectomy.

Exclusion Criteria:

* Body mass index (BMI) ≥35 kg/m2
* History of abdominal surgery.
* Infection at the injection site.
* Drug abuse.
* Allergic reaction to local anesthetics.
* Coagulation abnormalities.
* Pregnancy.
* Severe cardiovascular problems.
* Diabetic neuropathy.

Primary outcomes:
measure: Time to the 1st rescue analgesia
timeFrame: 48 hour Postoperatively
Secondary outcomes:
measure: Intraoperative fentanyl consumption
timeFrame: Intraoperatively
measure: Total morphine consumption
timeFrame: 48 hour postoperatively
measure: Degree of pain
timeFrame: 48 hours postoperatively
measure: Heart rate
timeFrame: Till the end of surgery
measure: Mean arterial pressure
timeFrame: Till the end of surgery
measure: The incidence of adverse events
timeFrame: 48 hour postoperatively
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References:
Clinical trial NCT04420078: Brugada Ablation of VF Substrate Ongoing MultiCenter Registry
Official title: Brugada Ablation of VF Substrate Ongoing MultiCenter Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brugada Syndrome
Lead sponsor: Pacific Rim Electrophysiology Research Institute
Sponsor class: OTHER
Collaborators: name: University Hospital, Bordeaux
name: University of Tsukuba
name: University of London
name: University of Amsterdam
name: Ogaki Municipal Hospital
name: Indiana University
name: Taipei Veterans General Hospital, Taiwan
name: Zhejiang University
First posted: 2020-06-09
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have positive Brugada ECG pattern and have underwent catheter ablation of VF substrates prior to enrollment.

Brief summary: Current treatment of high-risk Brugada Syndrome (BrS) patients (pts) with recurrent VF is limited. Catheter ablation (CA) has been performed for BrS but a large study with long-term outcomes of CA in BrS ablation are lacking.

Detailed description: Brugada syndrome (BrS) patients who undergo BRS substrate ablations from tertiary centers for catheter ablations of complex arrhythmias from three continents - Asia, Europe and North America - are registered in a common database. The investigators exclude patients who were lost to follow up in the outpatient clinic.

Eligibility criteria: Inclusion Criteria:

* Symptomatic Brugada Syndrome patients who had undergone catheter ablation of the arrhythmogenic substrates.

Exclusion Criteria:

* Patients who will not commit to regular follow up.

Primary outcomes:
measure: Death
timeFrame: 3 years
measure: ICD Therapy for VT/VF
timeFrame: 3 years
Secondary outcomes:
measure: Inappropriate ICD Therapy
timeFrame: 3 years
measure: Normalization of Brugada ECG pattern
timeFrame: 3 years
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Pacific Rim Electrophysiology Research Institute, Chulalongkorn University
Study officials:
References:
Clinical trial NCT03455478: Shanghai Eye Study for Adults
Official title: Shanghai Eye Study for Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Blindness,Visual Impairment, Refractive Error, Cataract, High Myopia, Aging
Lead sponsor: Shanghai Eye Disease Prevention and Treatment Center
Sponsor class: OTHER
Collaborators: name: Brien Holden Vision
First posted: 2018-03-06
Enrollment: 1000000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SCREENING

Brief summary: Blindness and visual impairment severely impact the visual health and life quality of people, particularly the 2.566 million senior citizens aged at 65 and above in Shanghai. The main reason is uncorrected refractive error, of which, 62.1% can be solved through refractive correction. For this reason, the uncorrected refractive errors of 154,000 senior citizens in Shanghai can be taken as a priority among the public health issues to prevent blindness. Now, with the aim to reduce the prevalence rate of blindness and visual impairment, it is planned to establish a public health service mechanism in terms of refractive error screening and correction for the elderly by relying on Shanghai's three-level (city-district-community) eye diseases prevention network, using proper refractive correction technology, and moving related services forward to communities in order to screen, identity, and correct blindness and visual impairment caused by refractive errors as early as possible.


Eligibility criteria: Inclusion Criteria:

* shanghai residents aged ≥18 years old

Exclusion Criteria:

* cognitive and/or mobility disorders; non-shanghai residents; younger than 18 years old.

Primary outcomes:
measure: best-corrected visual acuity (BCVA)
timeFrame: 5 years
measure: cataract surgery rate
timeFrame: 5 years
measure: cataract surgery coverage rate
timeFrame: 5 years
measure: visual impairment caused by high myopia
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Eye Disease Prevention & Treatment Center
state: Shanghai
Study officials:
References:
Clinical trial NCT02089178: Comparison of the Effect of Total Intravenous Anesthesia and Inhalation Anesthesia on Cancer Cell Cytotoxicity, Micrometastasis and Recurrence of Tumor in Patients Undergoing Breast Tumor Resection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Keywords: total intravenous anesthesia, inhalation anesthesia, cancer cell cytotoxicity, breast tumor
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-03-17
Enrollment: 48
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
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 compare the effect of total intravenous anesthesia and inhalation anesthesia on cancer cell cytotoxicity, micrometastasis and recurrence of tumor in patients undergoing breast tumor resection. Using propofol-remifentanil in total intravenous anesthesia group and sevoflurane -remifentanil in inhalation anesthesia group.


Eligibility criteria: Inclusion Criteria:

* patient between 20 and 65 of age with ASA physical status Ⅰ-Ⅲ
* breast cancer patients with no sign of local invasion (adjacent organs) and distant metastasis revealed by imaging studies
* surgery performed by the same surgical team

Exclusion Criteria:

* ASA physical status Ⅳ
* hepatic and renal impairment
* diabetes or other endocrine disorders
* body mass index \> 35 kg/m2
* immune disorders or immunosuppressive therapy
* steroid treatment in the last 6 months
* inflammation

Primary outcomes:
measure: number of NK cell
timeFrame: at 24 hour after surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
Clinical trial NCT06910878: Urinary Tract Infections Caused by Extended-spectrum Beta-lactamase-producing Enterobacteria
Official title: Urinary Tract Infections Caused by Extended-spectrum Beta-lactamase-producing Enterobacteria: Management by General Practitioners in Bas-Rhin.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Urinary Tract Infections
Keywords: Urinary Tract Infections
Beta-Lactamase
Enterobacteriaceae
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult (≥18 years old) with an Enterobacteriaceae urinary tract infection treated in a primary care setting for urinary tract infection between June 1, 2024 and December 31, 2024

Brief summary: Urinary tract infections (UTIs) are one of the most common pathologies encountered in general practice. However, with increasing bacterial resistance to antibiotics, their treatment is becoming increasingly complex. Extended-spectrum beta-lactamase-producing Enterobacteriaceae (ESBL-E) pose a particular challenge due to their increased resistance to many commonly used antibiotics. The aim of this thesis is to study the management of such infections by general practitioners in Bas-Rhin and to suggest possible avenues for improvement.


Eligibility criteria: Inclusion Criteria:

* Adult (≥18 years old)
* Subject with an Enterobacteriaceae urinary tract infection treated in a primary care setting for urinary tract infection between June 1, 2024 and December 31, 2024
* Subject not objecting, after being informed, to the reuse of their data for the purposes of this research.
* The subject's primary care physician agreeing to participate in the study

Exclusion Criteria:

* Subject and/or their primary care physician having expressed their opposition to participating in the study
* Subject under legal protection
* Subject under guardianship or curatorship

Primary outcomes:
measure: Prescription rates of appropriate antibiotics for the treatment of ESBL-E UTIs
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de maladies infectieuses et tropicales - Hôpitaux Universitaires de Strasbourg
Study officials:
References:
Clinical trial NCT02554578: Impact of mHealth in Heart Transplant Management
Official title: Effectiveness Improving Medication Adherence in Heart Transplant Management
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Transplant
Keywords: mHealth
multidisciplinary team
immunosuppressive medication
pharmaceutical care
adherence
heart transplant
recipients
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2015-09-18
Enrollment: 158
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: The purpose of this study is to improve medication adherence, engagement and support to heart transplant patients through implementation of a new clinical care programme conducted by the clinical pharmacy service in cooperation with the heart transplant team and supported by mobile health (mHealth).

Detailed description: Non-adherence to immunosuppressive medications generally ranges from 20-40% and is associated with acute rejection episodes and graft loss. Many solid organ transplant centres have incorporated transplant pharmacists into the multidisciplinary transplant clinical team focused on improving outcomes and safety associated with drug therapy.

Mobile technology has undergone rapid advances in the past several years and the use of mHealth in pharmaceutical care is changing pharmacy practice. Several published reports have identified general mobile applications suited for improve adherence. But evidence supporting the benefits in clinical practice is limited.

This study expects to analyse the potential of mHealth to improve medication adherence and heart transplant patient management in real clinical practice.

The investigators asses a new multidisciplinary follow-up programme in heart transplant recipients supported by mobile health (mHealth) with the aim to improve medication adherence, prevent drug related problems and improve patient clinical outcomes.

Eligibility criteria: Inclusion Criteria:

* Heart transplant patients ≥ 18 years of age
* Give informed consent.
* Be able to use a mobile device (smartphone).
* Sign a confidentiality agreement (interventional group).

Exclusion Criteria:

* Do not meet all the inclusion criteria.
* Non-available to receive a minimum of one-year clinical follow-up by the heart transplant unit.
* Suffer severe mental disorders, other mental pathologies or conditions that can be a barrier to use the mobile application

Primary outcomes:
measure: Medication adherence measured on validated scales and questionnaires
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.