louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06953180: Epigenetics and NCD Prevention in Kazakhstan: Personalized Approaches and Biological Age Prediction
Official title: Epigenetics and Prevention of Non-communicable Diseases in Kazakhstan: a Personalized Approach and Biological Age Prediction (2024-2026)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Diseases (CVD)
Type 2 Diabetes
Chronic Respiratory Diseases
Obesity (Disorder)
Chronic Kidney Diseases
Keywords: DNA methylation
precision medicine
preventive medicine
artificial intelligence
biomedical modeling
Lead sponsor: Asfendiyarov Kazakh National Medical University
Sponsor class: OTHER
First posted: 2025-05-01
Enrollment: 6720
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consists of 6,720 adult volunteers aged 18 to 69 years, residing across 17 regions of Kazakhstan. Participants are stratified by age and gender to ensure balanced representation within the following age groups:

* 18-29 years
* 30-44 years
* 45-59 years
* 60-69 years Each age group includes an equal proportion of men and women, ensuring gender balance. The selection follows a multistage cluster sampling design, incorporating various socioeconomic backgrounds and health statuses to enhance the generalizability of findings.

Brief summary: This study aims to enhance personalized and preventive care for non-communicable diseases (NCDs) in Kazakhstan by examining epigenetic factors, predicting biological age and reproductive function using machine learning, and developing health improvement recommendations.


Eligibility criteria: Inclusion Criteria:

* Adults aged 18 to 69 years.
* Residents of 17 regions of Kazakhstan.
* Willingness to participate and provide informed consent.

Exclusion Criteria:

* Age less than 18 years old or over 69 years old.
* Failure to provide informed consent or incomplete participation in data collection procedures.

Primary outcomes:
measure: Accuracy of Machine Learning Model for Predicting Biological Age
timeFrame: Within 10 months from start of data collection
measure: Accuracy of Reproductive Function Prediction Model
timeFrame: Within 10 months from start of data collection
Secondary outcomes:
Other outcomes:
Locations:
city: Almaty
country: Kazakhstan
facility: Asfendiyarov Kazakh National Medical University
Study officials:
References:
Clinical trial NCT03915080: Optimizing the Use of Prophylaxis in Patients With Severe Haemophilia A
Official title: Optimizing the Use of Prophylaxis in Patients With Severe Haemophilia A Using PK Measurement (myPKFiT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hemophilia A
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 14
Sex: MALE
Minimum age (years): 1
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: MyPKFiT is a web-based application recently developed by Baxalta for the use in patients treated with Advate. MyPkFit has its basis in Bayesian forecasting, which allows estimation of individual PK parameters by a sparse sampling schedule, where only 2-3 samples are taken between 4 and 48 hours post infusion. With myPKFiT, it will, therefore, be possible to define an individual PK curve for each patient based on just a few sampling points and hence, taking the bleeding phenotype and the life style into account, potentially adjust the prophylactic treatment accordingly to optimize cost-effectiveness.

Detailed description: As detailed in brief summary patients will, after accurate information verbally and written according to ethics approval, report bleeding events during previous 6 months. Blood samples are taken, FVIII analyzed (Advate patients) and the individual PK curve determined using MyPKFit. The curve will be discussed together with the patient and levels related to bleed events determined. If needed dose adjustment is done based on the curve. After a further 6 month follow-up bleeds will again be evaluated as well as factor consumption. In this way a better personalized treatment based on PK and clinical phenotype will hopefully be achieved.

Eligibility criteria: Inclusion Criteria:

* Children and adults with severe hemophilia A (FVIII:C \<1 %), being treated with Advate for more than 50 exposure days (EDs

Exclusion Criteria:

* Current evidence of inhibitor as measured by the Nijmegen-modified Bethesda assay
* Use of another investigational FVIII product in the previous month

Primary outcomes:
measure: PK measurement to individualize replacement therapy
timeFrame: 3 years
measure: PK measurement to influence FVIII consumption
timeFrame: 3 years
measure: Specific pharmacokinetic parameters to analyze
timeFrame: 3 years
Secondary outcomes:
measure: Signs of hemophilic arthropathy
timeFrame: 3 years
Other outcomes:
Locations:
city: Malmo
country: Sweden
facility: Malmö Centre for Thrombosis and Haemostasis
Study officials:
References:
Clinical trial NCT04687280: Comparison of Multiphase and Monophasic Arterial Hepatic MRI in the Detection of Arterial Enhancement of CHC Nodules
Official title: Comparison of Multiphase and Monophasic Arterial Hepatic MRI in the Detection of Arterial Enhancement of CHC Nodules in Cirrhotic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2020-12-29
Enrollment: 153
Sex: ALL
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: patient followed up for cirrhosis with discovery of a suspicious CHC nodule during imaging monitoring

Brief summary: The detection and diagnosis of hepatocellular carcinoma is a public health issue. MRI is the most sensitive examination for diagnosis and especially hypervascularization in the arterial phase.

Several studies have shown that MRI multiphase arterial sequences are superior to single phase to capture the arterial phase. The purpose of this study is to compare arterial enhancement sensibilities between multi and single phase sequences.


Eligibility criteria: Inclusion Criteria:

* patient included in CHIC study with histology of hepatocellular carcinoma

Exclusion Criteria:

* nodules already treated by chimioembolization

Primary outcomes:
measure: arterial enhancement
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03578380: Supermicrosurgery for Breast Cancer Survivors With Lymphedema.
Official title: Supermicrosurgery for Breast Cancer Survivors With Lymphedema. -Prospective Randomized Clinical and Patient-reported Outcomes.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Secondary Lymphedema
Breast Cancer
Keywords: Lymphovenous bypass
Lymphovenous anastomosis
Supermicrosurgery
Lymphangiography
MD Anderson Lymphedema Stage
Lead sponsor: Sykehuset Telemark
Sponsor class: OTHER_GOV
Collaborators: name: University of Oslo
name: Ohio State University
First posted: 2018-07-06
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomised prospective investigation of volume and quality of life results with lymphovenous anastomosis in patients with unilateral arm lymphedema after breast cancer using Indocyanine Green lymphangiography and MD Anderson Staging.

Detailed description: This is a randomized study comparing lymphovenous anastomosis versus conservative (compression) treatment for lymphoedema after breast cancer surgery - 50 patients to be included in each study arm. The primary endpoint is volume change measured by submersion and changes in arm circumference at defined levels from the wrist. Secondary endpoint is health related quality of life measured by questionnaire Short Form 36 (SF-36), Hospital Anxiety Depression Score (HADS), Fatigue Questionnaire (FQ) and a disease-specific questionnaire, Upper Limb Lymphedema score (ULL27).

Eligibility criteria: Inclusion Criteria:

* Unilateral lymphedema of the arm secondary to breast cancer treatment. Stage 1-3 operable lymphedema.

Exclusion Criteria:

* Frequent or severe cellulitis. All other lymphedema.

Primary outcomes:
measure: Volume
timeFrame: 12 months
Secondary outcomes:
measure: Health related quality of life ULL27
timeFrame: 12 months
Other outcomes:
Locations:
city: Skien
country: Norway
facility: Sykehuset Telemark
state: Telemark
Study officials:
affiliation: Sykehuset Telemark
name: Lars Johan Sandberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01903980: Epipericardial Fat Necrosis: A Misdiagnosed Condition
Official title: Epipericardial Fat Necrosis: A Misdiagnosed Condition
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epipericardial Fat Necrosis
Keywords: Epipericardial Fat Necrosis
Fat Necrosis
Chest Pain
Pericardial Necrosis
Pleuritic pain
Lead sponsor: Hospital Sirio-Libanes
Sponsor class: OTHER
First posted: 2013-07-19
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from the emergency department of SIrio-Libanes Hospital who performed a chest CT due to any reason

Brief summary: Epipericardial fat necrosis is a benign and self-limited condition that mainly curses with acute pleuritic chest pain and therefore must be an important differential diagnosis for patients in emergency department (ED). The knowledge of characteristics symptoms and correct management may avoid misdiagnosis or mistakes with other severe conditions like pulmonary embolism, pericarditis or acute coronary disease.

Despite the importance of this entity, only fewer than 40 cases have been reported since 1957, when the condition was first described.

We have seen a couple of similar cases in our institution during a short period of time, and we suspect that these numbers doesn't mean the real prevalence of epipericardial fat necrosis, so maybe this condition could be underdiagnosed. Instead, there isn't a study that tried to estimate an incidence of this entity.


Eligibility criteria: Inclusion Criteria:

* patients with imaging criteria of EFN (defined as a round fat attenuation lesion with peripheral stranding located in the epipericardial fat)

Exclusion Criteria:

* no exclusion criteria

Primary outcomes:
measure: Determinate the incidence of epipericardial fat necrosis
timeFrame: 18 months
Secondary outcomes:
measure: Identify misdiagnosed cases of epipericardial fat necrosis
timeFrame: 18 months
Other outcomes:
measure: Describe Clinical and Radiological data of epipericardial fat necrosis
timeFrame: 18 months
Locations:
city: Sao paulo
country: Brazil
facility: Hospital Sirio Libanes
city: Sao Paulo
country: Brazil
facility: Hospital Sirio-Libanes
Study officials:
References:
Clinical trial NCT00263380: Investigation on the Role of Corticosteroids and Beta-Agonists on Cytokine Production in COPD Patients
Official title: Experimental Study on the Role of Corticosteroids and Beta-Agonists on Cytokine Production in COPD Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COPD
Keywords: COPD
cytokines
corticosteroids
beta agonists
synergistic effect
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
First posted: 2005-12-08
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE

Brief summary: Research on the synergistic effect of corticosteroids and beta-agonists on the cytokine production in COPD patients. Blood will be obtained from healthy volunteers and COPD patients and blood monocytes will be stimulated to produce cytokines with or without the prementioned drugs.


Eligibility criteria: Inclusion Criteria:

* clinical COPD
* smoking
* age \> 40 years

Exclusion Criteria:

* age \< 40 years
* use of antibiotics, corticosteroids or beta-agonists

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nieuwegein
country: Netherlands
facility: St Antonius Hospital
state: Utrecht
city: Nieuwegein
country: Netherlands
facility: St Antonius Hospital
state: Utrecht
Study officials:
affiliation: St. Antonius Hospital
name: Robert Ten Broeke, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06149780: Fractionated 1927-nm Non Ablative Thulium Laser in Treating Post Inflammatory Hyperpigmentation
Official title: Efficacy and Safety of the Fractionated 1927-nm Non Ablative Thulium Laser in Treating Post Inflammatory Hyperpigmentation in Skin Phototypes IV-VI
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2023-11-29
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To study the effect of fractionated 1927-nm non ablative thulium laser in reduction of post inflammatory hyperpigmentation (PIH) using a validated and reproducible model for studying PIH.

* Determine if there is aa reduction in PIH in patients treated with three (3) monthly sessions of fractionated 1927-nm non ablative thulium laser
* Determine if there is efficacy of post-procedure clobetasol propionate 0.05% ointment in the management of PIH
* Determine the histological and molecular changes that occur with laser and laser plus topical steroid treatment compared to untreated skin

Detailed description: The design of the study consists of a total of six visits including one initial screening visit within 107-127 days depending on the scheduling of your screening and subsequent visits. Assessments such as visual examination, photography, Investigatory Global Assessment (IGA) of pigmentation and erythema; Colorimetry; and Diffuse Reflectance Spectroscopy of the intended treatment area will be conducted at Visits 1-5. Optional biopsies will be taken at various time points.

Eligibility criteria: Inclusion Criteria:

* Patient age 18 and older
* Patient with skin phototypes IV-VI
* Patient able to understand requirements of the study and risks involved
* Patient able to sign a consent form
* Patient to have discontinued all oral medications used to treat pigmentary abnormalities and all topical medications, except for sunscreen, used to treat pigmentary abnormalities on the buttocks one month prior to treatment

Exclusion Criteria:

* A patient who has skin dyspigmentation, birth marks, tattoos, or other skin findings at baseline on either buttock that may obscure study results
* A patient who is lactating, pregnant, or planning to become pregnant

Primary outcomes:
measure: Degree of Pigmentation in all 5 subjects
timeFrame: Visit 1 (Day 0) through Visit 5 (Day 112 ±5)
Secondary outcomes:
measure: Immunohistochemical changes in pigmentation in all 5 subjects
timeFrame: Visit 2 (Day 28±5) and Visit 5 (Day 112 ±5)
measure: Immunohistochemical changes in inflammation in all 5 subjects
timeFrame: Visit 2 (Day 28±5) and Visit 5 (Day 112 ±5)
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Medical Center
state: Michigan
Study officials:
References:
Clinical trial NCT02719080: The Relationship Between Cerebral State and Emotion in Anesthesiologist and Surgeon
Official title: Department of Anesthesiology, Ruijin Hospital, Shanghai JiaoTong University School of Medicine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burnout, Professional
Keywords: anaesthetists, surgeons, stress, burnout
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2016-03-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: anesthesiologist and surgeon in Ruijin hospital

Brief summary: This study was designed to observe the cerebral state obtained via wavelet analysis (HXD-I,Beijing Easymonitor Technology Co.Ltd, China) and evaluate the emotion in various states in anesthesiologist and surgeon. And we also explore the association between the characteristic of cerebral state and the emotion.

Detailed description: A total of 20 anesthesiologist (A group) and 20 surgeon(S group) in Ruijin hospital were enrolled for this study. Except had a medical history of mental illness or emotional disorder and pregnant woman. A group and S group completed emotional self-perceived questionnaire and then observe the characteristic of cerebral state via cerebral state monitor. They also completed anonymous questionnaire, including Maslach Burnout Inventory-General Survey(MBI-GS), Self-reporting Inventory-90(SCI-90), Burnout Measure(BM).

Eligibility criteria: Inclusion Criteria:

* A total of 20 anesthesiologist (A group) and 20 surgeon(S group) in Ruijin hospital were enrolled for this study.

Exclusion Criteria:

* had a medical history of mental illness or emotional disorder and pregnant woman.

Primary outcomes:
measure: The relationship between cerebral state and emotion in doctors
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Anesthesiology, Ruijin Hospital, Shanghai JiaoTong University School of Medicine
state: Shanghai
Study officials:
affiliation: Department of Anesthesiology, Ruijin Hospital, Shanghai JiaoTong University School of Medicine,
name: Yan Luo, M.D.,Ph.D
role: STUDY_DIRECTOR
References:
citation: Holmqvist R, Jeanneau M. Burnout and psychiatric staff's feelings towards patients. Psychiatry Res. 2006 Dec 7;145(2-3):207-13. doi: 10.1016/j.psychres.2004.08.012. Epub 2006 Oct 27.
citation: Murray D, Dodds C. The effect of sleep disruption on performance of anaesthetists--a pilot study. Anaesthesia. 2003 Jun;58(6):520-5. doi: 10.1046/j.1365-2044.2003.03131.x.
citation: Mountain SA, Quon BS, Dodek P, Sharpe R, Ayas NT. The impact of housestaff fatigue on occupational and patient safety. Lung. 2007 Jul-Aug;185(4):203-9. doi: 10.1007/s00408-007-9010-5. Epub 2007 May 3.
citation: Candra H, Yuwono M, Handojoseno A, Chai R, Su S, Nguyen HT. Recognizing emotions from EEG subbands using wavelet analysis. Annu Int Conf IEEE Eng Med Biol Soc. 2015;2015:6030-3. doi: 10.1109/EMBC.2015.7319766.
Clinical trial NCT00186680: CD34 Selection of the Peripheral Blood Stem Cell Graft for Autologous Transplant
Official title: Selection of CD34+THY-1 Positive Cells From Peripheral Blood Cells Procured for Autologous Hematopoietic Support Following High Dose Treatment With BCNU, Cyclophosphamide & Cisplatin for Stage IV Breast Cancer & Limited Prior Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Breast Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 99
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluate the feasibility and safety of autologous transplantation of CD34+Thy-1+ hematopoietic stem cells afer high dose marrow ablative chemotherapy in patients with breast cancer.

Detailed description: Selection of CD34+THY-1 Positive Cells From Peripheral Blood Cells Procured for Autologous Hematopoietic Support Following High Dose Treatment with BCNU, Cyclophosphamide \& Cisplatin for Stage IV Breast Cancer \& Limited Prior Treatment

Eligibility criteria: Inclusion Criteria:- stage IV breast cancer

* primary breast cancer does not express CD34+
* adequate organ function
* no evidence of active infection Exclusion Criteria:- chemotherapy within 4 weeks
* CNS disease

Primary outcomes:
measure: Feasibility and safety
Secondary outcomes:
measure: efficiency of mobilization
measure: tumor contamination
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Ginna Laport
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05958680: ASDactive: An Integrated Theory-based Intervention to Promote Habitual Physical Activity
Official title: ASDactive: Feasibility of An Integrated Theory-based Intervention to Promote Habitual Physical Activity Behaviours in Autistic Youth
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Physical Inactivity
Sedentary Behavior
Autism
Autism Spectrum Disorder
Asperger Syndrome
Behavioral
Keywords: behavior change
physical activity
exercise
autism
aspergers
feasibility
implementation mapping
Lead sponsor: Aberystwyth University
Sponsor class: OTHER
First posted: 2023-07-24
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: ASDactive is a theory-based behaviour change intervention aimed at improving the physical activity behaviours of autistic youth. The feasibility of the intervention will be tested through interviews with participants and stakeholders. "Proof of concept" will be tested through preliminary measures of physical activity measured before and after the intervention.

Detailed description: ASDactive is has been developed with guidance from autistic people and stakeholders in autism. It is informed by motivation and behaviour change theory, specifically habit theory. The intervention aims to improve the habitual exercise behaviours of autistic youth by focusing on their strengths and interests.

The feasibility study will run for 3-months, with a further 3-month follow-up period. Participants will attend motivational sessions in person where they will self-select physical activity habits to incorporate into their daily lives. They will be taught fundamental movement skills that they can use in their own leisure time. In-person sessions will be held once per fortnight with online sessions twice weekly. Participants will be encouraged to engage with as many sessions as possible, but part of the evaluation will assess uptake and engagement.

Self-determination theory and habit theory will underpin all aspects of the intervention and autistic strong interests will be embedded in the materials used.

Eligibility criteria: Inclusion Criteria:

* Young people aged 10-24-years diagnosed with Level 1 autism or Asperger's syndrome

Exclusion Criteria:

* Physical conditions or injuries that might hinder physical activity participation

Primary outcomes:
measure: Feasibility of the intervention through its Adoption
timeFrame: 3- months
measure: Feasibility through Implementation
timeFrame: 3- months
Secondary outcomes:
measure: Self-Report Habit Index
timeFrame: 3- and 6-months as a follow-up
measure: Basic Psychological Need Satisfaction Scale
timeFrame: 3 months
measure: International Physical Activity Questionnaire- Short form
timeFrame: 3- and -6 months as a follow-up
Other outcomes:
Locations:
city: Aberystwyth
country: United Kingdom
facility: Katherine Parsons
state: Ceredigion
Study officials:
affiliation: Aberystwyth University
name: Katherine Parsons
role: PRINCIPAL_INVESTIGATOR
References: