louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06369792: PROSPECTIVE EVALUATION OF BLOOD BIOMARKERS AS AN AID TO DIAGNOSTIC AND TREATMENT IN DRUG-NAIVE PATIENTS WITH DEPRESSION
Official title: EVALUATION PROSPECTIVE DE L'AIDE AU DIAGNOSTIC ET AU TRAITEMENT PAR BIOMARQUEURS SANGUINS CHEZ DES PATIENTS DRUG-NAÏFS AMBULATOIRES SOUFFRANT DE DEPRESSION
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Depressive Disorder
Bipolar Disorder
Bipolar Depression
Lead sponsor: Les Toises - Psychiatry and Psychotherapy Center
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 200
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: The study population includes drug-naïve adult outpatients (aged 18 or over) with depression (F32-33) and/or bipolar disorder (F30-F31) who start escitalopram, fluoxetine, sertraline or quetiapine.

Brief summary: This is an observational (non-interventional) prospective study, carried out in drug-naïve outpatients who start a treatment with escitalopram, fluoxetine, sertraline or quetiapine. Five blood samples are collected (i.e. before initiating the drug, and then after 1, 2, 4 and 8 weeks of treatment). It does not affect the choice or the treatment dose. The primary objective of this study is to measure the association between the EDIT-B® editing signature and response to pharmacological treatment in drug-naïve patients. Results of this research could provide an aid to early diagnosis, optimize pharmacological treatment and guide clinical practice towards individualized treatment.


Eligibility criteria: Inclusion Criteria:

* Adult drug-naïve outpatients suffering from depression and/or bipolar disorders who start a pharmacological treatment with escitalopram, fluoxetine, sertraline or quetiapine and who gave his written informed consent to participate in the present study.

Exclusion Criteria:

* Any patient without capacity of discernment or with harmful use of psychoactive substances

Primary outcomes:
measure: psychiatric symptomatology
timeFrame: At baseline, 1,2,4,8 weeks
measure: EDIT-B profiling
timeFrame: At baseline, 1,2,4,8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Les Toises - Psychiatry and Psychotherapy Center
Study officials:
References:
Clinical trial NCT03102892: Antimicrobial Photodynamic Therapy on Periodontal Treatment and Salivary Status of Type 1 Diabetes Mellitus Patients
Official title: Adjuvant Effect of Antimicrobial Photodynamic Therapy on Periodontal Treatment and Salivary Status of Type 1 Diabetes Mellitus Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Periodontal Diseases
Periodontal Pocket
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2017-04-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate adjuvant effect of antimicrobial photodynamic therapy in periodontal treatment and salivary status of type 1 diabetes patients.

Detailed description: Diabetes Mellitus is a risk factor for periodontal disease increasing its prevalence, extension and severity. Periodontal disease is considered the sixth complication of diabetes. There is a global epidemic of diabetes, including an increase of type 1 diabetes incidence in younger patients. Adjuvant treatments to scaling and root planing as antimicrobial photodynamic therapy show improved clinical outcomes. Thus, the aim of this randomized clinical trial is to evaluate adjuvant effect of antimicrobial photodynamic therapy in periodontal treatment and salivary status of type 1 diabetes patients.

Eligibility criteria: Inclusion Criteria:

* Diagnose of Type 1 diabetes mellitus
* Age between 18 to 65 years old
* Presence of at least one tooth for hemiarch
* Moderate and severe periodontal disease

Exclusion Criteria:

* Type 2 diabetes mellitus
* Total edentulism
* Smokers
* Pregnancy
* Systemic diseases as other endocrine diseases and blood diseases
* Use of drugs that alter periodontal tissue as phenytoin and cyclosporine

Primary outcomes:
measure: Periodontal disease (gingivitis and periodontitis) measured by a periodontal probe and classified according to severity
timeFrame: 6 months
measure: Salivary glucose - collection of stimulated saliva in 10 minutes and measured with a colorimetric kit
timeFrame: 6 months
Secondary outcomes:
measure: Salivary pH and buffering Capacity - collection of stimulated saliva in 10 minutes and measurement of acidity with a pHmeter
timeFrame: 6 months
measure: Capillary glycemia measured by a glucometer
timeFrame: 6 months
Other outcomes:
Locations:
city: Bauru
country: Brazil
facility: Bauru School of Dentistry
state: Sao Paulo
Study officials:
References:
citation: Al-Zahrani MS, Bamshmous SO, Alhassani AA, Al-Sherbini MM. Short-term effects of photodynamic therapy on periodontal status and glycemic control of patients with diabetes. J Periodontol. 2009 Oct;80(10):1568-73. doi: 10.1902/jop.2009.090206.
Clinical trial NCT01891292: Efficacy of Antioxidant Therapy Compared With Enalapril in Sickle Nephropathy
Official title: A Phase 2 Study of the Efficacy of Antioxidant Therapy Compared With Enalapril in Slowing the Progression of Sickle Nephropathy in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Microalbuminuria
Sickle Cell Nephropathy
Lead sponsor: The University of The West Indies
Sponsor class: OTHER
Collaborators: name: Caribbean Health Research Council
First posted: 2013-07-03
Enrollment: 30
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether enalapril or antioxidant therapy (N-Acetylcysteine) is effective in reducing microalbuminuria in children with sickle cell disease and and its progression to sickle nephropathy


Eligibility criteria: Inclusion Criteria:

* Homozygous S sickle cell disease
* Diagnosed by newborn screening
* determined to have persistent microalbuminuria
* satisfied criteria for microalbuminuria screening
* parental consent

Exclusion Criteria:

* Asymptomatic bacteriuria on screening urine cultures
* On Hydroxyurea therapy
* Pre-existing complications of SCD which would meet local criteria for HU therapy

Primary outcomes:
measure: urinary albumin excretion rate
timeFrame: 12 months
Secondary outcomes:
measure: Glomerular filtration rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Kingston
country: Jamaica
facility: Sickle Cell Unit
Study officials:
References:
citation: Sasongko TH, Nagalla S. Angiotensin-converting enzyme (ACE) inhibitors for proteinuria and microalbuminuria in people with sickle cell disease. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD009191. doi: 10.1002/14651858.CD009191.pub4.
Clinical trial NCT00070889: Brain Cell Injury in Patients With A First Episode of Psychosis
Official title: Oxidative Cell Injury: First Episode Psychotic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychoses
Keywords: Complementary Therapies
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2003-10-13
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Patients experiencing a first episode of psychosis may have brain cell damage due to a chemical process called oxidation. This study will compare patients with psychosis to healthy volunteers to determine if there are differences in their blood that reflect oxidative brain cell damage.

Detailed description: Preliminary research indicated that impaired antioxidant defense and increased lipid peroxidation is associated with brain changes during the onset of psychosis. Oxidative cell injury may contribute to poor outcomes in some patients. This study will define the extent and nature of oxidative cell injury that is associated with psychopathology at the onset of psychosis.

Participants in this study will be patients at the D. D. Eisenhower Army Medical Center who are experiencing a psychotic episode for the first time. Patients will be compared with 40 healthy volunteers (control group) matched with patients for age, gender, education, ethnic background, and occupational status. Patients and volunteers will have blood tests to determine the level of oxidative cell injury. Tests will be performed at onset of psychosis, and after 6 and 12 weeks of neuroleptic drug treatment. Medical histories and MRI scans will be used to examine the relationship of the laboratory tests to the clinical presentation.

Eligibility criteria: Inclusion Criteria

* Patients must meet clinical diagnostic criteria for psychosis
* Healthy (control) volunteers must not have any family history of mental illness

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Medical College of Georgia
state: Georgia
Study officials:
affiliation: Augusta University
name: Sahebrao P. Mahadik, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06725589: Brain Network Connectivity of Patients With Metabolic Diseases
Official title: Brain Network Connectivity of Patients With Metabolic Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolic Disease
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2024-12-10
Enrollment: 690
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent brain PET-CT examination in Sun Yat-sen Memorial Hospital from January 2018 to June 2024 and met our inclusion and exclusion criteria were included in the analysis. About 690 patients were included.

Brief summary: The global prevalence of metabolic diseases, including hypertension, type 2 T2DM mellitus (T2DM), gout and obesity, has risen over the past two decades. Brain controls human behavior and metabolism in organisms. It will be very interesting to explore whether there are similarities or relations among different metabolic diseases and how brain might be involved in the progression of different metabolic diseases.

We analyzed the PET-CT images and clinical biological markers of 112 cases of hypertension, 56 cases of T2DM, 11 cases of obesity, 14 cases of gout, and 497 cases without the above diseases. Standardized uptake value ratios (SUVRs) were extracted from different brain regions according to AAL brain atlas using Spatial-Normalization-of-Brain-PET-Images. Partial correlation analysis was used to analyze the correlation of the SUVRs of different brain regions with clinical biological markers by controlling sex, age and BMI. Brain network metabolic connectivity was analyzed using Permutation_IHEP software and visualized using BrainNet Viewer.


Eligibility criteria: Inclusion Criteria:

* Patients who underwent brain PET-CT in Sun Yat-sen Memorial Hospital from January 2018 to June 2024

Exclusion Criteria:

* Brain lesions, including patients with brain atrophy, cerebral ischemia and trauma, epilepsy, brain tumors, brain trauma, and psychiatric disorders; Patients with missing medical history or brain imaging data; Patients with tumor.

Primary outcomes:
measure: the correlation between metabolic changes in different brain regions and blood test results in patients without metabolic diseases, hypertension, T2DM, gout and obesity
timeFrame: 2024.01-2024.06
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital
Study officials:
References:
Clinical trial NCT00022789: Prevalence of Sleep-Disordered Breathing in Children
Official title: Prevalence of Sleep Disordered Breathing in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Diseases
Sleep Apnea Syndromes
Keywords: Sleep-Disordered Breathing
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2001-08-14
Enrollment: 700
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: PROBABILITY_SAMPLE
Study population: Random representative population sample of children in elementary school (K-5)

Brief summary: To investigate the prevalence and clinical significance of sleep-disordered breathing (SDB) in children.

Detailed description: BACKGROUND:

SDB in children appears to be a common condition, affecting approximately 1 to 3 percent of children. Many aspects of childhood SDB remain understudied and poorly understood, including its precise prevalence, the optimal means of identifying children who should undergo polysomnography, and the potentially major impact of this condition on health, cognitive development, and behavior.

DESIGN NARRATIVE:

The population-based, cross-sectional study of 6- to 16-year-old schoolchildren in Dauphin County, Pennsylvania is a two-part study. In the first part of the study, parents of every child enrolled in local elementary schools will complete a questionnaire that will assess general sleep, behavior, and learning problems. In the second part of the study, 1,000 children will be randomly selected based on their risk for SDB, as determined by the questionnaire. They will be evaluated in a sleep laboratory to determine the presence of SDB. A thorough pediatric ear, nose, throat, and pulmonary evaluation will be conducted; school records and behavior will also be assessed. The parents of the children will be interviewed, and information will be collected on the family history of risk factors associated with childhood SDB. This strategy will be beneficial in establishing the prevalence and clinical significance of SDB in children.

Eligibility criteria: Inclusion Criteria:

* Phase I: Sampled all children by questionnaire completed by parent or guardian in three school districts in Dauphin County, Pennsylvania
* Phase II: Recruited a representative sample of 700 to complete a more detailed analysis in the laboratory

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Pennsylvania State University Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Edward O. Bixler, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05612789: Improve Outcomes for Older Allogeneic Transplant Recipients
Official title: Intervening on Frailty to Improve Outcomes for Older Allogeneic Transplant Recipients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Allogeneic Transplantation
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2022-11-10
Enrollment: 72
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an interventional pilot study to determine whether implementation of a supervised exercise program can improve outcomes in subjects undergoing allogeneic HCT. The primary objective is to determine feasibility. Up to 60-72 evaluable subjects will be enrolled. Evaluable subjects are defined as those participating in the exercise intervention.


Eligibility criteria: Inclusion Criteria:

Cohort A (Prehab)

1. Age 60 years or older.
2. Planned allogeneic HCT in the next 1-6 months.
3. Hematological malignancy as the indication for HCT.
4. Pre-frail or frail by Fried frailty phenotype.

Cohort B (Rehab)

1. Age 60 years or older.
2. Planned allogeneic HCT or HCT within the last 30 days.
3. Hematological malignancy as the indication for HCT.

Exclusion Criteria:

Cohorts A and B

1. Comorbid disability or illness that prevents safe exercise.

Primary outcomes:
measure: Proportion of enrolled subjects who participate in the supervised exercise program
timeFrame: From 3 months prior to HCT to 100 days after HCT
measure: Median number of exercise sessions delivered pre-HCT and post-HCT.
timeFrame: From 3 months prior to HCT to 100 days after HCT
Secondary outcomes:
measure: Hospital LOS for HCT
timeFrame: From date of randomization until the date of first documented discharge from the hospital, assessed up to 100 months
measure: Rate of readmission
timeFrame: From time of discharge from initial hospital stay up through 1-2 years after HCT
measure: 6-month and 1-year overall mortality
timeFrame: From day 0 of HCT to 6 months and 1-year] 6. 1-year and 2-year OS
measure: 1-year and 2-year OS
timeFrame: From day 0 of HCT to 1-year and 2-years
measure: 1-year and 2-year PFS
timeFrame: From day 0 of HCT to 1-year and 2-years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Penn Medicine
state: Pennsylvania
Study officials:
affiliation: Penn Medicine
name: Shannon McCurdy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05926089: Acute Phase Reactant in Non-COVID-19 Bacterial Pneumonia
Official title: Acute Phase Reactant in Non-COVID-19 Community Acquired Pneumonia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonia
Acute-Phase Reaction
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All patients( 51 patients diagnosed as non-COVID19 Pneumonia) were subjected to:

1. Full historywith emphasis on:

   * Epidemiological features .
   * Risk factors (smoking, DM).
   * Clinical presentation (cough, Fever and duration of ilness).
2. Clinical examination (local chest examination).
3. Laboratory investigations: venous blood samples were taken for:• Complete blood picture, differential leucocytic count and platelets count, ESR ,CRP, d-dimer and ferritin

Brief summary: This study is a cross-sectional study, was conducted at Chest department of Kasr Al-ainy Hospital, Cairo university during the period between October 2020 and April 2021.

The aim of the work was to evaluate levels of acute phase reactants(APR) in Non-COVID-19 bacterial pneumonia, and to correlate between levels of APR and the disease severity.

Detailed description: 51 patients were included in our study, diagnosed as Non-COVID pneumonia

Inclusion criteria:

1. PCR(polymerase chain reaction) negative for COVID.
2. All patients of both sexes with pneumonia .

Exclusion criteria:

1. Non pulmonary infections.
2. Post surgery patients.
3. Renal patients.
4. hepatic patients.
5. Cardiac patients.
6. Recent pulmonary embolism.

Methodology in details:

All patients were subjected to:

1. Full history with emphasis on:

   * Epidemiological features (age, gender).
   * Risk factors (smoking, DM).
   * Clinical presentation (cough, Fever and duration of illness).
2. Clinical examination (local chest examination).
3. Laboratory investigations: venous blood samples were taken to measure APR

Eligibility criteria: Inclusion Criteria:

* COVID-19 negative bacterial pneumonia

Exclusion Criteria:

* COVID-19 positive
* other non-pulmonary infections

Primary outcomes:
measure: measurement of APR levels in non-Covid-19 pneumonia
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr alainy school of medicine
Study officials:
References:
Clinical trial NCT03366389: Serum Levels of Apelin, Chemerin and Adiponectin Adipokines in Irritable Bowel Syndrome and Healthy Subjects
Official title: Evaluation of the Serum Levels of Apelin, Chemerin and Adiponectin Adipokines in Patients With Irritable Bowel Syndrome and Healthy Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Irritable Bowel Syndrome
Lead sponsor: Lorestan University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Lorestan University of Medical Sciences
First posted: 2017-12-08
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients were recruited from the outpatient clinic at the Lorestan University of Medical Sciences, Khorramabad, Iran, by an attendant gastroenterologist.

Brief summary: In this observational case-control study investigators aimed to assess the serum levels of adipokines such as Apelin, Chemerin and adiponectin in patients with irritable bowel syndrome (IBS), and compare it with healthy controls. Furthermore, investigators evaluated the possible correlation of these adipokines with IBS-QoL, IBSSS, GI symptoms and other clinical and psychological disorders.


Eligibility criteria: Inclusion Criteria:

* Men and women between the ages of 18, and 80 years.
* IBS patients diagnosed according to the Rome III Diagnostic Criteria for Functional GI Disorders.

Exclusion Criteria:

* Any evidence of abdominal surgery or radiation
* celiac disease, or other primary GI illnesses
* GI infection obscuring IBS symptoms,
* using total parenteral nutrition therapy in the last 6 months
* pregnancy and lactation
* alcohol consumption
* concurrent chronic diseases such as diabetes, renal failure
* diagnosed and/or treated malignancy in the past 5 years
* anti-inflammatory drugs usage
* intake of vitamin D, omega-3, vitamin E, and calcium supplements
* being on a special diet or medication regimen during the last 6 months

Primary outcomes:
measure: Serum levels of Apelin, Chemerin and adiponectin
timeFrame: in recruitment
Secondary outcomes:
measure: IBS-Quality of life (IBS-QoL)
timeFrame: in recruitment
measure: IBS severity score system (IBSSS)
timeFrame: in recruitment
measure: Gastrointestinal symptoms
timeFrame: in recruitment
measure: Somatic Symptom
timeFrame: in recruitment
measure: Personality
timeFrame: in recruitment
measure: Perceived Stress Scale
timeFrame: in recruitment
Other outcomes:
Locations:
city: Khorramabad
country: Iran, Islamic Republic of
facility: Lorestan university of medical sciences
Study officials:
References: