louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03454828: Mechanisms of Obesity and Its Metabolic Complications in Youth
Official title: Mechanisms of Obesity and Its Metabolic Complications in Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Childhood
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-03-06
Enrollment: 85
Sex: ALL
Minimum age (years): 15
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overarching goal of this project is to determine whether the effect of gut microbiota on human metabolism might be mediated by short chain fatty acids (SCFA) and whether the SCFA might modulate lipid metabolism.

Detailed description: This would be the first study determining the effect of SCFA synthesis on hepatic de novo lipogenesis and to assess whether and how isocaloric dietary changes (namely low carbohydrates) might modify the composition of the gut microbiota and reduce the synthesis of SCFA during adolescence, a sensitive period for the development of obesity.

Eligibility criteria: Inclusion Criteria:

* Good general health,
* Taking no medication on a chronic basis
* Age 15 to 21 years,
* In puberty (girls and boys: Tanner stage III - V)
* BMI \>25th and \<85th for lean cohort; BMI \>95th for obese cohort
* Girls who begin menstruating must have a negative pregnancy test during the study.

Exclusion criteria:

* Baseline creatinine \>1.0 mg
* Food allergies
* Pregnancy
* Presence of endocrinopathies (e.g. Cushing syndrome)
* Significant chronic illness.

Primary outcomes:
measure: For an equal amount of dietary carbohydrates, obese youth will synthesize short chain fatty acids at higher rates than lean youth.
timeFrame: 4 hours
measure: If high rates of short chain fatty acid (SCFA) synthesis enhance hepatic de novo lipogenesis.
timeFrame: 12 hours
measure: The effect of an isocaloric low carbohydrate (CHO) diet on the bacterial synthesis of short chain fatty acids (SCFA).
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Hospital Research Unit
state: Connecticut
Study officials:
affiliation: Yale University
name: Nicola Santoro, Phd,MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Galuppo B, Cline G, Van Name M, Shabanova V, Wagner D, Kien CL, Santoro N. Colonic Fermentation and Acetate Production in Youth with and without Obesity. J Nutr. 2021 Nov 2;151(11):3292-3298. doi: 10.1093/jn/nxab277.
citation: Monga Kravetz A, Testerman T, Galuppo B, Graf J, Pierpont B, Siebel S, Feinn R, Santoro N. Effect of Gut Microbiota and PNPLA3 rs738409 Variant on Nonalcoholic Fatty Liver Disease (NAFLD) in Obese Youth. J Clin Endocrinol Metab. 2020 Oct 1;105(10):e3575-85. doi: 10.1210/clinem/dgaa382.
Clinical trial NCT05182528: Hematological Disorders in Covid 19 Patients
Official title: Hematological Disorders in Covid 19 Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hematological Abnormalities in covid19
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-01-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Covid 19 patients ranging from 18 years old to 90 years old

Brief summary: aim of the research is to detect hematological abnormalities in covid 19 patients and its correlation with the severity and outcome of the disease.

Detailed description: Covid 19 is an infectious disease caused by a newly discovered coronavirus.most people infected with the covid 19 virus will have mild to moderate respiratory illness and recover without specific treatment.older people and those with underlying medical problems like cardiac diseases,diabetes,any chronic respiratory disease and cancer are more likely to have serious illness.the covid 19 virus spreads primarily through droplets of saliva or discharge from the nose oral cavity when an infected person coughs or sneezes.people with covid19 have had a wide range of symptoms reported _ranging from mild to severe symptoms.symptoms may appear 2_14 days after exposure to the infection .any one can have mild to severe symptoms.people with these symptoms may have covid 19: fever or shivering,cough,shortness of breath,fatigue,body or muscle aches,headache,new loss of smell or taste ,sore thraot,congestion or running nose , nausea or vomiting,diarrhoea.

The most common hematological clinical findings include lymphocytopenia,neutrophilia,eosinophilia,mild thrombocytopenia,and less frequently thrombocytosis,the presence of reactive lymphocytes has been reported only occasionally the leucocyte count may be normal,reduced or increased.according to a meta analysis leucocytosis,lymphopenia and thrombocytopenia are associated with greater severity and fatality in covid 19 cases

Eligibility criteria: Inclusion Criteria:

all covid 19 patients diagnosed by pcr or CT chest

-

Exclusion Criteria:

* No

Primary outcomes:
measure: Hematological disorders in covid 19 patients
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Mizurini DM, Hottz ED, Bozza PT, Monteiro RQ. Fundamentals in Covid-19-Associated Thrombosis: Molecular and Cellular Aspects. Front Cardiovasc Med. 2021 Dec 17;8:785738. doi: 10.3389/fcvm.2021.785738. eCollection 2021.
Clinical trial NCT03192228: Impact of a Multidisciplinary Therapeutic Education Program Being Set up for Patients With Type 2 Diabetes Mellitus
Official title: Evaluation of a Multidisciplinary Program of Therapeutic Education in Type 2 Diabetes Mellitus Diabetes in Order to Fix Individualized Objectives
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Patient Education as Topic
Keywords: Diabetes Mellitus, Type 2 +
Patient Education
Lead sponsor: Groupe Hospitalier Pitie-Salpetriere
Sponsor class: OTHER
First posted: 2017-06-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This initial education program is intended for patients with type 2 diabetes:

* who have recently been diagnosed with type 2 diabetes
* or who have an HbA1c greater than 7% and unability to lower their blood glucose levels despite an optimal management by general practitioner but do not yet require insulin treatment

Brief summary: Therapeutic education programs allows in diabetic patients to promote self-care and better perception of the disease The multidisciplinary program of therapeutic education regroups in one day: individual interview, nutritional workshop, self-monitoring blood glucose workshop, physical activity and glycemic objectives workshop.

At the end of the program, individual and personalized goals are given to the patient.

This study aims to evaluate this program success rates and the psychological, anamnesis, and sociological factors linked to success.


Eligibility criteria: Inclusion Criteria:

* All Type 2 diabetic patients who participate in the multidisciplinary program
* Signature information form and consent by the patient

Exclusion Criteria:

* None

Primary outcomes:
measure: Success rate of the therapeutic education program
timeFrame: one month
Secondary outcomes:
measure: Long term success rate of the therapeutic education program
timeFrame: 6 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04705428: Preventive Therapy of White Spot Lesions Using Different Remineralizing Agents in Children From 3 to 12 Years Old
Official title: Preventive Therapy of White Spot Lesions Using Different Remineralizing Agents in Children From 3 to 12 Years Old
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: White Spot Lesion
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2021-01-12
Enrollment: 75
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Compare by clinical observation, photographs and fluorescence the efficacy of sodium fluoride, silanofluoride and thiefenfluoride in treating white spots.

Detailed description: This in vivo study will be a randomized experimental clinical trial to be carried out in the Department of Pediatric Dentistry of the International University of Catalonia. Patients between the ages of 3 and 12, who attend the dental university clinic of the International University of Catalonia, will be part of the study.

Parents or legal guardians will be informed of the treatment procedure with a patient information sheet and informed consent will be given. Once signed, the patient will be assigned to one of the 3 study groups.

Accepting an alpha risk of 5% and with a power of 80% in a bilateral contrast, 15 subjects in each group are required to detect a minimum difference of 4 points between two groups, assuming that there are 3 groups and a standard deviation of 4.9. a follow- up loss rate of 10% has been estimated. The total number of children will be 45 by 15 for each group.

In order to analyze the degree of agreement of one examiner, 15 children will be evaluated twice, with a separation of one month.

Eligibility criteria: Inclusion Criteria:

* Patients born between 2008 and 2017 of both sexes
* Patients with the active white spot lesions on vesicular and buccal surfaces of the incisors and molars of different sizes and with or without sensitivity to external stimuli
* Patients with white spot lesions that correspond to codifications of 0 to 2 of the ICDAS criteria.

Exclusion Criteria:

* Patients with mental disabilities or systemic diseases
* Patients with previously restored teeth
* Patients with clinical symptoms of irreversible pulpitis, allergy to fluoride and copper

Primary outcomes:
measure: visual examination,
timeFrame: 6 MONTHS
measure: tactile examination
timeFrame: 6 MONTHS
measure: fluorescence
timeFrame: 6 MONTHS
measure: photography
timeFrame: 6 MONTHS
Secondary outcomes:
Other outcomes:
Locations:
city: Sant Cugat del Vallès
country: Spain
facility: Universitat Internacional de Catalunya
state: Barcelona
Study officials:
References:
Clinical trial NCT04991428: Mechanism of Action of Transcranial Direct Current Stimulation in Neurofibromatosis Type 1
Official title: Mechanism of Action of Transcranial Direct Current Stimulation in Neurofibromatosis Type 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurofibromatosis 1
Lead sponsor: University of Manchester
Sponsor class: OTHER
First posted: 2021-08-05
Enrollment: 31
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Single-blind cross over experimental trial
Primary purpose: BASIC_SCIENCE

Brief summary: Intellectual impairment, particularly working memory deficits are a significant cause of morbidity in children with Neurofibromatosis type (NF1) with long-term implications on academic and occupational functioning. Whilst significant discoveries have been made in Nf1 animal models in trying to find treatments for these conditions, human translational studies have not been successful. This mechanistic experimental study will investigate the neural mechanisms underlying working memory deficits in NF1. In particular, we will investigate how individual differences in inhibitory neurotransmitter GABA relate to performance on working memory tests. Further, we will investigate the use of a novel, experimental intervention called transcranial Direct Current Stimulation (tDCS);known to modulate GABA. Using a randomized, crossover design in a cohort of 30 adolescents aged 11-17 years, we will apply real or sham tDCS to the dorsolateral prefrontal cortex (DLPFC). State-of-art real time imaging techniques such as Magnetic Resonance Spectroscopy (MRS) and task based functional MRI (fMRI) will be used to investigate the effect of tDCS on GABA concentration, changes in functional plasticity and working memory. We expect that results from this study will help elucidate the neural mechanisms underlying working memory deficits in people with NF1 and show biologic activity for a novel, low-cost intervention that can be used for cognitive remediation in NF1. This kind of focused mechanism trial method is a highly promising approach to understanding the complex neural system pathology in a multifactorial neurodevelopmental condition like NF1.


Eligibility criteria: Inclusion Criteria:

1. Meets National Institute of Health NF1 diagnostic criteria
2. Children aged 11-17 years
3. Written informed consent/assent

Exclusion Criteria:

1. No history of intracranial pathology other than asymptomatic optic pathway glioma or other asymptomatic and untreated NF1-associated white matter lesion
2. No history of epilepsy or any major mental illness
3. No MRI contraindications.

Primary outcomes:
measure: Corsi Block task
timeFrame: immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: University of Manchester
state: Greater Manchester
Study officials:
References:
Clinical trial NCT01400828: Investigate the Safety/Tolerability and Efficacy of Bilastine 20mg in Korean Patients With Seasonal Allergic Rhinitis
Official title: Randomized, Double-blind, Placebo/Active-controlled, Multi-center Clinical Trial to Investigate the Safety/Tolerability and Efficacy of Bilastine 20mg After 14-day Oral Administration in Patients With Seasonal Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Seasonal Allergic Rhinitis
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2011-07-22
Enrollment: 239
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the study was to determine the efficacy and tolerability of 20 mg of Bilastine, compared to Desloratadine and placebo for the treatment of Seasonal Allergic Rhinitis.


Eligibility criteria: Inclusion Criteria:

* The study disease was diagnosed on the basis of clinical criteria: Nasal symptoms (presence of nasal blockage, sneezing, nasal itching and rhinorrhea) and non-nasal symptoms (ocular itching, lacrimation, itching of ears and/or palate and ocular redness), as well as the skin prick test performed at the time of selection or within the year prior to entering.
* Patients with history of Seasonal Allergic Rhinitis, positive skin prick test and symptoms were included if they were between 12 and 70 years old, gave their informed consent, attended the required visits scheduled and also underwent a complete medical examination..

Exclusion Criteria:

* Patients were excluded if they had a significant nasal abnormality which could interfere with the aim of the study, acute or chronic sinusitis, asthma or any condition, disease or hypersensitivity that could be harmed.
* Patients were not allowed to take forbidden medications or not comply the study requirements.
* Patients who were currently participating in or had participated in another clinical trial within the previous three months or were planning to travel outside of the study area during the course of the study were excluded.
* Pregnant or breast-feeding women were also excluded.
* Women of childbearing potential had a pregnancy test done

Primary outcomes:
measure: AUC of TSS
timeFrame: 14 days
Secondary outcomes:
measure: Change in TSS. Reflective symptoms
timeFrame: 14 days
measure: Change in TSS. Instantaneous score
timeFrame: 14days
measure: Change in total nasal symptom score (TNSS)
timeFrame: 14 days
measure: •Change in total non-nasal symptom score (TNNSS)
timeFrame: 14 days
measure: VAS of discomfort
timeFrame: 14 days
measure: CGI
timeFrame: 14 days
measure: •Allergic rhinitis (AR) quality of life (QoL) questionnaire (RQLQ)
timeFrame: 14 days
measure: responde's rate
timeFrame: 14 days
measure: safety assessment
timeFrame: 14 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University college of Medicine, Gangnam Severance Hospital
Study officials:
References:
Clinical trial NCT03744728: Genotypic Versus Phenotypic Susceptibility Testing of Positive Blood Cultures
Official title: Randomized Trial of Fast Bacterial Identification and Phenotypic Antimicrobial Susceptibility Testing in Patients With Positive Blood Cultures Using the Accelerate PhenoTest™ BC Kit, Performed on the Accelerate Pheno™ System as Compared With the Verigene® BC-GP/GN
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bloodstream Infection
Lead sponsor: Accelerate Diagnostics, Inc.
Sponsor class: INDUSTRY
First posted: 2018-11-16
Enrollment: 774
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study is designed as a prospective, randomized, open-label trial evaluating antimicrobial utilization, clinical outcomes, and healthcare costs among patients with positive blood cultures. Patients will be randomized to one of the following FDA-cleared devices that will be used to assess the workflow impact of fast identification (ID) and antimicrobial susceptibility testing (AST) in the microbiology lab and in the quality of care in patients: 1) Standard culture and AST of positive blood culture bottles plus the Verigene® Blood Culture Gram-positive/Gram-negative kit (BC-GP/GN); or 2) Fast ID and AST of positive blood culture bottles using the Accelerate PhenoTest™ BC kit with the Accelerate Pheno™ System.


Eligibility criteria: Inclusion Criteria:

* All positive blood cultures (including on-panel/off-panel/contaminants) identified during local laboratory business hours
* All adult (≥18 years of age)

Exclusion Criteria:

* Identification of blood culture positivity outside of local laboratory business hours (e.g. whenever laboratories are staffed to perform both rapid testing and routine testing)
* Positive blood culture in the prior week with same Gram stain result
* Transferred from an outside hospital and had a history of a previously positive blood culture of the same Gram stain result
* Previously enrolled in the study
* Only the first positive culture for each patient will be included during the study period; any subsequent episode of bloodstream infection (BSI) will be excluded
* Died or were transitioned to comfort care within 24 hours of enrollment
* Negative Gram-stain
* Not admitted to hospital for ≥ 24 hours following blood culture positivity

Primary outcomes:
measure: Duration of anti-pseudomonal β-lactam therapy
timeFrame: 4 days after randomization
measure: Duration of anti-methicillin-resistant Staphylococcus aureus (MRSA) therapy
timeFrame: 4 days after randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
Study officials:
References:
Clinical trial NCT06661928: Conservative Surgery with Modified Widman Flap Vs Papilla Preservation Technique for the Treatment of Residual Pockets
Official title: Conservative Surgery with Modified Widman Flap Vs Conservative Surgery with Papilla Preservation Technique for the Treatment of Residual Pockets: a 5-year Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Periodontitis
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2024-10-28
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim of the study is to evaluate the efficacy of conservative surgery with or without papilla preservation technique in the treatment of deep residual pockets ≥ 6 mm in stage III-IV periodontitis patients after cause related therapy (step II) in terms of endpoints of therapy and other secondary outcomes at different time intervals (1, 3 and 5 years). Moreover, the study aims to evaluate the stability of the results obtained for the different surgical approaches over a 5 years follow-up period.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of stage III/IV periodontitis.
* Completed steps I-II periodontal therapy at least 6 weeks before.
* Full mouth plaque score of less than 15% at re-evaluation.
* Full mouth bleeding score of less than 15% at re-evaluation.
* Sextant with residual probing pocket depth (PPD) ≥ 6 mm at ≥ 2 natural teeth (third molars excluded).
* Signed informed consent.

Exclusion Criteria:

* Compromised general health which contraindicates the study procedures (ASA III-VI patients).
* Systemic diseases/medications which could influence the outcome of the therapy (e.g. uncontrolled diabetes mellitus, non-plaque-induced gingival diseases, antiepileptic drugs (phenytoin and sodium valproate), certain calcium channel-blocking drugs (e.g., nifedipine, verapamil, diltiazem, amlodipine, felodipine), immunoregulating drugs (e.g., ciclosporine), and high-dose oral contraceptives).
* Pregnant or nursing women.
* Presence of tooth mobility ≥ class 2.

Primary outcomes:
measure: Pocket closure
timeFrame: 5 years
Secondary outcomes:
measure: Tooth Retention
timeFrame: 5 years
measure: Number of instrumentation re-intervention
timeFrame: 5 years
measure: Mean Probing Pocket Depth changes
timeFrame: 5 years
measure: Mean Clinical Attachment Level changes
timeFrame: 5 years
measure: Mean recession changes
timeFrame: 5 years
Other outcomes:
measure: Discomfort during surgery
timeFrame: Immediately after surgery.
Locations:
Study officials:
References: