louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05102734: Physiologic Effect of Topical Nitroglycerin on Microcirculation Capacity in Patients With Circulatory Shock.
Official title: Trial of a Topical Nitroglycerin Challenge to Detect Reversible Microcirculatory Dysfunction in Patients With Circulatory Shock.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Circulatory Shock
Cardiovascular Shock
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2021-11-01
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing elective cardiovascular surgery

Brief summary: This is an open-label, single center, trial that will enroll up to 25 participants with circulatory shock after cardiac surgery. Participants will be administered a topical sublingual nitroglycerin solution and assessed for changes microcirculatory blood flow using incident dark field microscopy.


Eligibility criteria: Inclusion Criteria:

* Adult patients receiving elective CABG or valvular surgery requiring cardiopulmonary bypass
* Receiving postoperative catecholamine therapy to maintain a MAP \> 65mmHg, cardiac index \> 2 despite initial fluid resuscitation
* Invasive hemodynamic monitoring

Exclusion Criteria:

* Surgical hemorrhage
* Unable to tolerate sublingual microcirculatory flow imaging
* Known intolerance or allergy to nitroglycerin
* Inadequate microcirculation imaging (based on Massey Score)

Primary outcomes:
measure: Perfused Vessel Density (PVD)
timeFrame: Preoperative Control Group: assessed once preoperatively. For the topical nitroglycerin group, PVD measurements were obtained after surgery (baseline), then 3-minutes and 30-minutes after topical nitroglycerin administration.
Secondary outcomes:
measure: Mean Arterial Pressure
timeFrame: MAP was recorded for the control group, then for the NTG group at postoperative baseline, 3-minutes and 30-minutes after topical NTG application.
measure: Cardiac Index
timeFrame: Cardiac output was measured for the control group, then for the NTG group at postoperative baseline, 3-minuts, and 30-minutes after topical NTG application
measure: Central Venous Pressure
timeFrame: CVP was recorded for the control group, then for the NTG group at postoperative baseline, 3-minutes, and 30-minutes after topical NTG application
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of the Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: John C. Greenwood, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03718234: Subcutaneous Hydrocortisone Children With Congenital Adrenal Hyperplasia
Official title: Interval Bolus Delivery of Subcutaneous Hydrocortisone Via Infusion Pump in Children With Congenital Adrenal Hyperplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Congenital Adrenal Hyperplasia
Hyperplasia
Adrenal Hyperplasia
Congenital Disorders
Adrenocortical Hyperfunction
Disorders of Sex Development
Urogenital Abnormalities
Genetic Diseases, Inborn
Steroid Metabolic Diseases, Inborn
Adrenal Gland Disease
Hydrocortisone
Keywords: adrenal gland diseases
cortisol succinate
hydrocortisone
hyperplasia
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2018-10-24
Enrollment: 11
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: This is a non-randomized crossover study design.
Primary purpose: TREATMENT

Brief summary: This is an open-label, non-randomized crossover design feasibility trial comparing oral hydrocortisone treatment with interval bolus delivery (pulsatile) of subcutaneous hydrocortisone via infusion pump in children with congenital adrenal hyperplasia. Eight children, ages 4-18 yrs, will have 24-hr pharmacokinetic and pharmacodynamic profiles of cortisol, 17-hydroxyprogesterone and androstenedione concentrations while on oral hydrocortisone therapy (admission 1), during an initial trial of the subcutaneous hydrocortisone pump (admission 2), and after 6 weeks of subcutaneous hydrocortisone pump treatment (admission 3). An integrated pharmacokinetic and pharmacodynamic model will be used to determine cortisol, 17-hydroxyprogesterone and androstenedione parameters to compare the duration of time subjects have these concentrations outside acceptable ranges. Funding Source - FDA OOPD


Eligibility criteria: Inclusion Criteria:

* Children 4 - 18 years of age.
* Classic congenital adrenal hyperplasia (CAH) as confirmed by hormonal and molecular testing.
* Patients who have been on the same HC dosing regimen for 1 month

Exclusion Criteria:

* Patients with non-classic CAH.
* Patients on:

  * Dexamethasone
  * Prednisone, or
  * inhaled steroids.
* Patients with body surface areas under 1m2 or over 2m2
* Non-English speaking patients

Primary outcomes:
measure: Duration of hypocortisolemia and hypercortisolemia will be significantly shorter
timeFrame: From date of randomization assessed up to 20 weeks.
measure: Serum concentrations will be within an acceptable range
timeFrame: From date of randomization assessed up to 20 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Prism Clinical Research
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Kyriaki Sarafoglou, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ramirez Alcantara J, Halper A. Adrenal insufficiency updates in children. Curr Opin Endocrinol Diabetes Obes. 2021 Feb 1;28(1):75-81. doi: 10.1097/MED.0000000000000591.
Clinical trial NCT01038934: DNA of Oral Cytobrush in Three Means Conservation
Official title: Evaluation of Genomic DNA of Oral Cytobrush in Three Means Conservation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy
Keywords: Buccal Mucosa
DNA
Polymerase Chain Reaction
Lead sponsor: UPECLIN HC FM Botucatu Unesp
Sponsor class: OTHER
First posted: 2009-12-24
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Maximum age (years): 33
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to analyze genomic DNA of buccal cytobrush stored in three means conservation.

Detailed description: Blood samples are an excellent source of large amounts of genomic DNA. However, alternative sources are often needed in epidemiological studies because of difficulties in obtaining blood samples.

Eligibility criteria: Inclusion Criteria:

* healthy young

Exclusion Criteria:

* none

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Araçatuba
country: Brazil
facility: School of Dentistry, Sao Paulo State University, Unesp, Araçatuba/SP
state: São Paulo
Study officials:
affiliation: Univ. Estadual Paulista
name: Glauco I Miyahara, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07016334: We Analyse Metabolites in Dried Blood Spots From Newborns That Later in Life Developed an Eating Disorder.
Official title: The Role of Metabolic, Immune, and Neurotrophic Markers in the Etiology of Eating Disorders Using Neonatal Bloodspots
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Eating Disorders
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population born from 1981 with/or with out diagnosis of anorexia or bulimia nervosa

Brief summary: Anorexia nervosa (AN) and bulimia nervosa (BN) are serious eating disorders (EDs) with significant morbidity and mortality. Genetic studies have shown associations between EDs and metabolic traits, and longitudinal studies indicate distinct weight trajectories in children who later develop AN or BN, suggesting early involvement of metabolic factors. Biological studies also reveal differences in immune and neurotrophic markers in individuals with EDs compared to controls. Intriguingly, metabolites measured in neonatal blood could serve as very early markers of ED risk, unconfounded by state or scar factors related to prolonged starvation.

Here the investigators propose to comprehensively analyze neonatal biomarkers (metabolic, immune, and neurotrophic), epidemiological factors, and genetics to understand ED risk and develop risk prediction models


Eligibility criteria: Inclusion Criteria:

- in PKU-register with or withou life-time diagnosis of anorexia or bulimi nervosa

Exclusion Criteria:

* not in PKU register

Primary outcomes:
measure: Metabolomic factors measured by mass-spectrometry
timeFrame: Sampled at birth (day 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
References:
Clinical trial NCT00581334: Robotic-assisted Laparoscopic Sacrocolpopexy
Official title: Robotic-assisted Laparoscopic Sacrocolpopexy: A Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
Keywords: Pelvic organ prolapse
Robotic-assisted laparoscopic sacrocolpopexy
Post hysterectomy prolapse
Symptomatic apical prolapse of stage II or >
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2007-12-27
Enrollment: 20
Sex: FEMALE
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: Female urogynecology patient with symptomatic apical prolapse

Brief summary: Robotic-assisted Abdominal Sacrocolpopexy is both a feasible and safe method for apical prolapse repair of the vagina.

Detailed description: Robotics offers many advantages over traditional laparoscopy: 1) intuitive movement of instruments, 2) "wristed instruments" with increased degrees of freedom, 3) enhanced 12X magnification, 4) 3-D depth perception, 5)tremor filtration, 6) enhanced surgeon comfort and ergonomics, and 7) a steeper learning curve. With robotic assistance, the surgeon can comfortably perform precise, repetitive motions, with greater dexterity and vision. To date, there have been a small number of published cases of laparoscopic sacrocolpopexy and two cases of series utilizing robotic-assistance. There have been no prospective, randomized, controlled trials comparing either of these modalities to conventional abdominal sacrocolpopexy.

Eligibility criteria: Inclusion Criteria:

* Non-pregnant women
* Age \>18 years
* Eligible for sacrocolpopexy
* Prior hysterectomy
* Stage II or greater post hysterectomy vault prolapse
* Satisfied parity
* Patients electing for an abdominal repair to posthysterectomy vault prolapse

Exclusion Criteria:

* Prisoners
* Cognitively impaired adults
* Not medically stable to undergo laparoscopic or abdominal surgery
* Previous pelvic/vaginal radiation
* Participants electing to proceed with a vaginal repair of vaginal vault prolapse
* Participants electing to proceed with the traditional abdominal sacrocolpopexy
* History of recurrent vaginal infections
* Known urologic and/or gynecologic cancer

Primary outcomes:
measure: The primary outcomes are operative time, blood loss, complication rates, length of hospital stay, and cure. Objective cure can be measured using the pelvic organ prolapse quantification exam (POP-Q).
timeFrame: 2 years
Secondary outcomes:
measure: Secondary outcomes will measure the effects of the surgical repair using a series of questionnaires: SF-36, Pelvic Floor Distress Inventory which includes Pelvic Organ Prolapse Impact, Colo-Rectal-Anal Impact, and Urinary Impact Questionnaire.
timeFrame: 2 Years
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California, Irvine Medical Center
state: California
Study officials:
affiliation: University of California, Irvine
name: Felicia Lane, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02449434: Timing of Dietary Acid Intake, Brushing Teeth and Acid Erosion.
Official title: Timing of Dietary Acid Intake, Brushing Teeth and Acid Erosion.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tooth Wear
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2015-05-20
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred into the Dental institute of King's College London for dental treatment

Brief summary: This is a questionnaire based study investigating the relationship between the timing of dietary acid intake toothbrushing and erosive tooth wear. Data will be collected on the timing, nature, frequency and duration of dietary acid intakes and timing and frequency of the participants toothbrushing. Signs of the participants erosive tooth wear will then be recorded

Detailed description: The study group will consist of two cohorts, those presenting with tooth wear and a control group. Participants will be recruited from the care planning clinic of the Dental Institute King's College London. Suitable participants meeting the inclusion criteria will be approached on the clinic, given the patient information sheet and asked to consider participating. Written consent will be obtained from those accepting the request. An interviewer-led, previously validated questionnaire will question their frequency and timing of dietary acid intake, tooth brushing and any habits associated with dietary acid intake. This will be followed by a Basic Erosive Wear Examination.

The process will take 7-8 minutes and the participant is free to withdraw at any time

Eligibility criteria: Inclusion Criteria:

1. Severe tooth wear with a BEWE score of 12 and at least one score of 3 in three quadrants
2. Adult 18 years or older
3. No missing anterior teeth
4. minimum of at 10 teeth in the upper and 10 teeth in the lower jaw
5. No anterior crowns/ bridges or implants
6. Written consent to the study

Exclusion Criteria:

1. Pregnancy
2. Participation in other research within 30 days
3. Unable to speak or understand English
4. Presence of periodontal disease or caries on more than one tooth

Primary outcomes:
measure: Basic Erosive Wear Examination
timeFrame: Single reading of wear of the teeth at the appointment date. Examination of wear takes 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Dental Institute, Guy's Hospital
Study officials:
affiliation: King's College London
name: David Bartlett, BDS PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: O'Toole S, Bernabe E, Moazzez R, Bartlett D. Timing of dietary acid intake and erosive tooth wear: A case-control study. J Dent. 2017 Jan;56:99-104. doi: 10.1016/j.jdent.2016.11.005. Epub 2016 Nov 14.
Clinical trial NCT03749824: Investigation of Psychophysiological Response to Aversive Stimuli Over Time With Omega-3
Official title: Investigation of Psychophysiological Response to Aversive Stimuli Over Time With Omega-3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Conduct Disorder
ADHD
Oppositional Defiant Disorder
Lead sponsor: Yale-NUS College
Sponsor class: OTHER
First posted: 2018-11-21
Enrollment: 133
Sex: ALL
Minimum age (years): 7
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study investigates the psychophysiological responses to aversive stimuli in a population of 133 children clinically diagnosed with conduct disorder (CD) and/or attention-deficit/hyperactivity disorder (ADHD). Participants were administered with either omega-3 or placebo for a period of 6 months and were exposed to three stimuli every three months: 1) a loud sound, 2) threatening photographs from the International Affective Picture System (IAPS), and 3) the Trier Social Stress Task (TSST). Participants' psychophysiological features of heart rate and galvanic skin conductance were measured and analyzed in relation to their omega-3/placebo condition clinical diagnosis.


Eligibility criteria: Inclusion Criteria:

1. Subjects between ages 7 and 16 years
2. Subjects who fulfil all criteria for a DSM-IV diagnosis of ADHD, conduct disorder, or oppositional defiant disorder
3. Subjects with willingness to participate in a randomized, double-blind controlled trial
4. Subjects with complete written, informed parental consent and child assent
5. Subjects with IQ of 70 or more

Exclusion Criteria:

1. Subjects who have IQ in the below 70
2. Subjects who are younger than 7 years old or older than 16 years old
3. Those without written parental consent
4. Those with brain pathology such as serious head injury, epilepsy, etc.

Primary outcomes:
measure: Change from Baseline Heart Rate at 6 months
timeFrame: 7 minutes each at 0 months and 6 months
measure: Change from Baseline Skin Conductance Response at 6 months
timeFrame: 4 minutes each at 0 months and 6 months
measure: Change from Baseline Skin Conductance Response at 6 months
timeFrame: 4 minutes each at 0 months and 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Mental Health, Singapore
name: Daniel Fung
role: STUDY_DIRECTOR
References:
Clinical trial NCT00948324: Effect of Intensive Therapy Associated With CSII on β-cell Function With Newly Diagnosed Type 2 Diabetes
Official title: Effect of Intensive Therapy Associated With CSII on β-cell Function With Newly Diagnosed Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: ype 2 diabetes mellitus, continuous subcutaneous insulin infusion,
α-lipoic acid ,rosiglitazone ,metformin，therapy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2009-07-29
Enrollment: 400
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
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 investigate and evaluate the effects of different interventions (1.continuous subcutaneous insulin infusion,2.continuous subcutaneous insulin infusion combined with rosiglitazone 3.continuous subcutaneous insulin infusion combined with metformin,4.continuous subcutaneous insulin infusion combined with α- thioctic acid daily injections,) on glycemic control, B-cell function and the remission rate in newly-diagnosed type 2 diabetic patients.


Eligibility criteria: Inclusion Criteria:

* newly diagnosed type 2 diabetes,

Exclusion Criteria:

* received previous antihyperglycaemic therapy

Primary outcomes:
measure: beta cell function;fast blood glucose;
timeFrame: 2011/05
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ministry of Education
name: Li Yan Bing, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liu L, Ke W, Wan X, Zhang P, Cao X, Deng W, Li Y. Insulin requirement profiles of short-term intensive insulin therapy in patients with newly diagnosed type 2 diabetes and its association with long-term glycemic remission. Diabetes Res Clin Pract. 2015 May;108(2):250-7. doi: 10.1016/j.diabres.2015.02.011. Epub 2015 Feb 21.
Clinical trial NCT04900324: Intramuscular Injections of Botulinum Toxin in Lateral Pterygoid Muscle in the Treatment of Temporomandibular Dysfunctions: Studying the Interest of MRI Guidance and Ultrasound Guidance
Official title: Intramuscular Injections of Botulinum Toxin in Lateral Pterygoid Muscle in the Treatment of Temporomandibular Dysfunctions: Studying the Interest of MRI Guidance and Ultrasound Guidance
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Mandibular Dysfunction
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2021-05-25
Enrollment: 4
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 main hypothesis is that a significant pain improve (measured with Visual Analogic Scale \[VAS\]) can be observed after injection of botulinum toxin A, meaning the success of the guidance device.


Eligibility criteria: Inclusion Criteria:

* patients suffering from muscular TemporoMandibular Dysfunctions (TMD) with clinical diagnosis: myofascial pain, limited opening of the mouth, articular noise.
* \>= 18 years old
* with signed informed consent form

Exclusion Criteria:

* articular TMD: arthritis or other inflammatory disease of temporomandibular joint, arthrosis, bone deformation, previous fracture of condylar area ;
* electromyographic hypoactivity, pure muscular diseases ;
* oro-mandibular dystonia ;
* botulinum toxin allergy,
* risk of bleeding
* recent or active infection
* intercurrent antibiotic treatment (drug interaction) ;
* vaccination during the 15 days preceding the injection.

Primary outcomes:
measure: Pain improvement
timeFrame: Month 2
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHu de Besançon
Study officials:
affiliation: CHU de Besançon
name: Christophe MEYER, Md PhD
role: PRINCIPAL_INVESTIGATOR
References: