louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00151710: Effects of Pioglitazone in Congenital Adrenal Hyperplasia
Official title: Effects of Pioglitazone in Glucocorticoid-Induced Insulin Resistance. Studies in Congenital Adrenal Hyperplasia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Adrenal Hyperplasia
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2005-09-09
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Congenital adrenal hyperplasia, an autosomal recessive condition, is mainly caused by mutations in the gene 21-hydroxylase and is treated with glucocorticoids in a slightly supraphysiological dose. Adult patients seem to be characterized by insulin resistance, which may be caused by the glucocorticoids and/or the accompanying obesity. The hypothesis of this study is that pioglitazone can improve insulin sensitivity and correlated cardiovascular risk factors in this specific group of patients. This will be tested in a randomized, placebo-controlled, cross-over trial; insulin sensitivity will be quantified by euglycemic hyperinsulinemic clamp studies.


Eligibility criteria: Inclusion Criteria:

* biochemical and genetically proven congenital adrenal hyperplasia
* stable corticosteroid replacement for 3 months

Exclusion Criteria:

* age \< 18 years
* inability to give informed consent
* significant cardiovascular disease, defined as myocardial infarction or stroke, six months preceding the study
* significant renal disease, GFR \< 30 ml/min
* significant liver disease, defined as more than 3 times upper limit of normal values of alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
* pregnancy
* mental disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Cornelis J Tack, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05532410: Optic Disc Photograph Collection Study
Official title: Optic Disc Photograph Collection Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retina Disease
Glaucoma
Normal
Lead sponsor: Optos, PLC
Sponsor class: INDUSTRY
First posted: 2022-09-08
Enrollment: 121
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The objective of this study is to collect stereo-optic disc photographs for potential future analysis.


Eligibility criteria: Inclusion Criteria

1. Subjects 22 years of age or older on the date of informed consent
2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
3. Subjects met inclusion/exclusion criteria for the OPT1060 protocol

Exclusion Criteria

1. Subjects unable to tolerate ophthalmic imaging
2. Subjects not able to obtain acceptable OCT, Stereo, or Optomap images due to ocular media opacity or other reasons

Primary outcomes:
measure: Bland-Altman Plots of Stereo Disc Photos, SLO images and OCT Scans
timeFrame: 1 year
measure: Deming Regression of Stereo Disc Photos, SLO images and OCT Scans
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Illinois College of Optometry
state: Illinois
Study officials:
References:
Clinical trial NCT04709510: Short-term Perioperative Thromboprophylaxis After Major Abdominal Surgery
Official title: Outcomes of Short-term Perioperative Thromboprophylaxis After Gastrointestinal Cancer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deep Vein Thrombosis
Keywords: deep vein thrombosis
short-term thromboprophylaxis
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Retrospective Cohort
Primary purpose: DIAGNOSTIC

Brief summary: Major abdominal surgery for cancer is major risk factor for thromboembolism. Patients who undergo major abdominal surgery are prone to develop venous thromboembolism, both in the early postoperative period and after hospital discharger. There are strong recommendations in the international guidelines in favor to pharmacological thromboprophylaxis. Thus there is no consensus dor the duration of the prophylaxis. There are authors that suggest extended prophylaxis up to 4 week after surgery. On the other hand, there are prospective randomized trials that inpatient (short-term up to 7-10 days) prophylaxis is adequate.

Detailed description: This is a retrospective cohort study with 89 patients who underwent major abdominal surgery for colorectal and gastric cancer. All patients received short term prophylaxis (during hospital stay only) rather than extended prophylaxis (4 weeks). All participants received duplex ultrasound in the study period for the diagnosis of deep vein thrombosis.

Eligibility criteria: Inclusion Criteria:

* Older than 18
* Major abdominal surgery gor colorectal or gastric cancer
* Caprini Risk score less than 9
* No history of anticoagulant treatment
* Thromboprophylaxis during hospital stay only

Exclusion Criteria:

* Younger than 18
* Caprini Risk score 9 and above
* History of anticogulants
* Not reachable by phone etc

Primary outcomes:
measure: The incidence of thromboembolic events by radiological assessment
timeFrame: 3 years follow up
Secondary outcomes:
measure: Rate of predisposing factors of the patients
timeFrame: 3 years follow up
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medeniyet University
state: Kadikoy
Study officials:
affiliation: Istanbul Medeniyet University
name: Orhan Alimoglu, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT02045810: Surgical Pleth Index- Relevance in Small Children
Official title: Surgical Pleth Index - Relevance in Small Children. A Randomised Double Blinded Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Keywords: Measurement
nosiseption
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2014-01-27
Enrollment: 30
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Surgical Pleth index is a novel device aimed for measurement of intraoperative nosiseption. It has not been tested on small children. The aim of this study is to measure, whether there is a difference in nosiception measured by SPI in a group receiving local anesthetics prior to operation compared to group receiving plasebo.


Eligibility criteria: Inclusion Criteria:

* age 0-2 years
* Elective surgery planned for inguinal hernia, or testicle retention
* Written informed consent from parent received
* ASA I-III

Exclusion Criteria:

* Exstrasystolias, known cardiac problem, medication affecting rhytm, allergy to drugs used

Primary outcomes:
measure: Surgical Pleth Index (SPI) at the time of start of surgery
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Tampere University Hospital
name: Jarkko Harju, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tampere University Hospital
name: Arvi Yli-Hankala, Prof, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Harju J, Kalliomaki ML, Leppikangas H, Kiviharju M, Yli-Hankala A. Surgical pleth index in children younger than 24 months of age: a randomized double-blinded trial. Br J Anaesth. 2016 Sep;117(3):358-64. doi: 10.1093/bja/aew215.
Clinical trial NCT02006810: Development of Endothelial Biomarkers
Official title: Development of Endothelial Biomarkers for Use in Cohort Studies. Comparison With Reference Biomarkers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: Endothelium biomarkers
Atherosclerotic disease
Endothelial function
Nutritional stimuli
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2013-12-10
Enrollment: 50
Sex: MALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The main objective is to develop and validate new endothelial function markers discriminating and reproducible by assessing the ability to reveal changes in endothelial function in response to positive and negative nutritional stimuli.

Detailed description: The study will be randomized (on the order of taking the products: a single dose of lipids or a single dose of flavonoids), single-blinded, cross-over for each population (healthy and metabolic syndrome).

Eligibility criteria: Inclusion Criteria:

* - 40 to 65 years old
* male
* non-smokers

Specific inclusion criteria for healthy subjects :

* Healthy subjects should not take antihypertensive or statin.
* Healthy subjects should not present metabolic syndrome but one criterion of the metabolic syndrome will be tolerated.

Specific inclusion criteria for subjects with metabolic syndrome :

- subjects with metabolic syndrome must have at least 3 of the 5 criteria associated with the metabolic syndrome.

Exclusion Criteria:

* treatment vasodilator nitric oxide liberating,
* diabetes and coronary artery disease,
* chronic alcoholism,
* severe hepatic impairment,
* end stage renal failure or dialysis,
* neurological tremor,
* cancer, mental illness or other severe disease which can impact informed consent and / or results,
* Refusal to be registered in the National File of Volunteers
* Person in exclusion of the National Volunteer File

Primary outcomes:
measure: Flow Mediated Dilatation (FMD)compared to hyperemic velocity time integral (VTI) and endothelial microparticles (MPE)
timeFrame: at 150 mn after the product intake
Secondary outcomes:
measure: Changes in endothelial function evaluated by cell adhesion molecule (CAM) and micro-RNA (miRNA)
timeFrame: at 150 mn after the product intake
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Nicolas BARBER CHAMOUX
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02901210: A Modified Technique to Facilitate Pealing of the Rectal Mucosa in Delorme Operation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Prolapse
Keywords: Recta prolapse
Intraoperative bleeding
mucosal cauterization
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2016-09-15
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the investigator new modification for delorme procedure in patients with rectal prolapse , assessing intra-operative morbidity and recurrence rate .

Detailed description: In classic delorme operation stripping of the mucosa done and this is associated with extensive bleeding in addition to the time consumed in this step.the new modification done by the investigator replace this step with another associated with less intraoperative bleeding and not time consuming.

Eligibility criteria: Inclusion Criteria:

* Mild to moderate rectal prolapse
* Singed informed consent.

Exclusion Criteria:

* Huge rectal prolapse .
* Recurrent rectal prolapse

Primary outcomes:
measure: Recurrence rate assessed in this modified technique
timeFrame: One year follow up post operative
measure: intraoperative bleeding measured in this modified technique
timeFrame: one year follow up post operative.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03674710: A Multi-center, Prospective, Single-blind, Controlled Trial Comparing Diagnostic Value of Different EUS-FNA Techniques
Official title: A Multi-center, Prospective, Single-blind, Controlled Trial Comparing Suction Technique, Slow-pull Method and Wet Suction Technique on Specimen Quality and Diagnostic Accuracy in Endoscopic Ultrasound-guided Fine-needle Aspiration
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neoplasms
Infection
Inflammation
Lymphoma
Cancer
Sarcoid
Mass Lesion
Keywords: EUS-FNA
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2018-09-17
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to compare endoscopic ultrasound guided-fine needle aspiration (EUS-FNA) with a standard 22-gauge needle using "standard suction", "slow-pull" and "wet suction" for thoracic/abdominal solid/solid-cystic lesions. Investigators intend to compare the effectiveness and safety of the three methods in order to discover the optimized technique for obtaining diagnostic material and making accurate diagnosis.


Eligibility criteria: Inclusion Criteria:

* In-patients and out-patients between the age of 18years and 80 years with thoracic/abdominal solid/solid-cystic lesions for EUS-FNA.

Exclusion Criteria:

* Uncorrectable coagulopathy (INR \> 1.5)
* Uncorrectable thrombocytopenia (platelet \< 50,000)
* Cystic lesions
* Inaccessible lesions to EUS
* Contraindications for conscious sedation
* Uncooperative patients
* Refusal to consent form

Primary outcomes:
measure: Diagnostic yield of standard suction technique
timeFrame: 1 year
measure: Diagnostic yield of slow-pull technique
timeFrame: 1 year
measure: Diagnostic yield of wet suction technique
timeFrame: 1 year
measure: Specimen quality score of standard suction
timeFrame: Immediate
measure: Specimen quality score of slow-pull
timeFrame: Immediate
measure: Specimen quality score of wet suction
timeFrame: Immediate
Secondary outcomes:
measure: Adverse event
timeFrame: 1 week
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
city: Jinan
country: China
facility: Qilu Hospital, Shandong University
state: Shandong
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University
state: Shanghai
Study officials:
References:
Clinical trial NCT07009210: AI Assisted Personalized Legacy Program (Reflections: My Story) for Patients With Serious Illness
Official title: Feasibility and Acceptability of AI Assisted Personalized Legacy Program (Reflections: My Story) for Patients With Serious Illness
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Serious Illness
Existential Distress
Keywords: Legacy Work
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2025-06-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine if it is feasible and acceptable to recruit for and deliver the AI Assisted Personalized Legacy Program intervention to patients with serious illness.

Detailed description: This study is an investigator-initiated, multi-site Mayo Clinic prospective minimal risk pilot study to determine feasibility and acceptability of an AI Assisted Personalized Legacy Program. The AI Assisted Personalized Legacy Program intervention is a brief, individualized psychotherapy that aims to relieve psycho-emotional and existential distress and improve the experiences of patients whose lives are impacted by serious illness. This therapy offers patients an opportunity to reflect on their life with a trained facilitator and share their thoughts and memories with family and other people in their life. The sessions are recorded and transcribed. The interventionist will work with patients to edit the document and provide a final legacy document for patient to keep and give to loved ones.

Eligibility criteria: Participant population: Adults with serious illness - defined as a health condition that carries a high risk of mortality

Inclusion Criteria for patients:

1. Age ≥18 years
2. English fluency
3. Provide informed consent
4. Ability to complete questionnaire(s) by themselves or with assistance

Exclusion Criteria:

1. Other psychological co-morbidities such as untreated schizophrenia, bipolar disease
2. Recent suicide attempt or psychiatric illness severe enough that hospitalization has been necessary in last 6 months
3. Active delirium
4. Advanced dementia
5. Participation in concurrent legacy offerings through the palliative care clinic

Primary outcomes:
measure: Feasibility Number
timeFrame: 2 years
measure: Acceptability
timeFrame: 5-10 days post-delivery of the final legacy document
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Deirdre Pachman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06597110: The Effects of Autonomous Sensory Meridian Response (ASMR) on Sleep Quality Improvement in Adolescents
Official title: The Effects of Autonomous Sensory Meridian Response (ASMR) on Sleep Quality Improvement in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Sleep Quality
Keywords: adolescent sleep
ASMR
sleep intervention
sleep quality scale
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study involved sixty participants, divided evenly into four groups: three intervention groups (A, B, C) and one control group. For five consecutive days, the intervention groups engaged in pre-sleep ASMR listening sessions lasting 10, 20, and 30 minutes, respectively. Sleep quality was evaluated using mobile application tools and the subjective Sleep Quality Scale.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Background: This study explored the therapeutic impact of ASMR on sleep problems in high school students.

Methods: The study involved sixty participants, divided evenly into four groups: three intervention groups (A, B, C) and one control group. For five consecutive days, the intervention groups engaged in pre-sleep ASMR listening sessions lasting 10, 20, and 30 minutes, respectively. Sleep quality was evaluated using mobile application tools and the subjective Sleep Quality Scale.

Detailed description: Background: In recent years, there has been a notable surge in sleep-related challenges among adolescents. The emergence of Autonomous Sensory Meridian Response (ASMR) content across various social media platforms has sparked interest in its potential to address these issues. This study explored the therapeutic impact of ASMR on sleep problems in high school students.

Methods: The study involved sixty participants, divided evenly into four groups: three intervention groups (A, B, C) and one control group. For five consecutive days, the intervention groups engaged in pre-sleep ASMR listening sessions lasting 10, 20, and 30 minutes, respectively. Sleep quality was evaluated using mobile application tools and the subjective Sleep Quality Scale.

Eligibility criteria: Inclusion Criteria:

* Haven\&#39;t heard an ASMR trigger tone before.

Exclusion Criteria:

* heard an ASMR trigger tone before.

Primary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: 0ne month
Secondary outcomes:
measure: effective sleep time
timeFrame: 0ne month
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Huazhong University of Science and Technology
name: Huiping Zhang, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02563210: Airway Resistance Measurement in Children 3 to 6 Years of Age
Official title: Interrupter Technique and Plethysmography Airway Resistance Measurement: Comparison of These Two Techniques for the Diagnosis of Airway Obstruction Diagnosis and Bronchodilation Response in Children 3 to 6 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Obstruction
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2015-09-30
Enrollment: 130
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In preschool aged children, the most suitable techniques to assess airway obstruction is debit interruption technic (Rint) and plethysmographic measure of specific airway resistance (sRaw). Even if Rint is easily and routinely performed, it also includes a component of lung tissue and chest wall resistance as well as respiratory tissue viscoelasticity. sRaw seems to be better for discriminating airway obstruction. These two techniques will be compared in terms of concordance in the diagnosis of pulmonary obstruction and bronchodilator response.


Eligibility criteria: Inclusion Criteria:

* Child 3 to 6 years aged

Exclusion Criteria:

* Height below 90 centimeters
* Opposition to participation

Primary outcomes:
measure: airway resistance measure by interruption technique (Rint)
timeFrame: Day one
Secondary outcomes:
measure: measure of bronchodilator response
timeFrame: Day one
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
affiliation: University Hospital of Brest
name: Marie-Agnès METGES, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mauger-Hamel P, Du Boisbaudry C, Leon K, Alavi Z, Giroux-Metges MA. Relationship between baseline and post-bronchodilator interrupter resistance and specific airway resistance in preschool children. Ann Allergy Asthma Immunol. 2020 Apr;124(4):366-372. doi: 10.1016/j.anai.2020.01.003. Epub 2020 Jan 13.
Clinical trial NCT02919410: Bacterial Colonization With and Without Iodophor-impregnated Adhesive Drapes in Hip Surgery: a Prospective, Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Wound Infection
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2016-09-29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Primary purpose: PREVENTION

Brief summary: This is a prospective, randomized control trial evaluating the efficacy of iodophor-impregnated adhesive drapes for reducing bacterial count in hip surgery.


Eligibility criteria: Inclusion Criteria:

* Primary femoroacetabular osteoplasty (FAO) patients
* Primary Periacetabular Osteotomy (PAO) patients

Exclusion Criteria:

* Total hip arthroplasty (THA) patients
* Revision FAO surgery
* Septic or septic arthritis patients
* Patients with systemic or topical allergy to iodine

Primary outcomes:
measure: bacterial count from skin swabs
timeFrame: Immediately post-surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: