louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01964586: Comparison of Preincisional Infiltrated Dexmedetomidine and Lidocaine Plus Adrenaline for Nasal Sephoplasty Surgery.
Official title: Phase 4 Study of Comparison of Preincisional Infiltrated Dexmedetomidine and Lidocaine Plus Adrenaline for Surgical Conditions and Postoperative Analgesic Consumption in Nasal Sephoplasty Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Surgery
Pain
Keywords: Septoplasty, Dexmedetomidine, Surgical Conditions
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2013-10-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: It is very important to decrease the bleeding during nasal septoplasty in order to increase the visibility of the surgical site. Our primary goal was to investigate the effects of dexmedetomidine and lidocaine plus adrenaline on visibility of surgical site and postoperative analgesic consumption.

Detailed description: Nasal septoplasty is a surgery procedure which needs to have decrease the bleeding during the surgery for the visibility of surgical site.And postoperative pain is very usual after the surgery, so an effective postoperative analgesia procedure reduces the complications and helps to be discharged earlier from the hospital. An alpha 2 agonist Dexmedetomidine has an analgesic effect and vasoconstructive effect on the periferal blood vessels. Our hypothesis was dexmedetomidine makes a better surgecal conditions during the surgery and reduce the postoperative analgesic consumption. We administered the infiltrated dexmedetomidine or lidocaine plus adrenaline to the both side of the nasal septum 10 minutes before the surgery. Bleeding scores (Fromm and Boezaart Bleeding Scores) were recorded during the surgery. And postoperative analgesic consumptions were recorded in first 24 hours after the surgery.

Eligibility criteria: Inclusion Criteria:

* Scheduled for the nasal septoplasty surgery
* ASA 1-2 patients
* 18-60 yo patients

Exclusion Criteria:

* Pregnant patients
* ASA 3-4 patients
* Under 18 yo childrens

Primary outcomes:
measure: surgical conditions
timeFrame: during the surgery
Secondary outcomes:
measure: Analgesic Consumption
timeFrame: Up to 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: TC Erciyes University
name: Adnan Bayram, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03766386: The Natural History of Danon Disease
Official title: The Natural History of Danon Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Danon Disease
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Rocket Pharmaceuticals Inc.
First posted: 2018-12-06
Enrollment: 200
Sex: ALL
Minimum age (years): 0
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with Danon Disease (LAMP2 mutation) of any sex and any age.

Brief summary: Danon disease (DD) is a rare, X-linked disorder associated with severe cardiomyopathy, and in many cases, skeletal myopathy, and cognitive impairment caused by mutations in the LAMP2 gene. There is still uncertainty regarding the natural history of DD because of its rarity.

This study aims to determine the natural history of DD through the collection and analysis of retrospective and prospective data. To achieve this, the investigators will perform surveys and obtain medical records from DD patients. The same cohort of patients will also be assessed by a multidisciplinary team with expertise in DD (cardiologist, neurologist, ophthalmologist, psychologist, geneticist) at the University of California, San Diego. All patients with DD are eligible, including those who underwent a heart transplant. Additionally, data and records from deceased patients will provide valuable retrospective data for this study.

Detailed description: The study design will include:

1. Collection of information for all patients from:

   * Survey of patient or caregiver (if the patient has deceased)
   * Medical Charts
2. Collection of information from living patients assessed by the multidisciplinary team at the University of California, San Diego including:

   * A complete medical history and physical examination
   * Cardiac Testing (Electrocardiography; Echocardiography; Cardiac magnetic resonance imaging with gadolinium contrast agent-gadolinium contrast is optional-; Cardiopulmonary Test)
   * Pulmonary function testing (PFT)
   * Neuromuscular Assessment
   * Cognitive Tests
   * Vision exam including retinal evaluation
   * Laboratory Tests
   * Questionnaires on Quality of life
   * Needle Skeletal muscle biopsy (only for patients over 18 years old)
   * Abdominal Ultrasound for assessment of the liver structure

Eligibility criteria: Inclusion Criteria:

• Living or deceased patients with a diagnosis of Danon disease(including patients who may or may not have undergone heart transplantation) based on a genetic test positive for the LAMP2 mutation

Exclusion Criteria:

• Patients without a genetic test positive for a LAMP2 mutation

Primary outcomes:
measure: Cardiac structure over time
timeFrame: 6, 12, 18, 24, 30, 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego
state: California
Study officials:
References:
Clinical trial NCT00875186: The Influence of Aerobic Endurance Training After Roux-en-Y-Gastric Bypass
Official title: Impact of Aerobic Physical Exercising on Body Composition and co-Morbidities in Patients After Laparoscopic Roux-en-Y Gastric Bypass
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Morbid Obesity
Keywords: bariatric surgery
co-morbidities
aerobic physical exercise
Lead sponsor: Universitätsmedizin Mannheim
Sponsor class: OTHER
First posted: 2009-04-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: morbidly obese patients underwent laparoscopic Roux-en-Y gastric bypass as a primary procedure for morbid obesity

Brief summary: The aim of this study was to assess the efficiency of aerobic physical exercise (APE) on weight loss, body composition and co-morbidities in patients after laparoscopic Roux-en-Y Gastric bypass (RYGBP).

Detailed description: The only effective treatment for patients with morbid obesity is bariatric surgery. Sudden weight loss following bariatric operations for morbid obesity, such as Roux-en-Y gastric bypass (RYGBP) can result in a concurrent decrease in lean body mass. However the long-time results (weight reduction, elimination co-morbidities) are depending on the post operative treatment. Aerobic physical exercising (APE) is well accepted in conservative treatment of obesity as well as of diabetes mellitus type 2 (DM). The aim of this study was to assess the efficiency of APE on weight loss, body composition and co-morbidities in patients after laparoscopic Roux-en-Y Gastric bypass (RYGBP).

Eligibility criteria: Inclusion Criteria:

* Obesity WHO III

Exclusion Criteria:

* Contraindications of aerobic endurance training

Primary outcomes:
measure: effects of aerobic physical exercising (APE) on weight loss
timeFrame: 10 years
Secondary outcomes:
measure: effects of aerobic physical exercising (APE) on co-morbidities
timeFrame: 10 years
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Department of Surgery, University Hospital Mannheim
Study officials:
affiliation: Universitätsmedizin Mannheim
name: Edward Shang, M.D.
role: STUDY_CHAIR
affiliation: Universitätsmedizin Mannheim
name: Till Hasenberg, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01220986: Liver Regeneration After Liver Resection
Official title: An Observational Study of Liver Regeneration After Right Hepatectomy: Understanding the Molecular Primers of Liver Regeneration
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Diseases
Hepatectomy
Keywords: Liver regeneration
Innate immune response
Lead sponsor: Nottingham University Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2010-10-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing right hepatectomy for colorectal liver metastases.

Brief summary: The aim of this study is to characterize Kupffer cell activity and activation of the innate immune response in the early phase of liver regeneration after right hepatectomy. The investigators hypothesise that liver regeneration after right hepatectomy in humans is associated with Kupffer cell activation and initiation of the innate immune response and that impaired liver regeneration, liver failure and sepsis following liver resection are associated with Kupffer cell dysfunction and an impaired innate immune response. The objectives for this study are to characterise Kupffer cell activity and the innate immune response in human liver before and after right hepatectomy.


Eligibility criteria: Inclusion Criteria:

* Patients requiring right hepatectomy for colorectal liver metastases

Exclusion Criteria:

* Age \>75, neoadjuvant chemotherapy, recurrent disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust, Queens Medical Centre Campus
state: Nottinghamshire
Study officials:
affiliation: Reader in Surgery
name: Dileep N. Lobo, DM FRCS
role: STUDY_CHAIR
References:
Clinical trial NCT04018586: AVACEN Hand Heating on Fasting Blood Glucose
Official title: AVACEN Treatment Method on Fasting and Postprandial Blood Glucose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperglycemia
Hypertension
Lead sponsor: San Diego State University
Sponsor class: OTHER
First posted: 2019-07-12
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A double-blind crossover randomized controlled trial to investigate the effects of the AVACEN device on fasting blood glucose. The AVACEN device creates negative pressure around the hand while heating the palm. Two sham devices, one providing heat but no vacuum and one providing neither heat nor vacuum were also used. Each subject was tested while using each of these three devices on separate visits. Subjects arrived in the morning following an overnight fast. Fasting blood glucose, blood pressure, tympanic temperature, and subjective thermal ratings were measured before and throughout the 30 minutes that the device was used.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects

Exclusion Criteria:

* Diabetes diagnosis, diabetes medication, blood pressure medication

Primary outcomes:
measure: Fasting Blood Glucose
timeFrame: 30 minutes
Secondary outcomes:
measure: Blood Pressure
timeFrame: 30 minutes
measure: Tympanic Temperature
timeFrame: 30 minutes
measure: ASHRAE 7 point thermal sensation scale
timeFrame: 30 minutes
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego State University
state: California
Study officials:
affiliation: Graduate Student
name: Jeff M Moore, B.S./B.S.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06867263: Outcomes of Posterior Urethral Valve Fulguration
Official title: Long-term Evaluation of Patients with Fulguration of Posterior Urethral Valve: a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Posterior Urethral Valve
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 35
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric and children

Brief summary: To evaluate the long-term outcome after fulguration of the posterior urethral valve.

Detailed description: Posterior Urethral Valves (PUV) are the most common cause of lower urinary tract obstruction. More severe forms are detected early in pregnancy (mainly type I), while other forms are usually discovered later in childhood when investigating lower urinary tract symptoms. Bladder dysfunction is common and is associated with urinary incontinence in about 55% (0%-72%). Despite the removal of the obstruction by urethral valve ablation, pathological changes in the urinary tract can occur with progressive bladder dysfunction, which can cause deterioration of the upper urinary tract as well. For this reason, all children with PUV require long-term follow-up, always until puberty. In many cases, the life-long current status is uncertain. The current literature lacks research on long-term outcomes.

Eligibility criteria: Inclusion Criteria:

* Patients with fulguration of PUV since 1 year or more

Exclusion Criteria:

* Patients with neurogenic bladder or meningocele or spina bifida .

Patients with renal parenchymal disease and inflammation not related to posterior urethral valve .

Diabetic patients .

Parental refusal .

Primary outcomes:
measure: The rate of spontaneous voiding with insignificant or absent PMR ( according to equation to age ) after one year from fulguration of the PUV.
timeFrame: One year postoperative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Hennus PM, de Kort LM, Bosch JL, de Jong TP, van der Heijden GJ. A systematic review on the accuracy of diagnostic procedures for infravesical obstruction in boys. PLoS One. 2014 Feb 20;9(2):e85474. doi: 10.1371/journal.pone.0085474. eCollection 2014.
citation: Malin G, Tonks AM, Morris RK, Gardosi J, Kilby MD. Congenital lower urinary tract obstruction: a population-based epidemiological study. BJOG. 2012 Nov;119(12):1455-64. doi: 10.1111/j.1471-0528.2012.03476.x. Epub 2012 Aug 24.
Clinical trial NCT04906863: Genetic Studies of Early-onset Dementia
Official title: Genetic Studies of Early-onset Dementia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dementia, Early Onset
Keywords: Alzheimer's Disease
Memory loss
Early-onset Alzheimer's disease
Mild cognitive impairment
Normal cognition
Dementia
Genetics
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: University of Miami
name: National Institute on Aging (NIA)
First posted: 2021-05-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of individuals affected by dementia, mild cognitive impairment, cognitively healthy individuals, or their family members. Ascertainment is across both males and females, and all race-ethnic groups.

Brief summary: The aim of this study is to identify genetic factors that contribute to risk and progression of early-onset dementia (loss of memory function before the age of 70 years) across all ethnic groups, including Alzheimer's Disease, mild cognitive impairment and other dementias.

Detailed description: The study population includes individuals affected by Alzheimer's Disease, mild cognitive impairment, other dementias, cognitively healthy individuals without memory problems, or their family members.

Ascertainment is across both males and females, and all race and ethnic groups.

Eligibility criteria: Inclusion criteria:

* 18 years and older
* Individuals diagnosed with dementia, their family members and unrelated healthy controls without dementia.

Exclusion Criteria:

-Individuals with competing diagnosis such as Huntington's disease, traumatic brain injury, drug or alcohol abuse, or schizophrenia, etc., unless family members of a dementia affected individual

Primary outcomes:
measure: Genetic risk variants associated with early-onset dementia
timeFrame: 2 years
measure: Changes in blood biomarkers in early-onset dementia
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Christiane Reitz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01234363: Renal Allograft : Evaluation of Parenchymal Fibrosis by Elastography
Official title: Evaluation of the Potential of Elastography for Noninvasive Assessment of Fibrosis in Kidney Transplant
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Transplant
Keywords: Renal allograft
kidney
fibrosis
elastography
elasticity
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2010-11-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to assess the potential of elastography for noninvasive assessment of fibrosis in renal allograft.


Eligibility criteria: Inclusion Criteria:

* Renal allograft performed less than 3 months before enrolment

Exclusion Criteria:

* Contra-indication to magnetic resonance imaging
* Contra-indication to biopsy

Primary outcomes:
measure: Correlation between elasticity (as measured by elastography) and (a) Banff score for fibrosis, (b) glomerular filtration rate assessed by creatinine clearance, (c) glomerular filtration rate assessed by insulin clearance
timeFrame: 3 months and 12 months after graft
Secondary outcomes:
measure: Number of technical failures
timeFrame: 12 months
measure: Tolerance (assessed by a questionnaire)
timeFrame: 3 months and 12 months after graft
measure: Evolution of the elasticity of the transplant between 3 and 12 months after graft
timeFrame: 3 months and 12 months after graft
measure: Correlation between elasticity and arterial resistance index
timeFrame: 3 months and 12 months after graft
Other outcomes:
Locations:
city: Lyon
country: France
facility: Service de Radiologie, Pavillon P Radio, Hôpital Edouard Herriot
Study officials:
affiliation: Hospices Civils de Lyon Service de Radiologie, Pavillon P Radio, Hôpital Edouard Herriot, 69437 Lyon Cedex 03
name: ROUVIERE Olivier, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05551663: Isometric Exercise Training in Participants With Heart Failure With Preserved Ejection Fraction
Official title: Isometric Exercise Training in Patients With Heart Failure With Preserved Ejection Fraction: a Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure With Preserved Ejection Fraction
Keywords: Heart Failure
Isometric Exercise Training
Lead sponsor: St George's, University of London
Sponsor class: OTHER
First posted: 2022-09-23
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Heart failure with a preserved ejection fraction (HFpEF) is a major cause of morbidity and mortality. Hypertension remains one of the major modifiable risk factors in HFpEF development and progression. The role of aerobic exercise training for blood pressure (BP) reduction is well established, with positive cardiac, vascular, and neurohumoral adaptations all cited as potential mechanisms for improving arterial haemodynamics. However, recent evidence has shown that a specific type of resistance exercise alone, known as isometric exercise (IE), produces greater mean BP reductions than what has traditionally been seen with both aerobic and dynamic resistance exercise training programmes. Indeed, short duration IE training causes significant improvements in both cardiac structure and function, in addition to inducing significant reductions in resting BP in normotensive, pre-hypertensive and hypertensive individuals. This study aims to compare the acute and chronic effects of an IE training intervention on diastolic function parameters in patients who have been diagnosed with HFpEF compared to a control group.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with HFpEF.
* Patients under the care of a St George's Heart Failure cardiology consultant.
* Patients willing and able to provide informed consent.
* Male and female, aged 18 years or above.
* Medically optimised patients.

Exclusion Criteria:

* Recent myocardial infarction or electrocardiographic changes, complete heart block, unstable angina.
* Inability or unwilling to provide informed consent.
* Male and female, aged 17 years or younger.
* Patients with HFrEF.
* Patients with musculoskeletal injury that could conceivably be affected by their involvement.
* Resting BP values of ≥180/110 mmHg.
* Patients unable to understand verbal and written English.

Primary outcomes:
measure: Diastolic function
timeFrame: 1-year
Secondary outcomes:
measure: Blood pressure
timeFrame: 1-year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04745663: Optimizing Preoperative Disinfection of Eyes
Official title: Optimizing Preoperative Disinfection of Eyes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Eye Infections
Keywords: Disinfection
Pre-operative
Povidone Iodine
Eye surgery
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2021-02-09
Enrollment: 150
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Both eyes of the participants are tested; one eye randomised to receive the intervention and the second eye to receive the standard disinfection.
Primary purpose: PREVENTION

Brief summary: Topical povidone-iodine (PI) is widely used as ocular antiseptic before and after surgery. The standard dose of 5% PI is however, associated with ocular irritation. We therefore want to test if a lower concentration of PI can be similarly efficacious in reducing bacterial growth while reducing ocular irritation.


Eligibility criteria: Inclusion Criteria:

* Patients remitted to intravitreal injections at St. Olavs hospital.
* Patients competent to give written consent

Exclusion Criteria:

* Infectious disease
* Known epitheliopathy
* Contact lens wear
* Use of prescription ophthalmic medications
* Diabetes

Primary outcomes:
measure: Conjunctival bacterial culture
timeFrame: 1 hour. Bacterial sample is taken before and immediately after disinfection
Secondary outcomes:
measure: Patient pain score
timeFrame: During disinfection and after 1 hour when the anesthetic no longer is effective
measure: Ocular staining score (OSS)
timeFrame: 1 hour after disinfection
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: Norwegian University of Science and Technology
name: Jorunn Helbostad, MD PhD
role: STUDY_DIRECTOR
affiliation: Clinic of Ear-Nose-Throat, Eye and Maxillofacial Surgery, St. Olavs Hospital
name: Marit Fagerli, MD
role: STUDY_DIRECTOR
References: