louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01989832: Pharmaco-economical Study in Kidney Transplantation
Official title: Pharmaco-economical Study in Kidney Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Transplant
Keywords: cohort
pharmaco-economic
kidney
transplantation
quality of life
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2013-11-21
Enrollment: 570
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: renal transplant patients

Brief summary: The prevalence of renal acute rejection in transplantation is reduced thanks to the optimized use of immunosuppressive drugs. However, graft survival at ten years has not improved since then; this may be explained in part by the toxicity of these drugs, viral infections, and other comorbidities (diabetes, cardiovascular diseases ...).

According to transplant center, strategies for the combination of immunosuppressive drugs are different, and probably involve a difference in the global cost of patient management. There is no recommendation in France to establish similar practices.

EPHEGREN is an observational, prospective, multicentric, pharmacoeconomic study for the renal transplant patients.


Eligibility criteria: Inclusion Criteria:

* Patients in the first month of renal graft, or patients already included in an other epidemiological French study (EPIGREN) in the 0-6 month period
* Men of women aged more than 18 years
* Patients able to exercise in writing their informed and free consent to participate to the biological collection
* Patients not opposing to collect their medical data
* Patients registered with a social security system
* Patients able to complete the questionnaires

Exclusion Criteria:

* Patients aged less than 18 years and patients under guardianship
* Patients with a follow-up at another center other than those part of the study

Primary outcomes:
measure: Number of Death
timeFrame: 4 years
Secondary outcomes:
measure: to examine nature, dose and exposure in immunosuppresseurs.
timeFrame: 4 years
Other outcomes:
Locations:
city: Limoges
country: France
Study officials:
References:
Clinical trial NCT00750932: Biodistribution of Neutrophile Proteases in the Sputum of Patients Affected by Cystic Fibrosis
Official title: Study of the Biodistribution of PMN Serine Proteases in Sputum of Patients Affected by Cystic Fibrosis: Towards New Anti-inflammatory Therapies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2008-09-11
Enrollment: 52
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults and children with cystic fibrosis

Brief summary: The purpose of the proposed project is to characterize the neutrophile proteases which participate in the chronic inflammatory phenomenon associated with the cystic fibrosis and which are responsible for the degradation of the lung tissue.

The respiratory failure which results from it is one of main causes of the fatal evolution of this pathology but the anti-inflammatory therapies based on the use of antiproteases targeting specifically the soluble elastase did not end, until now, in the hoped results.

The identification of the other noxious targets is a crucial element to give new orientations to the anti-inflammatory strategies based on the administration of antiproteases which remain a promising way.


Eligibility criteria: Inclusion Criteria:

* Man /woman older than 18 years (for adult and group)
* Child aged 6 to 18 years (for child group)
* Suffering from cystic fibrosis in stable condition, ie not having presented thrust acute attack of the broncho-pulmonary or hospitalization for treatment of his illness during the previous 2 weeks

Exclusion Criteria:

* colonized by Burkholderia cepacia ou Stenotrophomonas maltophilia
* non smoker (control group)
* Without history or respiratory respiratory disease known (control group)
* Antibiotic treatment and / or anti-inflammatory drug (NSAID or corticosteroids) in the 2 weeks prior to the inclusion in the study (control group)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tours
country: France
facility: CHRU de Tours
Study officials:
affiliation: Tours Hospital
name: Patrice DIOT, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05922332: Application and Effect Evaluation of Medium Chain Fatty Acid Rich Milk Powder in Infants With Cholestatic Liver Disease
Official title: Application and Effect Evaluation of Medium Chain Fatty Acid Rich Milk Powder in Infants With Cholestatic Liver Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cholestatic Liver Disease
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2023-06-28
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To verify the effect of feeding milk powder rich in medium chain fatty acids on improving the nutritional status and disease status of infants with cholestatic liver disease and To evaluate the safety of feeding milk powder rich in medium chain fatty acids in infants with cholestatic liver disease.

Detailed description: This study will include all types of cholestatic liver disease in infants, randomized controlled study of the efficacy and safety of intervention with rich medium chain fatty acid milk powder,To verify the effect of feeding milk powder rich in medium chain fatty acids on improving the nutritional status and disease status of infants with cholestatic liver disease .

Eligibility criteria: Inclusion Criteria:

* meets the diagnostic criteria of cholestasis
* Artificial feeding (formula feeders)
* Age ≤6 months
* The course of cholestasis was \> 1 month
* Informed consent of the guardian

Exclusion Criteria:

* There are major non-cholestatic genetic diseases leading to nutritional intake disorders, such as gastrointestinal malformations
* Cholestasis with ascites and diarrhea
* In patients with oxidative impairment of medium chain fatty acids

Primary outcomes:
measure: Z-scores of weight for age
timeFrame: "from enrollment to the 4 weekend(28 days)"
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: zhaoyang Gou
Study officials:
affiliation: employee
name: Children's Hospital of Fudan University Children's Hospital of Fudan University
role: STUDY_CHAIR
References:
Clinical trial NCT02030132: Way to Be Active V (Framing vs. Forgiveness)
Official title: A Randomized Trial of Behavioral Economic Interventions to Improve Physical Activities: Framing vs. Forgiveness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Lifestyle
Keywords: Physical activity
Sedentary lifestyle
Pedometers
Walking
Financial Incentives
Behavioral Economics
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2014-01-08
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Employers are increasingly looking for opportunities to motivate sedentary employees to become more physically active. Workplace walking programs have had mixed success and typically show most improvement among participants that are already fairly active at a baseline. The goal of this study is to determine whether a financial incentive program can motivate sedentary employees to increase the number of steps they walk per day to meet a minimum threshold.

The primary outcome measure is the proportion of days a minimum activity of 7000 steps or more is achieved. Outcomes will be assessed each week for 3 months using incentives followed by 3 months of follow-up without incentives. Secondary outcomes will include the average steps walked per day.


Eligibility criteria: Inclusion Criteria:

* Age greater than 18.
* Participant will need an iPhone or Android smartphone to be able to use the Moves App for tracking steps

Exclusion Criteria:

* Pregnant or lactating
* Participating in another physical activity study

Primary outcomes:
measure: Proportion of days an individual walks 7000 steps or more
timeFrame: End of study - 6 months after enrollment
Secondary outcomes:
measure: Average number of steps per day and week
timeFrame: End of study- 6 months after enrollment
Other outcomes:
measure: Change in physical activity
timeFrame: End of study- 6 months after enrollment
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Kevin M Volpp, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Mitesh Patel, MD, MBA
role: STUDY_DIRECTOR
References:
Clinical trial NCT05111132: Can Peripheral NIRS Predict the Response to a Fluid Challenge in Pediatric Patients: An Interventional Study
Official title: Can Peripheral NIRS Predict the Response to a Fluid Challenge in Pediatric Patients: An Interventional Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2021-11-08
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study will be conducted on pediatric patients up to 14 years of age. The effect of two fluid challenge regimes on cerebral and peripheral NIRS will be assessed, in a randomized double blinded controlled trial. The findings will be correlated with two ultrasound measures, previously validated as markers of fluid responsiveness.

Detailed description: The patients will be recruited during the preoperative consultation. After inhalational induction and placement of all monitors, an intravenous access is established. After induction and securing of the airway via endotracheal tube or laryngeal mask, we note the reference values of all parameters. A pre-fluid challenge ultrasound is done, to assess the inferior vena cava distensibillity index, and the Vmax aortic peak flow velocity. After this the fluid challenge is performed. The second ultrasound measures are done after the fluid challenge. Finally an ultrasound is performed at the end of the operation, before emergence, to assess wether the standard peroperative fluid therapy has affecter these measures. NIBP, SpO2, HR, RR, NIRS values will be noted throughout the whole perioperative period. THe end-goald is to correlate the ultrasound findings to the NIRS-values, and see wether the NIRS can be used as a monitor of fluid therapy in pediatric patients.

Eligibility criteria: Inclusion Criteria:

* all operations excepting cardiac surgery
* BMI \< 30
* ages 1-14 years

Exclusion Criteria:

* any cardiac affection (congenital unoperated heart disease, arrythmias)
* icterus
* refusal

Primary outcomes:
measure: Effect of fluid challenge on quadricipital NIRS
timeFrame: 6 hours
measure: Effect of fluid challenge on deltoid NIRS
timeFrame: 6 hours
measure: Effect of fluid challenge on cerebbral NIRS
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Erasmus Hospital
Study officials:
affiliation: Medical doctor
name: Pierre Pandin, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01823432: Genetic Risks for Bicuspid Aortic Valve Disease
Official title: Genetic Risks for Bicuspid Aortic Valve Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bicuspid Aortic Valve
Unicuspid Aortic Valve
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2013-04-04
Enrollment: 454
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults at least 18 years old with unicuspid or bicuspid aortic valves

Brief summary: Bicuspid Aortic Valve (BAV) is the most common congenital heart malformation in adults, but very little is known about the genetic causes or risk factors for adverse outcomes. Currently, it is estimated that most cases of aortic stenosis in patients less than 65 years old are caused by BAVs. BAV patients are also at high risk to develop aneurysms of the ascending aorta, which may lead to aortic dissections. Dr. Prakash and his colleagues plan to use individual genetic information to identify persons with BAV who are at high risk for complications and to customize therapies.

Detailed description: To be included in the study, patients must have a bicuspid or unicuspid aortic valve, documented by clinical history or imaging studies. If the aortic valve was replaced surgically, they may still be eligible. Participants will be asked to donate a single tube of blood and fill out a questionnaire. Patients will also be followed up by telephone or email about once a year to determine if they experience any medical complications related to Bicuspid Aortic Valve (BAV), such as aortic aneurysms, aortic dissections or valve disease. Patients may not be included if they are less than 18 years old at the time of recruitment or have a recognized genetic syndrome or genetic mutation such as Marfan or Ehlers-Danlos syndrome.

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Diagnosis of bicuspid or unicuspid aortic valve

Exclusion Criteria:

* Less than 18 years of age
* Recognized syndrome or identified genetic mutation

Primary outcomes:
measure: Thoracic aortic aneurysms and dissections
timeFrame: 10 years
measure: Aortic valve replacement surgery
timeFrame: 10 years
Secondary outcomes:
measure: Aortic enlargement
timeFrame: 10 years
Other outcomes:
measure: Aortic valve degeneration
timeFrame: 10 years
Locations:
city: Houston
country: United States
facility: University of Texas Health Science Center Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Siddharth Prakash, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05930132: The Role of the Submucosal Conchoplasty Technique in Improving the Postoperative Middle Meatus Outcome After ESS
Official title: The Role of Using the Submucosal Conchoplasty Technique for the Management of Concha Bullosa in Decreasing the Postoperative Middle Meatus Synechia Formation After Endoscopic Sinus Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endoscopic Sinus Surgery
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2023-07-05
Enrollment: 56
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 study aimed to compare the applicability of the classic lateral lamellectomy versus the submucosal conchoplasty techniques in managing the concha bullosa during and after ESS.

Detailed description: The study included fifty-six patients with bilateral concha bullosa who were undergoing primary ESS for refractory chronic sinusitis. They were divided into two equal groups randomly. One group had the submucosal conchoplasty technique, and the other group had the lateral lamellectomy technique. The study compared the intraoperative findings including the time required for each technique and the amount of intraoperative bleeding. Furthermore, it compared the postoperative endoscopic outcome of the middle meatus and middle turbinate stability using the LKES and the POSE score. Also, the postoperative olfaction outcome was assessed.

Eligibility criteria: Inclusion Criteria:

* patients above 18 years
* patients diagnosed with chronic sinusitis based on the 2012 European Position Paper on Rhino-sinusitis and Nasal Polyps's criteria (EPOS 2012)
* patients presented by bilateral concha bullosa

Exclusion Criteria:

* patients below 18 years
* smokers
* patients with nasal polyps
* patients with primary ciliary dyskinesia
* patients with nasal masses
* revision cases

Primary outcomes:
measure: the clinical symptoms before and after the surgery through the Sino-nasal outcome test 22. (SNOT 22)
timeFrame: Patients were followed up at the end of six month after surgery ( change from baseline )
Secondary outcomes:
measure: the time of the technique
timeFrame: during the operation
measure: the amount of bleeding
timeFrame: during the operation
Other outcomes:
Locations:
city: Sakha
country: Egypt
facility: Kafrelsheikh university
state: Kafrelsheikh
Study officials:
References:
Clinical trial NCT06613932: Assessment of L-PRF, Nanohydroxyapatite Combined With L-PRF Using Pulpotomy in Mature Mandibular First Molars
Official title: Clinical and Radiographic Assessment of L-PRF, Nanohydroxyapatite Material Combined With L-PRF Scaffold in Vital Pulp Therapy. Treatments in Mandibular First Molars With Closed Apices "Randomized Controlled Trial"
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Irreversible Pulpitis
Lead sponsor: Future University in Egypt
Sponsor class: OTHER
First posted: 2024-09-26
Enrollment: 45
Sex: ALL
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clinical and Radiographic Assessment of L-PRF, Nanohydroxyapatite material combined with L-PRF scaffold in Vital pulp Therapy. Treatments in Mandibular First Molars with Closed Apices, Randomized Controlled Trial.

Detailed description: pulpotomy by using 3 materials. The first group(control group ) uses hydroxyapatite material as a pulpotomy agent, and the second group uses L-PRF as a pulpotomy agent. the third group uses combined material (L-PRF = Nano hydroxyapatite )as a pulpotomy agent .. then assesses the clinical and radiographic result of the 2 interventions group with control group

Eligibility criteria: Inclusion criteria:

Patients should be free from any systemic disease. Patients of either gender aged from 15-30. Patients will agree to the consent and will commit to a follow-up period. Soft tissues around the tooth are normal with no swelling or sinus tract. The tooth is restorable tooth has signs and symptoms of irreversible pulpitis of the mature root The tooth doesn\&#39;t contain any internal or external resorption or periapical lesions.

The tooth should give a positive response to the cold test.

Exclusion criteria:

Pregnant and lactating females. Patients with Mental disturbance. Patients who could/would not participate in a 6-month follow-up. A tooth with immature roots. Patients with necrotic pulp.• tooth with periapical lesions or infections. Soft tissue having fistula or swelling Homoeostasis after 10 minutes can not be controlled after total pulpotomy

Primary outcomes:
measure: post operative Pain assessment
timeFrame: 6, 12, 24, 72hours and 7 days after treatment
Secondary outcomes:
measure: Dentine bridge formation
timeFrame: 12 months post operative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: future university in Egypt
state: New Cairo
Study officials:
affiliation: future
name: wael K hussein, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02154932: Single Versus Double Dose Intra-vaginal Prostaglandin E2 "Misoprostol" Prior Abdominal Myomectomy
Official title: Single Versus Double Dose Intra-vaginal Prostaglandin E2 "Misoprostol" Prior Abdominal Myomectomy: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prostaglandin E2 "Misoprostol" Prior Abdominal Myomectomy
Keywords: Myomectomy, Misoprostol
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2014-06-03
Enrollment: 69
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: Introduction: The study aimed to investigate the effectiveness of a single versus double dose of Prostaglandin E2 "Misoprostol, 400 microgram" during myomectomy for multiple uterine fibroids. This was a prospective randomized controlled trial comprised of 69 patients with multiple myomas undergoing myomectomy. Patients randomly allocated to either an intra-vaginal single dose of 400 microgram Misoprostol 1 hour pre-operatively (group A, 34 cases) or 2 doses, 3 and 1 hours, prior surgery (group B, 35 cases). Operation time, intra and post-operative blood loss, hemoglobin concentration, blood pressure and body's temperature were estimated and compared in both groups.


Eligibility criteria: Inclusion Criteria:

* All patients had symptomatic multiple uterine fibroids (abnormal vaginal bleeding, lower abdominal dull aching pain and pelvic heaviness, subfertility or recurrent abortion)

Exclusion Criteria:

* hypertension, cardiac and pulmonary disease, chronic endocrine or metabolic diseases such as diabetes, obesity (body mass index \>30 kg/m2), all cases of single myoma and those known to be allergic to prostaglandin preparations.

Primary outcomes:
measure: the operative time
timeFrame: from skin to skin in minutes
measure: intra and post-operative blood loss
timeFrame: during and 6 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: