louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05995379: Donor Derived Cell-free DNA and Rejection of Kidney Allografts
Official title: Donor Derived Cell-free DNA and Rejection of Kidney Allografts
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Rejection Transplant
Lead sponsor: Paris Translational Research Center for Organ Transplantation
Sponsor class: OTHER
First posted: 2023-08-16
Enrollment: 2500
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Kidney transplant recipients recruited in 14 French centers

Brief summary: To assess the association of dd-cfDNA with the presence, activity and severity of allograft rejection, and determine whether dd-cfDNA adds value to standard of care monitoring parameters in detecting kidney allograft rejection.


Eligibility criteria: Inclusion Criteria:

* Recipients transplanted from a deceased or living donor, who undergone a kidney allograft biopsy with clinical, biological, histological and immunological data.
* Written informed consent at the time of transplantation for the center database

Exclusion Criteria:

* Combined organ transplantation
* Pregnant women
* Bone marrow transplant

Primary outcomes:
measure: The occurrence of biopsy-proven allograft rejection at the time of dd-cfDNA measurement
timeFrame: The allograft biopsies will be performed at 3 months and 1 year after transplant and/or in for cause biopsies performed at any time post transplantation in unstable patients.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Paris Institute for Transplantation and Organ Regeneration
name: Alexandre Loupy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06910579: Oxygenated Gel Therapy in the Management of Oral Aphthous Ulcers
Official title: Efficacy of Oxygenated Gel Therapy in the Management of Oral Aphthous Ulcers: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Aphthus Ulcer
Lead sponsor: British University In Egypt
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Interventions of both groups:

Oxygenated gel Group: 15 patients who used oxygenated gel (Blue®m, Wijhe, Netherlands) were trained by the co-investigator (A.H) through real demonstration for topical application of the gel on aphthous ulcers, which entails the application of 1-2 ml of oxygenated gel directly to the ulcer two times per day and this was repeated for 7 days.

Triamcinolone acetonide Group: 15 patients were treated with Kenalog in orabase (Triamcinolone acetonide 0.1% oral paste 5g), four times (i.e., at 8 am, 12 noon, 4 pm, and 8 pm) a day for 7 days at intervention group.

Patients in both groups were reexamined after treatment at different intervals (day 3, day 5, day 7, and day 10).


Eligibility criteria: Inclusion Criteria:

* Clinically diagnosed patients with chronic aphthous stomatitis measuring ≤6 mm in size in the oral cavity and who gave written consent for participation.
* Only single ulcers were considered for the study.
* Systemically healthy patients.

Exclusion Criteria:

* The study excluded patients with a history of associated systemic disease.
* Cases of chronic aphthous stomatitis (major), lesions of herpetic form, numerous aphthae, and smoking.
* Patients with a history of hypersensitivity to the used agents.
* Pregnancy and lactation

Primary outcomes:
measure: Pain intensity
timeFrame: 10 days
Secondary outcomes:
measure: Size of ulcers (in mm)
timeFrame: 10 days
measure: Complete healing duration
timeFrame: 10 days
measure: OHIP-14
timeFrame: 10 days
Other outcomes:
Locations:
city: Al Sherouk City
country: Egypt
facility: British University in Egypt
state: Cairo
Study officials:
References:
Clinical trial NCT04356079: Familial and Environmental Factors Behind Migraine
Official title: Familial and Environmental Factors Behind Migraine
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Migraine
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-04-22
Enrollment: 80
Sex: ALL
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Observational model: FAMILY_BASED
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from Headache between 15 and 45 years old

Brief summary: Migraine is a chronic neurological disease characterized by recurrent moderate to severe headaches often in association with a number of autonomic nervous system symptoms. Migraines are believed to be due to a mixture of environmental and genetic factors. About two-thirds of cases run in families. Changing hormone levels may also play a role, as migraines affect slightly more boys than girls before puberty, but about two to three times more women than men after puberty. The risk of migraines usually decreases during pregnancy. The exact mechanisms of migraine are not known. It is, however, believed to be a neurovascular disorder. The primary theory is related to increased excitability of the cerebral cortex and abnormal control of pain neurons in the trigeminal nucleus of the brainstem.

Detailed description: Environmental influences play a role, but family studies suggest that defective genes may be primarily involved in disease causation. The mode of transmission of typical migraine in families is still unclear, but it is widely believed to be multifactorial although a role for a major susceptibility gene cannot be excluded. Aim of study: we aim to study the familial risk for developed migraine and its relation to EEG changes.

Eligibility criteria: Inclusion Criteria:

* Fullfilled Migraine chriteria

Exclusion Criteria:

* Genereal Neurologic Disease

Primary outcomes:
measure: Diagnosis of risk factors for migraine
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04327479: Characterization of Cardiovascular Diseases and Risk Factors in Patients With Suspected SARS-CoV2/Covid-19 Infection
Official title: Characterization of Cardiovascular Diseases and Risk Factors in Patients With Suspected SARS-CoV2/Covid-19 Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Cardiovascular Risk Factor
SARS
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
First posted: 2020-03-31
Enrollment: 728
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: The registry will include consecutive patients, tested for suspected SARS-CoV2/Covid-19 infection at the University Hospital Essen

Brief summary: The Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infects host-cells via ACE2-receptors, which leads to pneumonia (COVID-19) but also can lead to myocarditis (acute myocardial injury) and chronic damage to the cardiovascular system. Therefore, cardiovascular protection may be necessary when treating patients with COVID-19 infection. This may especially be necessary in patients with cardiovascular diseases, risk factors, and co-medication.


Eligibility criteria: Inclusion Criteria:

* Patients with suspected SARS-CoV2/Covid-19 infection

Exclusion Criteria:

* Unwillingness to participate

Primary outcomes:
measure: All-cause mortality
timeFrame: During 1 year follow-up
Secondary outcomes:
measure: 30-day mortality
timeFrame: Within 30 days after inclusion
measure: Major adverse cardiovascular events
timeFrame: During 1 year follow-up
Other outcomes:
Locations:
city: Essen
country: Germany
facility: University Hospital Essen
state: NRW
Study officials:
affiliation: University Hospital Essen, Deparment of Cardiology and Vascular Medicine
name: Tienush Rassaf, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06564779: Development, Standardisation and Standardisation Project for a New Memory Assessment
Official title: Development, Standardisation and Standardisation Project for a New Memory Assessment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Memory Disorders
Keywords: Alzheimer
Episodic memory
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2024-08-21
Enrollment: 150
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient attending a memory consultation for suspected Alzheimer's disease.

Brief summary: Episodic memory (EM) is a neuropsychological marker of Alzheimer's disease (AD) (Thomas-Anterion, 2006). Current tests for its assessment do not take into account the identity and emotional aspects of memory (Van der Linden et al., 2018). However, there are models that integrate links with identity, self-awareness and experience. Pause et al. (2013) propose criteria to create ecological tools, including consideration of the emotional valence of memories and the spatio-temporal context of acquisition. In line with these criteria, we have developed a new tool: the NEM (New evaluation of Episodic Memory). Preliminary studies show different response profiles on the NEM among patients (Launay et al., 2023). We now want to evaluate the relevance of this tool in the differential diagnosis of AD.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 50 years
* Ability to understand judged sufficient by the assessor;
* Amnesic MCI profile (Petersen, 2003) during the 1st medical consultation prior to the assessment being prescribed.

Exclusion Criteria:

* Severe auditory and/or visual sensory impairment not compatible with neuropsychological assessment;
* Judged fit to take the test by the assessor;
* Patient under guardianship, curatorship or family guardianship;
* Opposition to data processing.

Primary outcomes:
measure: Score total NEM (new memory assessment)
timeFrame: baseline
Secondary outcomes:
measure: NEM sub-scores
timeFrame: baseline
measure: Total RL/RI 16 Recall
timeFrame: baseline
measure: Delayed Mem Logic Recall
timeFrame: baseline
Other outcomes:
Locations:
city: Tours
country: France
facility: University hospital
Study officials:
affiliation: Tours University Hospital
name: Alix LAUNAY
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01837784: Central Hemodynamics
Official title: Value of Non-invasively Measured Arterial Stiffness and Central Hemodynamics for Guiding Antihypertensive Treatment in Selected Patient Populations
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension
Lead sponsor: Luzerner Kantonsspital
Sponsor class: OTHER
First posted: 2013-04-23
Enrollment: 100
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: Patients referred for optimization of antihypertensive treatment to Luzerner Kantonsspital, Switzerland.

Brief summary: Guidelines recommend measuring end organ damage and in particular arterial stiffness in patients with hypertension. However, until now it was not possible to measure arterial stiffness with the use of simple methods. Recently, novel and innovative devices offering determination of arterial stiffness and central hemodynamics from simple and non-invasive arm cuff measurements have now become available. This study therefore evaluates the value of non-invasively measured arterial stiffness and central hemodynamics for guiding antihypertensive treatment in selected patient populations (i.e. elderly patients, patients with diabetes mellitus, patients with heart failure, and patients with resistant hypertension).


Eligibility criteria: Inclusion Criteria:

* Patients \>70 years (elderly cohort)
* Patients with diabetes mellitus (diabetes cohort)
* Patients with heart failure (heart failure cohort)
* Patients with resistant hypertension (resistant hypertension cohort)

Exclusion Criteria:

* Patient refuses study participation
* Severe renal failure
* Reduced life expectancy

Primary outcomes:
measure: Arterial stiffness and central hemodynamics
timeFrame: 3 months
measure: Cognitive function
timeFrame: 3 months
Secondary outcomes:
measure: Physical function
timeFrame: 3 months
measure: Orthostatic hypotension and falls
timeFrame: 3 months
measure: Renal failure
timeFrame: 3 months
Other outcomes:
Locations:
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital
Study officials:
affiliation: Luzerner Kantonsspital
name: Paul Erne, MD
role: STUDY_CHAIR
affiliation: Luzerner Kantonsspital
name: Paul Erne, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University hospital of Bern
name: Andreas W Schoenenberger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02966184: Comparison of Albuterol for Status Asthmaticus
Official title: Comparison of Benzalkonium Chloride Containing Albuterol Versus Preservative Free Albuterol for the Treatment of Status Asthmaticus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Status Asthmaticus
Lead sponsor: Norton Healthcare
Sponsor class: OTHER
First posted: 2016-11-17
Enrollment: 8
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to compare the length of continuous albuterol administration between two different albuterol formulations, BAC containing albuterol versus preservative free albuterol.

Detailed description: The primary objective of this study is to compare the length of continuous albuterol administration between patients receiving BAC containing albuterol versus preservative free albuterol. Secondary objectives include comparison of therapy escalation, asthma scores, forced expiratory volume in one second (FEV1) at discharge, length of hospital stay, and cost.

Eligibility criteria: Inclusion Criteria:

* Patients will be included in the study if they are admitted to the 5th floor of Norton Children's Hospital for the treatment of an acute asthma exacerbation, initiated on continuous albuterol inhalation therapy, and are between 5 and 17 years of age.

Exclusion Criteria:

* Patients will be excluded from the study if they are transferred from the 5th floor to the Pediatric Intensive Care Unit (PICU), admitted for any indication other than acute asthma exacerbation, or removed from the inpatient asthma protocol for any given reason.

Primary outcomes:
measure: Albuterol Administration
timeFrame: Hours until discontinuation of therapy, an average of 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Norton Children's Hospital
state: Kentucky
Study officials:
affiliation: Norton Healthcare
name: Tristan Murray, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04251884: Pudendal Nerve Block for Hemorrhoidectomy
Official title: Pudendal Nerve Block in Patient Treated for Hemorrhoidectomy Under Spinal Anaesthesia: Prospective Randomized Double-blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemorrhoids
Postoperative Pain
Lead sponsor: Ospedale Regionale Bellinzona e Valli
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized
Primary purpose: TREATMENT

Brief summary: Patients undergoing Milligan-Morgan hemorrhoidectomy will be randomized to receive or not the pudendal nerve block after the spinal anesthesia.

Detailed description: Patients included were those undergoing Milligan-Morgan hemorrhoidectomy under spinal anaesthesia from January 2018 to December 2019. Exclusion criteria were age \< 18 years old, pregnancy and allergy to local anaesthetics. Patients meeting inclusion and exclusion criteria were randomized to undergo an ultrasound-guided pudendal nerve block. Per-protocol all patients received postoperative metronidazole 500 mg for 3 days, laxative, a basis analgesia with NSAID and opioids as needed. Postoperative pain on the visual analogue scale (VAS) at 6, 12, 24 and 48 hours, opioids needed, complications and length of hospital stay were recorded. Patients and ward personnel were not informed about the treatment arm. All Patients were further controlled 6 weeks after the intervention.

Eligibility criteria: Inclusion criteria:

* Patients affected by haemorrhoids (grade III and IV) and treated with Milligan-Morgan hemorrhoidectomy under spinal anaesthesia
* Signed informed consent

Exclusion criteria:

* Age \< 18 years old
* Pregnancy
* Allergy to local anaesthetics

Primary outcomes:
measure: Postoperative Pain on the Visual Analogue Scale (VAS)
timeFrame: at 24 hours after the hemorrhoidectomy
Secondary outcomes:
measure: Postoperative Pain on the Visual Analogue Scale (VAS)
timeFrame: at 6, 12 and 48 hours after the operation
measure: Opioids Consumption
timeFrame: Within 48 hours
measure: Lenght of Hospital Stay
timeFrame: up to 2 weeks
measure: Complications Related to the Pudendal Nerve Block
timeFrame: Within 6 weeks
measure: Direct and Indirect Cost Analysis in Out- and In-patients
timeFrame: Within the hospital stay
Other outcomes:
Locations:
city: Bellinzona
country: Switzerland
facility: Ospedale Regionale di Bellinzona e Valli
Study officials:
References:
citation: Di Giuseppe M, Saporito A, La Regina D, Tasciotti E, Ghielmini E, Vannelli A, Pini R, Mongelli F. Ultrasound-guided pudendal nerve block in patients undergoing open hemorrhoidectomy: a double-blind randomized controlled trial. Int J Colorectal Dis. 2020 Sep;35(9):1741-1747. doi: 10.1007/s00384-020-03630-x. Epub 2020 May 30.
Clinical trial NCT00881179: To Demonstrate the Relative Bioavailability of Clarithromycin 250 mg Tablets Under Non-Fasting Conditions
Official title: A Relative Bioavailability of Clarithromycin 250 mg Tablets Under Non-Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Antibiotic
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-04-15
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To demonstrate the relative bioavailability of Cilostazol 50 mg tablets under fasting conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Bioequivalence based on AUC and Cmax
timeFrame: 9 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Novum Pharmaceutical Research Services
name: So Ran Hong, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01131884: Pilot Study of Fosamax in Spinal Cord Injury
Official title: Double Blind Placebo Controlled Trial to Evaluate Preservation of Bone Mineral Density of the Hip and Distal Femur by Biphosphate Therapy (Fosamax) Following Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Spinal Cord Injury
Osteoporosis
Keywords: ASIA A or ASIA B Spinal Cord Injury
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2010-05-27
Enrollment: 1
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: PREVENTION

Brief summary: Study is designed to evaluate the efficacy of oral fosamax in prevention on osteoporosis in acute spinal cord injury. Efficacy will be measured by a duel energy X-Ray absorptiometry (DEXA) scan every 6 months. Patients will complete 3 visits, screening, 6 months, 12 months and be required to take oral fosamax versus placebo weekly.

Detailed description: The project was funded on August 13, 2009 and was awarded to one of our trainees, Dr. Matthew Abraham, a PGY3 in our program and our IRB approval was obtained with much time and effort on February 24, 2010. We followed the protocol and so far we recruited just one patient on September 19, 2011 who completed the study but we encountered with many unexpected obstacles to recruit any more patients to the study. The main obstacle was that the spine surgeons' refusal to start the study drug for months after surgery for fear of complications with wound healing. Secondly, the few appropriate and eligible patients we tried to recruit declined to participate.

We were unable to recruit any more patients to this study and hence the study was closed.

The one patient that was recruited completed the study. Since it is only one subject in the study, no conclusions can be drawn.

Eligibility criteria: Inclusion Criteria:

* American Spinal Cord Injury Association (ASIA) A or American Spinal Cord Injury Association (ASIA) B Spinal Cord Injury

Exclusion Criteria:

* History of hypersensitivity to alendronate or other bisphosphonates
* esophageal abnormality
* inability to sit/stand upright for 30 minutes
* creatinine clearance less than 35 milliliters/minute
* hypothyroidism
* malignancy
* pregnancy
* prolonged steroid use

Primary outcomes:
measure: Bone Mineral Density
timeFrame: 1 year after enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Physical Medicine and Rehabilitation
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Kanakadurga R Poduri, M.D.
role: PRINCIPAL_INVESTIGATOR
References: