louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03654430: Study by 2D-strain of the Ventricular Wall Motion During Postnatal Adaptation
Official title: Longitudinal Study by 2D-speckle-tracking Echocardiography of the Ventricular Wall Motion During Postnatal Adaptation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Left ventricular Twist
2D-speckle-tracking
Postnatal adaptation
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: TIMC-IMAG
First posted: 2018-08-31
Enrollment: 36
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The left ventricular torsion during systole and diastole is a normal dynamic mechanism which participates in the ejection and the filling of the left ventricle. Postnatal hemodynamic modifications are major and probably affect this mechanism. The aim of this study is to compare the left ventricular twist in healthy newborns, between their first days of life and their third month of life, using the 2D-speckle tracking echocardiography.

Detailed description: The left ventricular torsion during systole and diastole is a normal dynamic mechanism which participates in the ejection and the filling of the left ventricle. Postnatal hemodynamic modifications are major and probably affect this mechanism.

The main objective is to compare the left ventricular twist mechanism in healthy newborns, at birth and at their third month of life, using the peak LV twist as primary endpoint. Secondarily, we compare other LV rotation and deformation parameters during the same period: peak LV torsion, peak LV twist rate, peak LV untwist rate, circumferential strain and radial strain. Finally, we compare the endo- and epicardial LV deformation, using the inner and outer circumferential strain as endpoints.

This is a longitudinal, prospective and monocentric study in the Grenoble-Alpes University Hospital between April 2018 and September 2018.

The number of required subjects is 30 with a statistical power of 80% and a p-value of 0,05

Eligibility criteria: Inclusion Criteria:

* Newborn hospitalized in the Grenoble University Hospital Maternity Unit
* Aged between 2 and 5 day of life at the first echocardiography
* Social security affiliation
* Signature of the consent document by both parents

Exclusion Criteria:

* Birth before 37 weeks gestation
* Birth weight \< 2,5kg or \> 4,5kg
* Gestational Diabetes Mellitus during pregnancy
* Fetal heart disease

Primary outcomes:
measure: Left ventricular Twist
timeFrame: 3 months
Secondary outcomes:
measure: Left ventricular Rotation
timeFrame: 3 months
measure: Untwist
timeFrame: 3 months
measure: Left ventricular deformation
timeFrame: 3 months
measure: Comparison between Endocardial and Epicardial deformation
timeFrame: 3 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Johanne Auriau
Study officials:
References:
Clinical trial NCT01509430: DAHANCA 25B: Progressive Resistance Training as Intervention for Regaining Muscle Mass After Radiation Therapy in Patients With HNSCC
Official title: Progressive Resistance Training as Intervention for Regaining Muscle Mass After Radiation Therapy in Patients With HNSCC - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Lead sponsor: Danish Head and Neck Cancer Group
Sponsor class: NETWORK
First posted: 2012-01-13
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Head and neck cancer patients often experience a critical weight loss of around 10% following radiation therapy. Of this up to 70% is muscle mass and is an independent predictor of mortality, lowers muscle strength and functional performance. The purpose of this study is in a randomized controlled trial to investigate the effects of progressive resistance training (PRET) on changes in muscle mass, muscle strength and functional performance in head and neck cancer survivors. The investigators hypothesize that PRET has a positive effect on all primary endpoints and increases muscle mass, muscle strength and functional performance.


Eligibility criteria: Inclusion Criteria:

* Histologically diagnosed with squamous cell carcinomas of the larynx (no glottis stage I+II), pharynx, oral cavity or in lymph nodes from an unknown primary tumour (stage I-IV and tumour node metastasis (TNM) classification, UICC, Geneva, 1987)
* Terminated curative radiotherapy treatment with/without chemotherapy;
* No metastases
* Complete tumour remission
* No current or previous malignancies that could prevent participation and training
* No excessive alcohol intake (men \> 21 and women \> 14 units/wk)
* No recent systematic resistance training or creatine ingestion (within 2 months)
* If woman, not pregnant
* WHO performance status of 0-1
* No psychological, social or geographical conditions that could disturb participation
* Written consent

Primary outcomes:
measure: Body composition
timeFrame: Baseline, 3 months and 6 months
Secondary outcomes:
measure: Maximal muscle strength
timeFrame: Baseline, 3 months and 6 months
measure: Maximal gait speed
timeFrame: Baseline, 3 months and 6 months
measure: Patient reported outcomes
timeFrame: Baseline, 3 months and 6 months
measure: Blood sampling
timeFrame: Baseline, 3 months and 6 months
measure: 30 s arm curl capacity
timeFrame: Baseline, 3 months, 6 months
measure: Stair climbing capacity
timeFrame: Baseline, 3 months, 6 months
measure: Jumping capacity
timeFrame: Baseline, 3 months, 6 months
measure: Chair rise capacity
timeFrame: Baseline, 3 months, 6 months
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Dept. of Experimental Clinical Oncology
Study officials:
affiliation: Danish Head and Neck Cancer Group
name: Jens Overgaard, Prof., MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05820230: Changes in the Blood-brain Barrier During Maintenance ECT in Formerly Depressed Patients
Official title: Changes in the Blood-brain Barrier During Maintenance ECT in Formerly Depressed Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2023-04-19
Enrollment: 7
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 treated with a series of ECT or maintenance ECT in a hospital at the Mental health services in the Capital Region of Denmark

Brief summary: The aim of the study is to examine the effect of electroconvulsive therapy (ECT) on the blood-brain barrier (BBB) in patients who had suffered from depression. We will study the BBB with dynamic contrast enhanced (DCE) MRI before and after treatment with a single ECT in patients currently undergoing ECT. The study is an observational (naturalistic) longitudinal study.

Detailed description: Primary hypothesis

1. The BBB permeability to Gadovist (measured as Ki) temporarily increases in the right and left hippocampus (HC) after a single ECT.

   Secondary hypothesises
2. The volume of the right and left HC increases after a single ECT and the volume increase is positively correlated with the BBB permeability
3. A larger post-ECT increase in systolic blood pressure correlates with a larger increase in BBB permeability in the right and left HC.
4. A larger increase in serum S100-B compared to baseline values is correlated with increased BBB permeability in the right and left HC.

Eligibility criteria: Inclusion Criteria:

- We will include patients (age 18-75) currently treated with a series of ECT or maintenance ECT referred to the treatment due to moderate to severe depression according to ICD-10.

Exclusion Criteria:

1. Schizophrenia
2. Psychotic symptoms
3. Any substance use (other than cigarette smoking and alcohol consumption within the recommendations of the Danish National Health Authority) within the last 3 months
4. Risk of suicide making transport or participation in the study hazardous
5. Claustrophobia or severe restlessness
6. Contraindications to DCE-MRI (e.g., metallic implants, increased body temperature, reduced kidney function (estimated Global Filtration Rate (eGFR) of \<40 ml/min/1.73 m2), pregnancy)
7. Somatic illness potentially confounding results (e.g., any central nervous system diseases or cancers)
8. Lack of consent to being informed of potential medically important findings on MRI or blood tests

Primary outcomes:
measure: Permeability
timeFrame: Permeability is measured before a single ECT and 0-8 hours after a single ECT
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Mental Health Services of the Capital Region of Denmaark
Study officials:
affiliation: University of Copenhagen & Mental Health Centre Glostrup
name: Poul Videbech, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02983630: Allergy Testing of Patients Labeled as Penicillin Allergic
Official title: Allergy Testing of Primary Care Patients Labeled as Penicillin Allergic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Drug Hypersensitivity
Lead sponsor: Albany Medical College
Sponsor class: OTHER
First posted: 2016-12-06
Enrollment: 37
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: Adults ages 18 and older from the general population.

Brief summary: Patients labeled as penicillin allergic, rarely have this confirmed and being labeled as "penicillin allergic" is associated with increased health care costs, adverse effects and antibiotic resistance. The investigators will recruit participants from primary care practices labeled as penicillin allergic and offer allergy testing. The aim of this study is to develop a community, outpatient program for evaluation of penicillin allergy.


Eligibility criteria: Inclusion Criteria:

1. Labeled as having penicillin or amoxicillin allergy
2. Family history of penicillin allergy

Exclusion Criteria:

1. History of beta-lactam associated toxic epidermal necrolysis/Stevens Johnson syndrome to penicillin or amoxicillin
2. History of Drug induced Eosinophilia with Systemic Symptoms (DRESS)
3. History of drug induced: autoimmune hepatitis/interstitial nephritis, or hemolytic anemia
4. Poorly controlled asthma or heart disease
5. Currently pregnant
6. Unable to discontinue certain medications that may interfere with testing including (antihistamines, steroids, beta-blockers, tricyclic antidepressants, omalizumab)

Primary outcomes:
measure: Allergy testing for penicillin allergy results
timeFrame: 6 months
Secondary outcomes:
measure: Participant satisfaction after allergy testing with follow-up questionnaire
timeFrame: Within 6 months following testing
measure: Development of new drug allergies following negative testing questionnaire
timeFrame: 6 months-2 years
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany Medical College Allergy, Asthma and Immunology Center
state: New York
Study officials:
References:
Clinical trial NCT03302130: The Effects of Mood on Cerebral Perfusion
Official title: The Effects of Mood on Cerebral Perfusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Perfusion
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2017-10-04
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Measuring brain perfusion is biased by a inter- and intrasubject variability, caused by physiological and lifestyle factors. In this study, the investigators want to investigate the effects of a different mood state (neutral, positive and negative mood), induced using subjects own memories, on both global and regional cerebral perfusion, measured with arterial spin labeling.


Eligibility criteria: Inclusion Criteria:

* Healthy university students
* between 18 and 30 years old

Exclusion Criteria:

* No informed consent
* Not using hormonal contraception
* MRI-contraindications
* Claustrophobia
* Pregnancy
* Chronic diseases and chronic medication use

Primary outcomes:
measure: Regional Cerebral perfusion (ml/100g/min) during positive mood induction
timeFrame: 2 minutes (ASL scan during mood state induction)
measure: Regional Cerebral perfusion (ml/100g/min) during negative mood induction
timeFrame: 2 minutes (ASL scan during mood state induction)
measure: Regional Cerebral perfusion (ml/100g/min) during neutral mood induction
timeFrame: 2 minutes (ASL scan during mood state induction)
measure: Regional Cerebral perfusion (ml/100g/min) after positive mood induction
timeFrame: 2 minutes (ASL scan after mood state induction)
measure: Regional Cerebral perfusion (ml/100g/min) after negative mood induction
timeFrame: 2 minutes (ASL scan after mood state induction)
measure: Regional Cerebral perfusion (ml/100g/min) after neutral mood induction
timeFrame: 2 minutes (ASL scan after mood state induction)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Ghent
name: Eric Achten, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06281730: Use of New Generation Fetoscopes in Pregnancies Affected by Fetal Diseases Amenable to Fetoscopy Therapy
Official title: Use of New Generation Fetoscopes in Pregnancies Affected by Fetal Diseases Amenable to Fetoscopy Therapy
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: In Utero Procedure Affecting Fetus or Newborn
Keywords: Fetoscopes
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The Researchers are trying to determine feasibility and safety of performing surgery in the womb with the Karl Storz fetoscopes (a tool used to access the baby in the body of the mother). This are new and improved fetoscopes that are not yet approved by the FDA.


Eligibility criteria: Inclusion Criteria:

* Patient is a pregnant woman 18 and older
* The mother must be healthy enough to have surgery
* The mother must be scheduled for surgery
* Patient provides signed informed consent that details the maternal and fetal risks involved with the procedure

Exclusion Criteria:

* Age \<18 years
* Contraindication to abdominal surgery, fetoscopic surgery, or general anesthesia
* Preterm labor, preeclampsia, or uterine anomaly (e.g., large fibroid tumor) in the index pregnancy.
* Fetal aneuploidy, any significant pathogenic or likely significant pathogenic findings on Karyotype or Microarray (if available, but not required), other major fetal anomalies that impacts significantly the fetal/neonatal survival.

Primary outcomes:
measure: Adverse events
timeFrame: 12 months
measure: Serious Adverse Events
timeFrame: 12 months
measure: Device malfunctions
timeFrame: 12 months
Secondary outcomes:
measure: Mean gestational age at delivery
timeFrame: 12 months
measure: Successful Completion
timeFrame: 12 months
measure: Satisfaction scores
timeFrame: 12 months
measure: Live births
timeFrame: 12 months
measure: Neonatal deaths
timeFrame: 12 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Mauro Schenone, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03350230: Embryonic Ploidy Status in the Oncofertility Population
Official title: Embryonic Ploidy Status in the Oncofertility Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oncology
Fertility
Lead sponsor: Reproductive Medicine Associates of New Jersey
Sponsor class: OTHER
First posted: 2017-11-22
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: oncofertility patient undergoing controlled ovarian hyperstimulation and embryo cryopreservation

Brief summary: looking at aneuploidy rates in embryos from patients who are going to or have undergone treatment for a malignancy with gonadotoxic treatment.

Detailed description: The study involves oncofertility patients--individuals who are undergoing or have undergone therapy for a malignancy--who are interested in pursuing or preserving fertility. In particular, it investigates chromosomal abnormalities or aneuploidy in the embryos of those individuals as compared to the general infertility population. Embryonic aneuploidy is largely due to reproductive senescence. As such the investigators will discuss oncofertility prevalence and treatment as well as reproductive senescence and assessment of embryonic aneuploidy. The study will seek to determine if there are changes in embryonic aneuploidy rates in oncofertility patients that differ from simple age related risks.

Eligibility criteria: Inclusion Criteria:

1.Present or past oncologic diagnosis requiring potentially gonadotoxic treatment

Exclusion Criteria:

1. Oocyte banking
2. Use of oocyte donation
3. Any contraindications to undergoing in vitro fertilization or gonadotropin stimulation
4. Single gene disorder requiring more detailed embryo genetic analysis

Primary outcomes:
measure: embryonic aneuploidy rates
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Reproductive Medicine Associates of New Jersey
state: New Jersey
Study officials:
affiliation: Reproductive Medicine Associates of New Jersey
name: Jason Franasiak, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06505330: Respiratory Tract Microbiome and Probiotics in Children With Cleft Palate
Official title: Study of the Effects of Probiotics on the Upper Respiratory Tract Microbiome and the Prevention of Otitis Media With Effusion in Children With Cleft Palate
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Otitis Media in Children
Cleft Palate Children
Keywords: otitis media
upper respiratory tract microbiome
cleft palate
probiotics
Lacticaseibacillus rhamnosus GG
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: Universiteit Antwerpen
First posted: 2024-07-17
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Otitis media with effusion (OME) involves fluid accumulation in the middle ear without infection, sometimes causing discomfort and hearing loss in children. Persistent middle ear fluid lasting over 3 months may require treatment, including placement of ventilation tubes if it affects hearing.

Children with a cleft palate are at higher risk for otorrea after ventilation tube placement. Treatment typically involves antibiotic drops and ear cleaning by an ENT doctor, often requiring repeated visits, which may impact quality of life for both the child and the parents.

The mouth, throat, and nose harbor bacteria that can influence ear infections. This study aims to determine if probiotics can alter the bacteria in the nasopharynx and middle ear fluid and reduce the number of episodes of eardischarge following ventilation tube placement in children with cleft palate.

Using Lacticaseibacillus rhamnosus GG and Bifidobacterium lactis BB-12 from Bactiol® Baby (Metagenics), patients will be divided into two groups: one receiving probiotic drops and one not. The study will assess if probiotics can reduce the number of episodes with ear discharge in children with cleft palate, by examining the following:

1. The airway microbiome composition in children with cleft palates.
2. Whether oral probiotics can reduce the number and duration of ear discharge episodes.


Eligibility criteria: Inclusion Criteria:

* cleft palate \& lip (uni/bilateral) or cleft palate
* No syndromal disorders

Exclusion Criteria:

* syndromal disorder
* history of ventilation tube placement

Primary outcomes:
measure: Microbiome composition
timeFrame: over the study period (= 13 months)
measure: Number of episodes of otorrea
timeFrame: over the study period (= 13 months)
Secondary outcomes:
measure: Effect of probiotics on the composition of the URT microbiome
timeFrame: over the study period (= 13 months)
measure: Transfer of bacteria
timeFrame: over the study period (= 13 months)
measure: Differences in abundances of lactic acid bacteria in control/probiotic treatment group
timeFrame: over the study period (= 13 months)
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: University Hospital Antwerp
state: Antwerp
Study officials:
References:
Clinical trial NCT00271830: Sexual Function in Male Renal Transplant Patients
Official title: Sexual Function in Male Renal Transplant Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Renal Transplant Recipients
Keywords: renal
transplant
sexual dysfunction
male
dialysis free
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2006-01-04
Enrollment: 110
Sex: MALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: Sexual dysfunction is common in male patients with chronic renal failure on dialysis and after renal trasnplantation. Multiple factors play a role in this important clinical problem. Recent studies suggest that certain immunosuppressive medication used for solid organ transplant may affect male sexual function. The purpose of this study is to compare the sexual function of male renal transplant patients on sirolimus and those patients not on sirolimus immunosuppression.

Detailed description: All male renal transplant recipients with a functioning allograft 1 month post transplant will be eligible to participate in this prospective serial observation study. As roughly half of renal transplant patients are assigned to rapamycin immunnosuppression clinically and half are not, we plan to assess routine clinical perameters, sex hormone levels, subjective sexual function as measured by standardized questionnaire and semen analysis in 55 patients on sirolimus treatment and 55 patients not on this treatment. Assessment will be made at baseline (1 mo post transplant) and 6 and 12 months later. All adult male renal transplant recipients ages 21-65 off dialysis 1 mo post transplant will be eleigible. Exclusion criteria will be female gender, patients requiring testosterone therapy, patients on dialysis, and those unwilling to give informed consent.

Eligibility criteria: Inclusion Criteria:male renal transplant recipients off dialysis by 1 month post transplant, ages 21-65,willing to give informed consent

-

Exclusion Criteria: female gender, patients requiring testosterone replacement treatment, patients with neglibile renal function requiring dialysis, unwilling to give informed consent

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Daniel Glicklich, MD
role: PRINCIPAL_INVESTIGATOR
References: