louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT07006207: Brain Olfactory Pathways in Prader-Willi Syndrome
Official title: Deciphering Brain Olfactory Pathways in Prader-Willi Syndrome
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prader-Willi Syndrome
Keywords: cerebral activity
Olfactory activation
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2025-06-05
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Studying the cerebral activity of children with Prader-Willi Syndrom (PWS) when the study propose to them nasal activations.

Detailed description: The present study propose to implement fMRI and olfactory tests to describe olfactory brain activation and olfactory skills in early OT-exposed and non-exposed children with PWS.

This study is part of a wider project in collaboration with the team of S. Steculorum at the Max Planck Institute in Germany who assess the architectural and molecular characterization of the olfactory system development in a mice model of PWS and the role of early OT treatment.

Moreover, the study will take advantage of the MRI to document the long-term brain connectivity of early OT-exposed and non-exposed children.

Eligibility criteria: Inclusion Criteria:

* child with a genetically confirmed diagnosis of PWS and for whom the genetic subtype (deletion or non deletion) has been identified
* Child aged between 5 and 7 years
* Child with a planned hospitalization at the Toulouse reference center for PWS

Exclusion Criteria:

* Presence of a contraindication to MRI
* Allergy to any of the fragrances used in the olfactory test
* Presence of an ENT infection such as rhinitis or sinusitis on the day of inclusion
* Reported anosmia
* Administrative problems.

Primary outcomes:
measure: hyperactivation of the right amygdala in young children with PWS not early OT-exposed and aged between 5 and 7 years in response to a sweet food odor compared to a neutral non-food odor.
timeFrame: day 1
Secondary outcomes:
measure: hyperactivation of the right amygdala in PWS children stimulated by a sweet food odor vs. a non-food odor compared to non-exposed children.
timeFrame: day 1
measure: composite outcome witn an association between olfactory fMRI results and eating behavior in early OT-exposed and non-exposed children with PWS.
timeFrame: day 1
measure: olfactory skills in early OT-exposed and non-exposed children with PWS.
timeFrame: Day 1
measure: resting brain connectivity in early OT-exposed and non-exposed children with PWS.
timeFrame: day 1
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital of Toulouse
name: Gwenaelle DIENE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03080207: Platelet Rich Plasma, Complex Decongestive Physiotherapy and Low Level Laser in Treatment of Lower Extremity Lymphoedema
Official title: Comparison of Efficacy of Platelets / Platelet Enriched Plasma Regard (PRP) Method, Complex Decongestive Physiotherapy and Low Level Laser in Treatment of Lower Extremity Lymphoedema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Extremity Lymphedema
Keywords: Lower Extremity Lymphedema
Physiotherapy
Complex Decongestive Physiotherapy
Low Level Laser
Platelet rich plasma
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2017-03-15
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: At the end of the study, comparative information about the effects of PRP, complex decongestive physiotherapy and low level laser on edema volume, range of motion, muscle strength, functional capacity and quality of life will be obtained in the treatment of patients with lower limb lymphedema.

Since there is no study about this field in the literature, this study will provide new and valuable contributions about treatment of lower extremity lymphedema for the researchers and clinicians.


Eligibility criteria: Inclusion Criteria:

* Having lower extremity lymphedema
* To be older than 18 ages.

Exclusion Criteria:

* Having received radiotherapy treatment in the last 6 months,
* Having received physiotherapy treatment in the last 6 months,
* General health status is not eligible for treatment

Primary outcomes:
measure: Health-related quality of life
timeFrame: 12 weeks
Secondary outcomes:
measure: Lower-extremity-circumference
timeFrame: 12 weeks
measure: Numeric rating scale
timeFrame: 12 weeks
measure: 6 minutes walking test
timeFrame: 12 weeks
measure: Tissue dielectric constant Questionnaire
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Faculty of Health Science
Study officials:
affiliation: Istanbul University
name: Ahmet Akgul, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University
name: Ela Tarakci, Assoc.Dr.
role: STUDY_DIRECTOR
affiliation: Istanbul University
name: Nilay Arman, PhD, PT
role: STUDY_DIRECTOR
affiliation: Istanbul University
name: Tugba Civi, PT
role: STUDY_DIRECTOR
affiliation: Bakirkoy Dr.Sadi Konuk Education and Research Hospital
name: Musa Cirak, MD, DR
role: STUDY_DIRECTOR
References:
citation: Akgul A, Tarakci E, Arman N, Civi T, Irmak S. A Randomized Controlled Trial Comparing Platelet-Rich Plasma, Low-Level Laser Therapy, and Complex Decongestive Physiotherapy in Patients with Lower Limb Lymphedema. Lymphat Res Biol. 2020 Oct;18(5):439-447. doi: 10.1089/lrb.2019.0064. Epub 2020 Feb 19.
Clinical trial NCT03605407: Patients Visit Prior to Hospital Admission & Intensive Care Unit
Official title: Effects of the Visit Prior to Hospital Admission on Anxiety, Depression and Satisfaction of Patients in an Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression
Intensive Care Unit Syndrome
Lead sponsor: Universidad de León
Sponsor class: OTHER
First posted: 2018-07-30
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The present study evaluates the effects of the visit prior to hospital admission on anxiety, depression and satisfaction of patients in an intensive care unit.


Eligibility criteria: Inclusion Criteria:

* Patient at hospital admission for surgery

Exclusion Criteria:

* Cognitive impairment

Primary outcomes:
measure: Hospital Anxiety and Depression Scale
timeFrame: Change from Baseline anxiety and depression at 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital La Princesa
Study officials:
References:
citation: Gonzalez-Martin S, Becerro-de-Bengoa-Vallejo R, Angulo-Carrere MT, Iglesias ME, Martinez-Jimenez EM, Casado-Hernandez I, Lopez-Lopez D, Calvo-Lobo C, Rodriguez-Sanz D. Effects of a visit prior to hospital admission on anxiety, depression and satisfaction of patients in an intensive care unit. Intensive Crit Care Nurs. 2019 Oct;54:46-53. doi: 10.1016/j.iccn.2019.07.001. Epub 2019 Jul 26.
Clinical trial NCT05515107: The Laryngoscopic View With C-MAC Videolaryngoscope Miller Blade Lifting the Epiglottis or the Vallecula in Children
Official title: Inönü University Department of Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation
Laryngoscopy
Keywords: Infant
glottis
Laryngoscopy
Intubation
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2022-08-25
Enrollment: 130
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Parallel Assignment
Primary purpose: PREVENTION

Brief summary: In this study, the investigators aim to evaluate the glottic visualization and time to intubation during laryngoscopy performed with the C-MAC VL size 1 Miller blade lifting the epiglottis or placing the tip of the blade on the base of the tongue (vallecula) in children younger than 2 years of age.

Detailed description: Direct laryngoscopy (DL) is the most widely used method to ensure airway safety. In pediatric patients under two years of age, Miller laryngoscope blade is recommended as it removes the long and drooping epiglottis from the eye during laryngoscopy and shows the laryngeal entrance better.

In the classical definition, the tip of the Miller blade is placed behind the epiglottis. However, if the intubator wishes, the Miller blade tip can be placed on the root of the tongue (vallecula) and used as a Macintosh blade.

In the literature search, no study has been found so far comparing C-MAC VL 1 numbered Miller blade with intubation by removing the epiglottis or placing the blade on the vallecula. In this study, the investigators aimed to evaluate the glottic image and intubation time during laryngoscopy performed by lifting the epiglottis with the C-MAC VL No. 1 Miller blade or placing the tip of the blade on the base of the tongue in children under 2 years of age.

Eligibility criteria: Inclusion Criteria:

* Younger than 2 years of age
* ASA I and II patients
* Elective surgery under general anesthesia with tracheal intubation

Exclusion Criteria:

* upper respiratory tract infection within the previous 4 weeks
* airway difficulties in the preoperative evaluation
* unstable reactions during intubation

Primary outcomes:
measure: Percentage of glottic opening score
timeFrame: immediately before endotracheal intubation
Secondary outcomes:
measure: Time to intubation
timeFrame: From beginning of holding videolaryngoscope to seeing two meaningful end-tidal carbon dioxide levels up to 3 minutes
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Inonu University
Study officials:
affiliation: Inonu University
name: Zekine Begec, Professor
role: STUDY_CHAIR
References:
citation: Varghese E, Kundu R. Does the Miller blade truly provide a better laryngoscopic view and intubating conditions than the Macintosh blade in small children? Paediatr Anaesth. 2014 Aug;24(8):825-9. doi: 10.1111/pan.12394. Epub 2014 Apr 2.
Clinical trial NCT01479907: Synbiotics and Gastrointestinal Function Related Quality of Life After Colectomy for Cancer
Official title: Synbiotics and Gastrointestinal Function Related Quality of Life After Colectomy for Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Neoplasms
Lead sponsor: University of Athens
Sponsor class: OTHER
First posted: 2011-11-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this double-blinded prospective randomised trial is to explore the potential benefits of early postoperative administration of Synbiotics (combination of prebiotics and probiotics) to patients who have undergone colectomy for cancer. The patients are randomised to either synbiotics or placebo administration at the day they are able to tolerate po liquid diet and for 15 days thereafter.

Primary end points of the study will be:

Assessment of gastrointestinal function-related quality of life at 1, 3 and 6 months postoperatively by the use of the validated questionnaire GIQLI (Gastrointestinal Quality of Life Index)

Secondary end points will be:

-Assessment of functional bowel disorders (diarrhea, constipation, etc) at 1, 3 and 6 months postoperatively based on the respective domains of the validated instrument EORTC QLQ-C30

Detailed description: The study patients are randomized before surgery to receive either synbiotics (Synbiotics group) or placebo (Control group). Equal randomization is accomplished using a computer-generated random allocation schedule. The method of allocation concealment is sequentially numbered sealed opaque envelopes technique. Both synbiotics and placebo preparations are in foil-sealed sachets stored in identical numbered containers. Both study products are white powders, identical in weight, smell, and taste. Thus, the identity of the specific product is blind to participants, support staff and investigators for the entire duration of the study period.

Eligibility criteria: Inclusion Criteria:

* Colectomy for histologically proven colorectal adenocarcinoma

Exclusion Criteria:

* Pregnancy,
* hereditary cancer,
* history of inflammatory bowel disease,
* metastatic disease at presentation,
* emergency operation,
* major postoperative complications

Primary outcomes:
measure: Assessment of gastrointestinal function-related quality of life at 1, 3 and 6 months postoperatively
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: First Department of Propaedeutic Surgery of Athens Medical School, Hippocration General Hospital
Study officials:
affiliation: University of Athens
name: George E Theodoropoulos
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03723707: Enhanced Quality in Primary Care for Elders With Diabetes and Dementia
Official title: Enhanced Quality in Primary Care for Elders With Diabetes and Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Dementia
Alzheimer Disease
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2018-10-29
Enrollment: 355
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to develop and test a care quality improvement intervention featuring use of consensus decisional guidance for the medical management of diabetes (DM) in patients with Alzheimer's disease and related dementia (ADRD) in primary care, provider (PCP) workflow enhancements supported by a panel manager(PM) for workflow support, electronic health record (EHR) decision support and feedback, and PCP collaborative learning.


Eligibility criteria: Inclusion Criteria:

* Patient must receive care at participating NYU FGP clinics.
* Patient must be English or Spanish speaking.
* Patient must have DM diagnosis.
* Patient must have documented cognitive impairment or an ADRD diagnosis.
* Patient must have someone who is identified as a family or friend who provides caregiving assistance.

Caregiver:

* Caregiver must have adequate knowledge of identified patient and/or participate in that member's healthcare decisions.
* Caregiver must be English or Spanish speaking.
* Caregiver must demonstrate capacity to consent to research participation.
* Caregiver must be at least 21 years old.

Exclusion Criteria:

Patient:

* Patient does not receive care at participating NYU FGP clinics.
* Patient is not 65 years and older.
* Patient is not English or Spanish speaking.
* Patient does not have DM diagnosis.
* Patient does not have documented Cognitive impairment or an ADRD diagnosis.
* Patient has severe dementia, other terminal illness with \<6 months to live, and/or is hospice eligible.
* Patient does not have a caregiver.

Caregiver:

* Caregiver does not have adequate knowledge of identified patient and/or does not participate in that member's healthcare decisions.
* Caregiver is not English or Spanish speaking.
* Caregiver lacks capacity to consent to research.
* Caregiver is under 21 years old.

Primary outcomes:
measure: Percent of Patients Who Reach Consensus Target HBA1c
timeFrame: Up to Month 24
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Joshua Chodosh, MD, MSHS, FACP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01310907: Identify the Genes Polymorphisms Related to Non-familial Bradyarrhythmia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bradyarrhythmia
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
Collaborators: name: China Medical University, China
First posted: 2011-03-09
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: PROBABILITY_SAMPLE
Study population: The case group include 200 patients and the control group include 200 patients.

Brief summary: Bradyarrhythmia, including sinus node dysfunction and atrioventricular block, is a major cause necessitating pacemaker implantation. In contrast to familial bradyarrhythmia known as by mutations at particular ion channels, limited information is available for the mechanistic study in non-familial bradyarrhythmia.

Possible gene polymorphisms related to non-familial bradyarrhythmia were studied. Comparison of multi-locus analysis and single-locus analysis will be analyzed between the cases and controls. Functional studies will perform to clarify the results of association study.


Eligibility criteria: Inclusion Criteria:

* The patients with non-familial bradyarrhythmia

Exclusion Criteria:

* Familial bradyarrhythmia Reversible bradyarrhythmia Bradyarrhythmia after open heart surgery and severe organic heart diseases

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: China Medical University Hospital
name: Jan-Yow Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mangrum JM, DiMarco JP. The evaluation and management of bradycardia. N Engl J Med. 2000 Mar 9;342(10):703-9. doi: 10.1056/NEJM200003093421006. No abstract available.
Clinical trial NCT04780607: Outcomes of Mitral Valve Surgery in Patients Affected by Rheumatic Heart Disease
Official title: Multicenter Results of Mitral Valve Surgery in Patients With Rheumatic Heart Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Outcomes of Mitral Valve Surgery in Patients Affected by Rheumatic Heart Disease
Keywords: rheumtic heart disease
mitral valve surgery
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2021-03-03
Enrollment: 4000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1. patients with rheumatic heart disease
2. mitral valve disease
3. patients underwent initial mitral valve surgery or intervention

Brief summary: rheumatic heart disease remains the majority valvular disease in low and middle income countries, which mostly affected mitral valve, surgical treatment is the most effective strategy to improve the outcomes of middle or late-stage RHD patient, however, whether mitral valve repair surgery is superior to replacement or other evolving interventional device remains controversial, this study aims to investigate the results of repair surgery compared with replacement or other treatment strategy from international multicenters.


Eligibility criteria: Inclusion Criteria:

* 1、rheumatic heart disease 2、mitral valve disease 3、combined with other heart valve disease(aortic valve, tricuspid valve, pulmonary valve) 4、patients underwent initial mitral valve surgery or intervention

Exclusion Criteria:

* 1、congenital heart disease degenerative heart valve disease 2、isolated aortic valve or tricuspid valve, pulmonary valve disease( doesn't affect mitral valve ) 3、patients received more than 1 time mitral valve operation

Primary outcomes:
measure: all-cause mortality
timeFrame: 2011-2024
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
state: Beijing
Study officials:
affiliation: Beijing Anzhen Hospital
name: xu meng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01884207: Multiparametric Characterization of Orbital Tumors by MRI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Orbital Tumors
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2013-06-21
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with orbital tumors

Brief summary: Prospective study on patients with orbital tumors of unknown origin. Aim of the study is to differentiate benign from malignant tumors upon MR imaging. Magnetic resonance imaging of the orbit will be performed including standard morphological sequences and advanced sequence techniques. These advanced sequence techniques may allow to differentiate benign from malignant tumors based on their cellularity and vascularity (diffusion and perfusion imaging). These MRI data will be analysed and the level of diffusion and perfusion will be measured and compared to the histological findings. Cut-off values of diffusion and perfusion will be calculated that allow to separate benign from malignant tumors.


Eligibility criteria: Inclusion Criteria:

* non-diagnosed orbital tumors

Exclusion Criteria:

* any metal implants, non-MRI compatible
* age below 18
* pregnancy
* recent surgery
* recent severe medical diseases

Primary outcomes:
measure: multiparametric characterization of orbital tumors by MRI
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite University
Study officials:
References:
Clinical trial NCT04204707: Patient Reported Outcomes After Surgery for Rectal Endometriosis
Official title: PROCURE: Patient Reported Outcomes After Surgery for Deep Endometriosis Infiltrating the Muscular Layer of the Rectum: a Prospective Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Endometriosis
Endometriosis, Rectum
Endometriosis-related Pain
Endometriosis; Bowel
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Semmelweis University
First posted: 2019-12-19
Enrollment: 294
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women scheduled for a multidisciplinary laparoscopic surgery for rectal endometriosis.

Brief summary: To describe the difference in patient reported outcomes after conservative treatment in comparison to radical rectal surgery in patients with deep endometriosis infiltrating the rectum (up to 15cm from the anus with at least involvement of the muscularis layer) and to determine predictors for radical surgery.


Eligibility criteria: Inclusion Criteria:

* Age: 18 - 45 years (both inclusive)
* BMI \<35
* Complaining of infertility and/or pain
* Deep endometriosis infiltrating the rectum on at least one imaging technique up to 15 cm from the anus and involving at least the muscularis layer in depth

Exclusion Criteria:

* Refusal of bowel resection/stoma
* History of laparotomy for endometriosis
* (history of) Hysterectomy
* Suspected pelvic malignancy
* Pregnancy
* Impossibility for postoperative follow-up in our hospital

Primary outcomes:
measure: The proportion of patients experiencing one of the following symptoms at 12 months postoperatively:
timeFrame: 12 months postoperatively
measure: The determination of possible risk factors for radical surgery.
timeFrame: 3 months postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
city: Budapest
country: Hungary
facility: Semmelweis University Hospital
Study officials:
affiliation: UZ Leuven
name: Carla Tomassetti, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: