louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06142500: WEST-KOaST Study: WES Analysis of Testicular Cancer Patientsand Their First-degree Family Members
Official title: WEST-KOaST Study: WES (Whole Exome Sequencing) Analysis of Testicular Cancer Patientsand Their First-degree Family Members
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Testicular Cancer
Keywords: testicular cancer
cancer
familiarity
genetic
male infertility
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2023-11-21
Enrollment: 4500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The project aims to identify the possible risk factors regarding the onset of the disease and to evaluate genes and gene modifications responsible for the onset od testicular cancer.

Detailed description: Testicular tumor represents a relatively rare disease that hit young-adults men. It represents 1% of all male cancers and 5% of all urological male tumors. Its incidence grow year by year. In the field of the oncological research, the lack of knowledge about genes related to this disease represent a very relevant clinical question. For this reason this project aims to collect biological samples of saliva from testicular cancer patients and from their first-degree family members; demographic-clinical variables will be also collected in order to draft a comprehensive panel of genes and gene modifications related to the testicular cancer, combining this survey with a very detailed description of this cohort of patient in terms of clinical features and quality of life.

Eligibility criteria: Inclusion Criteria:

* Male testicular cancer patients with an age \> 18 and \< 90
* First degree family members of Male testicular cancer patients with an age \> 18 and \< 90
* Ability to read and sign the informed consent
* Diagnosis of testicular cancer for the experimental group

Exclusion Criteria:

* Female for the experimental group
* Second degree family members of Male testicular cancer patients
* People with an age \< 18 and \> 90
* Diagnosis different from testicular cancer for the experimental group Incapacity to read and sign the informed consent

Primary outcomes:
measure: Saliva biological sample
timeFrame: Baseline
Secondary outcomes:
measure: Demographic-clinical variables
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: IRCCS Ospedale San Raffaele
name: Andrea Salonia, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03987100: Population Pharmacokinetics of Amoxicillin in Neonates
Official title: Population Pharmacokinetics of Amoxicillin in Neonates: Evaluation and Optimization of the Dose
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Emergencies
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2019-06-14
Enrollment: 200
Sex: ALL
Maximum age (years): 44
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates (including both preterm and full-term neonates) receiving amoxicillin as part of their routine clinical care (for suspected or proven neonatal sepsis).

Brief summary: The objective of NEOPOPI is to conduct a population pharmacokinetic study of amoxicillin in neonates, in order to evaluate and optimize neonatal dose regimen.

There will be no change to the medication treatment received by participants. An opportunistic pharmacokinetic sampling approach will be followed: samples will be scavenged from blood or cerebrospinal fluid drawn for routine biochemical tests. In this way, no additional invasive tests will be needed.

Detailed description: * Administration of the antibiotic according to the usual procedures for prescribing services: in particular, neither the indications nor the doses nor the methods of administration are fixed by the protocol
* Opportunistic sampling strategy: no biological samples are specifically collected for the purposes of the study (measurements of concentrations on "bottoms" or "left-over" samples); the performance of this non-invasive sampling strategy has been previously demonstrated in the neonatal population.
* Micro-analytical method (assay of concentrations on micro-volumes, of the order of 50μL)
* Population pharmacokinetic analysis

Eligibility criteria: Inclusion Criteria:

* Neonates receiving amoxicillin and blood/CSF tests during amoxicillin treatment, as part of their routine clinical care
* No parental opposition to the study participation

Exclusion Criteria:

• None

Primary outcomes:
measure: Achievement rate of therapeutic efficacy target of amoxicillin
timeFrame: 1 week
Secondary outcomes:
measure: Recording of Adverse Events
timeFrame: 1 week
measure: Minimum Inhibitory Concentration
timeFrame: 1 week
measure: Concentration of amoxicilin in Cerebrospinal Fluid (CSF)
timeFrame: 1 week
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU Rennes
Study officials:
References:
Clinical trial NCT01107600: Study on Immediate Loading of Immediately Placed Single Implants.
Official title: Study on Immediate Loading of Immediately Placed Single Implants in Extraction Sockets With Nobel Active™ Implants and Bio-oss®.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Dental Implants
Keywords: Dental Implants, Single-Tooth
Bone Regeneration
Dental Restoration
Socket preservation
Lead sponsor: Hospital San Pietro Fatebenefratelli
Sponsor class: OTHER
Collaborators: name: Nobel Biocare
name: Geistlich Pharma AG
First posted: 2010-04-21
Enrollment: 0
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Immediate loading
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate survival and success rates of dental implants placed with immediate loading protocol in extraction sockets. All patients were monitored for 1 year after implants placement.

Detailed description: The international literature supported the potential advantages offered by this approach, but indicated a higher risk when compared with immediate loading in healed ridges.

The hypothesis to demonstrate is an high success and survival rates of Nobel Active™ implants used in combination with Bio-Oss® material.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Single-tooth implant restorations in the aesthetic zone

Exclusion Criteria:

* Medical risk patient
* Smoking

Primary outcomes:
measure: Implant stability quote (ISQ) measurements.
timeFrame: 8 weeks
Secondary outcomes:
measure: Aesthetic Results and Patient Satisfaction
timeFrame: 1 year
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Marco Tallarico
city: Rome
country: Italy
facility: Odontoiatric center San Pietro Hospital, FBF
Study officials:
affiliation: San Pietro Hospital, FBF, Roma
name: Marco Gargari, Professor
role: STUDY_DIRECTOR
References:
citation: Atieh MA, Payne AG, Duncan WJ, Cullinan MP. Immediate restoration/loading of immediately placed single implants: is it an effective bimodal approach? Clin Oral Implants Res. 2009 Jul;20(7):645-59. doi: 10.1111/j.1600-0501.2009.01725.x.
Clinical trial NCT05887700: Lifetech CeraFlex™ ASD Closure System Post-Market Clinical Follow-Up
Official title: A Multi-center, Single-arm, Real-world Registry Assessing the Clinical Use of the Lifetech CeraFlex™ ASD Closure System
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Septal Defect
Keywords: Lifetech
Atrial Septal Defect
ASD
CeraFlex
ASD Closure System
Lead sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-06-05
Enrollment: 145
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a confirmed diagnosis of Atrial Septal Defect (ASD) and implanted with the investigational device.

Brief summary: The objective of this post-market registry is to assess the clinical use of the Lifetech CeraFlex™ Closure System in a real-world and on-label fashion.

Detailed description: The study intends to collect data from patients who have implanted with the device between 2019 and 2022. The data collection process is expected to complete by end of 2024. Final report shall be available in 2025.

Eligibility criteria: Inclusion Criteria:

1. Patients with a confirmed diagnosis of Atrial Septal Defect (ASD) and implanted with the investigational device as per IFU instructions.
2. Patients or legally authorized representatives have signed Data Release Consent or equivalent documents.

Exclusion Criteria:

Patients did not conduct any follow up visit after hospital discharge.

Primary outcomes:
measure: Procedural success
timeFrame: 6 months post-implantation
Secondary outcomes:
measure: Incidence of moderate or large residual shunt
timeFrame: At procedure, 6 months and 12 months post-implantation
measure: Incidence of device or procedure related Adverse Events (AEs)
timeFrame: From attempted procedure to 24 months post-implantation
measure: Incidence of device or procedure related Serious Adverse Events (SAEs)
timeFrame: From attempted procedure to 24 months post-implantation
measure: Incidence of Device Deficiencies (DD)
timeFrame: From attempted procedure to 24 months post-implantation
measure: Incidence of death
timeFrame: From attempted procedure to 24 months post-implantation
Other outcomes:
Locations:
city: Curitiba
country: Brazil
facility: Hospital Pequeno Príncipe
city: Fortaleza
country: Brazil
facility: Universidade Federal do Ceará
city: Porto Alegre
country: Brazil
facility: Santa Casa de Misericórdia de Porto Alegre
city: São Paulo
country: Brazil
facility: HCOR - Associação Beneficente Síria
city: São Paulo
country: Brazil
facility: Hospital Beneficência Portuguesa
city: Kallithéa
country: Greece
facility: Onassis Cardiac Surgery Center
city: Milan
country: Italy
facility: IRCCS Policlinico San Donato
Study officials:
References:
Clinical trial NCT07000500: INSIDE: Intervention in Nutritional Supplementation to Improve Cognitive Decline in Elderly.
Official title: INSIDE: Intervenção da Suplementação Nutricional na Melhoria do Declínio Cognitivo no Idoso.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cognitive Dysfunction, Cognitive Disorder
Dietary Supplements
Keywords: Cognitive Decline
Mild Cognitive Impairment
Aging
Nutritional Supplementation
Lead sponsor: Cooperativa de Ensino Superior, Politécnico e Universitário
Sponsor class: OTHER
First posted: 2025-06-03
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigates the effect of nutritional supplementation on cognitive performance in older adults over a 90-day period using a double-blind randomized controlled design. The study includes 50 participants, aged 65 or older, randomly assigned to either a supplement group or a placebo group. Participants will be randomly assigned to either the experimental or control group. Assessments will be conducted pre- and post-intervention to determine the effect of the supplementation on cognitive performance. Key outcomes include cognitive status measured by MoCA, adherence to supplementation, and potential side effects. The findings will provide insights into the potential role of nutritional interventions in mitigating age-related cognitive decline.


Eligibility criteria: Inclusion Criteria:

* Inclusion Criteria:

Community-dwelling adults aged 65 years or older Evidence of mild cognitive decline (score \< 26 on the Montreal Cognitive Assessment - MoCA) Ability to provide written informed consent Willingness and ability to comply with study procedures and attend scheduled evaluations

- Exclusion Criteria: Diagnosis of dementia or any neurodegenerative disease (e.g., Alzheimer's, Parkinson's) Epilepsy and neurologically related conditions Severe sensory deficits (e.g., profound visual or hearing impairment) that impair cognitive assessment Current use of cognitive-enhancing medications or supplements that cannot be discontinued History of allergy or intolerance to components of the nutritional supplement Unstable chronic medical conditions (e.g., uncontrolled diabetes, heart failure, renal insufficiency) Participation in another clinical trial in the previous 3 months

Primary outcomes:
measure: Cognitive Performance
timeFrame: baseline and 90 days
Secondary outcomes:
measure: Adherence to supplementation protocol
timeFrame: Daily, from Day 1 to Day 90
measure: Occurrence of adverse effects
timeFrame: Continuous, from baseline to Day 90
measure: Self-reported use of other supplements
timeFrame: Baseline and 90 days
measure: Self-perceived quality of life
timeFrame: baseline and 90 days
measure: Depressive symptoms
timeFrame: Baseline and Day 90
Other outcomes:
Locations:
city: Vila Nova de Famalicão
country: Portugal
facility: Escola Superior de Saúde do Vale do Ave
state: Braga
Study officials:
References:
Clinical trial NCT06614400: The RETRAIN Trial (Phase 1)
Official title: MonitoRing the Effect of TRAnscutaneous Functional electrIcal Stimulation of the Common Peroneal Nerve on Cerebral Haemodynamics in Patients With Ischaemic Strokes. A Single Centre Prospective Study (Phase 1).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischaemic Stroke
Lead sponsor: Countess of Chester NHS Foundation Trust
Sponsor class: OTHER
First posted: 2024-09-26
Enrollment: 18
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: Adults (over 18 years) with ischaemic stroke more than 7 days from onset

Brief summary: The primary objective is to investigate in stroke patients the impact of geko™ NMES treatment, when used as standard of care for VTE prevention, on brain haemodynamics at different stimulation levels and in three different postural positions (supine, semi-supine \[45° seated\] and seated). The aim is to identify the optimal stimulation level and postural position for the maximum response (NMES versus no NMES) with regard to relative total haemoglobin concentration (i.e., the sum of relative deoxyhaemoglobin and oxyhaemoglobin concentrations) using fNIRS and EEG.


Eligibility criteria: Inclusion Criteria:

* Adult over 18
* Patient with ischaemic stroke diagnosis confirmed by a stroke physician.
* No intracerebral haemorrhage as ruled out by computerised tomography (CT) or MRI scan.
* Able to achieve a supine, sitting and semi-sitting position of 45° with the help of another person.
* Receiving geko™ NMES treatment as standard of care for VTE prevention

Exclusion Criteria:

* Inability to gain consent from the patient.
* A transient ischaemic attack (TIA).
* Stroke survivors with ischaemic stroke less than 7 days from onset.
* History of epilepsy.
* Below/above knee amputation.
* History of established peripheral neuropathy.
* Too unwell to participate as judged by physician.
* Use of any other neuromodulation device that may interact with NMES

Primary outcomes:
measure: Primary outcome
timeFrame: 3 hours
Secondary outcomes:
measure: Secondary objective
timeFrame: 3 hours
Other outcomes:
Locations:
city: Chester
country: United Kingdom
facility: Countess of Chester Hospital NHS Foundation Trust
state: Cheshire
city: Chester
country: United Kingdom
facility: Countess of Chester Hospital NHS Foundation Trust
state: Cheshire
Study officials:
References:
Clinical trial NCT01418300: Comparison of Conventional Triple Therapy Versus Sequential Therapy for H. Pylori in Peptic Ulcer Disease: Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Helicobacter Infected Patients
Lead sponsor: Jeil Pharmacy Co.
Sponsor class: INDUSTRY
First posted: 2011-08-17
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to improve first line Helicobacter pylori eradication rate and to compare the sequential versus conventional triple therapy.


Eligibility criteria: Inclusion Criteria:

* peptic ulcer diseae
* two test positive rapid urease test, culture, histology

Exclusion Criteria:

* lactating or pregnant
* previous stomach surgery
* severe underlying disease

Primary outcomes:
measure: the eradication rate by urea breath test
timeFrame: 4-6 week later after completion of therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Gil Medical Center
Study officials:
References:
Clinical trial NCT02926300: Long-term Safety and Efficacy of FURESTEM-CD Inj. in Patients With Moderately Active Crohn's Disease(CD)
Official title: Extension Study, An Open-labelled, Multi Center, Comparative Phase I/IIa Clinical Trials to Evaluate the Efficacy and Safety of FURESTEM-CD Inj. in Patients With Moderately Active Crohn's Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Crohn's Disease
Keywords: crohn's disease
stem cell therapy
inflammatory bowel disease
hUCB-MSC
UCB-MSC
Umbilical cord Blood
Rheumatoid Arthritis
RA
Stem cell
Cell therapy
Furestem
Mesenchymal stem cell
MSC
Lead sponsor: Kang Stem Biotech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-10-06
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Gender: Both Age Limits: 19years to 70years Healthy Volunteers?: No.

Brief summary: The purpose of this clinical trial is to evaluate long-term safety and efficacy in patients who has history of FURESTEM-CD injection at least once.

Detailed description: This study is an extended study of KSTHD_FURESTEM-CD phase 1 / 2a clinical trials in patients with moderate active Crohn's disease who had received at least once a FURESTEM-CD injection. The purpose of this clinical trial is to evaluate long-term safety and efficacy in patients for approximately 36 months (144 weeks).

Eligibility criteria: Inclusion Criteria:

* patients who has history of FURESTEM-CD Inj. injection at least once.
* patients who understand and voluntarily sign an informed consent form.

Exclusion Criteria:

* any other condition which the Principle Investigator judges would make subject unsuitable for study participation.

Primary outcomes:
measure: all kinds of adverse events which occur during the clinical sutdy
timeFrame: 114 weeks
Secondary outcomes:
measure: ratio of patients who is applicable to CDAI<150
timeFrame: 114 weeks
measure: ratio of patients who reduce CDAI over 70 as contrasted witd baseline(V7)
timeFrame: 114 weeks
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National Universtiy Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Soeul
country: Korea, Republic of
facility: Soeul National University Hospital
city: Suwon-si
country: Korea, Republic of
facility: The Catholic University of Korea, St. Vincent'S Hospital.
Study officials:
affiliation: Asan Medical Center
name: Suk-kyun Yang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04677400: More Than Body Appearance (MBA) Intervention
Official title: More Than Body Appearance (MBA) Intervention: Investigation of the Efficacy of a Psychological Online Intervention to Improve Body Image
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Body Image
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2020-12-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The promotion of a positive body image is crucial to increase the efficacy of psychological interventions targeting body image. Recent studies indicated that positive body image also acts as a protective factor against the onset of ED symptoms. However, in the last decades, research has predominantly focused on reducing body dissatisfaction, with most available psychological interventions for body image adopting a disease reduction perspective while neglecting positive aspects of psychological functioning. This approach has shown limited efficacy in improving body image. Consequently, it is crucial to develop new psychological interventions including both perspectives (i.e., disease reduction and health promotion perspectives) to improve body image and to test their efficacy in different contexts and populations.

The aim of this study was to investigate the efficacy of a 2-week online psychological intervention (More than Body Appearance; MBA) designed to improve body image in young women at both high and low risk of developing Body Image Disorders and in female athletes practicing aesthetic sports.


Eligibility criteria: Inclusion Criteria:

* Age 18 or above

Exclusion Criteria:

* Presence of a full-blown Body Image Disorder (BID);
* Current treatment for a BID.

Primary outcomes:
measure: Body appreciation
timeFrame: 2 weeks
measure: Body dysmorphic disorder symptoms
timeFrame: 2 weeks
measure: Functionality appreciation
timeFrame: 2 weeks
Secondary outcomes:
measure: Risk of developing eating disorders
timeFrame: 2 weeks
measure: Intuitive eating
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Padua
country: Italy
facility: University of Padua
state: PD
Study officials:
affiliation: Department of General Psychology, University of Padova
name: Silvia Cerea, PhD
role: PRINCIPAL_INVESTIGATOR
References: