louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03908931: Descriptive Study of the Reconstruction of Osteochondral Lesions of the Knee: Clinical and Imaging Results
Official title: Descriptive Study of the Reconstruction of Osteochondral Lesions of the Knee: Clinical and Imaging Results
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteochondral Defect
Lead sponsor: Versailles Hospital
Sponsor class: OTHER
First posted: 2019-04-09
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the clinical results and MRI imaging of autologous cartilage reconstructions or collagen matrix of the knee.

There is currently little data in the literature on clinical outcomes and imaging of this type of lesion.


Eligibility criteria: Inclusion Criteria:

* cartilaginous reconstruction by autologous transplant or collagenous chondro-inducing knee matrix
* \> 18 years

Exclusion Criteria:

* Other cartilaginous reconstruction techniques,
* other than knee joint

Primary outcomes:
measure: Postoperative knee function assessed by clinical examination
timeFrame: 2 years post surgery
measure: Postoperative knee function assessed by scores
timeFrame: 2 years post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Le Chesnay
country: France
facility: CH de Versailles
Study officials:
References:
Clinical trial NCT02351531: Cow Milk Allergy: Evaluation of the Efficacy of a New Thickened Extensively Hydrolyzed Formula in Infants With Confirmed Cow Milk Allergy
Official title: Cow Milk Allergy: Evaluation of the Efficacy of a New Thickened Extensively Hydrolyzed Formula in Infants With Confirmed Cow Milk Allergy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cow Milk Allergy
Lead sponsor: United Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-01-30
Enrollment: 32
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to assess the hypoallergenicity of a new thickened extensively hydrolyzed formula.


Eligibility criteria: Inclusion Criteria:

* between 1 and 12 months old
* having a cow milk allergy confirmed by a positive double-blind food challenge performed in the last 3 months,
* whose parent(s) signed the informed consent form

Exclusion Criteria:

* Infants mainly or exclusively breastfed,
* Infants having a weight at inclusion \< 2500g,
* Infants who refused to drink an extensively hydrolyzed formula anytime prior to inclusion,
* Infants fed an amino acid based formula
* Infants who had an anaphylactic reaction in the past,

Primary outcomes:
measure: Number of patients dropped out for intolerance
timeFrame: 2 weeks
Secondary outcomes:
measure: Cow's milk protein hypersensitivity score
timeFrame: 2 weeks
measure: Growth (weight, height, head circumference)
timeFrame: 3 months
measure: Growth (weight, height, head circumference)
timeFrame: 4 months
Other outcomes:
Locations:
city: Namur
country: Belgium
facility: Centre Hospitalier Régional
city: Paris
country: France
facility: Necker Children's Hospital
city: Naples
country: Italy
facility: University of Naples Federico II
Study officials:
References:
citation: Dupont C, Bradatan E, Soulaines P, Nocerino R, Berni-Canani R. Tolerance and growth in children with cow's milk allergy fed a thickened extensively hydrolyzed casein-based formula. BMC Pediatr. 2016 Jul 18;16:96. doi: 10.1186/s12887-016-0637-3.
Clinical trial NCT05141331: Comparison of Piezoelectric Split-crest Technique Versus Expansion Using Hand Driven Ridge Expanders in Treatment of Maxillary Narrow Ridges
Official title: Comparison of Piezoelectric Split-crest Technique Versus Expansion Using Hand Driven Ridge Expanders in Treatment of Maxillary Narrow Ridges
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Edentulous Alveolar Ridge
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-12-02
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of Piezoelectric split-crest technique versus expansion using Hand Driven Ridge Expanders in treatment of Maxillary Narrow Ridges


Eligibility criteria: Inclusion Criteria:

* Participants are free from any systemic diseases.
* Participant have missing one or two premolars or molars with sufficient alveolar ridge height and insufficient alveolar ridge buccolingual (BL) width that interfere with conventional straight forward implant placement.
* The minimum BL ridge width included in the study will be 3.5 mm to facilitate ridge splitting and expansion

Exclusion Criteria:

* Patients with residual infections in the edentulous areas.
* Medically compromised groups.
* Smokers and patients with poor oral hygiene.

Primary outcomes:
measure: bone width
timeFrame: 5 months
Secondary outcomes:
measure: implant stability
timeFrame: 5 months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT02745431: Oxytocin Effects on Likeability After Being Liked or Disliked
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Behavior
Keywords: Likeability
Being liked
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
First posted: 2016-04-20
Enrollment: 86
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The current study aimed to investigate oxytocin effect on the response after the experience of being liked or disliked.

Detailed description: In a double-blind, between-subject, placebo controlled design study, the researchers aimed to investigate the intranasal OXT (40IU) treatment on rating response after being liked or disliked in healthy male subjects. All subjects completed a range of questionnaires measuring personality and affective traits and levels of anxiety: Positive and Negative Affect Schedule (PANAS) , State-Trait Anxiety Inventory (STAI) , Beck Depression Inventory (BDI), Cheek and Buss shyness Scale (CBSS),Autism Spectrum Quotient (ASQ), Empathy Quotient(EQ) before self-administration.Study participants were led to believe that other participants had formed an opinion on their likability based on their appearance in a photograph and they passively viewed the responses (like or dislike) from 'other participants'. After that, they rated 'other participants' about likeability (how much do you like the person), accuracy (have you seen the person), feeling (how good do you feel), and tendency (how much would do like have him/her as a friend). Likeability, tendency, feeling and accuracy were included into analysis as dependent variables.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects without past or current psychiatric or neurological disorder

Exclusion Criteria:

* history of head injury;
* claustrophobia;
* medical or psychiatric illness.

Primary outcomes:
measure: Oxytocin effect on likeability after being liked or disliked
timeFrame: 2 hour
Secondary outcomes:
measure: Relationship status may influence oxytocin effect
timeFrame: 2 hour
Other outcomes:
Locations:
city: Chengdu
country: China
facility: School of Life Science and Technology, University of Electronic Science and Technology
state: Sichuan
Study officials:
References:
citation: Zhao W, Ma X, Le J, Ling A, Xin F, Kou J, Zhang Y, Luo R, Becker B, Kendrick KM. Oxytocin biases men to be more or less tolerant of others' dislike dependent upon their relationship status. Psychoneuroendocrinology. 2018 Feb;88:167-172. doi: 10.1016/j.psyneuen.2017.12.010. Epub 2017 Dec 22.
Clinical trial NCT01822431: A Comparison Between Pupillometry, Heart Rate Variability and Metaiodobenzylguanidine Scintigraphy for the Diagnosis of Early Diabetic Autonomic Neuropathy in Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Autonomic Neuropathy
Lead sponsor: AHEPA University Hospital
Sponsor class: OTHER
First posted: 2013-04-02
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients: outpatient diabetes clinic of AHEPA university hospital Controls: residents of Thessaloniki area

Brief summary: This study will examine if one of the following methods: pupillometry, spectral analysis of heart rate variability and metaiodobenzylguanidine scintigraphy, is more capable to detect early diabetic autonomic neuropathy in patients with type 1 diabetes mellitus


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes mellitus

Exclusion Criteria:

* Type 2 diabetes mellitus
* Severe cardiac autonomic neuropathy
* Medications other than insulin
* Ocular disease other than refractive eye disorders
* History of neurologic disease
* History of cardiovascular disease
* Thyroid disease
* Vitamin B insufficiency
* Other possible cause for autonomic failure

Primary outcomes:
measure: number of participants with abnormal results
timeFrame: 1 day (at time of examination)
Secondary outcomes:
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: AHEPA hospital, First Propedeutic clinic of internal medicine
Study officials:
References:
Clinical trial NCT00172731: Measurement of Activity Participation for Persons With Schizophrenia Living in the Community
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2005-09-15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: The purpose of the study is to develop a questionnaire on community occupational participation for persons with schizophrenia living in the community. In the International Classification of Functioning, Disability, and Health (ICF) recently revised by World Health Organization, activity participation is recognized as an important indication of health-related status. From the perspective of occupational therapy, the researcher intends to investigate the experiences of occupational participation among schizophrenic patients living in the community, and to develop a measuring tool for occupational participation accordingly.

The development of the Community Occupational Participation Questionnaire will be based on the result of a qualitative research project which the researcher is carrying out at the moment. The resultant questionnaire will provide a quantitative measure of community occupational participation for persons with schizophrenia, as well as a measurement tool of activity participation for health-related research studies. Furthermore, it may provide valuable information to the development of community psychiatric services.

This current study will take one year. Tasks to be accomplished include: building item pool, examining content validity of each item, pilot testing, item analysis, norm establishment, and testing reliability and validity. Data will be collected in different areas of Taiwan, and will be analyzed with the following methods: content validity ratio, item-total correlation, Cronbach's alpha, and confirmatory factor analysis. The study will result in an occupational participation questionnaire with norm, validity and reliability.

Detailed description: First, the participants were informed the right and how to fill the self-report survey questionnare in. And then they began to complete the questionnare. After finishing it, the participants gave the questionnare back to the examinor and got a gift as a reward.

Eligibility criteria: Inclusion Criteria:

* person with Schizophrenia
* Must be able to read Chinese
* Majorly living in community

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University
Study officials:
affiliation: Department of Occupational Therapy, National Taiwan University
name: Chinyu Wu, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00540631: Multicenter Trial of Immunotherapy With House Dust Mite Allergoid
Official title: A Multicentre Randomized Placebo-controlled Double-blind Clinical Trial for Evaluation of Safety and Efficacy of a Specific Immunotherapy With an Aluminium Hydroxide-adsorbed Allergoid Preparation of House Dust Mite (Dermatophagoides Pteronyssinus) in Patients With Rhinitis/Rhinoconjunctivitis and/or Allergic Asthma Bronchiale
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rhinoconjunctivitis
Keywords: House Dust Mite Allergen
Aluminium hydroxide-adsorbed
Lead sponsor: Allergopharma GmbH & Co. KG
Sponsor class: INDUSTRY
First posted: 2007-10-08
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Multicenter Immunotherapy House Dust Mite Allergoid

Detailed description: A multicentre randomized placebo-controlled double-blind clinical trial for evaluation of safety and efficacy of a specific immunotherapy with an aluminium hydroxide-adsorbed allergoid preparation of house dust mite (Dermatophagoides pteronyssinus) in patients with rhinitis/rhinoconjunctivitis and/or allergic asthma bronchiale

Eligibility criteria: Inclusion Criteria:

* Positive SPT
* Positive EAST
* Positive specific provocation test

Exclusion Criteria:

* Serious chronic diseases
* other perennial allergies

Primary outcomes:
measure: The primary endpoint is the change of the area under the curve (AUC)of the Symptom-Medication-Score (SMS)after 2 years of double-blind treatment to baseline
timeFrame: November 2007 - February 2010
Secondary outcomes:
measure: Change of the AUC of the SMS after one year to baseline.
timeFrame: 1 year
measure: Change of Nasal Eosinophil Cationic Protein (ECP) after 2 years to baseline
timeFrame: 2 years
measure: Immunologic changes IgE, IgG1 and IgG4
timeFrame: 2 years
measure: Tolerability and safety of treatments during the entire study period
timeFrame: 4 years
Other outcomes:
Locations:
city: Reinbek
country: Germany
facility: Allergopharma GmbH & Co. KG
Study officials:
affiliation: University Ulm, Germany
name: Herbert Riechelmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04366531: Successful Transitions and Reintegration Tools for Veterans (START-VETS)
Official title: Development of a Psycho-social Transition Program and Transition Assessment Tools for Veterans With Mental Illness and/or Substance Use Disorders Leaving Prison
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Substance Use Disorder
Mental Illness
Recently Incarcerated
Keywords: reentry
Mental illness
prison
substance use disorder
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2020-04-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Veterans will be randomly assigned to either begin an eight week (actual number of weeks is to be determined based on phase 2) active treatment program or to a no treatment phase. At eight weeks veterans will switch the condition they were assigned.
Primary purpose: TREATMENT

Brief summary: This study will develop prison reentry materials for Veterans leaving prison.

Detailed description: This study will be conducted in three phases Phase 1is to collect qualitative data from Veterans who have recently been released from prison. The data will focus on their transition experience, stigma (both self and from others), and behaviors that interfered with success. Phase 2a will be to develop a transition program based around the needs identified in phase 1 Phase 2b will be to develop assessment tools to be used with the program Phase 3 will be to perform a two group randomized cross over design pilot study to assess the program

Eligibility criteria: Inclusion Criteria:

* Veteran with mental illness and/or substance use disorder released from prison within the past 36 months

Exclusion Criteria:

* psychosis or cognitive impairment precluding active participation

Primary outcomes:
measure: Change in the Brief Symptom Inventory -18
timeFrame: The Brief Symptom Inventory will be administered at the baseline of the subject's participation and again every 4 weeks for 16 weeks.
measure: Change in the World Health Organization Quality of Life 100
timeFrame: The World Health Organization Quality of Live 100 will be administered at the baseline of the subject's participation and again every 4 weeks for 16 weeks.
measure: Inventory of Criminal Thinking Style
timeFrame: The Inventory of Criminal Thinking Style will be administered at the baseline of the subject's participation and again every 4 weeks for 16 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
state: Texas
Study officials:
affiliation: VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
name: James P. LePage, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04803331: SPIO-enhanced MRI in Oral Cancer for Sentinel Lymph Node Identification
Official title: Superparamagnetic Iron Oxide-enhanced Magnetic Resonance Imaging for Sentinel Lymph Node Identification in Oral Cancer: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Head and Neck Squamous Cell Carcinoma
Keywords: Sentinel lymph node identification
Magnetic resonance imaging
Superparamagnetic iron oxide
Oral cancer
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2021-03-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To explore the feasibility of sentinel lymph node identification by SPIO injection followed by MRI in head-and-neck cancer patients.


Eligibility criteria: Inclusion Criteria:

* Male or female aged \>18 years.
* Patients with histopathologically proven cT1-2N0M0 squamous cell carcinoma of the oral cavity.
* Patients planned to undergo routine sentinel node biopsy with 99mTc-radioisotope and SPECT-CT.
* Patient provided written informed consent.

Exclusion Criteria:

* Patients who underwent previous surgery or radiotherapy to the neck.
* Contra-indications to SPIO (Hypersensitivity to iron oxide or dextran compounds, Presence of iron overload disease (hereditary hemochromatosis, hemosiderosis, chronic hemolytic anemia (e.g. thalassemia, sickle cell anemia))
* Contra-indications to MRI: Epilepsy, Claustrophobia, Metallic splinters, Pacemaker, pacemaker wires or implanted defibrillator, Implanted magnets in jaw, Metallic Arterial clips (carotid arteries), Pregnancy, Auditory implant, neurogenic bladder stimulator, insulin pump, neurostimulator, baclofen pump, Metallic tissue expander after mastectomy, Cochlear implant, Metallic braces, Other foreign bodies implanted
* Unable to provide informed consent.

Primary outcomes:
measure: MR (artefact) finetuning for optimization of SPIO dose and timing of MRI
timeFrame: 2 months
Secondary outcomes:
measure: Localization of sentinel lymph nodes detected by conventional 99mTC-nanocollloid injection and SPECT-CT and by SPIO injection and MRI
timeFrame: 1 year
measure: Comparison of SPIO distribution within a lymph node on MR-images and histopathological staining.
timeFrame: 1 year
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
Study officials:
affiliation: Radiation Oncology
name: J.H.A.M. Kaanders, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06917131: Royal Jelly as a Strategy to Modulate Inflammation and Oxidative Stress in Patients With Systemic Arterial Hypertension
Official title: Royal Jelly as a Strategy to Modulate Inflammation and Oxidative Stress in Patients With Systemic Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Cardiovascular Diseases (CVD)
Inflammation
Keywords: royal jelly
inflammation
Hypertension
cardiovascular diseases
Lead sponsor: Universidade Federal Fluminense
Sponsor class: OTHER
First posted: 2025-04-08
Enrollment: 34
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: HEALTH_SERVICES_RESEARCH

Brief summary: The study aims to evaluate the effect of the royal jelly on inflammation and oxidative stress in participants with systemic arterial hypertension. A longitudinal double-blind randomized clinical trial will be carried out, involving hypertensive participants for two months.

Detailed description: Royal jelly (RG) is considered a superfood that has been used in traditional medicine and dietary supplementation due to its antioxidant, anti-inflammatory, immunomodulatory, and regenerative properties. The antioxidant and anti-inflammatory effects of GR highlight its potential as a natural supplement for the prevention and management of several health conditions. Although in vitro and animal model data are promising, clinical studies are still needed to validate the effects of royal jelly in human populations.

Eligibility criteria: Inclusion Criteria:

* patients using one to three antihypertensive medications, undergoing regular follow-up at the HUAP Medical Clinic for more than 6 months and without the need for changes in medication doses in the last 3 months.

Exclusion Criteria:

* Patients with autoimmune and infectious diseases, diabetes, chronic kidney disease, liver disease, cancer and AIDS will be excluded; pregnant women; those using catabolic drugs or antibiotics; use of antioxidant vitamin supplements, prebiotics, probiotics, symbiotics, habitual intake of royal jelly, and who are allergic to cornstarch or report having an allergy to bee stings will also be excluded. Patients with acute myocardial infarction (AMI) and/or stroke (CVA) in the last 6 months will also be excluded; with HAS stages 2 or 3.

Primary outcomes:
measure: Change of inflammatory status in the participants
timeFrame: Baseline and 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rio de janeiro
country: Brazil
facility: Denise Mafra
Study officials:
affiliation: Universidade Federal Fluminense
name: Ludmila Cardozo, PhD
role: PRINCIPAL_INVESTIGATOR
References: