louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00245947: Study Evaluating ERB-041 in Active Crohn's Disease
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel- Design, Exploratory Pharmacogenomic, Safety and Activity Study of Orally Administered ERB-041 in Subjects With Inflammation Associated With Active Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Crohn's Disease
Keywords: Crohn's Disease
Inflammation
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-10-28
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the response of inflammatory serum markers to oral ERB-041 in subjects with inflammation associated with active Crohn's disease.


Eligibility criteria: Inclusion Criteria:

* Men and women, minimum 18 years of age with a diagnosis of Crohn's disease greater than 3 months,
* Eligible subjects must have adequate hematologic, renal, and hepatic function.

Other inclusions apply

Exclusion Criteria:

* Use of the following medications within the specified time period before randomization is prohibited:

Within 48 hours before randomization

* Nonsteroidal antiinflammatory drugs (NSAIDs) Within 2 weeks before randomization
* Herbal supplements (except for a daily multivitamin/mineral supplement not containing herbal components).

Other exclusions applies

Primary outcomes:
measure: Inflammatory serum markers
measure: Pharmacogenomics
measure: Safety
Secondary outcomes:
measure: Crohn's Disease Activity Index (CDAI) scores.
measure: Cell surface markers
measure: Fecal markers
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01618747: An Observational Study of Avastin (Bevacizumab) in Patients With Glioblastoma Multiforme in First or Second Relapse
Official title: A Single-arm, Open-label, Multicenter, Non-interventional Study to Assess Bevacizumab (Avastin) in Relapsed Glioblastoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glioblastoma Multiforme
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-06-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with previously treated glioblastoma multiforme in first or second relapse

Brief summary: This single-arm, open-label, multicenter, observational study will evaluate the efficacy and safety of Avastin (bevacizumab) in patients with glioblastoma multiforme in first or second relapse. Data will be collected from eligible patients initiated on Avastin treatment according to local label for up to 3 years.


Eligibility criteria: Inclusion Criteria:

* Adults patients, \>/= 18 years of age
* Histologically confirmed glioblastoma multiforme in first or second relapse

Exclusion Criteria:

* Patients not qualifying for Avastin treatment as per local label

Primary outcomes:
measure: Progression-free survival at 6 months
timeFrame: approximately 3 years
Secondary outcomes:
measure: Progression-free survival
timeFrame: approximately 3 years
measure: Time to disease progression
timeFrame: approximately 3 years
measure: Duration of objective response
timeFrame: approximately 3 years
measure: Overall survival
timeFrame: approximately 3 years
measure: Safety: Incidence of adverse events
timeFrame: approximately 3 years
Other outcomes:
Locations:
city: Kaohisung
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05087147: Clinical Evaluation of Bonded Versus Banded Space Maintainers
Official title: Clinical Evaluation of Bonded Versus Banded Space Maintainers in Children With Prematurely Lost First Primary Molars: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tooth Loss
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-10-21
Enrollment: 36
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Comparing bonded space maintainers to banded space maintainers

Detailed description: Comparing bonded space maintainers to banded ones regarding clinical success in maintaining the space for the prematurely lost primary molar and radiographic space loss in both banded and bonded space maintainers. Finally, patient satisfaction regarding both treatments.

Eligibility criteria: Inclusion criteria:

Patient and parent showing cooperation and compliance. Medically free children. Patients having mandibular first deciduous molar indicated for extraction due to extensive coronal caries beyond possible repair, root caries and/or failed pulp therapy.

Having all first permanent molars erupted and in Class I molar relation. According to space analysis available space is less than or equal to needed space.

Having all their mandibular incisors erupted. With deciduous canines and second deciduous molars in the side of the extraction maintained throughout the entire follow-up period. Caries free, non-restored buccal surfaces of the mandibular second primary molars and deciduous canines. 1/3 to less than 2/3 of the root of the permanent successor is formed to the prematurely lost primary molars.

Exclusion criteria:

Children with any parafunctional habits. Children with previous allergies to stainless steel. Crowned abutment teeth. Permanent successors with 2/3 of its roots formed and space analysis does not indicate the fabrication of space maintainer.

Primary outcomes:
measure: appliance failure
timeFrame: up to 12 months
Secondary outcomes:
measure: Radiographic space loss
timeFrame: up to 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Cairo U
name: Omar S Abo El Abbas
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06890377: Targeted Α-synuclein PET Imaging in the Diagnosis of Multiple System Atrophy
Official title: Targeted Α-synuclein PET Imaging in the Diagnosis of Multiple System Atrophy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple System Atrophy - Cerebellar Subtype (MSA-C)
Multiple System Atrophy - Parkinsonian Subtype (MSA-P)
Keywords: Multiple System Atrophy
PETCT
α-synuclein
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2025-03-24
Enrollment: 90
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: People who came to Third Xiangya Hospital of Central South University for consultation or online questionnaire recruitment

Brief summary: The aim of this study was to apply the targeted α-synuclein PET study technique to investigate the pathological load and spatial distribution characteristics of α-syn in MSA patients, and to assess its value as a biomarker for diagnostic typing, disease severity, and prognosis in MSA.


Eligibility criteria: Inclusion Criteria:

* Age\> 35 years old, gender is not limited;
* Clinically confirmed MSA and clinically probable MSA according to the 2022 MDS MSA diagnostic criteria;
* all patients had been ruled out of polyQ disease by genetic testing;
* Voluntarily participate in this study and sign the informed consent form.

Exclusion Criteria:

* pregnancy or breastfeeding;
* contraindications to MRI examination or inability to cooperate in completing neuroimaging examination;
* previous history of other neurological disorders or presence of other organic intracranial lesions on neuroimaging that cannot be interpreted by MSA, such as epilepsy, trauma, tumors, or high-grade cerebral white matter degeneration (Fazekas grade 2 and above);
* History of alcohol or drug abuse

Primary outcomes:
measure: Standard uptake value ratio(SUVR)
timeFrame: From enrollment to the end of treatment at 4 weeks
Secondary outcomes:
measure: UMSARS
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: H-Y stage
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: SCOPA-AUT
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: Wexner score
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: Frontal Assessment Battery
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: MoCA score
timeFrame: From enrollment to the end of treatment at 4 weeks
Other outcomes:
Locations:
city: Hunan
country: China
facility: Third Xiangya Hospital of Central South University
state: Changsha
Study officials:
References:
Clinical trial NCT06415877: The Effect of the Modified Simulation Model on Self-Efficacy, Anxiety, and Academic Motivation in Episiotomy Training
Official title: The Effect of the Modified Simulation Model on Self-Efficacy, Anxiety, and Academic Motivation in Episiotomy Training
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Episiotomy
Anxiety
Simulation
Keywords: episiotomy
anxiety
simulation
Lead sponsor: Osmaniye Korkut Ata University
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 90
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: It was planned as a randomized controlled study to determine the effect of the modified simulation model on self-efficacy, anxiety and academic motivation in episiotomy training. It will be held online with students from the midwifery department of Osmaniye Korkut Ata University.


Eligibility criteria: Inclusion Criteria:

* Midwifery student
* volunteers

Exclusion Criteria:

* involuntary

Primary outcomes:
measure: self-efficacy
timeFrame: 1 week
Secondary outcomes:
measure: academic motivation
timeFrame: 1 week
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01647477: Interventional Study Collecting Quantitative and Qualitative Data About Patient With Non Treated Cancer
Official title: Determinants of the Consultation Delay in Cancers of the Upper Aero Digestive Tract
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Upper Aerodigestive Tract Cancer
Keywords: non treated cancer
oral cavity
oropharynx
hypopharynx
larynx
first consultation
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
First posted: 2012-07-23
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to determine the impact of sociocognitive and emotional factors on the time of the initial consult

Detailed description: identify wich sociocognitive factors influence the delay to go to a doctor after the emergence of first symptoms

Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years
* oral cavity cancer, oropharynx cancer, hypopharynx cancer, larynx cancer
* non treated cancer
* patient informed of his diagnosis
* speak fluent french
* patient covered by health insurance
* signed informed consent

Inclusion Criteria for "interviewed " patients :

* no speech troubles
* patient consents being recorded

Exclusion Criteria:

* history of cancer
* psychological history
* patient under guardianship

Primary outcomes:
measure: time of first consultation
timeFrame: baseline
Secondary outcomes:
measure: identify variables associated with time of consultation
timeFrame: baseline
Other outcomes:
Locations:
city: Boulogne sur Mer
country: France
facility: Centre Hospitalier
city: Lens
country: France
facility: CH
city: Lille
country: France
facility: Oscar Lambret Center
city: Lille
country: France
facility: Centre Hospitalier Régional et Universitaire - Hopital HURIEZ
city: Lille
country: France
facility: La Louviere Hospital
city: Maubeuge
country: France
facility: Gray Center
city: St Martin les Boulogne
country: France
facility: Centre Médical Spécialisé du Littoral
Study officials:
affiliation: Lille 3 University
name: Veronique CHRISTOPHE, MDPhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02752477: Efficacy of Opioid-free Anesthesia in Reducing Postoperative Pain in Chronic Pain Patients Undergoing Spinal Surgery
Official title: Efficacy of Opioid-free Anesthesia in Reducing Postoperative Pain in Chronic Pain Patients Undergoing Spinal Surgery: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Chronic Pain
Anesthesia
Keywords: Opioid-sparing
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2016-04-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this trial is to determine whether an opioid-free general anesthetic (OFA) technique utilizing ketamine, dexmedetomidine, and lidocaine infusions can help reduce postoperative pain in opiate-dependent chronic pain patients (CPPs) undergoing spine surgery when compared with traditional opioid-containing techniques. It is expected that this OFA regimen will have a measurable reduction on postoperative opioid consumption and pain scores in CPPs.


Eligibility criteria: Inclusion Criteria:

* Chronic pain \> 6 months, opiate-using patients scheduled for thoracic or lumbar spinal surgery

Exclusion Criteria:

* Pregnant or breastfeeding women, significant hepatic, renal or cardiac disease, allergy to any of the study drugs, inability to consent, respond to pain assessments or use the patient controlled analgesia device

Primary outcomes:
measure: Quantified opioid-consumption
timeFrame: 48 hours following surgery
Secondary outcomes:
measure: Visual analogue scale (VAS) pain scores
timeFrame: 48 hours following surgery
measure: Time of stay in post-anesthetic care unit (PACU)
timeFrame: up to 5 hours following surgery
measure: Incidence of adverse events
timeFrame: 48 hours following surgery
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: Ben Lim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03893877: Comparison of Oxygenation Methods in Sedation
Official title: Noninvasive Mechanic Ventilation With Nasal Mask is Better Than Oxygen Delivery Via Nasal Cannula for Dental Treatments in Children Performed Under Deep Sedation: Randomised ,Prospective, Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Deep Sedation
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2019-03-28
Enrollment: 70
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Abstract

Backgrounds and objectives:

Dental treatments, especially in children who can not be cooperated, may require deep sedation due to intense anxiety and fear. During sedation oxygen is usually given to the patients by nasal cannula. Investigators want to use nasal mask for non-invasive mechanical ventilation for oxygenation of the patient during sedation for dental treatment and described it with nasal cannula.

Methods:

Seventy three children classified as ASA 1 or 2, aged between 3 to 17 will be included for this study. During deep sedation procedure group M will be applied nasal mask in order to noninvazive mechanical ventilation, group C will be applied nasal cannula connected to the oxygen flowmeter.

Detailed description: Majority of dental treatments can be performed under local anesthesia. However, this is not always possible for pediatric non-cooperative patients with severe anxiety. In these cases, unpleasant dental experiences may lead to dental phobia when they become adults. For such patients requiring short-term dental procedures, sedation can best choice.

In sedative procedures of patients it is necessary to delivery oxygen to the patient's respiratory system. This can achieved by means of nasal cannulas or interface masks like nasal mask which are connected to the oxygen flowmeter of the anesthesia machine. Investigators hypotezed that oxygen delivery via non-invazive machanic ventilation with nasal mask which is connected to the anesthesia-breathing circuit unit could be better than nasal cannula connected to the oxygen flowmeter of the anesthesia machine during deep sedation for dental treatment.

Eligibility criteria: Inclusion Criteria:

* patients aged betweeen 3-17
* patients with wn ASA( American Society of Anesthesiologists) score 1-2

Exclusion Criteria:

* patients under 3 years old
* patients above of ASA score 2

Primary outcomes:
measure: effects of non invasive mechanical ventilation on oxygen saturation during deep-sedated patients.
timeFrame: 30 MINUTES
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Seher Orbay Yasli
Study officials:
affiliation: Ercıyes University faculty of dentistry
name: Seher O Yasli
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04471077: Association Between Outcomes of Bariatric Surgery and Preoperative Gastrointestinal Microbiota
Official title: Association Between Outcomes of Bariatric Surgery and Preoperative Gastrointestinal Microbiota
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity, Morbid
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2020-07-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The investigators included patients undergoing surgical treatment for morbid obesity.

Brief summary: Purpose The aim of this study was to analyze the microbiota of patients undergoing LSG or LRYGB on three levels of gastrointestinal tract, using oral swab and stool sample. We compared samples from patients achieving favorable outcomes in terms of weight-loss with patients, who did not respond optimally to the bariatric operation.

Materials and methods Design This prospective cohort study was conducted in one academic, teaching hospital. The recommendations of the Metabolic and Bariatric Surgery Section of the Polish Surgical Society were used as indication for surgery, that is: Body Mass Index (BMI) ≥35 kg/m2 with obesity-related comorbidities or BMI ≥40 kg/m2 .

Analysis and endpoints Primary endpoint was to determine the difference in microbiota present in oral cavity and large intestine between patients ing Group 1 and Group 2. Secondary endpoint was to compare the results of microbiota analysis between LSG and LRYGB.


Eligibility criteria: Inclusion Criteria:

* informed consent to participate in the study, meeting the eligibility criteria for bariatric treatment, either for LSG or LRYGB.

Exclusion Criteria:

* type 1 or type 2 diabetes, treatment with antibiotics within 30 days prior to gathering microbiological material, treatment with probiotics within 30 days prior to gathering microbiological material, gastrointestinal infections, inflammatory bowel disease, thyroid diseases, cancer (especially the digestive tract), immunodeficiency.

Primary outcomes:
measure: Change of microbiota in oral cavity
timeFrame: 6 months
measure: Change of microbiota in large intestine
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cracovia
country: Poland
facility: 2nd Department of General Surgery, Jagiellonian University Medical College
state: Małopolska
Study officials:
References:
Clinical trial NCT06645977: Patients With Interstitial Lung Disease
Official title: Prospective Observational Study of Patients With Interstitial Lung Disease (RESPIRARE)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Interstitial Lung Disease
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients diagnosed with interstitial lung disease from ILD clinic of the Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome.

Brief summary: Prospective monocentric collection of data from adult patients with interstitial lung disease (ILD), to provide real-world data on current patient management at the ILD clinic.


Eligibility criteria: Inclusion Criteria:

* Age \>= 18 years
* Diagnosis of ILD, according to international guidelines.

Exclusion Criteria:

* Inability to give informed consent.

Primary outcomes:
measure: Prevalce ILD
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli
state: RM
Study officials:
References: