louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06487689: Oral Manifestations in Chronic Kidney Disease.
Official title: Oral Manifestations in Chronic Kidney Disease: Clinical Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Diseases
Hemodyalysis
Pre-dyalisis
Peritoneal Dyalisis
Lead sponsor: University of Barcelona
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 449
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Population with Chronic Kidney Disease, in pre-dialysis, hemodialysis, peritoneal dialysis

Brief summary: The goal of this observational study is to investigate oral manifestations in patients with Chronic Kidney Disease (CKD) for early detection, that alterations play an important point for dental guide during the progression and type of treatment of CKD .

An oral exam was performed for detection oral manifestations, age, smoking, alcoholic and oral hygiene habits were collected.

The study has 3 groups under study: hemodialysis (HD), peritoneal dialysis (PD) and pre-dialysis (P-D)


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years and ≤ 80 years;
* No change of medication in the last 3 months;
* History of CKD comported by data laboratory (GRF\<60 ml/min/1.73m²).

Exclusion Criteria:

* Age ≤ 18 years and ≥ 80 years;
* Patients undergoing orthodontic therapy;
* Patients taking drugs;
* Patients changes the medication or introduced a new medication.

Primary outcomes:
measure: Periodontal status
timeFrame: 2 years
Secondary outcomes:
measure: Sex
timeFrame: 2 years
measure: Age
timeFrame: 2 years
measure: Type of CKD
timeFrame: 2 years
measure: time with CKD
timeFrame: 2 years
measure: time of treatment
timeFrame: 2 years
measure: smoking and alcohol habits
timeFrame: 2 years
measure: oral lesions
timeFrame: 2 years
Other outcomes:
Locations:
city: Hospitalet de Llobregat
country: Spain
facility: University of Barcelona
state: Barcelona
Study officials:
References:
Clinical trial NCT04861389: Distal Transradial Access for Primary Percutaneous Coronary Intervention in STEMI Patients
Official title: The Comparison of Distal Transradial Access and Transradial Access for Primary Percutaneous Coronary Intervention in STEMI Patients（RESERVE Trial） A Single-center, Open, Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute ST-segment Elevation Myocardial Infarction
Radial Artery Occlusion
Distal Radial Artery Approach
Lead sponsor: Shenzhen People's Hospital
Sponsor class: OTHER
First posted: 2021-04-27
Enrollment: 414
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The transradial access (TRA) is currently the preferred approach for percutaneous coronary intervention (PCI). However, in patients with ACUTE ST-segment elevation myocardial infarction (STEMI) after emergency PCI, the high incidence of THE radial artery RAO limits the future choice of the radial artery for percutaneous intervention. The literature reported that distal transradial access (dTRA) significantly reduced RAO after elective PCI, but the application of dTRA in emergency PCI in STEMI has not been reported. We have completed 126 cases of dTRA undergoing emergency PCI after STEMI, which has been preliminarily confirmed to be safe and effective. A single-center, open, prospective, randomized controlled study is planned to compare the use of dTRA and TRA in emergency PCI in STEMI patients. The primary endpoint was the INCIDENCE of RAO within 24 hours after surgery. This clinical study verified that dTRA compared with TRA could reduce the RAO incidence of STEMI patients after emergency PCI. The project will explore a new artery approach to reduce RAO, and provide a basis for the selection of artery approach in STEMI emergency PCI patients.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of STEMI
* To undergo emergency PCI treatment
* Palpable pulsation of the radial artery and distal radial artery

Exclusion Criteria:

* Arteriovenous fistula of radial artery and cephalic vein has been performed with regular hemodialysis
* Suspicious left main block of electrocardiogram
* Had used the radial artery percutaneous interventional treatment before
* Cardiogenic shock

Primary outcomes:
measure: The RAO incidence during hospitalization
timeFrame: 7 days
Secondary outcomes:
measure: Puncture time
timeFrame: During the intervention
measure: Compression time
timeFrame: 4-24 hours
measure: Puncture success rate
timeFrame: During the intervention
measure: Incidence of hematoma, finger numbness or pain during hospitalization
timeFrame: 7days
measure: Incidence of RAO at 1 and 6 months after surgery
timeFrame: 1 and 6 months
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
Study officials:
affiliation: Shenzhen People's Hospital
name: Shaohong Dong, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01165489: Discovering Laryngomalacia
Official title: Discovering Laryngomalacia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Laryngomalacia
Keywords: Laryngomalacia
Congenital Anomalies
Associated Health Problems
Lead sponsor: Boushahri Clinic Medical Center
Sponsor class: OTHER
First posted: 2010-07-20
Enrollment: 1500
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Primary Care Clinic

Brief summary: Laryngomalacia is the most common congenital malformation of the larynx. It results from abnormal prolapse of supraglottic structures during inspiration. Symptoms usually appear within the first 2 weeks of life. Its severity increases in up to 6 months. 15-60% of infants with laryngeomalacia have synchronous airway anomalies.

Detailed description: 500 full term babies ≥37 weeks of both sexes delivered by different modes of delivery, with birth weights ≥2.5 kg, no history of natal or post-natal complications and from the same community. Mothers of these babies are from different socioeconomic standards and from the same community. These babies were diagnosed as having laryngomalacia. Clinical, flexible nasal and laryngeal scope, radiological and milk scintiscan were the tools used in our assessment. One thousand full term babies delivered with normal larynx, almost within the same period of time and from the same community were used as a control.

Laryngomalacia was recognized with significant statistical difference in dacryostenosis, deviated nasal septum, adenoid hypertrophy and gastroesophageal reflux disease. No significant statistical difference in pectus excavatum, cleft lip or palate, congenital lobar emphysema fistula and choanal atresia.

Eligibility criteria: Inclusion Criteria:

* 500 full term babies ≥ 37 weeks of both sexes were delivered by different modes of delivery, with birth weights of ≥ 2.5 kg, with no history of natal complications and from the same community.
* Mothers of these babies are from different socioeconomic standards with different educational levels.

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kuwait
country: Kuwait
facility: Boushahri Clinic Medical Center
Study officials:
affiliation: New Children's Hospital, Cairo University
name: Mohamed S EL-Sayed, MBBCh, MSc, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03718689: Effect of Er:YAG Laser on Hydrophilic Sealants
Official title: The Effect of Er:YAG Laser on Clinical Success of a Hydrophilic Fissure Sealant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fissure Sealant
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2018-10-24
Enrollment: 44
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was conducted on 44 (19 girls and 25 boys) patients presenting 132 permanent first molars, who applied for oral examination to Adnan Menderes University Faculty of Dentistry Department of Pediatric Dentistry. The patients involved in the study were aged between 7-11 years who had fully erupted permanent first molars, which were suitable for non-invasive fissure sealant application (narrow, deep fissures).

Detailed description: The permanent first molar teeth were cleaned using a polishing brush and pumice and isolated with cotton rolls. Caries status was assessed using DIAGNOdent pen (DIAGNOdent pen 2190, KaVo, Biberach, Germany) at the occlusal and proximal sites. Teeth having DIAGNOdent readings of 12 or less at the occlusal site and 7 or less at the proximal site were included in the study. Then, the teeth were divided into three groups. The first group (Grup A) of teeth were etched with phosphoric acid, the second group of teeth (Group L) were etched with Er:YAG laser and the third group of teeth (Group A+L) were etched with both Er:YAG laser and phosphoric acid. The patients were recalled for follow up examination at the 3rd, 6th and 9th months. The teeth were assessed using mouth mirror and explorer regarding new caries formation and retention of the fissure sealants. The obtained data were analyzed using SPSS 24.0 (SPSS 24.0 for Windows, SPSS Inc., Chicago, IL, USA).

Eligibility criteria: Inclusion Criteria:

* Patients who participated in this study had good general health and oral hygiene.
* Fully erupted permanent first molar teeth with deep, narrow fissures
* Teeth with no detectable occlusal and proximal caries

Exclusion Criteria:

* Hypomineralized areas such as fluorosis, molar incisor hypomineralization
* Allergy to resins, who were not willing to participate in the study.
* Teeth with hypomineralized areas such as fluorosis,
* Teeth with molar incisor hypomineralization

Primary outcomes:
measure: Retention rate
timeFrame: Change from Baseline retention rate at 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aydın
country: Turkey
facility: Hülya Yılmaz
Study officials:
References:
citation: Guclu ZA, Hurt AP, Donmez N, Coleman NJ. Effect of Er:YAG laser enamel conditioning and moisture on the microleakage of a hydrophilic sealant. Odontology. 2018 Jul;106(3):225-231. doi: 10.1007/s10266-017-0323-4. Epub 2017 Dec 13.
Clinical trial NCT00377689: Evaluation of an Intervention Program Targeted at Improving Balance and Functional Skills After Stroke
Official title: Evaluation of an Intervention Program Targeted at Improving Balance and Functional Skills After Stroke - a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cerebrovascular Accident
Musculoskeletal Equilibrium
Keywords: Accidental falls
Cerebrovascular accident
Balance
ADL
Self efficacy
Quality of Life
Gait parameters
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: Vardalinstitutet The Swedish Institute for Health Sciences
name: Erik & AnnMarie Detlofs Foundation
name: The Swedish National Stroke society
name: The Northern County Councils Regional Federation
First posted: 2006-09-18
Enrollment: 34
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to evaluate a 5-week intervention program targeted at improving balance and functional skills for people with stroke.

Detailed description: Many people with stroke experience a deterioration in balance and a functional decline due to hemiplegic muscle strength. This tend to restrict the persons activity in daily life and also leads to a low falls self efficacy.

High intensity exercise have shown to be effective for improving strength and balance for older people in general living in residential care facilities. It is interesting to see if this high intensity exercise also is applicable in the older stroke population.

Comparison: An intervention group receives three training sessions per week and one theory session per week during 5 weeks, compared to a control group that receives one theory session per week during 5 weeks.

Eligibility criteria: Inclusion Criteria:

* 55 years of age or older
* stroke diagnosis 3-6 months prior to inclusion
* ability to walk 10 meter with or without assistive device
* ability to understand simple instructions

Exclusion Criteria:

* TIA
* independent in walking outdoors
* serious visual impairment
* serious hearing impairment
* long distance to intervention station

Primary outcomes:
measure: Improvement in balance
timeFrame: post, 3 & 6 months
Secondary outcomes:
measure: Reduced falls
timeFrame: post, 3 & 6 months
measure: Improved self-efficacy
timeFrame: post, 3 & 6 months
measure: Improved ADL
timeFrame: post, 3 & 6 months
measure: Improved walking ability
timeFrame: post, 3 & 6 months
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Umeå University, department of Community science and rehabilitation
Study officials:
affiliation: Umeå University & The Vårdal Institute
name: Eva Holmgren, PhD student
role: PRINCIPAL_INVESTIGATOR
affiliation: Umeå University
name: Per Wester, MD Professor
role: STUDY_CHAIR
References:
Clinical trial NCT05604989: Associations Between the Oral and Intestinal Microbiome and Neovascular Age-related Macular Degeneration
Official title: Associations Between the Oral and Intestinal Microbiome and Neovascular Age-related Macular Degeneration and the Investigation on the Effect of Oral Probiotics as a Treatment - A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neovascular Age-related Macular Degeneration
Keywords: neovascular AMD
microbiome
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2022-11-03
Enrollment: 45
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A pilot study for Associations between the oral and intestinal microbiome and neovascular age-related macular degeneration and the investigation on the effect of oral probiotics as a treatment

The investigators recruit the neovascular AMD patients and control patients.

1. 15 neovascular AMD patients with anti-VEGF treatment and oral probiotics supplement
2. 15 neovascular AMD patients with anti-VEGF treatment and no oral probiotics supplement
3. 15 control patients and no oral probiotics supplement

The investigators will collect stool, blood, and saliva sample at the baseline and 6 months, and analyze the oral and intestinal microbiome changes.


Eligibility criteria: Inclusion Criteria:

* Normal BMI patients
* Diagnosed as neovascular AMD (experimental \& sham group)
* Normal patients (control group)

Exclusion Criteria:

* Obese (BMI \> 30)
* Past surgical history involving intestinal diseases
* Previous oral antibiotic treatment before 1 week at the baseline enroll
* Previous oral probiotics supplement
* Previous ophthalmic retinal diseases except neovascular AMD

Primary outcomes:
measure: Oral microbiome changes after oral probiotics supplement in neovascular AMD patients
timeFrame: 6 months after enrollment
measure: Intestinal microbiome changes after oral probiotics supplement in neovascular AMD patients
timeFrame: 6 months after enrollment
Secondary outcomes:
measure: Visual acuity changes after oral probiotics supplement
timeFrame: 6 months after enrollment
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Kwangsic Joo, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00965289: High-dose Chemotherapy With Rituximab for Adults With Aggressive Large B-cell Lymphoma
Official title: Front-line High-dose Chemotherapy (HDT) Combined With Rituximab for Adults With Aggressive Large B-cell Lymphoma (DLBCL) : Goelams 074 Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: B-Cell Lymphoma
Keywords: Aggressive large B-cell lymphoma (DLBCL)
Intensive chemotherapy
Rituximab
ASCT
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: French Innovative Leukemia Organisation
name: Hoffmann-La Roche
First posted: 2009-08-25
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A prospective pilot trial was proposed to patients with DLBCL, with IH or high adjusted IPI, up to the age of 60 y.o. This program consisted of 2 courses of high-dose R-CHOP-like regimen, followed by a course of high-dose methotrexate with cytarabin. For patients who achieved at least a PR, ASCT started with a BEAM regimen.

Detailed description: Superiority of HDT with autologous stem cell transplantation (ASCT) in the upfront treatment of poor-risk DLBCL remains an option for intermediate-high (IH) or high IPI young adults. We updated results of the prospective trial Goelams 074 to evaluate long-term efficacy and toxicity in 42 patients who underwent HDT with ASCT.

Eligibility criteria: Inclusion Criteria:

* Age 18 to 60 y.o
* Aggressive Large B-Cell Lymphoma (CD20+)
* Ann Arbor stage III, IV
* IH or high adjusted IPI
* signed inform consent

Exclusion Criteria:

* Age \< 18 ou \> 60 y.o
* other type of lymphoma
* serology VIH +
* other neoplasms apart from basal cell carcinoma or situ carcinoma

Primary outcomes:
measure: CR rate after 3 high dose chemotherapy courses
timeFrame: safety/efficacy of chemotherapy treatment
Secondary outcomes:
measure: CR and PR rate at the end of the study treatment
timeFrame: safety/efficacy of treatment30 days after the end of post ASCT aplasia
measure: PFS,EFS and OS
timeFrame: safety/efficacy of study treatment
measure: Tolerance of Rituximab combined with chemotherapy
timeFrame: safety/efficacy of immunotherapy combined with chemotherapy treatment
Other outcomes:
Locations:
city: Nantes
country: France
facility: University Hospital
Study officials:
affiliation: CHU NANTES/GOELAMS
name: Noel MILPIED, PD MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01688089: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ODM-103 in Healthy Volunteers
Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of Single and Repeated Escalating Doses of ODM-103: a Randomised, Double-blind, Placebo- and Entacapone-controlled Single Centre First-in-man Study in Healthy Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: volunteer
study
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2012-09-19
Enrollment: 67
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to evaluate the safety and tolerability of escalating doses of ODM-103 when given to healthy male volunteers.

Detailed description: The study is divided into two parts. Part one is a crossover study where healthy volunteers will receive two doses of ODM-103 and one dose of placebo. Part II of the study is a multiple ascending dose parallel group study where healthy volunteers will receive ODM-103 three times daily for seven days. Healthy volunteers taking part in Part II of the study will also receive levo/carbidopa and entacapone four times daily on day 1 and levo/carbidopa in addition to ODM-103 on day 9. The study will also look at the pharmacokinetic(how the body handles the drug) and pharmacodynamics (how the drug affects the body) of ODM-103.

Eligibility criteria: Inclusion Criteria:

* Male subjects aged between 18 and 45 years
* BMI 18-30 kg/m2
* Weight 55-90kg
* Written informed consent
* Good General Health

Exclusion Criteria:

* Vulnerable subjects
* Veins unsuitable for repeated venipuncture
* Evidence of clinically significant cardiovascular, renal, hepatic, hematological, Gi, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disorder
* History of or positive test for drug abuse
* Any condition requiring regular concomitant medication
* Blood donation or significant loss of blood within 3 months prior to screening
* Abnormal 12 lead ECG finding of clinical relevance
* Heart rate (HR) \<50bpm or \>90bpm after 10 minutes in a supine position
* Systolic blood pressure \<90mmHg or \>140mmHg after 10 minutes in a supine position
* Diastolic blood pressure \<50mmHg or \>90mmHg after 10 minutes in a supine position
* Abnormal 24 hour Holter recording of clinical relevance at screening
* Any abnormal laboratory value, vital signs or physical examination causing a health risk to the volunteer

Primary outcomes:
measure: Erythrocyte Catechol-O-methyltransferase (COMT) inhibition.
timeFrame: 0, 0.16, 0.33, 0.5, 0.75,1.0,1.5, 2, 3, 4, 6, 10, 16, 24h post dose
Secondary outcomes:
measure: Area under the plasma concentration curve (AUC)
timeFrame: 0, 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 2, 4, 6, 10, 16, 24h post dose
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Parexel International GmbH
Study officials:
affiliation: Parexel
name: Rainard Fuhr, MD
role: PRINCIPAL_INVESTIGATOR
References: