louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04921761: Dural Puncture Epidural Technique Versus Conventional Epidural Technique During Vaginal Surgeries
Official title: Dural Puncture Epidural Technique Versus Conventional Epidural Technique During Vaginal Surgeries
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Dural Puncture Epidural Technique
Lead sponsor: National Research Centre, Egypt
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2021-06-10
Enrollment: 0
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study aims to evaluate whether the dural puncture epidural technique (group B) improves sacral block anesthesia during vaginal surgeries compared with the conventional epidural technique (group A).


Eligibility criteria: Inclusion Criteria:

Age (25- 55) years. Height (150 -170) cm.

Exclusion Criteria:

Patient refusal. Hypersensitivity to local anesthetic drugs. Bleeding disorders and coagulopathy. Severe mitral or aortic stenosis. Local or systemic sepsis. Uncooperative patients. Sever spinal deformity. Blood or CSF in the epidural catheter during the procedure. Failure of the block and need for general anesthesia.

Primary outcomes:
measure: Time of onset of anesthesia to T10
timeFrame: During surgery
measure: Time for complete motor block
timeFrame: During surgery
measure: Time for first rescue analgesia will be required during surgery
timeFrame: During surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06787261: Involvement of Archaea in Carious Disease
Official title: Involvement of Archaea in Carious Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dental Caries
Keywords: Dental caries
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Dental caries is a major public health probleme the result of hard tissue demineralization and oral microbiota changes.

Methanogenic archaea, mainly Methanobrevibacter oralis, are associated with various oral problems, including pathologies periodontal.

Previous research has not really studied the Archaea in carious lesions, hence the importance of our study.

Our study aims to explore their potential role in the the development of caries by analysing their prevalence and their quantification in relation to the carious risk individual. The aim is to improve understanding of the Cavity microbiology to advance management of this pathology in terms of prevention or of treatment.

Our team is particularly competent in the field of Archaea, especially in the cultivation of Archaea methanogens since we have a dedicated platform. We also discovered the first human Nanoarchaea, opening up a whole new possible search field.


Eligibility criteria: Inclusion Criteria:

* Male or female of legal age.
* Patient who is a beneficiary or entitled beneficiary of a social security
* Patient under the care of the Restorative and Preventive Dentistry of the PROMOD - Timone Dentistry Unit.
* Patients capable of giving written consent.

Exclusion Criteria:

Patient in a period of exclusion from another research protocol at the time of signing the consent form, Subjects covered by articles L1121-5 to 1121-8 of the Public Health public health code (minor patients, patients of full age under guardianship, patients deprived of their liberty, pregnant or breast-feeding), A person who does not have a sufficient command of reading and understanding of the French language to be able to consent to take part in the research Presence of periodontitis (gingivitis not being a criterion for a criterion for non-inclusion). Antibiotics taken in the previous month. Use of mouthwash in the previous 7 days.

Primary outcomes:
measure: Presence/absence of Archaea in participants' saliva samples.
timeFrame: 36 months
Secondary outcomes:
measure: Quantity of Archaea in the salivary sample of the participants.
timeFrame: 36 months
measure: Viability/non-viability of Archaea in carious lesions
timeFrame: 36 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Asssistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: jean-olivier ARNAUD GENERAL DIRECTOR
role: STUDY_DIRECTOR
References:
Clinical trial NCT02936661: Tranexamic Acid for Preventing Postpartum Hemorrhage After Cesarean Section
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postpartum Hemorrhage， Cesarean Section
Keywords: postpartum hemorrhage， cesarean section， tranexamic acid
Lead sponsor: Shanghai First Maternity and Infant Hospital
Sponsor class: OTHER
First posted: 2016-10-18
Enrollment: 6700
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: It is a multicenter randomized, double-blind and placebo-controlled trial. Totally 6500 women to delivery by cesarean section will be recruited in this study. In addition to routinely oxytocin, the women in study group will receive TXA 1 g in 2 minutes after they delivered their babies, and those in control group will receive placebo. The incidence of postpartum hemorrhage, the amount of bleeding, as well as the side effects will be observed.


Eligibility criteria: Inclusion Criteria:

* gestational week more than 37;
* to delivery by cesarean section;
* informed consent form signed

Exclusion Criteria:

* Any known renal or liver disorders
* History of venous or arterial thrombosis
* Any disease or history tend to increase thrombosis: opertion in 1 month; active smoker.
* Do cesarean section because of active bleeding

Primary outcomes:
measure: postpartum hemorrhage
timeFrame: 24h after the cesarean section
Secondary outcomes:
measure: the amount of postpartum bleeding
timeFrame: 24h after the cesarean section
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02603861: A Study of LY3154207 on Sleep in Healthy Male Participants
Official title: An Evaluation of the Impact of Single Doses of LY3154207 on Sleep Latency in Sleep-Deprived Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2015-11-13
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study will evaluate the effect of single doses of LY3154207 on the amount of time it takes for healthy sleep-deprived men to fall asleep. The study will also estimate how much LY3154207 gets into the blood stream and how long it takes the body to remove it. Information about any side effects that occur will be collected. Each participant will complete four study periods, which will last a total of about 8 weeks.


Eligibility criteria: Inclusion Criteria:

* Overtly healthy males 18 years of age or older who have given consent and are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
* Have a regular sleep pattern with routine time spent in bed between 6.5 hours and 9 hours each night

Exclusion Criteria:

* Are shift workers who shifted work within 14 days prior to screening or plan to during the study
* Have a known sleep disorder or history of a sleep disorder
* Have traveled 2 time zones or more within 7 days prior to screening or plan to during the study
* Regularly take naps during the day
* Are hearing impaired

Primary outcomes:
measure: Time to Sleep Onset
timeFrame: Day 1: 2 hours post dose through 8 hours post dose in each period.
Secondary outcomes:
measure: Maximum Concentration (Cmax) of LY3154207
timeFrame: Day 1: 1 hour post dose through 24 hours post dose in each period.
measure: Area Under the Concentration Versus Time Curve (AUC) of LY3154207
timeFrame: Day 1: 1 hour post dose through 24 hours post dose in each period.
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Parexel Early Phase Unit at Glendale
state: California
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00569361: Nasal Epithelium Gene Expression Profiling in Child Respiratory Allergic Disease
Official title: Nasal Epithelium Gene Expression Profiling in Child Respiratory Allergic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergic Rhinitis
Keywords: allergic rhinitis to dust mite
allergic rhinitis associated with bronchial hyperreactivity
allergic rhinitis associated with asthma
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
Collaborators: name: ADPHUN, FRM
First posted: 2007-12-07
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Using a human pangenomic microarray, the researchers established expression profiles of nasal epithelial cells, collected by brushing of patients belonging to one of four distinct groups:

1. allergic rhinitis to dust mite (AR) isolated (n=12),
2. AR associated with bronchial hyperreactivity (n=12),
3. AR associated with asthma (n=14),
4. control (n=14).

Detailed description: Context: Asthma is the most frequent chronic disease in childhood. Allergic rhinitis has been described as a risk factor to develop asthma. The objective of the study was to evaluate the contribution of the respiratory epithelium to development of allergic rhinitis and asthma and to identify the molecular mechanisms driving rhinitis toward asthma.

Methods: Using a human pangenomic microarray, we established expression profiles of nasal epithelial cells, collected by brushing of patients belonging to one of four distinct children 2 to 18 years of age groups:

1. allergic rhinitis to dust mite (AR) isolated (n=12),
2. AR associated with bronchial hyperreactivity (n=12),
3. AR associated with asthma (n=14),
4. control (n=14).

Eligibility criteria: Inclusion Criteria:

Patients:

* Patients between 6 and 17 years old
* Patients with allergic rhinitis

Witness:

* Patients between 6 and 17 years old
* Patients without allergic rhinitis and asthma

Exclusion Criteria:

* Rhino-bronchitis infection dated from less than 15 days
* Patients younger than 6 or older than 17 years

Primary outcomes:
measure: Transcriptome analysis: genes statistically modulated between groups, predictive biomarkers allowing correct classification of groups
timeFrame: At the sample time
Secondary outcomes:
measure: Validation with other techniques: Q-PCR
timeFrame: At the sample time
Other outcomes:
Locations:
city: Nice
country: France
facility: Department of Pediatrics, Nice University Hospital
Study officials:
affiliation: Department of Pediatrics of Nice University Hospital
name: Marc Albertini, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Giovannini-Chami L, Marcet B, Moreilhon C, Chevalier B, Illie MI, Lebrigand K, Robbe-Sermesant K, Bourrier T, Michiels JF, Mari B, Crenesse D, Hofman P, de Blic J, Castillo L, Albertini M, Barbry P. Distinct epithelial gene expression phenotypes in childhood respiratory allergy. Eur Respir J. 2012 May;39(5):1197-205. doi: 10.1183/09031936.00070511. Epub 2011 Oct 17.
Clinical trial NCT03209661: Vascular Effects of a Single Bout of Electronic Cigarette Use
Official title: Vascular Effects of a Single Bout of Electronic Cigarette Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Arterial Stiffness
Keywords: vascular function
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2017-07-06
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Subjects will be asked to inhale one of three mediums; 5.4% NBV e-ciggarette, 0% NBV cigarette, and sham menthol inhaler (no vapor). Baseline measurements will be conducted upon arrival and followed immediately post inhalation, 1-hour post, and finally 2-hours post. All trials will require a minimum of 48 hours washout.
Primary purpose: OTHER

Brief summary: Investigating the acute effects of a single use E-Cigarette upon vascular health.

Detailed description: Subjects will inhale e-cigarettes of 5.4%, 0%, and sham menthol inhaler to determine the effects upon to measures of vascular health. These measures will include Cardio-Ankle Vascular Index and Flow Mediated Dilation.

Eligibility criteria: Inclusion Criteria:

* Apparently healthy, with no cardiovascular or metabolic diseases. Additionally, is not a frequent smoker of any kind.

Exclusion Criteria:

* Cardiovascular or Metabolic Diseases and/or regular smoker.

Primary outcomes:
measure: Changes in arterial stiffness and endothelial function with e-cigarette use.
timeFrame: Immediately Post, 1 hour, and 2 hour.
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: Cardiovascular Aging Research Lab at UT Austin
state: Texas
Study officials:
affiliation: University of Texas
name: Hirofumi Tanaka, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cossio R, Cerra ZA, Tanaka H. Vascular effects of a single bout of electronic cigarette use. Clin Exp Pharmacol Physiol. 2020 Jan;47(1):3-6. doi: 10.1111/1440-1681.13180. Epub 2019 Oct 7.
Clinical trial NCT03255161: Randomized Controlled Trial of a Community Health Worker Program on Hearing Loss (Oyendo Bien)
Official title: Oyendo Bien: Reducing Disparities in Access to Hearing Health Care on the U.S.-Mexico Border
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hearing Loss
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2017-08-21
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to test the effectiveness of a community health worker intervention to expand access to hearing health care among older adults facing health disparities.


Eligibility criteria: Inclusion Criteria:

* Minimum age: 50 years
* Audiometrically-confirmed hearing loss
* Availability of a communication partner to attend the program with the participant
* Be Spanish speaking and able to sign written informed consent

Exclusion Criteria:

* Cognitive impairment

Primary outcomes:
measure: Mean frequency of communication strategy use as measured at eight weeks post baseline for each of a series of study-specific strategies taught in the intervention
timeFrame: 8 weeks
Secondary outcomes:
measure: Mean number of hearing health actions taken and number of people who took each hearing health action at eight weeks post baseline
timeFrame: 8 weeks
Other outcomes:
measure: Mean value for hearing-specific health-related quality of life at eight weeks post baseline as measured by a series of study-specific questions, some of which are adapted from the Self Assessment of Communication
timeFrame: 8 weeks
measure: Communication function with partner: Mean frequency and severity of communication-related challenges as measured by a series of study-specific questions at eight weeks post baseline
timeFrame: 8 weeks
measure: Mean confidence in communication management at eight weeks post baseline as measured by a series of study-specific questions
timeFrame: 8 weeks
Locations:
city: Nogales
country: United States
facility: Mariposa Community Health Center
state: Arizona
Study officials:
affiliation: University of Arizona
name: Nicole Marrone, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marrone NL, Nieman CL, Coco L. Community-Based Participatory Research and Human-Centered Design Principles to Advance Hearing Health Equity. Ear Hear. 2022 Jul-Aug 01;43(Suppl 1):33S-44S. doi: 10.1097/AUD.0000000000001183. Epub 2020 Jun 13.
Clinical trial NCT03632161: Para-vertebral Dexmedetomidine and the Incidence of Postoperative Chronic Pain
Official title: Para-Vertebral Dexmedetomidine in Video-Assisted Thoracic Surgeries for Acute and Chronic Pain Prevention; A Randomized Double Blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-08-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Up to our knowledge there is no study focused upon the incidence of post VATS chronic pain when dexmedetomidine is used.

Detailed description: Most Video-Assisted Throcoscopy Surgery (VATS) procedures are considered low-risk interventions requiring short hospital stays or even outpatient settings. Because of these factors, VATS did not raise as much interest as thoracotomy in its postoperative pain management. However, it is a fact that pain following VATS can be severe and long-lasting .According to Richardson and colleagues, 38% of VATS procedures present persistent pain two months after surgery as a result of acute nerve damage during the surgical procedure.

Eligibility criteria: Inclusion Criteria:

* ASA II-III
* Adult
* Video-assisted thoracic surgery

Exclusion Criteria:

* Patient refusal
* Allergy to medication
* Coagulopathy
* Malformation

Primary outcomes:
measure: acute postoperative pain
timeFrame: 24 hours
Secondary outcomes:
measure: chronic post thoracic surgery pain
timeFrame: 3 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Emad Zarief Kamel Said
Study officials:
References:
citation: Abd-Elshafy SK, Abdallal F, Kamel EZ, Edwar H, Allah EA, Maghraby HHM, Sayed JA, Ali MS, Elkhayat H, Mahran GSK. Paravertebral Dexmedetomidine in Video-Assisted Thoracic Surgeries for Acute and Chronic Pain Prevention. Pain Physician. 2019 May;22(3):271-280.
Clinical trial NCT02895061: Effectiveness of Oral Alfacalcidol for Secondary Hyperparathyroidism in Chronic Hemodialysis Patients.
Official title: Effectiveness Between Daily Versus Pulse Oral Alfacalcidol for Secondary Hyperparathyroidism in Chronic Hemodialysis Patients: A Randomized Controlled Trial and Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alfacalcidol, Secondary Hyperparathyroidism, Hemodialysis
Lead sponsor: Phramongkutklao College of Medicine and Hospital
Sponsor class: OTHER
First posted: 2016-09-09
Enrollment: 502
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary objective was to evaluate the efficacy between daily and pulse oral alfacalcidol treatment of SHPT in chronic hemodialysis patients, a 12-week treatment. Secondary objective was to observe the adverse effects between these two treatment regimens.

Detailed description: ESRD patients with secondary hyperparathyroidism in 3 hemodialysis centers were enrolled. They were assigned to either oral daily or pulse (trice a week) alfacalcidol treatments using block-of-4 randomization. Alfacalcidol in both groups were equal at the dose of 6 microgram per week. Clinical and laboratory data were obtained at baseline and were monitored every 4 weeks for 12 weeks. Primary outcome was the difference of the mean PTH reduction between two groups at the end of the study by unpaired-T test. All possible adverse events were carefully monitored.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 y ESRD on HD KT/V ≥ 3.6/wk 2˚HPT Stable in P binder for 4 wk

Exclusion Criteria:

* Alfacalcidol allergy Serum Ca ≥ 10.5 mg/dL Serum P ≥ 5.5 mg/dL Pregnancy On phenytoin, phenobarbital

Primary outcomes:
measure: Primary outcome was the difference of the mean PTH reduction between two groups at the end of the study by unpaired-T test.
timeFrame: 12 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Gu Y, Ding F, Chen N, Mei CL, Qian JQ, Wang XY, Shi W, Hou FF, Li XW, Wang M, Chen YP. Comparisons between oral pulse alfacalcidol therapy and daily therapy in maintenance hemodialysis patients with secondary hyperparathyroidism: a randomized, controlled, and multicenter study. Ren Fail. 2005;27(2):205-12.
citation: Tarrass F, Yazidi A, Sif H, Zamd M, Benghanem MG, Ramdani B. A randomized trial of intermittent versus continuous oral alfacalcidol treatment of hyperparathyroidism in end-stage renal disease. Clin Nephrol. 2006 Jun;65(6):415-8. doi: 10.5414/cnp65415.
citation: Llach F, Yudd M. Pathogenic, clinical, and therapeutic aspects of secondary hyperparathyroidism in chronic renal failure. Am J Kidney Dis. 1998 Oct;32(2 Suppl 2):S3-12. doi: 10.1053/ajkd.1998.v32.pm9808139. No abstract available.
Clinical trial NCT06970561: Analysis of Recurrence of Intraductal Papilloma Treated With Vacuum-assisted Rotary Excision
Official title: Analysis of Factors Associated With Postoperative Recurrence of Intraductal Papilloma of the Breast Treated With Ultrasound-guided Vacuum-assisted Rotary Excision
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer Surgery
Benign Breast Tumors
Keywords: intraductal papilloma of the breast
treatment
vacuum-assisted rotational excision therapy
Lead sponsor: Wuhan Children's Hospital
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 106
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: IDP patients who underwent ultrasound-guided VAE treatment from January 2020 to August 2024 in Zhongnan Hospital of Wu han University.

Brief summary: To study the postoperative recurrence of intraductal papillomas (IDP) treated with ultrasound-guided vacuum-assisted excision (VAE), and to investigate the effect of different lesion characteristics on recurrence.

Detailed description: 106 patients with IDP with or without atypical ductal hyperplasia (ADH) treated with ultrasound-guided VAE at Zhongnan Hospital of Wuhan University from January 2020 to August 2024 were selected for the study, and the postoperative conditions of the patients were sorted out and followed up to analyze the characteristics of the lesions and to determine the relevant factors that affected the postoperative recurrence.

Eligibility criteria: Inclusion Criteria:

* IDP was diagnosed pathologically after VAE treatment
* the tumor was a solitary lesion with the margin \>1cm from the nipple and the longest diameter of the tumor \<3cm
* it was not associated with other breast diseases

Exclusion Criteria:

* previous ductal breast surgery
* abnormal coagulation function or taking anticoagulant drugs .recent or current use of hormonal or psychotropic drugs.

Primary outcomes:
measure: recurrence
timeFrame: The cut-off date for follow-up was September 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
Study officials:
References: