louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06391138: The Effect of OSA on Pregnancy and Fetal Outcomes
Official title: The Effect of Obstructive Sleep Apnea on Pregnancy and Fetal Outcomes
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pregnancy
Obstructive Sleep Apnea
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 500
Sex: FEMALE
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: Pregnant women with OSA who have established prenatal care records and undergone antenatal check-ups at PKUFH

Brief summary: This cohort study aims to investigate the impact of obstructive sleep apnea hypopnea syndrome (OSA) on pregnancy and fetal outcomes. The hypothesis posits that OSA may aggravate pregnancy complications, elevate the risk of adverse pregnancy outcomes, and potentially impact fetal development.


Eligibility criteria: Inclusion Criteria:

* Pregnant women with a confirmed diagnosis of OSA based on polysomnography or other validated sleep monitoring techniques.
* Pregnant women who are willing to participate in the study and provide informed consent.

Exclusion Criteria:

* Pregnant women with other respiratory or sleep disorders that may confound the diagnosis of OSA.
* Pregnant women with severe comorbidities or medical conditions that may significantly impact pregnancy outcomes.
* Pregnant women who have undergone surgical treatment for chronic tonsillitis or OSA during the study period.
* Pregnant women who refuse to participate in the study or are unable to provide informed consent.

Primary outcomes:
measure: rate of pre-eclampsia/ eclampsia
timeFrame: 10 months
Secondary outcomes:
measure: rate of preterm birth
timeFrame: 10 months
Other outcomes:
measure: birth weight
timeFrame: 10 months
measure: length of newborns
timeFrame: 10 months
measure: The Apgar score of newborns
timeFrame: 10 months
Locations:
Study officials:
affiliation: Peking University First Hospital
name: Xiaowan Du
role: STUDY_DIRECTOR
References:
Clinical trial NCT00864838: Oral Acetazolamide, Brimonidine Tartarate, and Anterior Chamber Paracentesis for Ocular Hypertension Control After Intravitreal Bevacizumab
Official title: Effectiveness of Oral Acetazolamide, Brimonidine Tartarate, and Anterior Chamber Paracentesis for Ocular Hypertension Control After Intravitreal Bevacizumab Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Age Related Macular Degeneration
Diabetic Retinopathy
Keywords: intraocular pressure
bevacizumab
acetazolamide
brimonidine
anterior chamber paracentesis
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Apoio ao Ensino Pesquisa e Assitência do HCFMRPUSP
First posted: 2009-03-19
Enrollment: 56
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 purpose of this study is to evaluate the effects of anterior chamber paracentesis, brimonidine and oral acetazolamide to reduce intra-ocular pressure variations after intravitreal bevacizumab injection.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of age related macular disease or diabetic retinopathy
* Able and willing to provide informed consent

Exclusion Criteria:

* History of ocular hypertension or glaucoma
* High Myopes (\> 6 spherical diopters)
* High Hyperopes (\> 4 spherical diopters)
* Pulmonary disease
* Renal disease
* Known allergy to any component of the study drug
* Myocardial infarction, transient ischemic attack within 4 months prior to randomization or any contraindication for bevacizumab use

Primary outcomes:
measure: Intraocular pressure (mmHg)
timeFrame: 1 hour and, 3 minutes before IVI. 3,10,20, 30 minutes after IVI
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Sao Paulo
name: Rodrigo Jorge, MD
role: STUDY_CHAIR
affiliation: University of Sao Paulo
name: Marco A Bonini-Filho, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinic´s Hospital, Ribeirão Preto Medical School, University of São Paulo
name: Bianka Y Katayama, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04367038: Endorphin at Labor Pain and Acupressure
Official title: The Impact of Different Acupressure Procedures Performed on the Hand During Labor on Endorphin Levels and Labor Pain Perception: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Keywords: acupressure
labor pain
Midwifery
pregnant women
endorphins
warm acupressure
cold acupressure
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was performed to determine the impact of different acupressure procedures, performed on women's hands during labor, on endorphin levels and labor pain perception.

The sample consisted of 140 pregnant women. The study was conducted with three experimental groups and one control group, each including 35 pregnant women. Conventional acupressure and warm and cold acupressure procedures were performed on the Large Intestinal 4 energy meridian zone acupressure point of the experimental group. No procedures were performed on the women in the control group. Data were collected using a "Personal Information Form", "Labor Intervention Follow-up Form", "Visual Analog Scale" and "Verbal Category Scale".

The comparison between the experimental and control groups indicated that the conventional acupressure procedure was effective in reducing labor pain and that the warm acupressure procedure increased endorphin levels.


Eligibility criteria: Inclusion Criteria:

* Being a primipara
* Having intact membranes
* No skin diseases (such as urticaria...),
* No use of narcotic drugs
* Having a term pregnancy
* Having a single fetus at vertex position
* Planning to have vaginal delivery
* Having contractions and ongoing regular augmentation
* Having recent augmentation starting periods
* Being in the latent phase (0-3 cm dilatation)
* Having no history of high-risk pregnancy
* Not using analgesic drugs to reduce pain during delivery
* Having no systemic and neurologic diseases
* Having no contraction anomaly (hypotonic or hypertonic contractions)

Exclusion Criteria:

Having any of the above criteria.

-

Primary outcomes:
measure: labor pain
timeFrame: through study completion, an average of 1month
measure: endorphin levels
timeFrame: through study completion, an average of 1month
Secondary outcomes:
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Health Research and Training Hospital of Tokat Gaziosmanpaşa University
Study officials:
affiliation: Atatürk University Faculty of Health Science, Department of Midwifery,
name: Hava Özkan, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05655338: Antimicrobial Photodynamic Therapy in Treatment of Aggressive Periodontitis (Stage III, Grade C Periodontitis)
Official title: Antimicrobial Photodynamic Therapy in Treatment of Aggressive Periodontitis (Stage III, Grade C Periodontitis): A Comparison Between Photodynamic Therapy and Antibiotic Therapy as an Adjunct to Non-Surgical Periodontal Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aggressive Periodontitis
Keywords: Photodynamic therapy
Antibiotic therapy
Lead sponsor: University of Ljubljana
Sponsor class: OTHER
First posted: 2022-12-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Treatment of aggressive periodontitis (stage III, grade C periodontitis) represents a big challenge. The aim of the study was to compare the long-term results of antimicrobial photodynamic therapy (aPDT) and antibiotic therapy as an adjunct to conventional non-surgical therapy in patients with aggressive periodontitis. Clinical parameters of probing depth, clinical attachment level and bleeding on probing (BOP) were assessed at baseline, 3, 6, 9 and 12 months after treatment.

Detailed description: Background: Treatment of aggressive periodontitis (stage III, grade C periodontitis) represents a big challenge. The aim of the study was to compare the long-term results of antimicrobial photodynamic therapy (aPDT) and antibiotic therapy as an adjunct to conventional non-surgical therapy in patients with aggressive periodontitis. Materials and methods: Twenty subjects with untreated aggressive periodontitis (stage III, grade C periodontitis) were divided into two groups: the test group (TG) received non-surgical therapy and two sessions of aPDT using a laser (HELBO TheraLite laser) with a wavelength of 670nm associated with HELBO Blue photosensitizer, and the control group (CG) received non-surgical therapy and antibiotics (amoxicillin 500mg and metronidazole 400mg, 7 days). Clinical parameters of probing depth, clinical attachment level and bleeding on probing (BOP) were assessed at baseline, 3, 6, 9 and 12 months after treatment.

Eligibility criteria: Inclusion Criteria:

* aggressive periodontitis (stage III, grade C periodontitis)
* nonsmokers
* at least 20 teeth in oral cavity
* systemically healthy

Exclusion Criteria:

* any previous periodontal treatment
* smoking
* pregnancy
* ingestion of systemic antibiotics within three months before therapy

Primary outcomes:
measure: Probing depth reduction
timeFrame: 3 months
measure: Bleeding on probing
timeFrame: 3 months
Secondary outcomes:
measure: Clinical attachment loss
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Ljubljana
name: Boris Gaspirc, Assoc.prof.
role: STUDY_CHAIR
References:
Clinical trial NCT04707638: Neurophysiological Characteristics of Subthalamic Deep-brain Stimulation (STN-DBS)
Official title: Neurophysiological Characteristics of Subthalamic Deep-brain Stimulation (STN-DBS) Under General Anesthesia for Patients With Parkinson's Disease or Dystonia and Their Correlation With Prognosis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Parkinson Disease
Dystonia
Keywords: Parkinson Disease
Dystonia
deep brain stimultation
neurophysiological characteristics
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
Collaborators: name: Huazhong University of Science and Technology
First posted: 2021-01-13
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Parkinson's disease or dystonia and STN-DBS in neurosurgery department of Wuhan Union Hospital.

Brief summary: The intraoperative neuroelectrophysiological signals were collected from patients undergoing STN-DBS under general anesthesia in the Neurosurgery Department of Wuhan union Hospital, and their preoperative conditions and postoperative efficacy will be evaluated.

Detailed description: The intraoperative neuroelectrophysiological signals were collected from patients undergoing STN-DBS under general anesthesia in the Neurosurgery Department of Wuhan union Hospital, and their preoperative conditions and postoperative efficacy will be evaluated. The intraoperative neuroelectrophysiological signals would be analyzed.

Eligibility criteria: Inclusion Criteria:

1. Patients underwentSTN-DBS in neurosurgery department of Wuhan Union Hospital.
2. Patients with Parkinson's disease or dystonia.

Exclusion Criteria:

1.Patients without enough follow-up length.

Primary outcomes:
measure: Unified Parkinson's Disease Rating Scale (UPDRS)
timeFrame: Two years postoperatively
measure: Burke Fahn Marsden's Dystonia Rating Scales(BFMDRS)
timeFrame: Two years postoperatively
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Neurosurgery department of Wuhan Union Hospital
name: Fu Peng, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tsai ST, Kuo CC, Chen TY, Chen SY. Neurophysiological comparisons of subthalamic deep-brain stimulation for Parkinson's disease between patients receiving general and local anesthesia. Tzu Chi Med J. 2016 Apr-Jun;28(2):63-67. doi: 10.1016/j.tcmj.2016.02.003. Epub 2016 Apr 10.
citation: Yamada K, Goto S, Kuratsu J, Matsuzaki K, Tamura T, Nagahiro S, Murase N, Shimazu H, Kaji R. Stereotactic surgery for subthalamic nucleus stimulation under general anesthesia: a retrospective evaluation of Japanese patients with Parkinson's disease. Parkinsonism Relat Disord. 2007 Mar;13(2):101-7. doi: 10.1016/j.parkreldis.2006.07.008. Epub 2006 Oct 19.
Clinical trial NCT06389643: Comparison of Safety and Efficacy of Four-Point Scleral Intraocular Lens Fixation and Yamane Techniques
Official title: Comparison of Safety and Efficacy of Four-Point Scleral Intraocular Lens Fixation and Yamane Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphakia
Keywords: scleral fixation IOL
sutureless fixation IOL
four-point scleral fixation
Yamane technique
aphakia
Lead sponsor: Military Institute od Medicine National Research Institute
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 50
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: Comparison of safety and efficacy of two scleral fixation intraocular lens (IOL) methods of four-point scleral fixation ( Akreos AO60) and the Yamane technique (AcrySof MA60AC)

Detailed description: Purpose of the study is to compare two methods of scleral fixation of IOL: two-point fixation of AcrySof MA60AC IOL (Alcon) using Yamane technique and four-point fixation of the Akreos AO60 IOL (Bausch \& Lomb) using polypropylene suture. The investigators rated the BCVA, refractive outcomes, intraocular pressure, and also determined intra- and postoperative complications.

Eligibility criteria: Inclusion Criteria:

* only adult men and women with aphakia without capsular support

Exclusion Criteria:

* Fuchs' dystrophy
* corneal haze or scarring
* history of corneal transplantation
* astigmatism of more than 2,0D
* clinically active uveitis
* advanced glaucoma
* macular diseases that affect visual acuity (age-related macular degeneration, diabetic maculopathy)

Primary outcomes:
measure: BCVA
timeFrame: before and 12 months after surgery
measure: RE
timeFrame: 12 months after surgery
measure: ECC
timeFrame: before and 12 months after surgery
Secondary outcomes:
measure: Number of complications
timeFrame: from day 1 until 12 months after surgery
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Military Institute of Medicine - National Research Institute
Study officials:
affiliation: Military Institute of Medicine - National Research Institute
name: Natalia Blagun, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03800043: Social Impact of Children's Dental Appearance
Official title: Social Impact of Children's Dental Appearance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Caries in Children
Keywords: Early Childhood Caries
children
dentistry
face perception
dental appearance
Lead sponsor: University of Göttingen
Sponsor class: OTHER
First posted: 2019-01-10
Enrollment: 180
Sex: ALL
Minimum age (years): 4
Maximum age (years): 9
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: children with or without caries experience and their parents

Brief summary: This study evaluates the social impact of children's dental perception from children with or without caries experience. For this, children and their parents are shown pictures of child faces with healthy teeth, decayed teeth and teeth after dental treatment.

Detailed description: Appearance and abnormalities in the face influences the life of children: attractive children get estimated as more competent and find friends easier than those with a less attractive appearance. Therefore this study aimes to evaluate the social impact of children's dental perception from children with or without own caries experience (and their parents). Both groups (with/without caries experience) are shown pictures of children with different dental status (healthy teeth, decayed teeth and teeth after dental treatment) and asked to complete established questionnaires.The division into the groups is based on photos of the children with visible teeth.

The results should be evaluated descriptively and graphically. Also the comparison between the answers of both groups for the three different dental status is planned.

Eligibility criteria: Inclusion Criteria:

* (parent of an child of) age 4-9 years
* sufficient compliance
* dividable into the two groups (with or without caries experience)

Exclusion Criteria:

* missing agreement to participate in the study
* insufficient compliance

Primary outcomes:
measure: Children: Evaluation of the whole photos
timeFrame: 2-3 minutes
measure: Children: Evaluation of the mouth on the photo
timeFrame: 2-3 minutes
measure: Children: Evaluation of their own teeth
timeFrame: 1-2 minutes
measure: Why do you feel like this?
timeFrame: 1-2 minutes
Secondary outcomes:
measure: Related parents: Evaluation of the whole photos
timeFrame: 1-2 minutes
Other outcomes:
Locations:
city: Göttingen
country: Germany
facility: Department of Preventive Dentistry, Periodontology and Cariology, University Medical Center Goettingen, Germany
state: Lower Saxony
Study officials:
affiliation: Dept. of Prev. Dentistry, Periodontology and Cariology, University Medical Center Göttingen, Germany
name: Annette Wiegand, Prof. Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01205243: ZIAGEN® Post-marketing Surveillance
Official title: An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance (PMS) to Monitor the Safety and Efficacy of ZIAGEN® Administered in Korean Patients According to the Prescribing Information
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection, Human Immunodeficiency Virus I
Keywords: Abacavir
post-marketing surveillance
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2010-09-20
Enrollment: 671
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients administrated ZIAGEN® at the site

Brief summary: An open label, multi-centre, non-interventional post-marketing surveillance (PMS) to monitor the safety and efficacy of ZIAGEN® administered in Korean patients according to the prescribing information.

Detailed description: This study will collect clinical data, mainly focused on safety, in Korean population as per the requirement of KFDA for market authorization.

ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship.

Eligibility criteria: All subjects must satisfy the following criteria.

* Subject who is treated in combination with other antiretroviral agents for the treatment of HIV infection.
* Subject who is considered to follow this post marketing surveillance protocol by the investigator.
* Subject who is treated with ZIAGEN® according to the prescribing information. As considering the characteristic of observational post marketing surveillance, the exclusion criteria is not strict. All investigators should prescribe ZIAGEN® according to the prescribing information which approved in Korea.
* Subjects with hypersensitivity to ZIAGEN® or ingredients
* Subjects with moderate or severe hepatic impairment
* Subject with end-stage renal disease

Primary outcomes:
measure: Occurrence of adverse event after ZIAGEN® administration
timeFrame: 12month
Secondary outcomes:
measure: Occurrence of serious adverse event after ZIAGEN® administration
timeFrame: 12month
measure: efficacy after ZIAGEN® administration
timeFrame: 12month
measure: Occurrence of unexpected adverse drug reaction after ZIAGEN® administration
timeFrame: 12 month
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: GSK Investigational Site
Study officials:
affiliation: ViiV Healthcare
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03878043: Factors Influencing Readmission Rates of Acute Traumatic Subdural Hematoma in the Elderly
Official title: A Retrospective Analysis of Factors Influencing Readmission Rates of Acute Traumatic Subdural Hematoma in the Elderly
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Subdural Hematoma
Keywords: subdural hematoma
readmission
risk factors
Lead sponsor: Ascension Health
Sponsor class: INDUSTRY
First posted: 2019-03-18
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to a Community General Hospital who were diagnosed with a Traumatic Subdural Hematoma.

Brief summary: Acute traumatic subdural hematomas (TSDH) readmission rate is high (27.8%) with an increase in morbidity and cost for the elderly. This study identifies risk factors affecting readmission rates for these patients and presents strategies to reduce it.

Detailed description: A retrospective analysis was conducted on patients with traumatic brain injuries (ICD-9-CM codes 800.20 - 801.86, 852.00 - 853.05) admitted between 2014 and 2016 at Genesys Regional Medical Center through the trauma service. From this group, the investigators selected patients admitted with traumatic SDH, and those patients were followed over the following 6 months as regards to readmission status. Patients who were readmitted versus patients who were not readmitted were compared. The risk of readmission within 6 months of discharge for SDH was analyzed adjusting for age, prior anticoagulation use, Injury Severity Score (ISS), Glasgow Coma Scale (GCS), gender, time to readmission and co-morbid conditions which included diabetes mellitus, cardiovascular disease, renal disease, chronic obstructive pulmonary disease, and osteoporotic/orthopedic fractures using Cox Proportional Hazards Regression analysis.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with Traumatic Subdural Hematoma during time of study

Exclusion Criteria:

* Patients who expired.

Primary outcomes:
measure: Number of participants readmitted to the hospital
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Grand Blanc
country: United States
facility: Genesys Regional Medical Center
state: Michigan
Study officials:
affiliation: Ascension Health
name: Tarik Wasfie, MD
role: PRINCIPAL_INVESTIGATOR
References: