louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04566705: Uterine Rupture During Labor Among Women With a Prior Cesarean Delivery
Official title: Uterine Rupture During Labor Among Women With a Prior Cesarean Delivery : Risks Factors, Maternal and Perinatal Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uterine Rupture
Mode of Delivery
Keywords: Risks factors
Uterine rupture after a previous cesarean delivery
Vaginal birth after cesarean
Prior cesarean
Perinatal outcome
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-09-28
Enrollment: 95
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with uterine rupture after previous cesarean delivery versus women without uterine rupture after previous cesarean delivery

Brief summary: Although a rare event, uterine rupture during labour is one of the most serious obstetric complications because of the dramatic maternal-fetal consequences that can result.

Identifying the risk factors associated with uterine rupture would enable gynecologists to provide patients with risks of uterine rupture in the event of attempted vaginal delivery.

The aim of our study is to determine risks factors for uterine rupture during labour in patients with a previous cesarean delivery who have not given birth since and to assess the occurrence of maternal-fetal comply-cations compared to patients with a previous cesarean delivery without uterine rupture.


Eligibility criteria: Inclusion criteria:

* Singleton pregnancy \> 24 weeks of gestation
* Second or multiparous with a previous cesarean section without vaginal delivery since
* Cephalic presentation or completed breech
* Uterine rupture during labor

Exclusion criteria:

* Incomplete uterine rupture
* Multiple gestation
* Transverse presentation or complete breech
* Vaginal delivery after cesarean
* Non-low transverse cesarean section
* Placenta praevia
* Antepartum intrauterine fetal death
* History of uterine surgery (myomectomy)

Primary outcomes:
measure: Assess the risks factors of uterine rupture
timeFrame: 1 day
Secondary outcomes:
measure: Number of Participants with Assess the maternal and perinatal complications and outcomes
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Florent FUCHS, PUPH
role: STUDY_DIRECTOR
References:
Clinical trial NCT04951505: Safety and Intrapulmonary Pharmacokinetics of Cefepime and Taniborbactam in Healthy Subjects
Official title: A Phase 1 Study to Evaluate the Safety and Intrapulmonary Pharmacokinetics of Cefepime and Taniborbactam in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Venatorx Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2021-07-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This is a single-center, open-label study to assess the safety and intrapulmonary pharmacokinetics of cefepime and taniborbactam in healthy adult male and female subjects. Thirty subjects will receive a total of 6 doses of cefepime-taniborbactam (2 g cefepime/0.5g taniborbactam) administered intravenously every 8 hours. Following the sixth dose of cefepime-taniborbactam, subjects will be assigned to one of six bronchoscopy sampling times.


Eligibility criteria: Inclusion Criteria:

1. Healthy adults 18-55 years
2. Males or non-pregnant, non-lactating females
3. Body mass index (BMI): ≥18 kg/m2 and ≤32.0 kg/m2, weight \>50.0 kg.
4. Must have negative alcohol, drug, or tobacco use/test and no use of alcohol, caffeine during the study

Exclusion Criteria:

1. History or presence of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorders
2. History of drug allergy or hypersensitivity to penicillin, cephalosporin, or beta-lactam antibacterial drug
3. Recent history of known or suspected Clostridioides difficile infection
4. Abnormal ECG or history of clinically significant abnormal rhythm disorder
5. Abnormal lab tests

Primary outcomes:
measure: ELF Cmax
timeFrame: 0-8 hours after 6th dose
Secondary outcomes:
measure: Number of subjects with adverse events
timeFrame: Day 1 - Day 8
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pulmonary Associates PA
state: Arizona
Study officials:
References:
Clinical trial NCT02434705: Food Antigen in Eosinophilic Esophagitis
Official title: Protocol for Food Antigen Staining in Esophageal Mucosa in Patients With Eosinophilic Esophagitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eosinophilic Esophagitis
Keywords: Eosinophilic
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2015-05-05
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Eosinophilic Esophagitis patients

Brief summary: The relationship or effect of food antigen (wheat based soy sauce) in eosinophilic esophagitis. It is believed that when food antigens are exposed to the esophageal tissue it starts an chronic allergy-based inflammation. This will be analyzed with the esophageal biopsies and the mucosal impedance probe.

Detailed description: One of the putative mechanisms of eosinophilic esophagitis is exposure of food antigens to antigen recognition cells in the esophageal mucosa that initiates a chronic allergy-based inflammatory response . It is believed that this exposure is facilitated through dilation of the intercellular spaces (DIS) between esophageal epithelial cells (termed spongiosis). This is substantiated by several studies which have demonstrated that: first, DIS is commonly found in biopsies from patients with active EoE and reverses with steroid therapy; second, DIS correlates to physiologic demonstration of increased esophageal epithelial permeability as shown through transepithelial small molecule flux in mucosal biopsies appraised in Ussing chambers and increased conductivity of electric current as measured in a mucosal impedance probe (Katzka, et al., in press, Clin Gastroenterol Hepatol). Although these mechanisms make intuitive sense, no one has shown the presence of food antigen in esophageal mucosa after ingestion and the correlation of this presence to dilation of intercellular spaces.

Eligibility criteria: Inclusion criteria:

* Patients between the ages of 18 and 80 with eosinophilic esophagitis diagnosed by a combination of compatible symptoms, endoscopic findings, histology, and lack of response to proton pump inhibitors.
* Patients previously diagnosed with Eosinophilic Esophagitis and are now in histologic remission due to treatment and have \<15 eos hpf.

Exclusion Criteria

* Acute allergy to wheat or soy
* Currently taking steroids
* Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy

Primary outcomes:
measure: Measurement of Gluten and Soy Antigen in Esophageal Mucosa
timeFrame: one year
Secondary outcomes:
measure: Dilated intercellular spaces (spongiosis)
timeFrame: one year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Joseph Murray, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00744705: Normative Database of the Retinal Nerve Fiber Layer Thickness Measured by the Cirrus HD OCT in Asians
Official title: Normative Database of the Retinal Nerve Fiber Layer Thickness Measured by the Cirrus HD OCT in Asians
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glaucoma
Keywords: Retinal nerve fiber layer
Glaucoma
Myopia
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2008-09-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Normal subjects who recieved a regular medical check-up in a comprehensive medical testing center of our institute

Brief summary: The normal range of retinal nerve fiber layer thickness might be different between Asians and Caucasians. However, the recently developed imaging device such as the Cirrus HD OCT includes only the Caucasian data. So, the investigators want to find its normal range of in Asians.

Detailed description: Characteristics of various ocular parameters are influenced by race. Because the retinal nerve fiber layer (RNFL) thickness is crucial in detecting early glaucomatous changes, its normal range is also important. Even though the normal range of RNFL thickness might be different according to race, the recently developed imaging device such as the Cirrus HD OCT includes only the Caucasian data. In the present study, we want to measure the RNFL thickness using the Cirrus HD OCT in normal Asian eyes and to determine its normal range in Asians.

Eligibility criteria: Inclusion Criteria:

* Normal subjects
* Good quality of the OCT images (signal intensity \> 8)

Exclusion Criteria:

* Any ocular history
* DM

Primary outcomes:
measure: Retinal nerve fiber layer thickness
timeFrame: when the OCT images are taking
Secondary outcomes:
measure: Refractive errors
timeFrame: when the OCT images are taking
measure: Intraocular pressure
timeFrame: when the OCT images are taking
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yongdong Severance Hospital, Yonsei University College of Medicine
Study officials:
affiliation: Yonsei University
name: Gong Je Seong, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06642805: Bilio-pancreatic Complications of Congenital Duodenal Obstructions
Official title: Bilio-pancreatic Complications of Congenital Duodenal Obstructions
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Duodenal Obstruction
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2024-10-15
Enrollment: 450
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients under 16 years who underwent surgery for duodenal atresia

Brief summary: Congenital duodenal obstructions, often grouped under the term duodenal atresias, encompass a range of malformations of the duodenum that cause partial or complete obstruction. In the long term, the main complications described fall within the spectrum of digestive occlusions (anastomotic stenosis, obstruction due to adhesions, and duodenal dysmotility) and may require surgical revisions. Biliary and pancreatic complications, which are embryologically logical, are reported in the form of rare clinical cases. The aim of the research is to identify biliopancreatic complications following duodenal atresia surgery in order to characterize them, estimate their national frequency, and determine any potential iatrogenic risk factors.


Eligibility criteria: Inclusion Criteria:

* Patients who underwent surgery for duodenal atresia in a pediatric surgery department participating in the study over the past 20 years,
* legal representatives did not object to data collection

Exclusion Criteria:

* Patients ≥ 16 years at the time of surgery.
* Objection from the legal representatives of the child or the adult patient to the collection and use of health data

Primary outcomes:
measure: frequency of biliar complication after surgical treatment of duodenal atresia
timeFrame: 1 year
measure: frequency of pancreatic complication after surgical treatment of duodenal atresia
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06904105: A Trial of HRS-7535 Tablets in Subjects With Overweight or Obesity
Official title: A Phase 3 Clinical Study to Evaluate the Efficacy and Safety of HRS-7535 Tablets in Subjects With Overweight or Obesity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Overweight
Obesity
Lead sponsor: Shandong Suncadia Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-04-01
Enrollment: 550
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: TREATMENT

Brief summary: The study is being conducted to evaluate the efficacy and safety of HRS-7535 in subjects with overweight or obesity.


Eligibility criteria: Inclusion Criteria:

1. On the day of signing the informed consent form, the age should be between 18 and 75 years old.
2. At the screening period, the Body Mass Index (BMI) should meet the criteria of ≥ 28.0 kg/m², or ≥ 24.0 kg/m² with at least one weight-related comorbidity, such as hyperglycemia, hypertension, dyslipidemia, obstructive sleep apnea, or non-alcoholic fatty liver disease.
3. The participant should have controlled their diet and exercise for 3 months or more prior to screening and randomization, and the weight change in the past 3 months should not exceed 5%.
4. Before the trial, the participants must voluntarily sign the informed consent form, fully understand the trial content, procedures and potential adverse reactions, and have the ability and willingness to comply with the protocol requirements to complete this study.

Exclusion Criteria:

1. At the screening period, relevant laboratory test results are abnormal.
2. Electrocardiogram (ECG) results at the screening period show clinically significant abnormalities.
3. Uncontrolled severe hypertension at the screening period.
4. Presence of endocrine diseases that may significantly affect the body weight.
5. History of acute or chronic pancreatitis.
6. History of significant gastrointestinal diseases.
7. Severe infections, significant trauma, or major surgery within 30 days prior to screening, as judged by the investigator.
8. Use of medications or treatments that may cause significant weight gain or loss within 90 days prior to screening.
9. Known or suspected abuse of alcohol or narcotics.
10. Any condition deemed by the investigator to be unsuitable for participation in this clinical trial.

Primary outcomes:
measure: The percentage change in body weight relative to the baseline.
timeFrame: The 50th week after administration.
measure: The proportion of participants with a body weight reduction of ≥ 5% relative to the baseline.
timeFrame: The 50th week after administration.
Secondary outcomes:
measure: The proportion of participants with a body weight reduction of ≥ 10% relative to the baseline.
timeFrame: The 50th week after administration.
measure: Adverse events (AEs).
timeFrame: About 52 weeks.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT03960905: A Study the Population Pharmacokinetics of Children of Infectious Disease in Central Nervous System
Official title: A Study the Population Pharmacokinetics of Children Receiving the Anti-infective Drugs for Treatment of Infectious Disease in Central Nervous System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Central Nervous System Infection
Lead sponsor: Shandong University
Sponsor class: OTHER
Collaborators: name: Beijing Children's Hospital
First posted: 2019-05-23
Enrollment: 800
Sex: ALL
Minimum age (years): 29
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children with infections of center nurous system therapies.

Brief summary: The investigators aim to study the population pharmacokinetics of children receiving the anti-infective drugs for treatment of infectious disease in central nervous system.

Detailed description: The investigators aim to study the population pharmacokinetics of children receiving the anti-infective drugs for treatment of infectious disease in central nervous system.In this study, the investigators will detect drug concentration in plasma by using residual blood samples of blood gas analysis and other clinical tests and employ computers for constructing population pharmacokinetic models.

Eligibility criteria: Inclusion Criteria:

* Children (29 days-18 years old) with anti-infective therapy against infectious disease in central nervous system.
* Clinical symptoms: acute onset, fever (axillary temperature 38 ℃ or higher), headache, altered level of consciousness, vomiting, irritability, sleepiness, low muscle tone, seizures, before the fontanelle full or uplift, positive meningeal stimulation;
* Aboratory examination: CSF appearance change, CSF routine WBC \>100 per ml, CSF routine WBC 10-100 per ml, glucose \<40mg/dl, protein \>100mg/dl), positive detection of etiology (bacterial culture, antigen detection, gram staining).

Exclusion Criteria:

* autoimmune encephalitis;
* central nervous system infection complicated with tumor;
* allergic to carbapenems or glycopeptide antibiotics;
* other cases not suitable for enrollment (small sample size, incomplete clinical data, etc.).

Primary outcomes:
measure: maximum concentration (Cmax)
timeFrame: up to 4 weeks
Secondary outcomes:
measure: time to achieve maximum concentration (Tmax)
timeFrame: up to 4 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Infectious Diseases, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health
state: Beijing
Study officials:
References:
Clinical trial NCT06187805: Retrospective Case Series - OSSIX Volumax Collagen Xenograft Scaffolding
Official title: Retrospective Case Series Evaluating the Outcome of Transcrestal Sinus Elevation Using Autogenous Bone Supporting an OSSIX Volumax Collagen Xenograft Scaffolding
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Dental Implants
Lead sponsor: Old Orchard Periodontics and Implant Dentistry LTD
Sponsor class: OTHER
First posted: 2024-01-03
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Up to 15 participants who meet the I/E will have data retrospectively reviewed and will include follow up data.

Brief summary: This study is designed as a retrospective, single center study. Up to 15 participants who had a transcrestal sinus elevation and implant placement using autogenous bone supporting an OSSIX Volumax collagen xenograft scaffolding will be enrolled. The study will include data collection from medical records and data collected at a follow up visit between January 2019 and March 2023.

Detailed description: The purpose of this study is to evaluate the outcome of transcrestal sinus elevation using autogenous bone supporting an OSSIX Volumax collagen scaffolding. Data to be collected includes demographics, past medical history including autoimmune diseases and connective tissue diseases, smoking history and known allergies. Implant data will be collected and change in crestal bone height will be measured radiographically and cone beam computed tomography at follow up. The protocol will include both single-staged and two-staged procedures. Adverse events will be collected and reported.

Eligibility criteria: Inclusion Criteria:

1. Transcrestal sinus lift planned
2. Implant therapy planned
3. Crestal bone height \< or equal to 6mm
4. Missing tooth or teeth for function
5. Nonsmoker -

Exclusion Criteria:

1. Patients with known collagen hypersensitivity
2. Patients with sensitivity to porcine-derived materials
3. Patients suffering from autoimmune diseases and connective tissue diseases, such as lupus erythematosus, dermatomyositis, etc.
4. Pregnant or planning to become pregnant (verbal confirmation)

Primary outcomes:
measure: Change in crestal bone height
timeFrame: 4 months to 57 months
Secondary outcomes:
Other outcomes:
Locations:
city: Skokie
country: United States
facility: Old Orchard Periodontics and Implant Dentistry
state: Illinois
Study officials:
References:
Clinical trial NCT04787705: Multicenter Validation of a Predictor Model of ACHD Patients and Cardiac Surgery
Official title: Novel Model of Preoperative Predictors of Outcome for Adults Undergoing Congenital Cardiac Surgery: Multicenter Model Validation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Adult Congenital Heart Disease
Cardiac Surgery
Keywords: Prediction model
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Providence Healthcare
name: Montreal Heart Institute
name: Auckland City Hospital
name: Melbourne Health
First posted: 2021-03-09
Enrollment: 547
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All ACHD patients undergoing cardiac surgery in TGH and the other collaborating cardiac centers.

Brief summary: This multicentre study is to validate prediction modeling for the ACHD population undergoing cardiac surgery. The validation of this prediction model will support and generalize its use as a risk stratification tool in the ACHD population.

Detailed description: The prediction model resulted from a preceding study, which uniquely based on comorbidities, was developed using 783 adults (\>16 years) who underwent surgery for congenital heart disease at Toronto General Hospital (TGH) during 2004-2015. It identifies five pre-operative variables, namely presence of cognitive impairment, hepatic function, \>3 chest incisions, anatomy diagnosis, and Body Mass Index \<20 and \>28, as significant predictors of composite adverse outcomes such as in-hospital mortality, prolonged ventilation (exceeding 7 days) and acute kidney injury.

This newly prediction model developed in a single-center has only been internally validated. It requires further external validation to demonstrate its utility in ACHD populations who require cardiac surgery in other cardiac institutions both nationally and internationally.

Eligibility criteria: Inclusion Criteria:

* all ACHD patients \>16 years of age undergoing cardiac surgery requiring an open sternotomy or thoracotomy and cardiopulmonary bypass (CPB) or CPB standby at TGH and the collaborating institutions from April 2019.

Exclusion Criteria:

* CHD patients \<16 years of age
* ACHD patients undergoing chest wall debridement and chest re-explorations for bleeding
* Non-cardiac surgery procedures and cardiology laboratory interventions

Primary outcomes:
measure: Composite adverse events
timeFrame: 30 days from the day of surgery.
Secondary outcomes:
measure: One-year mortality
timeFrame: 365 days from the day of surgery.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital - University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Jane Heggie, MD
role: PRINCIPAL_INVESTIGATOR
References: