louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00362726: Drug Interaction Study With Atazanavir Administered With and Without Ritonavir and a Cytochrome P450 Substrate Rosiglitazone
Official title: Effect of Atazanavir Administered With and Without Ritonavir on the Pharmacokinetics of the Cytochrome P450 2C8 Substrate Rosiglitazone in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: HIV
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-08-10
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this clinical research study is to assess the effect of Atazanavir 400 mg QD and Atazanavir/Ritonavir 300/100 mg QD at steady state on the single dose pharmacokinetics of RGZ in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female subjects between the ages 18 to 50 years old with a BMI 18 to 32 kg/m2

Primary outcomes:
measure: To assess the effect of Atazanavir 400 mg QD and Atazanavir/Ritonavir 300/100 mg QD at steady state on the single dose pharmacokinetics of Rosiglitazone in healthy subjects.
Secondary outcomes:
measure: To assess the safety and tolerability of Rosiglitazone and Atazanavir coadministration with and without Ritonavir.
measure: To explore the relationship between Atazanavir exposure, CYP2C8 genotype and the pharmacokinetics of Rosiglitazone exposure
Other outcomes:
Locations:
city: Hamilton
country: United States
facility: Local Institution
state: New Jersey
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT06195826: Gravity Versus Pump Infusion of Distending Media for Hysteroscopic Myomectomy
Official title: Gravity Versus Pump Infusion of Distending Media for Hysteroscopic Myomectomy: A Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hysteroscopic Myomectomy
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2024-01-08
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who received hysteroscopic myomectomy

Brief summary: To compare the perioperative outcome between the gravity versus pump infusion groups in women who received hysteroscopic myomectomy


Eligibility criteria: Inclusion Criteria:

* \>20 years old women
* women who received hysteroscopic myomectomy

Primary outcomes:
measure: Infusion volume of distension medium
timeFrame: 1 week
Secondary outcomes:
measure: Intraoperative blood loss
timeFrame: 1 week
measure: Postoperative pain
timeFrame: 1 week
measure: Surgical time
timeFrame: 1 week
Other outcomes:
Locations:
city: Banqiao
country: Taiwan
facility: Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital
state: New Taipei
Study officials:
References:
Clinical trial NCT04494126: Effect of Perioperative Tranexamic Acid on Blood Loss During Management of Maxillofacial Trauma
Official title: Effect of Perioperative Tranexamic Acid on Blood Loss During Management of Maxillofacial Trauma: A Randomized Double Blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Blood Loss
Keywords: Maxillofacial trauma; blood loss
Lead sponsor: College of Medical Sciences Teaching Hospital. Nepal
Sponsor class: OTHER
First posted: 2020-07-31
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, Parallel assignment
Primary purpose: PREVENTION

Brief summary: This is a prospective, randomized, double-blind study investigating whether intravenous tranexamic acid has any effect on blood loss during maxillofacial trauma surgery, or the subsequent postoperative sequelae. Intraoperative bleeding and postoperative ecchymosis and edema are objectively rated and complications are noted.

Detailed description: This is a prospective, randomized, double-blind pilot study investigating whether intravenous tranexamic acid has any effect on blood loss during maxillofacial trauma surgery, or the subsequent postoperative sequelae. Intraoperative bleeding is calculated from anaesthesia chart and recorded in ml. Postoperative ecchymosis and bleeding are recorded as dichotomous events (yes/no) and are subjectively rated by both patient and surgeon on postoperative days 1and 2. Any surgical or postoperative complications are noted. Scores are aggregated for statistical analysis.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing ORIF under GA for Maxillofacial fractures
* Patients between with ages of 16-65
* No cardiac comorbidities (hypertension, congenital heart malformation)
* No known coagulopathy
* No regular prescription medication altering normal blood coagulation (NSAIDs, other anticoagulants)
* ASA I and II patients

Exclusion Criteria:

* Patients younger than 16 and older than 65
* Patients with known coagulopathy
* Patients with cardiac comorbidities
* Patients with a family history of bleeding disorders
* ASA III or higher

Primary outcomes:
measure: Intraoperative blood loss
timeFrame: Surgical period
Secondary outcomes:
measure: Postoperative bleeding event
timeFrame: upto 48 hours after surgery
Other outcomes:
measure: Complications if any during surgery and upto 48 hours after surgery
timeFrame: upto 48 hours after surgery
Locations:
Study officials:
affiliation: College of Medical Sciences Teaching hospital, Bharatpur, Nepal
name: Rajesh Yadav, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03550326: Evaluation of Complications in Airway Management
Official title: Evaluation of Complications During Airway Management: An Observational Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Airway Complication of Anesthesia
Difficult Intubation
Keywords: anesthesia
difficult airway
supraglottic airway device
difficult intubation
airway complications
Lead sponsor: Derince Training and Research Hospital
Sponsor class: OTHER
First posted: 2018-06-08
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who undergo surgery under general anesthesia and who intubate/place supraglottic airway device will be recruit for study over a period of six months

Brief summary: In the current study researchers aim to evaluate the rate of the complication due to airway management (during intubation or placement of supraglottic airway devices)

Detailed description: Airway management is one of the most important subject of anesthesia practice. Airway devices ,helping anesthesiologists to maintain airway safety have many complications. 4 th national audit project (NAP 4) study was designed to evaluate the incidence of the major complication of airway management. Accordingly in current study authors aim to determine the complications and incidence of the complications during airway management.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing general anesthesia
* Patients to whom airway devices will be inserted

Exclusion Criteria:

* Patients who undergo surgery under regional anesthesia
* Patients who undergo surgery under sedation

Primary outcomes:
measure: The incidence of the complications due to airway management
timeFrame: 6 months
Secondary outcomes:
measure: variety of complications and reasons of the complications
timeFrame: 6 months
measure: preventable reasons of the complications
timeFrame: 6 months
measure: the time at which complications occurs more, during airway management
timeFrame: 6 months
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Derince Research and Training Hospital
Study officials:
affiliation: Sağlık Bilimleri Üniversitesi Kocaeli Derince SUAM
name: tolga k saracoglu, assoc. prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00011726: Lead Mobilization & Bone Turnover in Pregnancy/Lactation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lead Poisoning
Keywords: Pregnancy
Lead Exposure
Lactation
Bone Mineralization
Maternal-Fetal Exchange
Lead sponsor: National Institute of Environmental Health Sciences (NIEHS)
Sponsor class: NIH
First posted: 2001-03-01
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: NATURAL_HISTORY
Time perspective: PROSPECTIVE

Brief summary: We are examining the role of maternal bone lead turnover during pregnancy and lactation as a potential source of lead exposure for the fetus and the infant (via breast milk). A cohort, ascertained at entry to care, consists of \>1000 women to be followed through pregnancy. In the postpartum subjects are recruited for a nested case control study to assess the influence of lactation on maternal bone density, maternal blood lead and breast milk lead.


Eligibility criteria: 1. Positive pregnancy test, age 12-35 and informed consent;
2. Gestation \<28 weeks at entry to prenatal care;
3. No history of serious chronic or metabolic diseases, which could affect maternal growth or bone density;
4. Not corticosteroid user or diagnosed use of illicit drugs;
5. Eligible for lactation study: Ascertainment during or participation in the pregnancy study and a negative pregnancy test.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Sowers M, Jannausch M, Scholl T, Schall J. The reproducibility of ultrasound bone measures in a triethnic population of pregnant adolescents and adult women. J Bone Miner Res. 1998 Nov;13(11):1768-74. doi: 10.1359/jbmr.1998.13.11.1768.
citation: Sowers MF, Scholl T, Harris L, Jannausch M. Bone loss in adolescent and adult pregnant women. Obstet Gynecol. 2000 Aug;96(2):189-93. doi: 10.1016/s0029-7844(00)00903-0.
citation: Scholl TO. High third-trimester ferritin concentration: associations with very preterm delivery, infection, and maternal nutritional status. Obstet Gynecol. 1998 Aug;92(2):161-6. doi: 10.1016/s0029-7844(98)00157-4.
citation: Goodlin RC. High third-trimester ferritin concentration: associations with very preterm delivery, infection, and maternal nutritional status. Obstet Gynecol. 1999 Jan;93(1):156. doi: 10.1016/s0029-7844(98)00427-x. No abstract available.
citation: Scholl TO. Teenage pregnancy. In "Cambridge Encyclopedia of Growth and Development", SJ Ulijaszek, FE Johnson, MA Preece (eds), Cambridge Univ Press, 312-13,1998
citation: Scholl TO, Reilly T. Essential trace elements and mineral nutrition in human pregnancy. In "Clinical nutrition of the essential trace elements and mineral - The Guide for Health Professionals", John R. Bogden, Leslie Klevay (eds), Humana Press, 1999. ( In press)
Clinical trial NCT03166826: Development of Modified Combined Apgar Scoring System for Evaluation of Infants in the Delivery Room
Official title: Development of Modified Combined Apgar Scoring System for Evaluation of Infants in the Delivery Room
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neonatal Respiratory Failure
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2017-05-25
Enrollment: 800
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Term and Preterm Neonates delivered in our hospital

Brief summary: Apgar scoring system has been widely used for the evaluation of the infant's postnatal condition. As conventional Apgar scoring system is affected by gestational age and resuscitative efforts, there is a need for development of new scoring systems for the assessment in the delivery room. Herein, Modified Combined Apgar scoring system which includes two new parameters (cord blood pH and targeted oxygen saturation level) has been developed and the utility of this modified system was compared with Conventional and Combined Apgar scoring systems for prediction of hospitalization.

Detailed description: This is a prospective cohort study. Conventional, Combined and Modified Combined Apgar scores at minutes 1 and 5 are all recorded. For Modified scoring system, blood sample is obtained from the umbilical artery and pulse oximetry is used for measurement of oxygen saturation. Prediction of NICU hospitalization is used as a surrogate parameter to compare the scores.

Eligibility criteria: Inclusion Criteria:

Term neonates Preterm neonates Parental approval

Exclusion Criteria :

Major congenital/chromosomal abnormalities Lack of informed consent Stillbirth Outborn infants

Primary outcomes:
measure: Modified Combined Apgar scoring
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Suleyman Training and Research Hospital
state: Kucukcekmece
Study officials:
affiliation: Kanuni Sultan Suleyman Training and Research Hospital
name: Seda Yilmaz Semerci, MD
role: STUDY_DIRECTOR
affiliation: Neonatologist
name: Gokhan Buyukkale, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03753126: Stent Geometry in Sutureless Bioprosthetic Valves
Official title: Leaflet Thickening and Stent Geometry in Sutureless Bioprosthetic Aortic Valves
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Stenosis
Heart Valve Diseases
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2018-11-26
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A single-center prospective interventional trial. Patients implanted with a sutureless bioprosthetic aortic valve at Karolinska University Hospital in Stockholm, Sweden from 2012 will be eligible. 4-dimensional volume-rendered computed tomography (CT) of the heart will be performed. The aim of the CT is to assess valve geometry and hypo-atrenuated leaflet thickening. Results of the CT examination, preoperative clinical characteristics, and postoperative clinical data will be registered. Data will be collected prospectively and retrospectively. Informed consent will be obtained from patients meeting the inclusion criteria before the initiation of any study-specific procedures.


Eligibility criteria: Inclusion Criteria:

* Implanted with a sutureless Perceval (LivaNova) sutureless bioprosthetic aortic valve at Karolinska University Hospital in Stockholm, Sweden between 2012 and 2016
* Provide written informed consent

Exclusion Criteria:

•Contraindication for CT with intravenous contrast injection

Primary outcomes:
measure: Regional expansion of valve prosthesis
timeFrame: At CT performed once no less than 30 days and up to 10 years after aortic valve replacement
measure: Overall expansion of valve prosthesis
timeFrame: At CT performed once no less than 30 days and up to 10 years after aortic valve replacement
Secondary outcomes:
measure: Eccentricity of valve prosthesis
timeFrame: At CT performed once no less than 30 days and up to 10 years after aortic valve replacement
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska Institutet
name: Magnus Dalén, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Themudo R, Kastengren M, Bacsovics Brolin E, Cederlund K, Svensson A, Dalen M. Leaflet thickening and stent geometry in sutureless bioprosthetic aortic valves. Heart Vessels. 2020 Jun;35(6):868-875. doi: 10.1007/s00380-020-01553-9. Epub 2020 Jan 16.
Clinical trial NCT02403726: Osteoporosis Associated Vertebral Fractures - Medical and Socio-economic Aspects in Austria
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporotic Fractures
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2015-03-31
Enrollment: 694
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study was a retrospective case series of 694 patients, in which the fracture was caused due to primary or secondary osteoporosis, and who were treated at the department of trauma surgery at our level-I trauma center.

Brief summary: The purposes of this study were to analyse demographic, medical, gender and socio-economic aspects of osteoporosis associated vertebral fractures.


Eligibility criteria: Inclusion Criteria:

-patients older than 50 years of age with vertebral fractures at the thoracic or lumbar spine caused by a low-energy trauma or without any trauma, or with vertebral fractures at the thoracic or lumbar spine with typical osteoporotic deformity of the vertebrae (wedge, fish, or flat)

Exclusion Criteria:

* patients younger than 50 years of age
* vertebral fractures at the cervical spine
* vertebral fractures at the thoracic or lumbar spine caused by a high-energy trauma (motor-vehicle accident, sports-related accident, fall from a considerable height)
* patients suffering from a malignancy, making a pathological fracture presumably, patients with vertebral fractures, whose dataset of follow-up monitoring was lacking, to make an evaluation of osteoporotic involvement impossible

Primary outcomes:
measure: demographic aspects
timeFrame: at least two year follow up
measure: gender aspects
timeFrame: at least two year follow up
measure: socio economic aspects
timeFrame: at least two year follow up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06058026: Clinical Comparison of Composite Materials
Official title: Clinical Evaluation of Composite Resins in Class II Cavities
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Caries; Dentin
Lead sponsor: Recep Tayyip Erdogan University
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Teeth with primary caries, including at least one-third of the dentin (MO or DO), were included in the study.

Brief summary: Universal adhesive solutions have just entered the market, allowing dentists to choose an adhesive strategy based on the needs of patients and clinical situations. Theses adhesives contain a primer/adhesive resin mix in a single bottle for multi-mode etch-and-rinse or self-etch applications. The aim of this study was to evaluate the clinical performance of composite resins with diffent adesive agents on Class II cavities.

Detailed description: This study was a double-blind (evaluator and patient) randomized controlled clinical study with six study groups with an equal allocation. Two composite materials with two universal and one two-step self-etch adhesives were compared in Class II restorations.

The treated patients were called back for controls after one week, six months, and eighteen months. Restorations were evaluated clinically according to modified FDI criteria. In terms of esthetic property, marginal discoloration; in terms of function properties, fracture and retention, and marginal adaptation; in terms of the biological characteristics, post-operative sensitivity, and secondary caries criteria were examined.

Clinical evaluation was performed by two qualified clinicians. Bite-wing radiographs were taken from the patients who were called for controls at 6-moth and 18-month to evaluate the formation of secondary caries.

Differences between adhesives at each time period were evaluated using Fisher's Exact test. The effect of time on restorations was evaluated using the Friedman test (p \< 0.05).

Eligibility criteria: Inclusion Criteria:

* Individuals without systemic disease
* Individuals with good oral hygiene
* Must be a minimum of one carious defect
* Must be at least 18 years old
* Must have vital teeth in antagonist and proximal contact.

Exclusion Criteria:

* Pregnant or breastfeeding women
* Receiving orthodontic treatment
* Bruxism habit
* Direct or indirect pulp coverage
* Allergy to resin-based products

Primary outcomes:
measure: Evaluation of class II restorative materials restored with different adhesives
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Rize
country: Turkey
facility: Muhammet Karadaş
state: Merkez
Study officials:
affiliation: Recep Tayyip Erdogan University
name: Muhammet Karadaş, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06160726: MRI-based Artificial Intelligence Software (NNS-SOT) for Onset Time Estimation in Lesion With Acute Ischemic Stroke
Official title: Evaluating the Validation of MRI-based Artificial Intelligence Software (NNS-SOT) for Onset Time Estimation in Lesion With Acute Ischemic Stroke : a Single-center, Single-arm, Single-blind (Evaluator), Retrospective Pivotal Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Ischemic Stroke
Lead sponsor: Nunaps Inc
Sponsor class: INDUSTRY
First posted: 2023-12-07
Enrollment: 474
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cerebral infarction disease Brain imaging data taken from 474 subjects who visited clinical trial institution (From 2017 to March 27, 2023)

Brief summary: This study evaluates the efficacy of investigational device named Stroke Onset Time Artificial Intelligence(AI) (Model name:NNS-SOT). Using the investigational device, analyze the image and the onset time of occurrence of acute ischemic stroke lesion on the brain image (4.5 hours or more from the onset of symptoms) and evaluate the efficacy of correctly estimating the onset time.

Detailed description: This clinical trial software medical device (Model name: NNS-SOT) is developed based on artificial intelligence algorithms.

Through clinical validation, it will be easier to determine whether the golden hour (4.5 hours) has elapsed at the time of cerebral infarction in the medical field. It can be used for estimation of the onset time of occurrence in acute ischemic stroke.

Eligibility criteria: Inclusion Criteria:

* Brain imaging in patients with acute ischemic stroke aged 20 years and older
* Brain imaging of ischemic stroke manifestation lesion confirmed by medical staff in brain MR image
* Brain imaging taken within 24 hours of ischemic stroke symptoms
* Brain imaging including Magnetic Resonance(MR) images (DWI and FLAIR)
* Patients with clearly recorded onset time of acute ischemic stroke symptoms

Exclusion Criteria:

* Brain imaging used in NNS-SOT development process
* Brain imaging with noise (Artifact)
* Brain images damaged in data

Primary outcomes:
measure: Sensitivity and specificity
timeFrame: October - November 2023
Secondary outcomes:
measure: Area Under the Curve(AUC), which is the lower area of the Receiver Operating Characteristics(ROC) curve
timeFrame: October - November 2023
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Bum Joon Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: