louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03405532: Kidney Function in Diabetics During CPB (Cardio Pulmonary Bypass)
Official title: The Effect of the CPB on Kidney Blood Flow, Function and Oxygen Uptake During Open Heart Surgery in Patients With Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Diabetes Mellitus, Kidney, CPB
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2018-01-23
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diabetes mellitus undergoing surgery requiring CBP.

Brief summary: Filtration of urine in the kidney requires sufficient oxygen supply. The filtration of urine is greater in patents with diabetes. Our theory is that the diabetic kidney has a higher oxygen demand than the non diabetic kidney thereby making the diabetic kidney more sensitive to decreased oxygen delivery following reduced blood flow. With a catheter inserted into the kidney vein we will monitor the blood flow and oxygen saturation before and during CPB, in patient with diabetes.


Eligibility criteria: Inclusion Criteria:

* Patients with diabetes mellitus
* Serum creatinine \< 150 micromol/L preoperative
* Heart surgery requiring CPB
* LV (left ventricle) EF \>40 %
* Normal hemoglobin

Exclusion Criteria:

-

Primary outcomes:
measure: Renal O2 extraction
timeFrame: 2 years
Secondary outcomes:
measure: GFR
timeFrame: 2 years
measure: Renal blood flow
timeFrame: 2 years
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: Sahlgrenska Universitetssjukhuset
name: Sven-Erik Ricksten, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06273332: Assessment of the Artifical Intelligence Assisted Registration Versus Conventional Point Based Registration on Cone Beam-computed Tomography (CBCT) With Heavy Metal Artifacts
Official title: Assessment of the AI-assisted Registration Versus Conventional Point-based Registration on CBCTs With Heavy Metal Artifacts
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Registration Accuracy
Keywords: Point-based registration
AI registration
Accuracy
Digital implant planning
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-02-22
Enrollment: 16
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Our study investigates the accuracy and duration needed for 3D model registration using artifical intelligence (AI) assistance compared to conventional point-based registration. Manual segmentation of all cone beam computed tomography (CBCT) scans will be performed before the registration procedure.

Detailed description: CBCT images and intraoral scans will be screened following specific eligibility criteria. 16 CBCT images and intraoral scans that will meet the inclusion criteria will undergo manual segmentation via 3D medical image processing software. Afterward, point-based registration and AI-assisted registration will be performed by a single operator using specialized implant planning software. Then, the registration accuracy will be examined by measuring the distances between the three-dimensional models of CBCT data and intraoral scans. Also, the duration required for registration will be calibrated and recorded by a stopwatch.

Eligibility criteria: Inclusion Criteria:

CBCT scans for either the maxilla or mandible or both and intraoral scans or manual impressions with metal restorations.

Exclusion Criteria:

Scans without metal restorations.

Primary outcomes:
measure: Registration accuracy
timeFrame: immediately after the procedure
Secondary outcomes:
measure: Duration for registration
timeFrame: During the procedure
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Private maxillofacial digital lab
Study officials:
References:
Clinical trial NCT03766932: Antigenic and Antibody Detection of Candida
Official title: Department of Pulmonary & Critical Care Medicine, Chinese PLA General Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: To Evaluate the Diagnostic Value of Candida Antigen Antibody Detection for Candida Infection
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2018-12-06
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with positive aseptic humoral culture among hospitalized patients.The control group were volunteers for outpatient or physical examination

Brief summary: In this study, a multicenter, prospective, synchronous blind, and controlled study was adopted to set the cut-off values of candida specific IgG, IgM, and Mn with the blood culture results as the gold standard, so as to evaluate the diagnostic value of candida specific IgG, IgM, and Mn levels in candida infection.

1. the cut-off values of serum specific IgG, IgM and Mn of candida sinensis infected population in China were established by comparing the positive results of blood culture of 300 healthy people and 100 patients with positive candida sinensis blood culture as the gold standard and using ROC curve (ROC curve).
2. 100 patients with positive tracheal aspiration culture and 100 patients with positive urine culture were enrolled. Serum levels of candida specific IgG, IgM and Mn were detected, and sensitivity, specificity, positive predictive value, negative predictive value and likelihood ratio of candida specific IgG, IgM and Mn in tracheal aspiration and urine were evaluated.
3. 200 high risk patients with candida infection were enrolled, and the aseptic fluid culture and the simultaneous detection of serum specific IgG, IgM and Mn were adopted to explore the diagnostic value of the detection method.
4. positive candida culture in sputum and positive candida culture in tracheal aspirate were taken as the control group to compare the levels of IgG, IgM and Mn in serum of the two groups, and to explore the diagnostic value of different sampling methods for candida pulmonary infection.


Eligibility criteria: Inclusion Criteria:Age: (1) 18-85 years old; (2) Candida positive in aseptic humoral culture

-

Exclusion Criteria:(1) no informed consent has been signed; (2) patients with severe immune deficiency -

Primary outcomes:
measure: Serum specific IgG, IgM and Mn levels in the enrolled population
timeFrame: 1-2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Pulmonary and Critical Care Medicine, Chinese PLA General Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT01190332: Conventional Versus Rendezvous Technique of Intraoperative Endoscopic Retrograde Cholangiopancreatography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Common Bile Duct Gallstones
Keywords: common bile duct stones
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2010-08-27
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: One of the new methods for management of common bile duct stones is intraoperative endoscopic sphincterotomy. It can be performed by many techniques. In the study the investigators compare two methods to find out the best technique for intraoperative endoscopic sphincterotomy.


Eligibility criteria: Inclusion Criteria:

* patients with MRCP evidence of common bile duct stones

Exclusion Criteria:

* cholangitis pancreatitis ASA GRADE III, IV Unfit for laparoscopy unfit for ERCP

Primary outcomes:
measure: success/failure rate of common bile duct stones removal
Secondary outcomes:
measure: complication rate
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Gastroenterology Surgical Center
state: Dakahlia
Study officials:
References:
Clinical trial NCT02980432: Verticality Perception Assessed by the Haptic Vertical
Official title: Verticality Perception - Modulatory Effect of a Rotating Optokinetic Stimulus on the Haptic Vertical in Healthy Human Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: vestibular
spatial orientation
vision
optokinetic
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2016-12-02
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators previously shown that a rotating optokinetic stimulus results in shifts of the subjective visual vertical in healthy human subjects. However, the origin of these shifts is still poorly understood. Both torsional displacement of the eyes and a shift in the internal estimate of direction of gravity have been proposed as potential explanations. Here the investigators use a vision-independent setup to differentiate between these two hypotheses, predicting no impact of a rotating stimulus on the subjective haptic vertical if torsion triggers the shift.


Eligibility criteria: Inclusion Criteria:

* ages 18-65 years
* informed consent
* absence of exclusion criteria

Exclusion Criteria:

* peripheral-vestibular deficit
* disturbed consciousness
* history of sensory deficits
* visual field deficits
* other neurological or systemic disorder which can cause dementia or cognitive dysfunction
* intake of antidepressants, sedatives, or neuroleptics
* pregnancy, unless excluded by a negative pregnancy test
* known neck pain or status post neck trauma

Primary outcomes:
measure: Adjustment errors of aligning a rod along perceived direction of gravity while an optokinetic stimulus is presented.
timeFrame: 60 minutes
measure: Trial-to-trial variability of aligning a rod along perceived direction of gravity while an optokinetic stimulus is presented.
timeFrame: 60 minutes
Secondary outcomes:
measure: Comparison of adjustment errors between the subjective haptic vertical and the subjective visual vertical
timeFrame: 60 minutes
measure: Comparison of adjustment errors of perceived vertical using the subjective haptic vertical with and without presenting an optokinetic stimulus
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Dept. of Neurology
state: ZH
Study officials:
References:
Clinical trial NCT05671432: The Study of CM326 in Moderate-to-severe Atopic Dermatitis
Official title: A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of CM326 Injection in the Treatment of Adult Patients With Moderate-to-severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Moderate-to-severe Atopic Dermatitis
Lead sponsor: Keymed Biosciences Co.Ltd
Sponsor class: INDUSTRY
First posted: 2023-01-04
Enrollment: 240
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: This is a multi-center, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety, tolerance, pharmacokinetics, pharmacodynamics, and immunogenicity of CM326 in moderate-severe atopic dermatitis subjects.

Detailed description: The study consists of 3 periods, a up-to-4-week Screening Period, a 52-week Treatment Period and a 8-week Safety Follow-up Period.

Eligibility criteria: Inclusion Criteria:

* With confirmed Atopic Dermatitis (AD) at the screening.
* Age ≥ 18 years and ≤ 75 years, male or female.
* Have the ability to understand the nature of the study and voluntarily sign the informed consent.
* Be able to communicate well with investigators and follow up protocol requirements.

Exclusion Criteria:

* Not enough washing-out period for previous therapy.
* Received allergen specific immunotherapy (desensitization) within 6 months prior to baseline.
* Major surgery is planned during the study period.
* Women who are pregnant or breastfeeding, or who plan to become pregnant during the study.

Primary outcomes:
measure: Proportion of patients with Eczema Area and Severity Index (EASI)-75 (≥75 percent reduction in EASI scores from baseline) at visit 16
timeFrame: at week 16
measure: Proportion of patients with Investigator's Global Assessment (IGA) score = 0-1 and reduction from baseline of ≥2 points at Visit 16
timeFrame: at week 16
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's hospital
Study officials:
References:
Clinical trial NCT01355432: Heart Rate Changes With Propofol
Official title: Changes in Heart Rate Following Administration of Propofol After Inhalational Induction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Patients
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2011-05-18
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Surgery patients at Nationwide Children's Hospital.

Brief summary: This is a prospective pilot study to quantify the changes in heart rate when propofol is administered after inhalational anesthesia induction.


Eligibility criteria: Inclusion Criteria:

1. At least 1 year of age or older.
2. Routine (elective) surgical patients with ASA classifications of 1 or 2 (healthy).
3. Patients that are already scheduled to receive inhalational induction followed by IV propofol.

Exclusion Criteria:

1. Premature infants of less than 30 weeks, who are less that 60 weeks post-gestational age at the time of study.

Primary outcomes:
measure: Change in heart rate
timeFrame: Baseline & every 30 secs for 3 mins
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Christopher Lancaster, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02699632: Participate While Pregnant Survey
Official title: Research Participation in the Pregnant Population: A Survey Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Keywords: Survey
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2016-03-04
Enrollment: 360
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited online. Anyone can take this survey, however females who have been pregnant or are planning to become pregnant will be the most relevant population.

Brief summary: The main goal for this study is to assess concerns and barriers to research participation by pregnant women through an anonymous online survey (www.pbrc.edu/ParticipateWhilePregnantSurvey).

Detailed description: Participants will complete an online survey distributed through HIPAA compliant REDCap database. Collected data will consist of general multiple choice responses and optional "write-in" responses (e.g. providing a personal response for elaboration an "Other" option). No private health information will be collected.

Eligibility criteria: Inclusion Criteria:

* Any individual may complete this survey.

Primary outcomes:
measure: Willingness to Participate in Research While Pregnant
timeFrame: Day 1
Secondary outcomes:
measure: Preferred Methods for Learning About a Research Study
timeFrame: Day 1
measure: Comfort of Participating in Research While Pregnant
timeFrame: Day 1
measure: Concerns for Participating in Research While Pregnant
timeFrame: Day 1
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Leanne M Redman, PhD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sutton EF, Cain LE, Vallo PM, Redman LM. Strategies for Successful Recruitment of Pregnant Patients Into Clinical Trials. Obstet Gynecol. 2017 Mar;129(3):554-559. doi: 10.1097/AOG.0000000000001900.
Clinical trial NCT02036632: Eye Patch Therapy for Central Serous Retinopathy (CSR)
Official title: Eye Patching as a Potential Treatment Modality for and a Possible Etiological Insight on Central Serous Retinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Central Serous Retinopathy (CSR)
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2014-01-15
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: First, this study will investigate the viability of 24-hour eye patching as a potential treatment modality for CSR. Second, this study will assess a potential physiologic explanation for CSR, namely if inhibition of photic stimulation of the diseased retina will aid in ameliorating disease severity and disease duration.


Eligibility criteria: Inclusion Criteria:

* Adults 18 years of age and older
* Both males and females
* Patients diagnosed with active central serous retinopathy
* Patients who are willing to use an eye patch in the affected eye for 24 hours
* Patients who are able to make the follow up appointments as required by the study

Exclusion Criteria:

* Individuals under 18 years of age
* Patients with vision less than 20/40 in the unaffected eye.
* Patients who are not able to undergo mfERG testing in a realiable manner.

Primary outcomes:
measure: Change in multi-focal ERG response and macular thickness after 24-hour patch therapy in patients with CSR
timeFrame: 24 hours
measure: Change in multi-focal ERG response
timeFrame: 24 hours
Secondary outcomes:
measure: macular thickness
timeFrame: 24 hours
Other outcomes:
Locations:
city: St Louis
country: United States
facility: Washington Universtiy School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Gregory P Van Stavern, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04940832: Outcome Measures of Pulsed Radiofrequency of the Genicular Nerves When Performed With and Without Concomitant Local Corticosteroid Administration
Official title: A Single Blinded Randomized Controlled Clinical Trial Comparing Outcome Measures of Pulsed Radiofrequency of the Genicular Nerves When Performed With and Without Concomitant Local Corticosteroid Administration
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Pain Chronic
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2021-06-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A single blinded randomized controlled trial to compare outcomes of patients with chronic knee pain receiving radiofrequency with or without corticosteroids.


Eligibility criteria: Inclusion Criteria:

* Men and women with pain secondary to osteoarthritis of the knee
* Age of 18 years and up
* Fits criteria for procedure of genicular nerve block and pulsed radiofrequency neuromodulation

Exclusion Criteria:

* Patients who are incapable of judgment and/or to give informed consent
* Patients who are pregnant
* Patients who are under 18 years old
* Patients who have allergies to local anesthetic
* Patients with platelet dysfunction or bleeding disorders
* Patients who are currently mentally unstable
* Patients who have a diagnosis of fibromyalgia

Primary outcomes:
measure: Improvement in chronic knee pain
timeFrame: 2nd and 6th week
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
Study officials:
References:
Clinical trial NCT04463732: The Relationship Between Maximal Oxygen Consumption and Inspiratory Muscle Activation Pattern Under Loaded Inspiratory Muscle Tests in Healthy Adults
Official title: The Relationship Between Maximal Oxygen Consumption and Inspiratory Muscle Activation Pattern Under Loaded Inspiratory Muscle Tests in Healthy Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy population is free from abnormal breathing pattern caused by disease. Their terminals of cardiopulmonary exercise test are not limited by symptoms of disease.

Brief summary: Maximal oxygen consumption, VO2max, is the gold standard to evaluate human aerobic fitness, which stands for the maximal capacity of cardiorespiratory system and musculoskeletal system to transport and utilize oxygen. Previous study showed that there is significant correlation between maximal oxygen consumption from cardiopulmonary exercise test and strength and endurance of lower extremities. In people with sedentary lifestyle, they often limited by the lower limb muscle performance during cardiopulmonary exercise test. Their breathing patterns are more irregular than athletes during cardiopulmonary exercise test. However, there is no study comparing the activation pattern of respiratory muscles between these two groups. Whether the breathing pattern in people with lower exercise capacity is less efficient under exertional activities still unknown. The purpose of this study is to investigate the relationship between maximal oxygen consumption and inspiratory muscle activation pattern in healthy adults.


Eligibility criteria: Inclusion Criteria:

* Healthy adults (age \> 20 years old)
* Be able to cooperate with the measurements of this study

Exclusion Criteria:

* any clinical diagnosis that will influence the measurement, including any history of neuromyopathy
* angina, acute myocardial infarction in the previous one month
* pregnancy
* history of syncope during exercise
* any musculoskeletal system disorder that unable to perform cardiopulmonary exercise test

Primary outcomes:
measure: Diaphragm and Sternocleidomastoid muscle activation
timeFrame: during the loaded inspiratory muscle test condition; it would take about 3 minutes
measure: Maximal exercise capacity
timeFrame: during the cardiopulmonary exercise test; it would take about 12 to 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: School and Graduate Institute of Physical Therapy of National Taiwan University
state: Zhongzheng Dist
Study officials:
affiliation: National Taiwan University
name: Li-Ying Wang, PhD
role: STUDY_CHAIR
References: