louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01168115: Near-Infrared Spectroscopy for Blood Glucose Measurements
Official title: Near-Infrared Spectroscopy for Blood Glucose Measurements
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: InLight Solutions
Sponsor class: INDUSTRY
Collaborators: name: Luminous Medical
First posted: 2010-07-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males and females between the ages of 18 and 65

Brief summary: The purpose of this study is to evaluate the performance of a near-infrared transmission measurement in blood samples collected from healthy volunteers. We propose that NIR spectroscopic blood glucose measurements in healthy patients are as accurate as handheld glucometers and a Yellow Springs Instrument (YSI). We will also evaluate in vitro blood samples spiked with pharmacological interferents to test if the spectroscopic glucose measurement is affected by common medications.

Detailed description: Luminous Medical is developing an automated glucose measurement system that addresses the rapidly growing clinical demand for tight glycemic control in the intensive care unit (ICU), operating room (OR), and intermediate care units. The system automatically measures glucose and other analytes by spectroscopically analyzing blood as it passes through a disposable Sensor Set. Our unique optical measurement does not chemically interact with blood, is insensitive to sensor fouling, and, unlike a biosensor, does not require frequent recalibration.

Eligibility criteria: Inclusion Criteria:

* Males and females between the ages of 18 and 65
* Healthy
* Not currently pregnant
* Hematocrit \>38%

Exclusion Criteria:

* Pregnancy (Self Reported)
* Females that have given birth 6 weeks prior (self reported)
* Anemia (hematocrit \<38%) Hematocrit is checked via a capillary fingerstick and a blood hematocrit reader.
* Under the age of 18 or over the age of 65.
* Diagnosed with Type I or II Diabetes (Self-Reported).
* Donated blood (\>25 mls) in the last 8 weeks
* Heart rate \>100 beats per minute
* Weigh less than 110 lbs.
* Currently taking anticoagulants (ex: coumadin)
* Abnormal blood pressure (diastolic \>90)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: InLight Solutions
state: New Mexico
Study officials:
affiliation: UNMHSC
name: Mark Rohrscheib, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05303415: Study of Low-intensity Focused Ultrasound Effects on Heat Evoked fMRI Signals
Official title: Study of Low-intensity Focused Ultrasound Effects on Heat Evoked fMRI Signals
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 80
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: Study aims to examine the effects of noninvasive brain stimulation on brain signals. This insight may have potential clinical implications for addiction, pain, and mental health populations. Participants will receive MRI and CT imaging. Participants receive low-intensity focused ultrasound (LIFU) to temporarily change brain activity. Participants then receive fMRI scans to measure changes in both resting and heat evoked brain signaling using a quantitative sensory testing device. Heart rate, blood pressure, respiratory rate, and skin moisture is monitored. Participants complete a battery of questionnaires, both behavioral and symptom monitoring. The study takes place over 4 study visits.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers, all ethnicities, who understand and speak English.

Exclusion Criteria:

Claustrophobia (scanning environment may be uncomfortable). Contraindications to MRI: including pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants.

Contraindications to CT: pregnancy Active medical disorder or treatment with potential CNS effects (e.g. Alzheimer's) History of neurologic disorder. (e.g. Parkinson's, Epilepsy, or Essential Tremor) History of head injury resulting in loss of consciousness for \>10 minutes. History of alcohol or drug dependence (through self-report).

Primary outcomes:
measure: fMRI BOLD Signals
timeFrame: Participant study duration, approximately 3 weeks.
Secondary outcomes:
measure: Changes in self-reported perceived pain
timeFrame: Participant study duration, approximately 3 weeks.
Other outcomes:
measure: Monitoring changes to physiological measures
timeFrame: Participant study duration, approximately 3 weeks.
Locations:
city: Roanoke
country: United States
facility: Fralin Biomedical Research Institute
state: Virginia
Study officials:
References:
Clinical trial NCT05290415: Host DNA Methylation for Endometrial Cancer Screening
Official title: The Accuracy of Host DNA CDO1 and CELF4 Methylation for Endometrial Cancer Screening: a Multi-center Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer Screening
Endometrial Cancer
DNA Methylation
Cervical Cytology
Liquid Biopsy
Cohort Study
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Qiyuanjuhe Biotechnology Co., Ltd
First posted: 2022-03-22
Enrollment: 10000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants will accept surgeries harvesting endometrial histology.

Brief summary: Based on the previous study of NCT04651738, we performed this trial to further confirm the accuracy of host DNA CDO1 and CELF4 methylation for endometrial cancer screening in a multi-center cohort. Thirteen hospitals, including Peking Union Medical College Hospital, would enroll eligible patients in this study. The cervical cytology of 3 ml will be collected for the detection of DNA CDO1 and CELF4 methylation, and the results will compared with the endometrial histological pathology, which is achieved after collection of cervical cytology, by surgeries including hysteroscopy, dilation and curettage, total hysterectomy and others. The methylation testing would be double-blinded in operators and analysts. The study will enroll at least 10,000 patients.


Eligibility criteria: Inclusion Criteria:

* With uterine and uterine cervix intact
* Aged 18 years or older
* With accessible histological results of endometrium
* Signed an approved informed consents
* With accessible cervical cytology before harvesting endometrial histology

Exclusion Criteria:

* Not meeting all of the inclusion criteria

Primary outcomes:
measure: Sensitivity of methylation testing
timeFrame: One week
measure: Specificity of methylation testing
timeFrame: One week
Secondary outcomes:
measure: Positive predictive value of methylation testing
timeFrame: One week
measure: Negative predictive value of methylation testing
timeFrame: One week
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lei Li
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lei Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01694615: Cryoprobe Transbronchial Lung Biopsy in Lung Transplant Patients
Official title: Prospective Controlled Study of Transbronchial Cryoprobe Versus Forceps Biopsy for Acute Rejection in Lung Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Transplantation
Keywords: Lung Transplantation
Acute Rejection
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2012-09-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Lung transplant recipients undergo bronchoscopy with biopsies for clinical indications and for surveillance in the diagnosis of acute rejection using standard transbronchial forceps. It is recognized that standard forceps biopsies underestimate the presence or degree of airway rejection due to crush artifact and sample size. Transbronchial cryobiopsies have been shown in the literature to provide larger samples without crush artifact in a safe fashion in lung cancer patients. The aim of this study is to determine if transbronchial cryobiopsy is superior to standard transbronchial forceps biopsies in regards to sample size, architecture and the diagnosis of early rejection in lung transplant recipients which if discovered earlier may improve survival.


Eligibility criteria: Inclusion Criteria:

* Individuals referred for either clinically indicated or surveillance flexible bronchoscopy will be included in the study population
* Age greater than 18 years and having undergone bilateral orthotopic lung transplantation

Exclusion Criteria:

* Coagulopathy: plts \< 50,000 international normalized ratio (INR) \> 1.5
* Forced expiratory volume at one second (FEV1) \< 0.8
* Diffuse bullous disease
* Hemodynamic instability
* Severe hypoxemia

Primary outcomes:
measure: Differences in size of biopsy specimen and architectural preservation of the airways/alveoli (ie degree of crush artifact)
timeFrame: From date of study enrollment until the patient is 2 years post lung transplant
Secondary outcomes:
measure: Diagnostic yield (ie presence of acute cellular rejections (ACR), chronic rejection, lymphocytic bronchiolitis and infection)
timeFrame: From date of study enrollment until the patient is 2 years post lung transplant
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Lonny Yarmus
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00232115: Pimecrolimus Cream 1% in Adult Patients With Perioral Dermatitis
Official title: Pimecrolimus Cream 1% in Adult Patients With Perioral Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Perioral Dermatitis
Keywords: Perioral Dermatitis, pimecrolimus cream
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-10-04
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An evaluation of the safety and efficacy of the calcineurin inhibitor, pimecrolimus cream 1%, in adult patients with perioral dermatitis.

This study is not enrolling patients in the United States.


Eligibility criteria: Inclusion Criteria:

* clinically diagnosed perioral dermatitis associated or not associated with topical steroid use (the periorbital area may also be involved in addition to the perioral region)
* minimum severity score (PODSI) ≥ 4
* age 18 and older

Exclusion Criteria:

* Ongoing use of the following treatments is NOT allowed after the start of study drug:

Oral tetracyclines, oral erythromycin, oral steroids and oral calcineurin inhibitors. All topical treatments of the face, including steroids, calcineurin inhibitors, metronidazole, tetracyclines, erythromycin and emollients (exception: DAC Basiscreme).

* Systemic immunosuppression
* History of malignancy of any organ system, treated or untreated, within the past 5 years

Primary outcomes:
measure: Reduction of the Perioral Dermatitis Severity Index
Secondary outcomes:
measure: Time to disease recurrence
measure: Response rates
measure: Patient's quality of life assessment
measure: Patient's disease severity assessment
Other outcomes:
Locations:
city: Nürnberg
country: Germany
facility: Novartis Pharmaceuticals
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharma AG
role: STUDY_CHAIR
References:
citation: Schwarz T, Kreiselmaier I, Bieber T, Thaci D, Simon JC, Meurer M, Werfel T, Zuberbier T, Luger TA, Wollenberg A, Brautigam M. A randomized, double-blind, vehicle-controlled study of 1% pimecrolimus cream in adult patients with perioral dermatitis. J Am Acad Dermatol. 2008 Jul;59(1):34-40. doi: 10.1016/j.jaad.2008.03.043. Epub 2008 May 7.
Clinical trial NCT05594537: The Best Way to Improve the Near Visual Acuity After ZXR00 IOL Implantation
Official title: The Best Way to Improve the Near Visual Acuity After Implantation of Tecnis Symfony® ZXR00 Intraocular Lens
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cataract
Near Vision
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2022-10-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From December 2019 to present, cataract patients underwent phacoemulsification combined with ZXR00 IOLs or ZMB00 IOLs implantation by an experienced ophthalmologist (Dr. Zhao Yune) in Wenzhou Medical University Affiliated Eye Hospital(hangzhou branch).

Brief summary: The Best Way to Improve the Near Visual Acuity After ZXR00 IOL Implantation

Detailed description: ZXR00 intraocular lens is a new type of IOL that can achieve good continuous visual acuity. Its characteristic is to improve the distance and intermedia visual acuity and maintain good visual quality while sacrificing the near visual acuity. Previous studies report that there are mainly two ways to improve the near visual acuity of ZXR00：1.Bilateral implantation of ZXR00 with micromonovision. 2. Combined Implantation of ZXR00 and multifocal IOLs.This study aim to explore which is the best way to improve the near visual acuity after ZXR00 IOL implantation.

Eligibility criteria: Inclusion Criteria:

* Age of 18-80 years
* Cataract surgery is planned
* The operation was successful without any complications
* Implanted with ZXR00 IOLS or ZMB00 IOLs

Exclusion Criteria:

* The history of retinopathy or retinal surgery
* Irregular corneal astigmatism
* Regular corneal astigmatism of 1.00 diopter (D) or more
* Iris abnormalities
* Macular degeneration
* Neuro-ophthalmic disease
* The history of ocular inflammation

Primary outcomes:
measure: Uncorrected Visual Acuities
timeFrame: 2022.12.31
measure: Corrected Visual Acuities
timeFrame: 2022.12.31
measure: Defocus Curve
timeFrame: 2022.12.31
measure: Patient satisfaction
timeFrame: 2022.12.31
measure: Subjective quality of vision
timeFrame: 2022.12.31
measure: Adverse visual symptoms
timeFrame: 2022.12.31
measure: Stereopsis
timeFrame: 2022.12.31
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ophthalmology and Optometry Hospital
name: Yune Zhao
role: STUDY_DIRECTOR
References:
Clinical trial NCT01604837: The Optimal Oblique and Axial Angle of Fluoroscope for Superior Hypogastric Plexus Block
Official title: The Optimal Oblique and Axial Angle of Fluoroscope for Superior Hypogastric Plexus Block
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pelvic Pain
Pelvic Malignancy
Superior Hypogastric Plexus Block
Keywords: superior hypogastric plexus block
pelvic malignancy
chronic pelvic pain
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2012-05-24
Enrollment: 268
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Those undergoing abdominopelvic CT scan with pelvic malignancy or chronic pelvic pain with constitutional disease

Brief summary: The recommended entry angle for superior hypogastric plexus block is different among references, and there is a need for suggesting a more accurate entry angle for this procedure. The investigators are trying to evaluate the entry angle for superior hypogastric plexus block by measuring these angle on the computed tomography image and apply these angle to the real patients.

Detailed description: Superior hypogastric plexus block is a kind of sympathetic plexus block which are used to control the pelvic pain caused by malignancy or other chronic condition. Classic posterior approach for this procedure is inserting the block needle at L4 -5 level and proceed the needle 45 degrees medially and 30 degrees caudally to reach the target of anterolateral space of L5 - S1 intervertebral space. Waldman et al. introduced a different angle of 30 degrees medial and caudal with the same approach, while Stevens et al. recommended 15 degrees medial and 20 degrees caudal. As such, the recommended angle for this procedure is different among references, and there is a need for suggesting a more accurate entry angle for this procedure. Therefore, we are trying to evaluate the entry angle for superior hypogastric plexus block by measuring these angle on the computed tomography image and apply these angle to the real patients.

Eligibility criteria: Inclusion Criteria:

* Those undergoing abdominopelvic CT scan with pelvic malignancy or chronic pelvic pain with constitutional disease

Exclusion Criteria:

* Poor CT image with non-measurable axial or oblique entry angle

Primary outcomes:
measure: the oblique entry angle
timeFrame: 1 month after abdominopelvic CT scan performed
Secondary outcomes:
measure: the axial entry angle
timeFrame: 1 month after abdominopelvic CT scan performed
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Woo Seog Sim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: Won Ho Kim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: Hye Won Song, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00993837: Feasibility of Endoscopic Thyroidectomy for Thyroid Carcinoma
Official title: Comparison of Effectiveness and Safety of Thyroidectomy for Thyroid Carcinoma in Patients Undergo Endoscopic Surgery and Those Receive Conversion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thyroid Carcinoma
Keywords: endoscopic thyroidectomy
thyroid carcinoma
Lead sponsor: Second Military Medical University
Sponsor class: OTHER
First posted: 2009-10-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Endoscopic thyroidectomy has been used to treat thyroid diseases in China. However, whether this technique is rational to treat thyroid carcinoma is still in controversy. The diagnosis of thyroid carcinoma is predominantly made according to intra-operative frozen section pathological examination in China. In this research, the investigators want to compare clinical index (blood loss, operation duration, number of lymph nodes dissected, complication rates, etc) between patients underwent endoscopic thyroidectomy ( total thyroidectomy) and those underwent conversion to open procedure. The investigators want to evaluate the technical feasibility of endoscopic thyroidectomy for treating thyroid carcinoma.

Detailed description: intra-operative diagnosis of thyroid carcinoma is usually considered the indication of conversion to open surgery. with accumulation of experience of endoscopic thyroidectomy, the investigators want to evaluate the technical feasibility, completeness and safety of endoscopic thyroidectomy.

Eligibility criteria: Inclusion Criteria:

* lesion diameter less than 1 cm by ultrasound

Exclusion Criteria:

* frozen section diagnosis indicates benign lesion

Primary outcomes:
measure: to evaluate the completeness of thyroid resection and clearance of lymph nodes in the central compartment, and to observe the complications such as RLN palsy and hypocalcemia
timeFrame: 1 year after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changzheng Hospital
state: Shanghai
Study officials:
affiliation: Changzheng Hospital affliated to SMMU
name: Ming QIU, Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT02726737: Effect of Sodium Bicarbonate Buccal Infiltration on the Success of Inferior Alveolar Nerve Block
Official title: Effect of Sodium Bicarbonate Buccal Infiltration on the Success of Inferior Alveolar Nerve Block in the Mandibular First Molar With Symptomatic Irreversible Pulpitis: a Prospective, Randomized Double-blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Local Anesthesia
Keywords: inferior alveolar nerve block
irreversible pulpitis
local anesthesia
sodium bicarbonate
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2016-04-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this prospective, randomized, double blind study was to evaluate the effect of a buccal infiltration of sodium bicarbonate on the anesthetic success of the inferior alveolar nerve block (IANB) in patients with mandibular first molar experiencing symptomatic

Detailed description: Several studies have been done by adding Sodium Bicarbonate to local anesthesia in dentistry based on the theory that the amount of local anesthetic in the free-base un-ionized form will decrease to provide greater lipid penetration of the nerve and this could be cause of the failure of local anesthesia injected into the inflamed tissue with low PH and conflicting results were obtained. But, there are no study that evaluate effect of increasing PH in periradicular tissue on hindrance of resistance channels with supplementary infiltration injection of Sodium Bicarbonate

Eligibility criteria: Inclusion Criteria:

* vital mandibular molar tooth
* diagnosis of symptomatic irreversible pulpitis

Exclusion Criteria:

* younger than 18 years old
* history of significant medical conditions
* allergies to local anesthetics or sulfites
* pregnancy
* taking any medications that might influence anesthetic assessment
* active sites of pathosis in area of injection
* inability to give informed consent

Primary outcomes:
measure: success rate of IANB in the mandibular first molar with symptomatic irreversible pulpitis
timeFrame: Baseline
Secondary outcomes:
measure: Heft-Parker visual analog scale recording of pain
timeFrame: Baseline
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Isfahan University of Medical Sciences
Study officials:
affiliation: Isfahan University of Medical Sciences
name: Masoud Saatchi
role: STUDY_CHAIR
References: