louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03017742: Utility of Non-invasive Carboxyhemoglobin and Total Hemoglobin Measurement in the Emergency Department
Official title: A Multi-Center Study on the Utility of Non-invasive Carboxyhemoglobin and Total Hemoglobin Measurement in Emergency Department Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Conditions: Carbon Monoxide Poisoning
Anemia
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2017-01-11
Enrollment: 813
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine the clinical utility of triage screening for anemia and carbon monoxide poisoning (COP) in the ED setting.This is a prospective, nonrandomized, multi-center study of the performance of simultaneous non-invasive testing for two common disorders (COP and anemia). We will determine the limits of agreement and performance characteristics of non-invasive carboxyhemoglobin (SpCO) and hemoglobin (SpHb) values compared to standard blood tests for measurement of carboxyhemoglobin and hemoglobin, in the emergency department setting.


Eligibility criteria: Inclusion Criteria:

* Age 1 year or older.
* At least one digit has acceptable width as measured by study-provided digit gauge.
* Presenting to emergency department for any complaint.
* Potential for IV catheter and/or blood draw for CBC as standard of care.

Exclusion Criteria:

* Patients unable to consent for any reason
* Patients with fingernail polish, discoloration or trauma to fingers

Primary outcomes:
measure: Difference Between SpCO and COHb
timeFrame: Up to 3 hours
measure: SpCO Detection of Carbon Monoxide Poisoning (COP)
timeFrame: up to 3 hours
measure: Utility of SpCO as a Screening Tool for Carbon Monoxide Poisoning
timeFrame: up to 3 hours
measure: Carbon Monoxide (CO) Elimination Pharmacokinetics in Relation to Oxygen Administration
timeFrame: up to 3 hours
measure: Specificity of SpHb in Detecting Anemia.
timeFrame: up to 3 hours
measure: Sensitivity of SpHb Detection of Anemia.
timeFrame: up to 3 hours
measure: SpHb Utility for Screening Anemia
timeFrame: up to 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Tepecik Training and Research Hospital IEC
Study officials:
References:
Clinical trial NCT04879342: Evaluation of Values in Perspective (VIP) Program
Official title: Evaluation of Values in Perspective (VIP) Program
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Risk Behavior
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2021-05-10
Enrollment: 150
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to review and assess the usefulness of the Values in Perspective (VIP) program to avoid adolescent risky behaviors.


Eligibility criteria: Inclusion criteria

1. A youth residing in Miami-Dade County.
2. Must be in grades 6-12 and must be eligible for free and reduced lunch.
3. Must be able to speak and read English proficiently.

Exclusion criteria

1. Does not reside in Miami-Dade County.
2. Does not comprehend, speak, or read English proficiently.
3. In elementary school.
4. In high-income household as evidenced by not qualifying for free and reduced lunch.

Primary outcomes:
measure: SRAE Scores - Middle School
timeFrame: Up to 26 weeks
measure: SRAE Scores - High School
timeFrame: Up to 26 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Guerda Nicolas
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05349942: A Digital Method for Measurement of Palatal Asymmetry in Twins
Official title: A Digital Method for Measurement of Palatal Asymmetry in Twins
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Identity, Body
Palate; Deformity
Keywords: Human identification
Palate morphology
Intraoral scanner
Digital dentistry
Lead sponsor: Semmelweis University
Sponsor class: OTHER
First posted: 2022-04-27
Enrollment: 201
Sex: ALL
Minimum age (years): 17
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Intraoral scanner (Planmeca Emerald) data acquisition, 3 scans are taken for each participant. Data will be exported from dedicated software (Planmeca, Romexis) and imported into GOM surface analysis software. Sample comparisons and sample preparation are performed here. The results are collected in excel spreadsheets and analyzed in SPSS statistical software.
Primary purpose: SCREENING

Brief summary: The aim of the study is to evaluate the digital palatal model as a possible tool of human identification.

Detailed description: In this research, the investigators investigate the individual characteristics of the human upper and lower dentition and palate. The investigators use digital dentistry, record the data using an intraoral scanner, and store the extracted open source file format on a secure cloud-based server. Data validation is repeated annually. By comparing the initial and control digital samples, the investigators draw conclusions about the usability of the extracted information. The aim of the study is to develop a method and data storage protocol that will allow the patient data to be used years or decades later to replace or restore lost information.

Eligibility criteria: Inclusion Criteria:

* Monozygotic twins
* Same-sex Dizygotic twins
* Opposite-sex Dizygotic twins
* Triplets

Exclusion Criteria:

* Marfan-syndrome
* Non-twins

Primary outcomes:
measure: Deviation value between 3 human palatal scans
timeFrame: 30 second between data acquisition
measure: Deviation value among scans
timeFrame: 30 second between data acquisition
measure: Deviation value between 2 scans
timeFrame: 30 second between data acquisition
measure: Deviation value between original scans and mirrored scans of the individual
timeFrame: 30 second between data acquisition
measure: Deviation value between original human palatal scans and mirrored human palatal scans of the twins
timeFrame: 30 second between data acquisition
Secondary outcomes:
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University, Department of Conservative Dentistry
Study officials:
References:
Clinical trial NCT06274242: Mixed Natural Prebiotic-Fibers Impact on Stool Frequency and Fecal Microbiota in Constipated Thai Adults
Official title: Mixed Natural Prebiotic-Fibers Impact on Stool Frequency and Fecal Microbiota in Constipated Thai Adults: A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Constipation
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 98
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Mixed Natural Prebiotic-Fibers Impact on Stool Frequency and Fecal Microbiota in Constipated Thai Adults: A Randomized Clinical Trial.


Eligibility criteria: Inclusion Criteria:

* Healthy adults with a Body mass index (BMI) of 16.00 to 29.99 kg/m2
* Self-reported constipation according to the Rome IV criteria

Exclusion Criteria:

* Pregnancy
* Crohn's disease or any other inflammatory bowel disease
* Pelvic floor dyssynergia
* Have congenital diseases such as liver disease, diabetes, and thyroid dysfunction. hypercalcemia neurological disease
* Drink alcohol or smoke regularly.
* During the past 1 month or while in the project, have received antibiotics, steroids, NSAIDs, blood pressure-lowering drugs, antidepressants, anticonvulsants, or Parkinson's disease medications
* History of food allergy to Haruna's ingredients
* There has been a change in body weight (increase or decrease of 5 kilograms over a period of 6 months).
* During the past 2 weeks or while in the project, have received probiotics or other prebiotics

Primary outcomes:
measure: Change in Stool Frequency
timeFrame: 12 weeks
measure: Change in Fecal Microbiota
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Stool consistency
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Nakhon Pathom
country: Thailand
facility: Mahidol University
Study officials:
affiliation: Department of Clinical Microbiology and Applied Technology, Faculty of Medical Technology, Mahidol University
name: Sirirat Luk-in, phD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06406842: Association Between Local Cerebral Oxygenation Monitoring and Postoperative Stroke in Carotid Endarterectomy
Official title: Perioperative Application of Hemodynamic Management Based on Regional Cerebral Oxygen Saturation Monitoring of Cerebral Autoregulation in Carotid Endarterectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Carotid Endarterectomy
Cerebral Autoregulation
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2024-05-09
Enrollment: 560
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Carotid endarterectomy (CEA) is used to treat symptomatic extracranial internal carotid artery stenosis. The occult stroke of CEA patients evaluated by magnetic resonance imaging 3 days after operation was as high as 17%. Cerebral blood flow autoregulation (CA) is the ability of the brain to maintain the relative stability of cerebral blood flow, and cerebral oxygen index (COx) can be used to reflect CA. A negative value of cerebral oxygen index or a value near zero indicates that CA is complete, and cerebral oxygen index close to 1 indicates that CA has lost its ability. In theory, real-time monitoring of CA function by cerebral oxygen index and individualized management strategy with this goal can potentially reduce perioperative ischemic brain injury. The purpose of this study is to explore the influence of the management strategy of monitoring CA function based on regional cerebral oxygen saturation on the postoperative neurological complications of CEA patients.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for elective carotid endarterectomy
* ASA Ⅱ or Ⅲ
* aged 18-80 years old

Exclusion Criteria:

* preoperative moderate and severe cognitive impairment
* preoperative psychotropic medication history within one year
* history of neurosurgery
* have speech or language impairments

Primary outcomes:
measure: The incidence of postoperative cerebral ischemic events
timeFrame: postoperative 3 day
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tian Tan Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Tian Tan Hospital
name: Yuming MD Peng, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05305742: Evaluation of Postoperative Pain and Bacterial Load Reduction With ProTaper Ultimate Versus ProTaper Gold Rotary Systems
Official title: Evaluation of Postoperative Pain and Bacterial Load Reduction After Canal Preparation With ProTaper Ultimate Versus ProTaper Gold Rotary Systems in Patients With Necrotic Maxillary Premolars (Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post Operative Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 56
Sex: ALL
Minimum age (years): 22
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to research the effect of different instrument designs by comparing protaper ultimate versus protaper gold systems on root canal preparation by evaluating bacterial count reduction and post-operative pain following single visit treatment in patients with necrotic pulp in maxillary premolar teeth.


Eligibility criteria: Inclusion Criteria:

* Patient's age ranges between 22 to 45 years with no sex predilection.
* Medically free patients.
* Maxillary permanent premolar teeth:

  * Diagnosed clinically with pulp necrosis.
  * Absence of pain.
  * Radiographic evidence of two roots or single root with double canals.
  * Slight widening in the periodontal membrane space or with peri-apical radiolucency
  * No response to cold pulp tester and ethyl chloride spray.
* Patients who can understand Modified Visual Analogue Scale (VAS).
* Patients' acceptance to participate in the trial.

Exclusion Criteria:

* Medically compromised patients.
* Pregnant women.
* If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively.
* Patients reporting bruxism or clenching.
* Teeth with:

  i. Vital teeth. ii. Single canal maxillary premolar teeth iii. Association with swelling or fistulous tract. iv. Acute peri-apical abscess and swelling. v. Mobility Grade II or III. vi. Pocket depth more than 5mm. vii. Previous root canal therapy. viii. Non-restorable teeth: Hopeless tooth
* Immature teeth.
* Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification, root caries.

Primary outcomes:
measure: Post Operative Pain
timeFrame: Postoperative pain will be measured by modified Visual Analogue Scale immediately after the end of treatment, and at 6, 12, 24 and 48 hours.
Secondary outcomes:
measure: Number of needed analgesic tablets in case of intolerable pain
timeFrame: Patient will be contacted after 48 hours after endodontic treatment to know the number of analgesic tablets taken
measure: Antibacterial Effectiveness
timeFrame: First as a Baseline (T0): After the access cavity Sample 1 will be taken, after 15 minutes (T1) mechanical instrumentation will be done and Sample 2 will be taken, after 5 minutes from T1 (T2) final irrigation will be done and Sample 3 will be taken.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06735742: A Study to Learn About the Safety of TALZENNA for the Treatment of Breast Cancer
Official title: TALZENNA Capsules Special Investigation - Investigation on BRCA Mutation-Positive and HER2-Negative Unresectable or Recurrent Breast Cancer With a History of Cancer Chemotherapy -
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Keywords: BRCA mutation-positive and HER2-negative
unresectable or recurrent breast cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-12-16
Enrollment: 3
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who satisfy the inclusion criteria

Brief summary: The purpose of this study is to learn about the safety of TALZENNA for the patients with breast cancer that cannot be removed by surgery and has come back. These participants also have a past treatment with medicines that try to stop the growth of cancer cells.

This study is seeking for participants who:

* have breast cancer that cannot be removed by surgery and has come back
* have not used this medicine before. All patients in this study will receive TALZENNA according to the prescriptions.

Patients will be followed up to 52 weeks (12 months) from the day of start of treatment start (Day 1). However, in cases where treatment has been completed or stopped less than 52 weeks (12 months) after the start of giving study medicine, the participants will be checked until completion (discontinuation) of treatment.


Eligibility criteria: Inclusion Criteria:

* Patients with BRCA mutation-positive and HER2- negative unresectable or recurrent breast cancer with a history of cancer chemotherapy
* No history of previous use of this drug

Exclusion Criteria:

* None

Primary outcomes:
measure: Incidence of adverse drug reactions
timeFrame: Up to 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Pfizer
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02024542: Metabolic Responses to Bariatric Surgery
Official title: Genetic and Biochemical Characteristics of Medically-Complicated Obesity and Response to Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Morbid Obesity
Keywords: Bariatric Surgery
Obesity
Metabolic syndrome
Diabetes
Liver Disease
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2013-12-31
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who present for bariatric surgery to treat morbid obesity.

Brief summary: Research the genetic and biomechanical markers of human adipose tissue on patients with morbid obesity. Additional tissue/fluid collection is also gathered during the time of surgery.

Detailed description: Study participation by invitation after complete pre-surgical work up at UC Davis Health System. Patients will be invited to participate if they meet all inclusion criteria's after completing all necessary clinical visits including lab studies, counseling, and participation in educational programs. During the pre-operative visit patients interested in participation will complete all necessary consent documentation. Pre-operative labs (blood and urine) will be collected along with additional blood, urine, and fecal samples will be collected pre-operatively. During surgery (Roux-en-Y Gastric Bypass surgeries only) tissue collection will include subcutaneous \& omental fat, jejunum, and liver biopsy. Post surgery patient will be observed for weight loss and resolution of co-morbidities. At designated times post surgery when lab studies are ordered additional blood/urine samples will be collected and analyzed.

Eligibility criteria: Inclusion Criteria:

* Meet NIH Criteria for Bariatric Surgery
* Between the Age of 18-55
* Dyslipidemia controlled with medication
* Impaired glucose metabolism or type 2 diabetes

Exclusion Criteria:

* Uncontrolled Metabolic syndrome (uncontrolled diabetes, htn, dyslipidemia), one or all conditions.

Primary outcomes:
measure: Tensile Strength of White Adipose Tissue
timeFrame: July 2012
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
Study officials:
affiliation: University of California Davis Health System
name: Mohamed R Ali, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03033342: Single Dose and Multiple Dose Escalation Trial of an Oral Formulation of MRX-4
Official title: Randomized, Double-Blind, Placebo-Controlled Three-Part Phase 1 Study of Safety, Tolerability, Pharmacokinetics, and Food Effect of MRX-4 Administered Orally to Healthy Volunteers in Single and Multiple Ascending Dose Cohorts to Evaluate Drug Interactions With Omeprazole
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Safety
Keywords: Phase 1
Lead sponsor: MicuRx
Sponsor class: INDUSTRY
Collaborators: name: Worldwide Clinical Trials
First posted: 2017-01-26
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: A phase one study of the safety, tolerability, and pharmacokinetics of a new oxazolidinone antibiotic. Cohorts of healthy adults (female and male) will participate in:

single dose escalation study of increasing doses of MRX-4 given by mouth others will participate in multiple dose escalation cohorts of MRX-4 given twice daily by mouth.

other cohorts of subjects will participate in the study to evaluate the impact of concomitant food or Omeprazole on safety, tolerability and pharmacokinetics of MRX-4


Eligibility criteria: Inclusion Criteria:

* Healthy subjects

Exclusion Criteria:

* Underlying hepatic, renal, metabolic, hematologic, cardiovascular, or immunologic disorder

Primary outcomes:
measure: Safety of single and multiple ascending doses of MRX-4
timeFrame: Screening through end of study visit on Day 7 (Part 1), Day 17 (Part II) and Day 14 (Part III)
measure: Summary of concentration time data for MRX-4 and its metabolites
timeFrame: Pre-dose through 72 hours post dose
Secondary outcomes:
measure: Summary of the plasma concentration teim data for MRX-4 under fed or fasted conditions
timeFrame: Pre-dose through 72 hours post dose
measure: Safety of MRX-4 co-administered with omeprazole
timeFrame: Screening through end of study on Day 14
measure: Summary of the plasma concentration time data for MRX-4 co-administered with omeprazole
timeFrame: Pre-dose through 72 hours post dose
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02554942: A Study of Epoetin Beta (NeoRecormon) in Participants With Solid Tumors
Official title: An Open-Label Study of the Safety Of NeoRecormon in Patients With Solid Tumors Being Treated With Platinum Capable of Inducing Anemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-09-18
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety of subcutaneous (SC) epoetin beta (NeoRecormon) in adults with solid tumors being treated with platinum-based chemotherapy capable of inducing anemia. The anticipated time on study treatment is 16 weeks, and the target sample size is approximately 208 individuals.


Eligibility criteria: Inclusion Criteria:

* Adults at least 18 years of age
* Presence of solid tumor(s)
* Receiving platinum-based therapy capable of inducing anemia

Exclusion Criteria:

* Red blood cell transfusion within 7 days prior to study drug
* Relevant acute or chronic bleeding requiring therapy within 3 months prior to study drug
* Women who are pregnant or breastfeeding

Primary outcomes:
measure: Incidence of adverse events
timeFrame: Up to 16 weeks
Secondary outcomes:
measure: Hemoglobin response rate index
timeFrame: Up to 16 weeks
Other outcomes:
Locations:
city: Alcoy
country: Spain
city: Barakaldo
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Caceres
country: Spain
city: El Palmar Murcia
country: Spain
city: La Laguna
country: Spain
city: Manresa
country: Spain
city: Salamanca
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Zaragoza
country: Spain
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References: