louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01570621: Personalized Peroral Endoscopic Myotomy for Achalasia
Official title: Personalized Peroral Endoscopic Myotomy for Achalasia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Achalasia
Postoperative Complications
Keywords: achalasia
peroral endoscopic myotomy
LES pressure
postoperative complication
symptom relief
esophageal barium
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2012-04-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Achalasia is a rare esophageal motility disorder, characterized by incomplete lower esophageal sphincter relaxation, increased Lower esophageal sphincter (LES) tone, and aperistalsis of the esophagus. Typical clinical symptoms are dysphagia,regurgitation and chest pain. Traditional treatments include endoscopic balloon dilatation or botulinum toxin injection, laparoscopic Heller myotomy with or without a partial fundoplication. Peroral endoscopic myotomy (POEM) has been developed as a further endoscopic effective and minimal invasive treatment. The aim of this study is to investigate the efficacy and safety of POEM in our department, and to assess short-term and long-term efficacy of POEM by using Stooler score, Echardt score, esophageal barium and manometry.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed as achalasia according to symptoms, esophageal barium,manometry and esophagogastroduodenoscopy
* Age over 18 years old
* Signed written informed consent

Exclusion Criteria:

* Patients with previous surgery of the stomach or esophagus
* With known coagulopathy
* Active esophagitis,eosinophilic esophagitis or Barrett's esophagus
* Pregnancy
* Stricture of the esophagus
* Hiatal hernia \> 2cm

Primary outcomes:
measure: symptom relief
timeFrame: 1-12months
measure: Lower esophageal sphincter pressure
timeFrame: 1-12months
measure: improvement of esophageal barium
timeFrame: 1-12 months
measure: Postoperative complications
timeFrame: 0-12months
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
Study officials:
affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Tingsheng Ling
role: PRINCIPAL_INVESTIGATOR
References:
citation: von Renteln D, Inoue H, Minami H, Werner YB, Pace A, Kersten JF, Much CC, Schachschal G, Mann O, Keller J, Fuchs KH, Rosch T. Peroral endoscopic myotomy for the treatment of achalasia: a prospective single center study. Am J Gastroenterol. 2012 Mar;107(3):411-7. doi: 10.1038/ajg.2011.388. Epub 2011 Nov 8.
citation: Inoue H, Minami H, Kobayashi Y, Sato Y, Kaga M, Suzuki M, Satodate H, Odaka N, Itoh H, Kudo S. Peroral endoscopic myotomy (POEM) for esophageal achalasia. Endoscopy. 2010 Apr;42(4):265-71. doi: 10.1055/s-0029-1244080. Epub 2010 Mar 30.
Clinical trial NCT04562584: Pulse Oximeter Hypoxia
Official title: Accuracy of Pulse Oximeters With Profound Hypoxia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oximetry
Keywords: myhomedoc
pulse oximetry
oximeter
Lead sponsor: MyHomeDoc Ltd.
Sponsor class: INDUSTRY
First posted: 2020-09-24
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this project is to test the accuracy of pulse oximeters (devices intended to measure oxygen saturation in blood noninvasively) during mild, moderate and severe hypoxia (a lower-than-normal concentration of oxygen in arterial blood); ie, a range of arterial HbO2 saturations from 100 to down to 70%. This is done by comparing the reading of the pulse oximeter during brief, steady state hypoxia with a gold-standard measurement of blood oxyhemoglobin (hemoglobin carrying oxygen) saturation, that is arterial blood sample processed in a laboratory.


Eligibility criteria: Inclusion Criteria:

1. The subject is male or female, aged ≥18 and \<50.
2. The subject is in good general health with no evidence of any medical problems.
3. The subject is fluent in both written and spoken English.
4. The subject has provided informed consent and is willing to comply with the study procedures.

Exclusion Criteria:

1. The subject is obese (BMI\>30).
2. The subject has a known history of heart disease, lung disease, kidney or liver disease.
3. Diagnosis of asthma, sleep apnea, or use of CPAP.
4. Subject has diabetes.
5. Subject has a clotting disorder.
6. The subject a hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation.
7. The subject has any other serious systemic illness.
8. The subject is a current smoker.
9. Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly.
10. The subject has a history of fainting or vasovagal response.
11. The subject has a history of sensitivity to local anesthesia.
12. The subject has a diagnosis of Raynaud's disease.
13. The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).
14. The subject is pregnant, lactating or trying to get pregnant.
15. The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures.
16. The subject has any other condition, which in the opinion of the investigators' would make them unsuitable for the study.

Primary outcomes:
measure: Saturation level measurement
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Hypoxia Research Laboratory Department of Anesthesia and Perioperative Care University of California
state: California
Study officials:
affiliation: University of California, San Francisco
name: Philip E Bickler, Ph.D., M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02409784: PET Study of Cerebral Metabolism of 11C-acetoacetate and 18F-FDG in Patients Under Moderate Ketosis
Official title: PET Study of Cerebral Metabolism of 11C-acetoacetate and 18F-FDG in Patients Under Moderate Ketosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Brain metabolism
Ketones
Ketogenic diet
TEP scan
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2015-04-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Ten participants received a very high fat ketogenic diet (KD) (4.5:1; lipid:protein plus carbohydrates) for four days.
Primary purpose: BASIC_SCIENCE

Brief summary: Regional brain glucose hypometabolism occurs during aging and may contribute to the onset of aging-related cognitive impairment in humans. Ketones are the main alternative energy substrate to glucose for the brain. Several studies show that brain ketone uptake and metabolism are unaltered in cognitively-normal older persons and in Alzheimer's disease (AD). Nutritional ketosis is reported to have a positive impact on cognitive performances in mild cognitive impairment and AD. Nevertheless, changes in regional brain glucose and ketone uptake in adults are poorly understood during diet-induced experimental ketosis. The investigators hypothesis was that during diet-induced ketosis, brain ketone uptake would be directly correlated with the elevation of blood ketone levels and inversely correlated to brain glucose uptake.


Eligibility criteria: Inclusion Criteria:

* Healthy adults
* No signs of cognitive impairment

Exclusion Criteria:

* Not within the age limits
* Pregnancy or breast feeding
* Incapacity to withstand a supine position for 40 min
* Non lacunar infarction
* Known psychiatric history of schizophrenia, psychotic disorders, major affective disorders (bipolar disorder and major depression \<5 years), panic disorder, obsessive compulsive disorders and other conditions that may affect memory
* Epilepsy, brain trauma with loss of consciousness, subarachnoid hemorrhage
* History of alcool and/or substances abuse (excessive alcool consumption ≥10 drinks/weeks)
* Parkinson disease
* Down syndrome
* Inflammatory disease
* Abnormal blood pressure, liver or kidney function, blood count
* Dyslipidemia, hypothyroidism, osteoporosis
* Presence of a metal object in the body

Primary outcomes:
measure: Mean in Cerebral Metabolic Rate of Acetoacetate Before or After 4 Days of Ketogenic Diet
timeFrame: At baseline (approximatively 1 month before the onset of the diet) and right after a 4 days ketogenic diet
measure: Mean in Cerebral Metabolic Rate of Glucose Before or After 4 Days of Ketogenic Diet
timeFrame: At baseline (approximatively 1 month before the onset of the diet) and right after a 4 days ketogenic diet
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Université de Sherbrooke
name: Stephen C Cunnane, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01777984: Impact of Visceral Fat on the Pathogenesis of Age-related Macular Degeneration
Official title: Impact of Visceral Fat on the Pathogenesis of Age-related Macular Degeneration
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Age-related Macular Degeneration
Lead sponsor: Rudolf Foundation Clinic
Sponsor class: OTHER
First posted: 2013-01-29
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with age-related macular degeneration, over 60

Brief summary: The purpose of this study is to determine the relationship among the body fat distribution, especially the visceral fat, in patients with age-related macular degeneration in comparison to patients with a normal fundus.

Detailed description: In this study the investigators want to examine the relationship among visceral fat, serum leptin levels, and high-sensitive CRP (hsCRP), Tnf-alpha, Amyloid alpha and Amyloid Beta serum levels in patients with age-related macular degeneration in comparison to patients with a normal fundus.

Eligibility criteria: Inclusion Criteria:

* man and women over 18 years old
* filled informed consent
* diagnosis of age-related macular degeneration

Exclusion Criteria:

* inherited retinal disease
* other acquired retinal macular disease
* missing informed consent

Primary outcomes:
measure: visceral fat ratio
timeFrame: 1 day
Secondary outcomes:
measure: Leptin, Amyloid, TNF alpha, CRP
timeFrame: 1 day
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Rudolf Foundation Clinic
Study officials:
affiliation: Rudolf Foundation Clinic
name: Susanne Binder
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02031484: Comparison of Continuous Sternal ECG Patch Monitors (Carnation and Zio) Trial
Official title: Comparison of Continuous Sternal ECG Patch Monitors (Carnation and Zio) Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Syncope
Presyncope
Palpitations
Atrial Fibrillation
Supraventricular Tachycardia
Lead sponsor: Bardy Diagnostics, Inc.
Sponsor class: INDUSTRY
First posted: 2014-01-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in Chicago, Charlotte, and Iowa under the care of a physician for symptoms listed in the inclusion criteria

Brief summary: This study is intended to compare the new Carnation patch monitoring system with the Zio patch, which represents the current standard for continuous recording of the ECG over extended periods.

Detailed description: The purpose of this research is to confirm the clinical value of a new P-wave sensitive recording vector combined with an easy-to-use long-term cardiac rhythm monitoring patch system, the CarnationTM Ambulatory Monitoring (CAM) System. The P-wave is a critical aspect of the electrocardiogram and a key finding for proper arrhythmia diagnosis. The CAM system is optimized for both ease of use and for maximum P-wave clarity for arrhythmia diagnosis.

Eligibility criteria: Inclusion Criteria:

* Syncope of uncertain etiology or
* Pre-syncope of uncertain etiology or
* Palpitations of uncertain etiology or
* Management of known AF/SVT patients

Exclusion Criteria:

* Any dermatitis or infected skin over the sternum (Carnation patch) or left upper anterior thorax (Zio patch).
* A sternal or thoracic incision that extends under the patch within 3 months from the date of enrollment

Primary outcomes:
measure: ECG signal quality
timeFrame: 14 days
Secondary outcomes:
measure: Device comfort
timeFrame: 14 days
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Charlotte
country: United States
facility: Mid Carolina Cardiology
state: North Carolina
city: Kirkland
country: United States
facility: Eastside Cardiology
state: Washington
Study officials:
affiliation: Mid Carolina Cardiology
name: Mark Kremers, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03480984: Continuous Versus Intermittent Bolus Infusion of Paravertebral Blocks for Thoracic Surgery
Official title: A Comparison Between Continuous Versus Intermittent Bolus Infusion of Paravertebral Blocks for Thoracic Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thoracic Diseases
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-03-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The researchers are trying to determine pain medication consumption in the first 24 hours after surgery in patients given the standard continuous infusion of local anesthetic versus patients given the same total dose via programmed intermittent dosing. Both groups will receive the option of patient controlled pain medication as well as the same dose of pre-programmed pain medication. The only difference is the rate of administration: continuous vs. hourly intervals.


Eligibility criteria: Inclusion Criteria:

* Documentation of planned thoracic surgery for which a paravertebral catheter is indicated based on surgeon request as well as appropriateness of location of surgical site.
* Ability for subject to comply with the requirements of the study.

Exclusion Criteria:

* Pregnancy.
* Coagulopathy at time of evaluation or surgery.
* Infection at the site of needle insertion.
* Allergy to local anesthetic.
* Patient refusal.
* Chronic opioid use

Primary outcomes:
measure: Opioid consumption 24 hours postoperatively
timeFrame: first 24 hours postoperatively
Secondary outcomes:
measure: Opioid consumption 48 hours postoperatively
timeFrame: first 48 hours postoperatively
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Elird Bojaxhi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03262584: Evaluation of NGS for Detection and Follow-up of Fungal Pathogens in Immunocompromised Pediatric Patients
Official title: Evaluation of NGS for Detection and Follow-up of Fungal Pathogens in Immunocompromised Pediatric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Invasive Fungal Disease
Fever and Neutropenia
Invasive Fungal Infections
Immunocompromised
Lead sponsor: Karius, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Ann & Robert H Lurie Children's Hospital of Chicago
First posted: 2017-08-25
Enrollment: 40
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: Pediatric patients treated at Ann \& Robert H. Lurie Children's Hospital of Chicago on the hematology, oncology, neuro-oncology and stem cell transplant unit

Brief summary: The Sponsor hypothesize that Next-generation Sequencing (NGS) can identify fungal pathogens, is more accurate than other noninvasive options and can report fungal genomic load.

Detailed description: The Sponsor aims to describe the incidence of positivity for fungal specific pathogens on NGS analysis in a high-risk immunocompromised pediatric population.

Secondarily, the Sponsor will correlate results of the NGS analysis to other approved fungal tests if performed at the discretion of the treating provider (e.g. blood culture results, radiographic findings, biopsy results, bronchoalveolar lavage findings, galactomannan results or b-D-glucan (BG) results as evaluated via FDA-approved "Fungitell" assay). The Sponsor will use these other fungal tests, in addition to clinical criterion, to classify subjects as having possible, probable and proven IFD according to established criteria, and compare these categories against results from NGS analysis.

Lastly, to quantitatively evaluate follow-up test results to determine fungal DNA genomic load in subjects with positive results.

Eligibility criteria: Inclusion Criteria:

* Prolonged FN (≥96 hours) despite broad-spectrum antibiotic therapy with anticipated delayed neutrophil recovery
* Any findings that trigger the primary team to consider new fungal infection in a given inpatient, such as abnormal imaging results, recrudescent fevers in the setting of neutropenia or characteristic skin rashes

Exclusion Criteria:

-Those without concern for fungal infection or those currently being treated for a presumed or documented fungal infection will not be recruited for this study

Primary outcomes:
measure: Incidence of positivity for fungal specific pathogens on NGS analysis
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
Study officials:
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: Amy Armstrong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03232684: Rapid On-site Evaluation of Endobronchial Ultrasound Guided Transbronchial Needle Aspiration Samples by Pulmonologists
Official title: Rapid On-site Evaluation of EBUS-TBNA Samples From Intrathoracic Lymphadenopathy; Can it be Reliably Performed by a Pulmonologist?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intrathoracic Lymphadenopathy
Lead sponsor: Maggiore Bellaria Hospital, Bologna
Sponsor class: OTHER
First posted: 2017-07-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with enlarged intratoracic lymph nodes

Brief summary: The study is aimed at verifying if a pulmonologist in training can reliably assess the adequacy of EBUS-TBNA samples from intrathoracic lymphadenopathy after a period of training provided by an experienced pathologist.


Eligibility criteria: Inclusion Criteria:

* Indication to sampling of intrathoracic lymphadenopathy based on computed tomography (CT) and/or positron emission tomography (PET)/CT findings
* Signed informed consent

Exclusion Criteria:

* High risk conditions for the performance of bronchoscopy and endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA)
* High risk condition for deep sedation (ASA 4)
* Pregnancy

Primary outcomes:
measure: Accuracy with which the pulmonologist will identify inadequate EBUS-TBNA samples
timeFrame: Up to 1 week
Secondary outcomes:
measure: Accuracy with which the pulmonologist will be able, in case of adequate EBUS-TBNA sample, to assign the specimen to one of the following specific diagnoses: 1) reactive lymph node; 2) malignancy; 3) granulomatous inflammation
timeFrame: Up to 1 week
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Maggiore Hospital
state: Emilia Romagna
Study officials:
affiliation: Policlinico S. Orsola & Maggiore Hospitals
name: Rocco Trisolini, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Trisolini R, Cancellieri A, Tinelli C, Paioli D, Scudeller L, Casadei GP, Forti Parri S, Livi V, Bondi A, Boaron M, Patelli M. Rapid on-site evaluation of transbronchial aspirates in the diagnosis of hilar and mediastinal adenopathy: a randomized trial. Chest. 2011 Feb;139(2):395-401. doi: 10.1378/chest.10-1521. Epub 2010 Oct 28.
citation: Bonifazi M, Sediari M, Ferretti M, Poidomani G, Tramacere I, Mei F, Zuccatosta L, Gasparini S. The role of the pulmonologist in rapid on-site cytologic evaluation of transbronchial needle aspiration: a prospective study. Chest. 2014 Jan;145(1):60-65. doi: 10.1378/chest.13-0756.
Clinical trial NCT05772884: Healthy Aging Through Movement
Official title: The Potential of Exercise to Reduce Pain and Enhance Mobility in Mid-life Adults Undergoing Opioid Use Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Keywords: Pain
Exercise
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants receive the same (single) intervention.
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to examine the effectiveness of a supervised aerobic exercise program for persons with Opioid Use Disorder (OUD). Participants will be enrolled in a 12-week supervised aerobic exercise intervention.

Detailed description: The overall project goals are to test the feasibility and acceptability of our aerobic exercise intervention with this population. Study participation will include a screening and enrollment phase, a baseline assessment, and a 12-week intervention. Participants will be recruited and consented by University of Florida (UF) study staff.

Eligibility criteria: Inclusion Criteria:

* Adults must be aged 21-64 years old
* Currently enrolled in OMT (opioid maintenance treatment) or present with at least mild opioid use disorder (endorses at least 2 DSM-V criteria for OUD within a 12-month period),
* Insufficiently physically active (defined as exercising \< 20 minutes 3 times/week
* Able to understand and speak English
* Have a body mass index 18.5-40 kg/m\^2
* Willing and able to visit research center up to one time time/week for 12 weeks
* Participants will undergo a supervised maximal exercise test and physical exam by medical supervisor to be cleared for participation.

Exclusion Criteria:

* Participants must not have heart disease, or had a stroke, uncontrolled diabetes, thyroid condition an eating disorder
* An uncontrolled major psychiatric condition (e.g., schizophrenia; conditions that are well-controlled, however \[e.g., anxiety controlled through therapy\] will not be exclusionary), or other medical condition(s) that contraindicate exercise; and may not be participating in a structured exercise training or weight loss program.
* Participants cannot be pregnant; pregnancy is exclusionary
* One individual per household may enroll.

Primary outcomes:
measure: Recruitment feasibility
timeFrame: Baseline up to 4 weeks
measure: Intervention adherence
timeFrame: Up to 13 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Meredith S Berry, PhD
role: PRINCIPAL_INVESTIGATOR
References: