louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01747460: Pulse Oximetry_Performance Testing- PCBA-1 (Printed Circuit Board Assembly)
Official title: Controlled Acute Hypoxia Studies Using a Bedside Respiratory Patient Monitoring System With the Functional Patient Monitoring PCBA-1
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Subjects
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2012-12-11
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy Subjects

Brief summary: To determine accuracy specifications of the Pulse oximeter.


Eligibility criteria: Inclusion Criteria:

1. Male or female subjects between the ages of 18 to 50 years (inclusive).
2. Must undergo a physical examination by a licensed physician, advanced practice nurse or physician assistant, including a 12 lead ECG, a medical history, and a blood test checking complete blood count and screening for sickle cell trait or disease
3. All female volunteers must have a negative urine pregnancy test prior to participation.

Exclusion Criteria:

1. Pregnancy or lactating women
2. Unexplained syncopal episodes
3. Hypertension (defined as a systolic pressure of \>145 mmHg or a diastolic pressure \>90 mm Hg on three consecutive readings)
4. Premature ventricular contractions (PVC's) that are symptomatic or occur at a rate of more than 5/minute
5. History of seizures (except childhood febrile seizures) or epilepsy
6. Routine use of tranquilizers and/or excessive anxiety
7. History of frequent headaches or migraines
8. History of stroke
9. Previous injury or trauma to fingers or hands that may change blood flow or vascular supply and affect our ability to test multiple sensors
10. History of "altitude sickness" defined as headaches, malaise or dizziness when in the mountains or in an aircraft at altitude significantly above sea level for a prolonged period of time (\> 1 hour)
11. History of significant respiratory disease, such as severe asthma, emphysema, etc.
12. Sickle cell disease or trait.
13. The use of medications, pre-existing medical conditions, treatment for a medical condition or any other reason deemed relevant by the clinician conducting the study.
14. Abnormal ECG finding
15. Prior or known allergies to lidocaine (or similar pharmacologic agents, e.g., Novocain)
16. Prior or known allergies to heparin.
17. History of transient ischemic attacks or carotid artery disease
18. History of myocardial ischemia, angina, myocardial infarction, congestive heart failure or cardiomyopathy
19. History of chronic renal impairment
20. History of recent arterial cannulation (less than 1 month prior to study)
21. History of complications from previous arterial cannulation
22. Current use of blood thinners

Primary outcomes:
measure: SpO2 Accuracy (percentage of blood oxygen saturation)
timeFrame: Duration of subject visit- approx. 1.5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Boulder
country: United States
facility: Covidien
state: Colorado
Study officials:
References:
Clinical trial NCT04322760: Lidocaine 5% Patch Supplementation to Intra-articular Bupivacaine Dexmedetomidine After Arthroscopic Knee Surgery
Official title: Effect of Lidocaine 5% Patch Supplementation to Intra-articular Bupivacaine Dexmedetomidine After Arthroscopic Knee Surgery Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dexmedetomidine
Lidocaine 5% Patch
Arthroscopic Knee Surgery
Intra-articular
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-03-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients were allocated into 2 groups, 20 patients in each received 10 ml 0.5 % bupivacaine and 1µg/kg dexmedetomidine diluted in 10 ml saline injected intra-articularly; group A: no patch, group B: a patch of lidocaine 5% was applied to the skin.
Primary purpose: TREATMENT

Brief summary: Surgery of the knee is a very common procedure which can be very painful and sufficient postoperative pain treatment is often problematic. The aim of this work was to study the effects of supplementation of intra-articular bupivacaine dexmedetomidine with lidocaine 5% patch after arthroscopic knee surgery under general anesthesia and its role in improving quality of anesthesia.


Eligibility criteria: Inclusion Criteria:

* Adult patients
* ASA I \& II
* Aged between 18 to 60 years
* Weight between 60 to 100 kg
* Scheduled for elective arthroscopic knee surgery

Exclusion Criteria:

* patient refusal.
* history of cardiac disease.
* impaired renal or hepatic function.
* hypertension treated with α methyldopa, clonidine, or beta-adrenergic blockers.
* if they have used opioid analgesics within the previous 24 hr.
* previous sensitivity to local anesthetics.

Primary outcomes:
measure: The total dose of postoperative pethidine consumption
timeFrame: 24 hours
Secondary outcomes:
measure: First postoperative analgesia request time
timeFrame: 24 hours
measure: Pain intensity
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01933360: Misoprostol for Cervical Priming Prior to Vacuum Aspiration
Official title: Sublingual Versus Vaginal Misoprostol for Cervical Dilatation 1 or 3 Hours Prior to Surgical Abortion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: First Trimester Pregnancy
Surgical Termination of Pregnancy
Keywords: Misoprostol
First trimester pregnancy
Surgical abortion
Cervical priming
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2013-09-02
Enrollment: 184
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Despite of the widespread use, and extensive studies, the optimal route of administration of misoprostol before surgical abortion remains to be defined. Following administration of 400 mcg vaginally as per clinical guidelines, the time for optimal priming seems to be 3 hours, but the longer the interval the greater the risk or bleeding and expulsion of the uterine contents before the surgical evacuation. Sublingual administration seems to give adequate plasma concentration and cervical priming faster than oral or vaginal administration. This may allow a shorter waiting time with maintained efficacy, less side effects and logistic advantages.


Eligibility criteria: Inclusion Criteria:

* women opting for first trimester surgical abortion
* nulliparous
* able and willing to provide informed consent

Exclusion Criteria:

* unwilling to participate,
* unable to communicate in Swedish and English and
* minors (i.e. women \< 18 years of age),
* contraindications to misoprostol
* women with pathological pregnancies

Primary outcomes:
measure: Force needed for cervical dilatation
timeFrame: Measured at surgery
Secondary outcomes:
measure: Cervical diameter
timeFrame: Measured at surgery
measure: Number of Participants with Adverse Events
timeFrame: Up to surgery
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska Institutet
name: Kristina Gemzell Danielsson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Saav I, Kopp Kallner H, Fiala C, Gemzell-Danielsson K. Sublingual versus vaginal misoprostol for cervical dilatation 1 or 3 h prior to surgical abortion: a double-blinded RCT. Hum Reprod. 2015 Jun;30(6):1314-22. doi: 10.1093/humrep/dev071. Epub 2015 Apr 2.
Clinical trial NCT05772260: Autonomic Dysfunction and Hemodynamic Instability During Per-oral Endoscopic Myotomy
Official title: Effect of Autonomic Dysfunction on Hemodynamic Instability During Per-oral Endoscopic Myotomy in Achalasia Patients: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Achalasia
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients who are scheduled to undergo per-oral endoscopic myotomy in Gangnam Severance Hospital will be eligible.

Brief summary: This prospective observational study aims to investigate the association between the autonomic dysfunction and hemodynamic instability during per-oral endoscopic myotomy under general anesthesia in achalasia patients. Per-oral endoscopic myotomy is known as the effective treatment for achalasia patients. During per-oral endoscopic myotomy, capnoperitoneum, capnomediastinum, and systemic CO2 accumulation can potentially impair hemodynamics. Moreover, it has been suggested that achalasia is associated with autonomic dysfunction. We hypothesized that patients with autonomic dysfunstion would esperience more hemodynamic instability during per-oral endoscopic myotomy compared with patients without autonomic dysfunction. In this prospective observational study, the autonomic function test will be performed before surgery, and advanced hemodynamic parameters will be recorded using EV1000 clinical platform (Edwards Lifesciences, USA) during surgery. The association between the autonomic dysfunction and hemodynamic instability during per-oral endoscopic myotomy will be analyzed.


Eligibility criteria: Inclusion Criteria:

1. Patients who are scheduled to undergo per-oral endoscopic myotomy in Gangnam Severance Hospital
2. Patients aged ≥ 19 years

Exclusion Criteria:

1. Patients who are hemodynamically unstable before surgery
2. Patients in whom preoperative heart rate variability (HRV) test cannot be conducted
3. Pregnant women of breastfeeding women
4. Patients unable to read the informed consent form

Primary outcomes:
measure: Wobble of Systolic Arterial Pressure (SAP) during surgery
timeFrame: During the intraoperative period, from the enterance to the operating room to the emergence of anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: GangnamSeverance Hospital
Study officials:
References:
citation: Saugel B, Vokuhl C, Pinnschmidt HO, Rosch T, Petzoldt M, Loser B. Cardiovascular dynamics during peroral endoscopic myotomy for esophageal achalasia: a prospective observational study using non-invasive finger cuff-derived pulse wave analysis. J Clin Monit Comput. 2021 Aug;35(4):827-834. doi: 10.1007/s10877-020-00541-8. Epub 2020 Jun 5.
Clinical trial NCT01343160: Removable GORE VIABIL® Biliary Endoprosthesis for Treatment of Benign Biliary Strictures
Official title: Multicenter Study of Removable GORE VIABIL® Biliary Endoprosthesis for Treatment of Benign Biliary Strictures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Biliary Strictures
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2011-04-27
Enrollment: 43
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: The purpose of this study is to generate clinical data to support the use of GORE® VIABIL® Biliary Endoprosthesis in the endoscopic and percutaneous treatment of benign biliary strictures.


Eligibility criteria: Inclusion Criteria:

* Subject is diagnosed with treatable benign biliary stricture which necessitates the need for implantation of a biliary endoprosthesis
* Subject is ≥18 years of age
* Subject is able to comply with study protocol and follow-up requirements
* Written informed consent is obtained using the Investigational Review Board (IRB)/Ethics Committee (EC) approved consent form

Exclusion Criteria:

* Subject anatomy ruling out covered self expanding metal stent use (e.g. above hilar region)
* Treatment of stricture would require placement of a covered biliary endoprosthesis within a previously placed bare metal stent
* The subject has malignant biliary disease
* Subject has known pregnancy
* Participated in protocol involving investigational drug or device within 90 days prior to entry into this study

Primary outcomes:
measure: Safe Stent Removal
timeFrame: Upon Removal
Secondary outcomes:
Other outcomes:
measure: Primary Device Patency
timeFrame: 12 Months
measure: Successful Delivery and Deployment
timeFrame: Upon Implant
measure: Successful Treatment of Benign Stricture Upon Implant
timeFrame: Upon implant
measure: Secondary Patency
timeFrame: 12 Months
measure: Viability of Treatment
timeFrame: Upon Removal
measure: Secondary Patency Post Study Device Removal
timeFrame: 15 Months
measure: Primary Patency of Treated Stricture
timeFrame: 15 Months
Locations:
city: Ludwigsburg
country: Germany
facility: Klinikum Ludwigsburg
Study officials:
affiliation: Klinikum Ludwigsburg
name: Karel Caca, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02894060: A Study of Immunological Biomarkers as Predictors of Cardiovascular Events
Official title: A Study of Immunological Biomarkers as Predictors of Cardiovascular Events
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Abnormalities
Keywords: Cardiovascular events
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2016-09-09
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Cardiovascular disease linked to atherosclerosis (e.g. infarcts, cerebro-vascular accidents) are one of the main causes of mortality in the general population. The recruitment of macrophages from the walls of the arterial lumen followed by unregulated capture of oxidated LDL (LDLox) leads to the accumulation of cholesterol esters and the formation of foamy cells characteristic of fatty streaks, the first phase of atherogenesis. These fatty streaks are rarely followed by clinical events, but can progress to complicated atheromatoses (calcification, rupture) resulting in the occurrence of various clinical events such as myocardial infarction and cerebro-vascular accidents (CVA). Once oxidated, LDL becomes immunogenic and induces anti-LDLox antibody production that could be markers of progression of atherosclerosis. During LDL oxidation, a multitude of specific oxidative epitopes (SOE) such as oxidated phospholipids (PLox) and malondialdehyde-lysine epitopes (MDA) are generated. In order to measure the level of markers in the blood, researchers developed a series of immunologic levels in vitro, using specific antibodies directed against well-defined epitopes. Recently, it was shown that Lp(a ) would be the preferred transporter of these PLox. In fact, several clinical studies show a strong correlation between PLox/apoB concentrations and Lp(a). This marker (PLox/apoB) predicts future morbidity and mortality due to cardiovascular diseases, including CVA, up to 15 years in advance, independent of all other known risk factors. CD36 is a scavenger receptor that recognizes LDLox, but more specifically PLox present in these lipoproteins .One soluble form of inflammatory CD36 (sCD36) was recently identified. In this study, only healthy volunteers were recruited in order to be able to establish normal serum ranges of different immunologic biomarkers.


Eligibility criteria: Inclusion Criteria:

* Healthy adults
* Persons providing signed informed consent
* Persons with healthcare coverage

Exclusion Criteria:

* Renal disease
* Cardiovascular disease
* Auto immune disease
* Pregnancy in progress
* Infection
* Dementia
* Persons under legal protection
* Malnutrition

Primary outcomes:
measure: Blood level of immunologic biomarker PLox/apoB
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Michel ANDREJAK, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02238860: A Trial Comparing Entacavir and Tenofovir in Patients With HBV Decompensated Cirrhosis
Official title: A Randomised Trial Comparing Entacavir and Tenofovir in Patients With HBV Decompensated Cirrhosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cirrhosis Due to Hepatitis B
Keywords: Hepatitis B
cirrhosis
Entacavir
enofovir
Lead sponsor: Asian Institute Of Medical Sciences
Sponsor class: OTHER
First posted: 2014-09-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Entacavir and tenofovir are two first line therapies for chronic hepatitis B. Both agents have been claimed equivalent in treatment, there are no head to head trials available in the literature about there effectiveness in HBV Decompensated Cirrhosis. The investigators aimed to compare safety/efficacy and virological response in patients with HBV Decompensated Cirrhosis.

Detailed description: The effectiveness of entacavir and tenofovir has not been prospectively studied in HBV Decompensated cirrhosis? This prospective, randomised clinical trial will help us in better patient management more efficacy and cost effectiveness.

Eligibility criteria: Inclusion Criteria:

* Age (18 years- 70 years)
* Hbv surface antigen positive \> 6 months
* HbeAg (positive or negative both)
* Hbv DNA 10\^3
* ALT ULN
* No evidence of HCC
* Platelets count \> 30 thousands
* CTP score \> 7
* Hepatic encephalopathy (grade 1 - 2 only)
* No prior Drug resistance

Exclusion Criteria:

* Age \< 18 years
* HCC patients
* Prior drug resistance
* Current HE \> 2
* Solid organ transplantation
* Inadequate hematological function
* Co infection with hepatitis C and HIV
* Autoimmune disorders
* Pregnancy and Breast feeding
* Other hepatic diseases
* Patients on immunosuppressant or chemotherapy agents

Primary outcomes:
measure: Safety and efficacy
timeFrame: 48 weeks
Secondary outcomes:
measure: Safety
timeFrame: 48 weeks
Other outcomes:
measure: Outcome
timeFrame: 48 weeks
Locations:
city: Hyderabad
country: Pakistan
facility: Asian Institute of medical Sciences
state: Sindh
Study officials:
affiliation: AIMS Institute
name: Mohammad sadik Memon, Fcps gastro
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01982760: DDAVP in the Reduction of Post-operative Ecchymosis in Rhinoplasty
Official title: A Prospective Randomized Trial for the Use of DDAVP in the Reduction of Post-operative Ecchymosis in Rhinoplasty.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Postoperative Ecchymosis
Keywords: Rhinoplasty
Ecchymosis
Edema
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2013-11-13
Enrollment: 14
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: TREATMENT

Brief summary: This is study looking at the use of a medication, Desmopressin acetate (DDAVP), to reduce bleeding, swelling, and bruising in patients undergoing cosmetic nose surgery. DDAVP is a drug used in patients with bleeding disorders. It works by activating molecules in the blood stream called platelets that promote clotting. In the study, participants who are have cosmetic nose surgery (rhinoplasty) will be randomly assigned to receive or not receive medication. Photographs taken before and shortly after surgery will be evaluated for the amount of bruising and swelling. Patients with heart, lung, kidney, or liver problems are not eligible to participate.


Eligibility criteria: Inclusion Criteria:

* Undergoing Rhinoplasty where nasal bone osteotomy is necessary

Exclusion Criteria:

* Heart Disease
* Renal Disease with decreased GFR
* Liver Disease

Primary outcomes:
measure: Reduction in Ecchymosis and Swelling
timeFrame: surgery to 8 days post-operatively
Secondary outcomes:
measure: Patient Behavior Factors
timeFrame: Surgery to 3 weeks post-operatively
Other outcomes:
Locations:
city: Lyndhurst
country: United States
facility: Lyndhurst Surgery Center
state: Ohio
Study officials:
affiliation: University Hospitals
name: Bahman Guyuron, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00001176: Effects of Salt Intake on the Nervous Systems of Patients With Salt-Sensitive High Blood Pressure
Official title: The Function of Dopaminergic and Noradrenergic Systems in Salt-Sensitive Hypertension: The Effects of Changes in Sodium Intake
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperaldosteronism
Hypertension
Keywords: Adrenergic Nervous System
Dopaminergic Nervous System
Salt-Sensitive Hypertension
Hypertension
Primary Aldosteronism
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 1999-11-04
Enrollment: 110
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: Some patients with high blood pressure can experience an increase of blood pressure by 10 percent or more by taking in salt. These patients are referred to as having "salt-sensitive" (SS) hypertension.

Previous studies conducted on patients with salt sensitive hypertension suggest that their portion of the nervous system responsible for maintaining normal blood pressure (autonomic nervous system) may respond differently to salt than patients with non-salt sensitive (NSS) hypertension.

This study is designed to examine the response of the nervous system to high doses of salt in patients with salt-sensitive hypertension and patients with non-salt sensitive hypertension.

Detailed description: A subset of patients with idiopathic hypertension shows an increase in blood pressure of 10 percent or more in response to salt-loading and have been termed "salt-sensitive" (SS). Limited studies of adrenergic function in response to salt-loading suggest that the response of SS patients may differ from that of non-salt sensitive (NSS) patients. The present studies were designed to examine the response of the adrenergic and dopaminergic systems to salt-loading in SS and NSS patients with idiopathic hypertension.

Eligibility criteria: Eligibility criteria not identified in protocol.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Heart, Lung and Blood Institute (NHLBI)
state: Maryland
Study officials:
References:
citation: Kawasaki T, Delea CS, Bartter FC, Smith H. The effect of high-sodium and low-sodium intakes on blood pressure and other related variables in human subjects with idiopathic hypertension. Am J Med. 1978 Feb;64(2):193-8. doi: 10.1016/0002-9343(78)90045-1.
citation: Fujita T, Henry WL, Bartter FC, Lake CR, Delea CS. Factors influencing blood pressure in salt-sensitive patients with hypertension. Am J Med. 1980 Sep;69(3):334-44. doi: 10.1016/0002-9343(80)90002-9. No abstract available.
citation: Alexander RW, Gill JR Jr, Yamabe H, Lovenberg W, Keiser HR. Effects of dietary sodium and of acute saline infusion on the interrelationship between dopamine excretion and adrenergic activity in man. J Clin Invest. 1974 Jul;54(1):194-200. doi: 10.1172/JCI107743.