louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06237478: Effects of Glycopyrrolate on Heart Rate and Heart Rate Variability in Patients With Different Basic Heart Rate
Official title: Effects of Glycopyrrolate on Heart Rate and Heart Rate Variability in Patients With Different Basic Heart Rate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glycopyrrolate
Keywords: Glycopyrrolate
Heart rate
Heart rate variability
Autonomic nervous system
Lead sponsor: Yangzhou University
Sponsor class: OTHER
First posted: 2024-02-01
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Glycopyrrolate is an anticholinergic medication commonly used in respiratory medicine for treating chronic obstructive pulmonary disease (COPD), bronchial asthma, and other conditions . In the perioperative period, it is often administered before anesthesia to reduce secretions in the salivary glands, bronchi, and pharynx . It is used during the recovery period to counteract the muscarinic effects of anticholinesterase inhibitors and can also be employed to prevent/treat vagal reflexes and related arrhythmias induced by surgery or medications .

Heart rate (HR) is influenced by both the sympathetic and parasympathetic nervous systems. The baseline HR of different patients may vary due to differing levels of sympathetic and parasympathetic nerve activity within the body. It remains unclear whether patients with different baseline HRs exhibit varying degrees of HR elevation after the administration of glycopyrrolate(i.e.,the parasympathetic activity in vivo is antagonized). The primary aim of this study is to explore the impact of glycopyrrolate administration on HR in patients with different baseline HRs. The secondary objective is to investigate the effects of glycopyrrolate on heart rate variability (HRV) in patients with different baseline HR.


Eligibility criteria: Inclusion Criteria:

* 1.Weight not restricted; 2.American Society of Anesthesiologists (ASA) status I or II; 3.The operative time≥1 h; 4.Undergoing orthopedic or urological surgery.

Exclusion Criteria:

* 1.allergy to glycopyrrolate; 2.laparoscopic surgery; 3.liver or kidney dysfunction; 4.pre-existing abnormal electrocardiogram such as bradycardia; 5.concomitant glaucoma; 6.patients refusal to participate.

Primary outcomes:
measure: The maximum increase of HR
timeFrame: before induction of general anesthesia; 10 min after operation beginning; 30 min after glycopyrrolate injection
measure: the maximum increase ratio of HR
timeFrame: before induction of general anesthesia; 10 min after operation beginning; 30 min after glycopyrrolate injection
Secondary outcomes:
measure: HRV frequency indexes
timeFrame: before induction of general anesthesia; 10 min after operation beginning; 30 min after glycopyrrolate injection
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: the Affiliated Hospital of Yangzhou University, Yangzhou University
state: Jiangsu
Study officials:
References:
Clinical trial NCT03084978: Conscious Sedation vs General Anesthesia in TAVR Patients
Official title: Randomized Prospective Study in Transcatheter Aortic Valve Replacement Patients- Conscious Sedation VS. General Anesthesia Examining the Effect on Operative Time
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Aortic Stenosis
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2017-03-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled trial investigating the effect of general anesthesia versus conscious sedation on operative times in patients undergoing transcatheter aortic valve replacement.


Eligibility criteria: Inclusion Criteria:

1. Signed informed consent, signed Health Insurance Portability and Accountability Act (HIPAA) documentation)
2. Age over 18 years of age.
3. Women of child bearing age must have a negative urine or serum pregnancy test.
4. Clinical indication for a transfemoral aortic valve replacement.
5. English or Spanish speaking
6. No evidence of neurological impairment as defined by a NIHSS ≤ 1 and modified Rankin scale (mRS) ≤ 2 within 7 days prior to randomization.

Exclusion Criteria:

1. BMI \> 40
2. Diagnosis of severe obstructive sleep apnea based on previous polysomnography, with severe defined as an apnea-hypopnea index (AHI) \>30 episodes/hr.
3. High risk for aspiration such as severe esophageal disease (e.g. achalasia, gastroparesis, etc).
4. Inability to lie supine for more than 30 minutes.
5. Marginal femoral vessels with concern for possible conversion to transapical or transaortic access.
6. Patient refusal
7. Patient involved in another research study
8. Psychiatric condition precluding ability to provide informed consent
9. History of clinical stroke within 3 months prior to randomization

Primary outcomes:
measure: Time-on-table
timeFrame: <1 day
Secondary outcomes:
measure: Number of patients with serious adverse events
timeFrame: within 30 days
measure: Length of stay
timeFrame: within 30 days
measure: Readmissions
timeFrame: within 30 days
measure: Number of Patients with Valve Complications
timeFrame: within 30 days
measure: Contrast usage
timeFrame: <1 day
measure: Fluoroscopy time
timeFrame: <1 day
Other outcomes:
measure: Post-procedure Complications
timeFrame: within 30 days
measure: Quality of Life
timeFrame: Procedure start to 30 days
Locations:
Study officials:
affiliation: Montefiore Medical Center
name: Joseph DeRose, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brecker SJ, Bleiziffer S, Bosmans J, Gerckens U, Tamburino C, Wenaweser P, Linke A; ADVANCE Study Investigators. Impact of Anesthesia Type on Outcomes of Transcatheter Aortic Valve Implantation (from the Multicenter ADVANCE Study). Am J Cardiol. 2016 Apr 15;117(8):1332-8. doi: 10.1016/j.amjcard.2016.01.027. Epub 2016 Jan 28.
Clinical trial NCT02330978: Intravitreal Mesenchymal Stem Cell Transplantation in Advanced Glaucoma.
Official title: Intravitreal Autologous Bone Marrow-derived Mesenchymal Stem Cell Transplantation in Patients With Advanced Glaucoma. Phase I: Safety Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Retinal Degeneration
Primary Open-angle Glaucoma
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2015-01-05
Enrollment: 2
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Bone marrow-derived mesenchymal stem cells (MSC) therapy is a promising treatment for several degenerative diseases, including retinopathies and glaucoma, however no previous safety study involving humans has been conducted. The objective of this study is to evaluate effects of autologous bone marrow-derived MSC transplantation in the worst eye of 10 patients with legal bilateral blindness due to glaucoma. Primary outcome are types and severity of adverse effects. Secondary outcomes are changes in visual field, visual acuity, optical coherence tomography, and retinal ganglion cells function.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Advanced Bilateral Open-Angle Glaucoma;
* Best corrected visual acuity less than 0,1 in the better eye;
* Social and cognitive ability to participate.

Exclusion Criteria:

* Severe systemic morbidities;
* Other ocular blind conditions associated;
* Impossibility in performing any of the proposed examinations.

Primary outcomes:
measure: Type and Severity of Adverse Effects (AE) and Adverse Reactions (AR)
timeFrame: 6 months
Secondary outcomes:
measure: Changes in Visual Acuity
timeFrame: 6 months
measure: Changes in Visual Field
timeFrame: 6 months
measure: Changes in Optical Coherence Tomography Parameters Related to Glaucoma
timeFrame: 6 months
measure: Changes in Retinal Ganglion Cells Function by ERG
timeFrame: 6 months
Other outcomes:
Locations:
city: Ribeirao Preto
country: Brazil
facility: Ribeirão Preto Medical School
state: Sao Paulo
Study officials:
affiliation: Associate Professor
name: Jayter S Paula, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vilela CAP, Messias A, Calado RT, Siqueira RC, Silva MJL, Covas DT, Paula JS. Retinal function after intravitreal injection of autologous bone marrow-derived mesenchymal stromal cells in advanced glaucoma. Doc Ophthalmol. 2021 Aug;143(1):33-38. doi: 10.1007/s10633-021-09817-z. Epub 2021 Jan 19.
Clinical trial NCT02375178: Antimicrobial Activity of Two Mouthwashes
Official title: Antimicrobial Activity of Two Mouthwashes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periimplantitis
Dental Plaque
Periodontal Diseases
Caries
Oral Surgical Wound Infection
Keywords: anti-infective agents
local/therapeutic use
chlorhexidine
dental desinfectants
polyhexamethylene biguanide
mouthrinse
Lead sponsor: Universidade do Vale do Sapucai
Sponsor class: OTHER
First posted: 2015-03-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a three arm randomized trial. The aim is to evaluate the antimicrobial activity of chlorhexidine and polyhexamethylene biguanide oral antiseptics on the microorganisms of the oral cavity. A total of 30 healthy volunteers will be enrolled and randomly allocated to control group (CG, n=10), which will be instructed to rinse the mouth with 10ml of a sterile saline solution for one minute, to chlorhexidine group (ClG, n=10), which will be instructed to rinse the mouth with 10ml of an 0.12% chlorhexidine solution, for one minute, or to polyhexamethylene biguanide group (PG, n=10), which will be instructed to rinse the mouth with 10ml of an 0.07% polyhexamethylene biguanide solution, for one minute. Samples of saliva will be collected before the mouth wash and after 30, 60 and 180 minutes. Samples will be plated on manitol agar, mitis salivarius agar, EMB agar and Sabouraud agar. Samples will be processed by a blinded microbiologist.


Eligibility criteria: Inclusion Criteria:

* patients aged 18-30 years

Exclusion Criteria:

* patients with a hypersensitivity or allergic response by some component of the formula antiseptics,
* pregnant women,
* lactating,
* history of periodontal disease,
* smoking,
* decompensated diabetics,
* patients undergoing chemotherapy,
* radiotherapy patient,
* transplanted patient and refuses to participate,
* not signing a term of free and informed concentiment

Primary outcomes:
measure: Number of Colony Forming Units
timeFrame: 180 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Universidade do Vale do Sapucai
name: Daniela Veiga, MD,PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00620178: Atacand (Candesartan) Real Life Study
Official title: A REtrospective Study on the Effects of cAndesartan vs. Losartan on Blood Pressure, Health Care Consumption and cardiovascuLar Events In a "Real-liFe" GP sEtting in Sweden
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: candesartan
losartan
blood pressure
cardiovascular disease
health care consumption
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-02-21
Enrollment: 14000
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible subjects are all patients found in EPS systems at the participating centres, who were prescribed candesartan (ATC-C09CA06) or losartan (C09CA01) for hypertension from 1 January 1999 - 31 December 2004 inclusive. The first found prescription is designated as index.

Brief summary: This study is a Swedish historical cohort study in patients prescribed Atacand or Cozaar for hypertension by selected primary care centres. Data will be extracted anonymously from electronic medical records. In addition, data regarding morbidity and mortality will be collected by merging the cohort with the following national registries: the Hospital Discharge Register (Slutenvårdsregistret), the Cause of Death Register and the Heart Intensive Care Admission (RIKS-HIA)


Eligibility criteria: Inclusion Criteria:

* Recorded blood pressure prior to therapy of \> 140 and/or 90 mmHg
* Diagnosed as hypertensive within 15 months
* First prescription of Cozaar or Atacand between 1 January 1999 and 31 December 2007, inclusive

Exclusion Criteria:

* Previous prescription within 15 months any drug from the ATC groups C02, C03, C07 - C09 inclusive

Primary outcomes:
measure: The primary efficacy objective is to investigate, on basis of 'first to event', the development of new cardiovascular diseases (CVD).
timeFrame: 1999 - 2007
Secondary outcomes:
measure: Cardiovascular disease states and procedures in the background and over the entire observation period will be identified by use of ICD-9 and ICD-10 coding for diseases of the cardiovascular system. Specifically are death, acute cardiovascular events, new
timeFrame: 1999 - 2007
measure: Health care consumption will be assessed as contacts with health care providers, in-hospital time periods for cardiovascular disease states with associated therapeutic procedures, and times spent within various levels of care (e.g. ICU and general ward).
timeFrame: 1999 - 2007
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Research Site
Study officials:
affiliation: Eriksbergs vårdcentral
name: Jan Stålhammar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01790178: Ultrasound in Muscle Biopsy
Official title: Outcomes of Ultrasound-guided Versus Blind Core Muscle Biopsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopathy
Myositis
Muscular Dystrophy
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2013-02-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The objective of the proposed study is to evaluate the clinical utility of muscle ultrasonography for improving the diagnostic yield and safety of core muscle biopsy. Our facility currently uses core (needle) biopsy to obtain muscle samples in patients 18 years old or older. Currently, there is no imaging tool used to guide the actual biopsy. As muscle biopsy is an invasive and potentially painful procedure, improving the diagnostic yield of this test is important.


Eligibility criteria: Inclusion Criteria:

* Consecutive subjects scheduled for a biopsy at our EMG laboratory will be asked if they would like to participate until a total of 40 participants are obtained.

Exclusion Criteria:

* Age under 18 years.
* Inability to provide consent for participation.

Primary outcomes:
measure: Amount of Tissue Obtained
timeFrame: At time of biopsy
measure: Number of Patients Receiving Diagnosis From Muscle Biopsy
timeFrame: At time of biopsy
Secondary outcomes:
measure: Number of Participants With Adverse Events Related to Muscle Biopsy
timeFrame: Patient involvement limited to the time of biopsy; Records analyzed up to 10 months after biopsy
measure: Number of Times Biopsy Needle Was Inserted to Obtain Biopsy Tissue
timeFrame: At time of biopsy
measure: Number of Participants With Inadequate Biopsy Samples
timeFrame: At time of pathology review
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Lisa D. Hobson-Webb, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00750178: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK0683 in Patients With Advanced Cancer (0683-008)
Official title: A Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK0683 in Patients With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer, Advanced
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-09-10
Enrollment: 30
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, tolerability, pharmacokinetics, and pharmacodynamics of MK0683 in patients with advanced cancer.


Eligibility criteria: Inclusion Criteria:

* Patients 18 years or older
* Must agree to consume high fat meal and agree to fasting conditions
* Limit alcohol consumption

Exclusion Criteria:

* Patient has a history of drug or alcohol abuse within 5 years of start of study
* Patient is known to have HIV
* Patient has participated in another investigational study within 4 weeks of start of study
* Patient cannot stop taking certain medications or herbal remedies
* Patient will require immunologic, radiation, surgery, or chemotherapy during the study
* Patient requires frequent blood transfusions
* Female patient is pregnant or nursing
* Patient has an active Hepatitis B or C infection

Primary outcomes:
measure: Safety, tolerability, and PK of MK0683
timeFrame: 28 Days
Secondary outcomes:
measure: Urinary excretion of MK0683
timeFrame: 28 days
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Rubin EH, Agrawal NG, Friedman EJ, Scott P, Mazina KE, Sun L, Du L, Ricker JL, Frankel SR, Gottesdiener KM, Wagner JA, Iwamoto M. A study to determine the effects of food and multiple dosing on the pharmacokinetics of vorinostat given orally to patients with advanced cancer. Clin Cancer Res. 2006 Dec 1;12(23):7039-45. doi: 10.1158/1078-0432.CCR-06-1802.
Clinical trial NCT04525378: MSC-based Therapy in COVID-19-associated Acute Respiratory Distress Syndrome
Official title: Mesenchymal Stromal Cell-based Therapy for COVID-19-associated Acute Respiratory Distress Syndrome: a Pilot Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Covid19
ARDS, Human
Lead sponsor: D'Or Institute for Research and Education
Sponsor class: OTHER
First posted: 2020-08-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Considering the potential of mesenchymal stromal cells (MSCs) in the treatment of lung injuries by COVID-19, this pilot clinical trial evaluates the safety and potential efficacy of the cell therapy, administered intravenously, in patients with pneumonia associated with COVID-19-associated acute respiratory distress syndrome.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of COVID-19 confirmed by RT-PCR;
* Thorax CT image suggestive of viral pneumonia;
* Respiratory failure (SaO2 \<93% with O2 at 5L / min)
* Tracheal intubation (first 48 h);

Exclusion Criteria:

* Pregnancy or breastfeeding;
* Patients with a history of cancer, chemotherapy in the past 2 years;
* Life expectancy less than 6 months or in exclusive palliative care;
* Severe liver failure, with Child-Pugh score\> 12;
* High probability of death in the following 48 h;
* Previous renal failure: patients who were already on dialysis or patients with RFG \<30ml / min / 1.73 m2;
* Clinical or radiological suspicion of tuberculosis and bacterial pneumonia.

Primary outcomes:
measure: Intrahospital mortality
timeFrame: 28 days
Secondary outcomes:
measure: Length of stay in the ICU and Hospital
timeFrame: 28 days
measure: Days without mechanical ventilation in 28 days
timeFrame: 28 days
measure: PaO2 / FiO2 ratio
timeFrame: Day 1, Day 2 and Day 7 after cell infusion
measure: Incidence of secondary infections
timeFrame: 28 days
measure: Incidence of adverse events
timeFrame: 28 days
measure: Quantification of inflammatory response markers
timeFrame: Day 1, Day 3 and Day 7 after cell infusion
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Hospital São Rafael
state: Bahia
Study officials:
References:
Clinical trial NCT00855478: French Post-Marketing Surveillance Survey
Official title: French Post-Marketing Surveillance Survey
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Coronary Artery Disease
Lead sponsor: Cordis Corporation
Sponsor class: INDUSTRY
First posted: 2009-03-04
Enrollment: 4080
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: To assess the safety and effecacy of the Cypher stent ™ \& Cypher Select ™ in the normal use of medical practices, within the labeled indications.

Detailed description: Multi-center, retrospective and prospective French register. This register does not impose any constraint on the evaluated population, the procedure, or the required examinations. The local practice routines should be applied.

Eligibility criteria: Inclusion Criteria:

* Patients with symptomatic ischemic heart disease due to de novo lesions (lesions \<30 mm vessel reference diameter of 2.25 mm to 5 mm), assessed visually, native coronary arteries.

Exclusion Criteria:

* Patients suffering from coronary heart disease.
* Patients for whom treatment antiplatelet and / or anticoagulant is against the state;
* Patients with injuries incompatible with the full inflation of a balloon angioplasty;
* Transplant patients ;
* Patients with known allergy to Sirolimus, the stainless steel 316L, to polymethacrylates or copolymers polyolefins;

Primary outcomes:
measure: There is no pre-specified endpoint.
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: