louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05274984: Lidocaine Infusion for Propofol Dose Reduction in ERCP Procedure
Official title: Lidocaine Continuous Infusion for ERCP Procedures: a Prospective, Randomized, Double-blinded, Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Sedation
Lead sponsor: Iuliu Hatieganu University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2022-03-11
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to controll group or lidocaine group. Participants of control group are given placebo while participants of lidocaine group are given lidocaine.
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the dose reduction of propofol if associated with continuous infusion of lidocaine during ERCP procedures in patients over 65 years old.

Detailed description: The primary aim of this study was to evaluate the effect of continuous infusion of lidocaine on propofol consumption in older patients having ERCP sedation. Secondary outcomes were to evaluate patient adverse events, sedation quality and satisfaction of the patient and the endoscopist, postprocedural pain, and sedation-related time.For this the investigators randomised patients into 2 groups: Group Lidocaine received 1,5 mg/kg lidocaine 1% 10 min before procedure and then 2 mg/kg/h continuous infusion of lidocaine 1%, whereas the Group Control received an equal volume of saline solution, which could not be visually identified from lidocaine by the blinded anaesthesiologist. All patients received propofol bolus dose of 1mg/kg than 10-20 mg iv boluses during the procedure guided by capnograph monitoring and the patient's grimace, mobility, hemodynamic changes.

Eligibility criteria: Inclusion Criteria:

* 65-85 years old
* physical status ASA I, II, III,
* ERCP scheduled

Exclusion Criteria:

* ASA IV or higher
* severe renal, cardiac or liver failure,
* allergy to lidocaine,
* patients weighing less than 40 kg,
* inability to give informed consent

Primary outcomes:
measure: Propofol consumption between the 2 groups
timeFrame: During ERCP procedure
Secondary outcomes:
measure: Safety assessed by the rate of hypoxia during the procedure
timeFrame: During ERCP procedure
measure: Safety assessed by the rate of involuntary movement during the procedure
timeFrame: During ERCP procedure
measure: Lidocaine
timeFrame: During ERCP procedure
measure: Endoscopist satisfaction between 2 groups
timeFrame: After ERCP procedure
Other outcomes:
Locations:
city: Cluj-Napoca
country: Romania
facility: Regional Institute of Gastroenterology and Hepatology "Prof.dr.Octavian Fodor"
state: Cluj
Study officials:
affiliation: UMF Iuliu Hatieganu Cluj-Napoca
name: Daniela Ionescu, MD PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04965584: Microflora and Metabolomics of Crohn's Disease Patients
Official title: A Study Focused on the Microflora and Metabolomics of Crohn's Disease Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Crohn Disease
Keywords: Crohn's disease
microbiota
metabonomics
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2021-07-16
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Three different groups were created by healthy volunteers, patients with active Crohn's disease and patients with remission of Crohn's disease. The information of these individuals will be analyzed and some conclusions will be drawn.

Brief summary: The purpose of this study is to explore the microflora characteristics of different ecological loci and multiple metabolic pathways in Crohn's disease patients with different disease course states.

Detailed description: This study aims to investigate the characteristics of microflora in the oral and tongue base, small intestinal stomy and lower respiratory tract, as well as the characteristics of multiple metabolic pathways such as bile acid metabolism and amino acid metabolism in Crohn's disease patients with different course states.

Eligibility criteria: Inclusion Criteria:

1. individuals who were clear and signed the informed consent.
2. Male and female.

Exclusion Criteria:

1. Any one who can not provide accurate information.
2. Any one who denies the study.

Primary outcomes:
measure: Oral microbiota structure and function difference between active stage of Crohn's disease, remission of Crohn's disease and healthy controls
timeFrame: 3 months
measure: Small intestinal microbiota structure and function difference between active stage of Crohn's disease, remission of Crohn's disease and healthy controls
timeFrame: 3 months
measure: Sputum microbiota structure and function difference between active stage of Crohn's disease, remission of Crohn's disease and healthy controls
timeFrame: 3 months
Secondary outcomes:
measure: Metabolic difference of blood samples between active stage of Crohn's disease, remission of Crohn's disease and healthy controls
timeFrame: 3 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai 10th People's Hospital
state: Shanghai
Study officials:
References:
citation: Xia K, Gao R, Wu X, Sun J, Wan J, Wu T, Fichna J, Yin L, Chen C. Characterization of Specific Signatures of the Oral Cavity, Sputum, and Ileum Microbiota in Patients With Crohn's Disease. Front Cell Infect Microbiol. 2022 Apr 13;12:864944. doi: 10.3389/fcimb.2022.864944. eCollection 2022.
Clinical trial NCT01793584: Surgical Success After Laparoscopic vs Abdominal Hysterectomy
Official title: Randomized Trial of Laparoscopic Versus Abdominal Hysterectomy for Benign Indications and Impact on Surgical Success
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metrorrhagia
Menorrhagia
Leiomyoma
Adenomyosis
Pelvic Pain
Endometriosis
Pelvic Inflammatory Disease
Keywords: Comparative effectiveness
Surgical success
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2013-02-15
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of the proposed pilot study is to investigate the effectiveness, cost, safety, and long-term impact on quality of life of laparoscopic hysterectomy (LH) in relation to abdominal hysterectomy (AH) for the treatment of benign gynecologic disease in women through a randomized surgical trial.

Detailed description: The overall hypothesis is that neither mode of hysterectomy will be consistently superior to the other with respect to each of the three domains of complications, cost, and patient-centered outcomes. The overall goal of the study is to determine which clinically relevant factors may impact the choice of LH compared to AH. The results of the study may be useful for clinicians, patients, hospital administrators and health policy makers.

Eligibility criteria: Inclusion Criteria:

* Women undergoing hysterectomy for benign indications within 8 weeks of enrollment
* Women \>18 years of age
* Non-emergent surgery
* Non-pregnant

Exclusion Criteria:

* Candidate for vaginal hysterectomy
* Uterine size \>14 weeks by clinical exam OR \>300 mL by ultrasound measurement
* History of cancer of reproductive tract
* Requires concomitant pelvic organ prolapse (POP) surgery
* Requires surgery for urinary incontinence
* Has acute angle glaucoma
* Has severe cardiac/respiratory disease
* Desires supracervical hysterectomy

Primary outcomes:
measure: Quality of life
timeFrame: 1 year
Secondary outcomes:
measure: Cost
timeFrame: 1 year
measure: Complications
timeFrame: 1 year
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Parkland Hospital
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Kimberly Kho, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00821184: Behavioral Modification and Vesicare Versus Vesicare Alone for Urge Incontinence in Patients With Overactive Bladder
Official title: A Prospective Randomized Trial of Behavioral Modification and Solifenacin (Vesicare)vs Solifenacin (Vesicare) Alone for the Treatment of Urge Incontinence in Patients With an Overactive Bladder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Overactive Bladder
Keywords: urinary incontinence
overactive bladder
urinary frequency
Lead sponsor: Lahey Clinic
Sponsor class: OTHER
Collaborators: name: Astellas Pharma US, Inc.
First posted: 2009-01-13
Enrollment: 12
Sex: FEMALE
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 study will help determine if behavior modification performed in conjunction with oral Vesicare anticholinergic therapy is more effective for treating overactive bladder symptoms than oral Vesicare anticholinergic therapy alone.

Detailed description: Overactive bladder symptoms are commonly treated with oral anticholinergic medications that work by stopping muscles from tightening or behavioral modification. This study will help determine if behavior modification (fluid regulation, pelvic exercises, timed voiding) performed in conjunction wth oral Vesicare anticholinergic therapy, is more effective for treating overactive bladder symptoms than oral Vesicare anticholinergic therapy alone.

Eligibility criteria: Inclusion Criteria:

* Female patients \> 18 years of age
* OAB symptoms for \> 3 months
* Symptoms defined as greater than 3 episodes/week of an uncontrolled urge to void causing incontinence.
* May or may not be accompanied by urinary frequency
* May be accompanied by stress urinary incontinence where stress incontinence does not predominate

Exclusion Criteria:

* Male Patients
* Underlying cortical or spinal cord pathology including SCI, MS, or
* Parkinson's Disease
* Urinary retention with post-void residual \> 150cc
* Current treatment or treatment within the last 3 months with anticholinergic medications
* Patients not able to complete the questionaires or voiding diaries in English
* Pregnancy
* Active urinary tract infections
* Bladder Cancer or unevaluated hematuria
* Known diagnosis of narrow angle glaucoma
* Severe constipation
* History of reduced renal function (CrCl\<30ml/min)
* History of liver disease
* Current treatment with cytochrome P450 inhibitor medications

Primary outcomes:
measure: Change From Baseline in the Number of Incontinence Episodes Per 24 Hours Measured by Voiding Diaries.
timeFrame: 0 week - 12 weeks
Secondary outcomes:
measure: Improvement of Symptom Severity
timeFrame: 3 months
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
Study officials:
affiliation: Lahey Clinic
name: John T Stoffel, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06669884: Use of Determine Learning-based Cardiodynamicsgram (CDG) for Rapid and Precise Stratification of Chest Pain in Emergency Department
Official title: Use of Determine Learning-based Cardiodynamicsgram (CDG) for Rapid and Precise Stratification of Chest Pain in Emergency Department
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chest Pain
Acute Coronary Syndrome
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2024-11-01
Enrollment: 8000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who suffers from acute chest pain suspected with acute coronary syndrome (ACS)

Brief summary: Chest pain accounts for 10-20 percent of all emergency department visits. The stratification of chest pain is always a challenge. Electrocardiograms (ECG) have been used in clinical practice for 100 years, which is too important to be replaced due to its advantages of non-invasive, simple, rapid and inexpensive. ECG contains numerous signals derived from depolarization and repolarization of cardiomyocytes. However, the interpretation of ECG hasn't improved much in a hundred years. Based on determine-learning, Cong W's team developed an technique called "cardiodynamicsgram (CDG)", which is an outstanding method to identify myocardial ischemia. This study will further investigate the accuracy of CDG in stratification of patients with chest pain in Emergency department.


Eligibility criteria: Inclusion Criteria:

* aged 18 years or older
* Those with suspected ACS who have symptoms of acute chest pain, visiting in the emergency department

Exclusion Criteria:

* Those who diagnosed with ST-segment elevation myocardial infarction (STEMI)
* Those with hemodynamic instability (cardiogenic shock, cardiac arrest)
* Those with malignant arrhythmias(ventricular tachycardia, ventricular fibrillation, third-degree atrioventricular block)
* Those with aortic coarctation, or acute pulmonary embolism
* Those who has an unanalysable ECG report due to loosened leads, unstable baseline, or signal interference, etc.

Primary outcomes:
measure: The efficacy of CDG in the risk stratification of patients who have symptoms of acute chest pain suspected with acute coronary syndrome （ACS)
timeFrame: from the date of enrollment until the date of discharge, up to 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
affiliation: Qliu Hospital of Shandong University
name: Yuguo Chen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00267384: N-acetylcysteine Protects From Aminoglycosides Induced Nephrotoxicity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Drug Induced Nephrotoxicity
Keywords: Aminoglycosides
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2005-12-20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, double-blind, placebo-controlled clinical trial will be performed to assess the effect of N-acetylcysteine therapy on the incidence of nephrotoxicity among patients hospitalized with an infection and treated with aminoglycosides (AGs). Secondary goals of the study will be as follows: comparison of the mortality rates, and length of hospitalization among patients treated with N-acetylcysteine compared to the control group.


Eligibility criteria: Inclusion Criteria:

1. Patients hospitalized with presumptive gram-negative infection, as assessed by the treating house staff and requiring gentamycin therapy according to an infectious disease specialist decision.
2. Aged between 18 and 90.
3. Recruitment time between starting gentamycin therapy and initiation of the study intervention will be less than 24 hours.
4. Signed informed consent.

Exclusion Criteria:

1. Any known allergy or intolerance to one of the medications in the AG group.
2. Any known allergy or intolerance to N-acetylcysteine.
3. Any immunosuppressive therapy excluding steroid therapy.
4. Pregnancy.
5. HIV infection.
6. Non-sepsis-related neutropenia.
7. An estimated creatinine clearance of less than 30 mL/min.
8. Acute renal failure defined as elevation in creatinine level of 0.5 mg/dL above the patient's baseline.

Primary outcomes:
measure: The decrease in glomerular filtration rate (GFR)
Secondary outcomes:
Other outcomes:
Locations:
city: Beer-Sheva
country: Israel
facility: Soroka University Medical Center
Study officials:
affiliation: Internal Medicine Division, Soroka University Medical Center
name: Ohad Etzion, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Internal Medicine Division, Soroka University Medical Center
name: Victor Novack, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00142584: Evaluation of the Long-term Safety and Tolerability of Metoprolol Versus Nebivolol in Patients With Hypertension
Official title: An Open-label, Randomized Study Evaluating the Long-term Effects of Metoprolol (MET) Versus Nebivolol (NEB) as Monotherapy or in Combination With Amlodipine or Hydrochlorothiazide for the Treatment of Patients With Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: safety and tolerability study
hypertension
beta-blockers
Lead sponsor: Mylan Bertek Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-02
Enrollment: 336
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: The purpose of this study is to evaluate long-term safety,tolerability and blood pressure effects of metoprolol versus nebivolol in patients with hypertension. These drugs may be given alone or in combination with other drugs that are commonly used in the treatment of hypertension

Detailed description: Approximately 50 million Americans have hypertension defined as a systolic blood pressure (SBP) greater then or equal to 140 mmHg and/or a diastolic blood pressure (DBP) greater then or equal to 90 mmHg. To control blood pressure, more than 2 agents are required in many patients. The current study is a randomized, titration-to-effect, open-label, multi center study. Patients will be randomized to either nebivolol or metoprolol. The dose of the randomized treatment can be titrated as needed to achieve blood pressure control. If necessary, additional antihypertensive agents (calcium antagonist, diuretic, etc.) can be added to achieve control. Patients will be seen every 1-3 months for approximately 18 months to assess long-term safety, tolerability and effectiveness of nebivolol versus metoprolol.

Eligibility criteria: Inclusion Criteria:

* Completion of previous nebivolol study
* Stage 1-2 Hypertension (HTN) at baseline of first study

Exclusion Criteria:

* Recent myocardial infarction or stroke
* Contraindications to beta blocker therapy

Primary outcomes:
measure: Change in Average Sitting Diastolic Blood Pressure (DBP) Taken at Trough at the End of Treatment Compared to Baseline
timeFrame: Through study duration (approximately 18 months)
Secondary outcomes:
measure: Change From Baseline in Mean Trough Sitting Diastolic Blood Pressure (DBP) at Each Study Visit (Visits 1 Through 9) Compared to Baseline
timeFrame: Through study completion (approximately 18 months)
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: Through study completion (approximately 18 months)
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: Mylan Pharmaceuticals Inc.
state: West Virginia
Study officials:
affiliation: Mylan Pharmaceuticals Inc
name: Betty S Riggs, MD, MBA
role: STUDY_DIRECTOR
References:
Clinical trial NCT01883284: Action of Epigenetic Modifiers in Cystic Fibrosis Treatment
Official title: Action of Epigenetic Modifiers in Cystic Fibrosis Treatment: ex Vivo Model of Nasal Epithelium of CF Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Healthy Subjects
Keywords: Cystic Fibrosis
nasal epithelia
mucins
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2013-06-21
Enrollment: 39
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Epigenetic modifiers has been showed to rescue F508del-CFTR channel to apical membrane of epithelial cell lines. In this study, the investigators evaluate epigenetic modifiers effects firstly on CFTR rescue, then on secretion and synthesis of inflammatory factors (IL-8, LXA4 and SCGB1A1) and mucines (MUC5AC and MUC5B) in a dynamic epithelium model using an air-liquide interface culture of nasals cells from CF patients or controls.


Eligibility criteria: General inclusion criteria :

* informed consent
* benefit from disease insurance regimen
* men and women

Inclusion Criteria for CF patients

* 2 severe CF mutations
* age superior or equal to 12

Inclusion Criteria for controls :

* age superior or equal to 18
* no smoker (for 5 years)

General exclusion criteria :

* participation to an other interventionnal study
* subject in exclusion period
* law protected subject
* pregnant and breast fooding

Specific Exclusion Criteria:

* Xylocaine hypersensibility
* Porphyria
* severe hepatic failure
* Epilepsy
* Severe cardiac failure
* local anesthesic contra indication

Specific Control subject Exclusion Criteria:

* respiratory disease
* cystic fibrosis
* acute infection \< 6 weeks
* on treatment
* antibiotic treatment \< 3 months

Primary outcomes:
measure: Mature CFTR protein percentage variation after in vitro epigenetics modifiers treatment
timeFrame: 24 months
Secondary outcomes:
measure: Pro-inflammatory cytokines number variations after epigenetic modifiers treatment
timeFrame: 24 months
measure: Anti-inflammatory cytokines number variations after epigenetic modifiers treatment
timeFrame: 24 months
measure: Mucin composition variations after epigenetic modifiers treatment
timeFrame: 24 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Respiratory Diseases Department
Study officials:
affiliation: Arnaud de Villeneuve CHU Montpellier
name: Raphaël RC CHIRON, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01485484: Development and Validation of a NIRS-based Sinusitis Screening
Official title: Development and Validation of a NIRS-based Sinusitis Screening
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sinusitis
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Beckman Laser Institute University of California Irvine
First posted: 2011-12-05
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will be selected from outpatient clinic at Otolaryngology Clinic at the University of California, Irvine Medical Center.

Brief summary: The research at University of California Irvine, Beckman laser institute and Praxis Biosciences Incorporation, develope near-infrared trans-illumination methods. The optical imaging tool that can determine acute sinusitis and the response to treatment therapy.

Detailed description: In the United States, approximately one in seven people develop sinusitis each year, and 20 million cases of acute bacterial sinusitis become chronic to require medical treatment. The optic light from the illumination wand travelled through the pallet into the sinuses and exited the face. The optic device can determine air-filled and fluid/tissue-filled spaces in the sinus cavity during clinical exam.

Eligibility criteria: Inclusion Criteria:

* Male or female 18 years of age and older
* Subject with normal sinus
* Subject who has been diagnosed and confirm by their physician

Exclusion Criteria:

* Younger than 18 years old
* Pregnant women

Primary outcomes:
measure: Sinus Health
timeFrame: up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: UCI Beckman Laser Medical Clinic
state: California
Study officials:
affiliation: University of California, Irvine
name: Naveen Bhandarkar, MD
role: PRINCIPAL_INVESTIGATOR
References: