louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02652351: Human Umbilical Cord-Mesenchymal Stem Cells for Hepatic Cirrhosis
Official title: Safety and Efficacy Study of Human Umbilical Cord-Mesenchymal Stem Cells for Hepatic Cirrhosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Hepatic Cirrhosis
Keywords: Stem cell
Human Umbilical Cord Mesenchymal Stem Cell
Mesenchymal Stem Cell
Hepatic Cirrhosis
Lead sponsor: Shenzhen Hornetcorn Bio-technology Company, LTD
Sponsor class: INDUSTRY
Collaborators: name: The Second Hospital University of South China
First posted: 2016-01-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC) for Hepatic Cirrhosis.

Detailed description: Human umbilical cord mesenchymal stem cells exhibit the potential to differentiate into mature cells typical of several tissues, which have been confirmed in in vivo and in vitro experiments. There have been few clinical reports describing umbilical cord mesenchymal stem cells for treatment of Hepatic Cirrhosis.

To investigate the effects of hUC-MSC treatment for Hepatic Cirrhosis, 20 patients with Hepatic Cirrhosis will be enrolled and receive 4 times of hUC-MSC transplantation.

Eligibility criteria: Inclusion Criteria:

* The patient who have signed the informed consent document;
* Clinical, radiological, or biochemical evidence of liver cirrhosis.

Exclusion Criteria:

* Pregnant women or lactating mothers;
* Patients who have received any anti-inflammatory drugs including herb-drug within 14 days;
* Patients who received any drug by intra-articular injection for treatment within 2 months prior to this enrollment;
* Patients with positive human immunodeficiency (HIV) at screening indicative of current of pass infection;
* Abnormal blood coagulation, combine other tumor or special condition;
* Patients who had participated in other clinical trials within three months prior to this study.

Primary outcomes:
measure: Severity of adverse events
timeFrame: 12 months
Secondary outcomes:
measure: Hepatic function
timeFrame: 1, 3 ,6 and 12 months
measure: Liver fibrosis index
timeFrame: 1, 3 ,6 and 12 months
Other outcomes:
Locations:
city: Hengyang
country: China
facility: The second Affiliated Hospital of University of Soth China
state: Hunan
Study officials:
affiliation: The second Affiliated Hospital of University of Soth China
name: Gang Chen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02745951: HELIox CardiOPlegia Trial During Cardiac surgERy
Official title: HELIox CardiOPlegia Trial During Cardiac surgERy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: C.Surgical Procedure; Cardiac
Keywords: cardiopulmonary bypass
cardioplegia
cardioprotection
coronary artery bypass graft surgery
heliox
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2016-04-20
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The HELICOPTER-1 Trial is a single centre pilot study to determine the feasibility of administering Heliox in cardioplegia during cardiac surgery and whether it has the potential to reduce the incidence and severity of myocardial ischemia during and after cardiac surgery.

Detailed description: The HELICOPTER-1 Trial is a single centre, randomized trial evaluating the feasibility of administration of Heliox for prevention of myocardial ischemia in patients undergoing cardiac surgery. Half of the study population will be randomly assigned to the receive cardioplegia enriched with a 70:30 (Helium:Oxygen) Heliox mixture, while the other half will be randomized to receive the current clinical standard of care (nitrogen and oxygen in cardioplegia).

Subjects will be followed up daily during their post-operative course in hospital for clinical outcomes. A 30-day phone follow-up will be conducted for vital status and MI.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Cardiac surgery with CPB where use of a coronary sinus catheter is indicated

Exclusion Criteria:

* Patient refusal
* Recent myocardial infarction (less than 7 days old)
* Left ventricular ejection fraction less than 30%
* Known pregnancy on date of surgery

Primary outcomes:
measure: Feasibility of using Heliox to oxygenate the blood cardioplegia
timeFrame: 30 days from the intervention
Secondary outcomes:
measure: New Myocardial Infarction
timeFrame: 30 days from the intervention
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: David Mazer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05266651: Efficiency of Tadalafil for Management of Female Sexual Dysfunction
Official title: Efficiency of Tadalafil for Management of Female Sexual Dysfunction in Females With Genital Mutilation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Sexual Dysfunction
Keywords: female genital mutilation
Sexual dysfunction
Clitoral artery Doppler
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2022-03-04
Enrollment: 24
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: comparative study between tadalafil versus placebo effect for the management of circumsized female

Detailed description: the group of patient will be randomly divided into 2 groups, half of the patients will receive tadalafil and the other half will receive placebo

Eligibility criteria: Inclusion Criteria:

* female with history of female genital mutilation female with history of sexual dysfunction

Exclusion Criteria:

* any medical disorder

Primary outcomes:
measure: clitorial Artery Doppler
timeFrame: after one month duration of drug use
measure: Clitorial artery doppler
timeFrame: after one month duration of drug use
measure: Clitorial artery doppler
timeFrame: after one month duration of drug use
Secondary outcomes:
measure: score of sexual function
timeFrame: after on month of the drug use
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Elainy
Study officials:
References:
Clinical trial NCT00000451: Drug Therapy for Alcohol Dependence in Alaska Natives (Naltrexone/Sertraline)
Official title: Naltrexone and SSRI Therapy for Alcohol Dependence in Alaska Natives
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcoholism
Alcohol Dependence
Keywords: Alcoholism
Alcohol Dependence
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 1999-11-03
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the ability of naltrexone (Revia) to reduce the risk of relapse in Alaska natives with alcohol dependence. The study will also examine whether a combination of naltrexone and sertraline (Zoloft) yields better abstinence rates than naltrexone used alone. Alaska Native individuals will be recruited into a 16 week outpatient study.


Eligibility criteria: Inclusion Criteria:

* Alaska Native having biological Alaska Native ancestry.
* Meets criteria for alcohol dependence.
* Prior to entering the study must be abstinent between 3 and 14 days and have a withdrawal assessment.
* Stable residence to ensure that subjects can be located during the study.

Exclusion Criteria:

* Currently meets criteria for abuse or dependence on substances other than alcohol or nicotine.
* Current use of disulfiram.
* Psychotic or otherwise severely psychiatrically disabled.
* Use of other psychotropic medications including antidepressants and anxiolytics.
* Medical conditions that would not permit the use of sertraline or naltrexone, such as a history of unstable or severe hepatic, cardiovascular, metabolic, endocrine, gastrointestinal or kidney disease.
* Hepatocellular disease or elevated bilirubin levels.
* Females who are pregnant, nursing, or not using a reliable method of birth control.
* Probation or parole requirements that might interfere with participation in the study.
* Involvement in alcohol treatment other than provided by the study or AA.
* Use of monoamine oxidase inhibitors in the past month.
* Current use of Type 1C antiarrhythmics propafenone and flecainide.

Primary outcomes:
measure: Days abstinent
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
state: Connecticut
Study officials:
affiliation: Yale University
name: Dr. Stephanie O'Malley
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05451251: Deep Brain Stimulation for Refractory Trigeminal Neuralgia with a Pontine Lesion
Official title: Deep Brain Stimulation for Refractory Trigeminal Neuralgia with a Pontine Lesion: a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Trigeminal Neuralgia
Keywords: Multiple sclerosis
Deep brain stimulation
Pontine lesion
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2022-07-11
Enrollment: 6
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 aim of this study is to assess the feasibility of deep brain stimulation for refractory trigeminal neuralgia due to a pontine lesion, as is usually seen in the context of multiple sclerosis.

These patients usually have severe intractable facial pain and current medical and surgical options generally fail to achieve long lasting pain relief.

Hoping to improve pain control in this population, the investigators of this trial propose a novel technique consisting of implanting a deep brain stimulation lead within the pontine lesion to modulate the generation of pain signals.


Eligibility criteria: Inclusion Criteria:

* Adults of at least 18 years old
* Refractory trigeminal neuralgia : failure of at least 3 drugs and at least two lesioning surgical interventions (radiosurgery, percutaneous rhizotomy, or open rhizotomy).
* Pontine lesion proved by MRI in contact with trigeminal nerve tract

Exclusion Criteria:

* Absolute contraindication to MRI
* Medical contraindication to the procedure

Primary outcomes:
measure: Demonstrating the feasibility of the intervention by assessing protocol completion without deviation
timeFrame: 24 months
Secondary outcomes:
measure: Lead implantation accuracy
timeFrame: 24 months
measure: Pain evolution
timeFrame: 24 months
measure: Facial numbness
timeFrame: 24 months
measure: Complications
timeFrame: 24 months
measure: Quality of life progression
timeFrame: 24 months
measure: Patient acceptability of the procedure
timeFrame: 24 months
measure: Patient global impression of change
timeFrame: 24 months
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke (CHUS)
state: Quebec
Study officials:
References:
Clinical trial NCT01457651: Comparison of Four Different Recruitment Maneuvers in Patients After Coronary Surgery
Official title: Comparison of Different Types of Postoperative Pulmonary Recruitment and Predicting Its Efficacy Following Off-pump Coronary Artery Bypass Grafting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxemia
Recruitment
Keywords: Recruitment
Coronary artery bypass grafting
Postoperative period
Lead sponsor: Northern State Medical University
Sponsor class: OTHER
Collaborators: name: Regional hospital of Arkhangelsk
First posted: 2011-10-24
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The risk of respiratory failure after cardiac surgery is high, and it may result in many complications. The maneuver of alveolar recruitment may improve the oxygen transport in the human organism. The investigators compare three different types of alveolar recruitment in patient after cardiac surgery, to reveal which one is better.

Detailed description: The study compares three different approaches to alveolar recruitment maneuvers in the immediate postoperative period after off-pump coronary bypass grafting.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 75
* Off-pump coronary artery bypass grafting
* Possibility to discontinue respiratory support in the first day after intervention

Exclusion Criteria:

* Signs of ARDS
* COPD in decompensation phase
* Requirement for inotropic support(epinephrine \>0,1 mcg/kg/hr)
* Bronchiectases
* Pregnancy
* Morbid obesity
* Aortic aneurism
* AMI in previous month

Primary outcomes:
measure: Respiratory support
timeFrame: 24 hrs
Secondary outcomes:
measure: The incidence of postoperative atelectasis
timeFrame: 24 hrs
measure: Incidence of reintubation
timeFrame: 24 Hrs
measure: Oxygenation
timeFrame: 12 hrs after extubation
measure: Length of ICU and hospital stay
timeFrame: 28 Days
Other outcomes:
Locations:
city: Arkhangelsk
country: Russian Federation
facility: City hospital # 1
state: Arkhangelsk region
Study officials:
affiliation: Northern State Medical University
name: Mikhail Y. Kirov, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00751751: Olmesartan Medoxomil Versus Losartan in Elderly and Very Elderly
Official title: Comparison of the Efficacy of Olmesartan Medoxomil Versus Losartan on Diastolic Blood Pressure in Elderly and Very Elderly Patients With Essential Hypertension.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Essential Hypertension
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2008-09-12
Enrollment: 441
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the efficacy of individually optimized doses of olmesartan medoxomil compared to losartan in elderly and very elderly patients with essential hypertension. The study hypothesis is non-inferiority of olmesartan medoxomil compared to losartan in lowering mean sitting diastolic blood pressure after 12 weeks of treatment compared to baseline. The study duration is up to 60 weeks, including a 52-week treatment period. After 12 weeks of treatment hydrochlorothiazide may be added to control blood pressure. Efficacy and safety measurements are carried out at up to 18 visits during the trial.


Eligibility criteria: Inclusion Criteria:

* Age 65 years or older
* Mean sitting diastolic BP = 100-114 mmHg and mean sitting systolic BP \>=150 mm HG

Exclusion Criteria:

* Secondary hypertension
* Malignant hypertension
* Severe heart failure (NYHA III-IV)
* History or evidence of renal disease
* Recent history of myocardial infarction
* Hypersensitivity to study drugs
* History of drug or alcohol abuse

Primary outcomes:
measure: Change in mean sitting diastolic blood pressure assessed by conventional BP measurements
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in mean sitting diastolic BP assessed by conventional BP measurements
timeFrame: after 1, 2, 4, 8, 16, 20, 28, 36, 44, and 52 weeks
measure: Change in mean standing diastolic BP, mean sitting systolic BP and mean standing systolic BP
timeFrame: after 1, 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52 weeks
Other outcomes:
Locations:
city: Darmstadt
country: Germany
Study officials:
affiliation: IMFORM GmbH
name: Peter U Witte, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02237651: Topical Anesthesia / Bronchoscopy
Official title: Topical Nasopharyngeal Anesthesia in Outpatient Bronchoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Equally of Delivery Systems of Local Anesthesia in Bronchoscopy
Keywords: anesthesia
bronchosocopy
lung transplantation
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2014-09-11
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients after lung transplantation

Brief summary: The primary aim of this study is to compare a simplified single-use product (LMA® MAD Nasal™ Intranasal Mucosal Atomization Device, Teleflex medical, Kernen Germany) for topical nasopharyngeal anesthesia in comparison to a multi-use device (Laryngeal atomizer, Karl Storz, Tuttlingen, Germany in terms of patient self-rated nasopharyngeal symptoms.

Detailed description: Patients included in the first half of the study (topical anesthesia with the Laryngeal atomizer) and with need for another bronchoscopy in the second half of the study (topical anesthesia with the Intranasal Mucosal Atomization Device) will be asked to repeat the questionnaire after the second bronchoscopy to allow in-patient comparison.

Description of the primary efficacy analysis and population:

The primary endpoint of patient self-rated anesthesia by visual analogue scale after topical nasopharyngeal anesthesia for bronchoscopy.

Eligibility criteria: Inclusion Criteria:

* patients after lung transplantation (single, double or combined)
* Informed consent
* outpatient bronchoscopy

Exclusion Criteria:

* Oxygen requirement at rest
* Need for peri-interventional sedation
* limited German language skills or other reasons which might impair patient communication or computer handling

Primary outcomes:
measure: Equally
timeFrame: 30 min.
Secondary outcomes:
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Dep. Respiratory Medicine, Hannover Medical School
Study officials:
affiliation: Hannover Medical School
name: Thomas Fuehner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fuehner T, Fuge J, Jungen M, Buck A, Suhling H, Welte T, Gottlieb J, Greer M. Topical Nasal Anesthesia in Flexible Bronchoscopy--A Cross-Over Comparison between Two Devices. PLoS One. 2016 Mar 15;11(3):e0150905. doi: 10.1371/journal.pone.0150905. eCollection 2016.
Clinical trial NCT03922451: Pharmacokinetics of Antibiotics During Extracorporeal Membrane Oxygenation (ECMO) Support
Official title: Pharmacokinetics of Antibiotics During Extracorporeal Membrane Oxygenation (ECMO) Support
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Drug Effect
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2019-04-22
Enrollment: 4
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All pediatric patients who are supported on ECMO at Boston Children's Hospital Cardiac Intensive Care Unit (CICU) and receive piperacillin-tazobactam or cefazolin as part of routine care or infection management.

Brief summary: This study will measure plasma concentrations of piperacillin-tazobactam and cefazolin in pediatric patients supported with extracorporeal membrane oxygenation (ECMO) aiming to better understand the pharmacokinetics of these medications in this in vivo setting.


Eligibility criteria: Inclusion Criteria:

* supported on ECMO
* receive piperacillin-tazobactam or cefazolin as part of routine care or infection management

Exclusion Criteria:

* \>= 18 years
* No Consent provided

Primary outcomes:
measure: Plasma concentration: piperacillin-tazobactam
timeFrame: Peri drug dose administration until cessation of antibiotic therapy or cessation of ECMO support up to a maximum of 4 weeks.
measure: Plasma concentration: cefazolin
timeFrame: Peri drug dose administration until cessation of antibiotic therapy or cessation of ECMO support up to a maximum of 4 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT01912651: The Role of Antibiotics in Full Thickness Skin Graft Survival for Facial Reconstructive Surgery
Official title: The Role of Antibiotics in Full Thickness Skin Graft Survival for Facial Reconstructive Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Facial Defect
Keywords: facial skin wound
facial wound
skin wound
facial defect
reconstructive skin graft
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2013-07-31
Enrollment: 300
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: Antibiotics are sometimes prescribed to patients who have had reconstructive surgery of wounds on their face using skin grafts. But, it is not yet known whether antibiotics improve the healing of skin grafts and reduce the risk of infections after surgery in these patients. It is known that antibiotics, like all medications, have side-effects although these are rare. This research study is designed to show us whether antibiotics improve wound healing or not, so that we may determine if we should continue using antibiotics even if they have side-effects in some patients.

Our hypothesis is that patients treated with post-operative, systemic antibiotics will demonstrate a statistically significant improvement in the survival of their facial full thickness skin grafts compared to patients who are not treated with systemic antibiotics.


Eligibility criteria: Inclusion Criteria:

* all adult patients with a nasal or facial skin/soft tissue defect requiring reconstruction limited to or including a full-thickness skin graft

Exclusion Criteria:

* current or recent (within one week of surgery) systemic antibiotic use, intolerance to both clindamycin and cephalexin, discovery of a persistent cutaneous malignancy at the site of the defect following the reconstructive procedure and previous reconstruction at the site of the skin/soft-tissue defect.

Primary outcomes:
measure: Graft failure rate
timeFrame: 1 year
Secondary outcomes:
measure: Percentage surface area of graft failure
timeFrame: 1 year
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan Otolaryngology
name: Jeffrey Y Moyer, MD
role: PRINCIPAL_INVESTIGATOR
References: