louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05574361: Continued Access Study to Evaluate Performance of the Organ Recovery Systems _LifePort® Liver Transporter System, a Machine Perfusion System, for Liver Transplant (PILOT™_CA)
Official title: A Prospective Multi-Center Continued Access Protocol for the Use of the LifePort® Liver Transporter (LLT) System With Vasosol® in Orthotopic Liver Transplants (PILOT™_CA: Perfusion to Improve Liver Outcomes in Transplantation_ Continued Access Arm)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Liver Transplantation
Lead sponsor: Organ Recovery Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2022-10-10
Enrollment: 120
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: To provide continued access for the LLT system to provide additional safety data in support of the PILOT pivotal efficacy and safety trial

Detailed description: To provide continued access for the LLT System with Vasosol® for the preservation of whole explanted livers, thereby providing additional safety data in support of the PILOT pivotal efficacy and safety trial

Eligibility criteria: * ≥18 years of age.
* Active on the United Network for Organ Sharing (UNOS) waiting list for liver transplantation.
* De novo liver transplant recipient.
* Written informed consent required.

Exclusion Criteria:

* Subject is a multi-organ transplant recipient.
* Subject is antibodies blood group (ABO) liver incompatible.
* Subject has severe systemic infection.
* Subject is Human Immunodeficiency Virus (HIV) positive.
* Subject has acute/fulminant liver failure.
* Subject is pregnant.

Primary outcomes:
measure: Early Allograft Dysfunction (EAD)
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Newark
country: United States
facility: Rutgers New Jersey Medical School
state: New Jersey
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
Study officials:
affiliation: Organ Recovery Systems
name: Stan Harris
role: STUDY_DIRECTOR
affiliation: Organ Recovery Systems
name: Matthew Copithorne
role: STUDY_CHAIR
References:
Clinical trial NCT00480961: Congestive Heart Failure Surgical Treatmment With Autologous Stem Cell Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Congestive Heart Failure
Lead sponsor: The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
Sponsor class: OTHER
First posted: 2007-06-01
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: This research study was designed to test the safety and effectiveness of autologous stem cell graft in the myocardium of patients with refractory Congestive Heart Failure (CHF) with ischemic etiology. Cellular implantation will take place during off-pump revascularization surgery or during an ad hoc procedure using a mini-thoracotomy access.

Detailed description: Primary target: determine the safety of introducing CD 34+ autologous progenitor cells (centrally grafted or mobilized in peripheral blood) in the myocardium of ischemic cardiac disease patients. Secondary target: determine clinical effects of grafted cells on remodeling pathology.

Eligibility criteria: Inclusion criteria

* Age \>18 y/o
* CHF with EF \> 35%
* Bilirubinemia, serum transaminase\> 2.5 times normal max level
* Creatininemia \> 2.5 times max level
* NYHA Class \> 3
* Negative pregnancy test (for women in fertile age)

Exclusion criteria

* Impossibility to harvest the bone marrow
* Pregnancy or breast-feeding
* History of malignant neoplasia in the 5-year period before the study (save for in-situ carcinoma of the cervix treated successfully and skin tumors - not melanomas)
* Incapability or unwillingness to comply with the envisaged treatment protocol, follow-up, or tests.

Primary outcomes:
measure: Primary target: determine the safety of introducing CD 34+ autologous progenitor cells (centrally grafted or mobilized in peripheral blood) in the myocardium of ischemic cardiac disease patients.
timeFrame: 1 YEAR
Secondary outcomes:
measure: Secondary target: determine clinical effects of grafted cells on remodeling pathology.
timeFrame: 1 YEAR
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: Ismett
state: PA
Study officials:
affiliation: The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
name: CESARE SCARDULLA, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02633761: Mifepristone-misoprostol vs. Misoprostol Alone for Second Trimester Fetal Death
Official title: Mifepristone and Misoprostol Versus Misoprostol Alone for Treatment of Fetal Death at 14-28 Weeks of Pregnancy: A Randomized, Placebo-controlled Double-blinded Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Fetal Death
Keywords: Fetal death
mifepristone
misoprostol
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
First posted: 2015-12-17
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim of this trial is to compare the efficacy of mifepristone-misoprostol versus misoprostol alone for treatment of intrauterine fetal demise between 14 and 28 weeks LMP.

Detailed description: The primary aim of this trial is to compare the efficacy of mifepristone-misoprostol versus misoprostol alone for treatment of intrauterine fetal demise between 14 and 28 weeks LMP. This will be a randomized controlled double-blinded trial of 150 women comparing misoprostol alone to mifepristone plus misoprostol for evacuation of the uterus after fetal demise in the second and third trimester. All women in the trial will undergo routine screening and pre-medical induction care per standard practice at the hospital.

All eligible women agreeing to participate in the study will be randomized to receive one of the following regimens:

1. STUDY GROUP ONE: 200mg mifepristone followed in 24 hours by repeated doses of 200mcg buccal misoprostol given every 3 hours;
2. STUDY GROUP TWO: placebo followed in 24 hours by 200mcg buccal misoprostol given every three hours.

Eligibility criteria: Inclusion Criteria:

* Demised fetus of between 14 to 28 weeks duration confirmed by ultrasound
* Have no contraindications to study procedure, according to provider
* Be able to consent to procedure, either by reading consent document or by having consent document read to her
* Be willing to follow study procedures.

Exclusion Criteria:

* Allergies or other contraindications to the use of mifepristone or misoprostol;
* Placental abruption with active hemorrhage,
* Complete placenta previa, extreme uterine structural anomalies, or other contradictions to vaginal delivery of the fetus;
* Presentation in active labor (moderate to severe contractions every 10 minutes or less);
* Transmural uterine scars;
* Four or more previous deliveries.

Primary outcomes:
measure: Complete uterine evacuation of the fetus and placenta without surgical intervention
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Hospital General "Enrique Cabrera"
city: Mexico City
country: Mexico
facility: National Institute of Perinatology (INPer)
city: Hanoi
country: Vietnam
facility: National Ob-Gyn Hospital
Study officials:
affiliation: Gynuity Health Projects
name: Hillary Bracken, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04351061: Acetazolamide for the Prevention of Post Operative CSF Leak
Official title: Pilot Study of Acetazolamide to Prevent Post Operative Cerebrospinal Fluid (CSF) Leak in Patients Undergoing Endoscopic Skull Base Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Cerebrospinal Fluid Leak
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 0
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 research is to test the use of Acetazolamide in preventing post-operative cerebrospinal fluid leak in patients having endoscopic skull base surgery (it is a surgery performed through the nose and sinus).


Eligibility criteria: Inclusion Criteria:

* Elective transsphenoidal resection of a tumor expected to result in an intraoperative high flow CSF leak; such tumors include craniopharyngioma, meningioma, and Rathke cleft cyst.
* Elective transsphenoidal resection of a pituitary adenoma, with BMI \>25, or with observed low or high flow CSF leak during surgery, conferring an elevated risk of postoperative CSF leak.
* Patients who voluntarily sign Informed Consent
* Male subjects and female subjects of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception during study treatment and for at least 1 month after stopping study treatment. Male subjects should refrain from donating semen during treatment and 1 month after stopping treatment.

Exclusion Criteria:

* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
* Patients with prior adverse reactions to acetazolamide or who are taking aspirin concomitantly (which may increase the risk of adverse reactions to acetazolamide)
* Patients with moderate to severe chronic obstructive pulmonary disease (which may increase the risk of adverse effects of acetazolamide)
* Acetazolamide therapy is contraindicated in situations in which sodium and/or potassium blood serum levels are depressed, in cases of marked kidney and liver disease or dysfunction, in suprarenal gland failure, and in hyperchloremic acidosis.
* It is contraindicated in patients with cirrhosis because of the risk of development of hepatic encephalopathy
* Sulfonamide allergy
* Pregnant females, breastfeeding females, and males and females of childbearing potential who are unwilling or unable to use a highly effective method of contraception

Primary outcomes:
measure: Incidence of CSF Leakage
timeFrame: 30 days
Secondary outcomes:
measure: Incidence of suspected drug events
timeFrame: 14 days
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Ronald Benveniste, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00635661: Assessment of the Stroke Rehabilitation Assessment of Movement as a Clinical Tool
Official title: A Comparison of the Stroke Rehabilitation Assessment of Movement, the Functional Independence Measure and the Stroke Impact Scale
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: function
disability
Lead sponsor: State University of New York - Upstate Medical University
Sponsor class: OTHER
Collaborators: name: NYU Langone Health
First posted: 2008-03-14
Enrollment: 34
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: Adults who have sustained an ischemic stroke

Brief summary: The Stroke Rehabilitation Assessment of Movement (STREAM) is a relatively new measurement tool, which measures specific movement deficits (impairments) caused by a stroke. The STREAM is used to evaluate recovery of voluntary movement and basic mobility following the onset of a stroke. Several important clinical measurement properties of the STREAM remain to be explored, including its ability to measure impairments and clinical change in acute rehabilitation patients in the USA. We hypothesize that the STREAM will be able to detect and quantify a statistically significant change in the motor abilities of stroke patients from admission to discharge. An additional aim of the study is to compare the STREAM with two accepted and widely used clinical measures of function and disability, the Stroke Impact Scale (SIS)and the Functional Independence Measure (FIM). By linking movement deficits that are commonly assessed by physical therapists with measures of function and disability, the impact of the movement deficits can be understood.


Eligibility criteria: Inclusion Criteria:

* comprehension of English
* age 18 and older
* first-time stroke
* receiving in-patient rehabilitation at the Rusk Institute of Rehabilitation Medicine, New York, NY

Exclusion Criteria:

* hemorrhagic stroke
* brain stem or cerebellar infarct
* other pre-existing neurologic conditions

Primary outcomes:
measure: Stroke Rehabilitation Assessment of Movement (STREAM)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Rusk Institute of Rehabilitation Medicine
state: New York
Study officials:
affiliation: NYU Medical Center, Rusk Institute
name: Irene Ward, DPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03342261: Benefit of DAA Therapy in HCV Monoinfected and HIV-HCV Coinfected Patients With Mixed Cryoglobulinemia
Official title: Benefit of Direct-acting Antiviral Therapy in Hepatitis C Virus (HCV) Monoinfected and HIV-HCV Coinfected Patients With Mixed Cryoglobulinemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
Mixed Cryoglobulinemia
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-11-14
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HCV patients with mixed cryoglobulinemia

Brief summary: Mixed cryoglobulinemia (MC) is common in patients with chronic hepatitis C virus (HCV) infection. Direct-acting antiviral (DAA) regimens are today very effective with sustained virological response rates (SVR12) above 90%. The objective of this study was to investigate the impact of DAA therapy on cryoglobulin clearance in patients with HCV-associated MC.

Detailed description: We focused on HCV patients with or without HIV with MC who had at least one cryoglobulin level assessment before and after DAA therapy and investigated the impact of DAA therapy on cryoglobulin clearance.

Eligibility criteria: Inclusion Criteria:

* hepatitis C virus (HCV) infected patients
* symptomatic or asymptomatic mixed cryoglobulinemia
* coinfected or not with HIV
* treated by direct-acting antiviral (DAA) treatment
* at least one cryoglobulin measurement before and after DAA

Exclusion Criteria:

-

Primary outcomes:
measure: Cryoglobulin level at the end of therapy
timeFrame: End of treatment (12 or 24 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon - Croix-Rousse Hospital
Study officials:
affiliation: Hospices Civils de Lyon
name: Fabien Zoulim, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00826761: ProSat - Effect of Probiotics on Satiety
Official title: Probiotics and Satiety - Acute Effects and Persistence of Acute Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Appetite Regulation
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Chr Hansen
First posted: 2009-01-22
Enrollment: 22
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The aim of the ProSat study is to examine the effects of a probiotic capsule containing one of two doses (low and high dose) of Lb. Casei on subjective appetite sensation, ad libitum energy intake, and appetite hormone response in a single meal test and to determine whether the acute effects persist after daily supplementation of the probiotic capsule.


Eligibility criteria: Inclusion Criteria:

* Healthy men and women
* Normal to slight overweight (BMI: 22-28 kg/m2)
* 20-45 years of age

Exclusion Criteria:

* Smoking
* Daily medicine use (oral contraceptives excluded)
* Use of pre- and probiotic supplements and foods
* Blood donation 3 months prior to the study
* Hb\<8mmol/l
* Chronic illnesses such as hyperlipidemia, diabetes inflammatory diseases
* Pregnancy or breastfeeding
* Elite athletes (\>10 hours hard exercise/week)
* Vegetarians

Primary outcomes:
measure: Glucose; Insulin; GLP-1; CCK; PYY; grehlin; PP; amylin; LPS; TNF-alfa; hsCRP; fibrinogen
timeFrame: 2013
Secondary outcomes:
measure: Subjective appetite measurements; Spontaneous food intake
timeFrame: 2012
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Department of Human Nutrition
Study officials:
References:
Clinical trial NCT04770961: Erector Spinae Plane Block for Minimally Invasive Mitral Valve Surgery
Official title: Erector Spinae Plane Block for Minimally Invasive Mitral Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mitral Regurgitation
Mitral Valve Insufficiency
Mitral Valve Prolapse
Keywords: mitral valve replacement
mitral valve repair
mitral valve surgery
erector spinae plane
minimally invasive surgery
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2021-02-25
Enrollment: 50
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 goal of this project is to study whether local anesthetic via the erector spinae plane (ESP) block may be beneficial in minimally invasive mitral valve surgery (MIMVS).

Detailed description: This is a double blinded randomized controlled trial comparing a control group receiving cryoablation and sham block with an intervention group receiving cryoablation and ESP catheter. The primary outcome is total oral morphine equivalent (OME) consumption within the first 48 hours of recovery including intra-operative usage. Secondary outcomes to be evaluated would include pain scores, functional milestones like time to extubation, time to first PO intake, time to ambulation, time to chest tube removal, length of ICU and total hospital stay, complications, and patient satisfaction.

Eligibility criteria: Inclusion Criteria:

* Elective mitral valve repair or replacement
* Planned minimally invasive approach

Exclusion Criteria:

* Non-English speaking
* Emergency surgery
* Planned or unplanned sternotomy
* Previous history of sternotomy and cardiac surgery
* Allergy to ropivacaine
* Patients taking more than 60 OMEs per day
* Patients with coagulopathy or taking anticoagulant with laboratory findings contraindicated for ESP catheter

Primary outcomes:
measure: Total opiate consumption
timeFrame: 48 hours.
Secondary outcomes:
measure: Pain score
timeFrame: 48 hours
measure: Time to extubation.
timeFrame: Within 30 days from end of operation.
measure: Time to first oral intake
timeFrame: Within 30 days from end of operation.
measure: Time to ambulation
timeFrame: Within 30 days from end of operation.
measure: Time to chest tube removal
timeFrame: Within 30 days from end of operation.
measure: Length of intensive care stay
timeFrame: Within 30 days from end of operation.
measure: Length of hospital stay
timeFrame: Within 30 days from end of operation.
measure: Patient self-reported experience with surgery and postoperative recovery
timeFrame: 30 days after hospital discharge.
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Wilson Cui, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03896061: A Videographic Study to Evaluate the Impact of a Pulsed Firing Technique on Staple Line Interventions in Laparoscopic Sleeve Gastrectomy
Official title: A Videographic Study to Evaluate the Impact of a Pulsed Firing Technique on Staple Line Interventions in Laparoscopic Sleeve Gastrectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemostasis
Lead sponsor: Ethicon, Inc.
Sponsor class: INDUSTRY
First posted: 2019-03-29
Enrollment: 62
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who satisfy inclusion/exclusion criteria for informed consent to participate in the study.

Brief summary: Prospective, multi-center study will evaluate a pulsing technique with the ECHELON FLEX GST system for hemostasis at the staple line in laparoscopic sleeve gastrectomy procedures.

Detailed description: Prospective, multi-center study will evaluate a pulsing technique with the ECHELON FLEX GST system for hemostasis at the staple line in laparoscopic sleeve gastrectomy procedures.

Data collected for the study consists of videography imaging and audio. Video recordings (no subject identifiers) will involve the use of two cameras providing:

1. Synchronized Internal and external views of devices used, including the hands of the surgeon firing the endocutter; and
2. Audio of the procedure to record the motor noise of the device while firing (audio will help identify the surgeon's pulsing technique during the procedure).

Surgeon satisfaction with transection technique will also be collected. Videography will be evaluated for staple line hemostasis and need for surgical intervention at the staple line (defined in Criteria for Evaluation).

Eligibility criteria: Inclusion Criteria:

* Willingness to sign a Video, Audio and Digital Data Release consent for participation; and
* Scheduled for a laparoscopic sleeve gastrectomy procedure.

Exclusion Criteria:

* Prophylactic use of buttressing material
* Other staple line reinforcement

Primary outcomes:
measure: Occurrence of oozing/bleeding at the staple line
timeFrame: Intraoperative
measure: Occurence of sugical interventions required to achieve hemostasis at the staple line
timeFrame: Intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Metairie
country: United States
facility: Surgical Specialists of Louisiana
state: Louisiana
city: Buffalo
country: United States
facility: State University of New York at Buffalo
state: New York
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References: