louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00005339: Risk of Post Transfusion Hepatitis C Virus Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis, Viral, Human
Blood Transfusion
Blood Donors
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To determine the risk of transfusion-transmitted hepatitis C virus (HCV) in cardiac surgery patients before and after donor screening for anti-HCV and surrogate markers of non-A, non-B hepatitis (NANBH). Also, to characterize donors who were HCV seronegative and who lacked surrogate markers at the time of donation, but whose recipient seroconverted to HCV.

Detailed description: BACKGROUND:

In the early 1990s, posttransfusion NANBH, mainly caused by HCV, was the most common serious complication of transfusions, occurring in 2-5 percent of transfusion recipients. About 50 percent of those infected developed chronic hepatitis, of whom, 10 to 20 percent developed cirrhosis. Hepatocellular carcinoma had been reported to occur in some. This study provided the first evaluation of the effectiveness of donor screening for anti-HCV by the then recently licensed HCV antibody test and surrogate markers of NANBH. It also provided a precise estimate of the risk of transfusion-transmitted HCV. The results allowed examination of risk factors for HCV infected donors who were seronegative at the time of donation.

DESIGN NARRATIVE:

The study was a nonconcurrent prospective, seroepidemiologic study. To estimate the incidence of HCV infection, six-month postoperative serum samples were tested for antibody to HCV. Preoperative samples corresponding to positive postoperative sera were also tested. The donors of a patient who received blood screened for HCV, i.e., a donation since May, 1990, and seroconverted in the six months since transfusion were located and retested for antibodies to HCV. The donors were administered a questionnaire designed to ascertain risk factors for HCV infection. A sample of donors who were HCV positive at the time of donation were given the same questionnaire. Comparison of these three groups of donors (i.e., seropositives, donors tested negative but implicated in seroconversion, seronegatives) allowed an investigation of factors associated with false negative screening results. Analytical methods included standard methods for contingency tables and both conditional and unconditional logistic regression.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Donahue JG, Munoz A, Ness PM, Brown DE Jr, Yawn DH, McAllister HA Jr, Reitz BA, Nelson KE. The declining risk of post-transfusion hepatitis C virus infection. N Engl J Med. 1992 Aug 6;327(6):369-73. doi: 10.1056/NEJM199208063270601.
Clinical trial NCT02262039: Reducing Operative and Post-operative Morbidity in Living Kidney Donors With the Airseal System
Official title: Reducing Operative and Post-operative Morbidity in Living Kidney Donors With the Airseal System: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: living
kidney
donors
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: SurgiQuest, Inc.
First posted: 2014-10-10
Enrollment: 41
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if the Airseal System will reduce post-operative pain and reduce the need for narcotics in laparoscopic living kidney donor surgeries.

Detailed description: Our hypothesis is that Airseal Insufflation System will provide reduced mean operative insufflation pressure and operative mean ETCO2, resulting in improved post-operative pain control and improved operative safety.

The Airseal System has demonstrated decreased variability in intra-abdominal pressure, less post-operative shoulder pain, lower mean ETCO2 and reduced narcotic pain administration. These metrics have been demonstrated in human subjects undergoing gynecologic, urologic and bariatric procedures. The established benefits in a human model provide a foundation for translating this technology to living kidney donors. The advantage lies in the ability to improve pain-related outcomes in this population, which translates into increased living donation; the single solution to reduce mortality for patients suffering from end-stage kidney disease.

Eligibility criteria: Inclusion Criteria:

* Any living donor who has been approved to donate a kidney is eligible to participate.

Exclusion Criteria:

* none

Primary outcomes:
measure: Narcotic Use (mg)
timeFrame: Intra-Operative on day of surgery
measure: Narcotic Use (mg)
timeFrame: Post-operative (until time of discharge, typically 2-4 days)
measure: Narcotic Use (mg)
timeFrame: Operative and Post-operative (until time of discharge, typically 2-4 days)
Secondary outcomes:
measure: Subjective Pain Score
timeFrame: 1 hour post-op
measure: Subjective Pain Score
timeFrame: 6 hours post-op
measure: Subjective Pain Score
timeFrame: 12 hours post-op
measure: Mean ETCO2
timeFrame: intraoperative
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Transplantation Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Sanjay Kulkarni, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06364839: Liver Transplantation for Hepatocellular Carcinoma Arising in Non-cirrhotic Liver: a Propensity Score-matched Retrospective Cohort Study of Two National Databases
Official title: Liver Transplantation for Hepatocellular Carcinoma Arising in Non-cirrhotic Liver: a Propensity Score-matched Retrospective Cohort Study of Two National Databases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma, Non-cirrhotic Liver
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2024-04-15
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Previously registered liver transplant recipients

Brief summary: Background: Majority of liver transplantation (LT) recipients for hepatocellular carcinoma (HCC) were concomitant with liver cirrhosis, while few researches focusing on recipients without cirrhosis. Here we aim to investigate the prognosis of non-cirrhosis HCC recipients, expecting to provide theoretical basis for further improvement of these patients.

Methods: This retrospective study analyze outcomes between adult HCC recipients arising in non-cirrhotic and cirrhotic liver from two national databases (CLTR and UNOS, January 2015 to December 2020). Based on important variables, 1:2 and 1:1 propensity score matching (PSM) were performed respectively.


Eligibility criteria: Inclusion Criteria:

* liver transplants, performed from January 2015 to December 2020

Exclusion Criteria:

* pediatric LT; LT for non-tumor lesions; LT for other malignant tumors (cholangiocarcinoma, carcinoma of gallbladder, mixed carcinoma, and secondary tumors); re-transplantation or combined liver-kidney transplantation; incomplete laboratory or clinical data; death within 1 week due to post-operative hemorrhage after LT.

Primary outcomes:
measure: Postoperative complications were evaluated by postoperative imaging and serological examination
timeFrame: 3 months
measure: The overall survival rate was evaluated by follow-up investigation and outpatient review
timeFrame: 1-3 years
measure: The tumor-free survival rate was evaluated by follow-up investigation and outpatient review
timeFrame: 1-3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Xiao Xu
state: Zhejiang
Study officials:
References:
Clinical trial NCT02367339: Assessment of the Prevalence of Extended-Spectrum Betalactamase Producing Enterobacteriaceae Among ICU Staff
Official title: Assessment of the Prevalence of Extended-Spectrum Betalactamase Producing Enterobacteriaceae Among ICU Staff
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Antibiotic Resistance
Extended-spectrum Betalactamase
Enterobacteriaceae
Escherichia Coli
Keywords: Critical Care
Nursing staff
Medical staff
Extended-spectrum betalactamase
Digestive tract colonization
Cross-contamination
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: University Hospital, Estaing
name: Hopital Gabriel Montpied
First posted: 2015-02-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ICU staff

Brief summary: Evaluation of the prevalence of ESBL-Enterobacteriaceae colonization among ICU staff

Detailed description: Prospective epidemiological study with voluntary non-medical staff member (i.e. nurses and nursing assistants) and medical staff in two French ICUs.

Assessment of self-reported risk factors for MDR-bacteria colonization. Self-performed rectal swab with isolation of ESBL-producting Enterobacteriaceae, identification of bacterial species and antibiotic suspectibilities.

Characterization of Escherichia coli ESBL.

Eligibility criteria: Inclusion Criteria:

* volunteers

Exclusion Criteria:

-

Primary outcomes:
measure: Digestive tract colonization by ESBL
timeFrame: at day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Julien PASCAL
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02095639: Inflammation and Electroconvulsive Therapy
Official title: Does Electroconvulsive Therapy Cause Neuroinflammation? An [18F]FEPPA Positron Emission Tomography Study in Treatment Resistant Depression
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Major Depressive Disorder
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2014-03-26
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community and tertiary care clinic

Brief summary: The purpose of this study is to explore whether electroconvulsive therapy (ECT) accidentally leads to a side effect of brain inflammation. Patients with treatment resistant depression who are planning to take ECT will be subsequently approached to participate in the study.

Detailed description: The first scan will take place before the first ECT session. The second scan will occur after a minimum of six ECT sessions (average 2.5 weeks). Secondary measures will include mood symptom severity, neurocognitive measures, peripheral inflammatory markers and TSPO genotype.

The hypothesis is that neuroinflammation will be increased by ECT.

There will be no alterations to standard care of depressed patients due to participation in the study.

Eligibility criteria: Inclusion Criteria:

* stable physical health
* diagnosis of non-psychotic, non-catatonic, major depressive disorder, either unipolar or bipolar and a non-response to at least three clinical trials at appropriate dose of antidepressant medication from at least three different pharmacological classes
* at least a 17 on the17-item HDRS despite taking antidepressant treatment prior to ECT
* have not received ECT within the last 12 weeks

Exclusion Criteria:

* currently pregnant
* current substance abuse or dependence
* neurological or unstable medical illness
* use of anti-inflammatory drugs within the past month
* diazepam or other benzodiazepine use within the past month, except for lorazepam and clonazepam

Primary outcomes:
measure: Change in translocator protein distribution volume (TSPO Vt) measured by [18F]FEPPA PET
timeFrame: Baseline scan and a second PET scan after an expected average time of 2.5 weeks of ECT treatment
Secondary outcomes:
measure: 17-item Hamilton Depression Rating Scale (HDRS)
timeFrame: Baseline and after average 2.5 weeks of ECT treatment
measure: Neurocognitive Battery
timeFrame: Baseline and after average 2.5 to 5 weeks of ECT treatment
measure: Peripheral Inflammatory Markers
timeFrame: Baseline and after average 2.5 to 5 weeks of ECT treatment
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Research Imaging Centre, Centre for Addiction and Mental Health
name: Jeffrey H Meyer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01615939: A Study Comparing Continuous Sciatic Nerve Block to Single Shot Sciatic Nerve Block
Official title: A Randomized Controlled Trial Comparing Continuous Sciatic Nerve Block to Single Shot Sciatic Nerve Block
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Fracture of Foot
Keywords: Sciatic Nerve Block
Continuous Nerve Block
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2012-06-11
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to compare the incidence of postoperative symptoms of neurologic injury after a single shot infragluteal-parabiceps sciatic nerve block versus a continuous infragluteal-parabiceps sciatic nerve catheter.

Detailed description: There are a limited number of prospective studies in the literature examining the risk of neurologic injury and symptoms after sciatic nerve blocks. The incidence of transient neurological symptoms after a continuous catheter is not well reported.

Eligibility criteria: Inclusion Criteria:

* all patients ( ≥18 and ≤ 80) who are scheduled to undergo elective scheduled foot surgery and agreed to receive a sciatic nerve catheter as a part of their postoperative pain management. this study.

Exclusion Criteria:

* history of hemostatic abnormalities
* chronic pain syndrome
* a foot deformity restricting normal foot movement
* severe liver or renal disease
* a preexisting neurologic disorder
* patient refusal to participate
* the presence of language barrier that prohibits proper communication with patient.

Primary outcomes:
measure: Temporary Neurologic Symptoms Between Groups
timeFrame: 1 month
Secondary outcomes:
measure: Participant Satisfaction With Anesthesia
timeFrame: 24 hours
measure: Pain Control
timeFrame: 72 hrs
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
Study officials:
affiliation: Northwestern University Feinberg School of Medicine
name: Antoun Nader, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06557239: Salivary Oxytocin as a Biomarker in Psychedelic Assisted Psychotherapy
Official title: Salivary Oxytocin as a Biomarker in Psychedelic Assisted Psychotherapy for Anxiety and Depression: a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression, Anxiety
Lead sponsor: University of Geneva, Switzerland
Sponsor class: OTHER
First posted: 2024-08-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be selected from consecutive patients in the Addiction Department who have received approval from the Federal office of Public healthfor compassionate treatment with LSD as part of Psychedelic assisted psychotherapy for refractory anxiety disorder or depression. ol. Main criteria: Inclusion:

Brief summary: The main objective of this pilot study is to obtain preliminary data on the reactivity of salivary oxytocin during a single LSD intake as part of PAP treatment for anxiety disorders or depression (treatment authorisations granted in advance by the Federal Officie of Public Health for compassionate use of the substance).

There will be no interference with the usual clinical routine in our Service. The protocol is only for taking additional saliva measurements to measure oxytocin levels on the day of treatment.

Participants will be asked to give 4 saliva samples the day of their LSD treatment .In addition they will fill-in self-report questionnaires which are part of the clinical routine


Eligibility criteria: Inclusion Criteria:

* ongoing psychotherapy with a certified psychotherapist, anxiety disorder or depression resistant to usual treatments, agreement to stop necessary medication

Exclusion Criteria:

* Exclusion: psychotic or bipolar disorder, high suicidal risk, severe cardiovascular disease, severe liver disease, neurological disease of the central nervous system, pregnancy and breastfeeding

Primary outcomes:
measure: Salivary oxytocin
timeFrame: the day of treatment administration (one day)
Secondary outcomes:
measure: Self-reported symptoms of anxiety (STAI-T)
timeFrame: over 6 months
measure: Self-reported depressive symptoms (BDI-II)
timeFrame: over 6 months
measure: Self-reported intensity of mystical experience
timeFrame: The 1 day of treatment administration
measure: Self-reported intensity of Connectedness
timeFrame: The 1 day of treatment administration
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospitals
Study officials:
References:
Clinical trial NCT01138839: Dexamethasone Efficacy in HELLP I Syndrome
Official title: Dexamethasone Efficacy in HELLP I Syndrome, a Multicentric, Double-blind, Placebo-controlled, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: HELLP Syndrome
Keywords: HELLP 1
Dexamethasone
Clinical trial
Lead sponsor: Universidad del Valle, Colombia
Sponsor class: OTHER
First posted: 2010-06-07
Enrollment: 160
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 48
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy of dexamethasone for treatment of HELLP I (hemolysis, elevated liver enzymes and low platelet count) syndrome.

Detailed description: Treatment of HELLP syndrome usually is restricted to measures of support and treatment of complications. In 2005, in a subgroup analysis we showed that, among patients with HELLP 1, there were a shorter average time to platelet recovery and less duration of hospitalization in women who received dexamethasone therapy, however the importance of this finding is diminished because this was an unplanned analysis and the severity of the disease was not taken into account at randomization.

Eligibility criteria: Inclusion Criteria:

* Women who were at \>20 weeks of gestation or during the first 3 days of puerperium if hypertension developed during the pregnancy or the puerperium with:
* platelet count, \< or = 50,000/mm3; aspartate aminotransferase (AST), \> or = 70 U/L; lactate dehydrogenase (LDH), \> or = 600 U/L.
* Women who consent to be included informed consent by signature

Exclusion Criteria:

* diabetic ketoacidosis
* oral temperature \> 37.5 grade
* Contraindication for use steroids

Primary outcomes:
measure: Duration of hospitalization
timeFrame: Average: 15 days
Secondary outcomes:
measure: Recovery time of platelets to more than 100000/mm3
timeFrame: Average:7 days
measure: Recovery of AST, ALT and LDH
timeFrame: Average: 10 days
measure: Transfusion of blood products
timeFrame: Average: 7 days
Other outcomes:
Locations:
city: Cali
country: Colombia
facility: Universidad del Valle
state: Valle
Study officials:
affiliation: Universidad del Valle
name: Javier Fonseca, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00958139: Passive Prophylaxis of Lyme Disease Using Permethrin Treated Clothes
Official title: Passive Prophylaxis of Lyme Disease Using Permethrin Treated Clothes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Lyme Disease
Keywords: Lyme disease
tick
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2009-08-13
Enrollment: 61
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Hypothesis: Does treatment of lower extremity clothing with permethrin prevent Lyme disease?

This is a double-blind, randomized clinical trial using permethrin treatment of clothing to prevent Lyme disease.

Detailed description: This is a double-blind, randomized clinical trial using permethrin treatment of clothing to prevent Lyme disease.

Subjects (N=200) will be recruited from camp staff to participate in the study and screened by inclusion and exclusion criteria.Qualifying subjects will be randomized to either the treatment (N=100) or non-treatment arm (N=100).

Subjects in the treatment arm will have their scout shorts, pants, and socks sprayed with 0.5% permethrin and allowed to dry. Subjects in the non-treatment arm will have their scout shorts, pants, and socks sprayed with water and allowed to dry.

Subjects will then be followed over the summer camping season to see if they develop Lyme disease. At 70 days, all subjects will have their Lyme titers rechecked to ensure that all cases of Lyme disease were documented.

Following the 70 day visit, there will be an assessment of the final study outcomes.

Eligibility criteria: Inclusion Criteria:

* Summer camp staff at Tomahawk Scout Reservation
* Works in an outdoor environment
* Sleeps in an outdoor environment (platform tent)
* Present for the entire camp season (June - August)
* Informed consent

Exclusion Criteria:

* Contraindication, allergy or previous reaction to permethrin
* Inability of subject or surrogate (e.g., parent if \< 18 years of age) to provide informed consent

Primary outcomes:
measure: Incidence of Lyme disease
timeFrame: Day <=70
Secondary outcomes:
Other outcomes:
Locations:
city: Rice Lake
country: United States
facility: Tomahawk Scout Camp
state: Wisconsin
Study officials:
affiliation: University of Minnesota
name: David R. Boulware, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: